Nuclear Regulatory Commission staff approaches to improving the integration of regulatory guidance documents and prelicensing reviews

International Nuclear Information System (INIS)

Johnson, R.L.

1994-01-01

The Nuclear Regulatory Commission staff is conducting numerous activities to improve the integration of its regulatory guidance documents (i.e., License Application Review Plan (LARP) and open-quotes Format and Content for the License Application for the High-Level Waste repositoryclose quotes (FCRG)) and pre-license application (LA) reviews. Those activities related to the regulatory guidance documents consist of: (1) developing an hierarchy of example evaluation findings for LARP; (2) identifying LARP review plan interfaces; (3) conducting an integration review of LARP review strategies; (4) correlating LARP to the ongoing technical program; and (5) revising the FCRG. Some of the more important strategies the staff is using to improve the integration of pre-LA reviews with the LA review include: (1) use of the draft LARP to guide the staff's pre-LA reviews; (2) focus detailed pre-LA reviews on key technical uncertainties; (3) identify and track concerns with DOE's program; and (4) use results of pre-LA reviews in LA reviews. The purpose of this paper is to describe these ongoing activities and strategies and discuss some of the new work that is planned to be included in LARP Revision 1 and the final FCRG, which are scheduled to be issued in late 1994. These activities reflect both the importance the staff has placed on integration and the staff's approach to improving integration in these areas. The staff anticipates that the results of these activities, when incorporated in the FCRG, LARP, and pre-LA reviews, will improve its guidance for DOE's ongoing site characterization program and LA annotated outline development

Codes and standards and other guidance cited in regulatory documents

International Nuclear Information System (INIS)

Nickolaus, J.R.; Bohlander, K.L.

1996-08-01

As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800)

Codes and standards and other guidance cited in regulatory documents

Energy Technology Data Exchange (ETDEWEB)

Nickolaus, J.R.; Bohlander, K.L.

1996-08-01

As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

Development of regulatory guidance for risk-informing digital system reviews

International Nuclear Information System (INIS)

Arndt, S. A.

2006-01-01

In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

Regulatory relevant and reliable methods and data for determining the environmental fate of manufactured nanomaterials

DEFF Research Database (Denmark)

Baun, Anders; Sayre, Phil; Steinhäuser, Klaus Günter

2017-01-01

The widespread use of manufactured nanomaterials (MN) increases the need for describing and predicting their environmental fate and behaviour. A number of recent reviews have addressed the scientific challenges in disclosing the governing processes for the environmental fate and behaviour of MNs,...... data. Gaps do however exist in test methods for environmental fate, such as methods to estimate heteroagglomeration and the tendency for MNs to transform in the environment.......The widespread use of manufactured nanomaterials (MN) increases the need for describing and predicting their environmental fate and behaviour. A number of recent reviews have addressed the scientific challenges in disclosing the governing processes for the environmental fate and behaviour of MNs......, however there has been less focus on the regulatory adequacy of the data available for MN. The aim of this paper is therefore to review data, testing protocols and guidance papers which describe the environmental fate and behaviour of MN with a focus on their regulatory reliability and relevance. Given...

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issuance of the guidance in 1997

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the U.S. Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issue of the guidance in 1997. (Author)

Improving nuclear regulation. Compilation of Nea regulatory guidance booklets

International Nuclear Information System (INIS)

2009-01-01

A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are operated at all times and later decommissioned in an acceptably safe manner. In meeting this objective the regulator must keep in mind that it is the operator that has responsibility for safely operating a nuclear facility; the role of the regulator is to oversee the operator's activities as related to assuming that responsibility. For the first time, the full series of these reports have been brought together in one edition. As such, it is intended to serve as a knowledge management tool both for current regulators and the younger generation of nuclear experts entering the regulatory field. While the audience for this publication is primarily nuclear regulators, the information and ideas may also be of interest to nuclear operators, other nuclear industry organisations and the general public. (author)

78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

Science.gov (United States)

2013-11-13

... New Reactors and Specific Environmental Guidance for Integral Pressurized Water Reactors Reviews... Environmental Issues Associated with New Reactors'' and draft ISG ESP/ COL-ISG-027, ``Interim Staff Guidance on...://www.regulations.gov and search for Docket ID NRC-2013-0212 for ESP/COL- ISG-026 or NRC-2013-0211 for...

Codes and standards and other guidance cited in regulatory documents. Revision 1

International Nuclear Information System (INIS)

Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R.

1994-08-01

As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800)

Codes and standards and other guidance cited in regulatory documents. Revision 1

Energy Technology Data Exchange (ETDEWEB)

Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R. [Pacific Northwest Lab., Richland, WA (United States)

1994-08-01

As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).

Environmental sciences division: Environmental regulatory update table July 1988

International Nuclear Information System (INIS)

Langston, M.E.; Nikbakht, A.; Salk, M.S.

1988-08-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Applicability of federal and state environmental requirements to selected DOE field installations and recommendations for development of generic compliance guidance. Final report

International Nuclear Information System (INIS)

1982-01-01

This final report identifies and describes federal and state environmental requirements applicable to selected Department of Energy (DOE) nuclear field installations, establishes priorities for the requirements, determines the need for development of additional compliance guidance, and recommends development of compliance guidance for specific priority requirements. Compliance guidance developed as part of the study is summarized. The applicability of environmental requirements to 12 DOE field installations was reviewed. Five installations were examined under Task 4. They are: Nevada Test Site; Lawrence Berkeley Laboratory; Paducah Gaseous Diffusion Plant; Oak Ridge Y-12 Plant; and Los Alamos Scientific Laboratory. Seven other installations were reviewed under Task 2 and included: Idaho National Engineering Laboratory; Hanford; Savannah River Plant; Oak Ridge Gaseous Diffusion Plant; Pantex Plant; Rocky Flats Plant; and Lawrence Livermore Laboratory. This report combines results of the two tasks. The objective of the study was to identify the set of environmental requirements which are applicable to DOE field installations, track changes in the requirements, and prepare compliance guidance for important requirements and important regulatory developments as necessary. A cumulative calendar update for July 1982 represents the current status of applicable requirements. Environmental profiles of each facility, along with ambient monitoring results, are presented. Applicable federal requirements are identified. The specific applicability of federal and state requirements is detailed for each installation. Compliance guidance available from various agencies is described. Each requirement described is ranked by priority, and recommendations are made for development of additional guidance

Environmental Regulatory Update Table, December 1989

International Nuclear Information System (INIS)

Houlbert, L.M.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

1990-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental regulatory update table, March 1989

International Nuclear Information System (INIS)

Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

1989-04-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental Regulatory Update Table, April 1989

International Nuclear Information System (INIS)

Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

1989-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental Regulatory Update Table, December 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, August 1990

International Nuclear Information System (INIS)

Houlberg, L.M.; Nikbakht, A.; Salk, M.S.

1990-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental Regulatory Update Table, October 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-12-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-10-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Improving nuclear regulation. NEA regulatory guidance booklets volumes 1-14

International Nuclear Information System (INIS)

2011-01-01

A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are continuously maintained and operated in an acceptably safe manner. In meeting this objective the regulator must bear in mind that it is the operator that has responsibility for safely operating the nuclear facility; the role of the regulator is to assess and to provide assurance regarding the operator's activities in terms of assuming that responsibility. The full series of these reports was brought together in one edition for the first time in 2009 and was widely found to be a useful resource. This second edition comprises 14 volumes, including the latest on The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services. The reports address various challenges that could apply throughout the lifetime of a nuclear facility, including design, siting, manufacturing, construction, commissioning, operation, maintenance and decommissioning. The compilation is intended to serve as a knowledge management tool both for current regulators and the new nuclear professionals and organisations entering the regulatory field. Contents: Executive Summary; Regulatory Challenges: 1. The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture; 2. Regulatory Response Strategies for Safety Culture Problems; 3. Nuclear Regulatory Challenges Related to Human Performance; 4. Regulatory Challenges in Using Nuclear Operating Experience; 5. Nuclear Regulatory Review of Licensee Self-assessment (LSA); 6. Nuclear Regulatory Challenges Arising from Competition in Electricity Markets; 7. The Nuclear Regulatory Challenge of Judging Safety Back-fits; 8. The Regulatory Challenges of Decommissioning Nuclear Reactors; 9. The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services

Environmental Regulatory Update Table, August 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M., Hawkins, G.T.; Salk, M.S.

1991-09-01

This Environmental Regulatory Update Table (August 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-08-01

This Environmental Regulatory Update Table (July 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

Science.gov (United States)

Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

2012-07-01

Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

Environmental Regulatory Update Table, January/February 1995

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

1995-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January/February 1995

International Nuclear Information System (INIS)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

1995-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental Regulatory Update Table, January--February 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1994-01-01

The Environmental Regulatory Update Table provides information on regulatory of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table November--December 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

1995-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, May--June 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

1994-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, May/June 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, March--April 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E. [Oak Ridge National Lab., TN (United States). Health Sciences Research Div.; Salk, M.S. [Oak Ridge National Lab., TN (United States). Environmental Sciences Div.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table July/August 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, March/April 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1993-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly wit information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, July--August 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September/October 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operation and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January--February 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations ad contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, September--October 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July/August 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

1994-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, March/April 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July/August 1994

International Nuclear Information System (INIS)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

1994-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental Regulatory Update Table, January/February 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action. This table is for January/February 1992.

Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

International Nuclear Information System (INIS)

1984-02-01

This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed

Global guidance on environmental life cycle impact assessment indicators: Progress and case study

DEFF Research Database (Denmark)

Frischknecht, Rolf; Fantke, Peter; Tschümperlin, Laura

2016-01-01

Purpose The life cycle impact assessment (LCIA) guidance flagship project of the United Nations Environment Programme (UNEP)/Society of Environmental Toxicology and Chemistry (SETAC) Life Cycle Initiative aims at providing global guidance and building scientific consensus on environmental LCIA in...

Identification of technical guidance related to ground water monitoring

Energy Technology Data Exchange (ETDEWEB)

Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.

1987-05-01

Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act.

Identification of technical guidance related to ground water monitoring

International Nuclear Information System (INIS)

Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.

1987-05-01

Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act

Guidance on the environmental risk assessment of plant pests

DEFF Research Database (Denmark)

Baker, R.; Candresse, T.; Dormannsne Simon, E.

2011-01-01

The European Food Safety Authority (EFSA) requested the Panel on Plant Health to develop a methodology for assessing the environmental risks posed by harmful organisms that may enter, establish and spread in the European Union. To do so, the Panel first reviewed the methods for assessing...... the environmental risks of plant pests that have previously been used in pest risk assessment. The limitations identified by the review led the Panel to define the new methodology for environmental risk assessment which is described in this guidance document. The guidance is primarily addressed to the EFSA PLH...... (biodiversity) and the functional (ecosystem services) aspects of the environment, this new approach includes methods for assessing both aspects for the first time in a pest risk assessment scheme. A list of questions has been developed for the assessor to evaluate the consequences for structural biodiversity...

Analytical laboratory quality assurance guidance in support of EM environmental sampling and analysis activities

International Nuclear Information System (INIS)

1994-05-01

This document introduces QA guidance pertaining to design and implementation of laboratory procedures and processes for collecting DOE Environmental Restoration and Waste Management (EM) ESAA (environmental sampling and analysis activities) data. It addresses several goals: identifying key laboratory issues and program elements to EM HQ and field office managers; providing non-prescriptive guidance; and introducing environmental data collection program elements for EM-263 assessment documents and programs. The guidance describes the implementation of laboratory QA elements within a functional QA program (development of the QA program and data quality objectives are not covered here)

Comparing Distributions of Environmental Outcomes for Regulatory Environmental Justice Analysis

Directory of Open Access Journals (Sweden)

Glenn Sheriff

2011-05-01

Full Text Available Economists have long been interested in measuring distributional impacts of policy interventions. As environmental justice (EJ emerged as an ethical issue in the 1970s, the academic literature has provided statistical analyses of the incidence and causes of various environmental outcomes as they relate to race, income, and other demographic variables. In the context of regulatory impacts, however, there is a lack of consensus regarding what information is relevant for EJ analysis, and how best to present it. This paper helps frame the discussion by suggesting a set of questions fundamental to regulatory EJ analysis, reviewing past approaches to quantifying distributional equity, and discussing the potential for adapting existing tools to the regulatory context.

Regulatory impact analysis of the proposed great lakes water quality guidance. Final report

International Nuclear Information System (INIS)

Raucher, R.; Dixon, A.; Trabka, E.

1993-01-01

The Regulatory Impact Analysis provides direction to the Great Lakes States and Tribes on minimum water quality standards and contains numerical water quality criteria for 32 pollutants as well as methodologies for the development of water quality criteria for additional pollutants discharged to these waters. It also provides guidance to the Great Lakes States and Tribes on antidegradation policies and standards and implementation procedures

Development of an environmental safety case guidance manual

International Nuclear Information System (INIS)

Wellstead, Matthew John

2014-01-01

NDA RWMD is currently considering the scope, purpose and structure of a safety case manual that covers the development of nuclear operational, transport and environmental safety cases for a geological disposal facility in the United Kingdom. This paper considers the Environmental Safety Case (ESC) input into such a manual (herein referred to as the 'ESC Manual'), looking at the drivers and benefits that a guidance manual in this area may provide. (authors)

BIOSENSORS FOR ENVIRONMENTAL MONITORING: A REGULATORY PERSPECTIVE

Science.gov (United States)

Biosensors show the potential to complement laboratory-based analytical methods for environmental applications. Although biosensors for potential environmental-monitoring applications have been reported for a wide range of environmental pollutants, from a regulatory perspective, ...

Using Inequality Measures to Incorporate Environmental Justice into Regulatory Analyses

Science.gov (United States)

Harper, Sam; Ruder, Eric; Roman, Henry A.; Geggel, Amelia; Nweke, Onyemaechi; Payne-Sturges, Devon; Levy, Jonathan I.

2013-01-01

Formally evaluating how specific policy measures influence environmental justice is challenging, especially in the context of regulatory analyses in which quantitative comparisons are the norm. However, there is a large literature on developing and applying quantitative measures of health inequality in other settings, and these measures may be applicable to environmental regulatory analyses. In this paper, we provide information to assist policy decision makers in determining the viability of using measures of health inequality in the context of environmental regulatory analyses. We conclude that quantification of the distribution of inequalities in health outcomes across social groups of concern, considering both within-group and between-group comparisons, would be consistent with both the structure of regulatory analysis and the core definition of environmental justice. Appropriate application of inequality indicators requires thorough characterization of the baseline distribution of exposures and risks, leveraging data generally available within regulatory analyses. Multiple inequality indicators may be applicable to regulatory analyses, and the choice among indicators should be based on explicit value judgments regarding the dimensions of environmental justice of greatest interest. PMID:23999551

Environmental Regulatory Update Table, March/April 1993. Revision 1

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). As these requirements were adopted into regulations in the United States, it was recognised that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination (D and D) objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997. (Author)

Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity material and Surface Contaminated Objects. As these requirements were adopted into regulations in the US, it was recognized that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997

Framework of the NPP I and C Security for Regulatory Guidance

International Nuclear Information System (INIS)

Kim, Young Mi; Jeong, Choong Heui

2013-01-01

I and C (Instrumentation and control) systems which have computers are a critical part of the safety and security at nuclear facilities. As the use of computers in I and C continue to grow, so does the target for cyber-attack. They include desktop computers, mainframe systems, servers, network devices, embedded systems and programmable logic controllers (PLSs) and other digital computer systems. As the Stuxnet malware shows, I and C systems of the NPPs are no longer safe from the threat of cyber-attacks. These digital I and C systems must be protected from the cyber-attacks. This paper presents framework of the NPP I and C security for regulatory guidance. KINS regulatory guideline 8.22 has been applied to new and operation nuclear power plants. This guideline refers the applicable scope of the cyber security activities, cyber security policies and security plans, and assessments of cyber security and execution of the cyber security activities. Newly developed guideline will be helpful for implement security control to ensure safe operation of NPP I and C systems

Framework of the NPP I and C Security for Regulatory Guidance

Energy Technology Data Exchange (ETDEWEB)

Kim, Young Mi; Jeong, Choong Heui [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2013-10-15

I and C (Instrumentation and control) systems which have computers are a critical part of the safety and security at nuclear facilities. As the use of computers in I and C continue to grow, so does the target for cyber-attack. They include desktop computers, mainframe systems, servers, network devices, embedded systems and programmable logic controllers (PLSs) and other digital computer systems. As the Stuxnet malware shows, I and C systems of the NPPs are no longer safe from the threat of cyber-attacks. These digital I and C systems must be protected from the cyber-attacks. This paper presents framework of the NPP I and C security for regulatory guidance. KINS regulatory guideline 8.22 has been applied to new and operation nuclear power plants. This guideline refers the applicable scope of the cyber security activities, cyber security policies and security plans, and assessments of cyber security and execution of the cyber security activities. Newly developed guideline will be helpful for implement security control to ensure safe operation of NPP I and C systems.

77 FR 46640 - Hours of Service of Drivers of Commercial Motor Vehicles; Regulatory Guidance for Oil Field...

Science.gov (United States)

2012-08-06

... Embassy Suites Hotel, 550 Cherrington Parkway, Coraopolis, PA 15108. The Agency will provide details on... submitted on behalf of an association, business, labor union, etc.). You may review the DOT's complete... comments online. FOR FURTHER INFORMATION CONTACT: For the regulatory guidance issued on June 5, 2012...

Sampling quality assurance guidance in support of EM environmental sampling and analysis activities

International Nuclear Information System (INIS)

1994-05-01

This document introduces quality assurance guidance pertaining to the design and implementation of sampling procedures and processes for collecting environmental data for DOE's Office of EM (Environmental Restoration and Waste Management)

78 FR 41852 - Hours of Service for Commercial Motor Vehicle Drivers; Regulatory Guidance Concerning Off-Duty Time

Science.gov (United States)

2013-07-12

... provided: 1. The driver is relieved of all duty and responsibility for the care and custody of the vehicle... Service for Commercial Motor Vehicle Drivers; Regulatory Guidance Concerning Off-Duty Time AGENCY: Federal... motor vehicle (CMV) driver to record meal and other routine stops made during a work shift as off-duty...

Environmental regulatory reform in Poland: lessons for industrializing economies

Energy Technology Data Exchange (ETDEWEB)

Brown, H.S.; Angel, D. [Clark University, Worcester, MA (USA). George Perkins Marsh Institute

2000-09-01

This paper examines the environmental regulatory reform in Poland during the 1990s and uses the findings to consider the extent to which elements of successful regulatory systems are transferable across national boundaries. Drawing on five case studies of privatized firms, a mailed questionnaire, and policy and institutional analysis, it investigates how Poland developed an effective system for managing industrial pollution while also achieving considerable socioeconomic progress. The fundamental legitimacy of the regulators and regulatory process, the availability of information about firms and regulatory intents, and the capacity for case-specific decision-making are among the key explanatory factors. The study also shows how in Poland a good 'fit' between regulatory institutions and policies on one hand and their social context on the other hand has evolved, and how it contributes to the effectiveness of the regulatory system. Industrializing economies can indeed simultaneously pursue environmental protection and socioeconomic welfare, but elements of a proven regulatory system cannot be automatically adopted among countries and cultures. Learning from each other's experience must be sensitive to the cultural and institutional context of each regulatory system. 42 refs., 3 figs., 1 tab.

Environmental monitoring guidance for DOE Order 5820.2A, Chapter 3

International Nuclear Information System (INIS)

Dolenc, M.R.

1988-01-01

The Defense Low-Level Waste Management Program (DLLWMP) is preparing guidance to support the requirements outlined in DOE Order 5820.2A, Chapter 3, Management of Low-Level Waste. One of these documents is the Environmental Monitoring Guidance. Environmental monitoring is required for all operational and nonoperational treatment, storage, and disposal facilities to ensure that the facility conforms to all appropriate DOE orders. An adequate environmental monitoring program must be designed to measure key parameters that may affect both short- and long-term site performance. These parameters include measuring both chemical and radiological releases in surface soil, air, surface water, flora, fauna, and subsurface soil and groundwater, both in the saturated and unsaturated zones. The monitoring program must be capable of detecting performance trends in sufficient time to allow corrective action before the facility exceeds performance objectives. The program should also provide the data input necessary to evaluate the performance assessment of the facility. This paper outlines the approach being planned to accomplish these tasks

Consideration of sky-shine radiation effects for the development of Korean regulatory guidance about industrial radiography

International Nuclear Information System (INIS)

Yong Ki Chi; Bokyun Seo; Wantae Kim

2015-01-01

Although most of the sky-shine radiation levels in industrial radiography are below regulatory limits, sky-shine radiation could make a valuable contribution to the total radiation level near shielding facility with little shielding and open field without shielding. Therefore sky-shine radiation should be thoroughly predicted and supervised with the ALARA principle. In this study, we simulated sky-shine radiation for mobile irradiators using MCNP and newly suggested the equation for calculating sky-shine radiation. Also these results were applied to developing Korean regulatory guidance about industrial radiography and to recommending the requirement of the facility design, controlled or supervised area at work places. (author)

Environmental restoration value engineering guidance document

International Nuclear Information System (INIS)

1995-07-01

This document provides guidance on Value Engineering (VE). VE is an organized team effort led by a person trained in the methodology to analyze the functions of projects, systems, equipment, facilities, services, and processes for achieving the essential functions at the lowest life cycle cost while maintaining required performance, reliability, availability, quality, and safety. VE has proven to be a superior tool to improve up-front project planning, cut costs, and create a better value for each dollar spent. This document forms the basis for the Environmental Restoration VE Program, describes the VE process, and provides recommendations on when it can be most useful on ER projects

Safety cases for radioactive waste disposal facilities: guidance on confidence building and regulatory review IAEA-ASAM co-ordinated research project

International Nuclear Information System (INIS)

Ben Belfadhel, M.; Bennett, D.G.; Metcalf, P.; Nys, V.; Goldammer, W.

2008-01-01

The IAEA has been conducting two co-ordinated research programmes (CRPs) projects to develop and apply improved safety assessment methodologies for near-surface radioactive waste disposal facilities. The more recent of these projects, ASAM (application of safety assessment methodologies), included a Regulatory Review Working Group (RRWG) which has been working to develop guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides an overview of the ASAM project, focusing on the safety case and regulatory review. (authors)

78 FR 76757 - Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become...

Science.gov (United States)

2013-12-19

... limitations for unforeseen reasons, is the driver in violation of the Sec. 395.3 rest break provision if more... unforeseen reasons, is not in violation of the Sec. 395.3 rest-break requirements if 8 or more hours have... Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become Ineligible for...

Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

International Nuclear Information System (INIS)

Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Easton, E.P.; Coodk, J.R.

1998-01-01

The U.S. Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying these regulatory requirements, a detailed set of logic-flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects, (DOT/NRC, 1997). These logic-flow diagrams, as developed, are specific to the U.S. regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic-flow diagrams adapted in the IAEA regulations, and demonstrated how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements. (authors)

78 FR 37324 - Preparation of Environmental Reports for Nuclear Power Plant License Renewal Applications

Science.gov (United States)

2013-06-20

... Environmental Reports for Nuclear Power Plant License Renewal Applications AGENCY: Nuclear Regulatory Commission... for Nuclear Power Plant License Renewal Applications.'' This regulatory guide provides guidance to... renewal of a nuclear power plant operating license. Applicants should use this regulatory guide when...

Environmental Regulatory Compliance Plan for Site Characterization

International Nuclear Information System (INIS)

1988-12-01

The DOE is committed to conduct its operations in an environmentally safe and sound manner, and will comply with applicable environmental statutes and regulations. These objectives are described in DOE Order 5400.1 (Environmental Protection Program Requirements). This document -- the Environmental Regulatory Compliance Plan (ERCP) -- is one method of implementing the policy set forth in DOE Order 5400.1 and the NWPA. The ERCP describes the plan by which the DOE will comply with applicable Federal environmental statutes and regulations. The ERCP also discusses how DOE will address State and local environmental statutes and regulations. 180 refs., 27 figs., 1 tab

Environmental Guidance Regulatory Bulletin

International Nuclear Information System (INIS)

1995-01-01

On September 15, 1994, EPA promulgated a Final Rule revising 40 CFR Part 300: the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). NCP establishes a national response system for responding to discharges of oil and releases of hazardous substances. Figures illustrate the roles of the national response system. Response operations, planning and preparation, and designation of federal trustees are discussed, followed by definitions

Track 2 sites: Guidance for assessing low probability hazard sites at the INEL

International Nuclear Information System (INIS)

1994-01-01

This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations

Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

International Nuclear Information System (INIS)

Yun, Y. C.; Lee, J. H.; Lee, H. C.; Lee, J. S.

2000-01-01

In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage

Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

Energy Technology Data Exchange (ETDEWEB)

Yun, Y. C. [LG-EDS Systems, Seoul (Korea, Republic of); Lee, J. H.; Lee, H. C.; Lee, J. S. [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

2000-05-01

In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage.

Environmental Guidance Program Reference Book: Comprehensive Environmentally Response, Compensation, and Liability Act

Energy Technology Data Exchange (ETDEWEB)

1991-12-31

This Reference Book contains a current copy of the Comprehensive Environmental Response Compensation, and Liability Act and those regulations that implement the statute and appear to be most relevant to Department of Energy (DOE) activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (FTS 896-2609 or Commercial 202/586-2609).

Federal environmental inspections handbook

International Nuclear Information System (INIS)

1991-10-01

This Federal Environmental Inspection Handbook has been prepared by the Department of Energy (DOE), Office of Environmental Guidance, RCRA/CERCLA Division (EH-231). It is designed to provide DOE personnel with an easily accessible compilation of the environmental inspection requirements under Federal environmental statutes which may impact DOE operations and activities. DOE personnel are reminded that this Handbook is intended to be used in concert with, and not as a substitute for, the Code of Federal Regulations (CFR). Federal Register (FR), and other applicable regulatory documents

Legal framework of the environmental regulatory regime

International Nuclear Information System (INIS)

Black, D.

1992-01-01

The growing concern regarding environmental issues has presented a number of new challenges to those exploring and developing the hydrocarbon reserves located on the Newfoundland continental shelf. Not the least of these challenges is the development of new technologies in the harsh environment of the North Atlantic; in addition, these new technologies must be implemented in an existing and ever-changing regulatory regime. The legal framework of the environmental regulatory regime relating to offshore development in Canada is reviewed along with some of the more important legislation involved in regulating environmental issues in the offshore area. The legal basis for exploration, development, and management of resources located on the Newfoundland continental shelf is the Canada-Newfoundland Accord on Joint Management of Offshore Oil and Gas Resources off Newfoundland and Labrador. Administration of the Accord is the responsibility of the Canada-Newfoundland Offshore Petroleum Board. To be able to apply Canadian laws to the continental shelf, legislation was passed including the Canadian Laws Offshore Application Act as well as the Act implementing the Accord. The latter gives the Offshore Petroleum Board authority to regulate all stages involved in bringing an oil pool to production, such as granting of licenses and work authorizations. Granting of such licenses and authorizations is subject to compliance with environmental requirements, and there are provisions against certain environmental offenses such as spills. Other federal legislation applicable to the offshore includes the Canada Shipping Act and the Canadian Environmental Protection Act

Biodiversity maintenance in food webs with regulatory environmental feedbacks.

Science.gov (United States)

Bagdassarian, Carey K; Dunham, Amy E; Brown, Christopher G; Rauscher, Daniel

2007-04-21

Although the food web is one of the most fundamental and oldest concepts in ecology, elucidating the strategies and structures by which natural communities of species persist remains a challenge to empirical and theoretical ecologists. We show that simple regulatory feedbacks between autotrophs and their environment when embedded within complex and realistic food-web models enhance biodiversity. The food webs are generated through the niche-model algorithm and coupled with predator-prey dynamics, with and without environmental feedbacks at the autotroph level. With high probability and especially at lower, more realistic connectance levels, regulatory environmental feedbacks result in fewer species extinctions, that is, in increased species persistence. These same feedback couplings, however, also sensitize food webs to environmental stresses leading to abrupt collapses in biodiversity with increased forcing. Feedback interactions between species and their material environments anchor food-web persistence, adding another dimension to biodiversity conservation. We suggest that the regulatory features of two natural systems, deep-sea tubeworms with their microbial consortia and a soil ecosystem manifesting adaptive homeostatic changes, can be embedded within niche-model food-web dynamics.

Glossary of CERCLA, RCRA and TSCA related terms and acronyms. Environmental Guidance

Energy Technology Data Exchange (ETDEWEB)

1993-10-01

This glossary contains CERCLA, RCRA and TSCA related terms that are most often encountered in the US Department of Energy (DOE) Environmental Restoration and Emergency Preparedness activities. Detailed definitions are included for key terms. The CERCLA definitions included in this glossary are taken from the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), as amended and related federal rulemakings. The RCRA definitions included in this glossary are taken from the Resource Conservation and Recovery Act (RCRA) and related federal rulemakings. The TSCA definitions included in this glossary are taken from the Toxic Substances and Control Act (TSCA) and related federal rulemakings. Definitions related to TSCA are limited to those sections in the statute and regulations concerning PCBs and asbestos.Other sources for definitions include additional federal rulemakings, assorted guidance documents prepared by the US Environmental Protection Agency (EPA), guidance and informational documents prepared by the US Department of Energy (DOE), and DOE Orders. The source of each term is noted beside the term. Terms presented in this document reflect revised and new definitions published before July 1, 1993.

Track 2 sites: Guidance for assessing low probability hazard sites at the INEL. Revision 6

Energy Technology Data Exchange (ETDEWEB)

1994-01-01

This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations.

Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

Energy Technology Data Exchange (ETDEWEB)

Holmes, K. John; Graham, Judith A.; McKone, Thomas; Whipple, Chris

2008-06-01

Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

Brookhaven National Laboratory environmental monitoring plan for Calendar Year 1996

Energy Technology Data Exchange (ETDEWEB)

Naidu, J.R.; Paquette, D.; Lee, R. [and others

1996-10-01

As required by DOE Order 5400.1, each U.S. Department of Energy (DOE) site, facility, or activity that uses, generates, releases, or manages significant quantities of hazardous materials shall provide a written Environmental Monitoring Plan (EMP) covering effluent monitoring and environmental surveillance. DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, provides specific guidance regarding environmental monitoring activities.

Brookhaven National Laboratory environmental monitoring plan for Calendar Year 1996

International Nuclear Information System (INIS)

Naidu, J.R.; Paquette, D.; Lee, R.

1996-01-01

As required by DOE Order 5400.1, each U.S. Department of Energy (DOE) site, facility, or activity that uses, generates, releases, or manages significant quantities of hazardous materials shall provide a written Environmental Monitoring Plan (EMP) covering effluent monitoring and environmental surveillance. DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, provides specific guidance regarding environmental monitoring activities

Overcoming regulatory barriers: DOE environmental technology development program

International Nuclear Information System (INIS)

Kurtyka, B.M.; Clodfelter-Schumack, K.; Evans, T.T.

1995-01-01

The potential to improve environmental conditions via compliance or restoration is directly related to the ability to produce and apply innovative technological solutions. However, numerous organizations, including the US General Accounting Office (GAO), the EPA National Advisory Council for Environmental Policy and Technology (NACEPT), the DOE Environmental Management Advisory Board (EMAB), and the National Science and Technology Council (NSTC) have determined that significant regulatory barriers exist that inhibit the development and application of these technologies. They have noted the need for improved efforts in identifying and rectifying these barriers for the purpose of improving the technology development process, providing innovative alternatives, and enhancing the likelihood of technology acceptance by all. These barriers include, among others, regulator and user bias against ''unknown/unproven'' technologies; multi-level/multi-media permit disincentives; potential liability of developers and users for failed implementation; wrongly defined or inadequate data quality objectives: and lack of customer understanding and input. The ultimate goal of technology development is the utilization of technologies. This paper will present information on a number of regulatory barriers hindering DOE's environmental technology development program and describe DOE efforts to address these barriers

Review of Technical Studies in the United States in Support of Burnup Credit Regulatory Guidance

International Nuclear Information System (INIS)

Wagner, John C.; Parks, Cecil V.; Mueller, Don; Gauld, Ian C.

2010-01-01

Taking credit for the reduction in reactivity associated with fuel depletion can enable more cost-effective, higher-density storage, transport, disposal, and reprocessing of spent nuclear fuel (SNF) while maintaining sufficient subcritical margin to establish an adequate safety basis. Consequently, there continues to be considerable interest in the United States (U.S.), as well as internationally, in the increased use of burnup credit in SNF operations, particularly related to storage, transport, and disposal of commercial SNF. This interest has motivated numerous technical studies related to the application of burnup credit, both domestically and internationally, as well as the design of SNF storage, transport and disposal systems that rely on burnup credit for maintaining subcriticality. Responding to industry requests and needs, the U.S. Nuclear Regulatory Commission (NRC) initiated a burnup credit research program in 1999, with support from the Oak Ridge National Laboratory (ORNL), to develop regulatory guidance and the supporting technical bases for allowing and expanding the use of burnup credit in pressurized-water reactor SNF storage and transport applications. Although this NRC research program has not been continuous since its inception, considerable progress has been achieved in many key areas in terms of increased understanding of relevant phenomena and issues, availability of relevant information and data, and subsequently updated regulatory guidance for expanded use of burnup credit. This paper reviews technical studies performed by ORNL for the U.S. NRC burnup credit research program. Examples of topics include reactivity effects associated with reactor operating characteristics, fuel assembly characteristics, burnable absorbers, control rods, spatial burnup distributions, cooling time, and assembly misloading; methods and data for validation of isotopic composition predictions; methods and data for validation of criticality calculations; and

STATE INSPECTION METHODOLOGY OF ENVIRONMENTAL REGULATORY ACTIVITY FOCUSED ON THE LIFE CYCLE PROCESSESES

Directory of Open Access Journals (Sweden)

Yuniey Quiala Armenteros

2016-10-01

Full Text Available The Cuban Environmental Regulatory Activity has on the Environmental State Inspection an instrument for control and monitoring of compliance of current legal standards regarding environmental protection and rational use of natural resources. In this research, a design methodology for effective implementation of environmental regulatory activity in Cuba directed to processes is proposed; based on the life cycle assessment and the applicable environmental management standards, including new performance indicators, which form a new tool based on scientific criterions for the Center of Environmental Inspection and Control.

Safety of magnetic fusion facilities: Guidance

International Nuclear Information System (INIS)

1996-05-01

This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities

UK regulatory standards - the 'Guidance on requirements for authorisation'

International Nuclear Information System (INIS)

Williams, C.R.

1999-01-01

In the United Kingdom, disposal of radioactive waste requires an authorisation under the Radioactive Substances Act 1993. The power to grant such authorisations rests with the Environment Agency for disposals in England and Wales, and with similar Agencies in Scotland and Northern Ireland - namely the Scottish Environment Protection Agency (SEPA) and the Environment and Heritage Service (EHS) of the Department of the Environment for Northern Ireland. In 1997, following two rounds of consultation, the Environment Agency jointly with SEPA and EHS published a document 'Disposal Facilities on Land for Low and Intermediate Level Radioactive Wastes: Guidance on Requirements for Authorisation' - the GRA document. The GRA document outlines the regulatory framework governing the disposal of radioactive waste, general guidance on procedures, the principles and criteria against which proposals for a disposal facility will be assessed, and the radiological and technical requirements which a facility will be expected to meet. In particular, the document states that, in the period after control is withdrawn, the assessed radiological risk from a facility to a representative member of the potentially exposed group at greatest risk should be consistent with a risk target of 10 -6 per year. The document also specifies the information which a developer will need to provide, to demonstrate that a proposal is consistent with the principles and requirements, and identifies other, non-risk-based, criteria. In March 1997, the Secretary of State for the Environment rejected a planning appeal by United Kingdom Nirex Ltd for an underground Rock Characterisation Facility located near Sellafield in Cumbria. That decision has effectively delayed the construction of any deep repository in the UK. Subsequently a House of Lords Select Committee has commenced a major review of nuclear waste management. The Environment Agency continues to be responsible for the authorisation of the shallow

Guidance on the environmental risk assessment of genetically modified plants

DEFF Research Database (Denmark)

Bartsch, Detlef; Chueca, Cristina; De-Schrijver, Adinda

risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible......This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified...... organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach...

Environmental Guidance Regulatory Bulletin - revised rule issued, October 17, 1994

International Nuclear Information System (INIS)

1995-01-01

On September 15, 1994, at 59 FR 47384-47495, the Environmental Protection Agency promulgated a Final Rule revising 40 CFR Part 300; the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). One of the primary purposes of the revised NCP is to provide for efficient, coordinated, and effective action to minimize adverse impact from oil discharges and hazardous substance releases. The NCP is required by Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act and Section 311 (c) (2) of the Clean Water Act. The NCP establishes an organizational structure and procedures for preparing for and responding to discharges of oil and releases of hazardous substances, pollutants, and contaminants under these two Acts. The Oil Pollution Act of 1990 (OPA) amends the existing provisions of the Clean Water Act (CWA) and creates major new authorities addressing oil, and to a lesser extent, hazardous substance spill response. These amendments to the CWA, in turn, require revision of the NCP. The OPA specifies a number of revisions to the NCP that enhance and expand upon the current framework, standards, and procedures for response. A Notice of Proposed Rulemaking on changes to the NCP was issued on October 22, 1993 (58 FR 54702). DOE solicited comments on the proposed rule from DOE program and field offices, and submitted those comments to EPA on December 20, 1993

Strategies for environmental restoration in an evolving regulatory environment

International Nuclear Information System (INIS)

Keller, J.F.; Geffen, C.A.

