Safety evaluation report related to the operation of Wolf Creek Generating Staton, Unit No. 1, (Docket No. STN 50-482). Supplement No. 4

International Nuclear Information System (INIS)

1983-12-01

Supplement No. 4 to the Safety Evaluation Report related to the operation of the Wolf Creek Generating Station, Unit No. 1 updates the information contained in the Safety Evaluation Report, dated April 1982 and Supplements 1, 2, and 3, dated August 1982, June 1983 and August, 1983, respectively. Supplement No. 4 addresses open issues, confirmatory items and addresses Board Notifications. The Safety Evaluation and its supplements pertain to the application for a license to operate the Wolf Creek Generating Station, Unit No. 1 filed by Kansas Gas and Electric Company on February 19, 1980. The Construction Permit No. CPPR-147 was issued on May 17, 1977

Safety evaluation report related to operation of Fast Flux Test Facility. Supplement No. 1

International Nuclear Information System (INIS)

1979-05-01

This supplement provides (1) the staff's evaluation of additional information received since issuance of the Safety Evaluation Report regarding previously identified uncompleted review items, (2) a discussion of comments made by the ACRS in its report of November 8, 1978, and (3) the staff's evaluation of additional or revised information related to new or old issues that have arisen since the issuance of the Safety Evaluation Report

76 FR 14590 - Defense Federal Acquisition Regulation Supplement; Safety of Facilities, Infrastructure, and...

Science.gov (United States)

2011-03-17

... makes it unlikely that a small business could afford to sustain the infrastructure required to perform...-AG73 Defense Federal Acquisition Regulation Supplement; Safety of Facilities, Infrastructure, and... facilities, infrastructure, and equipment that are intended for use by military or civilian personnel of the...

Safety evaluation report related to the operation of River Bend Station (Docket No. 50-458). Supplement No. 2

International Nuclear Information System (INIS)

1985-08-01

Supplement No. 2 to the Safety Evaluation Report on the application filed by Gulf States Utilities Company as applicant and for itself and Cajun Electric Power Cooperative, as owners, for a license to operate River Bend Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in West Feliciana Parish, near St. Francisville, Louisiana. This supplement reports the status of certain items that had not been resolved at the time the Safety Evaluation Report was published

Safety evaluation report related to the operation of Hope Creek Generating Station (Docket No. 50-354). Supplement 2

International Nuclear Information System (INIS)

1985-08-01

Supplement No. 2 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company as applicant for itself and Atlantic City Electric Company, as owners, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

Safety Evaluation Report related to the operation of Hope Creek Generation Station (Docket No. 50-354). Supplement No. 6

International Nuclear Information System (INIS)

1986-07-01

Supplement No. 6 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company on its own behalf as co-owner and as agent for the other co-owner, the Atlantic City Electric Company, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that has not been resolved at the time of the publication of the Safety Evaluation Report. This supplement supports the issuance of a full-power license to operate Hope Creek Generating Station

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: Testing an EFS tired approach

NARCIS (Netherlands)

Speijers, G.; Bottex, B.; Dusemund, B.; Lugasi, A.; Toth, J.; Amberg-Muller, J.; Galli, C.; Silano, V.; Rietjens, I.

2010-01-01

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified

Safety Evaluation Report related to the operation of Enrico Fermi Atomic Power Plant, Unit No. 2 (Docket No. 50-341). Supplement No. 4

International Nuclear Information System (INIS)

1984-09-01

Supplement No. 4 to the Safety Evaluation Report related to the operation of the Enrico Fermi Atomic Power Plant, Unit 2, provides the staff's evaluation of additional information submitted by the applicant regarding outstanding review issues identified in Supplement No. 3 to the Safety Evaluation Report, dated January 1983

Safety Evaluation Report related to the operation of Fermi-2 (Docket No. 50-341). Supplement No. 5

International Nuclear Information System (INIS)

1985-03-01

Supplement No. 5 to the Safety Evaluation Report (SER) related to the operation of the Fermi-2 facility, provides the NRC staff's evaluation of additional information submitted by the applicant regarding outstanding review issues identified in Supplement No. 4 to the SER dated September 1984. This supplement contains the staff's conclusion that there are no outstanding issues which must be resolved prior to issuance of a low-power operating license (i.e., less than five percent of full rated power) for the Fermi-2 facility. Supplement No. 5 to the SER also summarizes the conditions which are placed in the Fermi-2 operating license

Safety evaluation report related to the operation of Millstone Nuclear Power Station, Unit No. 3 (Docket No. 50-423). Supplement No. 5

International Nuclear Information System (INIS)

1986-01-01

This report supplements the Safety Evaluation Report (NUREG-1031) issued in July 1984, Supplement 1 issued in March 1985, Supplement 2 issued in September 1985, Supplement 3 issued in November 1985, and Supplement 4 issued in November 1985 by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by Northeast Nuclear Energy Company (licensee and agent for the owners) for a license to operate Millstone Nuclear Power Station, Unit No. 3 (Docket 50-423). The supplement provides more recent information regarding resolution of license conditions identified in the SER. Because of the favorable resolution of the items discussed in this report, the staff concludes that Millstone Nuclear Power Station, Unit No. 3, can be operated by the licensee at power levels greater than 5% without endangering the health and safety of the public. 13 refs

Safety Evaluation Report related to the operation of Millstone Nuclear Power Station, Unit No. 3 (Docket No. 50-423). Supplement No. 3

International Nuclear Information System (INIS)

1985-11-01

This report supplements the Safety Evaluation Report (NUREG-1031) issued in July 1984, Supplement 1 issued in March 1985, and Supplement 2 issued in September 1985 by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by Northeast Nuclear Energy Company (applicant and agent for the owners) for a license to operate Millstone Nuclear Power Station, Unit No. 3 (Docket 50-423). The facility is located in the Town of Waterford, New London County, Connecticut, on the north shore of Long Island Sound. This supplement provides more recent information regarding resolution or updating of some of the open and confirmatory items and license conditions identified in the Safety Evaluation Report

Safety Evaluation Report related to the operation of Hope Creek Generating Station (Docket No. 50-354). Supplement No. 1

International Nuclear Information System (INIS)

1985-03-01

Supplement No. 1 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company as applicant for itself and Atlantic City Electric Company, as owners, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

Science.gov (United States)

Vujić, Mario; Pollak, Lea

2015-12-01

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

Implementing a "quality by design" approach to assure the safety and integrity of botanical dietary supplements.

Science.gov (United States)

Khan, Ikhlas A; Smillie, Troy

2012-09-28

Natural products have provided a basis for health care and medicine to humankind since the beginning of civilization. According to the World Health Organization (WHO), approximately 80% of the world population still relies on herbal medicines for health-related benefits. In the United States, over 42% of the population claimed to have used botanical dietary supplements to either augment their current diet or to "treat" or "prevent" a particular health-related issue. This has led to the development of a burgeoning industry in the U.S. ($4.8 billion per year in 2008) to supply dietary supplements to the consumer. However, many commercial botanical products are poorly defined scientifically, and the consumer must take it on faith that the supplement they are ingesting is an accurate representation of what is listed on the label, and that it contains the purportedly "active" constituents they seek. Many dietary supplement manufacturers, academic research groups, and governmental organizations are progressively attempting to construct a better scientific understanding of natural products, herbals, and botanical dietary supplements that have co-evolved with Western-style pharmaceutical medicines. However, a deficiency of knowledge is still evident, and this issue needs to be addressed in order to achieve a significant level of safety, efficacy, and quality for commercial natural products. The authors contend that a "quality by design" approach for botanical dietary supplements should be implemented in order to ensure the safety and integrity of these products. Initiating this approach with the authentication of the starting plant material is an essential first step, and in this review several techniques that can aid in this endeavor are outlined.

Safety Evaluation Report related to the operation of Beaver Valley Power Station, Unit 2 (Docket No. 50-412). Supplement No. 2

International Nuclear Information System (INIS)

1986-08-01

This report, Supplement No. 2 to the the Safety Evaluation Report for the application filed by the Duquesne Light Company, et al. (the applicant) for a license to operate the Beaver Valley Power Station Unit 2 (Docket No. 50-412), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time the Safety Evaluation Report was published

Safety evaluation report related to the operation of Hope Creek Generation Station (Docket No. 50-354). Supplement No. 5

International Nuclear Information System (INIS)

1986-04-01

Supplement No. 5 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company on its own behalf as co-owner and as agent for the other co-owner, the Atlantic City Electric Company, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that had not been resolved at the time of the publication of the Safety Evaluation Report

Safety Evaluation Report related to the operation of Hope Creek Generating Station (Docket No. 50-354). Supplement No. 4

International Nuclear Information System (INIS)

1985-12-01

Supplement No. 4 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company on its own behalf as co-owner and as agent for the other co-owner, the Atlantic City Electric Company, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

Safety Evaluation Report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). Supplement No. 4

International Nuclear Information System (INIS)

1986-09-01

This report supplements the Safety Evaluation Report (NUREG-1047, February 1985) for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate Nine Mile Point Nuclear Station, Unit 2 (Docket No. 50-410). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. Supplement 1 to the Safety Evaluation Report was published in June 1985, and contained the report from the Advisory Committee on Reactor Safeguards as well as the resolution of a number of outstanding issues from the Safety Evaluation Report. Supplement 2 was published in November 1985, and contained the resolution of a number of outstanding and confirmatory issues. Supplement 3 was published in July 1986, and contained the resolution of a number of outstanding and confirmatory items, one new confirmatory item, the evaluation of the Engineering Assurance Program, and evaluation of a number of exemption requests

Safety Evaluation Report related to the operation of Fermi-2 (Docket No. 50-341). Supplement No. 6

International Nuclear Information System (INIS)

1985-07-01

Supplement No. 6 to the Safety Evaluation Report (SER) related to the operation of the Fermi-2 facility, provides the NRC staff's evaluation of additional information submitted by the licensee regarding outstanding review issues identified in Supplement No. 5 to the SER dated March 1985 and also contains the staff's evaluation of the Independent Design Verification Program. Supplement No. 6 to the SER also summarizes the conditions which are placed in the Fermi-2 full-power operating license, NPF-43, and evaluates recent proposed changes to the Fermi-2 Technical Specifications. This supplement presents the staff's conclusion that there are no outstanding issues which must be resolved prior to issuance of a full power operating license for the Fermi-2 facility

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 14

Energy Technology Data Exchange (ETDEWEB)

Tam, P.S.