1990-03-01

The US Department of Energy (DOE) is faced with the immense challenge of effectively implementing a program to mitigate and manage the environmental impacts created by past and current operations at its facilities. Such a program must be developed and administered in accordance with the Comprehensive Environmental Response, Compensation and Liability Act and the Resource Conservation and Recovery Act. These regulations are extremely complex, burdening the environmental restoration process with a number of planning and public interaction requirements that must be met before remediation of a site may begin. Existing regulatory and institutional requirements for environmental restoration dictate that extensive planning, characterization and assessment activities be conducted. An important part of the process is the involvement of regulators and the public in the site characterization and assessment activities and in developing reasonable solutions for cleanup. This paper identifies the regulatory requirements and highlights implementation strategies for key aspects of the environmental restoration process for DOE. Trends in legislation and policy relevant to the DOE environmental restoration process are highlighted, with strategies identified for dealing with the evolution of the regulations while maintaining continuity in the technical activities required for cleaning up the DOE hazardous and mixed waste sites. 10 refs

Quality assurance guidance for laboratory assessment plates in support of EM environmental sampling and analysis activities

International Nuclear Information System (INIS)

1994-05-01

This document is one of several guidance documents developed to support the EM (DOE Environmental Restoration and Waste Management) Analytical Services program. Its purpose is to introduce assessment plates that can be used to conduct performance assessments of an organization's or project's ability to meet quality goals for analytical laboratory activities. These assessment plates are provided as non-prescriptive guidance to EM-support organizations responsible for collection of environmental data for remediation and waste management programs at DOE facilities. The assessments evaluate objectively all components of the analytical laboratory process to determine their proper selection and use

NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

Science.gov (United States)

Scroggins, Sharon; Duda, Kristen

2008-01-01

This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

Assessing the relevance of ecotoxicological studies for regulatory decision making.

Science.gov (United States)

Rudén, Christina; Adams, Julie; Ågerstrand, Marlene; Brock, Theo Cm; Poulsen, Veronique; Schlekat, Christian E; Wheeler, James R; Henry, Tala R

2017-07-01

Regulatory policies in many parts of the world recognize either the utility of or the mandate that all available studies be considered in environmental or ecological hazard and risk assessment (ERA) of chemicals, including studies from the peer-reviewed literature. Consequently, a vast array of different studies and data types need to be considered. The first steps in the evaluation process involve determining whether the study is relevant to the ERA and sufficiently reliable. Relevance evaluation is typically performed using existing guidance but involves application of "expert judgment" by risk assessors. In the present paper, we review published guidance for relevance evaluation and, on the basis of the practical experience within the group of authors, we identify additional aspects and further develop already proposed aspects that should be considered when conducting a relevance assessment for ecotoxicological studies. From a regulatory point of view, the overarching key aspect of relevance concerns the ability to directly or indirectly use the study in ERA with the purpose of addressing specific protection goals and ultimately regulatory decision making. Because ERA schemes are based on the appropriate linking of exposure and effect estimates, important features of ecotoxicological studies relate to exposure relevance and biological relevance. Exposure relevance addresses the representativeness of the test substance, environmental exposure media, and exposure regime. Biological relevance deals with the environmental significance of the test organism and the endpoints selected, the ecological realism of the test conditions simulated in the study, as well as a mechanistic link of treatment-related effects for endpoints to the protection goal identified in the ERA. In addition, uncertainties associated with relevance should be considered in the assessment. A systematic and transparent assessment of relevance is needed for regulatory decision making. The relevance

2002 WIPP Environmental Monitoring Plan

Energy Technology Data Exchange (ETDEWEB)

Washington TRU Solutions LLC

2002-09-30

DOE Order 5400.1, General Environmental Protection Program, requires each DOE | facility to prepare an environmental management plan (EMP). This document is | prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment; applicable sections of Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) Part 834, ''Radiation Protection of the Public and Environment'' (draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1, which is the driver for the annual Site Environmental Report (SER) and the guidance source for preparing many environmental program documents. The WIPP Project is operated by Westinghouse TRU Solutions (WTS) for the DOE. This plan defines the extent and scope of WIPP's effluent and environmental | monitoring programs during the facility's operational life and also discusses WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP Project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance.

77 FR 14047 - Guidance for Decommissioning Planning During Operations

Science.gov (United States)

2012-03-08

...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...

12 CFR 562.2 - Regulatory reports.

Science.gov (United States)

2010-01-01

... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting... limited to, the accounting instructions provided in the TFR, guidance contained in OTS regulations...

Methodology for the Systematic Assessment of the Regulatory Competence Needs (SARCoN) for Regulatory Bodies of Nuclear Installations

International Nuclear Information System (INIS)

2015-03-01

A regulatory body’s competence is dependent, among other things, on the competence of its staff. A necessary, but not sufficient, condition for a regulatory body to be competent is that its staff can perform the tasks related to the functions of the regulatory body. In 2001, the IAEA published TECDOC 1254, Training the Staff of the Regulatory Body for Nuclear Facilities: A Competency Framework, which examines the manner in which the recognized regulatory functions of a nuclear regulatory body results in competence needs. Using the internationally recognized systematic approach to training, TECDOC 1254 provides a framework for regulatory bodies for managing training and developing, and maintaining the competence of its staff. It has been successfully used by many regulatory bodies all over the world, including States embarking on a nuclear power programme. The IAEA has also introduced a methodology and an assessment tool — Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) — which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2013, the IAEA published Safety Reports Series No. 79, Managing Regulatory Body Competence, which provides generic guidance based on IAEA safety requirements in the development of a competence management system within a regulatory body’s integrated management system. An appendix in the Safety Report deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an embarking State’s regulatory system. This publication provides guidance for the analysis of required and existing competences to identify those required by the regulatory body to perform its functions and therefore associated needs for acquiring competences. Hence, it is equally applicable to the needs of States embarking on nuclear power

Environmental protection and regulatory compliance at the Elk Hills field

International Nuclear Information System (INIS)

Chappelle, H.H.; Donahoe, R.L.; Kato, T.T.; Ordway, H.E.

1991-01-01

Environmental protection has played an integral role in the development and operation of the Elk Hills field since production at the maximum efficient rate was authorized in 1976. The field is located in a non-attainment area for California and National Ambient Air Quality Standards for two criteria pollutants and their associated precursors, is home to four endangered species, and operates within the California regulatory framework. Environmental protection and regulatory compliance is a multi-faceted program carried out through a substantial commitment of resources and workforce involvement. This paper describes the actions taken and resources employed to protect the environment, specific technologies and projects implemented, and the ongoing nature of these efforts at Elk Hills

78 FR 49782 - Interim Staff Guidance on Changes During Construction

Science.gov (United States)

2013-08-15

... Construction AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment... During Construction.'' This ISG provides guidance to the NRC staff on the Preliminary Amendment Request...-ISG-025 ``Interim Staff Guidance on Changes during Construction under 10 CFR Part 52'' is available...

Environmental regulatory compliance plan, Deaf County site, Texas: Draft revision 1

International Nuclear Information System (INIS)

1987-01-01

The DOE is committed to conduct its operation in an environmentally safe and sound manner and comply with the letter and spirit of applicable environmental statues and regulations. These objectives are codified in DOE order N 5400.2, ''Environmental Policy Statement.'' This document, the Deaf Smith County site (Texas) Environmental Regulatory Compliance Plam (ERCP), is one means of implementing that policy. The ERCP describes the environmental regulatory requirements applicable to the Deaf Smith County site (Texas), and presented the framework within which the Salt Repository Project Office (SRPO) will comply with the requirements. The plan also discusses how DOE will address State and local environmental requirements. To achieve this purpose the ERCP will be developed in phases. This version of the ERCP is the first phase in the delopment of the ERCP. It represents the Salt Repository Project Office's understanding of environmental requirements for the site characterization phase of repository development. After consultation with the appropriate federal and state agencies and affected Indian tribes, the ERCP will be updated to reflect the results of consultation with these agencies and affected Indian tribes. 6 refs., 38 figs

Regulatory aspects of mixed waste

International Nuclear Information System (INIS)

Boyle, R.R.; Orlando, D.A.

1990-01-01

Mixed waste is waste that satisfies the definition of low-level radioactive waste in the Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) and contains hazardous waste that is either: (1) listed as a hazardous waste in 40 CFR 261, Subpart D; or (2) causes the waste to exhibit any of the characteristics identified in 40 CFR 261, Subpart C. Low-level radioactive waste is defined in the LLRWPAA as radioactive material that is not high level waste, spent nuclear fuel, or byproduct material, as defined in Section 11e(2) of the Atomic Energy Act of 1954, and is classified as low-level waste by the U.S. Nuclear Regulatory Commission (NRC). This paper discusses dual regulatory (NRC and Environmental Protection Agency) responsibility, overview of joint NRC/EPA guidance, workshops, national mixed waste survey, and principal mixed waste uncertainties

2002 Waste Isolation Pilot Plant Environmental Monitoring Plan

International Nuclear Information System (INIS)

Washington TRU Solutions LLC

2002-01-01

DOE Order 5400.1, General Environmental Protection Program, requires each DOE | facility to prepare an environmental management plan (EMP). This document is | prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment; applicable sections of Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) Part 834, ''Radiation Protection of the Public and Environment'' (draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1, which is the driver for the annual Site Environmental Report (SER) and the guidance source for preparing many environmental program documents. The WIPP Project is operated by Westinghouse TRU Solutions (WTS) for the DOE. This plan defines the extent and scope of WIPP's effluent and environmental | monitoring programs during the facility's operational life and also discusses WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP Project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance

Radionuclide Data Quality Evaluation Guidance

International Nuclear Information System (INIS)

Tucker, B.J.; Winters, M.S.; Evans, D.

2009-01-01

A considerable amount of radioanalytical data is generated during various phases of the characterization and remediation of radiologically-contaminated sites and properties. It is critical that data generated from the analysis of collected samples be to a level of quality usable by the project and acceptable to stakeholders. In July 2004, the final version of a multi-agency guidance manual entitled Multi-Agency Radiological Analytical Protocols Manual (MARLAP) was issued by the Environmental Protection Agency, Department of Energy, Department of Homeland Security, Nuclear Regulatory Commission, Department of Defense, National Institute of Standards and Technology, U. S. Geological Survey, Food and Drug Administration, and the States of Kentucky and California. The authors' purpose is to introduce readers to some key elements of MARLAP as it relates to radioanalytical lab quality control, and to demonstrate how these guidance elements can be effectively incorporated into mature radioanalytical lab operations and data validation regimes. Based upon the logic and statistical methodologies presented in MARLAP, the authors have revised existing project-specific Radioanalytical Data Evaluation Guidance (RadDEG) used at the FUSRAP Maywood Site in Maywood, NJ. The RadDEG allows users to qualify data in a meaningful way by tying the usability of the data to its activity and uncertainty relative to project action levels and QC results. This exercise may be useful to other projects looking to implement a MARLAP-based approach into their project/site-specific data evaluation methodologies. (authors)

75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “Consideration of the Effects of Climate...

Science.gov (United States)

2010-02-23

..., ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Consideration of the Effects of Climate Change... visionary and versatile law that can be used effectively to address new environmental challenges facing our...

Quality Assurance Guidance for the Collection of Meteorological Data Using Passive Radiometers

Science.gov (United States)

This document augments the February 2000 guidance entitled Meteorological Monitoring Guidance for Regulatory Modeling Applications and the March 2008 guidance entitled Quality Assurance Handbook for Air Pollution Measurement Systems Volume IV: Meteorological Measurements Version ...

Implementation of a laboratory information management system for environmental regulatory analyses

Energy Technology Data Exchange (ETDEWEB)

Spencer, W.A.; Aiken, H.B.; Spatz, T.L.; Miles, W.F.; Griffin, J.C.

1993-09-07

The Savannah River Technology Center created a second instance of its ORACLE based PEN LIMS to support site Environmental Restoration projects. The first instance of the database had been optimized for R&D support and did not implement rigorous sample tracking, verification, and holding times needed to support regulatory commitments. Much of the R&D instance was transferable such as the work control functions for backlog reports, work assignment sheets, and hazard communication support. A major enhancement of the regulatory LIMS was the addition of features to support a {open_quotes}standardized{close_quotes} electronic data format for environmental data reporting. The electronic format, called {open_quotes}AN92{close_quotes}, was developed by the site environmental monitoring organization and applies to both onsite and offsite environmental analytical contracts. This format incorporates EPA CLP data validation codes as well as details holding time and analytical result reporting requirements. The authors support this format by using special SQL queries to the database. The data is then automatically transferred to the environmental databases for trending and geological mapping.

UV DISINFECTION GUIDANCE MANUAL FOR THE ...

Science.gov (United States)

Provides technical information on selection, design and operation of UV systems; provides regulatory agencies with guidance and the necessary tools to assess UV systems at the design, start-up, and routine operation phase; provides manufacturers with the testing and performance standards for UV components and systems for treating drinking water. Provide guidance to water systems, regulators and manufacturers on UV disinfection of drinking water.

First update to the US Nuclear Regulatory Commission's regulatory strategy for the high-level waste repository program

International Nuclear Information System (INIS)

Johnson, R.L.; Linehan, J.J.

1991-01-01

The US Nuclear Regulatory Commission (NRC) staff has updated its initial regulatory strategy for the High-Level Waste Repository Licensing Program. The update describes changes to the initial strategy and summarizes progress and future activities. This paper summarizes the first update of the regulatory strategy. In general the overall strategy of identifying and reducing uncertainties is unchanged. Identifying regulatory and institutional uncertainties is essentially complete, and therefore, the current and future emphasis is on reducing those regulatory and institutional uncertainties identified to date. The NRC staff has improved the methods of reducing regulatory uncertainties by (1) enhancing the technical basis preparation process for potential rulemakings and guidance and (2) designing a new guidance document, called a staff position, for clarifying regulatory uncertainties. For guiding the US DOE's reduction of technical uncertainties, the NRC staff will give more emphasis to prelicense application reviews and less emphasis on preparing staff technical positions

Nuclear Regulatory Commission and its role in environmental standards

International Nuclear Information System (INIS)

Mattson, R.J.

1976-01-01

The NRC and its predecessors in the Atomic Energy Commission represent considerable experience in environmental standards setting. The Atomic Energy Act of 1954, the 1970 Supreme Court decision on Federal pre-emption of radiation standards, the Calvert Cliffs decision of 1971, the Energy Reorganization Act of 1974, and the Appendix I ''as low as reasonably achievable'' decision of 1975, to name a few of our landmarks, are representative of the scars and the achievements of being in a role of national leadership in radiation protection. The NRC, through a variety of legislative authorities, administrative regulations, regulatory guides, and national consensus standards regulates the commercial applications of nuclear energy. The purposes of regulation are the protection of the environment, public health and safety, and national security. To understand NRC's responsibilities relative to those of other Federal and state agencies concerned with environmental protection, we will briefly review the legislative authorities which underlie our regulatory program. Then we will examine the intent or the spirit of that program as embodied in our system of regulations, guides, and standards. Finally we will speak to what's happening today and what we see in the future for environmental standards

Strategic Environmental Assessment as catalyst of healthier spatial planning: The Danish guidance and practice

DEFF Research Database (Denmark)

Kørnøv, Lone

2009-01-01

and guidance. This paper examines the inclusion of health as a formal component in impact assessment of spatial plans. Based upon a documentary study of 100 environmental reports, the paper analyses and discusses how health impact considerations are incorporated in SEA practice. It is found that health impacts...

Physical protection of shipments of irradiated reactor fuel; Interim guidance. Regulatory report

International Nuclear Information System (INIS)

1980-06-01

During May, 1979, the U.S. Nuclear Regulatory Commission approved for issuance in effective form new interim regulations for strengthening the protection of spent fuel shipments against sabotage and diversion. The new regulations were issued without benefit of public comment, but comments from the public were solicited after the effective date. Based upon the public comments received, the interim regulations were amended and reissued in effective form as a final interim rule in May, 1980. The present document supersedes a previously issued interim guidance document, NUREG-0561 (June, 1979) which accompanied the original rule. This report has been revised to conform to the new interim regulations on the physical protection of shipments of irradiated reactor fuel which are likely to remain in effect until the completion of an ongoing research program concerning the response of spent fuel to certain forms of sabotage, at which time the regulations may be rescinded, modified or made permanent, as appropriate. This report discusses the amended regulations and provides a basis on which licensees can develop an acceptable interim program for the protection of spent fuel shipments

78 FR 13097 - Electric Power Research Institute; Seismic Evaluation Guidance

Science.gov (United States)

2013-02-26

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0038] Electric Power Research Institute; Seismic... Electric Power Research Institute (EPRI)-1025287, ``Seismic Evaluation Guidance: Screening, Prioritization... guidance and clarification of an acceptable approach to assist nuclear power reactor licensees when...

75 FR 80287 - Environmental Protection Agency Implementation of OMB Guidance on Drug-Free Workplace Requirements

Science.gov (United States)

2010-12-22

... of omnibus drug legislation on November 18, 1988. Federal agencies issued an interim final common...; FRL- 9242-2] Environmental Protection Agency Implementation of OMB Guidance on Drug-Free Workplace... Protection Agency is removing its regulation implementing the Governmentwide common rule on drug-free...

Using Inequality Measures to Incorporate Environmental Justice into Regulatory Analyses

Science.gov (United States)

Abstract: Formally evaluating how specific policy measures influence environmental justice is challenging, especially in the context of regulatory analyses in which quantitative comparisons are the norm. However, there is a large literature on developing and applying quantitative...

Guidance for regulation of underground repositories for disposal of radioactive wastes

International Nuclear Information System (INIS)

1989-01-01

Deep geological formations are favoured for disposal of high level and alpha bearing wastes from the nuclear fuel cycle: varying depths of emplacement, including shallow land disposal, with or without engineered barriers may be foreseen for low and intermediate level wastes. Most countries will regulate such disposal through licensing actions by a regulatory body whose purpose is to review and analyse the safety of all stages of the disposal programme. This regulatory function may be performed either by a single national authority or a system of authorities. It is the intent of the IAEA that this publication will be used as a guide to develop regulatory requirements for licensing waste disposal facilities. This report updates IAEA Safety Series No. 51. Development of the regulatory process is maturing rapidly in Member States, hence there is a clear need to revise the nearly ten year old text of that publication. The purpose of this report is to provide general guidance for the regulation of underground disposal of low, intermediate and high level radioactive wastes once a fundamental decision to pursue this option has been made. It is intended to reflect the experience of those countries with mature regulatory programmes and to provide some guidance to those countries that wish to develop regulatory programmes. Guidance is given on what issues should be addressed in the licensing review, what decision points are important, and what guidance should be given to the applicant by the regulatory system in the course of the licensing actions. The orientation of the report is on technical factors rather than the social and political aspects that need to be taken into account when regulating the underground disposal of radioactive wastes. The financing aspects are not discussed

Waste Isolation Pilot Plant CY 2000 Site Environmental Report

International Nuclear Information System (INIS)

Westinghouse TRU Solutions, LLC; Environmental Science and Research Foundation, Inc.

2001-01-01

The U.S. Department of Energy's (DOE) Carlsbad Field Office and Westinghouse TRU Solutions, LLC (WTS) are dedicated to maintaining high quality management of Waste Isolation Pilot Plant (WIPP) environmental resources. DOE Order 5400.1, General Environmental Protection Program, and DOE Order 231.1, Environmental, Safety, and Health Reporting, require that the environment at and near DOE facilities be monitored to ensure the safety and health of the public and the environment. This Waste Isolation Pilot Plant 2000 Site Environmental Report summarizes environmental data from calendar year (CY) 2000 that characterize environmental management performance and demonstrate compliance with federal and state regulations. This report was prepared in accordance with DOE Order 5400.1, DOE Order 231.1, the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T), and the Waste Isolation Pilot Plant Environmental Protect ion Implementation Plan (DOE/WIPP 96-2199). The above orders and guidance documents require that DOE facilities submit an Annual Site Environmental Report to DOE Headquarters, Office of the Assistant Secretary for Environment, Safety, and Health. The purpose of this report is to provide a comprehensive description of operational environmental monitoring activities, to provide an abstract of environmental activities conducted to characterize site environmental management performance to confirm compliance with environmental standards and requirements, and to highlight significant programs and efforts of environmental merit at WIPP during CY 2000. The format of this report follows guidance offered in a June 1, 2001 memo from DOE's Office of Policy and Guidance with the subject ''Guidance for the preparation of Department of Energy (DOE) Annual Site Environmental Reports (ASERs) for Calendar Year 2000.'' WIPP received its first shipment of waste on March 26, 1999. In 2000, no evidence was found of any adverse

Waste Isolation Pilot Plant CY 2000 Site Environmental Report

Energy Technology Data Exchange (ETDEWEB)

Westinghouse TRU Solutions, LLC; Environmental Science and Research Foundation, Inc.

2001-12-31

The U.S. Department of Energy's (DOE) Carlsbad Field Office and Westinghouse TRU Solutions, LLC (WTS) are dedicated to maintaining high quality management of Waste Isolation Pilot Plant (WIPP) environmental resources. DOE Order 5400.1, General Environmental Protection Program, and DOE Order 231.1, Environmental, Safety, and Health Reporting, require that the environment at and near DOE facilities be monitored to ensure the safety and health of the public and the environment. This Waste Isolation Pilot Plant 2000 Site Environmental Report summarizes environmental data from calendar year (CY) 2000 that characterize environmental management performance and demonstrate compliance with federal and state regulations. This report was prepared in accordance with DOE Order 5400.1, DOE Order 231.1, the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T), and the Waste Isolation Pilot Plant Environmental Protect ion Implementation Plan (DOE/WIPP 96-2199). The above orders and guidance documents require that DOE facilities submit an Annual Site Environmental Report to DOE Headquarters, Office of the Assistant Secretary for Environment, Safety, and Health. The purpose of this report is to provide a comprehensive description of operational environmental monitoring activities, to provide an abstract of environmental activities conducted to characterize site environmental management performance to confirm compliance with environmental standards and requirements, and to highlight significant programs and efforts of environmental merit at WIPP during CY 2000. The format of this report follows guidance offered in a June 1, 2001 memo from DOE's Office of Policy and Guidance with the subject ''Guidance for the preparation of Department of Energy (DOE) Annual Site Environmental Reports (ASERs) for Calendar Year 2000.'' WIPP received its first shipment of waste on March 26, 1999. In 2000, no

76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants

Science.gov (United States)

2011-12-05

... Guidance for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Issuance of NUREG... Support of Nuclear Power Plants;'' NSIR/DPR-ISG-01, ``Interim Staff Guidance Emergency Planning for Nuclear Power Plants;'' and NUREG/CR-7002, ``Criteria for Development of Evacuation Time Estimate Studies...

EPRI Guidance for Transition from Operations to Decommissioning

International Nuclear Information System (INIS)

McGrath, Richard; Reid, Richard; Snyder, Michael

2016-01-01

A wide range of key activities are necessary after permanent shutdown of a nuclear power plant before active dismantlement of the plant can begin. This period is typically referred to as the transition period. In some cases these activities are prescribed by regulation and in others they may be more practically driven or even optional. In either case, planning for transition activities should optimally take place prior to final shutdown. Additionally, execution of some transition period activities, such as filing required regulatory submittals, may be performed prior to plant shut down. In addition to general transition period activities such as defueling, management of operational wastes, fulfilling regulatory requirements and changes to plant technical specifications, there are a number of optional activities that may have a long-range impact on future decommissioning activities. This includes activities such as the timing of staff reductions and performance of chemical decontamination. EPRI is nearing completion of a project to develop guidance for transitioning a nuclear power plant to decommissioning. This project includes the following elements: - A review of required and recommended transition period activities. For countries where a clear regulatory framework exists, this includes country-specific requirements; - A review of pending regulatory activities in the US and other countries where there is currently no clear regulatory framework for transitioning to decommissioning; - A summary of activities that have been performed during the transition period for past and current decommissioning sites, as well as current sites that are actively planning decommissioning activities; and - Guidance for development of a transition plan for changing from an operational to decommissioning status. Informed planning of the transition period activities will provide immediate benefits in reducing costs and minimizing the duration of the transition period, as well as longer

NRC ARDC Guidance Support Status Report

Energy Technology Data Exchange (ETDEWEB)

Holbrook, Mark R. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2017-07-01

This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”

NRC ARDC Guidance Support Status Report

International Nuclear Information System (INIS)

Holbrook, Mark R.

2017-01-01

This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”

Regulatory review of probabilistic safety assessment (PSA) level 1

International Nuclear Information System (INIS)

2000-02-01

Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

Regulatory analysis technical evaluation handbook. Final report

International Nuclear Information System (INIS)

1997-01-01

The purpose of this Handbook is to provide guidance to the regulatory analyst to promote preparation of quality regulatory analysis documents and to implement the policies of the Regulatory Analysis Guidelines of the US Nuclear Regulatory Commission (NUREG/BR-0058 Rev. 2). This Handbook expands upon policy concepts included in the NRC Guidelines and translates the six steps in preparing regulatory analyses into implementable methodologies for the analyst. It provides standardized methods of preparation and presentation of regulatory analyses, with the inclusion of input that will satisfy all backfit requirements and requirements of NRC's Committee to Review Generic Requirements. Information on the objectives of the safety goal evaluation process and potential data sources for preparing a safety goal evaluation is also included. Consistent application of the methods provided here will result in more directly comparable analyses, thus aiding decision-makers in evaluating and comparing various regulatory actions. The handbook is being issued in loose-leaf format to facilitate revisions. NRC intends to periodically revise the handbook as new and improved guidance, data, and methods become available

Regulatory Control of Radiation Sources. Safety Guide

International Nuclear Information System (INIS)

2009-01-01

This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture.

Science.gov (United States)

Dillon, Lindsey; Sellers, Christopher; Underhill, Vivian; Shapiro, Nicholas; Ohayon, Jennifer Liss; Sullivan, Marianne; Brown, Phil; Harrison, Jill; Wylie, Sara

2018-04-01

We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt-led EPA and the extent to which these shifts steer the EPA away from its stated mission to "protect human and environmental health." Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely-more so than at similar moments in the agency's 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching.

Managing Regulatory Body Competence

International Nuclear Information System (INIS)

2013-01-01

In 2001, the IAEA published TECDOC 1254, which examined the way in which the recognized functions of a regulatory body for nuclear facilities results in competence needs. Using the systematic approach to training (SAT), TECDOC 1254 provided a framework for regulatory bodies for managing training and developing and their maintaining their competence. It has been successfully used by many regulators. The IAEA has also introduced a methodology and an assessment tool - Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) - which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2009, the IAEA established a steering committee (supported by a bureau) with the mission to advise the IAEA on how it could best assist Member States to develop suitable competence management systems for their regulatory bodies. The committee recommended the development of a safety report on managing staff competence as an integral part of a regulatory body's management system. This Safety Report was developed in response to this request. It supersedes TECDOC 1254, broadens its application to regulatory bodies for all facilities and activities, and builds upon the experience gained through the application of TECDOC 1254 and SARCoN and the feedback received from Member States. This Safety Report applies to the management of adequate competence as needs change, and as such is equally applicable to the needs of States 'embarking' on a nuclear power programme. It also deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an 'embarking' State's regulatory system

Potential environmental and regulatory implications of naturally occurring radioactive materials (NORM)

International Nuclear Information System (INIS)

Paschoa, A.S.

1998-01-01

The immense volume of naturally occurring radioactive materials (NORM) wastes produced annually by extracting industries throughout the world deserves to come to the attention of international and national environmental protection agencies and regulatory bodies. Although a great deal of work has been done in the fields of radiation protection and remedial actions concerning uranium and other mines, the need to dispose of diffuse NORM wastes will have environmental and regulatory implications that thus far are not fully appreciated. NORM wastes constitute, by and large, unwanted byproducts of industrial activities as diverse as thorium and uranium milling, niobium, tin and gold mining extraction, water treatment, and the production of oil, gas, phosphate fertilizer, coal fire and aluminium. The volumes of NORM wastes produced annually could reach levels so high that the existing low level radioactive waste (LLRW) facilities would be readily occupied by NORM if controlled disposal procedures were not adopted. On the other hand, NORM cannot just be ignored as being below radiological concern (BRC) or lower than exempt concentration levels (ECLs), because sometimes NORM concentrations reach levels as high as 1 x 10 3 kBq/kg for 226 Ra, and not much less for 228 Ra. Unfortunately, thus far, there is not enough information available concerning NORM wastes in key industries, though the international scientific community has been concerned, for a long time now, with technologically enhanced natural radiation exposures (TENRE). This article is written with the intention of examining, to the extent possible, the potential environmental and regulatory implications of NORM wastes being produced in selected industries. (Author)

EPA Region 1 Environmentally Sensitive Areas

Science.gov (United States)

This coverage represents polygon equivalents of environmentally sensitive areas (ESA) in EPA Region I. ESAs were developed as part of an EPA headquarters initiative based on reviews of various regulatory and guidance documents, as well as phone interviews with federal/state/local government agencies and private organizations. ESAs include, but are not limited to, wetlands, biological resources, habitats, national parks, archaeological/historic sites, natural heritage areas, tribal lands, drinking water intakes, marinas/boat ramps, wildlife areas, etc.

Draft Guidance for Protective Action Strategies Development

Energy Technology Data Exchange (ETDEWEB)

Park, Sang Hyun; Jeong, Seung Young; Kim, Wanjoo [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

National nuclear emergency preparedness and response (EPR) framework has been improved since the Fukushima accident in 2011. There are still many needs to be amended and improved in regulatory requirements and technical criteria to warrant efficacy of the EPR framework. As an important part of the framework, protective actions have to be implemented with optimized and justified manner during whole emergency phases. In this study, to enhance protective action strategies in response to severe accident or general emergency, existing procedures were reviewed. And generic guidance to develop protective action recommendations (PARs) was proposed considering revised EPZ and recent technical information on protective action strategies. The generic guidance for PARs based on facility status was introduced. Revision of EPZ and some recent information on protective action strategies, such as staged evacuation, specific approach for rapidly progressing accident were considered. It would be employed as a basis to develop site-specific strategies of PARs and regulatory guidance for emergency plan by nuclear licensee. It was focused on an early phase of nuclear emergency. Further efforts to develop site specific strategies of PARs and strategies which cover full range of nuclear emergency would be followed by several stake holders.

Safety culture as a matter of regulatory control and regulatory effectiveness

International Nuclear Information System (INIS)

Camargo, C.T.M.; Furieri, E.B.; Arrieta, L.A.I.; Almeida, C.U.C.

2002-01-01

More than 15 years have passed since the term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG), and although the concept now is widely accepted, practical applications and characteristics have been disseminated mainly for nuclear power plant operating organizations. There is still a lack of international guidance on the use of safety culture as a regulatory matter and on the application of the concept within regulatory organizations. This work explores the meaning of safety culture in two different fields: as an element of safety management systems it shall be a matter of regulatory control; as a complementary tool for quality management it should be used to enhance regulatory effectiveness. Brazilian recent experience on regulating nuclear power reactors provide some examples on how the concept of safety culture may influence regulatory strategies and regulatory management. (author)

Information management systems for integrating the technical data and regulatory requirements of environmental restoration activities

International Nuclear Information System (INIS)

Geffen, C.A.; Garrett, B.A.; Walter, M.B.

1990-03-01

Current environmental regulations require that comprehensive planning be conducted before remediating a hazardous waste site to characterize the nature and extent of site contamination, calculate the risk to the public, and assess the effectiveness of various remediation technologies. Remediation of Department of Energy (DOE) sites contaminated with hazardous or mixed wastes will require the effective integration of scientific and engineering data with regulatory and institutional requirements. The information management challenge presented by waste site cleanup activities goes beyond merely dealing with the large quantity of data that will be generated. The information must be stored, managed, and presented in a way that provides some consistency in approach across sites, avoids duplication of effort, and facilitates responses to requests for information from the regulators and the public. This paper provides background information on the regulatory requirements for data gathering and analysis for environmental restoration activities, and outlines the data and information management requirements for completing the pre-remediation phases of an environmental restoration project. Information management systems for integrating the regulatory and institutional requirements of the environmental restoration process with the technical data and analysis requirements are also described. 7 refs

Low-rank coal study. Volume 4. Regulatory, environmental, and market analyses

Energy Technology Data Exchange (ETDEWEB)

1980-11-01

The regulatory, environmental, and market constraints to development of US low-rank coal resources are analyzed. Government-imposed environmental and regulatory requirements are among the most important factors that determine the markets for low-rank coal and the technology used in the extraction, delivery, and utilization systems. Both state and federal controls are examined, in light of available data on impacts and effluents associated with major low-rank coal development efforts. The market analysis examines both the penetration of existing markets by low-rank coal and the evolution of potential markets in the future. The electric utility industry consumes about 99 percent of the total low-rank coal production. This use in utility boilers rose dramatically in the 1970's and is expected to continue to grow rapidly. In the late 1980's and 1990's, industrial direct use of low-rank coal and the production of synthetic fuels are expected to start growing as major new markets.

Risk-based Regulatory Evaluation Program methodology

International Nuclear Information System (INIS)

DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

1987-01-01

The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

Potential environmental benefits from regulatory consideration of synthetic drilling muds

International Nuclear Information System (INIS)

Burke, C.J.; Veil, J.A.

1995-02-01

When drilling exploration and production wells for oil and gas, drillers use specialized drilling fluids, referred to as muds, to help maintain well control and to remove drill cuttings from the hole. Historically, either water-based muds (WBMs) or oil-based muds (OBMs) have been used for offshore wells. Recently, in response to US Environmental Protection Agency (EPA) regulations and drilling-waste discharge requirements imposed by North Sea nations, the drilling industry has developed several types of synthetic-based muds (SBMs) that combine the desirable operating qualities of OBMs with the lower toxicity and environmental impact qualities of WBMs. This report describes the operational, environmental, and economic features of all three types of muds and discusses potential EPA regulatory barriers to wider use of SBMs

SPAR-H Step-by-Step Guidance

Energy Technology Data Exchange (ETDEWEB)

April M. Whaley; Dana L. Kelly; Ronald L. Boring; William J. Galyean

2012-06-01

Step-by-step guidance was developed recently at Idaho National Laboratory for the US Nuclear Regulatory Commission on the use of the Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method for quantifying Human Failure Events (HFEs). This work was done to address SPAR-H user needs, specifically requests for additional guidance on the proper application of various aspects of the methodology. This paper overviews the steps of the SPAR-H analysis process and highlights some of the most important insights gained during the development of the step-by-step directions. This supplemental guidance for analysts is applicable when plant-specific information is available, and goes beyond the general guidance provided in existing SPAR-H documentation. The steps highlighted in this paper are: Step-1, Categorizing the HFE as Diagnosis and/or Action; Step-2, Rate the Performance Shaping Factors; Step-3, Calculate PSF-Modified HEP; Step-4, Accounting for Dependence, and; Step-5, Minimum Value Cutoff.

Pesticide Substitution: Combining Food Safety with Environmental Quality

DEFF Research Database (Denmark)

Fantke, Peter

2015-01-01

Various pesticides are authorized for use on agricultural food crops. Despite regulatory risk assessments aiming at ensuring consumer and environmental safety, pesticides contribute to human and environmental impacts. Guidance is needed to optimize pesticide use practice and minimize human...... and environmental exposure. Comparative pesticide substitution scenarios are presented to address this need. In a case study on wheat, different pesticides have been compared with respect to their substitution potential with focus on human health. Results demonstrate that health impacts can be reduced up to 99......% by defining adequate substitution scenarios. Comprehensive scenarios need to also consider worker and environmental burden, and information on crop rotation, pest pressure, environmental conditions, application costs and efficacy. Such scenarios help to increase food safety and more sustainable use...

78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

Science.gov (United States)

2013-02-19

...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

Technical efficiency under alternative environmental regulatory regimes : the case of Dutch horticulture

NARCIS (Netherlands)

Vlist, van der A.J.; Withagen, C.A.A.M.; Folmer, H.

2007-01-01

We consider the performance of small and medium sized enterprises in Dutch horticulture under different environmental policy regimes across time. We address the question whether technical performance differs under these alternative regulatory regimes to test Porter's hypothesis that stricter

Guidelines for IAEA International Regulatory Review Teams (IRRTs)

International Nuclear Information System (INIS)

2002-01-01

The IAEA International Regulatory Review Team (IRRT) programme provides advice and assistance to Member States to strengthen and enhance the effectiveness of the nuclear regulatory body whilst recognizing the ultimate responsibility of each Member State for nuclear safety. The IRRT programme, initiated in 1989, is not restricted to any particular group of Member States, whether developing or industrialized, but is available to all countries with nuclear installations in operation or approaching operation. The basic concepts, purposes and functions of a national regulatory body are well recognized in all Member States having a nuclear power programme. The IAEA Safety Standards Series publication entitled 'Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety: Requirements', No. GS-R-1 (2000), provides a general consensus reference for the practices necessary for a national organization to fulfil the regulatory purposes and discharge the regulatory functions. The Requirements also defines the terms used in these guidelines. The guidance given in the Requirements recognizes that the organizational structure and regulatory processes will vary from country to country depending on their existing constitutional, legal and administrative systems; the size and structure of their nuclear programme; the technical skills and professional and financial resources available to their regulatory body, and social customs and cultural traditions. The objective of this report is to provide guidance on the basic structure of an IRRT mission and provide a common reference both across the various areas covered by an IRRT mission and across all the missions in the programme. As such, it is addressed, principally, to the team members of IRRT missions but it also provides guidance to a host regulatory body receiving a mission. This report identifies the objectives of the IRRT mission and sets out the scope of the topic areas that are

Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

Energy Technology Data Exchange (ETDEWEB)

Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A. [Nuclear Regulatory Commission, Washington, DC (United States). Div. of Industrial and Medical Nuclear Safety; Tingle, W. [Dept. of Environment, Health, and Natural Resources, Raleigh, NC (United States). Div. of Radiation Protection

1997-05-01

As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ``Applications for the Use of Sealed Sources in Portable Gauging Devices,`` and in NMSs Policy and guidance Directive 2-07, ``Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.`` This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications.

Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

International Nuclear Information System (INIS)

Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A.; Tingle, W.

1997-05-01

As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ''Applications for the Use of Sealed Sources in Portable Gauging Devices,'' and in NMSs Policy and guidance Directive 2-07, ''Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.'' This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications

Residential surface soil guidance values applied worldwide to the original 2001 Stockholm Convention POP pesticides.

Science.gov (United States)

Jennings, Aaron A; Li, Zijian

2015-09-01

Surface soil contamination is a worldwide problem. Many regulatory jurisdictions attempt to control human exposures with regulatory guidance values (RGVs) that specify a soil's maximum allowable concentration. Pesticides are important soil contaminants because of their intentional toxicity and widespread surface soil application. Worldwide, at least 174 regulatory jurisdictions from 54 United Nations member states have published more than 19,400 pesticide RGVs for at least 739 chemically unique pesticides. This manuscript examines the variability of the guidance values that are applied worldwide to the original 2001 Stockholm Convention persistent organic pollutants (POP) pesticides (Aldrin, Chlordane, DDT, Dieldrin, Endrin, Heptachlor, Mirex, and Toxaphene) for which at least 1667 RGVs have been promulgated. Results indicate that the spans of the RGVs applied to each of these pesticides vary from 6.1 orders of magnitude for Toxaphene to 10.0 orders of magnitude for Mirex. The distribution of values across these value spans resembles the distribution of lognormal random variables, but also contain non-random value clusters. Approximately 40% of all the POP RGVs fall within uncertainty bounds computed from the U.S. Environmental Protection Agency (USEPA) RGV cancer risk model. Another 22% of the values fall within uncertainty bounds computed from the USEPA's non-cancer risk model, but the cancer risk calculations yield the binding (lowest) value for all POP pesticides except Endrin. The results presented emphasize the continued need to rationalize the RGVs applied worldwide to important soil contaminants. Copyright © 2015 Elsevier Ltd. All rights reserved.

[International trend of guidance for nanomaterial risk assessment].

Science.gov (United States)

Hirose, Akihiko

2013-01-01

In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

Strategic Environmental Assessment as catalyst of healthier spatial planning: The Danish guidance and practice

International Nuclear Information System (INIS)

Kornov, Lone

2009-01-01

A wide range of factors within spatial planning can affect health. There is therefore an important scope for Strategic Environmental Assessment (SEA) of spatial plans to protect and improve human health. Due to the EU Directive 2001/42/EC on SEA, health has been made explicit in Danish legislation and guidance. This paper examines the inclusion of health as a formal component in impact assessment of spatial plans. Based upon a documentary study of 100 environmental reports, the paper analyses and discusses how health impact considerations are incorporated in SEA practice. It is found that health impacts are included in SEA practice and are being interpreted in a broader sense than what the national guidance exemplifies. The frequent included health aspects are noise, drinking water, air pollution, recreation/outdoor life and traffic safety. The primary determinant for health is transport-whether it is at the overall or local planning level. The main conclusion is that SEA shows a potential to catalyse healthier spatial planning. Despite the broad inclusion of health in SEA practice the examination shows potential improvements, hereunder qualification of assessments by better explaining the nature and significance of impacts and by including the distributional aspects of human health impacts. Inclusion from the health sector is put forward as an important institutional mean to secure cross disciplinarily and higher quality assessment

Regulatory activities

International Nuclear Information System (INIS)

2001-01-01

This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

Environment, Environmental Restoration, and Waste Management Field Organization Directory

International Nuclear Information System (INIS)

1993-07-01

This directory was developed by the Office of Environmental Guidance, RCRA/CERCLA Division (EH-231) from an outgrowth of the Departments efforts to identify and establish the regulatory response lead persons in the Field Organizations. The directory was developed for intemal EH-231 use to identify both the DOE and DOE contractor Field Organizations in the Environment, Environmental Restoration and Waste Management areas. The Field Organization directory is divided into three substantive sections: (1) Environment; (2) Environmental Restoration; and (3) Waste Management which are organized to correspond to the management hierarchy at each Field Organization. The information provided includes the facility name and address, individual managers name, and telephone/fax numbers

Establishing exemption and clearance criteria by the regulatory authority

International Nuclear Information System (INIS)

Salih, A.E.A.

2012-04-01

This Project work discusses the relationship between the concepts of exemption and clearance, and their practical use in the overall scheme of regulatory control of practices. It also discusses how exemptions and clearance is established and the scope of its applications for regulatory control. The concept of general clearance levels for any type of material and any possible pathway of disposal is also introduced in this work. Guidance of the Group of Experts establishing scenarios for general clearance, parameter values, and a nuclide-specific list of calculated clearance levels is also presented. Regulatory authorities are required to develop guidance on exemption and clearance levels to assist licensees and registrants to know which practices and sources within practices are exempted from regulatory control and those to be cleared from further controls. Exemption and clearance levels are tools for assisting the Regulatory Authority to optimize the use of resources. (author)

Regulatory Control of Radiation Sources. Safety Guide (Arabic Edition)

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

Regulatory review of probabilistic safety assessment (PSA) Level 2

International Nuclear Information System (INIS)

2001-07-01

Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

Guidance for implementing an environmental, safety, and health-assurance program. Volume 15. A model plan for line organization environmental, safety, and health-assurance programs

Energy Technology Data Exchange (ETDEWEB)

Ellingson, A.C.; Trauth, C.A. Jr.

1982-01-01

This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. This particular document presents a model operational-level ES and H Assurance Program that may be used as a guide by an operational-level organization in developing its own plan. The model presented here reflects the guidance given in the total series of 15 documents.

Guidance for modeling causes and effects in environmental problem solving

Science.gov (United States)

Armour, Carl L.; Williamson, Samuel C.

1988-01-01

Environmental problems are difficult to solve because their causes and effects are not easily understood. When attempts are made to analyze causes and effects, the principal challenge is organization of information into a framework that is logical, technically defensible, and easy to understand and communicate. When decisionmakers attempt to solve complex problems before an adequate cause and effect analysis is performed there are serious risks. These risks include: greater reliance on subjective reasoning, lessened chance for scoping an effective problem solving approach, impaired recognition of the need for supplemental information to attain understanding, increased chance for making unsound decisions, and lessened chance for gaining approval and financial support for a program/ Cause and effect relationships can be modeled. This type of modeling has been applied to various environmental problems, including cumulative impact assessment (Dames and Moore 1981; Meehan and Weber 1985; Williamson et al. 1987; Raley et al. 1988) and evaluation of effects of quarrying (Sheate 1986). This guidance for field users was written because of the current interest in documenting cause-effect logic as a part of ecological problem solving. Principal literature sources relating to the modeling approach are: Riggs and Inouye (1975a, b), Erickson (1981), and United States Office of Personnel Management (1986).

Improvements in inservice testing regulatory guidance

Energy Technology Data Exchange (ETDEWEB)

Campbell, P.L.

1996-12-01

Over the last few years, the NRC has issued guidance to licensees toward improving the quality of requests for relief or alternatives to the code requirements and bring some measure of consistency to the implementation of the code requirements. Based on the majority of the recent submittals, the overall quality has improved. If all of the steps in the internal process for responding to the requests are timely, the review of an updated program can be completed in six to nine months. When a single or only a few requests are submitted, the staff is generally able to complete an evaluation in less than three months. When schedules are related to outages or exigent circumstances, the NRC responds accordingly. The improvements in schedules can be attributed to publication of staff guideline documents, licensees` efforts in preparing more complete descriptions and justification and an increase in the number of NRC technical staff reviewers assigned to IST.

Improvements in inservice testing regulatory guidance

International Nuclear Information System (INIS)

Campbell, P.L.

1996-01-01

Over the last few years, the NRC has issued guidance to licensees toward improving the quality of requests for relief or alternatives to the code requirements and bring some measure of consistency to the implementation of the code requirements. Based on the majority of the recent submittals, the overall quality has improved. If all of the steps in the internal process for responding to the requests are timely, the review of an updated program can be completed in six to nine months. When a single or only a few requests are submitted, the staff is generally able to complete an evaluation in less than three months. When schedules are related to outages or exigent circumstances, the NRC responds accordingly. The improvements in schedules can be attributed to publication of staff guideline documents, licensees' efforts in preparing more complete descriptions and justification and an increase in the number of NRC technical staff reviewers assigned to IST

Critical considerations on the environmental protection. On the technical regulatory guide of air

Energy Technology Data Exchange (ETDEWEB)

Rasch, R

1978-11-01

The author critically examines the problem of environmental protection maintaining living conditions even with further development of technology. He deals in detail with the success-promising slogans put forth plastics and hydrochloric acid, nuclear energy, as well as keeping the air clean, sulfur dioxide as main topic from the viewpoint of environmental protection. Furthermore, the technical regulatory guides in maintaining clean air and flue gas purification are treated.

National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.

Science.gov (United States)

Barchi, Francis; Little, Madison T

2016-10-22

Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in

How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

Science.gov (United States)

Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

2017-07-01

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

Assessment of regulatory effectiveness. Peer discussions on regulatory practices

International Nuclear Information System (INIS)

1999-09-01

regulatory approaches of the regulatory body and its organization are important factors. Whilst regulatory effectiveness cannot easily be measured directly, there are various characteristics which can be attributed to an effective regulatory body. These characteristics can be used as indicators. They can also provide guidance on the assessment of regulatory effectiveness. They may also indicate possible fields of enhancement of the effectiveness of a regulatory body. In order to assist Member States in achieving and maintaining a high level of regulatory effectiveness, the IAEA convened the seventh series of peer discussions on 'Assessment of Regulatory Effectiveness'. The results and findings of these discussions are summarized in this report which concentrates on common findings and good practices identified during the discussions. Its intention is primarily to disseminate information on existing experience and to identify beneficial aspects of practices in order to provide guidance to Member States. This report is structured so that it covers the subject matter under the following main headings: Elements of an Effective Regulatory Body; Possible Indicators of Regulatory Effectiveness; Assessment and Suggestions for Good Practices to Enhance Effectiveness. It is important to note that recommendations of good practice are included if they have been identified by at least one of the groups. It does not follow that all of the groups or individual Member States would necessarily endorse all of the recommendations. However, it is considered that if a single group of senior regulators judge that a particular practice is worthy of recommendation, it needs to receive serious consideration. In some cases the same recommendations arise from all of the groups. These are considered to be particularly meritorious

75 FR 70254 - PSD and Title V Permitting Guidance for Greenhouse Gases

Science.gov (United States)

2010-11-17

... Guidance for Greenhouse Gases AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability..., ``PSD and Title V Permitting Guidance for Greenhouse Gases'' on its significant guidance Internet Web... guidance titled, ``PSD and Title V Permitting Guidance for Greenhouse Gases.'' This document has been...

Enterprise-Level Motivations, Regulatory Pressures, and Corporate Environmental Management in Guangzhou, China

Science.gov (United States)

Tang, Shui-Yan; Li, Pansy Honying; Fryxell, Gerald E.; Lo, Carlos Wing-Hung

2015-09-01

This study examines the effects of internal motivations and external pressures on the integration of environmental management (EM) practices within manufacturing operations in China. The moderating role of perceptions toward the regulatory process is also considered along with comparisons between wholly Chinese-owned and foreign-owned enterprises. From a sample of 131 manufacturing companies in the Guangzhou area, it was found that the salience of fees and fines has a strong positive influence on perceptions toward the regulator (the local Environmental Protection Bureau, EPB). This also has a positive effect on perceptions toward regulations themselves for foreign-owned enterprises. Business-case motivations for EM positively shape enterprise perceptions toward regulations, whereas risk-reduction motivations have a negative effect on perceptions toward regulations in foreign-owned enterprises. Enterprise perceptions toward the regulatory process have direct effects on the integration of EM practices in wholly Chinese-owned enterprises, but in opposite directions. While positive perceptions toward regulations have positive influence, positive perceptions toward regulators (i.e., the EPB) negatively affect it. Overall, these results indicated that promoting the adoption of EM practices depends on convincing business leaders that EM practices contribute to profit making. The regulatory process can potentially promote these practices, but measures need to be taken to ensure that the regulator is not co-opted by the regulated, especially in wholly Chinese-owned enterprises.

The future of environmental protection: A U.S. regulator's perspective

International Nuclear Information System (INIS)

Dicus, G.J.

2002-01-01

The U.S. has the largest number of nuclear installations of any country in the world. This puts us at an extreme end of the spectrum. As a result, I have touched on many issues relative to environmental protection. Therefore in summary, let me list these issues: Before moving ahead, look at what has been done thus far. Executive policy and a national regulatory infrastructure. - Environmental Impact Statements. - Environmental Justice. Standards determined by law or courts. Consultation with other national agencies and countries. Improving the timetable for issuing regulations and supporting guidance. Improved communications and training of staff. Transparency and flexibility throughout the regulatory process. Differences in regulatory approaches are OK, as long as the end result is to achieve sound national environmental and public health and safety policy. I believe that this series of conferences represents an excellent opportunity to come to resolution about the future of environmental regulations and policies. Having this information will assist us in harmonizing any proposed recommendation(s) for radiological protection of the environment involving commodities containing radioactive materials or unrestricted release of slightly radioactive materials by using the existing environmental radiation protection framework as a starting point. Doing so in an open, encompassing manner will, in my opinion, go a long way towards resolving some of the current controversies about radiation protection standards in the U.S., as well as around the world, with the desirable end result of increasing public confidence in our environmental radiation protection programs. (author)

75 FR 35510 - License Renewal Interim Staff Guidance Process, Revision 2 Notice of Availability

Science.gov (United States)

2010-06-22

... Related Regulatory Functions.'' An electronic copy of the revised LR-ISG process is available in the NRC's Agencywide Documents Access and Management System (ADAMS) under Accession No. ML100920158. The revised LR-ISG... interim changes to certain NRC license renewal guidance documents. These guidance documents facilitate the...

Environmental Guidance Program Reference Book: American Indian Religious Freedom Act

Energy Technology Data Exchange (ETDEWEB)

1987-11-01

This Reference Book contains a copy of the American Indian Religious Freedom Act and guidance for DOE compliance with the statute. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically.

78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

Science.gov (United States)

2013-09-25

... FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is...

Evaluating physical protection systems of licensed nuclear facilities using systems engineered inspection guidance

International Nuclear Information System (INIS)

Bradley, R.T.; Olson, A.W.; Rogue, F.; Scala, S.; Richard, E.W.

1980-01-01

The Lawrence Livermore National Laboratory (LLNL) and the US Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) have applied a systems engineering approach to provide the NRC Office of Inspection and Enforcement (IE) with improved methods and guidance for evaluating the physical protection systems of licensed nuclear facilities

76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

Science.gov (United States)

2011-01-07

... Web page at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm . FDA guidances are issued and updated regularly. We recommend you check the Web site to ensure that you have the most up-to-date... electronic diaries provided by study subjects. When paper source documents are available for review, tracing...

Single nucleotide polymorphism in transcriptional regulatory regions and expression of environmentally responsive genes

International Nuclear Information System (INIS)

Wang, Xuting; Tomso, Daniel J.; Liu Xuemei; Bell, Douglas A.

2005-01-01

Single nucleotide polymorphisms (SNPs) in the human genome are DNA sequence variations that can alter an individual's response to environmental exposure. SNPs in gene coding regions can lead to changes in the biological properties of the encoded protein. In contrast, SNPs in non-coding gene regulatory regions may affect gene expression levels in an allele-specific manner, and these functional polymorphisms represent an important but relatively unexplored class of genetic variation. The main challenge in analyzing these SNPs is a lack of robust computational and experimental methods. Here, we first outline mechanisms by which genetic variation can impact gene regulation, and review recent findings in this area; then, we describe a methodology for bioinformatic discovery and functional analysis of regulatory SNPs in cis-regulatory regions using the assembled human genome sequence and databases on sequence polymorphism and gene expression. Our method integrates SNP and gene databases and uses a set of computer programs that allow us to: (1) select SNPs, from among the >9 million human SNPs in the NCBI dbSNP database, that are similar to cis-regulatory element (RE) consensus sequences; (2) map the selected dbSNP entries to the human genome assembly in order to identify polymorphic REs near gene start sites; (3) prioritize the candidate polymorphic RE containing genes by searching the existing genotype and gene expression data sets. The applicability of this system has been demonstrated through studies on p53 responsive elements and is being extended to additional pathways and environmentally responsive genes

Tiered guidance for risk-informed environmental health and safety testing of nanotechnologies

International Nuclear Information System (INIS)

Collier, Zachary A.; Kennedy, Alan J.; Poda, Aimee R.; Cuddy, Michael F.; Moser, Robert D.; MacCuspie, Robert I.; Harmon, Ashley; Plourde, Kenton; Haines, Christopher D.; Steevens, Jeffery A.

2015-01-01

Provided the rapid emergence of novel technologies containing engineered nanomaterials, there is a need to better understand the potential environmental, health, and safety effects of nanotechnologies before wide-scale deployment. However, the unique properties of nanomaterials and uncertainty regarding applicable test methods have led to a lack of consensus regarding the collection and evaluation of data related to hazard and exposure potentials. Often, overly conservative approaches to characterization and data collection result in prolonged, unfocused, or irrelevant testing, which increases costs and delays deployment. In this paper, we provide a novel testing guidance framework for determining whether a nanotechnology has the potential to release material with nano-specific parameters that pose a risk to humans or the environment. The framework considers methods to categorize nanotechnologies by their structure and within their relevant-use scenarios to inform testing in a time- and resource-limited reality. Based on the precedent of dredged sediment testing, a five-tiered approach is proposed in which opportunities are presented to conclude testing once sufficient risk-related information has been collected, or that the technology in question does not require nano-specific scrutiny. A series of screening stages are suggested, covering relevant aspects including size, surface area, distribution, unique behaviors, and release potential. The tiered, adaptive guidance approach allows users to concentrate on collecting the most relevant data, thus accelerating technology deployment while minimizing risk

75 FR 63823 - Final Guidance, “Federal Greenhouse Gas Accounting and Reporting”

Science.gov (United States)

2010-10-18

... COUNCIL ON ENVIRONMENTAL QUALITY Final Guidance, ``Federal Greenhouse Gas Accounting and Reporting...''), entitled ``Federal Leadership in Environmental, Energy, and Economic Performance.'' 74 FR 52117, Oct. 8... emissions associated with agency operations. This Final Guidance, ``Federal Greenhouse Gas Accounting and...

Developing site-specific interactive environmental management tools: An exciting method of communicating training, procedures, and other information

Energy Technology Data Exchange (ETDEWEB)

Jaeckels, J.M.

1999-07-01

Environmental managers are faced with numerous programs that must be communicated throughout their organizations. Among these are regulatory training programs, internal environmental policy, regulatory guidance/procedures and internal guidance/procedures. Traditional methods of delivering this type of information are typically confined to written materials and classroom training. There are many challenges faced by environmental managers with these traditional approaches including: determining if recipients of written plans or procedures are reading and comprehending the information; scheduling training sessions to reach all affected people across multiple schedules/shifts; and maintaining adequate training records. In addition, current trends toward performance-based or competency-based training requires a more consistent method of measuring and documenting performance. The use of interactive computer applications to present training or procedural information is a new and exciting tool for delivering environmental information to employees. Site-specific pictures, text, sound, and even video can be combined with multimedia software to create informative and highly interactive applications. Some of the applications that can be produced include integrated environmental training, educational pieces, and interactive environmental procedures. They can be executed from a CD-ROM, hard drive, network or a company Intranet. Collectively, the authors refer to these as interactive environmental management tools (IEMTs). This paper focuses on site-specific, interactive training as an example of an IEMT. Interactive training not only delivers a highly effective message, but can also be designed to focus on site-specific environmental issues that are unique to each company. Interactive training also lends itself well to automated record keeping functions and to reaching all affected employees.

Integrating human health into environmental impact assessment: an unrealized opportunity for environmental health and justice.

Science.gov (United States)

Bhatia, Rajiv; Wernham, Aaron

2008-08-01

The National Environmental Policy Act and related state laws require many public agencies to analyze and disclose potentially significant environmental effects of agency actions, including effects on human health. In this paper we review the purpose and procedures of environmental impact assessment (EIA), existing regulatory requirements for health effects analysis, and potential barriers to and opportunities for improving integration of human health concerns within the EIA process. We use statutes, regulations, guidelines, court opinions, and empirical research on EIA along with recent case examples of integrated health impact assessment (HIA)/EIA at both the state and federal level. We extract lessons and recommendations for integrated HIA/EIA practice from both existing practices as well as case studies. The case studies demonstrate the adequacy, scope, and power of existing statutory requirements for health analysis within EIA. The following support the success of integrated HIA/EIA: a proponent recognizing EIA as an available regulatory strategy for public health; the openness of the agency conducting the EIA; involvement of public health institutions; and complementary objectives among community stakeholders and health practitioners. We recommend greater collaboration among institutions responsible for EIA, public health institutions, and affected stakeholders along with guidance, resources, and training for integrated HIA/EIA practice.

The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

Energy Technology Data Exchange (ETDEWEB)

Hughes, P. J. [HM Nuclear Installations Inspectorate Marine Engineering Submarines Defence Nuclear Safety Regulator Serco Assurance Redgrave Court, Merton Road, Bootle L20 7HS (United Kingdom); Westwood, R.N; Mark, R. T. [FLEET HQ, Leach Building, Whale Island, Portsmouth, PO2 8BY (United Kingdom); Tapping, K. [Serco Assurance,Thomson House, Risley, Warrington, WA3 6GA (United Kingdom)

2006-07-01

The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety cases for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)

Guidance for implementing an environmental, safety, and health assurance program. Volume 10. Model guidlines for line organization environmental, safety and health audits and appraisals

International Nuclear Information System (INIS)

Ellingson, A.C.

1981-10-01

This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. The Standard specifies that the operational level of an institution must have an internal assurance function, and this document provides guidance for the audit/appraisal portion of the operational level's ES and H program. The appendixes include an ES and H audit checklist, a sample element rating guide, and a sample audit plan for working level line organization internal audits

Radiation protection guidance to Federal agencies for occupational exposure. Recommendations approved by the President. Part II The President

International Nuclear Information System (INIS)

Thomas, Lee M.

1987-01-01

This memorandum transmits recommendations that would update previous guidance to Federal agencies for the protection of workers exposed to ionizing radiation. These recommendations were developed cooperatively by the Nuclear Regulatory Commission, the Occupational Safety and Health Administration, the Mine Safety and Health Administration, the Department of Defense, the Department of Energy, the National Aeronautics and Space Administration, the Department of Commerce, the Department of Transportation, the Department of Health and Human Services, and the Environmental Protection Agency. In addition, the National Council on Radiation Protection and Measurements (NCRP), the National Academy of Sciences (NAS), the Conference of Radiation Control Program Directors (CRCPD) of the States, and the Health Physics Society were consulted during the development of this guidance. These recommendations are based on consideration of (1) current scientific understanding of effects on health from ionizing radiation, (2) recommendations of international and national organizations involved in radiation protection, (3) proposed 'Federal Radiation Protection Guidance for Occupational Exposure' published on January 23, 1981 (46 FR 7836) and public comments on that proposed guidance, and (4) the collective experience of the Federal agencies in the control of occupational exposure to ionizing radiation. A summary of the considerations that led to these recommendations is provided

Quantitative Guidance for Stove Usage and Performance to Achieve Health and Environmental Targets.

Science.gov (United States)

Johnson, Michael A; Chiang, Ranyee A

2015-08-01

Displacing the use of polluting and inefficient cookstoves in developing countries is necessary to achieve the potential health and environmental benefits sought through clean cooking solutions. Yet little quantitative context has been provided on how much displacement of traditional technologies is needed to achieve targets for household air pollutant concentrations or fuel savings. This paper provides instructive guidance on the usage of cooking technologies required to achieve health and environmental improvements. We evaluated different scenarios of displacement of traditional stoves with use of higher performing technologies. The air quality and fuel consumption impacts were estimated for these scenarios using a single-zone box model of indoor air quality and ratios of thermal efficiency. Stove performance and usage should be considered together, as lower performing stoves can result in similar or greater benefits than a higher performing stove if the lower performing stove has considerably higher displacement of the baseline stove. Based on the indoor air quality model, there are multiple performance-usage scenarios for achieving modest indoor air quality improvements. To meet World Health Organization guidance levels, however, three-stone fire and basic charcoal stove usage must be nearly eliminated to achieve the particulate matter target (< 1-3 hr/week), and substantially limited to meet the carbon monoxide guideline (< 7-9 hr/week). Moderate health gains may be achieved with various performance-usage scenarios. The greatest benefits are estimated to be achieved by near-complete displacement of traditional stoves with clean technologies, emphasizing the need to shift in the long term to near exclusive use of clean fuels and stoves. The performance-usage scenarios are also provided as a tool to guide technology selection and prioritize behavior change opportunities to maximize impact.

Canadian and international approaches to regulatory effectiveness

International Nuclear Information System (INIS)

Lojk, R.

2014-01-01

Regulatory effectiveness is an important attribute of any regulator, particularly nuclear regulators. As the nuclear industry has matured, and as the social landscape has changed, so have views on what constitutes regulatory effectiveness. Canada has evolved its regulatory structure and modernized its legislative framework and technical requirements and guidance over time. In addition, Canada continues to collaborate with international agencies, particularly the NEA and the IAEA, to ensure that there is a common understanding of the indicators and key attributes of regulatory effectiveness. This paper discusses Canadian and international views on the subject, including perspectives from other industries. (author)

Final environmental and regulatory assessment of using asphalt as a sealant in mine shafts

International Nuclear Information System (INIS)

1987-01-01

This report discusses the properties of asphalt, the current regulatory status governing asphalt and future regulatory implications which may be pertinent in using asphalt as a waterproof shaft sealant. An understanding of the inherent organic composition of asphalt, an increase in the number of health and environmental research publications conducted on asphalt and an examination of the apparent trend of regulatory agencies toward more stringent environmental regulation governing the use of organic materials suggests asphalt could become regulated at a future time. This would only occur, however, if asphalt was found to conform to the present regulatory definitions of pollutants, contaminants or hazardous substances or if asphalt was included on a regulated substance list. In this regard, the study points out that asphalt contains very low levels of hazardous poly-nuclear aromatics (PNA's). These levels are significantly lower than the levels present in coal tars, a substance known to contain high levels of hazardous PNA's. Asphalt, however, has the inherent potential of producing higher concentrations of PNA's if the adverse condition of cracking should occur during the refinery production stage or on-site preparation of the asphalt. Also, unless existing control technology is applied, emission levels of sulfur dioxide, carbon monoxide, particulates and volatile organic carbons from the on-site preparation facilities could approach the permissible health standard levels of EPA. The study indicates, however, that available literature is limited on these issues

Implementation of NUREG-1318 guidance within the Yucca Mountain Project

International Nuclear Information System (INIS)

La Monica, L.B.; Waddell, J.D.; Hardin, E.L.

1990-01-01

The US Department of Energy's Yucca Mountain Project is implementing a quality assurance program that fulfills the requirements of the US Nuclear Regulatory Commission (NRC). Additional guidance for this program was provided in NUREG 1318, ''Technical Position on Items and Activities in the High-Level Waste Geologic Repository Program Subject to Quality Assurance Requirements'' for identification of items and activities important to public radiological safety and waste isolation. The process and organization for implementing this guidance is discussed. 3 refs., 2 figs

Technical efficiency under alternative environmental regulatory regimes: The case of Dutch horticulture

International Nuclear Information System (INIS)

Van der Vlist, Arno J.; Withagen, Cees; Folmer, Henk

2007-01-01

We consider the performance of small and medium sized enterprises in Dutch horticulture under different environmental policy regimes across time. We address the question whether technical performance differs under these alternative regulatory regimes to test Porter's hypothesis that stricter environmental regulation reduces technical inefficiency. For this purpose, we use a stochastic production frontier framework allowing for inclusion of policy variables to measure the effect of alternative environmental policy regimes on firms' performance. The main result is that stricter environmental policy regimes have indeed reduced technical inefficiencies in Dutch horticulture. The estimation results indicate amongst others that the 1997 agreement on energy, nutrient and pesticides use enhances technical efficiency. Firms under the strict environmental policy regime are found to be more technically efficient than those under a lax regime, thereby supporting the claims by Porter and Van der Linde (Porter, M., Van der Linde, C., 1995. Green and Competitive: Ending the stalemate. Harvard Business Review 73, pp. 120-137) concerning Dutch horticulture. (author)

Teaching Negotiation in the Context of Environmental Regulatory Enforcement: An Experiential Learning Approach

Science.gov (United States)

Choy, Marisa S.; Johnson, Stephen A.; Ortolano, Leonard

2011-01-01

This article describes a simulation-based teaching approach that helps university students learn about negotiation in the context of environmental regulatory enforcement. The approach centers on negotiation of a penalty between government agencies and a fictitious corporation that has violated provisions of the U.S. Clean Water Act. The exercise…

Regulatory analysis for amendments to regulations for the environmental review for renewal of nuclear power plant operating licenses. Final report

International Nuclear Information System (INIS)

1996-05-01

This regulatory analysis provides the supporting information for a proposed rule that will amend the Nuclear Regulatory Commission's environmental review requirements for applications for renewal of nuclear power plant operating licenses. The objective of the proposed rulemaking is to improve regulatory efficiency by providing for the generic evaluation of certain environmental impacts associated with nuclear plant license renewal. After considering various options, the staff identified and analyzed two major alternatives. With Alternative A, the existing regulations would not be amended. This option requires that environmental reviews be performed under the existing regulations. Alternative B is to assess, on a generic basis, the environmental impacts of renewing the operating license of individual nuclear power plants, and define the issues that will need to be further analyzed on a case-by-case basis. In addition, Alternative B removes from NRC's review certain economics-related issues. The findings of this assessment are to be codified in 10 CFR 51. The staff has selected Alternative B as the preferred alternative

MGR COMPLIANCE PROGRAM GUIDANCE PACKAGE FOR RADIATION PROTECTION EQUIPMENT, INSTRUMENTATION, AND FACILITIES

International Nuclear Information System (INIS)

2000-01-01

This Compliance Program Guidance Package identifies the regulatory guidance and industry codes and standards addressing radiation protection equipment, instrumentation, and support facilities considered to be appropriate for radiation protection at the Monitored Geologic Repository (MGR). Included are considerations relevant to radiation monitoring instruments, calibration, contamination control and decontamination, respiratory protection equipment, and general radiation protection facilities. The scope of this Guidance Package does not include design guidance relevant to criticality monitoring, area radiation monitoring, effluent monitoring, and airborne radioactivity monitoring systems since they are considered to be the topics of specific design and construction requirements (i.e., ''fixed'' or ''built-in'' systems). This Guidance Package does not address radiation protection design issues; it addresses the selection and calibration of radiation monitoring instrumentation to the extent that the guidance is relevant to the operational radiation protection program. Radon and radon progeny monitoring instrumentation is not included in the Guidance Package since such naturally occurring radioactive materials do not fall within the NRC's jurisdiction at the MGR

The Regulatory Approach for the Assessment of Safety Culture in Germany: A Tool for Practical Use for Inspections

International Nuclear Information System (INIS)

Fassmann, W.; Beck, J.; Kopisch, C.

2016-01-01

Need for methods to assess licencees’ safety culture has been recognised since the Chernobyl accident. Several conferences organized by IAEA and OECD-NEA stated the need for regulatory oversight of safety culture and for suitable methods. In 2013, IAEA published a Technical Document (TECDOC 1707) on the process of safety culture oversight by regulatory authorities which leaves much room for regulators’ ways of performing safety culture oversight. In response to these developments, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) as the federal regulatory body commissioned GRS in 2011 to develop a practical guidance for assessing licencees’ safety culture in the process of regulatory oversight. This research and development project was completed just recently. The publicly available documentation comprises a shorter guidance document with the indispensable information for an appropriate, practical application and a report with more detailed information about the scientific basis of this guidance. To achieve best possible adaptation to regulators’ needs, GRS asked members of the regulatory authority of Baden-Wuerttemberg (one of the federal states of Germany) for comments on a draft of the guidance which was then finalised by duly considering this highly valuable and favorable feedback. Decisions regarding future use rest with German regulatory authorities.

Instream sand and gravel mining: Environmental issues and regulatory process in the United States

Science.gov (United States)

Meador, M.R.; Layher, A.O.

1998-01-01

Sand and gravel are widely used throughout the U.S. construction industry, but their extraction can significantly affect the physical, chemical, and biological characteristics of mined streams. Fisheries biologists often find themselves involved in the complex environmental and regulatory issues related to instream sand and gravel mining. This paper provides an overview of information presented in a symposium held at the 1997 midyear meeting of the Southern Division of the American Fisheries Society in San Antonio, Texas, to discuss environmental issues and regulatory procedures related to instream mining. Conclusions from the symposium suggest that complex physicochemical and biotic responses to disturbance such as channel incision and alteration of riparian vegetation ultimately determine the effects of instream mining. An understanding of geomorphic processes can provide insight into the effects of mining operations on stream function, and multidisciplinary empirical studies are needed to determine the relative effects of mining versus other natural and human-induced stream alterations. Mining regulations often result in a confusing regulatory process complicated, for example, by the role of the U.S. Army Corps of Engineers, which has undergone numerous changes and remains unclear. Dialogue among scientists, miners, and regulators can provide an important first step toward developing a plan that integrates biology and politics to protect aquatic resources.

HUMAN FACTORS GUIDANCE FOR CONTROL ROOM EVALUATION

International Nuclear Information System (INIS)

OHARA, J.; BROWN, W.; STUBLER, W.; HIGGINS, J.; WACHTEL, J.; PERSENSKY, J.J.

2000-01-01

The Human-System Interface Design Review Guideline (NUREG-0700, Revision 1) was developed by the US Nuclear Regulatory Commission (NRC) to provide human factors guidance as a basis for the review of advanced human-system interface technologies. The guidance consists of three components: design review procedures, human factors engineering guidelines, and a software application to provide design review support called the ''Design Review Guideline.'' Since it was published in June 1996, Rev. 1 to NUREG-0700 has been used successfully by NRC staff, contractors and nuclear industry organizations, as well as by interested organizations outside the nuclear industry. The NRC has committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool in the face of emerging and rapidly changing technology. This paper addresses the current research to update of NUREG-0700 based on the substantial work that has taken place since the publication of Revision 1

Regulatory activities; Actividades regulatorias

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-07-01

This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information.

Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2002-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

2012-01-01

The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following two general common positions are discussed and to be issued in this fiscal year. Verification and Validation throughout the life cycle of safety systems using digital computers. The Impact of Cyber Security Features on Digital I and C Safety Systems. (author)

Safety design guides for environmental qualification for CANDU 9

International Nuclear Information System (INIS)

Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young; A. C. D. Wright

1996-03-01

This safety design guide describes the safety philosophy and requirements for the environmental qualification of safety related systems and components for CANDU 9. The environmental qualification program identifies the equipments to be qualified and conditions to be used for qualification and provides comprehensive set of documentation to ensure that the qualification is complete and can be maintained for the life of the plant. A summary of the system, components and structures requiring environmental qualification is provided in the table for the guidance of the system design, and this table will be subject to change or confirmation by the environmental qualification program. Also, plant ares subject to harsh environment is provided in the figure. The change status of the regulatory requirements, code and standards should be traced and this safety design guide shall be updated accordingly. 1 tab., 5 figs. (Author) .new

Review of soil contamination guidance

International Nuclear Information System (INIS)

Mueller, M.A.; Kennedy, W.E. Jr.; Soldat, J.K.