1994-12-01

Supplement No. 14 to the Safety Evaluation Report for the application filed by the Tennessee Valley Authority for license to operate Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, located in Rhea County, Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation with additional information submitted by the applicant since Supplement No. 13 was issued, and matters that the staff had under review when Supplement No. 13 was issued.

Safety Evaluation Report related to the operation of Shearon Harris Nuclear Power Plant, Unit No. 1 (Docket No. STN 50-400). Supplement No. 4

International Nuclear Information System (INIS)

1986-10-01

This report, Supplement No. 4 to the Safety Evaluation Report for the application filed by the Carolina Power and Light Company and North Carolina Eastern Municipal Power Agency (the applicants) for a license to operate the Shearon Harris Nuclear Power Plant Unit 1 (Docket No. 50-400), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1, 2, and 3

Safety Evaluation Report related to the operation of Shearon Harris Nuclear Power Plant, Unit No. 1 (Docket No. STN 50-400). Supplement No. 2

International Nuclear Information System (INIS)

1985-06-01

This report, Supplement No. 2 to the Safety Evaluation Report for the application filed by the Carolina Power and Light Company and North Carolina Eastern Municipal Power Agency (the applicants) for a license to operate the Shearon Harris Nuclear Power Plant Unit 1 (Docket No. 50-400), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement No. 1

Safety Evaluation Report related to the operation of Shearon Harris Nuclear Power Plant, Unit No. 1 (Docket No. STN 50-400). Supplement No. 3

International Nuclear Information System (INIS)

1986-05-01

This report, Supplement No. 3 to the Safety Evaluation Report for the application filed by the Carolina Power and Light Company and North Carolina Eastern Municipal Power Agency (the applicants) for a license to operate the Shearon Harris Nuclear Power Plant Unit 1 (Docket No. 50-400), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1 and 2

Safety Assessment of Tocotrienol Supplementation in Subjects with Metabolic Syndrome: A Randomised Control Trial

International Nuclear Information System (INIS)

Lin, G.Y.; Ming, L.O.; Nesaratnam, K.; Kim-Tiu, T.; Selvaduray, K.R.; Meganathan, P.; Yen, F.J.

2016-01-01

Previous studies have reported that tocotrienols (T3) possess many distinct properties such as antioxidant, cardioprotective, neuroprotective, anti-cancer, anti-inflammatory and anti-angiogenic, which are beneficial for the improvement of human health. However, there is limited data available on the safety assessment of T3 compared to tocopherols (T). A randomised, double-blinded, cross-over and placebo-controlled human clinical trial was conducted to determine the safety and tolerance of T3 supplementation in 31 subjects with metabolic syndrome. The subjects were supplemented with tocotrienol-rich fra tion (TRF) 200 mg or placebo capsules twice daily for two weeks followed by a post-intervention visit. Results showed that T3 supplementation had no significant adverse effect on the red blood cell (RBC), white blood cell (WBC) and platelet counts between TRF (5.10 ± 0.78 x 10"1"2 litre"-"1, 7.35 ± 1.59 x 10"9 litre"-"1, 279.45 ± 73.86 x 10"9 litre"-"1, respectively) and placebo interventions (5.13 ± 0.76 x 10"1"2 litre"-"1, 7.25 ± 1.95 x 10"9 litre"-"1, 267.45 ± 68.72 x 10"9 litre"-"1, respectively). Measures of serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT)) and albumin did not differ between TRF (25.68 ± 10.72 IU litre"-"1, 38.26 ± 24.74 IU litre"-"1, 43.61 ± 2.26 g litre"-"1, respectively) and placebo interventions (27.39 ± 16.44 IU litre"-"1, 42.23 ± 33.58 IU litre"-"1, 43.68 ± 2.15 g litre"-"1, respectively).This study indicated that supplementation with T3 at the dosage of 400 mg per day for 14 days did not induce haematoxicity and hepatotoxicity in subjects with metabolic syndrome. (author)

Dietary Supplements: What You Need to Know

Science.gov (United States)

... product. How can I be a smart supplement shopper? Be a savvy supplement user. Here’s how: • When ... gov/Safety/ReportaProblem/ConsumerComplaintCoordinators • File a safety report online through the Safety Reporting Portal at: http://www. ...

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.

Science.gov (United States)

Speijers, Gerrit; Bottex, Bernard; Dusemund, Birgit; Lugasi, Andrea; Tóth, Jaroslav; Amberg-Müller, Judith; Galli, Corrado L; Silano, Vittorio; Rietjens, Ivonne M C M

2010-02-01

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

Safety assessment of green tea based beverages and dried green tea extracts as nutritional supplements.

Science.gov (United States)

Dekant, Wolfgang; Fujii, Kenkichi; Shibata, Eiichiro; Morita, Osamu; Shimotoyodome, Akira

2017-08-05

The safety of green tea infusions and green tea extract (GTE)-based products is reviewed regarding catechins. Epigallocatechin 3-gallate (EGCG), the major catechin present in green tea, is suspected of being responsible for liver toxicity reported in humans consuming food supplements. Intake of EGCG with green tea infusions and GTE-based beverages is up to about 450mg EGCG/person/day in Europe and higher in Asia. Consumption of green tea is not associated with liver damage in humans, and green tea infusion and GTE-based beverages are considered safe in the range of historical uses. In animal studies, EGCG's potency for liver effects is highly dependent on conditions of administration. Use of NOAELs from bolus administration to derive a tolerable upper intake level applying the margin of safety concept results in acceptable EGCG-doses lower than those from one cup of green tea. NOAELs from toxicity studies applying EGCG with diet/split of the daily dose are a better point of departure for risk characterization. In clinical intervention studies, liver effects were not observed after intakes below 600mg EGCG/person/day. Thus, a tolerable upper intake level of 300mg EGCG/person/day is proposed for food supplements; this gives a twofold safety margin to clinical studies that did not report liver effects and a margin of safety of 100 to the NOAELs in animal studies with dietary administration of green tea catechins. Copyright © 2017 Elsevier B.V. All rights reserved.

Safety Evaluation Report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 4

International Nuclear Information System (INIS)

1985-03-01

This report supplements the Safety Evaluation Report, NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), and Supplement No. 3 (January 1985) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the open and confirmatory items and license conditions identified in the Safety Evaluation Report

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391): Supplement No. 19

International Nuclear Information System (INIS)

1995-11-01

Supplement No. 19 to the Safety Evaluation Report for the application filed by the Tennessee Valley Authority for license to operate Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, located in Rhea County Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation with (1) additional information submitted by the applicant since Supplement No. 18 was issued, and (2) matters that the staff had under review when Supplement No. 18 was issued

Safety evaluation report related to the operation of LaSalle County Station, Units 1 and 2, (Docket Nos. 50-373 and 50-374). Supplement No. 7

International Nuclear Information System (INIS)

1983-12-01

Supplement No. 7 to the Safety Evaluation Report of Commonwealth Edison Company's application for a license to operate its La Salle County Station, Unit 2, located on Brookfield Township, La Salle County, Illinois, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement is to update our evaluations on Unit 2 issues identified in the previous Safety Evaluation Report and Supplements that need resolution prior to issuance of the operating license for Unit 2

Safety Evaluation Report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 8

International Nuclear Information System (INIS)

1984-12-01

Supplement 8 (SSER 8) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

Safety evaluation report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 7

International Nuclear Information System (INIS)

1984-09-01

Supplement 7 (SSER 7) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

Safety evaluation report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 6

International Nuclear Information System (INIS)

1984-07-01

Supplement 6 (SSER 6) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

Safety Evaluation Report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322). Supplement No. 9

International Nuclear Information System (INIS)

1985-12-01

Supplement 9 (SSER 9) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

Active components in food supplements

NARCIS (Netherlands)

Siemelink M; Jansen EHJM; Piersma AH; Opperhuizen A; LEO

2000-01-01

The growing food supplement market, where supplements are both more diverse and more easily available (e.g. through Internet) formed the backdrop to the inventory of the active components in food supplements. The safety of an increased intake of food components via supplements was also at issue

Safety Evaluation Report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). Supplement No. 5

International Nuclear Information System (INIS)

1986-10-01

This report supplements the Safety Evaluation Report (NUREG-1047, February 1985) for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate Nine Mile Point Nuclear Station, Unit 2 (Docket No. 50-410). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. Supplement 1 to the Safety Evaluation Report was published in June 1985 and contained the report from the Advisory Committee on Reactor Safeguards as well as the resolution of a number of outstanding issues from the Safety Evaluation Report. Supplement 2 was published in November 1985 and contained the resolution of a number of outstanding and confirmatory issues. Supplement 3 was published in July 1986 and contained the resolution of a number of outstanding and confirmatory items, one new confirmatory item, the evaluation of the Engineering Assurance Program, and the evaluation of a number of exemption requests. Supplement 4 was published in September 1986 and contained the resolution of a number of outstanding and confirmatory issues and the evaluation of a number of exemption requests. This report contains the resolution of a number of issues that have been resolved since Supplement 4 was issued. It also contains the evaluation of a number of requests for exemption from the applicant. This report also supports the issuance of the low-power license for Nine Mile Point Nuclear Station, Unit 2

An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.