1981-08-01

A review of existing and proposed radioactive soil contamination standards and guidance was conducted for United Nuclear Corporation (UNC), Office of Surplus Facilities Management. Information was obtained from both government agencies and other sources during a literature survey. The more applicable standards were reviewed, evaluated, and summarized. Information pertaining to soil contamination for both facility operation and facility decommissioning was obtained from a variety of sources. These sources included: the Code of Federal Regulations, regulatory guides, the Federal Register, topical reports written by various government agencies, topical reports written by national laboratories, and publications from the American National Standards Institute (ANSI). It was difficult to directly compare the standards and guidance obtained from these sources since each was intended for a specific situation and different units or bases were used. However, most of the information reviewed was consistent with the philosophy of maintaining exposures at levels as low as reasonably achievable

Synthetic fuels and the environment: an environmental and regulatory impacts analysis

Energy Technology Data Exchange (ETDEWEB)

None

1980-06-01

Since July 1979 when DOE/EV-0044 report Environmental Analysis of Synthetic Liquid fuels was published the synthetic fuels program proposals of the Administration have undergone significant modifications. The program year for which the development goal of 1.5 million barrels per day is to be reached has been changed from 1990 to 1995. The program plan is now proposed to have two stages to ensure, among other things, better environmental protection: an initial stage emphasizing applied research and development (R and D), including environmental research, followed by a second stage that would accelerate deployment of those synthetic fuel technologies then judged most ready for rapid deployment and economic operation within the environmental protection requirements. These program changes have significantly expanded the scope of technologies to be considered in this environmental analysis and have increased the likelihood that accelerated environmental R and D efforts will be successful in solving principal environmental and worker safety concerns for most technologies prior to the initiation of the second stage of the accelerated deployment plan. Information is presented under the following section headings: summary; study description; the technologies and their environmental concerns (including, coal liquefaction and gasification, oil shale production, biomass and urban waste conversion); regulatory and institutional analyses; and environmental impacts analysis (including air and water quaility analyses, impacts of carbon dioxide and acid rain, water availability, solid and hazardous wastes, coal mining environmental impacts, transportation issues, community growth and change, and regional impacts). Additional information is presented in seventeen appendixes. (JGB)

Implementation of NUREG 1318 guidance within the Yucca Mountain Project

International Nuclear Information System (INIS)

La Monica, L.B.; Waddell, J.D.; Hardin, E.L.

1990-01-01

This paper discusses the implementation of a quality assurance program that fulfills the requirements of the U.S. Nuclear Regulatory Commission (NRC). Additional guidance for this program was provided in NUREG 1318, Technical Position on Items and Activities in the High-Level Waste Geologic Repository Program Subject to Quality Assurance Requirements for the identification of items and activities important to public radiological safety and waste isolation for placement on a Q-List and Quality Activities List and also for graded application of QA measures. The process and organization for implementing this guidance is discussed

RCRA Programmatic Information Policy and Guidance

Data.gov (United States)

U.S. Environmental Protection Agency — This asset includes program policy and guidance documents that are used by the EPA regions, states, tribes and private parties to implement the hazardous waste...

An overview of regulatory, environmental and social siting considerations

Energy Technology Data Exchange (ETDEWEB)

Jones, Jason [Tetra Tech (United States)

2011-07-01

There is the potential for involvement of different levels of government and many other actors in the location and, finally, the feasibility of a modern wind energy project. This paper gives an overview of the social, regulatory, and environmental considerations that can influence the location of a wind energy project. At the beginning the site has to be identified and wind resources and transmission feasibility have to be assessed. Environmental and engineering issues and public and government acceptability have to be considered. Federal, provincial, local and municipal considerations are discussed. A fatal flaw analysis also known as Critical Issues Analysis (CIA) is performed and the results are given. Constructability issues, telecommunications and aviation screening are omitted from the CIA. Different reasons for setbacks and causes of concern are mentioned and explained. Bird and bat fatalities from collision with turbines are mentioned as a concern. Studies relating to matters of heritage and cultural resources have also been conducted. Finally, issues relating to socioeconomic impact, communications infrastructure and transportation issues are discussed.

Influence of the experimental design of gene expression studies on the inference of gene regulatory networks: environmental factors

Directory of Open Access Journals (Sweden)

Frank Emmert-Streib

2013-02-01

Full Text Available The inference of gene regulatory networks gained within recent years a considerable interest in the biology and biomedical community. The purpose of this paper is to investigate the influence that environmental conditions can exhibit on the inference performance of network inference algorithms. Specifically, we study five network inference methods, Aracne, BC3NET, CLR, C3NET and MRNET, and compare the results for three different conditions: (I observational gene expression data: normal environmental condition, (II interventional gene expression data: growth in rich media, (III interventional gene expression data: normal environmental condition interrupted by a positive spike-in stimulation. Overall, we find that different statistical inference methods lead to comparable, but condition-specific results. Further, our results suggest that non-steady-state data enhance the inferability of regulatory networks.

Advanced alarm system design and human performance: Guidance development and current research

Energy Technology Data Exchange (ETDEWEB)

O` Hara, J M [Brookhaven National Lab., Upton, NY (United States)

1997-09-01

This paper describes a research program sponsored by the U.S. Nuclear Regulatory Commission to address the human factors engineering (HFE) aspects of nuclear power plant alarm systems. The overall objective of the program is to develop HFE review guidance for advanced alarm systems. Guidance has been developed based on a broad base of technical and research literature. As part of the development effort, aspects of alarm system design for which the technical basis was insufficient to support guidance development were identified and prioritized. Research is currently underway to address the highest priority topics: alarm processing and display characteristics. (author). 29 refs, 2 figs.

Advanced alarm system design and human performance: Guidance development and current research

International Nuclear Information System (INIS)

O'Hara, J.M.

1997-01-01

This paper describes a research program sponsored by the U.S. Nuclear Regulatory Commission to address the human factors engineering (HFE) aspects of nuclear power plant alarm systems. The overall objective of the program is to develop HFE review guidance for advanced alarm systems. Guidance has been developed based on a broad base of technical and research literature. As part of the development effort, aspects of alarm system design for which the technical basis was insufficient to support guidance development were identified and prioritized. Research is currently underway to address the highest priority topics: alarm processing and display characteristics. (author). 29 refs, 2 figs

Savannah River Site Environmental Monitoring Plan. Volume 1, Section 1000 Addendum: Revision 3

International Nuclear Information System (INIS)

Jannik, G.T.

1994-01-01

This document -- the Savannah River Site Environmental Monitoring Plan (SRS EM Plan) -- has been prepared according to guidance contained in the DOE 5400 Series orders, in 10 CFR 834, and in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and environmental Surveillance [DOE, 1991]. The SRS EM Plan's purpose is to define the criteria, regulations, and guideline requirements with which SRS will comply. These criteria and requirements are applicable to environmental monitoring activities performed in support of the SRS Environmental Monitoring Program (SRS EM Program), WSRC-3Q1-2, Volume 1, Section 1100. They are not applicable to monitoring activities utilized exclusively for process monitoring/control. The environmental monitoring program requirements documented in the SRS EM Plan incorporate all applicable should requirements of DOE/EH-0173T and expand upon them to include nonradiological environmental monitoring program requirements

Remedial design and remedial action guidance for the Idaho National Engineering Laboratory

International Nuclear Information System (INIS)

1993-10-01

The US Department of Energy, Idaho Operations Office (DOE-ID), the US Environmental Protection Agency, Region X (EPA), and the Idaho Department of Health and Welfare (IDHW) have developed this guidance on the remedial design and remedial action (RD/RA) process. This guidance is applicable to activities conducted under the Idaho National Engineering Laboratory (INEL) Federal Facility Agreement and Consent Order (FFA/CO) and Action Plan. The INEL FFA/CO and Action Plan provides the framework for performing environmental restoration according to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The guidance is intended for use by the DOE-ID, the EPA, and the IDHW Waste Area Group (WAG) managers and others involved in the planning and implementation of CERCLA environmental restoration activities. The scope of the guidance includes the RD/RA strategy for INEL environmental restoration projects and the approach to development and review of RD/RA documentation. Chapter 2 discusses the general process, roles and responsibilities, and other elements that define the RD/RA strategy. Chapters 3 through 7 describe the RD/RA documents identified in the FFA/CO and Action Plan. Chapter 8 provides examples of how this guidance can be applied to restoration projects. Appendices are included that provide excerpts from the FFA/CO pertinent to RD/RA (Appendix A), a applicable US Department of Energy (DOE) orders (Appendix B), and an EPA Engineering ''Data Gaps in Remedial Design'' (Appendix C)

Regulatory control of nuclear power plants

International Nuclear Information System (INIS)

2002-01-01

The purpose of this book is to support IAEA training courses and workshops in the field of regulatory control of nuclear power plants as well as to support the regulatory bodies of Member States in their own training activities. The target group is the professional staff members of nuclear safety regulatory bodies supervising nuclear power plants and having duties and responsibilities in the following regulatory fields: regulatory framework; regulatory organization; regulatory guidance; licensing and licensing documents; assessment of safety; and regulatory inspection and enforcement. Important topics such as regulatory competence and quality of regulatory work as well as emergency preparedness and public communication are also covered. The book also presents the key issues of nuclear safety such as 'defence-in-depth' and safety culture and explains how these should be taken into account in regulatory work, e.g. during safety assessment and regulatory inspection. The book also reflects how nuclear safety has been developed during the years on the basis of operating experience feedback and results of safety research by giving topical examples. The examples cover development of operating procedures and accident management to cope with complicated incidents and severe accidents to stress the importance of regulatory role in nuclear safety research. The main target group is new staff members of regulatory bodies, but the book also offers good examples for more experienced inspectors to be used as comparison and discussion basis in internal workshops organized by the regulatory bodies for refreshing and continuing training. The book was originally compiled on the basis of presentations provided during the two regulatory control training courses in 1997 and 1998. The textbook was reviewed at the beginning of the years 2000 and 2002 by IAEA staff members and consistency with the latest revisions of safety standards have been ensured. The textbook was completed in the

Routine environmental audit of the Hanford Site, Richland, Washington

Energy Technology Data Exchange (ETDEWEB)

1994-05-01

This report documents the results of the routine environmental audit of the Hanford Site (Hanford), Richland, Washington. During this audit, the activities conducted by the audit team included reviews of internal documents an reports from previous audits and assessments; interviews with US Department of Energy (DOE), State of Washington regulatory, and contractor personnel; and inspections and observations of selected facilities and operations. The onsite portion of the audit was conducted May 2--13, 1994, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety and Health (EH). The audit evaluated the status of programs to ensure compliance with Federal, State, and local environmental laws and regulations; compliance with DOE orders, guidance, and directives; and conformance with accepted industry practices and standards of performance. The audit also evaluated the status and adequacy of the management systems developed to address environmental requirements.

Routine environmental audit of the Hanford Site, Richland, Washington

International Nuclear Information System (INIS)

1994-05-01

This report documents the results of the routine environmental audit of the Hanford Site (Hanford), Richland, Washington. During this audit, the activities conducted by the audit team included reviews of internal documents an reports from previous audits and assessments; interviews with US Department of Energy (DOE), State of Washington regulatory, and contractor personnel; and inspections and observations of selected facilities and operations. The onsite portion of the audit was conducted May 2--13, 1994, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety and Health (EH). The audit evaluated the status of programs to ensure compliance with Federal, State, and local environmental laws and regulations; compliance with DOE orders, guidance, and directives; and conformance with accepted industry practices and standards of performance. The audit also evaluated the status and adequacy of the management systems developed to address environmental requirements

Engineering assessment and feasibility study of Chattanooga Shale as a future source of uranium. [Environmental, socioeconomic, regulatory impacts

Energy Technology Data Exchange (ETDEWEB)

1978-06-01

This volume characterizes the major baseline environmental features of the Chattanooga Shale study and projects the effects which may accrue from implementation of a large scale development to recover uranium from the shale. Environmental, socioeconomic, and regulatory impacts are covered. The prototype project is located in Dekalb County in Tennessee. (DLC)

Preparation of safety regulatory requirements for new technology like digital system

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following four general common positions have been discussed in this fiscal year. The Treatment of Common Cause Failure Resulting from Software within Digital Safety Systems, The Treatment of Hardware Description Language(HDL) Programmed Devices for Use in Nuclear Safety System, Factory Acceptance Test and Site Acceptance Test, The Use of Automatic Tests to Perform Surveilance for Digital Systems. (author)

Performance-Based (Risk-Informed) Regulation: A Regulatory Perspective

International Nuclear Information System (INIS)

Kadambi, N. Prasad

2005-01-01

Performance-based regulation (PBR) has been mandated at the national level in the United States and at the agency level, where appropriate, at the U.S. Nuclear Regulatory Commission (USNRC). Guidance has been developed that implements the USNRC's definitions of PBR and other such conceptual regulatory improvements. This paper describes why PBR is important, what constitutes PBR in the context of direction provided at the USNRC, and how PBR can be implemented using a five-step process. The process steps articulate questions to be posed by the analyst regarding various aspects of a regulatory issue so that a suitably performance-based resolution can be developed. A regulatory alternative thus developed can be included among other options to be considered as part of the regulatory decision-making process

Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

International Nuclear Information System (INIS)

Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

2009-06-01

The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

Energy Technology Data Exchange (ETDEWEB)

Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

2009-06-15

The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

Assistance to Oil and Gas State Agencies and Industry through Continuation of Environmental and Production Data Management and a Water Regulatory Initiative

Energy Technology Data Exchange (ETDEWEB)

Grunewald, Ben; Arthur, Dan; Langhus, Bruce; Gillespie, Tom; Binder, Ben; Warner, Don; Roberts, Jim; Cox, D.O.

2002-05-31

This grant project was a major step toward completion of the Risk Based Data Management System (RBDMS) project. Additionally the project addresses the needs identified during the projects initial phases. By implementing this project, the following outcomes were sought: (1) State regulatory agencies implemented more formalized environmental risk management practices as they pertain to the production of oil and gas, and injection via Class II wells. (2) Enhancement of oil and gas production by implementing a management system supporting the saving of abandoned or idle wells located in areas with a relatively low environmental risk of endangering underground sources of drinking water (USDWs) in a particular state. (3) Verification that protection of USDWs is adequate and additional restrictions of requirements are not necessary in areas with a relatively low environmental risk. (4) Standardization of data and information maintained by state regulatory agencies and decrease the regulatory cost burden on producers operating in multiple states, and (5) Development of a system for electronic data transfer among operators and state regulatory agencies and reduction of overall operator reporting burdens.

Environmental Compliance Guide. Guidance manual for Department of Energy compliance with the Clean Water Act: National Pollutant Discharge Elimination System (NPDES)

Energy Technology Data Exchange (ETDEWEB)

1982-07-01

This manual provides general guidance for Department of Energy (DOE) officials for complying with Sect. 402 of the Clean Water Act (CWA) of 1977 and amendments. Section 402 authorizes the US Environmental Protection Agency (EPA) or states with EPA approved programs to issue National Pollutant Discharge Elimination System (NPDES) permits for the direct discharge of waste from a point source into waters of the United States. Although the nature of a project dictates the exact information requirements, every project has similar information requirements on the environmental setting, type of discharge(s), characterization of effluent, and description of operations and wastewater treatment. Additional information requirements for projects with ocean discharges, thermal discharges, and cooling water intakes are discussed. Guidance is provided in this manual on general methods for collecting, analyzing, and presenting information for an NPDES permit application. The NPDES program interacts with many sections of the CWA; therefore, background material on pertinent areas such as effluent limitations, water quality standards, toxic substances, and nonpoint source pollutants is included in this manual. Modifications, variances, and extensions applicable to NPDES permits are also discussed.

Overcoming regulatory and economic challenges facing pharmacogenomics.

Science.gov (United States)

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

Environmental Regulatory Compliance Plan for Site Characterization; Yucca Mountain Site, Nevada Research and Development Area, Nevada: Revision 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1988-12-01

The DOE is committed to conduct its operations in an environmentally safe and sound manner, and will comply with applicable environmental statutes and regulations. These objectives are described in DOE Order 5400.1 (Environmental Protection Program Requirements). This document -- the Environmental Regulatory Compliance Plan (ERCP) -- is one method of implementing the policy set forth in DOE Order 5400.1 and the NWPA. The ERCP describes the plan by which the DOE will comply with applicable Federal environmental statutes and regulations. The ERCP also discusses how DOE will address State and local environmental statutes and regulations. 180 refs., 27 figs., 1 tab.

75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

Science.gov (United States)

2010-04-09

... Guide, DG-8036, ``Personnel Monitoring Device--Direct-Reading Pocket Dosimeters.'' FOR FURTHER.... The draft regulatory guide (DG), entitled, ``Personnel Monitoring Device--Direct-Reading Pocket... this guide included guidance on indirect-reading pocket dosimeters, this guide excludes such dosimeters...

Developing regulatory approaches

International Nuclear Information System (INIS)

Axelsson, Lars

2012-01-01

Lars Axelsson presented SSM progress on oversight of LMfS/SC since the Chester 1 Workshop in 2007. Current SSM approaches for safety culture oversight include targeted safety management and safety culture inspections, compliance inspections which cover aspects of safety management/safety culture and multi-disciplinary team inspections. Examples of themes for targeted inspections include management of ambiguous operational situations or other weak signals, understanding of and attitudes to Human Performance tools, the Safety Department's role and authority and Leadership for safety. All regulatory activities provide inputs for the SSM yearly safety evaluation of each licensee. A form has been developed to capture safety culture observations from inspections and other interactions with licensees. Analysis will be performed to identify patterns and provide information to support planning of specific Safety Culture activities. Training has been developed for regulatory staff to enhance the quality of regulatory interventions on safety culture. This includes a half-day seminar to provide an overview of safety culture, and a workshop which provides more in-depth discussion on cultural issues and how to capture those during regulatory activities. Future plans include guidance for inspectors, and informal seminars on safety culture with licensees

Surface Environmental Surveillance Procedures Manual

International Nuclear Information System (INIS)

Hanf, Robert W.; Poston, Ted M.

2000-01-01

Shows and explains certain procedures needed for surface environmental surveillance. Hanford Site environmental surveillance is conducted by the Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy (DOE) under the Surface Environmental Surveillance Project (SESP). The basic requirements for site surveillance are set fourth in DOE Order 5400.1, General Environmental Protection Program Requirements. Guidance for the SESP is provided in DOE Order 5484.1, Environmental Protection, Safety, and Health Protection Information Reporting Requirements and DOE Order 5400.5, Radiation Protection of the Public and Environment. Guidelines for environmental surveillance activities are provided in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance. An environmental monitoring plan for the Hanford Site is outlined in DOE/RL 91-50 Rev. 2, Environmental Monitoring Plan, United States Department of Energy, Richland Operations Office. Environmental surveillance data are used in assessing the impact of current and past site operations on human health and the environment, demonstrating compliance with applicable local, state, and federal environmental regulations, and verifying the adequacy of containment and effluent controls. SESP sampling schedules are reviewed, revised, and published each calendar year in the Hanford Site Environmental Surveillance Master Sampling Schedule. Environmental samples are collected by SESP staff in accordance with the approved sample collection procedures documented in this manual. Personnel training requirements are documented in SESP-TP-01 Rev.2, Surface Environmental Surveillance Project Training Program.

Guidance for performing preliminary assessments under CERCLA

Energy Technology Data Exchange (ETDEWEB)

NONE

1991-09-01

EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.

Workshop on environmental assessment

International Nuclear Information System (INIS)

Watson, E.C.

1982-07-01

Objectives of the workshop were: to review and evaluate the state-of-the-art of environmental impact assessments as applied to the regulation of applications of nuclear energy and related ancillary systems; to identify areas where existing technology allows establishing acceptable methods or standard practices that will meet the requirements of the NRC regulations, standards and guides for both normal operations and off-standard conditions including accident considerations; to illuminate topics where existing models or analytical methods are deficient because of unverified assumptions, a paucity of empirical data, conflicting results reported in the literature or a need for observation of operation systems; to compile, analyze and synthesize a prioritized set of research needs to advance the state-of-the-art to the level which will meet all of the requirements of the Commission's regulations, standards and guides; and to develop bases for maintaining the core of regulatory guidance at the optimum level balancing technical capabilities with practical considerations of cost and value to the regulatory process. The discussion held in small group sessions on aquatic, atmospheric, and terrestrial pathways are presented. The following research needs were identified as common to all three groups: validation of models; characterization of source terms; development of screening techniques; basis for de minimis levels of contamination; and updating of objectives for environmental monitoring programs

Hazardous Substance Release Reporting Under CERCLA, EPCR {section}304 and DOE Emergency Management System (EMS) and DOE Occurrence Reporting Requirements. Environmental Guidance

Energy Technology Data Exchange (ETDEWEB)

Traceski, T.T.

1994-06-01

Releases of various substances from DOE facilities may be subject to reporting requirements under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the Emergency Planning and Community Right-to-Know Act (EPCRA), as well as DOE`s internal ``Occurrence Reporting and Processing of Operations Information`` and the ``Emergency Management System`` (EMS). CERCLA and EPCPA are Federal laws that require immediate reporting of a release of a Hazardous Substance (HS) and an Extremely Hazardous Substance (EHS), respectively, in a Reportable Quantity (RQ) or more within a 24-hour period. This guidance uses a flowchart, supplemental information, and tables to provide an overview of the process to be followed, and more detailed explanations of the actions that must be performed, when chemical releases of HSs, EHSs, pollutants, or contaminants occur at DOE facilities. This guidance should be used in conjunction with, rather than in lieu of, applicable laws, regulations, and DOE Orders. Relevant laws, regulations, and DOE Orders are referenced throughout this guidance.

Perfluorooctanoic acid (PFOA) - main concerns and regulatory developments in Europe from an environmental point of view

Energy Technology Data Exchange (ETDEWEB)

Vierke, Lena [Federal Environment Agency, Dessau-Rosslau (Germany); Leuphana University of Lueneburg, Lueneburg (Germany); Staude, Claudia; Biegel-Engler, Annegret; Drost, Wiebke; Schulte, Christoph [Federal Environment Agency, Dessau-Rosslau (Germany)

2012-12-15

Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) are the most investigated substances of the group of per- and polyfluorinated chemicals (PFCs). Whereas for PFOS regulatory measures are already in force on international level (inclusion in Stockholm Convention on Persistent Organic Pollutants) such activities are missing for PFOA. The environmental concerns of PFOA, which are summarized in the present study, underline the necessity of regulatory measures on an international level for PFOA. Since it seems more likely to agree on a regulation within the European Union first, a regulatory strategy based on the European chemicals regulation REACH (EC No. 1907/2006), is discussed in the present study. PFOA is persistent in the environment, ubiquitous present in surface waters, and subject to long-range transport. It accumulates in biota, especially in top predators. PFOA is increasingly analyzed in food items, and in drinking water. PFOA's intrinsic properties such as its persistency (P), its potential for bioaccumulation (B) and its toxicity (T) suggest that PFOA is a promising candidate for being identified as a Substance of Very High Concern (SVHC) under REACH. Because of the dispersive occurrence of PFOA in the environment, the presence in imported products, and the use of PFCs, which can degrade to PFOA in various consumer products, a restriction under REACH seems to be the most effective regulatory measure to minimize human and environmental exposure to PFOA in the European Union. Due to its intrinsic properties, PFOA fulfills the REACH PBT-criteria. The next regulatory step will be the identification of PFOA and its ammonium salt (APFO) as SVHC according to REACH and the addition to the REACH Candidate List. As a second step, a restriction proposal will be prepared to include both substances and precursors into REACH Annex XVII. (orig.)

NPP License Renewal and Aging Management: Revised Guidance

International Nuclear Information System (INIS)

Hull, A.B.; Hiser, A.L.; Lindo-Talin, S.E.

2012-01-01

Based on the Atomic Energy Act, the NRC issues licenses for commercial power reactors to operate for up to 40 years and allows these licenses to be renewed for up to another 20 years. NRC has approved license renewal for well over 50% of U.S. located reactors originally licensed to operate for 40 years. Of these 104 reactors (69 PWRs, 35 BWRs), the NRC has issued renewed licenses for 71 units and is currently reviewing applications for another 15 units. As of May 1, 2012, ten plants at nine sites had entered their 41st year of operation and thus are in their first period of extended operation (PEO). Five more plants will enter the PEO by the end of 2012. One foundation of the license renewal process has been license renewal guidance documents (LRGDs). The U.S. Nuclear Regulatory Commission (NRC) revised key guidance documents used for nuclear power license renewal in 2010 and 2011. These include NUREG-1800, 'Standard Review Plan for Review of License Renewal Applications,' revision 2 (SRP-LR), and NUREG-1801, 'Generic Aging Lessons Learned (GALL) Report,' revision 2 (GALL Report). The guidance documents were updated to reflect lessons learned and operating experience gained since the guidance documents were last issued in 2005. (author)

Compliance determination procedures for environmental radiation protection standards for uranium recovery facilities 40 CFR part 190

International Nuclear Information System (INIS)

1982-03-01

Uranium Milling operations are licensed by the Nuclear Regulatory Commission and by some States in agreement with the Commission. The radiation dose to any individual from the operation of facilities within the uranium fuel cycle is limited to levels set by the Environmental Protection Agency. These levels are contained in the EPA Environmental Radiation Protection Standards for Nuclear Power Operations, in Part 190 of Title 40 of the Code of Federal Regulations (40 CFR Part 190). This report describes the procedures used within NRC's Uranium Recovery Licensing Branch for evaluating compliance with these regulations for uranium milling operations. The report contains descriptions of these procedures, dose factors for evaluating environmental measurement data, and guidance to the NRC staff reviewer

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Professional and Regulatory Search

Science.gov (United States)

Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

WODA Technical Guidance on Underwater Sound from Dredging.

Science.gov (United States)

Thomsen, Frank; Borsani, Fabrizio; Clarke, Douglas; de Jong, Christ; de Wit, Pim; Goethals, Fredrik; Holtkamp, Martine; Martin, Elena San; Spadaro, Philip; van Raalte, Gerard; Victor, George Yesu Vedha; Jensen, Anders

2016-01-01

The World Organization of Dredging Associations (WODA) has identified underwater sound as an environmental issue that needs further consideration. A WODA Expert Group on Underwater Sound (WEGUS) prepared a guidance paper in 2013 on dredging sound, including a summary of potential impacts on aquatic biota and advice on underwater sound monitoring procedures. The paper follows a risk-based approach and provides guidance for standardization of acoustic terminology and methods for data collection and analysis. Furthermore, the literature on dredging-related sounds and the effects of dredging sounds on marine life is surveyed and guidance on the management of dredging-related sound risks is provided.

28 CFR 91.53 - Other guidance.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Other guidance. 91.53 Section 91.53 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) GRANTS FOR CORRECTIONAL FACILITIES Environmental... Justice has also published NEPA procedures that incorporate the CEQ regulations at 28 CFR part 61...

Waste Isolation Pilot Plant Environmental Monitoring Plan

International Nuclear Information System (INIS)

2008-01-01

U.S. Department of Energy (DOE) Order 450.1, Environmental Protection Program, requires each DOE site to conduct environmental monitoring. Environmental monitoring at the Waste Isolation Pilot Plant (WIPP) is conducted in order to: (a) Verify and support compliance with applicable federal, state, and local environmental laws, regulations, permits, and orders; (b) Establish baselines and characterize trends in the physical, chemical, and biological condition of effluent and environmental media; (c) Identify potential environmental problems and evaluate the need for remedial actions or measures to mitigate the problems; (d) Detect, characterize, and report unplanned releases; (e) Evaluate the effectiveness of effluent treatment and control, and pollution abatement programs; and (f) Determine compliance with commitments made in environmental impact statements, environmental assessments, safety analysis reports, or other official DOE documents. This Environmental Monitoring Plan (EMP) explains the rationale and design criteria for the environmental monitoring program, extent and frequency of monitoring and measurements, procedures for laboratory analyses, quality assurance (QA) requirements, program implementation procedures, and direction for the preparation and disposition of reports. Changes to the environmental monitoring program may be necessary to allow the use of advanced technology and new data collection techniques. This EMP will document changes in the environmental monitoring program. Guidance for preparation of EMPs is contained in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance.

NPP License Renewal and Aging Management: Revised Guidance

International Nuclear Information System (INIS)

Hull, A.B.; Hiser, A.L.; Lindo-Talin, S.E.

2012-01-01

Based on the Atomic Energy Act, the NRC issues licenses for commercial power reactors to operate for up to 40 years and allows these licenses to be renewed for up to another 20 years. NRC has approved license renewal (LR) for well over 50% of U.S. located reactors originally licensed to operate for 40 years. Of these 104 reactors (69 PWRs, 35 BWRs), the NRC has issued renewed licenses for 71 units and is currently reviewing applications for another 15 units. As of May 1, 2012, ten plants at nine sites had entered their 41st year of operation and thus are in their first period of extended operation (PEO). Five more plants will enter the PEO by the end of 2012. One foundation of the license renewal process has been license renewal guidance documents (LRGDs). The U.S. Nuclear Regulatory Commission (NRC) revised key guidance documents used for nuclear power LR in 2010 and 2011. These include NUREG-1800, 'Standard Review Plan for Review of License Renewal Applications,' revision 2 (SRP-LR), and NUREG-1801, 'Generic Aging Lessons Learned (GALL) Report,' revision 2 (GALL Report). The guidance documents were updated to reflect lessons learned and operating experience gained since the guidance documents were last issued in 2005. The reactor LRGDs referenced in this poster can all be accessed at http://www.nrc.gov/reactors/operating/licensing/renewal/guidance.html (author)

78 FR 1562 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2013-01-08

... agenda incorporates the objective and criteria, when applicable, of the regulatory reform program under the Executive Order and other regulatory guidance. It contains DoD issuances initiated by DoD... statutory administration requirements as required. Starting with the fall 2007 edition, the Internet became...

76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators

Science.gov (United States)

2011-12-01

... for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION: Interim staff guidance; issuance... (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam Generators.'' This LR-ISG provides the...) document, NEI 97-06, ``Steam Generator Program Guidelines,'' (NRC's Agencywide Documents Access and...

Stability of volatile organics in environmental soil samples

Energy Technology Data Exchange (ETDEWEB)

Maskarinec, M.P.; Bayne, C.K.; Jenkins, R.A.; Johnson, L.H.; Holladay, S.K.

1992-11-01

This report focuses on data generated for the purpose of establishing the stability of 19 volatile organic compounds in environmental soil samples. The study was carried out over a 56 day (for two soils) and a 111 day (for one reference soil) time frame and took into account as many variables as possible within the constraints of budget and time. The objectives of the study were: 1) to provide a data base which could be used to provide guidance on pre-analytical holding times for regulatory purposes; and 2) to provide a basis for the evaluation of data which is generated outside of the currently allowable holding times.

Prediction of transcriptional regulatory elements for plant hormone responses based on microarray data

Directory of Open Access Journals (Sweden)

Yamaguchi-Shinozaki Kazuko

2011-02-01

Full Text Available Abstract Background Phytohormones organize plant development and environmental adaptation through cell-to-cell signal transduction, and their action involves transcriptional activation. Recent international efforts to establish and maintain public databases of Arabidopsis microarray data have enabled the utilization of this data in the analysis of various phytohormone responses, providing genome-wide identification of promoters targeted by phytohormones. Results We utilized such microarray data for prediction of cis-regulatory elements with an octamer-based approach. Our test prediction of a drought-responsive RD29A promoter with the aid of microarray data for response to drought, ABA and overexpression of DREB1A, a key regulator of cold and drought response, provided reasonable results that fit with the experimentally identified regulatory elements. With this succession, we expanded the prediction to various phytohormone responses, including those for abscisic acid, auxin, cytokinin, ethylene, brassinosteroid, jasmonic acid, and salicylic acid, as well as for hydrogen peroxide, drought and DREB1A overexpression. Totally 622 promoters that are activated by phytohormones were subjected to the prediction. In addition, we have assigned putative functions to 53 octamers of the Regulatory Element Group (REG that have been extracted as position-dependent cis-regulatory elements with the aid of their feature of preferential appearance in the promoter region. Conclusions Our prediction of Arabidopsis cis-regulatory elements for phytohormone responses provides guidance for experimental analysis of promoters to reveal the basis of the transcriptional network of phytohormone responses.

Continuous improvement of the regulatory framework for the control of medical exposure

International Nuclear Information System (INIS)

Larcher, Ana M.; Ortiz Lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

2008-01-01

One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for more specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need for regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual user of radiation, to enable them compliance with safety standards. Purpose: Within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self-assessment tool for the regulatory control of medical exposure has been designed. Method: National experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are analyzed and a self-assessment approach and possible regulatory solutions a are presented. Results and discussion: In this study the following documents are being produced: 1) transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self-assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (author)

Remedial Investigation/Feasibility Study (RI/FS) process, elements and techniques guidance

Energy Technology Data Exchange (ETDEWEB)

1993-12-01

This manual provides detailed guidance on Remedial Investigation/Feasibility Studies (RI/FSs) conducted pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) at Department of Energy (DOE) facilities. The purpose of the RI/FS, to assess the risk posed by a hazardous waste site and to determine the best way to reduce that risk, and its structure (site characterization, risk assessment, screening and detailed analysis of alternatives, etc.) is defined in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) and further explained in the Environmental Protection Agency`s (EPA`s) Guidance for Conducting Remedial Investigations and Feasibility Studies Under CERCLA (Interim Final) 540/G-89/004, OSWER Directive 9355.3-01, October 1988. Though issued in 1988, the EPA guidance remains an excellent source of information on the conduct and structure of an RI/FS. This document makes use of supplemental RI/FS-related guidance that EPA has developed since its initial document was issued in 1988, incorporates practical lessons learned in more than 12 years of experience in CERCLA hazardous site remediation, and drawing on those lessons, introduces the Streamlined Approach For Environmental Restoration (SAFER), developed by DOE as a way to proceed quickly and efficiently through the RI/FS process at DOE facilities. Thus as its title implies, this guidance is intended to describe in detail the process and component elements of an RI/FS, as well as techniques to manage the RI/FS effectively.

Environmental monitoring for low-level radioactive waste-disposal facilities

International Nuclear Information System (INIS)

Shum, E.Y.; Starmer, R.J.; Westbrook, K.; Young, M.H.

1990-01-01

The U.S. Nuclear Regulatory Commission prepared a Branch Technical Position (BTP) paper on environmental monitoring of a low-level radioactive waste-disposal facility. The BTP provides guidance on what is required in Section 61.53 of 10 CFR Part 61 for those submitting a license application. Guidance is also provided on choosing constituents to measure, setting action levels, relating measurements to appropriate actions in a corrective action plan, and quality assurance. The environmental monitoring program generally consists of three phases: preoperational, operational, and postoperational. Each phase should be designed to fulfill specific objectives defined in the BTP. During the preoperational phase, program objectives are to provide site characterization information, demonstrate site suitability and acceptability, and obtain background or baseline information. Emphasis during the operational phase is on measurement shifts. Monitoring data are obtained to demonstrate compliance with regulations, with dose limits of 10 CFR Part 61, or with applicable U.S. Environmental Protection Agency standards. Data are also used to update important pathway parameters to improve predictions of site performance and to provide a record of performance for public information. The postoperational phase emphasizes measurements to demonstrate compliance with site closure requirements and continued compliance with the performance objective for release. Data are used to support evaluation of long-term impacts to the general public and for public information

Offsite dose calculation manual guidance: Standard radiological effluent controls for pressurized water reactors

International Nuclear Information System (INIS)

Meinke, W.W.; Essig, T.H.

1991-04-01

This report contains guidance which may be voluntarily used by licensees who choose to implement the provision of Generic Letter 89-01, which allows Radiological Effect Technical Specifications (RETS) to be removed from the main body of the Technical Specifications and placed in the Offsite Dose Calculation Manual (ODCM). Guidance is provided for Standard Effluent Controls definitions, Controls for effluent monitoring instrumentation, Controls for effluent releases, Controls for radiological environmental monitoring, and the basis for Controls. Guidance on the formulation of RETS has been available in draft from (NUREG-0471 and -0473) for a number of years; the current effort simply recasts those RETS into Standard Radiological Effluent Controls for application to the ODCM. Also included for completeness are: (1) radiological environmental monitoring program guidance previously which had been available as a Branch Technical Position (Rev. 1, November 1979); (2) existing ODCM guidance; and (3) a reproduction of generic Letter 89-01

Advance notification of shipments of nuclear waste and spent fuel: guidance

International Nuclear Information System (INIS)

1982-06-01

U.S. Nuclear Regulatory Commission regulations in 10 CFR 70.5b and 73.37(f) require NRC licensees to notify the governor of a state prior to making a shipment of nuclear waste or spent fuel within or through the state. This guidance document was prepared to assist licensees in carrying out those requirements

Final generic environmental impact statement on decommissioning of nuclear facilities

International Nuclear Information System (INIS)

1988-08-01

This final generic environmental impact statement was prepared as part of the requirement for considering changes in regulations on decommissioning of commercial nuclear facilities. Consideration is given to the decommissioning of pressurized water reactors, boiling water reactors, research and test reactors, fuel reprocessing plants (FRPs) (currently, use of FRPs in the commercial sector is not being considered), small mixed oxide fuel fabrication plants, uranium hexafluoride conversion plants, uranium fuel fabrication plants, independent spent fuel storage installations, and non-fuel-cycle facilities for handling byproduct, source and special nuclear materials. Decommissioning has many positive environmental impacts such as the return of possibly valuable land to the public domain and the elimination of potential problems associated with increased numbers of radioactively contaminated facilities with a minimal use of resources. Major adverse impacts are shown to be routine occupational radiation doses and the commitment of nominally small amounts of land to radioactive waste disposal. Other impacts, including public radiation doses, are minor. Mitigation of potential health, safety, and environmental impacts requires more specific and detailed regulatory guidance than is currently available. Recommendations are made as to regulatory decommissioning particulars including such aspects as decommissioning alternatives, appropriate preliminary planning requirements at the time of commissioning, final planning requirements prior to termination of facility operations, assurance of funding for decommissioning, environmental review requirements. 26 refs., 7 figs., 68 tabs

75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

Science.gov (United States)

2010-08-16

... provides this draft guidance for public review and comment to ensure accessibility of Federal accounting... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting... recommended Federal GHG reporting and accounting procedures. On April 5, 2010, DOE-FEMP submitted the final...