Science.gov (United States)

Cohen, Pieter A; Bloszies, Clayton; Yee, Caleb; Gerona, Roy

2016-01-01

The amphetamine isomer β-methylphenylethylamine (BMPEA) was first synthesized in the early 1930s, but its efficacy and safety in humans has not been studied. Recently, the United States Food and Drug Administration (FDA) detected BMPEA in dietary supplements labelled as containing Acacia rigidula. Over a year after the FDA reported its findings, we analyzed Acacia rigidula dietary supplements to determine if BMPEA had been removed. Supplements were analyzed using liquid chromatography-quadrupole time-of-flight mass spectrometry. Diluted methanolic extract from each supplement was run three times and each data set obtained was analyzed using Agilent MassHunter Qualitative Analysis. The presence of BMPEA was confirmed by accurate mass, retention time and mass spectra match against a reference standard. Quantification of BMPEA was determined using an eight-point calibration curve of spiked standard to a matrix blank. Twenty-one brands of Acacia rigidula supplements were analyzed. More than half (11/21; 52.4%) of the Acacia rigidula supplement brands contained BMPEA. The stimulant was present at quantities such that consumers following recommended maximum daily servings would consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Safety Evaluation Report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 3

International Nuclear Information System (INIS)

1985-01-01

This report supplements the Safety Evaluation Report, NUREG-0847 (June 1982), Supplement No. 1 (September 1982), and Supplement No. 2 (January 1984) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the open and confirmatory items and license conditions identified in the Safety Evaluation Report

Safety evaluation report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446): Supplement No. 21

International Nuclear Information System (INIS)

1989-04-01

Supplement 21 to the Safety Evaluation Report related to the operation of the Comanche Peak Steam Electric Station (CPSES), Units 1 and 2 (NUREG-0797), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission (NRC). The facility is located in Somervell County, Texas, approximately 40 miles southwest of Fort Worth, Texas. This supplement reports the status of certain issues that had not been resolved when the Safety Evaluation Report and Supplements 1, 2, 3, 4, 6, and 12 to that report were published. This supplement also lists the new issues that have been identified since Supplement 12 was issued and includes the evaluations for licensing items resolved in this interim period. 21 refs

Safety evaluation report related to the operation of Catawba Nuclear Station, Units 1 and 2 (Docket Nos. 50-413 and 50-414). Supplement 2

International Nuclear Information System (INIS)

1984-06-01

This report supplements the Safety Evaluation Report (NUREG-0954) and Supplement 1 with respect to the application filed by Duke Power Company, North Carolina Municipal Power Agency Number 1, North Carolina Membership Corporation, and Saluda River Electric Cooperative, Inc., as applicants and owners, for licenses to operate the Catawba Nuclear Station, Units 1 and 2 (Docket Nos., 50-413 and 50-414, respectively). The facility is located in York County, South Carolina, approximately 9.6 km (6 mi) north of Rock Hill and adjacent to Lake Wylie. This supplement provides more recent information regarding resolution or updating of some of the open and confirmatory issues and license conditions identified in the Safety Evaluation Report

Review of the ethnobotany, chemistry, biological activity and safety of the botanical dietary supplement Morinda citrifolia (noni).

Science.gov (United States)

Pawlus, Alison D; Kinghorn, Douglas A

2007-12-01

Morinda citrifolia, commonly called noni, has a long history as a medicinal plant and its use as a botanical dietary supplement has grown tremendously in recent years. This has prompted a concomitant increase in research on the phytochemical constituents and biological activity of noni. A relatively large number of scientific publications on noni have been published in recent years, including a number of review articles. The goals of this review are to provide an updated categorization of the phytochemical constituents found in noni and to provide perspective for its extensive utilization as a major botanical dietary supplement. Included herein are a comprehensive list of known ethnobotanical uses and common names of M. citrifolia, a brief summary of relevant biological studies and a discussion of the safety of noni as a supplement.

Safety Evaluation Report related to the final design approval of the GESSAR II BWR/6 Nuclear Island Design (Docket No. 50-447). Supplement No. 3

International Nuclear Information System (INIS)

1985-01-01

Supplement 3 to the Safety Evaluation Report (SER) for the application filed by General Electric Company for the final design approval for the GE BWR/6 nuclear island design has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. This report supplements the GESSAR II SER (NUREG-0979), issued in April 1983, summarizing the results of the staff's safety review of the GESSAR II BWR/6 nuclear island design. Subject to favorable resolution of the items discussed in this supplement, the staff concludes that the GESSAR II design satisfactorily addresses the severe-accident concerns described in draft NUREG-1070

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 18

International Nuclear Information System (INIS)

Tam, P.S.

1995-10-01

In June 1982, the Nuclear Regulatory Commission staff (NRC staff or staff) issued a Safety Evaluation Report, NUREG-0847, regarding the application by the Tennessee Valley Authority (TVA or the applicant) for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2. Each of the following sections and appendices of this supplement is numbered the same as the section or appendix of the SER that is being updated, and the discussions are supplementary to, and not in lieu of, the discussion in the SER, unless otherwise noted. Accordingly, Appendix A continues the chronology of the safety review. Appendix E lists principal contributors to this supplement. Appendix FF is added in this supplement. The other appendices are not changed by this supplement

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446). Supplement No. 7

International Nuclear Information System (INIS)

1985-01-01

Supplement 7 to the Safety Evaluation Report for the Texas Utilities Electric Company application for a license to operate Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445, 50-446), located in Somervell County, Texas, has been jointly prepared by the Office of Nuclear Reactor Regulation and the Comanche Peak Technical Review of the US Nuclera Regulatory Commission. This supplement provides the results of the staff's evaluation and resolution of approximately 80 technical concerns and allegations in the areas of Electric/Instrumentation and Test Programs regarding construction and plant readiness testing practices at the Comanche Peak facility. Issues raised during Atomic Safety and Licensing Board hearings will be dealt with in future supplements to the Safety Evaluation Report

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446). Supplement No. 8

International Nuclear Information System (INIS)

1985-02-01

Supplement 8 to the Safety Evaluation Report for the Texas Utilities Electric Company application for a license to operate Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445, 50-446), located in Somervell County, Texas, has been jointly prepared by the Office of Nuclear Reactor Regulation and the Comanche Peak Technical Review Team of the US Nuclear Regulatory Commission. This Supplement provides the results of the staff's evaluation and resolution of approximately 80 technical concerns and allegations relating to civil and structural and miscellaneous issues regarding construction and plant readiness testing practices at the Comanche Peak facility. Issues raised during recent Atomic Safety and Licensing Board hearings will be dealt with in future supplements to the Safety Evaluation Report

[Quality control in herbal supplements].

Science.gov (United States)

Oelker, Luisa

2005-01-01

Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

Safety Evaluation Report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 7

International Nuclear Information System (INIS)

1986-09-01

Supplement No. 7 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since Supplement No. 6 was issued

Safety evaluation report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 5

International Nuclear Information System (INIS)

1986-01-01

Supplement No. 5 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc. as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since supplement No. 4 was issued

Safety Evaluation Report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 4

International Nuclear Information System (INIS)

1985-02-01

Supplement No. 4 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since Supplement No. 3 was issued

Safety Evaluation Report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Supplement No. 6

International Nuclear Information System (INIS)

1986-07-01

Supplement No. 6 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since Supplement No. 5 was issued

Safety evaluation report related to the operation of Shearon Harris Nuclear Power Plant, Unit No. 1 (Docket No. STN 50-400). Supplement No. 1

International Nuclear Information System (INIS)

1984-06-01

This report, Supplement No. 1 to the Safety Evaluation Report for the application filed by the Carolina Power and Light Company and North Carolina Eastern Municipal Power Agency (the applicant) for license to operate the Shearon Harris Nuclear Power Plant Unit 1 (Docket No. 50-400), has been prepared by the Office of Nuclear Reactor Regulation of the U.S. Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

Influence of A Thermogenic Dietary Supplement on Safety Markers, Body Composition, Energy Expenditure, Muscular Performance and Hormone Concentrations: A Randomized, Placebo-Controlled, Double-Blind Trial

Directory of Open Access Journals (Sweden)

Grant M. Tinsley, Stacie Urbina, Jacy Mullins, Jordan Outlaw, Sara Hayward, Matt Stone, Cliffa Foster, Colin Wilborn, Lem Taylor

2017-12-01

Full Text Available Dietary supplementation is commonly employed by individuals seeking to improve body composition and exercise performance. The purpose of the present study was to examine the safety and effectiveness of a commercially available dietary supplement designed to promote thermogenesis and fat loss. In a randomized double-blind trial, participants were assigned to consume placebo or a multi-ingredient supplement containing caffeine, green tea extract, l-carnitine, evodiamine and other ingredients that purportedly enhance thermogenesis. The study included acute baseline testing, a 6-week progressive resistance training and supplementation intervention, and post-intervention testing. Laboratory assessments included resting energy expenditure responses to acute supplement ingestion, evaluation of body composition and muscular performance, and analysis of blood variables (metabolic panel, testosterone, estrogen and cortisol. Dependent variables were analyzed using ANOVA with repeated measures. No unfavorable effects of supplementation were reported, and the supplement did not adversely affect safety markers. However, the supplement did not reduce fat mass or increase lean mass relative to placebo. In the supplement group, lower body maximal strength was increased relative to placebo (+18%, d=1.1 vs. +10%, d=0.5, and cortisol concentrations were decreased relative to placebo (-16%; d=-0.4 vs. +15%, d=.75. However, no differences were observed for upper body maximal strength or muscular endurance. REE increased in response to both supplement and placebo ingestion (placebo: +5%; supplement: +11.5%, but the difference between conditions was not statistically significant. Overall, some select parameters may have been beneficially modified by supplementation, but this did not result in superior weight or fat loss over 6 weeks of supplementation and resistance training.

Safety evaluation report related to the operation of Sequoyah Nuclear Plant, Units 1 and 2, Docket Nos. 50-327 and 50-328, Tennessee Valley Authority. Supplement No. 2

Energy Technology Data Exchange (ETDEWEB)

NONE

1980-08-01

The purpose of this supplement is to further update the Safety Evaluation Report by providing (1) our evaluation of additional information submitted by the licensee since the issuance of Supplement No. 1 to the Safety Evaluation Report, (2) our evaluation and status of the Non-TMI-2 outstanding issues identified in Part I of SER Supplement No. 1, (3) our evaluation of TMI-2 requirements which must be completed prior to the issuance of a full-power operating license, (4) our evaluation of dated requirements which the licensee must implement by the dates identified in NUREG-0694, TMI-Related Requirements for New Operating Licenses, and (5) our evaluation of additional information for those sections of the Safety Evaluation Report where further discussion or changes are in order.

Safety evaluation report related to the operation of Sequoyah Nuclear Plant, Units 1 and 2, Docket Nos. 50-327 and 50-328, Tennessee Valley Authority. Supplement No. 2

International Nuclear Information System (INIS)

1980-08-01

The purpose of this supplement is to further update the Safety Evaluation Report by providing (1) our evaluation of additional information submitted by the licensee since the issuance of Supplement No. 1 to the Safety Evaluation Report, (2) our evaluation and status of the Non-TMI-2 outstanding issues identified in Part I of SER Supplement No. 1, (3) our evaluation of TMI-2 requirements which must be completed prior to the issuance of a full-power operating license, (4) our evaluation of dated requirements which the licensee must implement by the dates identified in NUREG-0694, TMI-Related Requirements for New Operating Licenses, and (5) our evaluation of additional information for those sections of the Safety Evaluation Report where further discussion or changes are in order

Safety Evaluation Report related to the operation of Millstone Nuclear Power Station, Unit No. 3 (Docket No. 50-423). Supplement No. 4

International Nuclear Information System (INIS)

1985-11-01

This report supplements the Safety Evaluation Report (NUREG-1031) issued in July 1984, Supplement 1 issued in March 1985, Supplement 2 issued in September 1985, and Supplement 3 issued in November 1985, by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by Northeast Nuclear Energy Company (applicant and agent for the owners) for a license to operate Millstone Nuclear Power Station, Unit No. 3 (Docket 50-423). The facility is located in the Town of Waterford, New London County, Connecticut, on the north shore of Long Island Sound. This supplement provides more recent information supporting the license for initial criticality and power ascension to 5% power operation for Millstone 3. 37 refs., 10 tabs

Should states and local governments regulate dietary supplements?