Regulatory viewpoint on nuclear fuel quality assurance

International Nuclear Information System (INIS)

Tripp, L.E.

1976-01-01

Considerations of the importance of fuel quality and performance to nuclear safety, ''as low reasonably achievable'' release of radioactive materials in reactor effluents, and past fuel performance problems demonstrate the need for strong regulatory input, review and inspection of nuclear fuel quality assurance programs at all levels. Such a regulatory program is being applied in the United States of America by the US Nuclear Regulatory Commission. Quality assurance requirements are contained within government regulations. Guidance on acceptable methods of implementing portions of the quality assurance program is contained within Regulatory Guides and other NRC documents. Fuel supplier quality assurance program descriptions are reviewed as a part of the reactor licensing process. Inspections of reactor licensee control of their fuel vendors as well as direct inspections of fuel vendor quality assurance programs are conducted on a regularly scheduled basis. (author)

Guidance on the application of quality assurance for characterizing a low-level radioactive waste disposal site

International Nuclear Information System (INIS)

Pittiglio, C.L. Jr.; Starmer, R.J.; Hedges, D.

1990-10-01

This document provides the Nuclear Regulatory Commission's staff guidance to an applicant on meeting the quality control (QC) requirements of Title 10 of the Code of Federal Regulations, Part 61, Section 61.12 (10 CFR 61.12), for a low-level waste disposal facility. The QC requirements combined with the requirements for managerial controls and audits are the basis for developing a quality assurance (QA) program and for the guidance provided herein. QA guidance is specified for site characterization activities necessary to meet the performance objectives of 10 CFR Part 61 and to limit exposure to or the release of radioactivity. 1 tab

DEVELOPMENT OF HUMAN FACTORS ENGINEERING GUIDANCE FOR SAFETY EVALUATIONS OF ADVANCED REACTORS

International Nuclear Information System (INIS)

O'HARA, J.; PERSENSKY, J.; SZABO, A.

2006-01-01

Advanced reactors are expected to be based on a concept of operations that is different from what is currently used in today's reactors. Therefore, regulatory staff may need new tools, developed from the best available technical bases, to support licensing evaluations. The areas in which new review guidance may be needed and the efforts underway to address the needs will be discussed. Our preliminary results focus on some of the technical issues to be addressed in three areas for which new guidance may be developed: automation and control, operations under degraded conditions, and new human factors engineering methods and tools

Regulatory Information By Topic

Science.gov (United States)

EPA develops and enforces regulations that span many environmental topics, from acid rain reduction to wetlands restoration. Each topic listed below may include related laws and regulations, compliance enforcement information, policies guidance

Blue Water Footprint Management in a UK Poultry Supply Chain under Environmental Regulatory Constraints

Directory of Open Access Journals (Sweden)

Naoum Tsolakis

2018-02-01

Full Text Available Chicken is the most consumed meat in the UK, accounting for 40% of meat consumption, while national production sufficiency reaches about 80%. As a farmed animal product, chicken meat is responsible for significant freshwater appropriation volumes during its production cycle. In this context, this research aims at exploring freshwater dynamics in the UK processed poultry industry. Specifically, we develop a System Dynamics model to capture the blue water footprint, as a key sustainability performance indicator of a poultry supply chain, in the case that relevant environmental and regulatory constraints are applied. The model contributes towards investigating the impact of two potential policy-making scenarios, namely, the “water penalty” and the “water tax”, on the nexus between profitability and water usage across the poultry supply chain. Responding to the regulatory constraints, the food processor either reconfigures the supply chain through rethinking desired inventory levels or implements a water management intervention. The results indicate that investing in water-friendly production technologies could offer a greater advantage to sustainable supply chains in terms of blue water efficiency and profitability, compared to employing inventory management strategies. Overall, our analysis highlights that effective policy-making and technology-driven interventions could provide potential towards ensuring economic growth and environmental sustainability of the UK poultry sector.

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

Ito, Juichiro; Takita, Masami

2011-01-01

The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG (Digital Instrumentation and Control Working Group) of MDEP (Multinational Design Evaluation Program). MDEP DICWG held in OECD/NEA (Organisation for Economic Co-operation and Development/Nuclear Energy Agency) gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance regarding digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed upon process and framework. Five general common positions are under discussion in this fiscal year. Simplicity in Design, Software Common Cause Failures, Software Tools, Data communication, Verification and Validation throughout the life cycle of safety systems using digital computers. In addition, the technical evaluation of standards of the Japan Electric Association about digital system for safety was made to support NISA (Nuclear and Industrial Safety Agency). (author)

Continuous Improvement of the Regulatory Framework for the Control of Medical Exposure

International Nuclear Information System (INIS)

Larcher, A.M.; Ortiz lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

2011-01-01

Background: One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need of regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual users of radiation, to enable them compliance with safety standards. Purpose: within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self assessment tool for the regulatory control of medical exposure has been designed. Method: national experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are included in national regulations are analyzed and a self assessment approach and possible regulatory solutions are presented. Results and discussion: in tis study the following documents are being produced: 1) Transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (authors)

Environmental evaluation of electric power from a systems perspective. Guidance for sustainable development; Miljoevaerdering av el ur systemperspektiv. En vaegledning foer haallbar utveckling

Energy Technology Data Exchange (ETDEWEB)

Gode, Jenny; Byman, Karin; Persson, Agneta; Trygg, Louise

2009-12-15

The electricity market is deregulated. This means that all electricity customers are free to choose their electricity supplier. Many utilities market renewable electricity products such as wind power or hydroelectric power, saying that the customer makes a contribution to the environment by choosing these products. But is that really true? In this report, four researchers and consultants give an account of their views on how environmental valuation of electricity should be made. Specifically they discusses the driving forces for the development of the electricity system and the purchase of environmentally certified electricity and the link to environmental benefits. An important objective is to provide guidance as to how individuals and businesses through their actions can contribute to sustainable development

The regulatory instruments for the correction of energy-related environmental externalities

International Nuclear Information System (INIS)

Labanderia Villot, X.; Lopez Otero, X.; Rodriguez Mendez, M.

2007-01-01

In this paper we deal with the different regulatory instruments for the correction of energy-related environmental externalities. This objective is justified by the size and general occurrence of this type of externalities in contemporary societies. In this sense, we distinguish between three main generations of instruments: conventional regulations, market mechanisms and voluntary approaches. In all cases, some practical examples of their application are presented, albeit emphasizing the experience with the so-called market instruments and the results of hypothetical simulations for the Spanish case. As a general conclusion we underline the role of economic analysis in the design, choice and evaluation of those mechanisms, which also explains the structure and contents of the article. (Author)

77 FR 14507 - Revision to Guidance, “Federal Greenhouse Gas Accounting and Reporting”

Science.gov (United States)

2012-03-12

... accounting procedures. CEQ provides this draft revision of the guidance for public review and comment to... COUNCIL ON ENVIRONMENTAL QUALITY Revision to Guidance, ``Federal Greenhouse Gas Accounting and..., ``Federal Greenhouse Gas Accounting and Reporting''. SUMMARY: On October 5, 2009, President Obama signed...

Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

Science.gov (United States)

Johnson, F Reed; Zhou, Mo

Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

Science.gov (United States)

2012-04-25

...] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes... Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food... determining whether changes in manufacturing process, including the intentional reduction in particle size to...

Mission Risk Reduction Regulatory Change Management

Science.gov (United States)

Scroggins, Sharon

2007-01-01

NASA Headquarters Environmental Management Division supports NASA's mission to pioneer the future in space exploration, scientific discovery, and aeronautics research by integrating environmental considerations into programs and projects early-on, thereby proactively reducing NASA's exposure to institutional, programmatic and operational risk. As part of this effort, NASA established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) as a resource for detecting, analyzing, and communicating environmental regulatory risks to the NASA stakeholder community. The RRAC PC focuses on detecting emerging environmental regulations and other operational change drivers that may pose risks to NASA programs and facilities, and effectively communicating the potential risks. For example, regulatory change may restrict how and where certain activities or operations may be conducted. Regulatory change can also directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Regulatory change can result in significant adverse impacts to NASA programs and facilities due to NASA's stringent performance requirements for materials and components related to human-rated space vehicles. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented a system for proactively managing regulatory change to minimize potential adverse impacts to NASA programs and facilities. This presentation highlights the process utilized by the RRACPC to communicate regulatory change and the associated

Aligning environmental and regulatory procedures with a holistic project management approach for residue deposits

CSIR Research Space (South Africa)

Snyman, BJ

2006-01-01

Full Text Available ). 1.1 Legislative responses in South Africa The advent of a democratic South Africa has brought about the promulgation of new environmental legislation. This was necessary to give legal effect to the principles of sustainability as laid down.... Often project delays can be ascribed to non-conformance to the legal and regulatory processes, because: • The South African EIA legislative process that is applicable to mine residue deposition does not focus on project management procedures, project...

The regulatory reform in the European Union environmental policy: A first appraisal

International Nuclear Information System (INIS)

Leveque, Francois

1996-01-01

This paper is aimed to outline the expected outcome of the regulatory reform which is occurring in the European Union environmental policy: it intends to point out the new institutional procedures for rulemaking introduced by the Maastricht Treaty and the fifth Programme of Action, which would result in the use of market-based instruments and voluntary approaches oppositely to traditional command and control mechanisms. The paper consists of three sections: while the first one is plainly introductory, the following two sections represent a survey on eight recent pieces of European Union legislation, chiefly directives, showing the systematic decrease in the environmental objectives due to the presence of industrial interest groups, and the new problems affecting public intervention caused by the development of the above mentioned voluntary approaches. Moreover, the former provides an analytical model of a firm's involvement in the policy process, the latter an analytical apparatus on the very nature and failures of self-and co-regulation

Long-Term Stewardship Baseline Report and Transition Guidance

Energy Technology Data Exchange (ETDEWEB)

Kristofferson, Keith

2001-11-01

Long-term stewardship consists of those actions necessary to maintain and demonstrate continued protection of human health and the environment after facility cleanup is complete. As the Department of Energy’s (DOE) lead laboratory for environmental management programs, the Idaho National Engineering and Environmental Laboratory (INEEL) administers DOE’s long-term stewardship science and technology efforts. The INEEL provides DOE with technical, and scientific expertise needed to oversee its long-term environmental management obligations complexwide. Long-term stewardship is administered and overseen by the Environmental Management Office of Science and Technology. The INEEL Long-Term Stewardship Program is currently developing the management structures and plans to complete INEEL-specific, long-term stewardship obligations. This guidance document (1) assists in ensuring that the program leads transition planning for the INEEL with respect to facility and site areas and (2) describes the classes and types of criteria and data required to initiate transition for areas and sites where the facility mission has ended and cleanup is complete. Additionally, this document summarizes current information on INEEL facilities, structures, and release sites likely to enter long-term stewardship at the completion of DOE’s cleanup mission. This document is not intended to function as a discrete checklist or local procedure to determine readiness to transition. It is an overarching document meant as guidance in implementing specific transition procedures. Several documents formed the foundation upon which this guidance was developed. Principal among these documents was the Long-Term Stewardship Draft Technical Baseline; A Report to Congress on Long-Term Stewardship, Volumes I and II; Infrastructure Long-Range Plan; Comprehensive Facility Land Use Plan; INEEL End-State Plan; and INEEL Institutional Plan.

Virtual reality technology for radiation visualisation during the remediation at Andreeva Bay in Russia as support to operational and regulatory supervision - 59400

International Nuclear Information System (INIS)

Mark, Niels-Kristian; Sneve, Malgorzata

2012-01-01

Document available in abstract form only. Full text of publication follows: The Norwegian Radiation Protection Authorities (NRPA) has since 1996 carried out a program of regulatory support projects, funded by the Norwegian Ministry of Foreign Affairs (NMFA) The objective of the program has been to support the Russian civilian and military regulators, the Federal Medical Biological Authorities of Russia (FMBA) and the Federal Environmental, Industrial and Nuclear Supervision Service of Russia, as well as the corresponding nuclear and radiation safety authority within the Russian Ministry of Defense with development and implementation of methods and tools for better regulatory supervision of the Andreeva Bay and Gremikha Sites of Temporary Storage (STS) for Spent Nuclear Fuel (SNF) and Radioactive Waste (RW). In 2005-2009 regulatory investigations were completed at the Andreeva Bay and Gremikha within the collaborative NRPAFMBA program. The radiation and radio-ecological situation was assessed, and criteria and regulations of the STS remediation were developed, as well as the guidance for their application for three possible options of environmental remediation (conservation, conversion and liquidation). As part of the project the Federal Medical-Biological Centre, a technical support organisation to FMBA, developed the DOSEMAP and DATAMAP applications for the FMBA, supporting radiation risk monitoring, worker radiation exposure control

Environmental Impact Statement Filing Guidance

Science.gov (United States)

Describes how to submit an environmental impact statement through the e-NEPA electronic submission system. Describes how EPA submits a notice of availability in to the Federal Register and how the comment time period if set forth.

Stability of volatile organics in environmental soil samples. Final report

Energy Technology Data Exchange (ETDEWEB)

Maskarinec, M.P.; Bayne, C.K.; Jenkins, R.A.; Johnson, L.H.; Holladay, S.K.

1992-11-01

This report focuses on data generated for the purpose of establishing the stability of 19 volatile organic compounds in environmental soil samples. The study was carried out over a 56 day (for two soils) and a 111 day (for one reference soil) time frame and took into account as many variables as possible within the constraints of budget and time. The objectives of the study were: 1) to provide a data base which could be used to provide guidance on pre-analytical holding times for regulatory purposes; and 2) to provide a basis for the evaluation of data which is generated outside of the currently allowable holding times.

Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols

International Nuclear Information System (INIS)

2012-01-01

This publication is aimed at enhancing States' understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that will be supported by detailed guidance and examples in 'Safeguards Implementation Practices' (SIPs) to be published separately.

Inspection and enforcement by the regulatory body for nuclear power plants. A safety guide. A publication within the NUSS programme

International Nuclear Information System (INIS)

1996-01-01

The purpose of this Safety Guide is to provide guidance on fulfilling the requirements for inspection and enforcement by the regulatory body, as set out in the Code on the Safety of Nuclear Power Plants; Governmental Organization. This Safety Guide deals with the responsibilities of the regulatory body, the organization of inspection programmes, the inspection resources of the regulatory body, methods of inspection, requirements on the applicant/licensee in regard to regulatory inspection, inspection reports, and regulatory action and enforcement. It is recognized that many of the provisions of this Safety Guide may be applicable to the regulations of other nuclear facilities and related activities including research reactors, fuel processing and manufacturing plants, irradiated fuel processing plants and radioactive waste management facilities. This Safety Guide does not deal specifically with the functions of a regulatory body responsible for such matters; however, the guidance presented here may be applied as appropriate to these activities. 11 refs, 1 fig

Waste Isolation Pilot Plant Environmental Monitoring Plan

International Nuclear Information System (INIS)

Westinghouse Electric Company Waste Isolation Division

1999-01-01

DOE Order 5400.1, General Environmental Protection Program Requirements (DOE, 1990a), requires each DOE facility to prepare an EMP. This document is prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment (DOE, 1990b); Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) 834, Radiation Protection of the Public and Environment (Draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1 (DOE, 1995), which is the driver for the Annual Site Environmental Report (ASER) and the guidance source for preparing many environmental program documents. The WIPP project is operated by Westinghouse Electric Company, Waste Isolation Division (WID), for the DOE. This plan defines the extent and scope of the WIPP's effluent and environmental monitoring programs during the facility's operational life and also discusses the WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE, 1991). This document references DOE orders and other federal and state regulations affecting environmental monitoring programs at the site. WIPP procedures, which implement

Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

International Nuclear Information System (INIS)

Korsah, Kofi; Wood, Richard Thomas

2008-01-01

To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.

Quality assurance guidance for a low-level radioactive waste disposal facility

International Nuclear Information System (INIS)

Pittiglio, C.L. Jr.; Hedges, D.

1991-04-01

This document provides guidance to an applicant on meeting the quality control (QC) requirements of 10 CFR 61.12(j) for a low-level radioactive waste (LLRW) disposal facility. The QC requirements, plus audits and managerial controls requirements, establish the need for developing a quality assurance (QA) program and the guidance provided herein. The criteria developed for this document are similar to the criteria developed for Appendix B to Title 10 of the Code of Federal Regulations (10 CFR) Part 50. Although Appendix B is not a regulatory requirement for an LLRW disposal facility, the criteria that were developed for 10 CFR Part 50 are basic to any QA program. This document establishes QA guidance for the design, construction, and operation of those structures, engineered or natural systems, and components whose function is required to meet the performance objectives of Subpart C of 10 CFR Part 61 and to limit exposure to or release of radioactivity. 7 refs

Large-scale Topographical Screen for Investigation of Physical Neural-Guidance Cues

Science.gov (United States)

Li, Wei; Tang, Qing Yuan; Jadhav, Amol D.; Narang, Ankit; Qian, Wei Xian; Shi, Peng; Pang, Stella W.

2015-03-01

A combinatorial approach was used to present primary neurons with a large library of topographical features in the form of micropatterned substrate for high-throughput screening of physical neural-guidance cues that can effectively promote different aspects of neuronal development, including axon and dendritic outgrowth. Notably, the neuronal-guidance capability of specific features was automatically identified using a customized image processing software, thus significantly increasing the screening throughput with minimal subjective bias. Our results indicate that the anisotropic topographies promote axonal and in some cases dendritic extension relative to the isotropic topographies, while dendritic branching showed preference to plain substrates over the microscale features. The results from this work can be readily applied towards engineering novel biomaterials with precise surface topography that can serve as guidance conduits for neuro-regenerative applications. This novel topographical screening strategy combined with the automated processing capability can also be used for high-throughput screening of chemical or genetic regulatory factors in primary neurons.

The environmental survey manual

International Nuclear Information System (INIS)

1987-08-01

The purpose of this manual is to provide guidance to the Survey and Sampling and Analysis teams that conduct the one-time Environmental Survey of the major US Department of Energy (DOE) operating facilities. This manual includes a discussion of DOE's policy on environmental issues, a review of statutory guidance as it applies to the Survey, the procedures and protocols to be used by the Survey teams, criteria for the use of the Survey teams in evaluating existing environmental data for the Survey effort, generic technical checklists used in every Survey, health and safety guidelines for the personnel conducting the Survey, including the identification of potential hazards, prescribed protective equipment, and emergency procedures, the required formats for the Survey reports, guidance on identifying environmental problems that need immediate attention by the Operations Office responsible for the particular facility, and procedures and protocols for the conduct of sampling and analysis

Regulatory guidelines for biosimilars in Malaysia.

Science.gov (United States)

Abas, Arpah

2011-09-01

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.

Regulatory instrument review: Management of aging of LWR [light water reactor] major safety-related components

International Nuclear Information System (INIS)

Werry, E.V.

1990-10-01

This report comprises Volume 1 of a review of US nuclear plant regulatory instruments to determine the amount and kind of information they contain on managing the aging of safety-related components in US nuclear power plants. The review was conducted for the US Nuclear Regulatory Commission (NRC) by the Pacific Northwest Laboratory (PNL) under the NRC Nuclear Plant Aging Research (NPAR) Program. Eight selected regulatory instruments, e.g., NRC Regulatory Guides and the Code of Federal Regulations, were reviewed for safety-related information on five selected components: reactor pressure vessels, steam generators, primary piping, pressurizers, and emergency diesel generators. Volume 2 will be concluded in FY 1991 and will also cover selected major safety-related components, e.g., pumps, valves and cables. The focus of the review was on 26 NPAR-defined safety-related aging issues, including examination, inspection, and maintenance and repair; excessive/harsh testing; and irradiation embrittlement. The major conclusion of the review is that safety-related regulatory instruments do provide implicit guidance for aging management, but include little explicit guidance. The major recommendation is that the instruments be revised or augmented to explicitly address the management of aging

Tank waste remediation system environmental program plan

International Nuclear Information System (INIS)

Borneman, L.E.

1998-01-01

This Environmental Program Plan has been developed in support of the Integrated Environmental, Safety and Health Management System and consistent with the goals of DOE/RL-96-50, Hanford Strategic Plan (RL 1996a), and the specifications and guidance for ANSI/ISO 14001-1996, Environmental Management Systems Specification with guidance for use (ANSI/ISO 1996)

Tank waste remediation system environmental program plan

Energy Technology Data Exchange (ETDEWEB)

Borneman, L.E.

1998-01-09

This Environmental Program Plan has been developed in support of the Integrated Environmental, Safety and Health Management System and consistent with the goals of DOE/RL-96-50, Hanford Strategic Plan (RL 1996a), and the specifications and guidance for ANSI/ISO 14001-1996, Environmental Management Systems Specification with guidance for use (ANSI/ISO 1996).

Regulatory inspection of the implementation of quality assurance programmes

International Nuclear Information System (INIS)

1989-01-01

This Manual provides guidance to Member States in the organization and performance of their regulatory inspection functions regarding the implementation of nuclear power plant quality assurance programmes. It addresses the interface between, and is consistent with, the IAEA Nuclear Safety Standards (NUSS programme) documents on quality assurance and governmental organization. The Manual offers a practical model and examples for performing regulatory inspections to ensure that the quality assurance programme is operating satisfactorily in the siting, design, manufacturing, construction, commissioning, operation and decommissioning of nuclear power plants. The primary objective is to confirm that the licensee has the capability to manage and control the effective performance of all quality assurance responsibilities during all phases of a nuclear power project. The guidance provided through this Manual for proper establishment and execution of the regulatory inspections helps to enforce the effective implementation of the quality assurance programme as a management control system that the nuclear industry should establish and use in attaining the safety and reliability objectives for nuclear installations. This enforcement action by national regulatory bodies and the emphasis on the purposes and advantages of quality assurance as an important management tool integrated within the total project task have been recommended by the IAEA International Nuclear Safety Advisory Group (INSAG). The primary intended users of this Manual are the management personnel and high level staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors. They all are inevitable partners in a nuclear power project and this document offers all of them valuable information on the better accomplishment of quality assurance activities to ensure the common objective of safe and reliable nuclear power production

Environmental guidance documents for exploration, development, Production, and transportation of crude oil and natural gas in texas: Quarterly technical report, January 1, 1997-March 31, 1997

International Nuclear Information System (INIS)

Savage, L.

1997-01-01

The following technical report provides a detailed status report of the DOE grant project entitled ''Environmental Guidance Documents for Exploration, Development, Production, and Transportation of Crude Oil and Natural Gas in Texas.'' The grant funding allocated is for the purpose of provided the Railroad Commission of Texas (Commission) with resources and capabilities to draft, publish and distribute documents that provide guidance to oil and gas operators on issues concerning oil and gas naturally occurring radioactive material (NORM) waste, oil and gas hazardous waste, remediation of crude oil spills, management of non-hazardous oil and gas wastes, and mechanical integrity testing of Class II injection and disposal wells

75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

Science.gov (United States)

2010-07-16

... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting... Greenhouse Gas Accounting and Reporting.'' SUMMARY: On October 5, 2009, President Obama signed Executive Order (E.O.) 13514--Federal Leadership in Environmental, Energy, and Economic Performance (74 FR 52117...

Current status of developmental neurotoxicity: regulatory view

DEFF Research Database (Denmark)

Hass, Ulla

2003-01-01

in the testing strategy for new and existing substances, and biocides. Hopefully, this will lead to an improved database for risk assessment of potential developmental neurotoxicants. However, the regulatory authorities and toxicologists will also be faced with the challenge that decisions have to be made......The need for developmental neurotoxicity testing has been recognized for decades and guidelines are available, as the USEPA guideline and the OECD draft TG 426. Regulatory testing of industrial chemicals for developmental neurotoxicity is required to some extent, especially for pesticides in the US....... Until recently, however, developmental neurotoxicity testing of industrial chemicals has not been a clear regulatory requirement in EU, probably due to the lack of an accepted OECD TG. The revised EU Technical Guidance Document for Risk Assessment (EU-TGD) has now included the OECD draft TG 426...

WODA technical guidance on underwater sound from dredging

NARCIS (Netherlands)

Thomsen, F.; Borsani, F.; Clarke, D.; Jong, C. de; Wit, P. de; Goethals, F.; Holtkamp, M.; Martin, E.S.; Spadaro, P.; Raalte, G. van; Victor, G.Y.V.; Jensen, A.

2016-01-01

The World Organization of Dredging Associations (WODA) has identified underwater sound as an environmental issue that needs further consideration. A WODA Expert Group on Underwater Sound (WEGUS) prepared a guidance paper in 2013 on dredging sound, including a summary of potential impacts on aquatic

40 CFR 73.86 - State regulatory autonomy.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...

Nuclear Security Recommendations on Nuclear and Other Radioactive Material out of Regulatory Control: Recommendations

International Nuclear Information System (INIS)

2011-01-01

This publication presents recommendations for the nuclear security of nuclear and other radioactive material that is out of regulatory control. It is based on national experiences and practices and guidance publications in the field of security as well as the nuclear security related international instruments. The recommendations include guidance for States with regard to the nuclear security of nuclear and other radioactive material that has been reported as being out of regulatory control as well as for material that is lost, missing or stolen but has not been reported as such, or has been otherwise discovered. In addition, these recommendations adhere to the detection and assessment of alarms and alerts and to a graded response to criminal or unauthorized acts with nuclear security implications

A guide to approaching regulatory considerations for lentiviral-mediated gene therapies.

Science.gov (United States)

White, Michael; Whittaker, Roger; Stoll, Elizabeth Ann

2017-06-12

Lentiviral vectors are increasingly the gene transfer tool of choice for gene or cell therapies, with multiple clinical investigations showing promise for this viral vector in terms of both safety and efficacy. The third-generation vector system is well-characterized, effectively delivers genetic material and maintains long-term stable expression in target cells, delivers larger amounts of genetic material than other methods, is non-pathogenic and does not cause an inflammatory response in the recipient. This report aims to help academic scientists and regulatory managers negotiate the governance framework to achieve successful translation of a lentiviral vector-based gene therapy. The focus is on European regulations, and how they are administered in the United Kingdom, although many of the principles will be similar for other regions including the United States. The report justifies the rationale for using third-generation lentiviral vectors to achieve gene delivery for in vivo and ex vivo applications; briefly summarises the extant regulatory guidance for gene therapies, categorised as advanced therapeutic medicinal products (ATMPs); provides guidance on specific regulatory issues regarding gene therapies; presents an overview of the key stakeholders to be approached when pursuing clinical trials authorization for an ATMP; and includes a brief catalogue of the documentation required to submit an application for regulatory approval of a new gene therapy.

Co-ordinate regulation of Salmonella typhimurium invasion genes by environmental and regulatory factors is mediated by control of hilA expression.

Science.gov (United States)

Bajaj, V; Lucas, R L; Hwang, C; Lee, C A

1996-11-01

During infection of their hosts, salmonellae enter intestinal epithelial cells. It has been proposed that when Salmonella typhimurium is present in the intestinal lumen, several environmental and regulatory conditions modulate the expression of invasion factors required for bacterial entry into host cells. We report here that the expression of six different S. typhimurium invasion genes encoded on SPI1 (Salmonella pathogenicity island 1) is co-ordinately regulated by oxygen, osmolarity, pH, PhoPQ, and HilA. HilA is a transcriptional activator of the OmpR/ToxR family that is also encoded on SPI1. We have found that HilA plays a central role in the co-ordinated regulation of invasion genes by environmental and regulatory conditions. HilA can activate the expression of two invasion gene-lacZY fusions on reporter plasmids in Escherichia coll, suggesting that HilA acts directly at invasion-gene promoters in S. typhimurium. We have found that the regulation of invasion genes by oxygen, osmolarity, pH, and PhoPQ is indirect and is mediated by regulation of hilA expression by these environmental and regulatory factors. We hypothesize that the complex and co-ordinate regulation of Invasion genes by HilA is an important feature of salmonella pathogenesis and allows salmonellae to enter intestinal epithelial cells.

Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols

International Nuclear Information System (INIS)

2016-01-01

This publication is aimed at enhancing States’ understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that is supported by detailed guidance and examples in safeguards implementation practices presented in other publications in the series. (This version is the 2016 update.)

Regulatory oversight of safety culture in nuclear installations - New IAEA developments

International Nuclear Information System (INIS)

Kerhoas, Anne; )

2012-01-01

Ms. Anne Kerhoas described the IAEA work on guidance for regulatory oversight of safety culture. She summarised the various IAEA, OECD/NEA and ANS meetings that have been held on the topic between 1995 and 2011. The IAEA has carried out two recent projects with the Bulgarian and Romanian regulatory bodies to develop a safety culture oversight program. The work was funded by the Norwegian government and has involved 30 experts from 17 different countries. Draft guidance for regulators on how to monitor licensee safety culture has also been produced (IAEA-TECDOC-DD1070). The document is intended to provide practical guidance on oversight strategies and is applicable to a wide range of nuclear installations, including nuclear power plants, fuel cycle facilities, research reactors and waste management facilities. A number of principles for regulatory oversight of safety culture were summarised. For example, the primary responsibility for safety remains with the licensee, safety culture oversight should be performed at all stages of the life cycle of the nuclear installation, and multiple data collection methods should be used. The overall approach to safety culture described in the draft IAEA Tech doc includes a range of approaches to build up a meaningful picture of the licensee's safety culture. These include interviews, observations, review of documents, review of events, discussions and surveys. The importance of ongoing discussion with the licensee throughout the process to develop a deeper shared understanding of issues was emphasised. The results of the Chester 2 workshop will be used as an input to finalization of the draft Tech Doc

Environmental radioactivity studies and regulatory issues

International Nuclear Information System (INIS)

Abalkina, I.L.; Sarkisov, A.A.; Linge, I.I.; Kazakov, S.V.; Panchenko, S.V.; Savelieva, E.A.

2008-01-01

During the last decades, Russia has developed regulations applying to the territories affected by radioactive contamination. Some regulatory approaches appear to be quite ineffective and contradictory. This paper shows by means of examples the problems and issues associated with some existing situations. A better way for the future is indicated

Regulatory and management requirements for investigation-derived waste generated during environmental investigations and cleanups

International Nuclear Information System (INIS)

Clary, M.B.

1994-01-01

Environmental cleanup efforts often result in the generation of waste materials, such as soil samples, drill cuttings, decontamination water, drilling muds, personal protective equipment, and disposable sampling equipment. The management of associated with site characterization and remediation issues is a complicated issue at many CERCLA/RCRA facilities throughout the country, primarily because of the federal hazardous waste regulations. The hazardous waste regulations were intended to apply to the active generation of hazardous waste at industrial facilities and do not often make sense when applied to sites con by poor disposal practices of the past. In order to manage investigation derived waste in a more rational, logical manner, EPA issued guidance on the management of investigation-derived waste (IDW) at Superfund sites in January, 1992. The basic intent of the EPA guidance is to provide Superfund Site Managers with options for handling, managing, and disposing of IDW. The second part of this paper provides a detailed analysis of current IDW practices at various Department of Energy (DOE) facilities and Superfund sites across the nation. Some sites, particularly the DOE facilities, with more complicated on-going cleanup efforts have developed site-specific written procedures for managing IDW, often incorporating risk assessment. In come cases, these site-specific policies are going farther than the current EPA and Colorado policies in terms of conservatively managing IDW

Regulatory requirements for groundwater monitoring networks at hazardous waste sites

International Nuclear Information System (INIS)

Keller, J.F.

1989-10-01

In the absence of an explicit national mandate to protect groundwater quality, operators of active and inactive hazardous waste sites must use a number of statutes and regulations as guidance for detecting, correcting, and preventing groundwater contamination. The objective of this paper is to provide a framework of the technical and regulatory considerations that are important to the development of groundwater monitoring programs at hazardous waste sites. The technical site-specific needs and regulatory considerations, including existing groundwater standards and classifications, will be presented. 14 refs., 2 tabs

Recommendations to the NRC for review criteria for alternative methods of low-level radioactive waste disposal: Environmental monitoring and surveillance programs

International Nuclear Information System (INIS)

Denham, D.H.; Stenner, R.D.; Eddy, P.A.; Jaquish, R.E.; Ramsdell, J.V. Jr.

1988-07-01

Licensing of a facility for low-level radioactive waste disposal requires the review of the environmental monitoring and surveillance programs. A set of review criteria is recommended for the US Nuclear Regulatory Commission (NRC) staff to use in each monitoring phase---preoperational, operational, and post operational---for evaluating radiological and selected nonradiological parameters in proposed environmental monitoring and surveillance programs at low-level waste disposal facilities. Applicable regulations, industry standards, and technical guidance on low-level radioactive waste are noted throughout the document. In the preoperational phase, the applicant must demonstrate that the environmental monitoring program identifies radiation levels and radionuclide concentrations at the site and also provides adequate basic data on the disposal site. Data recording and statistical analyses for this phase are addressed

Statutory Rewards to Environmental Self-Auditing: Do They Reduce Pollution and Save Regulatory Costs? Evidence from a Cross-State Panel

OpenAIRE

Guerrero, Santiago; Innes, Robert

2008-01-01

State-level statutes provide firms that engage in environmental self-audits, and that self-report their environmental violations, with a variety of different regulatory rewards, including "immunity" from penalties and "privilege" for information contained in self-audits. This paper studies a panel of State-level industries from 1989-2003, in order to determine the effects of the different statutes on toxic pollution and government inspections. We find that, by encouraging self-auditing, privi...

76 FR 7762 - Drinking Water: Regulatory Determination on Perchlorate

Science.gov (United States)

2011-02-11

...-9262-8] RIN 2040-AF08 Drinking Water: Regulatory Determination on Perchlorate AGENCY: Environmental...'s) regulatory determination for perchlorate in accordance with the Safe Drinking Water Act (SDWA... substantial likelihood that perchlorate will occur in public water systems with a frequency and at levels of...

Proposed Guidance for Preparing and Reviewing Molten Salt Nonpower Reactor Licence Applications (NUREG-1537)

Energy Technology Data Exchange (ETDEWEB)

Belles, Randy [ORNL; Flanagan, George F. [ORNL; Voth, Marcus [Boston Government Services, LLC

2018-05-01

Development of non-power molten salt reactor (MSR) test facilities is under consideration to support the analyses needed for development of a full-scale MSR. These non-power MSR test facilities will require review by the US Nuclear Regulatory Commission (NRC) staff. This report proposes chapter adaptations for NUREG-1537 in the form of interim staff guidance to address preparation and review of molten salt non-power reactor license applications. The proposed adaptations are based on a previous regulatory gap analysis of select chapters from NUREG-1537 for their applicability to non-power MSRs operating with a homogeneous fuel salt mixture.

The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

Science.gov (United States)

van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

2015-07-15

Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

Environmental and Source Monitoring for Purposes of Radiation Protection. Safety Guide (Spanish ed.)

International Nuclear Information System (INIS)

2010-01-01

The purpose of this Safety Guide is to provide international guidance, coherent with contemporary radiation protection principles and IAEA safety requirements, on the strategy of monitoring in relation to: (a) control of radionuclide discharges under practice conditions, and (b) intervention, such as in cases of nuclear or radiological emergencies or past contamination of areas with long lived radionuclides. Three categories of monitoring are discussed: monitoring at the source of the discharge (source monitoring), monitoring in the environment (environmental monitoring) and monitoring of individual exposure in emergencies (individual monitoring). The Safety Guide also provides general guidance on assessment of the doses to critical groups of the population due to the presence of radioactive materials or radiation fields in the environment both from routine operation of nuclear and other related facilities (practice) and from nuclear or radiological emergencies and past contamination of areas with long lived radionuclides (intervention). The dose assessments are based on the results of source monitoring, environmental monitoring, individual monitoring or their combinations. This Safety Guide is primarily intended for use by national regulatory bodies and other agencies involved in national systems of radiation monitoring, as well as by operators of nuclear installations and other facilities where natural or human made radionuclides are treated and monitored. Contents: 1. Introduction; 2. Meeting regulatory requirements for monitoring in practices and interventions; 3. Responsibilities for monitoring; 4. Generic aspects of monitoring programmes; 5. Programmes for monitoring in practices and interventions; 6. Technical conditions for monitoring procedures; 7. Considerations in dose assessment; 8. Interpretation of monitoring results; 9. Quality assurance; 10. Recording of results; 11. Education and training; Glossary.

Analysis of costs for compliance with Federal Radiation Protection Guidance for Occupational Exposure. Volume 1: cost of compliance with proposed radiation protection guidance for workers

International Nuclear Information System (INIS)

1983-11-01

On January 23, 1981 the Office of Radiation Programs, U.S. Environmental Protection Agency published in the Federal Register proposals for revisions in the existing Federal Radiation Protection Guidance for Occupational Exposures. This report is a part of the continuing analysis by EPA of the cost/feasibility of the proposed revisions. Specifically, the report evaluates each of the proposed changes in the guidance to estimate the cost of compliance to all segments of the private sector wherein impacts are expected to be significant. This study concentrates its effort on estimating the direct resource costs for each industry that must comply with the regulations that result from the revision to the guidance. These costs that are met by industry participants will account for a significant portion of the total costs associated with the guidance. These costs were estimated through a series of case studies and independent research

rSNPBase 3.0: an updated database of SNP-related regulatory elements, element-gene pairs and SNP-based gene regulatory networks.

Science.gov (United States)

Guo, Liyuan; Wang, Jing

2018-01-04

Here, we present the updated rSNPBase 3.0 database (http://rsnp3.psych.ac.cn), which provides human SNP-related regulatory elements, element-gene pairs and SNP-based regulatory networks. This database is the updated version of the SNP regulatory annotation database rSNPBase and rVarBase. In comparison to the last two versions, there are both structural and data adjustments in rSNPBase 3.0: (i) The most significant new feature is the expansion of analysis scope from SNP-related regulatory elements to include regulatory element-target gene pairs (E-G pairs), therefore it can provide SNP-based gene regulatory networks. (ii) Web function was modified according to data content and a new network search module is provided in the rSNPBase 3.0 in addition to the previous regulatory SNP (rSNP) search module. The two search modules support data query for detailed information (related-elements, element-gene pairs, and other extended annotations) on specific SNPs and SNP-related graphic networks constructed by interacting transcription factors (TFs), miRNAs and genes. (3) The type of regulatory elements was modified and enriched. To our best knowledge, the updated rSNPBase 3.0 is the first data tool supports SNP functional analysis from a regulatory network prospective, it will provide both a comprehensive understanding and concrete guidance for SNP-related regulatory studies. © The Author(s) 2017. Published by Oxford University Press on behalf of Nucleic Acids Research.

Environment and T regulatory cells in allergy.

Science.gov (United States)

Braga, M; Schiavone, C; Di Gioacchino, G; De Angelis, I; Cavallucci, E; Lazzarin, F; Petrarca, C; Di Gioacchino, M

2012-04-15

The central role of T regulatory cells in the responses against harmless environmental antigens has been confirmed by many studies. Impaired T regulatory cell function is implicated in many pathological conditions, particularly allergic diseases. The "hygiene hypothesis" suggests that infections and infestations may play a protective role for allergy, whereas environmental pollutants favor the development of allergic diseases. Developing countries suffer from a variety of infections and are also facing an increasing diffusion of environmental pollutants. In these countries allergies increase in relation to the spreading use of xenobiotics (pesticides, herbicides, pollution, etc.) with a rate similar to those of developed countries, overcoming the protective effects of infections. We review here the main mechanisms of non-self tolerance, with particular regard to relations between T regulatory cell activity, infections and infestations such as helminthiasis, and exposure to environmental xenobiotics with relevant diffusion in developing countries. Copyright © 2010 Elsevier B.V. All rights reserved.

75 FR 8412 - Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of...

Science.gov (United States)

2010-02-24

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0047] Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of Accidental Radionuclide Releases; Solicitation of Public... ground water flow and transport of accidental radionuclide releases necessary to demonstrate compliance...

Development of regulatory procedures for the disposal of solid radioactive waste in deep, continental formations

International Nuclear Information System (INIS)

1980-01-01

For the disposal of radioactive waste, and in particular, of the high-level and alpha-bearing waste from the nuclear fuel cycle, the most favoured solution in most countries is disposal in deep, continental geological formations. Commitment to this disposal method involves a number of issues related to the various stages of the disposal programme which must be addressed through some reasoned decision-making process. Most countries are opting for regulating such a programme through licensing actions by a body whose purpose is to review, certify and ensure the safety of all the stages of the disposal programme. This regulatory body may either be one single national authority or a system of authorities designated by the government. The key to such regulation is the set of procedures, determined in advance, for the actions of the implementing organization, the review by the regulatory body and the involvement of other parties. This document concerns itself with the procedures which could logically be followed in reaching a set of rational decisions by the regulatory body. Care in the preparation and application of such procedures is an important element in the acceptability of the concept, the site and the other aspects of the disposal programme. The intention of this document is to give guidance as to what issues should be addressed in the licensing review, what decision points are important, and what guidance should be given to the applicant by the regulatory body in the course of the licensing actions. The procedures are keyed to be designed according to the logical steps involved in the development and operation of the repository. However, the document does not pretend to give guidance regarding the optimal interactions between the implementing organization and the regulatory body. This document is oriented to the disposal of solid radioactive waste in deep, continental geological formations using mining techniques

76 FR 10205 - Department of Homeland Security Implementation of OMB Guidance on Drug-Free Workplace Requirements

Science.gov (United States)

2011-02-24

... Flexibility Act, 5 U.S.C. 605(b), as amended by the Small Business Regulatory Enforcement and Fairness Act of... Guidance on Drug-Free Workplace Requirements AGENCY: Department of Homeland Security (DHS). ACTION: Final... consolidate all Federal regulations on drug-free workplace requirements for financial assistance into one...

Guidance manual for conducting technology demonstration activities

International Nuclear Information System (INIS)

Jolley, R.L.; Morris, M.I.; Singh, S.P.N.

1991-12-01

This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety

Guidance manual for conducting technology demonstration activities

Energy Technology Data Exchange (ETDEWEB)

Jolley, Robert L.; Morris, Michael I.; Singh, Suman P.N.

1991-12-01

This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety.

Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols (Spanish Edition)

International Nuclear Information System (INIS)

2015-01-01

This publication is aimed at enhancing States’ understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that will be supported by detailed guidance and examples in ‘Safeguards Implementation Practices’ (SIPs) to be published separately

Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols (Arabic Edition)

International Nuclear Information System (INIS)

2017-01-01

This publication is aimed at enhancing States’ understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that will be supported by detailed guidance and examples in ‘Safeguards Implementation Practices’ (SIPs) to be published separately.

National legislative and regulatory activities

International Nuclear Information System (INIS)

2012-01-01

This section gathers the following national legislative and regulatory activities sorted by country: Bulgaria: General legislation; Czech Republic: General legislation; France: General legislation, Regulatory infrastructure and activity; Germany: General legislation; India: Liability and compensation, Organisation and structure; Ireland: Radiation protection, General legislation; Korea (Republic of): Organisation and structure; Lithuania: Regulatory infrastructure and activity, Radioactive waste management, Radiation protection, international cooperation, Nuclear safety; Poland: General legislation; Romania: Environmental protection; Russian Federation: Radioactive waste management; Slovenia: Nuclear safety; Spain: Liability and compensation, Nuclear security; Sweden: Nuclear safety; Turkey: Radiation protection, Regulatory infrastructure and activity, Nuclear safety, Liability and compensation; United States: General legislation

Regulatory compliance issues related to the White Oak Creek Embayment time-critical removal action

International Nuclear Information System (INIS)

Leslie, M.; Kimmel, B.L.

1992-01-01

In September 1990, Martin Marietta Energy Systems (Energy Systems) discovered high levels of Cesium-137 present in surface sediments at the mouth of White Oak Creek (WOC) Embayment. WOC receives the majority of surface water drainage from Oak Ridge National Laboratory. Following this discovery, the Department of Energy (DOE) and Energy Systems pursued stabilizing sediment migration under provisions of the National Contingency Plan (NCP) Section 300.400 et. seq. as a time-critical removal action. However, significant uncertainty exists concerning the applicability of NCP procedural requirements designed for conducting US EPA-led, Superfund-financed response actions, because NCP Subpart K dealing with response actions at federal facilities has not been promulgated. In addition, relatively new guidance exists from DOE concerning National Environmental Policy Act documentation requirements for categorical exclusions associated with conducting removal actions at DOE facilities. A proactive approach was taken to identify issues and involve appropriate state and federal regulatory agencies. This approach required achieving consensus among all involved parties and identification of all applicable or relevant and appropriate regulatory requirements related to the removal action. As a result, this project forms a framework for conducting future time-critical removal actions at federal facilities

Hanford Site National Environmental Policy Act (NEPA) Characterization Report, Revision 17

Energy Technology Data Exchange (ETDEWEB)

Neitzel, Duane A.; Bunn, Amoret L.; Cannon, Sandra D.; Duncan, Joanne P.; Fowler, Richard A.; Fritz, Brad G.; Harvey, David W.; Hendrickson, Paul L.; Hoitink, Dana J.; Horton, Duane G.; Last, George V.; Poston, Ted M.; Prendergast-Kennedy, Ellen L.; Reidel, Steve P.; Rohay, Alan C.; Sackschewsky, Michael R.; Scott, Michael J.; Thorne, Paul D.

2005-09-30

. Information in Chapter 6 of this document can be adapted and supplemented with specific information for a chapter covering statutory and regulatory requirements in an environmental assessment or environmental impact statement. When preparing environmental assessments and EISs, authors should also be cognizant of the document titled Recommendations for the Preparation of Environmental Assessments and Environmental Impact Statements published by the DOE Office of NEPA Oversight (DOE 2004). Additional guidance on preparing DOE NEPA documents can be found at http://tis.eh.doe.gov/nepa/guidance.html. Any interested individual seeking baseline data on the Hanford Site and its past activities may also use the information contained in this document to evaluate projected activities and their impacts. For this 2005 revision, the following sections of the document were reviewed by the authors and updated with the best available information through May 2005: Climate and Meteorology Air Quality Geology – Seismicity section only Hydrology – Flow charts for the Columbia and Yakima rivers only Ecology – Threatened and Endangered Species subsection only Socioeconomics Occupational Safety All of Chapter 6.

The Safety Culture of an Effective Nuclear Regulatory Body

International Nuclear Information System (INIS)

Carlsson, Lennart; Bernard, Benoit; Lojk, Robert; Koskinen, Kaisa; Rigail, Anne-Cecile; Stoppa, Gisela; Lorand, Ferenc; Aoki, Masahiro; Fujita, Kenichi; Takada, Hiroko; Kurasaki, Takaaki; Choi, Young Sung; Smit, Martin; Bogdanova, Tatiana; Sapozhnikov, Alexander; Smetnik, Alexander; Cid Campo, Rafael; Axelsson, Lars; Carlsson, Lennart; Edland, Anne; Ryser, Cornelia; Cohen, Miriam; Ficks, Ben; Valentin, Andrea; Nicic, Adriana; Lorin, Aurelie; Nezuka, Takayoshi; Creswell, Len

2016-01-01

The fundamental objective of all nuclear safety regulatory bodies is to ensure that activities related to the peaceful use of nuclear energy are carried out in a safe manner within their respective countries. In order to effectively achieve this objective, the nuclear regulatory body requires specific characteristics, one of which is a healthy safety culture. This regulatory guidance report describes five principles that support the safety culture of an effective nuclear regulatory body. These principles concern leadership for safety, individual responsibility and accountability, co-operation and open communication, a holistic approach, and continuous improvement, learning and self-assessment. The report also addresses some of the challenges to a regulatory body's safety culture that must be recognised, understood and overcome. It provides a unique resource to countries with existing, mature regulators and can be used for benchmarking as well as for training and developing staff. It will also be useful for new entrant countries in the process of developing and maintaining an effective nuclear safety regulator. (authors)

Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

Science.gov (United States)

Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

2017-12-01

Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

EMP Attachment 3 DOE-SC PNNL Site Dose Assessment Guidance

Energy Technology Data Exchange (ETDEWEB)

Snyder, Sandra F.

2011-12-21

This Dose Assessment Guidance (DAG) describes methods to use to determine the Maximally-Exposed Individual (MEI) location and to estimate dose impact to that individual under the U.S. Department of Energy Office of Science (DOE-SC) Pacific Northwest National Laboratory (PNNL) Site Environmental Monitoring Plan (EMP). This guidance applies to public dose from radioactive material releases to the air from PNNL Site operations. This document is an attachment to the Pacific Northwest National Laboratory (PNNL) Environmental Monitoring Plan (EMP) and describes dose assessment guidance for radiological air emissions. The impact of radiological air emissions from the U.S. Department of Energy Office of Science (DOE-SC) PNNL Site is indicated by dose estimates to a maximally exposed member of the public, referred to as the maximally exposed individual (MEI). Reporting requirements associated with dose to members of the public from radiological air emissions are in 40 CFR Part 61.94, WAC 246-247-080, and DOE Order 458.1. The DOE Order and state standards for dose from radioactive air emissions are consistent with U.S. Environmental Protection Agency (EPA) dose standards in 40 CFR 61.92 (i.e., 10 mrem/yr to a MEI). Despite the fact that the current Contract Requirements Document (CRD) for the DOE-SC PNNL Site operations does not include the requirement to meet DOE CRD 458.1, paragraph 2.b, public dose limits, the DOE dose limits would be met when EPA limits are met.

Environmental Compliance Issue Coordination

Science.gov (United States)

An order to establish the Department of Energy (DOE) requirements for coordination of significant environmental compliance issues to ensure timely development and consistent application of Departmental environmental policy and guidance

Inspection and enforcement by the regulatory body for nuclear power plants

International Nuclear Information System (INIS)

1980-01-01

This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Code of Practice on Governmental Organization for the Regulation of Nuclear Power Plants, IAEA Safety Series No.50-C-G and should be used in conjunction with that document. The purpose of this Guide is to provide information, guidance and recommendations to assist Member States in (1) establishing and conducting a regulatory inspection programme for nuclear power plants, (2) establishing requirements for the applicant/licensee in regard to regulatory inspection, (3) establishing a system for enforcing compliance with the requirements and decisions of the regulatory body

Comprehensive Environmental Response, Compensation, and Liability Act, as amended by the Superfund Amendments and Reauthorization Act Section 120(e)(5)

International Nuclear Information System (INIS)

1992-05-01

The US Department of Energy (DOE) is committed to conducting its operations. In a safe and environmentally sound manner. High priorities for the Department are identifying and correcting environmental problems at DOE facilities that resulted from past operations, and preventing environmental problems from occurring during present and future operations. In this regard, the Department is committed to the 30-year goal of cleanup of all facilities by the year 2019. DOE has issued an Order and guidance establishing policy and procedures for activities conducted under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended by the Superfund Amendments and Reauthorization Act (SARA), and has developed a Five-Year Plan, updated annually, that integrates planing for corrective activities, environmental restoration, and waste management operations at its facilities. During Calendar Year 1991 and early 1992, DOE made significant progress in reaching agreements with regulatory entities, undertaking cleanup actions, and initiating preventive measures designed to eliminate future environmental problems. These accomplishments are described

European regulatory tools for advanced therapy medicinal products.

Science.gov (United States)

Flory, Egbert; Reinhardt, Jens

2013-12-01

Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

Challenges in long-term operation of nuclear power plants - Implications for regulatory bodies

International Nuclear Information System (INIS)

Soda, Kunihisa; Van Wonterghem, Frederik; Khouaja, Hatem; Vilpas, Martti; Osouf, Nicolas; Harikumar, S.; Ishigaki, Hiroki; Osaki, Toru; Yamada, Tomoho; Carlsson, Lennart; Shepherd, David; Galloway, Melanie; Liszka, Ervin; Svab, Miroslav; Pereira, Ken; Huerta, Alejandro

2012-01-01

Nuclear power reactors have become a major source of electricity supply in many countries in the past half a century. Based on this experience, many operators have sought and have received authorisation for long-term operation, whereby plant operation continues beyond the period considered in the design of the plant. Acceptance of a nuclear power plant for extended service should be based on assurance of the fitness of the plant and the operator for safe and reliable operation over the entire period considered for long-term operation. This assurance may be obtained by establishment of appropriate regulatory requirements, specification of goals and safety levels and regulatory assessment and oversight of the operator's programme for long-term operation. The operators and regulators should ensure that operating experience continues to be evaluated during long-term operation to ensure that any relevant lessons are effectively applied. Other considerations for assurance of safe operation are effective management of ageing, possible need for safety improvements, application of lessons learnt from operating experience, evaluation of environmental impacts, adequate staff resources and performance, review of security at the plant, action in response to emerging issues, and openness and transparency in the transition to long-term operation. Even though most of these considerations are addressed under the regulatory framework that applies to the initial operating period, additional regulatory activities in these areas may be necessary for long-term operation. Although there can be significant differences in regulatory approaches used by different countries for evaluating acceptability of long-term operation, there is general agreement on the purposes and goals of the regulatory reviews. An authorisation of long-term operation could involve a licence renewal or a periodic safety review or an approach that melds elements of both. This report presents guidance that is intended

GUIDANCE FOR NUCLEAR POWER PLANT CONTROL ROOM AND HUMAN-SYSTEM INTERFACE MODERNIZATION

International Nuclear Information System (INIS)

Naser, J.; Morris, G.

2004-01-01

Several nuclear power plants in the United States are starting instrumentation and control (I and C) modernization programs using digital equipment to address obsolescence issues and the need to improve plant performance while maintaining high levels of safety. As an integral part of the I and C modernization program at a nuclear power plant, the control room and other human-system interfaces (HSIs) are also being modernized. To support safe and effective operation, it is critical to plan, design, implement, train for, operate, and maintain the control room and HSI changes to take advantage of human cognitive processing abilities. A project, jointly funded by the Electric Power Research Institute (EPRI) and the United States Department of Energy (DOE) under the Nuclear Energy Plant Optimization (NEPO) Program, is developing guidance for specifying and designing control rooms, remote shut-down panels, HSIs etc. The guidance is intended for application by utilities and suppliers of control room and HSI modernization. The guidance will facilitate specification, design, implementation, operations, maintenance, training, and licensing activities. This guidance will be used to reduce the likelihood of human errors and licensing risk, to gain maximum benefit of implemented technology, and to increase performance. The guidance is of five types. The first is planning guidance to help a utility develop its plant-specific control room operating concepts, its plant-specific endpoint vision for the control room, its migration path to achieve that endpoint vision, and its regulatory, licensing, and human factors program plans. The second is process guidance for general HSI design and integration, human factors engineering analyses, verification and validation, in-service monitoring processes, etc. The third is detailed human factors engineering guidance for control room and HSI technical areas. The fourth is guidance for licensing. The fifth is guidance for special topics

76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Science.gov (United States)

2011-12-02

... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

Nuclear Security Recommendations on Nuclear and other Radioactive Material out of Regulatory Control: Recommendations (Spanish Edition)

International Nuclear Information System (INIS)

2012-01-01

This publication presents recommendations for the nuclear security of nuclear and other radioactive material that is out of regulatory control. It is based on national experiences and practices and guidance publications in the field of security as well as the nuclear security related international instruments. The recommendations include guidance for States with regard to the nuclear security of nuclear and other radioactive material that has been reported as being out of regulatory control as well as for material that is lost, missing or stolen but has not been reported as such, or has been otherwise discovered. In addition, these recommendations adhere to the detection and assessment of alarms and alerts and to a graded response to criminal or unauthorized acts with nuclear security implications.

Nuclear Security Recommendations on Nuclear and Other Radioactive Material out of Regulatory Control: Recommendations (Arabic Edition)

International Nuclear Information System (INIS)

2012-01-01

This publication presents recommendations for the nuclear security of nuclear and other radioactive material that is out of regulatory control. It is based on national experiences and practices and guidance publications in the ? field of security as well as the nuclear security related international instruments. The recommendations include guidance for States with regard to the nuclear security of nuclear and other radioactive material that has been reported as being out of regulatory control as well as for material that is lost, missing or stolen but has not been reported as such, or has been otherwise discovered. In addition, these recommendations adhere to the detection and assessment of alarms and alerts and to a graded response to criminal or unauthorized acts with nuclear security implications.

Nuclear Security Recommendations on Nuclear and Other Radioactive Material out of Regulatory Control: Recommendations (Russian Edition)

International Nuclear Information System (INIS)

2011-01-01

This publication presents recommendations for the nuclear security of nuclear and other radioactive material that is out of regulatory control. It is based on national experiences and practices and guidance publications in the field of security as well as the nuclear security related international instruments. The recommendations include guidance for States with regard to the nuclear security of nuclear and other radioactive material that has been reported as being out of regulatory control as well as for material that is lost, missing or stolen but has not been reported as such, or has been otherwise discovered. In addition, these recommendations adhere to the detection and assessment of alarms and alerts and to a graded response to criminal or unauthorized acts with nuclear security implications.

Hazardous waste management system--Environmental Protection Agency. Notice of regulatory reform actions; request for comments.

Science.gov (United States)

1982-12-13

In response to Executive Order 12291 and the President's Task Force on Regulatory Relief, the Environmental Protection Agency is reviewing and reassessing the hazardous waste regulations developed under the Resource Conservation and Recovery Act (RCRA). A variety of activities are underway that will simplify procedures and reduce paperwork, modify existing regulations to make them more workable and cost effective, and control new wastes and new processes. The purpose of this notice is to inform the public of these activities and invite comments on the general approaches being taken.

Guidance documents relating to landfills and contaminants

Energy Technology Data Exchange (ETDEWEB)

Schomaker, N.B.; Zunt, D.A.

1990-01-01

The Environmental Protection Agency is developing and updating a series of Technical Guidance Documents to provide best engineering control technology to meet the needs of the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), respectively. These documents are the compilation of the research efforts to date relating to containment of pollutants from waste disposal to the land as relates to residuals management. The specific areas of research being conducted under the RCRA land disposal program relates to laboratory, pilot and field validation studies in cover systems, waste leaching and solidification, liner systems and disposal facility evaluation. The specific areas of research being conducted under the CERCLA uncontrolled waste sites (Superfund) program relate to in situ treatment, solidification/stabilization for treating hazardous waste, combustion technologies, best demonstrated available technology (BDAT), on-site treatment technologies, emerging biosystems, expert systems, personnel health protection equipment, and site and situation assessment. The Guidance Documents are intended to assist both the regulated community and the permitting authorities, as well as the Program Offices, and Regions, as well as the states and other interested parties, with the latest information relevant to waste management.

Guidance for establishment and implementation of field sample management programs in support of EM environmental sampling and analysis activities

International Nuclear Information System (INIS)

1994-01-01

The role of the National Sample Management Program (NSMP) proposed by the Department of Energy's Office of Environmental Management (EM) is to be a resource for EM programs and for local Field Sample Management Programs (FSMPs). It will be a source of information on sample analysis and data collection within the DOE complex. The purpose of this document is to establish the suggested scope of the FSMP activities to be performed under each Operations Office, list the drivers under which the program will operate, define terms and list references. This guidance will apply only to EM sampling and analysis activities associated with project planning, contracting, laboratory selection, sample collection, sample transportation, laboratory analysis and data management

Interim Consequence Management Guidance for a Wide-Area Biological Attack

Energy Technology Data Exchange (ETDEWEB)

Raber, Ellen [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Kirvel, Robert [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); MacQueen, Don [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Love, Adam [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Dombroski, Matthew [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); McGrann, Thomas [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Richards, John [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Melius, Carl [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Bunt, Thomas [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Hibbard, Wilthea [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Greenwalt, Robert [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Miles, Robin [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Dillon, Michael [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Mancieri, Sav [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Harris, Steve [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Michalik, Richard [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Wheeler, Richard [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Hoppes, Bill [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Tucker, Mark [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Krauter, Paula [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Knowlton, Robert [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Yang, Lynn [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Franco, Dave [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Einfeld, Wayne [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Brockman, John [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Betty, Rita [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

2011-05-17

The Interagency Biological Restoration Demonstration (IBRD) program is a collaborative, interagency effort co-chaired by the Department of Homeland Security and Department of Defense aimed at improving the nation‘s ability to respond to and recover from a large-scale, wide-area, domestic attack involving the release of an environmentally persistent biological warfare agent. The program is focused on understanding interactions between the civilian and military sectors, and in building mutual support to carry out such remediations. This Interim Consequence Management Guidance document provides guidance for decisionmakers in executing activities required to respond to and recover from a biological incident affecting a wide urban area insofar as information is currently available. The spore-forming bacterium Bacillus anthracis is discussed as the biological agent of primary concern because it is the most difficult of known bioterrorism agents to inactivate and is considered to be one of the key threat agents. Most other biological threat agents are much easier to remediate, and in many cases, inactivation would occur naturally within days as a result of environmental exposure; however, the framework and operational questions that need to be addressed are expected to remain the same. The guidance in this document is applicable to (1) enclosed facilities, such as commercial, residential, and continental U.S. military facilities; (2) semi-enclosed facilities, such as subways and public transit facilities; (3) outdoor areas (both localized and wide area), such as building exteriors, streets, parks, and other open spaces; (4) drinking water facilities; and (5) drinking water sources. This document follows an interagency framework [Planning Guidance for Recovery Following Biological Incidents (DHS and EPA 2009)]—which considered Raber et al. (2002) in its development—but takes the framework to a more operational level and provides guidance at key action and decision

Waste Isolation Pilot Plant 2001 Site Environmental Report

Energy Technology Data Exchange (ETDEWEB)

Westinghouse TRU Solutions, Inc.

2002-09-20

The United States (U.S.) Department of Energy's (DOE) Carlsbad Field Office (CBFO) and Westinghouse TRU Solutions LLC (WTS) are dedicated to maintaining high quality management of Waste Isolation Pilot Plant (WIPP) environmental resources. DOE Order 5400.1, General Environmental Protection Program, and DOE Order 231.1, Environmental, Safety, and Health Reporting, require that the environment at and near DOE facilities be monitored to ensure the safety and health of the public and the environment. This Waste Isolation Pilot Plant 2001 Site Environmental Report summarizes environmental data from calendar year (CY) 2001 that characterize environmental management performance and demonstrate compliance with federal and state regulations. This report was prepared in accordance with DOE Order 5400.1, DOE Order 231.1, the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH- 0173T), and the Waste Isolation Pilot Plant Environmental Protection Implementation Plan (DOE/WIPP 96-2199). The above Orders and guidance documents require that DOE facilities submit an annual site environmental report to DOE Headquarters, Office of the Assistant Secretary for Environment, Safety, and Health; and the New Mexico Environment Department (NMED). The purpose of this report is to provide a comprehensive description of operational environmental monitoring activities, to provide an abstract of environmental activities conducted to characterize site environmental management performance to confirm compliance with environmental standards and requirements, and to highlight significant programs and efforts of environmental merit at WIPP during CY 2001. WIPP received its first shipment of waste on March 26, 1999. In 2001, no evidence was found of any adverse effects from WIPP on the surrounding environment.

Waste Isolation Pilot Plant 2001 Site Environmental Report

International Nuclear Information System (INIS)

Westinghouse TRU Solutions, Inc.

2002-01-01

The United States (U.S.) Department of Energy's (DOE) Carlsbad Field Office (CBFO) and Westinghouse TRU Solutions LLC (WTS) are dedicated to maintaining high quality management of Waste Isolation Pilot Plant (WIPP) environmental resources. DOE Order 5400.1, General Environmental Protection Program, and DOE Order 231.1, Environmental, Safety, and Health Reporting, require that the environment at and near DOE facilities be monitored to ensure the safety and health of the public and the environment. This Waste Isolation Pilot Plant 2001 Site Environmental Report summarizes environmental data from calendar year (CY) 2001 that characterize environmental management performance and demonstrate compliance with federal and state regulations. This report was prepared in accordance with DOE Order 5400.1, DOE Order 231.1, the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH- 0173T), and the Waste Isolation Pilot Plant Environmental Protection Implementation Plan (DOE/WIPP 96-2199). The above Orders and guidance documents require that DOE facilities submit an annual site environmental report to DOE Headquarters, Office of the Assistant Secretary for Environment, Safety, and Health; and the New Mexico Environment Department (NMED). The purpose of this report is to provide a comprehensive description of operational environmental monitoring activities, to provide an abstract of environmental activities conducted to characterize site environmental management performance to confirm compliance with environmental standards and requirements, and to highlight significant programs and efforts of environmental merit at WIPP during CY 2001. WIPP received its first shipment of waste on March 26, 1999. In 2001, no evidence was found of any adverse effects from WIPP on the surrounding environment

Waste Isolation Pilot Plant 1999 Site Environmental Report

Energy Technology Data Exchange (ETDEWEB)

Evans, Roy B.; Adams, Amy; Martin, Don; Morris, Randall C.; Reynolds, Timothy D.; Warren, Ronald W.

2000-09-30

The U.S. Department of Energy's (DOE)Carlsbad Area Office and the Westinghouse Waste Isolation Division (WID) are dedicated to maintaining high quality management of Waste Isolation Pilot Plant (WIPP) environmental resources. DOE Order 5400.1, General Environmental Protection Program, and DOE Order 231.1, Environmental, Safety, and Health Reporting, require that the environment at and near DOE facilities be monitored to ensure the safety and health of the public and the environment. This Waste Isolation Pilot Plant 1999 Site Environmental Report summarizes environmental data from calendar year 1999 that characterize environmental management performance and demonstrate compliance with federal and state regulations. This report was prepared in accordance with DOE Order 5400.1, DOE Order 231.1, the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH- 0173T), and the Waste Isolation Pilot Plant Environmental Protection Implementation Plan (DOE/WIPP 96-2199). The above orders and guidance documents require that DOE facilities submit an Annual Site Environmental Report to DOE Headquarters, Office of the Assistant Secretary for Environment, Safety, and Health. The purpose of this report is to provide a comprehensive description of operational environmental monitoring activities, to provide an abstract of environmental activities conducted to characterize site environmental management performance to confirm compliance with environmental standards and requirements, and to highlight significant programs and efforts of environmental merit at WIPP during calendar year 1999. WIPP received its first shipment of waste on March 26, 1999. In 1999, no evidence was found of any adverse effects from WIPP on the surrounding environment. Radionuclide concentrations in the environment surrounding WIPP were not statistically higher in 1999 than in 1998.

75 FR 21871 - Spring 2010 Regulatory Agenda

Science.gov (United States)

2010-04-26

... Review 10/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Tad Wysor, Environmental...: wysor.tad@epamail.epa.gov Tom Eagles, Environmental Protection Agency, Air and Radiation, 6103A...

Waste Isolation Pilot Plant Environmental Monitoring Plan

International Nuclear Information System (INIS)

2004-01-01

U.S. Department of Energy (DOE) Order 450.1, Environmental Protection Program, requires each DOE site to conduct environmental monitoring. Environmental monitoring at the Waste Isolation Pilot Plant (WIPP) is conducted in order to: (a) Verify and support compliance with applicable federal, state, and local environmental laws, regulations, permits, and orders; (b) Establish baselines and characterize trends in the physical, chemical, and biological condition of effluent and environmental media; (c) Identify potential environmental problems and evaluate the need for remedial actions or measures to mitigate the problem; (d) Detect, characterize, and report unplanned releases; (e) Evaluate the effectiveness of effluent treatment and control, and pollution abatement programs; and (f) Determine compliance with commitments made in environmental impact statements, environmental assessments, safety analysis reports, or other official DOE documents. This Environmental Monitoring Plan (EMP) has been written to contain the rationale and design criteria for the monitoring program, extent and frequency of monitoring and measurements, procedures for laboratory analyses, quality assurance (QA) requirements, program implementation procedures, and direction for the preparation and disposition of reports. Changes to the environmental monitoring program may be necessary to allow the use of advanced technology and new data collection techniques. This EMP will document any proposed changes in the environmental monitoring program. Guidance for preparation of Environmental Monitoring Plans is contained in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance. The plan will be effective when it is approved by the appropriate Head of Field Organization or their designee. The plan discusses major environmental monitoring and hydrology activities at the WIPP and describes the programs established to ensure that WIPP operations do not

Additional guidance for including nuclear safety equivalency in the Canister Storage Building and Cold Vacuum Drying Facility final safety analysis report

Energy Technology Data Exchange (ETDEWEB)

Garvin, L.J.

1997-05-20

This document provides guidance for the production of safety analysis reports that must meet both DOE Order 5480.23 and STD 3009, and be in compliance with the DOE regulatory policy that imposes certain NRC requirements.

Additional guidance for including nuclear safety equivalency in the Canister Storage Building and Cold Vacuum Drying Facility final safety analysis report

International Nuclear Information System (INIS)

Garvin, L.J.

1997-01-01

This document provides guidance for the production of safety analysis reports that must meet both DOE Order 5480.23 and STD 3009, and be in compliance with the DOE regulatory policy that imposes certain NRC requirements

The UK's Draft Guidance for Health in SEA in light of HIA community priorities and the UNECE SEA Protocol

International Nuclear Information System (INIS)

Posas, Paula J.

2011-01-01

The Protocol on Strategic Environmental Assessment (SEA) to the United Nations Economic Commission for Europe (UNECE) Espoo Convention came into force on 11 July 2010. This Protocol, to which the European Union is party, gives a legal basis for enhanced attention to human health in the SEA process. In this context, the United Kingdom's (UK's) 2007 Draft Guidance on Health in Strategic Environmental Assessment represents an important early government-led effort to bring health issues and public health considerations more significantly into the SEA process. Since the UK is a worldwide leader in environmental and various other types of impact assessment, and since other countries may eventually consider its example in efforts to meet UNECE SEA Protocol requirements, scrutiny of its outputs is warranted. This paper thus examines the UK's Draft Guidance from both HIA academic and practitioner perspectives. First it assesses the extent to which the Draft Guidance reflects recent issues and lessons learned in the academic literature. In order to make the assessment, a meta-analysis of 70 HIA-related peer-reviewed articles was undertaken to extract authors' priority recommendations. These recommendations were subsequently compared with the contents of the Draft Guidance. Secondly, the Draft Guidance was assessed for its accordance with recommendations of the UNECE SEA Protocol background paper written by two HIA practitioners. Overall, the Draft Guidance's accordance with both sets of recommendations was found to be high, with only a few easily-remedied gaps. This evaluation suggests that the UK's Draft Guidance can be a useful starting point in the creation of future guidance on health in SEA in both the UK and other countries.

Guidance on the import and export of radioactive sources

International Nuclear Information System (INIS)

2005-03-01

The IAEA Code of Conduct on the Safety and Security of Radioactive Sources, published in January 2004 with the symbol IAEA/CODEOC/2004, provides guidance on how States can safely and securely manage radioactive sources that may pose a significant risk. The concept of such an international undertaking on the safety and security of radioactive sources was highlighted in the major findings of the International Conference on the Safety of Radiation Sources and Security of Radioactive Materials held in Dijon, France, in September 1998. Following that conference, the IAEA Board of Governors requested the Director General to initiate exploratory discussions relating to an international undertaking in the areas of the safety and security of radiation sources. This request was reflected in an Action Plan on the Safety of Radiation Sources and Security of Radioactive Materials, with the Secretariat organizing a series of open-ended meetings of technical and legal experts nominated by Member States to further explore the concept of such an undertaking. Noting comments made in the Board of Governors, the experts agreed that any international undertaking should, for the present, be in the form of a 'code of conduct'. The text of a Code of Conduct on the Safety and Security of Radioactive Sources was accordingly developed. Steps to strengthen the provisions of the Code were subsequently initiated following the International Conference of National Regulatory Authorities with Competence in the Safety of Radiation Sources and the Security of Radioactive Material held in Buenos Aires in December 2000. Moreover, growing international concern about the security of radioactive sources after the events of 11 September 2001 led to a number of issues being considered further by technical and legal experts. Furthermore, the International Conference on Security of Radioactive Sources held in Vienna in March 2003 made recommendations regarding additional actions that might be needed. In June

Land contamination. Technical guidance on special sites: nuclear sites

International Nuclear Information System (INIS)

Hill, M.; Steeds, J.; Slade, N.

2001-01-01

Part IIA of the Environmental Protection Act 1990 sets out a regulatory regime for the identification and remediation of land where contamination is causing unacceptable risks to defined receptors. The Environment Agency has a number of regulatory roles under this regime. Where land is designated as a Special Site, as defined in the Contaminated Land (England) Regulations 2000, the Agency will act as the enforcing authority. It is expected that a similar regime will be introduced in Wales during 2001, but the reader should check whether definitions of Special Sites in the Welsh regulations are the same as in the English ones. The Environment Agency's approach to carrying out its regulatory responsibilities is set out in its Part RA Process Documentation,, available on the Agency website (www.environment-agency. gov.uk). This documentation sets out how the Agency intends to carry out its responsibilities under Part IIA of the Environmental Protection Act 1990, which came into force in England on 1 April 2000

Guidance Manual for Conducting Screening Level Ecological Risk Assessments at the INEL

Energy Technology Data Exchange (ETDEWEB)

R. L. VanHorn; N. L. Hampton; R. C. Morris

1995-06-01

This document presents reference material for conducting screening level ecological risk assessments (SLERAs)for the waste area groups (WAGs) at the Idaho National Engineering Laboratory. Included in this document are discussions of the objectives of and processes for conducting SLERAs. The Environmental Protection Agency ecological risk assessment framework is closely followed. Guidance for site characterization, stressor characterization, ecological effects, pathways of contaminant migration, the conceptual site model, assessment endpoints, measurement endpoints, analysis guidance, and risk characterization are included.