Science.gov (United States)

Starr, Ranjani

2016-01-01

Federal regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act of 1994. The law has been criticized as weak and ineffective. Alarming research has emerged demonstrating that supplements may be mislabelled, contaminated, adulterated with dangerous or unknown compounds, or sold at toxic doses. As a result, the health community has raised concerns about the safety and quality of dietary supplements. Increased federal oversight is an important avenue for improving supplement safety; however, states and local governments may also pursue strategies to strengthen the overall regulatory control of dietary supplements. States and local governments have substantial experience in regulating other products that pose a risk to public health, such as tobacco. Additionally, much has been learned about the tactics the tobacco industry has employed to protect its interests. Lessons learned may be applied to new regulatory efforts aimed at improving the safety of dietary supplements at the state and local levels. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Safety Evaluation Report related to the operation of Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement No. 3

International Nuclear Information System (INIS)

1986-08-01

In June 1985, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1137) regarding the application of Georgia Power Company, Municipal Electric Authority of Georgia, Oglethorpe Power Corporation, and City of Dalton, Georgia, for a license to operate the Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement 1 to NUREG-1137 was issued by the staff in October 1985, and Supplement 2 was issued in May 1986. The facility is located in Burke County, Georgia, approximately 26 miles south-southeast of Augusta, Georgia, and on the Savannah River. This third supplement to NUREG-1137 provides recent information regarding resolution of some of the open and confirmatory items that remained unresolved at the time the Safety Evaluation Report was issued. This supplement also discusses some new open items

Safety Evaluation Report related to the operation of Wolf Creek Generating Station, Unit No. 1 (Docket No. STN 50-482). Supplement No. 6

International Nuclear Information System (INIS)

1985-06-01

This report supplements the Safety Evaluation Report (SER) for the application filed by the Kansas Gas and Electric Company, as applicant and agent for the owners, for a license to operate the Wolf Creek Generating Station, Unit 1 (Docket No. STN 50-482). The facility is located in Coffey County, Kansas. This supplement provides recent information regarding resolution of the license conditions identified in the SER. Because of the favorable resolution of the items discussed in this report, the staff concludes that the facility can be operated by the licensee at power levels greater than 5% without endangering the health and safety of the public

Usage, biological activity, and safety of selected botanical dietary supplements consumed in the United States

Directory of Open Access Journals (Sweden)

P. Annécie Benatrehina

2018-04-01

Full Text Available In view of the continuous growth of the botanical dietary supplement industry and the increased popularity of lesser known or exotic botanicals, recent findings are described on the phytochemical composition and biological activities of five selected fruits consumed in the United States, namely, açaí, noni, mangosteen, black chokeberry, and maqui berry. A review of the ethnomedicinal uses of these plants has revealed some similarities ranging from wound-healing to the treatment of fever and infectious diseases. Laboratory studies on açaí have shown both its antioxidant and anti-inflammatory activities in vitro, and more importantly, its neuroprotective properties in animals. Anthraquinones and iridoid glucosides isolated from noni fruit induce the phase II enzyme quinone reductase (QR, and noni fruit juice exhibited antitumor and antidiabetic activities in certain animal models. Antitumorigenic effects of mangosteen in animal xenograft models of human cancers have been attributed to its xanthone content, and pure α-mangostin was shown to display antineoplastic activity in mice despite a reported low oral bioavailability. Work on the less extensively investigated black chokeberry and maqui berry has focused on recent isolation studies and has resulted in the identification of bioactive secondary metabolites with QR-inducing and hydroxyl-radical scavenging properties. On the basis of the safety studies and toxicity case reports described herein, these fruits may be generally considered as safe. However, cases of adulteration found in a commercialized açaí product and some conflicting results from mangosteen safety studies warrant further investigation on the safety of these marketed botanical dietary supplements. Keywords: Açaí, Noni, Mangosteen, Black chokeberry, Maqui berry

Potential harmful effects of dietary supplements in sports medicine.

Science.gov (United States)

Deldicque, Louise; Francaux, Marc

2016-11-01

The purpose of this article is to collect the most recent data regarding the safety of well-known or emerging dietary supplements used by athletes. From January 2014 to April 2016, about 30 articles have been published in the field. New data show that 90% of sports supplements contain trace of estrogenic endocrine disruptors, with 25% of them having a higher estrogenic activity than acceptable. About 50% of the supplements are contaminated by melamine, a source of nonprotein nitrogen. Additional data accumulate toward the safety of nitrate ingestion. In the last 2 years, the safety of emerging supplements such as higenamine, potentially interesting to lose weight, creatine nitrate and guanidinoacetic acid has been evaluated but still needs further investigation. The consumption of over-the-counter supplements is very popular in athletes. Although most supplements may be considered as safe when taking at the recommended doses, athletes should be aware of the potential risks linked to the consumption of supplements. In addition to the risks linked to overdosage and cross-effects when combining different supplements at the same time, inadvertent or deliberate contamination with stimulants, estrogenic compounds, diuretics or anabolic agents may occur.

Contaminants in food supplements and associated health risks

NARCIS (Netherlands)

Reeuwijk, N.M.

2014-01-01

Summary

Through the increasing use and availability of food supplements on the market, safety Aconcerns relating to the safety of these food supplements are growing as well. The aim of the present PhD thesis was to investigate the presence and actual levels of contaminants of

Safety Evaluation Report related to the operation of Wolf Creek Generating Station, Unit No. 1 (Docket No. STN 50-482). Supplement No. 5

International Nuclear Information System (INIS)

1985-03-01

This report supplements the Safety Evaluation Report (SER) for the application filed by the Kansas Gas and Electric Company, as applicant and agent for the owners, for a license to operate the Wolf Creek Generating Station, Unit 1 (Docket No. STN 50-482). The facility is located in Coffey County, Kansas. This supplement has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission and provides recent information regarding resolution of the open items identified in the SER. Because of the favorable resolution of the items discussed in this report, the staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public

Safety Evaluation Report related to the operation of Waterford Steam Electric Station, Unit No. 3 (Docket No. 50-382). Supplement 9

International Nuclear Information System (INIS)

1984-12-01

Supplement 9 to the Safety Evaluation Report for Louisiana Power and Light's application for a license to operate Waterford Steam Electric Station, Unit 3 (Docket No. 50-382), located in St. Charles Parish, Louisiana, has been jointly prepared by the Office of Nuclear Reactor Regulation and the Region IV Office of the US Nuclear Regulatory Commission. This supplement provides the results of the staff's completion of its evaluation of approximately 350 allegations and concerns of poor construction practices at the Waterford 3 facility

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 15

International Nuclear Information System (INIS)

Tam, P.S.

1995-06-01

This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), and Supplement No. 14 (December 1994) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items, and proposed license conditions identified in the SER

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446). Supplement No. 11

International Nuclear Information System (INIS)

1985-05-01

Supplement 11 to the Safety Evaluation Report for the Texas Utilities Electric Company application for a license to operate Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445, 50-446), located in Somervell County, Texas, has been jointly prepared by the Office of Nuclear Reactor Regulation and the Comanche Peak Technical Review Team (TRT) of the US Nuclear Regulatory Commission (NRC) and is in two parts. Part 1 (Appendix 0) of this supplement provides the results of the TRT's evaluation of approximately 124 concerns and allegations relating specifically to quality assurance and quality control (QA/QC) issues regarding construction proctices at the Comanche Peak facility. Part 2 (Appendix P) contains an overall summary and conclusion of the QA/QC aspects of the NRC Technical Review Team efforts as reported in supplemental Safety Evaluation Report SERs 7, 8, 9, and 10. Since QA/QC issues are also contained in each of the other supplements, the TRT considered that such a summary and conclusion from all supplements was necessary for a complete TRT description of QA/QC activities at Comanche Peak

Safety Evaluation Report related to the operation of Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement No. 2

International Nuclear Information System (INIS)

1986-05-01

In June 1985, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1137) regarding the application of Georgia Power Company, Municipal Electric Authority of Georgia, Oglethorpe Power Corporation, and City of Dalton, Georgia, for a license to operate the Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement 1 to NUREG-1137 was issued by the staff in October 1985. The facility is located in Burke County, Georgia, approximately 26 miles south-southeast of Augusta, Georgia, and on the Savannah River. This second supplement to NUREG-1137 provides recent information regarding resolution of some of the open and confirmatory items that remained unresolved at the time the Safety Evaluation Report was issued. This supplement also discusses some new open and confirmatory items

Safety evaluation report related to the operation of Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425): Supplement 8

International Nuclear Information System (INIS)

1989-02-01

In June 1985, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1137) regarding the application of Georgia Power Corporation, and the City of Dalton, Georgia, for licenses to operate the Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement 1 to NUREG-1137 was issued by the Staff in October 1985, Supplement 2 was issued in May 1986, Supplement 3 was issued in August 1986, Supplement 4 was issued in December 1986, Supplement 5 was issued in January 1987, Supplement 6 was issued in March 1987, and Supplement 7 was issued in January 1988. The facility is located in Burke County, Georgia, approximately 26 miles south-southeast of Augusta, Georgia, and on the Savannah River. This eighth supplement to NUREG-1137 provides recent information regarding resolution of some of the open and confirmatory items that remained unresolved following issuance of Supplement 7. 5 figs., 3 tabs

Safety Evaluation Report related to the operation of Braidwood Station, Units 1 and 2 (Docket Nos. 50-456 and 50-457). Supplement No. 2

International Nuclear Information System (INIS)

1986-10-01

In November 1983, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1002) regarding the application filed by the Commonwealth Edison Company, as applicant and owner, for a license to operate Braidwood Station, Units 1 and 2 (Docket Nos. 50-456 and 50-457). The first supplement to NUREG-1002 was issued in September 1986. This second supplement to NUREG-1002 reports the status of certain items that remained unresolved at the time Supplement 1 was published. The facility is located in Reed Township, Will County, Illinois

Efficacy and Safety of the TCM Qi-Supplementing Therapy in Patients with Myasthenia Gravis: A Systematic Review and Meta-Analysis

Directory of Open Access Journals (Sweden)

Xi-qian Yang

2017-01-01

Full Text Available Background. The Traditional Chinese Medicine (TCM Qi-supplementing therapy has been used widely for treating myasthenia gravis (MG in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of Qi-supplementing therapy as an adjunctive therapy in MG patients. Methods. Seven electronic databases were searched through June 2016. Randomized controlled trials (RCTs evaluating the add-on effect of Qi-supplementing therapy in MG patients were included. The outcome measures were the total effective rate, relapse rate, and adverse events. Results. Twenty-three RCTs involving 1,691 MG patients were included. The included studies were of low-to-moderate quality. Meta-analysis showed that Qi-supplementing therapy combined with Western medicine (WM significantly improved the total response rate and reduced the relapse risk during 6–24 months of follow-up. Subgroup analysis showed that Qi-supplementing therapy only affected the total response rate within the first 6 months of treatment. Moreover, the rate of adverse events was lower with the addition of Qi-supplementing therapy to WM than with WM only. Conclusions. Short-term Qi-supplementing therapy combined with WM appears to be superior to WM for improving the total response rate and reducing the relapse rate. However, more high-quality RCTs are warranted owing to methodological flaws of previous trials.

Safety Evaluation Report related to the operation of Limerick Generating Station, Units 1 and 2 (Docket Nos. 50-352 and 50-353). Supplement 3

International Nuclear Information System (INIS)

1984-10-01

In August 1983 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0991) regarding the application of the Philadelphia Electric Company (the applicant) for licenses to operate the Limerick Generating Station, Units 1 and 2. Supplement 1 was issued in December 1983 and addressed several outstanding issues. Supplement 1 also contains the comments made by the Advisory Committee on Reactor Safeguards in its report dated October 18, 1983. Supplement 2 was issued in October 1984 and addressed fourteen outstanding and fifty-three confirmatory issues and closed them put. This Supplement 3 addresses the remaining issues that require resolution before issuance of the operating license for Unit 1 and closes them out

Safety Evaluation Report related to the operation of Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441). Supplement No. 7

International Nuclear Information System (INIS)

1985-11-01

Supplement No. 7 to the Safety Evaluation Report (NUREG-0887) on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO), as applicants and owners, for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket No. 50-440 and 50-441) has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio, approximately 35 miles northeast of Cleveland, Ohio. This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1 through 6 to that report

Safety Evaluation Report related to the operation of Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441). Supplement No. 6

International Nuclear Information System (INIS)

1985-04-01

Supplement No. 6 to the Safety Evaluation Report (NUREG-0887) on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO), as applicants and owners, for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-540 and 50-441), has been prepared by the Office of the Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio, approximately 35 miles northeast of Cleveland, Ohio. This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1 through 5 to that report

Safety Evaluation Report related to the operation of Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441). Supplement No. 8

International Nuclear Information System (INIS)

1986-01-01

Supplement No. 8 to the Safety Evaluation Report (NUREG-0887) on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO), as applicants and owners, for a license to operate the Perry Nuclear Power Plant, Units and 1 and 2 (Docket Nos. 50-440 and 50-441), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio, approximately 35 miles northeast of Cleveland, Ohio. This supplement reports the status of certain issues that has not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1 through 7 to that report

Safety Evaluation Report related to the operation of Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441). Supplement No. 5

International Nuclear Information System (INIS)

1985-02-01

Supplement No. 5 to the Safety Evaluation Report (NUREG-0887) on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, The Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO), as applicants and owners, for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio, approximately 35 miles northeast of Cleveland, Ohio. This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1 through 4 to that report

Safety evaluation report related to the operation of Waterford Steam Electric Station, Unit No. 3 (Docket No. 50-382). Supplement No. 7

International Nuclear Information System (INIS)

1984-09-01

Supplement 7 to the Safety Evaluation Report for Louisiana Power and Light's application for a license to operate Waterford Steam Electric Station, Unit 3 (Docket No. 50-382), located in St. Charles Parish, Louisiana, has been jointly prepared by the Office of Nuclear Reactor Regulation and the Region IV Office of the US Nuclear Regulatory Commission. This supplement provides the results to date of the staff's evaluation of approximately 350 allegations and concerns of poor construction practices at the Waterford 3 facility

Safety Evaluation Report related to the operation of Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Docket Nos. STN 50-528, STN 50-529, and STN 50-530). Supplement No. 7

International Nuclear Information System (INIS)

1984-12-01

Supplement No. 7 to the Safety Evaluation Report for the application filed by Arizona Public Service Company et al. for licenses to operate the Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Docket Nos. STN 50-528/529/530), located in Maricopa County, Arizona, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation Report by providing an evaluation of: (1) additional information submitted by the applicant since Supplement No. 6 was issued; and (2) matters that the staff had under review when Supplement No. 6 was issued

International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine.

Science.gov (United States)

Kreider, Richard B; Kalman, Douglas S; Antonio, Jose; Ziegenfuss, Tim N; Wildman, Robert; Collins, Rick; Candow, Darren G; Kleiner, Susan M; Almada, Anthony L; Lopez, Hector L

2017-01-01

Creatine is one of the most popular nutritional ergogenic aids for athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations which may help explain the observed improvements in high intensity exercise performance leading to greater training adaptations. In addition to athletic and exercise improvement, research has shown that creatine supplementation may enhance post-exercise recovery, injury prevention, thermoregulation, rehabilitation, and concussion and/or spinal cord neuroprotection. Additionally, a number of clinical applications of creatine supplementation have been studied involving neurodegenerative diseases (e.g., muscular dystrophy, Parkinson's, Huntington's disease), diabetes, osteoarthritis, fibromyalgia, aging, brain and heart ischemia, adolescent depression, and pregnancy. These studies provide a large body of evidence that creatine can not only improve exercise performance, but can play a role in preventing and/or reducing the severity of injury, enhancing rehabilitation from injuries, and helping athletes tolerate heavy training loads. Additionally, researchers have identified a number of potentially beneficial clinical uses of creatine supplementation. These studies show that short and long-term supplementation (up to 30 g/day for 5 years) is safe and well-tolerated in healthy individuals and in a number of patient populations ranging from infants to the elderly. Moreover, significant health benefits may be provided by ensuring habitual low dietary creatine ingestion (e.g., 3 g/day) throughout the lifespan. The purpose of this review is to provide an update to the current literature regarding the role and safety of creatine supplementation in exercise, sport, and medicine and to update the position stand of International Society of Sports Nutrition (ISSN).

Safety Evaluation Report related to the operation of Grand Gulf Nuclear Station, Units 1 and 2 (Docket Nos. 50-416 and 50-417). Supplement 6

International Nuclear Information System (INIS)

1984-08-01

Supplement 6 to the Safety Evaluation Report for Mississippi Power and Light Company et al. joint application for licenses to operate the Grand Gulf Nuclear Station, Units 1 and 2, located on the east bank of the Mississippi River near Port Gibson in Claiborne County, Mississippi, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the NRC staff's evaluation of open items from previous supplements and Technical Specification changes required before authorizing operation of Unit 1 above 5% of rated power

Supplement to safety analysis report. 306-W building operations safety requirement

International Nuclear Information System (INIS)

Richey, C.R.

1979-08-01

The operations safety requirements (OSRs) presented in this report define the conditions, safe boundaries, and management control needed for safely conducting operations with radioactive materials in the Pacific Northwest Laboratory (PNL) 306-W building. The safety requirements are organized in five sections. Safety limits are safety-related process variables that are observable and measurable. Limiting conditions cover: equipment and technical conditions and characteristics of the facility and operations necessary for continued safe operation. Surveillance requirements prescribe the requirements for checking systems and components that are essential to safety. Equipment design controls require that changes to process equipment and systems be independently checked and approved to assure that the changes will have no adverse effect on safety. Administrative controls describe and discuss the organization and administrative systems and procedures to be used for safe operation of the facility. Details of the implementation of the operations safety requirements are prescribed by internal PNL documents such as criticality safety specifications and radiation work procedures

30 CFR 75.361 - Supplemental examination.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Supplemental examination. 75.361 Section 75.361... MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.361 Supplemental examination. (a) Except for certified persons conducting examinations required by this subpart, within 3 hours before anyone...

Safety evaluation report related to the operation of Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441). Supplement No. 10

International Nuclear Information System (INIS)

1986-09-01

Supplement No. 10 to the Safety Evaluation Report (NUREG-0887) on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO), as applicants and owners for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio, approximately 35 miles northeast of Cleveland, Ohio. This supplement reports the status of certain issues and action items that had not been resolved or completed at the time of publication of the Safety Evaluation Report and Supplements Nos. 1 through 9 to that report

Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents

Directory of Open Access Journals (Sweden)

Naohide Yamashita

2014-09-01

Full Text Available Objective: This study aimed to examine the safety of 5-aminolevulinic acid phosphate (5-ALA with sodium ferrous citrate (SFC in diabetic patients treated with one or more oral hypoglycemic agents (OHAs. Background: Recent intervention studies performed in the USA and Japan have shown that a nutritional supplement of 5-ALA with SFC efficiently reduced blood glucose levels in pre-diabetic population without any adverse events. Thus, it was anticipated that 5-ALA with SFC may potentially be taken as a beneficial supplement by diabetic patients who were being treated with OHA therapy. Nevertheless, it is important to examine its safety and efficacy in diabetic population. Methods: This study was a prospective single-blinded, randomized, placebo-controlled and parallel-group comparison study. Medically treated diabetic patients between the ages of 30 and 75 were recruited from the Tokyo metropolitan area of Japan and 45 subjects were selected after screening. These subjects were randomly assigned to three groups: daily intake of 15mg 5-ALA, 50mg 5-ALA, and a placebo (n=15, respectively. The supplement or placebo was administered for 12 weeks followed by a four week washout period. The primary endpoint was safety and occurrence of hypoglycemic attack, while the secondary endpoint was changes of fasting blood glucose (FBG and hemoglobin A1c (HbA1c. Results: Adverse events related to 5-ALA with SFC were not observed in all the groups. Abnormalities in blood and urine tests were not observed either. Significant decrease in FBG was not detected in all the groups. However, there was a small but significant decrease in HbA1c at 4 and 8 week in the 15 mg 5-ALA group. Significant decrease in HbA1c was not observed in the 50 mg 5-ALA group, although a tendency to decrease after 4 weeks was apparent. Conclusion: 5-ALA with SFC is a safe and potentially beneficial supplement if taken by diabetic patients treated with OHAs.