76 FR 50433 - Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators...

Science.gov (United States)

2011-08-15

... operating under share-cropping agreements are common or contract carriers; and third, whether FMCSA should.... FMCSA is issuing guidance that farmers operating under share-cropping or similar arrangements are not... farmer, the Agency sought as much public involvement and comment as possible on these issues. It is worth...

Multimedia Environmental Pollutant Assessment System (MEPAS) application guidance. Guidelines for evaluating MEPAS input parameters for Version 3.1

International Nuclear Information System (INIS)

Buck, J.W.; Whelan, G.; Droppo, J.G. Jr.; Strenge, D.L.; Castleton, K.J.; McDonald, J.P.; Sato, C.; Streile, G.P.

1995-02-01

The Multimedia Environmental Pollutant Assessment System (MEPAS) was developed by Pacific Northwest Laboratory (PNL) for the U.S. Department of Energy (DOE) Office of Environment, Safety and Health and Office of Environmental Management and Environmental Restoration. MEPAS is a set of computer codes developed to provide decision makers with risk information integrated for hazardous, radioactive, and mixed-waste sites based on their potential hazard to public health. It is applicable to a wide range of environmental management and regulatory conditions, including inactive sites covered under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and active air and water releases covered under the Clean Air Act, the Clean Water Act, and the Resource Conservation and Recovery Act. MEPAS integrates contaminant release, transport, and exposure models into a single system. An interactive user interface assists the investigator in defining problems, assembling data and entering input, and developing reports. PNL has compiled two documents that explain the methodology behind the MEPAS model and instruct the user in how to input, retrieve, and evaluate data. This report contains detailed guidelines for defining the input data required to conduct an analysis with MEPAS. Entries for each variable have a short definition, units, and text explaining what a variable is and how it can be quantified. As appropriate, ranges and typical values are given. This report also contains listings of the input screens (worksheets) that are used in the MEPAS user interface for these variables

Soil Vapor Extraction System Optimization, Transition, and Closure Guidance

Energy Technology Data Exchange (ETDEWEB)

Truex, Michael J.; Becker, Dave; Simon, Michelle A.; Oostrom, Martinus; Rice, Amy K.; Johnson, Christian D.

2013-02-08

Soil vapor extraction (SVE) is a prevalent remediation approach for volatile contaminants in the vadose zone. A diminishing rate of contaminant extraction over time is typically observed due to 1) diminishing contaminant mass, and/or 2) slow rates of removal for contamination in low-permeability zones. After a SVE system begins to show indications of diminishing contaminant removal rate, SVE performance needs to be evaluated to determine whether the system should be optimized, terminated, or transitioned to another technology to replace or augment SVE. This guidance specifically addresses the elements of this type of performance assessment. While not specifically presented, the approach and analyses in this guidance could also be applied at the onset of remediation selection for a site as a way to evaluate current or future impacts to groundwater from vadose zone contamination. The guidance presented here builds from existing guidance for SVE design, operation, optimization, and closure from the U.S. Environmental Protection Agency, U.S. Army Corps of Engineers, and the Air Force Center for Engineering and the Environment. The purpose of the material herein is to clarify and focus on the specific actions and decisions related to SVE optimization, transition, and/or closure.

WHO informal consultation on scientific basis for regulatory evaluation of candidate human vaccines from plants, Geneva, Switzerland, 24-25 January 2005.

NARCIS (Netherlands)

Laan, Jan Willem van der; Minor, Philip; Mahoney, Richard; Arntzen, Charles; Shin, Jinho; Wood, David

2006-01-01

In January 2005, WHO convened a meeting of leading experts in plant-derived vaccines and experts from regulatory authorities for an informal discussion on the state-of-the-art and to analyse whether specific guidance might be needed for plant-derived vaccines that is not yet provided by regulatory

Court-agency interaction in environmental policymaking: the cases of the Nuclear Regulatory Commission and the Environmental Protection Agency

International Nuclear Information System (INIS)

Thomas, L.W.

1981-01-01

This study examines the increasingly active participation of courts in the administrative process as well as agency responses to court-imposed policy shifts. More specifically, it is an investigation of the interaction between the federal courts, primarily the Supreme Court and the District of Columbia Court of Appeals, and two federal regulatory agencies, the Nuclar Regulatory Commission and the Environmental Protection Agency. There are five objectives to the study. The first is to examine the natura of court-agency interaction and to determine the extent to which patterns of judicial review of administrative actions can be discerned. The second is to examine the effect of court orders on agency programs and policies. The third is to assess the anticipatory dimension of court-agency relations. The fourth is to inquire into the recurring dimension of court-agency interaction and to determine its effect on subsequent court decisions. The last is to assess the institutional capacity of courts to deal with scientific and technological issues. This study indicates that judicial review has a substantial effect on the NRC's and the EPA's decision-making activities. Few, if any, recent major policy decisions of the two agencies have not been scrutinized closely by federal appellate courts. During the past decade, the courts have blocked policy initiative on numerous occasions and have been the primary source of change in others. In addition, the mere anticipation of judicial review was found to be a factor motivating the two agencies to make reasoned decisions

Quantifying environmental performance using an environmental footprint calculator

Energy Technology Data Exchange (ETDEWEB)

Smith, D.B.; Loney, A.C.; Chan, V. [Conestoga-Rovers & Associates, Waterloo, Ontario (Canada)

2009-07-01

This paper provides a case study using relevant key performance indicators (KPIs) to evaluate the environmental performance of a business. Using recognized calculation and reporting frameworks, Conestoga-Rovers & Associates (CRA) designed the Environmental Footprint Calculator to quantify the environmental performance of a Canadian construction materials company. CRA designed the Environmental Footprint calculator for our client to track and report their environmental performance in accordance with their targets, based on requirements of relevant guidance documents. The objective was to design a tool that effectively manages, calculates, and reports environmental performance to various stakeholders in a user-friendly format. (author)

Quantifying environmental performance using an environmental footprint calculator

International Nuclear Information System (INIS)

Smith, D.B.; Loney, A.C.; Chan, V.

2009-01-01

This paper provides a case study using relevant key performance indicators (KPIs) to evaluate the environmental performance of a business. Using recognized calculation and reporting frameworks, Conestoga-Rovers & Associates (CRA) designed the Environmental Footprint Calculator to quantify the environmental performance of a Canadian construction materials company. CRA designed the Environmental Footprint calculator for our client to track and report their environmental performance in accordance with their targets, based on requirements of relevant guidance documents. The objective was to design a tool that effectively manages, calculates, and reports environmental performance to various stakeholders in a user-friendly format. (author)

The WODA guidance paper on underwater sound from dredging (abstract)

NARCIS (Netherlands)

Thomsen, F.; Borsani, F.; Clarke, D.; Jong, C.A.F. de; Witt, P. de; Holtkamp, M.; Goethals, F.; San Martin, E.; Spadaro, P.; Raalte, G. van; Jensen, A.

2013-01-01

The World Organisation of Dredging Associations (WODA) has identified underwater sound as an environmental issue that needs further consideration. A WODA Expert Group on Underwater Sound (WEGUS) was established to provide a guidance paper on dredging sound, impact on aquatic biota and advice on

Ecological risk assessment guidance for preparation of remedial investigation/feasibility study work plans

International Nuclear Information System (INIS)

Pentecost, E.D.; Vinikour, W.S.

1993-08-01

This guidance document (1) provides instructions on preparing the components of an ecological work plan to complement the overall site remedial assessment investigation/feasibility study (RI/FS) work plan and (2) directs the user on how to implement ecological tasks identified in the plan. Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfired Amendments and Reauthorization Act of 1986 (SARA), an RI/FS work plan win have to be developed as part of the site-remediation scoping the process. Specific guidance on the RI/FS process and the preparation of work plans has been developed by the US Environmental Protection Agency (EPA 1988a). This document provides guidance to US Department of Energy (DOE) staff and contractor personnel for incorporation of ecological information into environmental remediation planning and decision making at CERCLA sites. An overview analysis of early ecological risk assessment methods (i.e., in the 1980s) at Superfund sites was conducted by the EPA (1989a). That review provided a perspective of attention given to ecological issues in some of the first RI/FS studies. By itself, that reference is of somewhat limited value; it does, however, establish a basis for comparison of past practices in ecological risk with current, more refined methods

Annual Report 2008. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2009-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

Annual Report 2007. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2008-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

Regulatory requirements for the use of consumer products containing radioactive substances

International Nuclear Information System (INIS)

Mason, G.C.; Paynter, R.A.; Schmitt-Hannig, A.; Sztanyik, L.B.

1996-01-01

In almost 100 years since the discovery of radioactivity, the properties of radioactive materials have been exploited in products such as clocks and watches incorporating luminous paint which are freely available to members of the public. Over time, regulatory authorities have felt it necessary to apply some degree of control to the supply and use of such products in order to protect public health. In many areas of radiation protection, national authorities take note of international recommendations when developing national standards, but the existing detailed guidance of the International Atomic Energy Agency (IAEA) for consumer products is incomplete and out of date. Recently, a thorough revision of the International Basic Safety Standards (BSS) has occurred, which has prompted a review and revision of the related guidance published by the IAEA. A draft Guide on Regulatory Requirements for the Use of Consumer Products Containing Radioactive Substances has now been completed and is currently under review within the IAEA's system for development of documents in its Safety Series of publications. (author)

Career guidance in communities

DEFF Research Database (Denmark)

Thomsen, Rie

for the development of a critically reflexive career guidance practice. The considerations are organised around seven elements. 1. Creating opportunity, structure and access 2. Entering a community and increasing visibility 3. Providing guidance in communities 4. Exploring potentials in guidance situations 5...... in career guidance practices as well as in the lives of the people in the communities. This paper falls into two parts: The first part considers the collective as the starting point for the development of meaningful career guidance activities. Based on previous research on career guidance in communities......The aim of this paper is to inspire practitioners and professionals to leave their offices to bring career guidance into communities that might not identify with career guidance in the first instance. By making the effort to engage with communities, practitioners may bring about a critical change...

Applying Human-performance Models to Designing and Evaluating Nuclear Power Plants: Review Guidance and Technical Basis

Energy Technology Data Exchange (ETDEWEB)

O' Hara, J.M.

2009-11-30

Human performance models (HPMs) are simulations of human behavior with which we can predict human performance. Designers use them to support their human factors engineering (HFE) programs for a wide range of complex systems, including commercial nuclear power plants. Applicants to U.S. Nuclear Regulatory Commission (NRC) can use HPMs for design certifications, operating licenses, and license amendments. In the context of nuclear-plant safety, it is important to assure that HPMs are verified and validated, and their usage is consistent with their intended purpose. Using HPMs improperly may generate misleading or incorrect information, entailing safety concerns. The objective of this research was to develop guidance to support the NRC staff's reviews of an applicant's use of HPMs in an HFE program. The guidance is divided into three topical areas: (1) HPM Verification, (2) HPM Validation, and (3) User Interface Verification. Following this guidance will help ensure the benefits of HPMs are achieved in a technically sound, defensible manner. During the course of developing this guidance, I identified several issues that could not be addressed; they also are discussed.

Applying Human-performance Models to Designing and Evaluating Nuclear Power Plants: Review Guidance and Technical Basis

International Nuclear Information System (INIS)

O'Hara, J.M.

2009-01-01

Human performance models (HPMs) are simulations of human behavior with which we can predict human performance. Designers use them to support their human factors engineering (HFE) programs for a wide range of complex systems, including commercial nuclear power plants. Applicants to U.S. Nuclear Regulatory Commission (NRC) can use HPMs for design certifications, operating licenses, and license amendments. In the context of nuclear-plant safety, it is important to assure that HPMs are verified and validated, and their usage is consistent with their intended purpose. Using HPMs improperly may generate misleading or incorrect information, entailing safety concerns. The objective of this research was to develop guidance to support the NRC staff's reviews of an applicant's use of HPMs in an HFE program. The guidance is divided into three topical areas: (1) HPM Verification, (2) HPM Validation, and (3) User Interface Verification. Following this guidance will help ensure the benefits of HPMs are achieved in a technically sound, defensible manner. During the course of developing this guidance, I identified several issues that could not be addressed; they also are discussed.

76 FR 60937 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-02; Aging Management Program for Steam...

Science.gov (United States)

2011-09-30

...-2011-02; Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION... License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam... using Revision 3 of NEI 97-06 to manage steam generator aging. The Draft LR-ISG revises the NRC staff's...

Handbook for value-impact assessments of NRC regulatory actions

International Nuclear Information System (INIS)

Mullen, M.F.; DiPalo, A.J.

1985-01-01

According to current Nuclear Regulatory Commission (NRC) procedures, value-impact (cost-benefit) assessments must be prepared for all rulemaking actions and for a broad range of other regulatory requirements and guidance. Probabilistic risk assessment (PRA) methods furnish an important part of the information base for these assessments. PRA methods are frequently the principal quantitative tool for estimating the benefits (e.g., public risk reduction) of proposed regulatory actions. In December 1983, the NRC published A Handbook for Value-Impact Assessment, NUREG/CR-3568, which provides a set of systematic procedures for performing value-impact assessments. The Handbook contains methods, data, and sources of information that can assist the regulatory analyst in conducting such assessments. The use of probabilistic risk analysis to estimate the benefits of proposed regulatory actions is described. Procedures and methods are also given for evaluating the costs and other consequences associated with regulatory actions. The Handbook has been adopted by the NRC as the recommended guideline for value impact assessments. This paper presents the background, objectives, and scope of the Handbook, describes the value-impact assessment methods (including the use of probabilistic risk assessment to estimate benefits), and discusses a selection of current and planned applications, with examples to illustrate how the methods are used

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

Science.gov (United States)

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory

Features of DOE implementation of radiation protection guidance

International Nuclear Information System (INIS)

Jarrett, R.D.; Foulke, J.D.; Jones, C.R.

1991-01-01

In 1988 the Department of Energy became the first Federal agency to adopt the Presidential Guidance prepared by the Environmental Protection Agency, which incorporated the recommendations of the International Commission on Radiological Protection published in 1977. The most important provisions adopted are discussed in this paper. Two controversial issues are also discussed. Problem areas which gave rise to proposed revisions are explained

Implementation of IAEA Code of Conduct and Guidance – Exporting State Perspective

International Nuclear Information System (INIS)

Hayes, T.

2010-01-01

Canadian Nuclear Safety Commission (CNSC) is a federal agency reporting to Parliament through Natural Resources Minister It Regulates all nuclear facilities and activities to protect the health, safety and security of persons and the environment, assure that Canada meets its international commitments and obligations on the peaceful use of nuclear energy by Implementation of the IAEA Code and Guidance. There were 99 States committed to the IAEA Code of Conduct (as of July 2010) while 59 States committed to the IAEA Guidance on Import and Export (as of July 2010) Use of risk-informed regulatory processes to optimize resource allocation and decision-making. Canadian Nuclear Safety Commission Control of Radioactive Sources. As such, the Canadian Government is a strong proponent of the establishment and maintenance of an effective, efficient and harmonized international regime for ensuring the safety and security of such sources

Toxic Substances Control Act. Environmental Guidance Program Reference Book: Revision 6

Energy Technology Data Exchange (ETDEWEB)

1992-05-15

This Reference Book contains a current copy of the Toxic Substances Control Act and those regulations that implement the statute and appear to be most relevant to DOE activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).

Environmental Guidance Program reference book: Toxic substances control act. Revision 7

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-12-01

This Reference Book contains a current copy of the Toxic Substances Control Act and those regulations that implement the statute and appear to be most relevant to DOE activities. The document is provided to DOE staff for informational purposes only and should not be interpreted as legal guidance. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).

Regulatory status of burnup credit for storage and transport of spent fuel in Germany

International Nuclear Information System (INIS)

Neuber, J.C.; Schweer, H.H.; Johann, H.G.

2001-01-01

This paper describes the regulatory status of burnup credit applications to pond storage and dry-cask transport and storage of spent fuel in Germany. Burnup credit for wet storage of LWR fuel at nuclear power plants has to comply with the newly developed safety standard DIN 25471. This standard establishes the safety requirements for burnup credit criticality safety analysis of LWR fuel storage ponds and gives guidance on meeting these requirements. Licensing evaluations of dry transport systems are based on the application of the IAEA Safety Standards Series No.ST-1. However, because of the fact that burnup credit for dry-cask transport becomes more and more inevitable due to increasing initial enrichment of the fuel, and because of the increasing importance of dry-cask storage in Germany, the necessity of giving regulatory guidance on applying burnup credit to dry-cask transport and storage is seen. (author)

Techno-economic viability assessments of greener propulsion technology under potential environmental regulatory policy scenarios

International Nuclear Information System (INIS)

Nalianda, D.K.; Kyprianidis, K.G.; Sethi, V.; Singh, R.

2015-01-01

Highlights: • An advanced method is presented for techno-economic assessment under potential environmental regulatory policy scenarios. • The viability of the contra-rotating open rotor concept is investigated under various environmental policies. • CO_2 taxation is needed to drive the aerospace industry towards greener solutions. - Abstract: Sustainability of the aviation industry, as any other industry, depends on the elasticity of demand for the product and profitability through minimising operating costs. Of paramount importance is assessing and understanding the interdependency and effects of environmentally optimised solutions and emission mitigation policies. This paper describes the development and application of assessment methodologies to better understand the effects of environmental taxation/energy policies aimed at environmental pollution reduction and the future potential economic impact they may have on the adaptation of “greener” novel technologies. These studies are undertaken using a Techno-economic Environmental Risk Assessment approach. The methodology demonstrated allows the assessment of the economic viability of new technologies compared to conventional technologies, for various CO_2 emission taxation and fuel price scenarios. It considers relative increases in acquisition price and maintenance costs. A study undertaken as a ‘proof of concept’ compares a Counter Rotating Open Rotor aircraft with a conventional aircraft for short range operations. It indicates that at current fuel price and with no carbon taxation, a highly fuel efficient technology, such as the one considered, could be rendered economically unviable. The work goes on to demonstrate that in comparison to the conventional aircraft, any economic benefits that may be accrued from improvement in fuel consumption through such a technology, may well be negated through increases in acquisition price and maintenance costs. The work further demonstrates that if policy

Generic Overview of the Status of Characterization Surveys and Guidance for Decommissioning

International Nuclear Information System (INIS)

Abu Eid, Rateb Boby

2012-01-01

This paper presents an overview of several topical areas pertaining to characterization and survey for decommissioning, including: U.S. NRC regulatory requirements for decommissioning and survey; a description of the decommissioning processes particularly role of characterization and survey; characterization survey types and NRC categorization of decommissioning groups; status of U.S. characterization survey guidance; and overview of key characterization and survey Issues. The specific topical areas are briefly discussed below: - The paper addresses the U.S. NRC requirements under 10 CFR Part 20, Subpart E - 'Radiological Criteria for License Termination', and final status surveys requirements under 10 CFR 20.1501(a). Other requirements under 10CFR Parts 50.75, 50.82, 51.53, and 51.95) as well as, reporting and record keeping for decommissioning planning will be outlined. The paper also discusses NRC general decommissioning process for materials and fuel cycle facilities, as well as, for power reactor facilities. - Strategy and planning for decommissioning using the data quality objectives (DQO) approach and its seven step process will be presented in some detail. - The US NRC 'Surveys and Site Investigation Process' as described in NUREG 1757 and categorization of 'Decommissioning Groups' in the context of characterization and survey needs will be addressed. - The paper briefly outlines methodologies, approaches, and status of U.S. multi-agency key guidance documents such as MARSSIM (NUREG-1575), MARSAME (NUREG- 1575, Supp.1), and more recently, the NRC Subsurface Guidance NUREG/CR 7021. - Dose modeling and software development/update in support of radiological survey and characterization for derivation of derived concentration guideline levels. - Lessons Learned from Regulatory 'Reviews of Survey Plans' particularly attributes of survey plans, common survey issues, and key aspects for decommissioning success are discussed in the paper. (author)

Basis for revision 2 of the U.S. Nuclear Regulatory Commission's Regulatory Guide 1.99

International Nuclear Information System (INIS)

Randall, P.N.

1986-01-01

Regulatory Guide 1.99. ''Radiation Damage to Reactor Vessel Materials,'' is being updated to reflect recent studies of the physical basis for neutron radiation damage and efforts to correlate damage to chemical composition and fluence. Revision 2 of the Guide contains several significant changes. Welds and base metal are treated separately. Nickel content is added as a variable and phosphorus removed. The exponent in the fluence factor is reduced, especially at high fluences. And, guidance is given for calculating attenuation of damage through the vessel wall. This paper describes the basis for these changes in the Guide

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2010-01-01

Concerning International regulatory activities, we find for the european atomic energy community an entry into force of the lisbon treaty (2009), it amends the treaty on European union and replaces the treaty establishing the European Community by the new treaty on the functioning of the European Union; more, an amendment to council regulation on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station (2009). About International atomic energy agency is reported an open-ended meeting of technical and legal experts for sharing of information on states implementation of the code of conduct on the safety and security of radioactive sources and its supplementary guidance on the import and export of radioactive sources (2010). (N.C.)

Environmental and social risks: defensive National Environmental Policy Act in the US Forest Service

Science.gov (United States)

Michael J. Mortimer; Marc J. Stern; Robert W. Malmsheimer; Dale J. Blahna; Lee K. Cerveny; David N. Seesholtz

2011-01-01

The National Environmental Policy Act (NEPA) and its accompanying regulations provide a spectrum of alternative analytical pathways for federal agencies proposing major actions that might significantly impact the human environment. Although guidance from the President's council on Environmental Quality suggests the decision to develop an environmental impact...

Regulatory experience in nuclear power station decommissioning

International Nuclear Information System (INIS)

Ross, W.M.; Waters, R.E.; Taylor, F.E.; Burrows, P.I.

1995-01-01

In the UK, decommissioning on a licensed nuclear site is regulated and controlled by HM Nuclear Installations Inspectorate on behalf of the Health and Safety Executive. The same legislative framework used for operating nuclear power stations is also applied to decommissioning activities and provides a continuous but flexible safety regime until there is no danger from ionising radiations. The regulatory strategy is discussed, taking into account Government policy and international guidance for decommissioning and the implications of the recent white paper reviewing radioactive waste management policy. Although each site is treated on a case by case basis as regulatory experience is gained from decommissioning commercial nuclear power stations in the UK, generic issues have been identified and current regulatory thinking on them is indicated. Overall it is concluded that decommissioning is an evolving process where dismantling and waste disposal should be carried out as soon as reasonably practicable. Waste stored on site should, where it is practical and cost effective, be in a state of passive safety. (Author)

Protection against malevolent use of vehicles at Nuclear Power Plants. Vehicle barrier system siting guidance for blast protection

International Nuclear Information System (INIS)

Nebuda, D.T.

1994-08-01

This manual provides guidance for determining the minimum safe standoff distance between vital safety related equipment and the design basis vehicle bomb threat adopted by the U.S. Nuclear Regulatory Commission. Vital safety related equipment should survive the design basis vehicle bomb attack when the minimum safe standoff distance is provided. Guidance is provided for exposed vital safety related equipment and for equipment housed within vital area barriers. The type of vital area barriers addressed are 12-, 18-, 24-, and 30-inch-thick reinforced concrete slabs with reinforcing ratios of 0.2, 0.4, 0.6, 0.8, and 1.0 percent

Headquarters Air Force Logistics Command guidance manual for hazardous waste minimization (PACER REDUCE): Hazardous Waste Remedial Actions Program

International Nuclear Information System (INIS)

Jones, L.W.; Weeter, D.; Roth, J.A.; Debelak, K.A.; Bowers, A.R.

1988-09-01

This manual provides guidance for the Air Force Logistics Command (AFLC) Waste Minimization Program, called PACER REDUCE, and applies to all AFLC installations and personel who are responsible for implementing and monitoring activities relating to PACER REDUCE. This guidance for waste minimization provides management and technical approaches for assessing potential waste reduction techniques and for making informed decisions concerning industrial process and waste stream management. Such actions will assist in achieving regulatory compliance with the Resource Conservation and Recovery Act of 1976 as updated by the Hazardous and Solid Waste Amendments of 1984. 37 refs., 14 figs., 22 tabs

Environmental Governance as a Model of Environmental Management

Directory of Open Access Journals (Sweden)

Budi Kristianto

2016-02-01

Full Text Available The concept of environmental governance does not promise practical solutions and provides short guidance in solving intertwined environmental problems in Indonesia. But at least environmental concept is useful when we try to realize environmental management in Indonesia currently. The worst is that the mistake has become routine manifesting in pragmatism in environmental management. Before it all too late, it is better that we keep in mind a German proverb in the beginning of this writing, which more or less, means “ we do not know what the future brings, but we know that we should act.”

Annual Report 2009. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2010-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

Regulatory Initiatives for Control and Release of Technologically Enhanced Naturally-Occurring Radioactive Material

International Nuclear Information System (INIS)

Egidi, P.V.

1999-01-01

Current drafts of proposed standards and suggested State regulations for control and release of technologically-enhanced naturally-occurring radioactive material (TENORM), and standards for release of volumetrically-contaminated material in the US are reviewed. These are compared to the recommendations of the International Atomic Energy Association (IAEA) Safety Series and the European Commission (EC) proposals. Past regulatory efforts with respect to TENORM in the US dealt primarily with oil-field related wastes. Currently, nine states (AK, GA, LA, MS, NM, OH, OR SC, TX) have specific regulations pertaining to TENORM, mostly based on uranium mill tailings cleanup criteria. The new US proposals are dose- or risk-based, as are the IAEA and EC recommendations, and are grounded in the linear no threshold hypothesis (LNT). TENORM wastes involve extremely large volumes, particularly scrap metal and mine wastes. Costs to control and dispose of these wastes can be considerable. The current debate over the validity of LNT at low doses and low dose rates is particularly germane to this discussion. Most standards setting organizations and regulatory agencies base their recommendations on the LNT. The US Environmental Protection Agency has released a draft Federal Guidance Report that recommends calculating health risks from low-level exposure to radionuclides based on the LNT. However, some scientific and professional organizations are openly questioning the validity of LNT and its basis for regulations, practices, and costs to society in general. It is not clear at this time how a non-linear regulatory scheme would be implemented

Regulatory Initiatives for Control and Release of Technologically Enhanced Naturally-Occurring Radioactive Materials

Energy Technology Data Exchange (ETDEWEB)

Egidi, P.V.

1999-03-02

Current drafts of proposed standards and suggested State regulations for control and release of technologically-enhanced naturally-occurring radioactive material (TENORM), and standards for release of volumetrically-contaminated material in the US are reviewed. These are compared to the recommendations of the International Atomic Energy Association (IAEA) Safety Series and the European Commission (EC) proposals. Past regulatory efforts with respect to TENORM in the US dealt primarily with oil-field related wastes. Currently, nine states (AK, GA, LA, MS, NM, OH, OR SC, TX) have specific regulations pertaining to TENORM, mostly based on uranium mill tailings cleanup criteria. The new US proposals are dose- or risk-based, as are the IAEA and EC recommendations, and are grounded in the linear no threshold hypothesis (LNT). TENORM wastes involve extremely large volumes, particularly scrap metal and mine wastes. Costs to control and dispose of these wastes can be considerable. The current debate over the validity of LNT at low doses and low dose rates is particularly germane to this discussion. Most standards setting organizations and regulatory agencies base their recommendations on the LNT. The US Environmental Protection Agency has released a draft Federal Guidance Report that recommends calculating health risks from low-level exposure to radionuclides based on the LNT. However, some scientific and professional organizations are openly questioning the validity of LNT and its basis for regulations, practices, and costs to society in general. It is not clear at this time how a non-linear regulatory scheme would be implemented.

76 FR 17160 - Office of New Reactors; Final Interim Staff Guidance on the Review of Nuclear Power Plant Designs...

Science.gov (United States)

2011-03-28

... design certification (DC) application for new nuclear power reactors under Title 10 of the Code of... NUCLEAR REGULATORY COMMISSION [NRC-2010-0033; DC/COL-ISG-021] Office of New Reactors; Final Interim Staff Guidance on the Review of Nuclear Power Plant Designs Using a Gas Turbine Driven Standby...

International guidance on the qualifications of nuclear power plant operations personnel

International Nuclear Information System (INIS)

Csik, B.J.

1984-01-01

Nuclear power plant operation and maintenance as well as training of operations personnel are activities where a large amount of experience is available. Though it would seem that the status of a well-established practice, requiring constant attention but no major efforts directed towards improvements, should have been reached, this is not the case. Currently, upgrading of the qualification requirements and training procedures of nuclear power plant operations personnel is a major issue and substantial efforts are being expended to this effect. The availability of international guidance in this field is perceived to be of benefit to all; therefore the Agency has undertaken to develop such guidance. In addition to earlier publications, a guidebook on this subject area is being prepared. Important problems and current issues have been identified and these are commented upon in the present paper. The specific topics referred to include: the role of the operating organization and the regulatory body; organizational aspects; staffing requirements; competence requirements for personnel; establishment and verification of competence; and personnel management. It is recognized that developing international guidance is a difficult and delicate task, especially when it is intended to go beyond stating the obvious and expressing generalities which are certain to meet a general consensus. (author)

Offsite dose calculation manual guidance: Standard radiological effluent controls for boiling water reactors

International Nuclear Information System (INIS)

Meinke, W.W.; Essig, T.H.

1991-04-01

This report contains guidance which may be voluntarily used by licensees who choose to implement the provision of Generic Letter 89-- 01, which allows Radiological Effluent Technical Specifications (RETS) to be removed from the main body of the Technical Specifications and placed in the Offsite Dose Calculation Manual (ODCM). Guidance is provided for Standard Effluent Controls definitions, Controls for effluent monitoring instrumentation, Controls for effluent releases, Controls for radiological environmental monitoring, and the basis for Controls. Guidance on the formulation of RETS has been available in draft form for a number of years; the current effort simply recasts those RETS into Standard Radiological Effluent Controls for application to the ODCM. 11 tabs

Visual tracking for multi-modality computer-assisted image guidance

Science.gov (United States)

Basafa, Ehsan; Foroughi, Pezhman; Hossbach, Martin; Bhanushali, Jasmine; Stolka, Philipp

2017-03-01

With optical cameras, many interventional navigation tasks previously relying on EM, optical, or mechanical guidance can be performed robustly, quickly, and conveniently. We developed a family of novel guidance systems based on wide-spectrum cameras and vision algorithms for real-time tracking of interventional instruments and multi-modality markers. These navigation systems support the localization of anatomical targets, support placement of imaging probe and instruments, and provide fusion imaging. The unique architecture - low-cost, miniature, in-hand stereo vision cameras fitted directly to imaging probes - allows for an intuitive workflow that fits a wide variety of specialties such as anesthesiology, interventional radiology, interventional oncology, emergency medicine, urology, and others, many of which see increasing pressure to utilize medical imaging and especially ultrasound, but have yet to develop the requisite skills for reliable success. We developed a modular system, consisting of hardware (the Optical Head containing the mini cameras) and software (components for visual instrument tracking with or without specialized visual features, fully automated marker segmentation from a variety of 3D imaging modalities, visual observation of meshes of widely separated markers, instant automatic registration, and target tracking and guidance on real-time multi-modality fusion views). From these components, we implemented a family of distinct clinical and pre-clinical systems (for combinations of ultrasound, CT, CBCT, and MRI), most of which have international regulatory clearance for clinical use. We present technical and clinical results on phantoms, ex- and in-vivo animals, and patients.

Oak Ridge Reservation Annual Site Environmental Report, 2003

Energy Technology Data Exchange (ETDEWEB)

Hughes, JF

2004-08-24

This document is prepared annually to summarize environmental activities, primarily environmental-monitoring activities, on the ORR and within the ORR surroundings. The document fulfills the requirement of U.S. Department of Energy (DOE) Order 231.1, ''Environment, Safety and Health Reporting,'' for an annual summary of environmental data to characterize environmental performance. The environmental monitoring criteria are described in DOE Order 450.1, ''Environmental Protection Program''. The results summarized in this report are based on data collected prior to and through 2003. This report is not intended to provide the results of all sampling on the ORR. Additional data collected for other site and regulatory purposes, such as environmental restoration remedial investigation reports, waste management characterization sampling data, and environmental permit compliance data, are presented in other documents that have been prepared in accordance with applicable DOE guidance and/or laws. Corrections to the report for the previous year are found in Appendix A. Environmental monitoring on the ORR consists primarily of two major activities: effluent monitoring and environmental surveillance. Effluent monitoring involves the collection and analysis of samples or measurements of liquid and gaseous effluents at the point of release to the environment; these measurements allow the quantification and official reporting of contaminants, assessment of radiation and chemical exposures to the public, and demonstration of compliance with applicable standards and permit requirements. Environmental surveillance consists of the collection and analysis of environmental samples from the site and its environs; these activities provide direct measurement of contaminants in air, water, groundwater, soil, foods, biota, and other media subsequent to effluent release into the environment. Environmental surveillance data provide information regarding

FDA-EPA Public Health Guidance on Fish Consumption: A Case Study on Informal Interagency Cooperation in "Shared Regulatory Space".

Science.gov (United States)

Holden, Mark

2015-01-01

This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.

GUIDANCE ON SELECTING AGE GROUPS FOR ...

Science.gov (United States)

This guidance document provides a set of early-lifestage age groups for Environmental Protection Agency scientists to consider when assessing children’s exposure to environmental contaminants and the resultant potential dose. These recommended age groups are based on current understanding of differences in behavior and physiology which may impact exposures in children. A consistent set of early-life age groups, supported by an underlying scientific rationale, is expected to improve Agency exposure and risk assessments for children by increasing the consistency and comparability of risk assessments across the Agency; by improving accuracy and transparency in assessments for those cases where current practice might too broadly combine behaviorally and physiologically disparate age groups; and by fostering a consistent approach to future exposure surveys and monitoring efforts to generate improved exposure factors for children. see description

Guidance for implementing the long-term surveillance program for UMTRA Project Title I Disposal Sites

International Nuclear Information System (INIS)

1996-02-01

This guidance document has two purposes: it provides guidance for writing site-specific long-term surveillance plans (LTSP) and it describes site surveillance, monitoring, and long-term care techniques for Title I disposal sites of the Uranium Mill Tailings Radiation Control Act (UMTRCA) (42 USC Section 7901 et seq.). Long-term care includes monitoring, maintenance, and emergency measures needed to protect public health and safety and the environment after remedial action is completed. This document applies to the UMTRCA-designated Title I disposal sites. The requirements for long-term care of the Title I sites and the contents of the LTSPs are provided in U.S. Nuclear Regulatory Commission (NRC) regulations (10 CFR Section 40.27) provided in Attachment 1

Selection of the situations taken into account for the safety demonstration of a repository in deep geological formations - French regulatory guidance and IPSN modelling experience

International Nuclear Information System (INIS)

Escalier des Orres, P.; Greneche, D.

1993-01-01

A regulatory guidance has been recently set up in France for the safety assessment of radwaste deep geological disposal: the present paper deals with the methodology related to the safety demonstration of such a disposal, particularly the situations to be taken into account to address the potential evolution of the repository under natural or human induced events. This approach, based on a selection of events considered as reasonably envisageable, relies on a reference scenario characterized by a great stability of the geological formation and on hypothetical situations corresponding to the occurrence of random events of natural origin or of conventional nature. The implementation of this methodology within the framework of the IPSN (Protection and Nuclear Safety Institute, CEA) participation in the CEC EVEREST project is addressed. This programme consists in the evaluation of the sensitivity of the radiological consequences associated to deep radwaste disposal systems to the different elements of the performance assessment (scenario characteristics, phenomena, physico-chemical parameters) in three types of geological formations (granite, salt and clay).(author). 11 refs., 3 tabs

Federal Transit Administration's noise and vibration Guidance Manual: Updates after 10 years of experience

Science.gov (United States)

Hanson, Carl E.

2005-09-01

In April 1995, the Federal Transit Administration of the U.S. Department of Transportation issued its guidance manual, ``Transit Noise and Vibration Impact Assessment.'' The manual was written to provide direction for the preparation of noise and vibration sections of environmental documents for public transportation projects in the interest of promoting quality and uniformity in assessments. In the 10 years since its release, the guidance manual has been used as the basis of noise and vibration assessments in over 80 environmental documents and has been used worldwide as a standard method for performing transit noise analyses. An updated version has recently been prepared that takes account of improvements in tools, changes in the environmental assessment procedures, modifications of impact criteria, and experience with mitigation measures. These factors, and other background information, will be discussed to provide insight regarding the revisions in the new edition.

Regulatory requirements of the integrated technology demonstration program, Savannah River Site (U)

International Nuclear Information System (INIS)

Bergren, C.L.