Acute and chronic safety and efficacy of dose dependent creatine nitrate supplementation and exercise performance.

Science.gov (United States)

Galvan, Elfego; Walker, Dillon K; Simbo, Sunday Y; Dalton, Ryan; Levers, Kyle; O'Connor, Abigail; Goodenough, Chelsea; Barringer, Nicholas D; Greenwood, Mike; Rasmussen, Christopher; Smith, Stephen B; Riechman, Steven E; Fluckey, James D; Murano, Peter S; Earnest, Conrad P; Kreider, Richard B

2016-01-01

Creatine monohydrate (CrM) and nitrate are popular supplements for improving exercise performance; yet have not been investigated in combination. We performed two studies to determine the safety and exercise performance-characteristics of creatine nitrate (CrN) supplementation. Study 1 participants (N = 13) ingested 1.5 g CrN (CrN-Low), 3 g CrN (CrN-High), 5 g CrM or a placebo in a randomized, crossover study (7d washout) to determine supplement safety (hepatorenal and muscle enzymes, heart rate, blood pressure and side effects) measured at time-0 (unsupplemented), 30-min, and then hourly for 5-h post-ingestion. Study 2 participants (N = 48) received the same CrN treatments vs. 3 g CrM in a randomized, double-blind, 28d trial inclusive of a 7-d interim testing period and loading sequence (4 servings/d). Day-7 and d-28 measured Tendo™ bench press performance, Wingate testing and a 6x6-s bicycle ergometer sprint. Data were analyzed using a GLM and results are reported as mean ± SD or mean change ± 95 % CI. In both studies we observed several significant, yet stochastic changes in blood markers that were not indicative of potential harm or consistent for any treatment group. Equally, all treatment groups reported a similar number of minimal side effects. In Study 2, there was a significant increase in plasma nitrates for both CrN groups by d-7, subsequently abating by d-28. Muscle creatine increased significantly by d-7 in the CrM and CrN-High groups, but then decreased by d-28 for CrN-High. By d-28, there were significant increases in bench press lifting volume (kg) for all groups (PLA, 126.6, 95 % CI 26.3, 226.8; CrM, 194.1, 95 % CI 89.0, 299.2; CrN-Low, 118.3, 95 % CI 26.1, 210.5; CrN-High, 267.2, 95 % CI 175.0, 359.4, kg). Only the CrN-High group was significantly greater than PLA (p power (PLA, 59.0, 95 % CI 4.5, 113.4; CrM, 68.6, 95 % CI 11.4, 125.8; CrN-Low, 40.9, 95 % CI -9.2, 91.0; CrN-High, 60.9, 95 % CI 10.8, 111.1, W) and

Safety Evaluation Report related to the operation of Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Docket Nos. STN 50-528, STN 50-529, and STN 50-530). Supplement No. 9

International Nuclear Information System (INIS)

1985-12-01

Supplement No. 9 to the Safety Evaluation Report for the application filed by Arizona Public Service Company et al. for licenses to operate the Palo Verde Nuclear Generating Station, Units 1, 2 and 3 (Docket Nos. STN 50-528/529/530), located in Maricopa County, Arizona, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation Report by providing an evaluation of: (1) additional information submitted by the applicant since Supplement No. 8 was issued; and (2) matters that the staff had under review when Supplement No. 8 was issued, specifically those issues which required resolution prior to Unit 2 fuel loading and testing up to 5% of full power

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, Tennessee Valley Authority. Supplement number 20

International Nuclear Information System (INIS)

1996-02-01

This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), Supplement No. 14 (December 1994), Supplement No. 15 (June 1995), Supplement No. 16 (September 1995), Supplement No. 17 (October 1995), Supplement No. 18 (October 1995), and Supplement No. 19 (November 1995) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the issues identified in the SER

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446). Supplement No. 9

International Nuclear Information System (INIS)

1985-03-01

This supplement addresses TUEC's analyses in support of its request to amend the Comanche Peak Final Safety Analysis Report to eliminate the commitment that coatings inside the reactor Containment Building be qualified for Units 1 and 2. In addition, this supplement provides the results of the staff's evaluation and resolution of 62 technical concerns and allegations in the coatings area for Unit 1. Because of the favorable resolution of the items discussed in this report, the staff concludes for the issues considered herein, that there is reasonable assurance that the facility can be operated by TUEC without endangering the health and safety of the public

Safety Evaluation Report related to the full-term operating license for Millstone Nuclear Power Station, Unit No. 1 (Docket No. 50-245). Supplement No. 1

International Nuclear Information System (INIS)

1986-08-01

This report, prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission, supplements the Safety Evaluation Report (NUREG-1143, October 1985). It fulfills a commitment to provide the Advisory Committee on Reactor Safeguards report, identifies the changes that have occurred since the Safety Evaluation Report was issued, and specifies the effective lifetime for the Full-Term Operating License

Biological and Chemical Standardization of a Hop (Humulus lupulus) Botanical Dietary Supplement

OpenAIRE

Krause, Elizabeth; Yuan, Yang; Hajirahimkhan, Atieh; Dong, Huali; Dietz, Birgit M.; Nikolic, Dejan; Pauli, Guido F.; Bolton, Judy L.; van Breemen, Richard B.

2014-01-01

Concerned about the safety of conventional estrogen replacement therapy, women are using botanical dietary supplements as alternatives for the management of menopausal symptoms such as hot flashes. Before botanical dietary supplements can be evaluated clinically for safety and efficacy, botanically authenticated and standardized forms are required. To address the demand for a standardized, estrogenic botanical dietary supplement, an extract of hops (Humulus lupulus, L.) was developed. Althoug...

Safety evaluation report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). Supplement No. 1

International Nuclear Information System (INIS)

1985-06-01

This report supplements the Safety Evaluation Report for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate the Nine Mile Point Nuclear Station Unit 2. The facility is located near Oswego, New York. Subject to favorable resolution of the issues discussed in this report, the NRC staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public. 1 fig., 3 tabs

Safety Evaluation Report related to the operation of Byron Station, Units 1 and 2 (Docket Nos. STN 50-454 and STN 50-455). Supplement No. 7

International Nuclear Information System (INIS)

1986-11-01

Supplement No. 7 to the Safety Evaluation Report related to Commonwealth Edison Company's application for licenses to operate the Byron Station, Units 1 and 2, located in Rockvale Township, Ogle County, Illinois, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement provides additional information supporting the license for initial criticality and power ascension to full-power operation for Unit 2

Raspberry ketone in food supplements – High intake, few toxicity data – A cause for safety concern?

DEFF Research Database (Denmark)

Bredsdorff, Lea; Wedebye, Eva Bay; Nikolov, Nikolai Georgiev

2015-01-01

Raspberry ketone (4-(4-hydroxyphenyl)-2-butanone) is marketed on the Internet as a food supplement. The recommended intake is between 100 and 1400 mg per day. The substance is naturally occurring in raspberries (up to 4.3 mg/kg) and is used as a flavouring substance. Toxicological studies...... on raspberry ketone are limited to acute and subchronic studies in rats. When the lowest recommended daily dose of raspberry ketone (100 mg) as a food supplement is consumed, it is 56 times the established threshold of toxicological concern (TTC) of 1800 μg/day for Class 1 substances. The margin of safety (MOS......) based on a NOAEL of 280 mg/kg bw/day for lower weight gain in rats is 165 at 100 mg and 12 at 1400 mg. The recommended doses are a concern taking into account the TTC and MOS. Investigations of raspberry ketone in quantitative structure-activity relationship (QSAR) models indicated potential cardiotoxic...

Safety evaluation report related to the operation of Sequoyah Nuclear Plant, Units 1 and 2, Docket Nos. 50-327 and 50-328, Tennessee Valley Authority. Supplement No. 4

Energy Technology Data Exchange (ETDEWEB)

NONE

1981-01-01

On September 17, 1980, the Nuclear Regulatory Commission (NRC) issued the facility operating license DPR-77 to the Tennessee Valley Authority for the Sequoyah Nuclear Plant, Unit 1, located in Hamilton County, Tennessee. The license authorized operation of Unit 1 at 100 percent power; however, a license condition regarding the adequacy of the hydrogen control system was included that required resolution by January 31, 1981. The purpose of Supplement No. 4 to the SER is to further update our Safety Evaluation Reports on the hydrogen control measures (Section 22.2, II.B.7), and to comply with the license condition which is as follows: 'By January 31, 1981, TVA shall by testing and analysis show to the satisfaction of the NRC staff that an interim hydrogen control system will provide with reasonable assurance protection against breach of containment in the event that a substantial quantity of hydrogen is generated.' TVA submitted on December 11, 1980, the first quarterly report on the research program for hydrogen control. Also, TVA revised volume 2 of the Sequoyah Core Degradation Program Report to incorporate additional information on the overall program. Section II.B.7 of Supplement No. 4 responds to the license condition. Each section is supplementary to and not in lieu of discussion in the Safety Evaluation Report and Supplements Nos. 1, 2, and 3, except where specifically noted. Supplements No. 2 and 3 to the Safety Evaluation Report provided a basis for concluding that the full-power licensing of Sequoyah Unit 1 need not await completion of ongoing work on hydrogen control measures. This supplement concludes that operation of the IDIS for an interim period of one year is appropriate.

Safety Evaluation Report related to the operation of Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Docket Nos. STN 50-528, STN 50-529, and STN 50-530). Supplement No. 8

International Nuclear Information System (INIS)

1985-05-01

Purpose of this supplement is to update the Safety Evaluation Report by providing an evaluation of additional information submitted by the applicant since Supplement No. 7 was issued and matters that the staff had under review when Supplement No. 7 was issued, specifically those issues which required resolution prior to plant operation of Unit 1 above 5% full power

Methylsulfonylmethane: Applications and Safety of a Novel Dietary Supplement

OpenAIRE

Matthew Butawan; Rodney L. Benjamin; Richard J. Bloomer

2017-01-01

Methylsulfonylmethane (MSM) has become a popular dietary supplement used for a variety of purposes, including its most common use as an anti-inflammatory agent. It has been well-investigated in animal models, as well as in human clinical trials and experiments. A variety of health-specific outcome measures are improved with MSM supplementation, including inflammation, joint/muscle pain, oxidative stress, and antioxidant capacity. Initial evidence is available regarding the dose of MSM needed ...

Nuclear safety in Slovak Republic. Status of safety improvements

International Nuclear Information System (INIS)

Toth, A.

1999-01-01

Status of the safety improvements at Bohunice V-1 units concerning WWER-440/V-230 design upgrading were as follows: supplementing of steam generator super-emergency feed water system; higher capacity of emergency core cooling system; supplementing of automatic links between primary and secondary circuit systems; higher level of secondary system automation. The goal of the modernization program for Bohunice V-1 units WWER-440/V-230 was to increase nuclear safety to the level of the proposals and IAEA recommendations and to reach probability goals of the reactor concerning active zone damage, leak of radioactive materials, failures of safety systems and damage shields. Upgrading program for Mochovce NPP - WWER-440/V-213 is concerned with improving the integrity of the reactor pressure vessel, steam generators 'leak before break' methods applied for the NPP, instrumentation and control of safety systems, diagnostic systems, replacement of in-core monitoring system, emergency analyses, pressurizers safety relief valves, hydrogen removal system, seismic evaluations, non-destructive testing, fire protection. Implementation of quality assurance has a special role in improvement of operational safety activities as well as safety management and safety culture, radiation protection, decommissioning and waste management and training. The Year 2000 problem is mentioned as well

Safety evaluation report related to the operation of Limerick Generating Station, Units 1 and 2 (Docket Nos. 50-352-50-353). Supplement 1

International Nuclear Information System (INIS)

1983-12-01

This report supplements the Safety Evaluation Report (NUREG-0991, August 1983) for the application filed by the Philadelphia Electric Company, as applicant and owner, for licenses to operate the Limerick Generating Station Units 1 and 2 (Docket Nos. 50-352 and 50-353). The facility is located near Pottstown, Pennsylvania. Subject to favorable resolution of the items discussed in this report, the NRC staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public

Safety Evaluation Report related to the operation of Millstone Nuclear Power Station Unit No. 3 (Docket No. 50-4423). Supplement No. 1

International Nuclear Information System (INIS)

1985-03-01

In July 1984 staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report regarding the application of Northeast Nuclear Energy Company (applicant and agent for the owners) for a license to operate Millstone Nuclear Power Station, Unit No. 3 (Docket 50-423). The facility is located in the town of Waterford, New London County, Connecticut, on the north shore of Long Island Sound. This first supplement to NUREG-1031 reports the status of certain items that remained unresolved at the time the Safety Evaluation Report was published

Development of Safe and Effective Botanical Dietary Supplements.

Science.gov (United States)

van Breemen, Richard B

2015-11-12

Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug-botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements.

Development of Safe and Effective Botanical Dietary Supplements

Science.gov (United States)

2015-01-01

Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug–botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements. PMID:26125082

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). Supplement No. 17

International Nuclear Information System (INIS)

Tam, P.S.

1995-10-01

This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), 1991), Supplement No. 8 (January 1992), Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April.1993), Supplement No. 12 (October 1993), Supplement No. 13 (April 1994), Supplement No. 14 (December 1994), Supplement No. 15 (June 1995), and Supplement No. 16 (September 1995) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50--390 and 50--391). The facility is located in Rhea county, Tennessee, near the Watts Bar Dam on the Tennessee River. In this supplement, NRC examines the significant problems of construction quality and quality assurance effectiveness that led TVA to withdraw its certification in 1985 that Watts Bar Unit I was ready to load fuel. Also discussed are the extensive corrective actions performed by TVA according to its nuclear performance plans and other supplemental programs, and NRC's extensive oversight to determine whether the Watts Bar Unit 1 construction quality and TVA's operational readiness and quality assurance effectiveness are adequate for a low-power operating license to be issued. SSER 17 does not address Watts Bar Unit 2, except for the systems which are necessary to support Unit 1 operation

Dietary Supplements: Regulatory Challenges and Research Resources

OpenAIRE

Johanna T. Dwyer; Paul M. Coates; Michael J. Smith

2018-01-01

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes e...

Status of safety issues at licensed power plants: TMI Action Plan requirements; unresolved safety issues; generic safety issues; other multiplant action issues

International Nuclear Information System (INIS)

1993-12-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. This third annual NUREG report, Supplement 3, presents updated information as of September 30, 1993. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

Safety evaluation report related to the operation of Sequoyah Nuclear Plant, Units 1 and 2, Docket Nos. 50-327 and 50-328, Tennessee Valley Authority. Supplement No. 3

Energy Technology Data Exchange (ETDEWEB)

NONE

1980-09-01

It was stated in Supplement No. 2 to the Safety Evaluation Report that except for the hydrogen control measures for the Sequoyah units, all matters had been resolved to the extent that the activities authorized by the license can be conducted without endangering the health and safety of the public. The staff is presently reviewing a recent report from TVA entitled 'Report on the Safety Evaluation of the Interim Distributed Ignition System' (Volume 1 and 2) dated September 2, 1980. This supplement provides further information and reviews on the hydrogen issue. Pending further action which may be required as a result of rulemaking, but no later than January 31, 1981, TVA shall by testing and analysis show to the NRC's satisfaction that the interim distributed ignition system will function in a manner that will mitigate the risk which could stem from the generation of hydrogen.

Safety evaluation report related to the operation of Sequoyah Nuclear Plant, Units 1 and 2, Docket Nos. 50-327 and 50-328, Tennessee Valley Authority. Supplement No. 3

International Nuclear Information System (INIS)

1980-09-01

It was stated in Supplement No. 2 to the Safety Evaluation Report that except for the hydrogen control measures for the Sequoyah units, all matters had been resolved to the extent that the activities authorized by the license can be conducted without endangering the health and safety of the public. The staff is presently reviewing a recent report from TVA entitled 'Report on the Safety Evaluation of the Interim Distributed Ignition System' (Volume 1 and 2) dated September 2, 1980. This supplement provides further information and reviews on the hydrogen issue. Pending further action which may be required as a result of rulemaking, but no later than January 31, 1981, TVA shall by testing and analysis show to the NRC's satisfaction that the interim distributed ignition system will function in a manner that will mitigate the risk which could stem from the generation of hydrogen

Commercially marketed supplements for bodybuilding athletes.

Science.gov (United States)

Grunewald, K K; Bailey, R S

1993-02-01

We conducted a survey of 624 commercially available supplements targeted towards bodybuilding athletes. Over 800 performance claims were made for these supplements. Supplements include amino acids, boron, carnitine, choline, chromium, dibencozide, ferulic acid, gamma oryzanol, medium chain triglycerides, weight gain powders, Smilax compounds and yohimbine. Many performance claims advertised were not supported by published research studies. In some instances, we found no research to validate the claims; in other cases, research findings were extrapolated to inappropriate applications. For example, biological functions of some non-essential compounds were interpreted as performance claims for the supplements. Claims for others were based on their ability to enhance hormonal release or activity. We suggest that more research be conducted on this group of athletes and their nutritional needs. Furthermore, the effectiveness and safety of supplements merit further investigation.

Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

Science.gov (United States)

... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...

SAFETY OF MICRONUTRIENTS

African Journals Online (AJOL)

ingestion of vitamins A, D and B6-' most of the side-effects that occur with vitamin supplements are rapidly reversible on withdrawal of the supplementation and leave minimal or no ... Children> 12 months of age .... safety (since the infant receives relatively low doses of ... metabolism of protein, fat and carbohydrate. Because ...

Safety Evaluation Report related to the operation of Braidwood Station, Units 1 and 2 (Docket Nos. 50-456 and 50-457). Supplement No. 1

International Nuclear Information System (INIS)

1986-09-01

In November 1983 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1002) regarding the application filed by the Commonwealth Edison Company, as applicant and owner, for a license to operate Braidwood Station, Units 1 and 2 (Docket Nos. STN 50-456 and STN 50-457). The facility is located in Reed Township, Will County, Illinois. This first supplement to NUREG-1002 reports the status of certain items that remained unresolved at the time the Safety Evaluation Report was published

Herbal Supplements for Prostate Enlargement: Current State of the Evidence.

Science.gov (United States)

Nabavizadeh, Reza; Zangi, Mahdi; Kim, Michelle M; Yavari Bejestani, Maryam; Tabatabaei, Shahin

2018-02-01

To provide a comprehensive review of the current state of herbal supplement market for lower urinary tract symptoms (LUTS) and correlate the ingredients of each product with available scientific evidence. Twenty-seven products from Amazon.com that were advertised as herbal supplements for LUTS and had listed their active ingredients were selected. Active ingredients were reviewed on Google Scholar. Product price, warranty, and consumer review information were also collected. A total of 58 unique active ingredients were identified. The mean number of ingredients was 8.26 (standard deviation 5.25). Whereas 17 (63%) products had an ingredient with a systematic review to support their use, 20 (74%) had an ingredient with conflicting evidence based on systematic reviews. Out of the supplements that contained ingredients supported by literature, all (100%) products simultaneously had other ingredients with no, conflicting, or refuting evidence. There was no (0%) product that contained only scientifically proven ingredients. There is no scientific study to evaluate these supplements as a whole. Despite the widespread use of herbal supplements for LUTS, there is scant scientific evidence to support their safety and efficacy. Lack of adequate regulation and government support for research and development are some of the factors that disincentivize researchers to study safety and efficacy of these products. We encourage physicians to warn their patients on the lack of adequate evidence to support the safety and efficacy of many of these supplements. Copyright © 2017 Elsevier Inc. All rights reserved.

Safety Evaluation Report related to the operation of Limerick Generating Station, Units 1 and 2 (Docket Nos. 50-352 and 50-353). Supplement No. 6

International Nuclear Information System (INIS)

1985-08-01

In August 1983 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0991) regarding the application of the Philadelphia Electric Company (the licensee) for licenses to operate the Limerick Generating Station, Units 1 and 2, located on a site in Montgomery and Chester Counties, Pennsylvania. A license for the operation of Limerick Unit 1 was issued on October 26, 1984. The license, which was restricted to a five percent power level, contained conditions which required resolution prior to proceeding beyond the five percent power level. Supplement 4, issued in May 1985, addressed some of these issues. Supplement 4 also contained the comments made by the Advisory Committee on Reactor Safeguards in its report dated November 6, 1984, regarding full power operation of Limerick Unit 1. Supplement 5, issued in July 1985, and this Supplement 6 address further issues, principally the status of offsite emergency planning, that require resolution prior to proceeding beyond the five percent power level

Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial.