1992-01-01

The integrated demonstration program at the Savannah River Site (SRS) involves demonstration, testing and evaluation of new characterization, monitoring, drilling and remediation technologies for soils and groundwater impacted by organic solvent contamination. The regulatory success of the demonstration program has developed as a result of open communications between the regulators and the technical teams involved. This open dialogue is an attempt to allow timely completion of applied environmental restoration demonstrations while meeting all applicable regulatory requirements. Simultaneous processing of multiple regulatory documents (satisfying RCRA, CERCLA, NEPA and various state regulations) has streamlined the overall permitting process. Public involvement is achieved as various regulatory documents are advertised for public comment consistent with the site's community relations plan. The SRS integrated demonstration has been permitted and endorsed by regulatory agencies, including the Environmental Protection Agency (EPA) and the South Carolina Department of Health and Environmental Control. EPA headquarters and regional offices are involved in DOE's integrated Demonstration Program. This relationship allows for rapid regulatory acceptance while reducing federal funding and time requirements. (author)

Pantex Plant Cell 12-44-1 tritium release: Re-assessment of environmental doses for 1990 to 1992

International Nuclear Information System (INIS)

Snyder, S.F.; Hwang, S.T.

1994-03-01

A release of tritium gas occurred within Cell 12-44-1 at the Pantex Plant on May 17, 1989. The release was the result of a nuclear component containment failure. This document summarizes past assessments and characterization of the release. From 1990 to 1992, the average annual dose to the offsite maximally exposed individual (MEI), re-assessed using updated methods and data, ranged from 9E-6 to 2E-4 mrem/y. Doses at this level are well below the regulatory dose limit and support the discontinuation of the distinct calculation of the MEI doses from the cell's tritium releases in future Pantex Annual Site Environmental Reports. Additional information provides guidance for the evaluation of similar releases in the future. Improved Environmental Protection Department sampling plans and assessment goals will increase the value of the data collected during future incidents

78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

Science.gov (United States)

2013-11-07

... for such products. These inconsistent interpretations of the definitions may inadvertently result in... amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is... of clarity regarding how the Agency defines a hearing aid versus a personal sound amplification...

Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Diocument: are they sufficiently protective for insecticides?

NARCIS (Netherlands)

Wijngaarden, van R.P.A.; Maltby, L.; Brock, T.C.M.

2015-01-01

BACKGROUND The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides.

Mound Plant Environmental Monitoring Plan

International Nuclear Information System (INIS)

Bauer, L.R.; Tullis, M.S.; Paulick, R.P.; Roush, L.L.

1994-07-01

The purpose of this Environmental Monitoring Plan (EMP) is to describe the environmental monitoring and surveillance programs in place at Mound. The Plan is required by DOE Order 5400.1 (DOE, 1990). The programs described in the EMP are required by the DOE 5400 Order series and by the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environment Surveillance (DOE 1991a), referred to as the Regulatory Guide throughout this Plan

The Establishment of a Green Supplier Selection and Guidance Mechanism with the ANP and IPA

Directory of Open Access Journals (Sweden)

Chih-Chao Chung

2016-03-01

Full Text Available This study aims to establish a green supplier selection and guidance mechanism by integrating the features of an ANP (Analytic Network Process and an IPA (Importance–Performance Analysis to achieve sustainable management for green supply chains. Using an expert survey, this study developed green supplier selection criteria. It adopted an ANP, which allows for interdependencies and feedback between the various criteria, to select competitive green suppliers. Then, it used an IPA, which can analyze the criteria’s significance and performance levels, to provide green suppliers with direction for guidance and improvements. The green supplier selection and guidance mechanism featuring an ANP and IPA is thus established and validated through case studies. The research results showed the following: (1 the green supplier selection criteria comprise a total of 11 performance evaluation criteria from the three dimensions of operation, competence, and environmental consciousness; (2 as shown by the APN evaluation results, environmental benefits, environmental regulations, finance, technological competence, and delivery time are the top five among the overall green criteria of the company; the performance of the various suppliers is thus arranged in order, and the most competitive supplier is selected; (3 an IPA is used to analyze the criteria’s significance and supplier performance levels and to provide the suppliers with suggestions on priority improvements, including implementing the requirements in the environmental regulations, establishing comprehensive financial management procedures, improving corporate technological competence, and consolidating customer service; (4 it is suggested that an ANP and IPA should be integrated in the applications, which could simplify the green supplier selection and guidance mechanisms and increase the efficiency of supplier management, thus creating a three-win situation for the clients, the company, and the

Waste treatability guidance program. User's guide. Revision 0

International Nuclear Information System (INIS)

Toth, C.

1995-01-01

DOE sites across the country generate and manage radioactive, hazardous, mixed, and sanitary wastes. It is necessary for each site to find the technologies and associated capacities required to manage its waste. One role of DOE HQ Office of Environmental Restoration and Waste Management is to facilitate the integration of the site- specific plans into coherent national plans. DOE has developed a standard methodology for defining and categorizing waste streams into treatability groups based on characteristic parameters that influence waste management technology needs. This Waste Treatability Guidance Program automates the Guidance Document for the categorization of waste information into treatability groups; this application provides a consistent implementation of the methodology across the National TRU Program. This User's Guide provides instructions on how to use the program, including installations instructions and program operation. This document satisfies the requirements of the Software Quality Assurance Plan

Regulatory dendritic cells in autoimmunity: A comprehensive review.

Science.gov (United States)

Liu, Juan; Cao, Xuetao

2015-09-01

Dendritic cells (DCs) are professional antigen-presenting cells (APC) with significant phenotypic heterogeneity and functional plasticity. DCs play crucial roles in initiating effective adaptive immune responses for elimination of invading pathogens and also in inducing immune tolerance toward harmless components to maintain immune homeostasis. The regulatory capacity of DCs depends on their immature state and distinct subsets, yet not restricted to the immature state and one specialized subset. The tolerogenicity of DC is controlled by a complex network of environmental signals and cellular intrinsic mechanisms. Regulatory DCs play an important role in the maintenance of immunological tolerance via the induction of T cell unresponsiveness or apoptosis, and generation of regulatory T cells. DCs play essential roles in driving autoimmunity via promoting the activation of effector T cells such as T helper 1 and T helper 17 cells, and/or suppressing the generation of regulatory T cells. Besides, a breakdown of DCs-mediated tolerance due to abnormal environmental signals or breakdown of intrinsic regulatory mechanisms is closely linked with the pathogenesis of autoimmune diseases. Novel immunotherapy taking advantage of the tolerogenic potential of regulatory DCs is being developed for treatment of autoimmune diseases. In this review, we will describe the current understanding on the generation of regulatory DC and the role of regulatory DCs in promoting tolerogenic immune responses and suppressing autoimmune responses. The emerging roles of DCs dysfunction in the pathogenesis of autoimmune diseases and the potential application of regulatory DCs in the treatment of autoimmune diseases will also be discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

78 FR 53791 - Draft Program-Specific Guidance About Irradiator Licenses

Science.gov (United States)

2013-08-30

... CONTACT: Tomas Herrera, Office of Federal and State Materials and Environmental Management Programs; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415- 7138; email: Tomas.Herrera...

Oak Ridge Reservation: Annual Site Environmental Report for 2015

Energy Technology Data Exchange (ETDEWEB)

Rochelle, James [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Rogers, Ben [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Roche, Paula R. [Y-12 National Security Complex, Oak Ridge, TN (United States); Hughes, Joan [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Coffey, Mike [East Tennessee Technology Park (ETTP), Oak Ridge, TN (United States)

2016-09-01

The Oak Ridge Reservation Annual Site Environmental Report is prepared annually and presents summary environmental data to (1) characterize environmental performance, (2) summarize environmental occurrences reported during the year, (3) confirm compliance with environmental standards and requirements, and (4) highlight significant program activities. The report fulfills the requirement contained in DOE Order 231.1A, Environment, Safety and Health Reporting (DOE 2004) that an integrated annual site environmental report be prepared. The results summarized in this report are based on data collected prior to and through 2015. This report is not intended to nor does it present the results of all environmental monitoring associated with the ORR. Data collected for other site and regulatory purposes, such as environmental restoration/remedial investigation reports, waste management characterization sampling data, and environmental permit compliance data, are presented in other documents that have been prepared in accordance with applicable DOE guidance and/or laws and are referenced herein as appropriate. Environmental monitoring on the ORR consists primarily of two major activities: effluent monitoring and environmental surveillance. Effluent monitoring involves the collection and analysis of samples or measurements of liquid and gaseous effluents at the points of release to the environment; these measurements allow the quantification and official reporting of contaminant levels, assessment of radiation and chemical exposures to the public, and demonstration of compliance with applicable standards and permit requirements. Environmental surveillance consists of direct measurements and collection and analysis of samples taken from the site and its environs exclusive of effluents; these activities provide information on contaminant concentrations in air, water, groundwater, soil, foods, biota, and other media. Environmental surveillance data support determinations regarding

Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

International Nuclear Information System (INIS)

Baeckstroem, Ola; Haeggstroem, Anna; Maennistoe, Ilkka

2010-04-01

document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174

Guidance to risk-informed evaluation of technical specifications using PSA

International Nuclear Information System (INIS)

Baeckstroem, O.; Haeggstroem, A.; Maennistoe, I.

2010-10-01

document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174. (Author)

Guidance to risk-informed evaluation of technical specifications using PSA

Energy Technology Data Exchange (ETDEWEB)

Baeckstroem, O.; Haeggstroem, A. (Scandpower AB, Stockholm (Sweden)); Maennistoe, I. (VTT, Helsingfors (Finland))

2010-04-15

document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174. (Author)

Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

Energy Technology Data Exchange (ETDEWEB)

Baeckstroem, Ola; Haeggstroem, Anna (Scandpower AB, Stockholm (Sweden)); Maennistoe, Ilkka (VTT, Helsingfors (Finland))

2010-04-15

document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174

Ranking system for national regulatory jurisdictions based on pesticide standard values in major exposures

Directory of Open Access Journals (Sweden)

Zijian Li

2017-07-01

Full Text Available To control the risk of human exposure to pesticides, about 50 nations have promulgated pesticide soil regulatory guidance values (RGVs, and 104 nations have provided pesticide drinking water maximum concentration levels (MCLs. In addition, 90 nations have regulated pesticide agricultural commodity maximum residue limits (MRLs. Pesticide standard values (PSVs for one single pesticide varied in a range of six, seven, or even eight orders of magnitude. Some PSVs are too large to prevent the impact of pesticides on human health. Many nations have not provided PSVs for some commonly used pesticides until now. This research has introduced several completeness values and numerical values methods to evaluate the national jurisdiction’s performance on PSVs on a nation base. The national jurisdiction ranking system developed by these methods will be beneficial to the environmental regulation makers in the management of PSVs. Results also indicate that European countries perform better in the regulation of pesticide soil RGVs, drinking water MCLs, and agricultural commodity MRLs.

A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

Science.gov (United States)

Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

2018-06-01

Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Frontiers of environmental regulation: environmental management systems: a regulator`s perspective

Energy Technology Data Exchange (ETDEWEB)

Stone, M.J. [South Australian Dept. of Mines and Energy, Adelaide, SA (Australia)

1996-12-31

Leading edge companies throughout the world have embraced management systems to achieve optimal sustainable performance in the ever changing business environment of the 1990s. Given that the natural environment and environmental performance have become major issues affecting organizations, the need for integrating environmental management with all the other components of an organization`s overall management approach is now widely recognized. This paper is organized in five parts. The first explores recently released environmental standards, the interim environmental management systems (EMS) general guidelines standard AS/NZS ISO 14004 (Int) and identifies how this has dealt with the regulator/community/company interface. The second identifies company requirements for addressing environmental issues. The third, considers regulatory theory to identify current requirements for an effective regulatory system and how this can interface with a company`s EMS. These form the basis in the fourth section for identifying some opportunities which occur at the company/ regulator interface. The fifth and final section draws a number of conclusions about the current frontiers of environmental regulation. The coincidence of the requirements of a regulatory framework with the areas of interface between what is referred to in the draft International Standard for EMS as `Interested Parties`, the regulators and community, are identified. (author). 1 tab., 2 figs., 20 refs.

Improving the Clinical Pharmacologic Assessment of Abuse Potential: Part 1: Regulatory Context and Risk Management.

Science.gov (United States)

Sellers, Edward M

2018-02-01

This article brings to the attention of drug developers the Food and Drug Administration's (FDA's) recent final Guidance to Industry on Assessment of Abuse Potential and provides practical suggestions about compliance with the Guidance. The Guidance areas are reviewed, analyzed, and placed in the context of current scientific knowledge and best practices to mitigate regulatory risk. The Guidance provides substantial new detail on what needs to be done at all stages of drug development for central nervous system-active drugs. However, because many psychopharmacologic agents have unique preclinical and clinical features, the plan for each agent needs to be not only carefully prepared but also reviewed and approved by the FDA. Examples are provided where assumptions about interpretation of the Guidance can delay development. If the expertise and experience needed for assessing abuse potential during drug development do not exist within a company, external preclinical and clinical expert should be involved. Consultation with the FDA is encouraged and important because the specific requirements for each drug will vary.

Nuclear Regulatory Infrastructure in the Philippines

International Nuclear Information System (INIS)

Leonin, Teofilo V. Jr.

2015-01-01

Regulating the use of radioactive materials in the Philippines involves the adherence to legislation, regulations, standards and regulatory guides. It is based on a detailed review and assessment of the radiation safety program of owners and users of these materials and associated equipment against safety requirements and on additional verification of the operating practices and procedures. Republic Acts 5207 and 2067, both as amended, are implemented through the regulations which are titled Code of PNRI Regulations or CPRs are developed and issued together with supporting regulatory guides, Bulletins and other documents detailing the safety requirements. These issuance adhere to internationally accepted requirements on radiation protection, and nuclear safety and security, as well as safeguards. Design documents and technical Specifications of important radioactive materials, equipment and components are required to be submitted and reviewed by the PNRI before the issuance of an authorization in the form of a license Verification of adherence to regulations and safety requirements are periodically checked through the implementation of an inspection and enforcement program. The ISO certified regulatory management system of PNRI is documented in a QMS manual that provides guidance on all work processes. It involves systematic planning and evaluation of activities, multiple means of getting feedback on the work processes, and continuous efforts to improve its effectiveness. Efforts are implemented in order to strengthen the transparency openness, independence, technical competence and effectiveness of the regulatory body. (author)

The changing regulatory environment

International Nuclear Information System (INIS)

Caron, G.

1999-01-01

The role and value of regulation in the energy sector was discussed, demonstrating how, despite common perception, regulation is an essential part of Canada's strategy to find and develop new opportunities. The future vision of regulation for industry participants was presented with particular focus on issues related to streamlining the regulatory process. As far as pipelines are concerned, regulatory actions are necessary to facilitate capacity increases and to ensure the line's integrity, safety and environmental record. Furthermore, regulation provides economic solutions where market forces cannot provide them, as for example where business has elements of monopoly. It arbitrates interests of landowners, business, consumers, and environmental groups. It looks for ways to ensure conditions under which competition can flourish. It acts as the guardian of citizens' rights in a democratic society by providing citizens with an opportunity to be heard on the building or expansion of pipelines and associated facilities. As citizens become more and more concerned about their property and the land that surrounds them, citizen involvement in decision making about how industry activity affects their quality of life will become correspondingly more important. Regulatory agencies are committed to facilitate this engagement by flexible hearing procedures and by making use of evolving communication and information technology

Routine environmental audit of the Y-12 Plant, Oak Ridge, Tennessee

International Nuclear Information System (INIS)

1994-09-01

This report documents the results of the routine environmental audit of the Oak Ridge Y-12 Plant (Y-12 Plant), Anderson County, Tennessee. During this audit, the activities conducted by the audit team included reviews of internal documents and reports from previous audits and assessments; interviews with U.S. Department of Energy (DOE), State of Tennessee regulatory, and contractor personnel; and inspections and observations of selected facilities and operations. The onsite portion of the audit was conducted August 22-September 2, 1994, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety and Health (EH). DOE 5482.1 B, open-quotes Environment, Safety, and Health Appraisal Program,close quotes establishes the mission of EH-24 to provide comprehensive, independent oversight of DOE environmental programs on behalf of the Secretary of Energy. The ultimate goal of EH-24 is enhancement of environmental protection and minimization of risk to public health and the environment. EH-24 accomplishes its mission by conducting systematic and periodic evaluations of DOE's environmental programs within line organizations, and by using supplemental activities that strengthen self-assessment and oversight functions within program, field, and contractor organizations. The audit evaluated the status of programs to ensure compliance with Federal, state, and local environmental laws and regulations; compliance with DOE Orders, guidance, and directives; and conformance with accepted industry practices and standards of performance. The audit also evaluated the status and adequacy of the management systems developed to address environmental requirements

Oak Ridge Reservation Annual Site Environmental Report for 2003

Energy Technology Data Exchange (ETDEWEB)

None

2004-09-30

This document is prepared annually to summarize environmental activities, primarily environmental-monitoring activities, on the ORR and within the ORR surroundings. The document fulfills the requirement of U.S. Department of Energy (DOE) Order 231.1, “Environment, Safety and Health Reporting,” for an annual summary of environmental data to characterize environmental performance. The environmental monitoring criteria are described in DOE Order 450.1, “Environmental Protection Program.” The results summarized in this report are based on data collected prior to and through 2003. This report is not intended to provide the results of all sampling on the ORR. Additional data collected for other site and regulatory purposes, such as environmental restoration remedial investigation reports, waste management characterization sampling data, and environmental permit compliance data, are presented in other documents that have been prepared in accordance with applicable DOE guidance and/or laws. Corrections to the report for the previous year are found in Appendix A. Environmental monitoring on the ORR consists primarily of two major activities: effluent monitoring and environmental surveillance. Effluent monitoring involves the collection and analysis of samples or measurements of liquid and gaseous effluents at the point of release to the environment; these measurements allow the quantification and official reporting of contaminants, assessment of radiation and chemical exposures to the public, and demonstration of compliance with applicable standards and permit requirements. Environmental surveillance consists of the collection and analysis of environmental samples from the site and its environs; these activities provide direct measurement of contaminants in air, water, groundwater, soil, foods, biota, and other media subsequent to effluent release into the environment. Environmental surveillance data provide information regarding conformity with applicable DOE

Oak Ridge Reservation Annual Site Environmental Report for 2006

Energy Technology Data Exchange (ETDEWEB)

McMahon, Wayne [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States). Y-12 Complex; Hughes, Joan [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Coffey, Mike [East Tennessee Technology Park (ETTP), Oak Ridge, TN (United States); Thompson, Sharon [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

2007-09-01

This document is prepared annually to summarize environmental activities, primarily environmental-monitoring activities, on the Oak Ridge Reservation (ORR) and within the ORR surroundings. The document fulfills the requirement of Department of Energy (DOE) Order 23l.IA, 'Environment, Safety and Health Reporting,' for an annual summary of environmental data to characterize environmental performance. The environmental-monitoring criteria are described in DOE Order 450.1, 'Environmental Protection Program.' The results summarized in this report are based on data collected prior to and through 2006. This report is not intended to provide the results of all sampling on the ORR. Additional data collected for other site and regulatory purposes, such as environmental restoration remedial investigation reports, waste management characterization sampling data, and environmental permit compliance data, are presented in other documents that have been prepared in accordance with applicable DOE guidance and/or laws and are referenced herein as appropriate. Corrections to the report for the previous year are found in Appendix A. Environmental monitoring on the ORR consists primarily of two major activities: effluent monitoring and environmental surveillance. Effluent monitoring involves the collection and analysis of samples or measurements of liquid and gaseous effluents at the point of release to the environment; these measurements allow the quantification and official reporting of contaminants, assessment of radiation and chemical exposures to the public, and demonstration of compliance with applicable standards and permit requirements. Environmental surveillance consists of the collection and analysis of environmental samples from the site and its environs; these activities provide direct measurement of contaminant concentrations in air, water, groundwater, soil, foods, biota, and other media. Environmental surveillance data provide information regarding

Self-Assessment of Nuclear Security Culture in Facilities and Activities. Technical Guidance

International Nuclear Information System (INIS)

2017-01-01

The IAEA has developed a comprehensive methodology for evaluating nuclear security culture. When implemented by a State, this methodology will help to make nuclear security culture sustainable. It will also promote cooperation and the sharing of good practices related to nuclear security culture. This publication is the first guidance for assessing nuclear security culture and analysing its strengths and weaknesses within a facility or activity, or an organization. It reflects, within the context of assessment, the nuclear security culture model, principles and criteria set out in the Implementing Guide, IAEA Nuclear Security Series No. 7. This guidance will be useful for organizations and operating facilities in conducting the self-assessment of nuclear security culture by providing practical methods and tools. It will also help regulatory bodies and other competent authorities to understand the self-assessment methodology used by operators, encourage operators to start the self-assessment process or, if appropriate, conduct independent assessments of nuclear security culture.

Graphic Turbulence Guidance

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

Priorities for Addressing Severe Accident and L3PSA in Radiation Environmental Report

Energy Technology Data Exchange (ETDEWEB)

Jang, M. S.; Kang, H. S.; Kim, S. R. [NESS, Daejeon (Korea, Republic of); Yang, Y. H.; Yoon, Y. I. [KHNP, Daejeon (Korea, Republic of)

2016-05-15

Domestic rules for the radiation environment impact assessment were enacted based on NUREG-0555, the guidance to the nuclear regulatory commission staff in implementing provisions of 10 CFR 51, 'environmental protection regulations for domestic licensing and related regulatory functions', related to NPPs. A revised document of NUREG-0555 was published in 2000 as NUREG-1555, Vol. 1 and 2. The related domestic rules would have made some revisions in accordance with NUREG-1555 in 2016. In this paper, we would introduce the new technical standards and review legal and technical issues on legislation. There are three legal and technical issues on revised legislation that includes severe accidents and L3PSA results in RER. First, it may need a regular and continuing education for the severe accident concept, probabilistic assessment method and conservative assumptions for severe accident, how to interpret the assessment results, the probability of a severe accident, SAMA and etc. to obtain the public understanding for severe accident. Second, it needs the development of strategy and technology not only to evaluate the risk of multi-unit accidents and failure case and the impacts of inter-unit shared systems and common events for the probabilistic assessment of severe accidents but also to solve many potential L3PSA challenges. Finally, the cost-beneficial SAMAs analysis would be added in radiation environmental impact and severe accident impact analysis.

Air pollution and public health: a guidance document for risk managers.

Science.gov (United States)

Craig, Lorraine; Brook, Jeffrey R; Chiotti, Quentin; Croes, Bart; Gower, Stephanie; Hedley, Anthony; Krewski, Daniel; Krupnick, Alan; Krzyzanowski, Michal; Moran, Michael D; Pennell, William; Samet, Jonathan M; Schneider, Jurgen; Shortreed, John; Williams, Martin

2008-01-01

This guidance document is a reference for air quality policymakers and managers providing state-of-the-art, evidence-based information on key determinants of air quality management decisions. The document reflects the findings of five annual meetings of the NERAM (Network for Environmental Risk Assessment and Management) International Colloquium Series on Air Quality Management (2001-2006), as well as the results of supporting international research. The topics covered in the guidance document reflect critical science and policy aspects of air quality risk management including i) health effects, ii) air quality emissions, measurement and modeling, iii) air quality management interventions, and iv) clean air policy challenges and opportunities.

Guidance notes for the protection of persons against ionising radiations arising from medical and dental use

International Nuclear Information System (INIS)

1988-01-01

Guidance notes have been prepared by the NRPB, the Health Departments and the Health and Safety Executive for the protection of all persons against ionising radiations arising from medical and dental use. The guidance notes are a guide to good radiation protection practice consistent with regulatory requirements. The areas covered include medical and dental radiology, diagnostic X-ray equipment for medical and dental radiography, beam therapy and remotely controlled after-loading, brachytherapy, diagnostic and therapeutic uses of unsealed radioactive substances, diagnostic uses of sealed or other solid radioactive sources, patients leaving hospital after administration of radioactive substances, precautions after death of a patient whom radioactive substances have been administered, storage and movement of radioactive substances, disposal of radioactive waste and contingency planning and emergency procedures. (U.K.)

Overall review strategy for the Nuclear Regulatory Commission's High-Level Waste Repository Program

International Nuclear Information System (INIS)

Johnson, R.L.

1994-11-01

The Overall Review Strategy gives general guidance to the Nuclear Regulatory Commission staff for conducting it's license application and pre-license application reviews. These reviews are in support of the Commission's construction authorization decision for a geologic repository for the disposal of high-level radioactive waste. Objectives and strategies are defined that focus the staff's reviews on determining compliance with requirements of 10 CFR Part 60. These strategies define how the staff prioritizes its reviews on those key technical uncertainties considered to be most important to repository performance. Strategies also give guidance for developing, in an integrated way, the License Application Review Plan together with supporting performance assessments, analyses, and research

78 FR 17660 - Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles...

Science.gov (United States)

2013-03-22

... ENVIRONMENTAL PROTECTION AGENCY [FRL-9792-9] Draft Guidance for E85 Flexible Fuel Vehicle... draft EPA guidance to auto manufacturers for weighting the greenhouse gas (GHG) emissions of a flexible... all federal government work days from 8:30 a.m. to 4:30 p.m.; generally, it is open Monday through...

Scenario guidance handbook for emergency-preparedness exercises at nuclear facilities

International Nuclear Information System (INIS)

Laughlin, G.J.; Martin, G.F.; Desrosiers, A.E.

1983-01-01

As part of the Emergency Preparedness Implementation Appraisal Program conducted by the Nuclear Regulatory Commission (NRC) with the technical assistance of the Pacific Northwest Laboratory (PNL), emergency preparedness exercises are observed on an annual basis at all licensed reactor facilities. One of the significant findings to arise from these observations was that a large number of the commonly observed problems originated in the design of the scenarios used as a basis for each exercise. In an effort to help eliminate some of these problems a scenario guidance handbook has been generated by PNL for the NRC to assist nuclear power plant licensees in developing scenarios for emergency preparedness exercises

Non-cable vehicle guidance

Energy Technology Data Exchange (ETDEWEB)

Daugela, G.C.; Willott, A.M.; Chopiuk, R.G.; Thornton, S.E.

1988-06-01

The purpose is to determine the most promising driverless mine vehicle guidance systems that are not dependent on buried cables, and to plan their development. The project is presented in two phases: a preliminary study and literature review to determine whether suitable technologies exist to justify further work; and an in-depth assessment and selection of technologies for vehicle guidance. A large number of guidance elements are involved in a completely automated vehicle. The technologies that hold the best potential for development of guidance systems for mine vehicles are ultrasonics, radar, lasers, dead reckoning, and guidance algorithms. The best approach to adaptation of these technologies is on a step by step basis. Guidance modules that are complete in themselves and are designed to be integrated with other modules can provide short term benefits. Two modules are selected for development: the dragline operations monitor and automated machine control for optimized mining (AMCOM). 99 refs., 20 figs., 40 tabs.

Environmental management assessment of the National Institute for Petroleum and Energy Research

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-08-01

This report documents the results of the environmental management assessment of the National Institute for Petroleum and Energy Research (NIPER), located in Bartlesville, Oklahoma. The assessment was conducted August 15-26, 1994, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety and Health. The assessment included reviews of documents and reports, as well as inspections and observations of selected facilities and operations. Further, the team conducted interviews with management and staff from the Bartlesville Project Office (BPO), the Office of Fossil Energy (FE), the Pittsburgh Energy Technology Center (PETC), state and local regulatory agencies, and BDM Oklahoma (BDM-OK), which is the management and operating (M&O) contractor for NIPER. Because of the transition from a cooperative agreement to an M&O contract in January 1994, the scope of the assessment was to evaluate (1) the effectiveness of BDM-OK management systems being developed and BPO systems in place and under development to address environmental requirements; (2) the status of compliance with DOE Orders, guidance, and directives; and (3) conformance with accepted industry management practices. An environmental management assessment was deemed appropriate at this time in order to identify any systems modifications that would provide enhanced effectiveness of the management systems currently under development.

Comparison of the guidance documents in support of EU risk assessments with those for the derivation of EU water quality standards

NARCIS (Netherlands)

Vos JH; Janssen MPM; SEC

2005-01-01

Risks of both new and existing substances and of biocides in Europe are being evaluated using the Technical Guidance Document (TGD). The European Water Framework Directive refers to this document for establishing Environmental Quality Standards (EQSs) for water. Another guidance document for the

A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

Energy Technology Data Exchange (ETDEWEB)

Korsah, Kofi [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Muhlheim, Michael David [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wood, Richard [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

2016-04-01

The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRC Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.

75 FR 7591 - Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and...

Science.gov (United States)

2010-02-22

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-SFUND-2009-0907; FRL-9114-6] RIN 2050-ZA05 Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites; Extension of... Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response...

Guidance for Developing Principal Design Criteria for Advanced (Non-Light Water) Reactors

Energy Technology Data Exchange (ETDEWEB)

Holbrook, Mark [Idaho National Lab. (INL), Idaho Falls, ID (United States); Kinsey, Jim [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2015-03-01

In July 2013, the US Department of Energy (DOE) and US Nuclear Regulatory Commission (NRC) established a joint initiative to address a key portion of the licensing framework essential to advanced (non-light water) reactor technologies. The initiative addressed the “General Design Criteria for Nuclear Power Plants,” Appendix A to10 Code of Federal Regulations (CFR) 50, which were developed primarily for light water reactors (LWRs), specific to the needs of advanced reactor design and licensing. The need for General Design Criteria (GDC) clarifications in non-LWR applications has been consistently identified as a concern by the industry and varied stakeholders and was acknowledged by the NRC staff in their 2012 Report to Congress1 as an area for enhancement. The initiative to adapt GDC requirements for non-light water advanced reactor applications is being accomplished in two phases. Phase 1, managed by DOE, consisted of reviews, analyses and evaluations resulting in recommendations and deliverables to NRC as input for NRC staff development of regulatory guidance. Idaho National Laboratory (INL) developed this technical report using technical and reactor technology stakeholder inputs coupled with analysis and evaluations provided by a team of knowledgeable DOE national laboratory personnel with input from individual industry licensing consultants. The DOE national laboratory team reviewed six different classes of emerging commercial reactor technologies against 10 CFR 50 Appendix A GDC requirements and proposed guidance for their adapted use in non-LWR applications. The results of the Phase 1 analysis are contained in this report. A set of draft Advanced Reactor Design Criteria (ARDC) has been proposed for consideration by the NRC in the establishment of guidance for use by non-LWR designers and NRC staff. The proposed criteria were developed to preserve the underlying safety bases expressed by the original GDC, and recognizing that advanced reactors may take

Annual Report 2010. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2010-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2010. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

Annual Report 2011. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2011-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2011. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

Regulatory assessment of safety culture in nuclear organisations - current trends and challenges

International Nuclear Information System (INIS)

Tronea, M.

2010-01-01

The paper gives an overview of the current practices in the area of regulatory assessment of safety culture in nuclear organisations and of the associated challenges. While the assessment and inspection procedures currently in use by regulatory authorities worldwide are directed primarily at verifying compliance with the licensing basis, there is a recognised need for a more systematic approach to the identification, collection and review of data relevant to the safety culture in licensees' organisations. The paper presents a proposal for using the existing regulatory inspection practices for gathering information relevant to safety culture and for assessing it in an integrated manner. The proposal is based on the latest requirements and guidance issued by the International Atomic Energy Agency (IAEA) on management systems for nuclear facilities and activities, particularly as regards the attributes needed for a strong nuclear safety culture. (author)

Configuration management: Phase II implementation guidance

Energy Technology Data Exchange (ETDEWEB)

1994-03-01

Configuration management (CM) is essential to maintaining an acceptable level of risk to the public, workers, environment, or mission success. It is a set of activities and techniques used to maintain consistency among physical and functional configuration, applicable requirements, and key documents. This document provides guidance for continuing the implementation of CM in a phased and graded manner. It describes a cost-effective approach to documented consistency with requirements, with early emphasis on items most important to safety and environmental protection. It is intended to help responsible line managers and configuration management staff personnel in meeting the Energy Systems configuration management policy standard.

The Federal Energy Technology Center annual site environmental report for calendar year 1998

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-10-31

A comprehensive Directives Program aimed at environmental, safety, and health requirements and risks was initiated in 1997 and will be completed in late 1999 or early 2000. The primary objective of the program is to identify or develop a set of standards that, when implemented, provides reasonable assurance that the health and safety of the workers, public, and the environment will be protected during the performance of the work. In conjunction with the Directives Program, the use of the voluntary environmental management system, ISO 14000, was evaluated. This includes the only environmental management standard to which an entity can be registered. Plans are to consider the specifications and guidance from this standard in the identification of an effective environmental management system for the merged FETC sites. A performance measurement system continued to be maintained during 1998 to assist in evaluating how effectively activities at FETC meet mission-critical goals and how well missions and strategies are connected in the DOE strategic plan. This system also provides data to assist in gauging performance against the DOE critical success factors, that is, performance against technical objectives. Various environmental milestones can be tracked to completion, thus giving the FETC measures by which to gauge the site's goals of remaining in regulatory compliance and achieving best-in-class environmental performance.

Regulatory status of burnup credit for dry storage and transport of spent nuclear fuel in the United States

International Nuclear Information System (INIS)

Carlson, D.E.

2001-01-01

During 1999, the Spent Fuel Project Office of the U.S. Nuclear Regulatory Commission (NRC) introduced technical guidance for allowing burnup credit in the criticality safety analysis of casks for transporting or storing spent fuel from pressurized water reactors. This paper presents the recommendations embodied by the current NRC guidance, discusses associated technical issues, and reviews information needs and industry priorities for expanding the scope and content of the guidance. Allowable analysis approaches for burnup credit must account for the fuel irradiation variables that affect spent fuel reactivity, including the axial and horizontal variation of burnup within fuel assemblies. Consistent with international transport regulations, the burnup of each fuel assembly must be verified by pre-loading measurements. The current guidance limits the credited burnup to no more than 40 GWd/MTU and the credited cooling time to five years, imposes a burnup offset for fuels with initial enrichments between 4 and 5 wt% 235U, does not include credit for fission products, and excludes burnup credit for damaged fuels and fuels that have used burnable absorbers. Burnup credit outside these limits may be considered when adequately supported by technical information beyond that reviewed to-date by the NRC staff. The guidance further recommends that residual subcritical margins from the neglect of fission products, and any other nuclides not credited in the licensing-basis analysis, be estimated for each cask design and compared against estimates of the maximum reactivity effects associated with remaining computational uncertainties and potentially nonconservative modeling assumptions. The NRC's Office of Nuclear Regulatory Research is conducting a research program to help develop the technical information needed for refining and expanding the evolving guidance. Cask vendors have announced plans to submit the first NRC license applications for burnup credit later this year

Regulatory issues associated with the Multi-Purpose (MPC) system

International Nuclear Information System (INIS)

Roberts, J.P.; Desell, L.J.; Birch, M.L.; Morgan, R.G.

1994-01-01

The US Department of Energy Office of Civilian Radioactive Waste Management is developing a Multi-Purpose Canister system to promote compatibility between the waste program elements of storage, transportation, and disposal. The development of a Multi-Purpose Canister system requires meeting various regulatory requirements. These regulatory requirements are set forth in environmental and Nuclear Regulatory Commission (NRC) regulations. This paper discusses the more significant regulatory issues that must be addressed in the development of a Multi-Purpose Canister system by the Department of Energy

Workshop on environmental assessment. [Regulation of applications of nuclear energy and related ancillary systems

Energy Technology Data Exchange (ETDEWEB)

Watson, E.C. (comp.)

1982-07-01

Objectives of the workshop were: to review and evaluate the state-of-the-art of environmental impact assessments as applied to the regulation of applications of nuclear energy and related ancillary systems; to identify areas where existing technology allows establishing acceptable methods or standard practices that will meet the requirements of the NRC regulations, standards and guides for both normal operations and off-standard conditions including accident considerations; to illuminate topics where existing models or analytical methods are deficient because of unverified assumptions, a paucity of empirical data, conflicting results reported in the literature or a need for observation of operation systems; to compile, analyze and synthesize a prioritized set of research needs to advance the state-of-the-art to the level which will meet all of the requirements of the Commission's regulations, standards and guides; and to develop bases for maintaining the core of regulatory guidance at the optimum level balancing technical capabilities with practical considerations of cost and value to the regulatory process. The discussion held in small group sessions on aquatic, atmospheric, and terrestrial pathways are presented. The following research needs were identified as common to all three groups: validation of models; characterization of source terms; development of screening techniques; basis for de minimis levels of contamination; and updating of objectives for environmental monitoring programs.

Incorporation of environmental costs in electric utility planning and resource selection

International Nuclear Information System (INIS)

Anon.

1991-01-01

Generation of electricity is pervasively regulated for economic, environmental and other governmental objectives at both the state and federal levels. A panoply of legislative and regulatory devices implicitly or explicitly influence the acquisition of generation and fuel resources seeking to achieve environmentally sound selections. Effective implementation or enforcement of these laws and policies may be impeded by the regional or global character of the environmental impacts; jurisdictional conflicts and limitations; and the division of regulatory authority between economic regulatory agencies and their environmental or energy policy counterparts. This chapter reviews the state and federal statutory and regulatory treatment of environmental externalities and discusses alternatives for their consideration