Science.gov (United States)

Smilowitz, Jennifer T; Moya, Jackelyn; Breck, Melissa A; Cook, Chelsea; Fineberg, Annette; Angkustsiri, Kathleen; Underwood, Mark A

2017-05-30

Historically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant in infants in developing nations, levels of intestinal bifidobacteria are low among infants in developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies of Bifidobacterium, B. longum subsp. infantis (B. infantis), yet supplementation of breastfed, healthy, term infants with this organism, has not been reported. The IMPRINT Study, a Phase I clinical trial, was initiated to determine the safety and tolerability of supplementing breastfed infants with B. infantis (EVC001). Eighty mother-infant dyads were enrolled in either lactation support plus B. infantis supplementation (BiLS) or lactation support alone (LS). Starting with Day 7 postnatal, BiLS infants were fed 1.8-2.8 × 10 10  CFU B. infantis EVC001 daily in breast milk for 21 days. Mothers collected fecal samples, filled out health questionnaires, and kept daily logs about their infants' feeding and gastrointestinal symptoms from birth until Day 61 postnatal. Safety and tolerability were determined from maternal reports. There were no differences in the mean gestational age at birth, weight 1 and 2 months postnatal, and breast milk intake between groups. The mean Log 10 change in fecal Bifidobacterium from Day 6 to Day 28 was higher (p = 0.0002) for BiLS (6.6 ± 2.8 SD) than for LS infants (3.5 ± 3.5 SD). Daily stool number was higher (p jaundice, number of illnesses, sick doctor visits, or diagnoses of eczema were different for the groups at any point. The B. infantis EVC001 supplement was safely consumed and well-tolerated. Stools were fewer and better formed in infants in the BiLS group compared with LS group. Adverse events were those expected in healthy infants and not different between groups. ClinicalTrials.gov NCT02457338 . Registered May 27, 2015.

The Public Health Impact of Herbs and Nutritional Supplements

Science.gov (United States)

Cassileth, Barrie R.; Heitzer, Marjet; Wesa, Kathleen

2009-01-01

Dietary supplement use has increased exponentially in recent years despite the lack of regulatory oversight and in the face of growing safety concerns. This paper provides an overview of the public health implications and safety concerns associated with dietary supplement use, especially by cancer patients. Botanical research is actively pursued at the Memorial Sloan-Kettering Cancer Center (MSKCC) Integrative Medicine department. Work of the MSKCC Center for the Study of Botanical Immunomodulators is described, and guidelines for cancer patients’ use of dietary supplements outlined. Herbs and other botanicals are complex, physiologically active agents, but little is known about most of the popular, widely available dietary supplements. Herb-drug interactions, a major concern, are exacerbated in the cancer setting. Biologically active agents may interfere with chemotherapy and other prescription medications. They may exert anti-coagulant activity at rather inconvenient times such as during surgery, and create other serious problems. Research on the bioavailability, effective dosage, safety and benefits of these complex agents is sorely needed. Oncology professionals and other healthcare providers should educate themselves and their patients about these issues. Probably the largest, continuously-updated free information resource is MSKCC’s AboutHerbs website (www.mskcc.org/AboutHerbs). PMID:19890479

Safety Evaluation Report related to the operation of Grand Gulf Nuclear Station, Units 1 and 2 (Docket Nos. 50-416 and 50-417). Supplement No. 5

International Nuclear Information System (INIS)

1984-08-01

Supplement 5 to the Safety Evaluation Report for Mississippi Power and Light Company, et al., joint application for licenses to operate the Grand Gulf Nuclear Station, Units 1 and 2, located on the east bank of the Mississippi River near Port Gibson in Claiborne County, Mississippi, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status on the resolution of those issues that require further evaluation before authorizing operation of Unit 1 above 5% of rated power

Final safety evaluation report related to the certification of the System 80+ design: Docket Number 52-002. Supplement 1

International Nuclear Information System (INIS)

1997-05-01

This report supplements the final safety evaluation report (FSER) for the System 80+ standard design. The FSER was issued by the US Nuclear Regulatory Commission (NRC) staff as NUREG-1462 in August 1994 to document the NRC staff's review of the System 80+ design. The System 80+ design was submitted by Asea Brown Boveri-Combustion Engineering (ABB-CE), in accordance with the procedures of Subpart B to Part 52 of Title 10 of the Code of Federal Regulations. This supplement documents the NRC staff's review of the changes to the System 80+ design documentation since the issuance of the FSER. ABB-CE made these changes as a result of its review of the System 80+ design details. The NRC staff concludes that the changes to the System 80+ design documentation are acceptable, and that ABB-CE's application for design certification meets the requirements of Subpart B to 10 CFR Part 52 that are applicable and technically relevant to the System 80+ design

Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

Science.gov (United States)

Gibson, James E; Taylor, David A

2005-09-01

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

Safety Evaluation Report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323). Supplement No. 28

International Nuclear Information System (INIS)

1985-04-01

Supplement 28 to the Safety Evaluation Report for the Pacific Gas and Electric Company's application for licenses to operate Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323) has been prepared jointly by the Office of Nuclear Reactor Regulation and the Region V Office of the US Nuclear Regulatory Commission. The supplement reports on the status of the staff's investigation, inspection, and evaluation of those allegations or concerns that have been identified to the NRC as of March 1, 1985

Safety-evaluation report related to the operation of Diablo Canyon Nuclear Power Plants, Units 1 and 2. Docket Nos. 50-275 and 50-323. Supplement No. 18

International Nuclear Information System (INIS)

1983-08-01

Supplement 18 to the Safety Evaluation Report for Pacific Gas and Electric Company's application for licenses to operate Diablo Canyon Nuclear Power Plants, Units 1 and 2 (Docket Nos. 50-275 and 50-323), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports on the verification effort for Diablo Canyon Unit 1 that was performed between November 1981 and the present in response to Commission Order CLI-81-30 and an NRC letter to the licensee

The safety and regulation of natural products used as foods and food ingredients.

Science.gov (United States)

Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

2011-10-01

The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

Safety Evaluation Report related to the operation of Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441). Supplement No. 9

International Nuclear Information System (INIS)

1986-03-01

Supplement No. 9 to the Safety Evaluation Report (NUREG-0887) on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO) for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio, approximately 35 miles northeast of Cleveland, Ohio. This supplement reports the staff's evaluation findings pertaining to the earthquake event that occurred in the vicinity of the Perry Nuclear Power Plant site on January 31, 1986, and is limited to that evaluation. Future supplemental reports will continue reporting on the status of new or unresolved issues since Supplement No. 8 was issued in January 1986

Final safety evaluation report related to the certification of the Advanced Boiling Water Reactor design. Supplement 1

International Nuclear Information System (INIS)

1997-05-01

This report supplements the final safety evaluation report (FSER) for the US Advanced Boiling Water Reactor (ABWR) standard design. The FSER was issued by the US Nuclear Regulatory Commission (NRC) staff as NUREG-1503 in July 1994 to document the NRC staff's review of the US ABWR design. The US ABWR design was submitted by GE Nuclear Energy (GE) in accordance with the procedures of Subpart B to Part 52 of Title 10 of the Code of Federal Regulations. This supplement documents the NRC staff's review of the changes to the US ABWR design documentation since the issuance of the FSER. GE made these changes primarily as a result of first-of-a-kind-engineering (FOAKE) and as a result of the design certification rulemaking for the ABWR design. On the basis of its evaluations, the NRC staff concludes that the confirmatory issues in NUREG-1503 are resolved, that the changes to the ABWR design documentation are acceptable, and that GE's application for design certification meets the requirements of Subpart B to 10 CFR Part 52 that are applicable and technically relevant to the US ABWR design

Final safety evaluation report related to the certification of the Advanced Boiling Water Reactor design. Supplement 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-05-01

This report supplements the final safety evaluation report (FSER) for the US Advanced Boiling Water Reactor (ABWR) standard design. The FSER was issued by the US Nuclear Regulatory Commission (NRC) staff as NUREG-1503 in July 1994 to document the NRC staff`s review of the US ABWR design. The US ABWR design was submitted by GE Nuclear Energy (GE) in accordance with the procedures of Subpart B to Part 52 of Title 10 of the Code of Federal Regulations. This supplement documents the NRC staff`s review of the changes to the US ABWR design documentation since the issuance of the FSER. GE made these changes primarily as a result of first-of-a-kind-engineering (FOAKE) and as a result of the design certification rulemaking for the ABWR design. On the basis of its evaluations, the NRC staff concludes that the confirmatory issues in NUREG-1503 are resolved, that the changes to the ABWR design documentation are acceptable, and that GE`s application for design certification meets the requirements of Subpart B to 10 CFR Part 52 that are applicable and technically relevant to the US ABWR design.

Dietary Supplements: Regulatory Challenges and Research Resources.

Science.gov (United States)

Dwyer, Johanna T; Coates, Paul M; Smith, Michael J

2018-01-04

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

Dietary supplements containing prohibited substances: A review (Part 1)

OpenAIRE

van der Bijl, P

2014-01-01

Dietary supplements and chemical agents have been used for a number of decades among athletes striving to achieve increased strength and performance. This has led to a huge, growing market for the food supplement industry. The latter's products are classified as 'foods' rather than drugs and are therefore free of the stringent requirements for registration of pharmaceuticals, i.e. no safety and efficacy data are required prior to registration. During the past decade, some dietary supplements ...

Safety evaluation report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323). Supplement No. 25

International Nuclear Information System (INIS)

1984-07-01

Supplement 25 to the Safety Evaluation Report for Pacific Gas and Electric Company's application for licenses to operate Diablo Canyon Nuclear Power Plants, Unit 1 and Unit 2 (Docket Nos. 50-275 and 50-323) has been prepared by the Office of Nuclear Reactor Regulation (NRR) of the US Nuclear Regulatory Commission. This supplement reports on the staff's inspection and evaluation efforts on the matter of piping and piping supports as related to the seven technical license conditions in an Order Modifying License issued by NRR on April 18, 1984

Evaluation of the Structural Safety of a Vessel with Different Material(Cr-13)-Supplemented Screw Thread

Energy Technology Data Exchange (ETDEWEB)

Choi, Yong Hoon; Bae, Jun Ho; Kim, Chul [Pusan National University, Busan (Korea, Republic of)

2015-04-15

The dome and neck part of a vessel is generally formed by a hot spinning process with a seamless tube. However, as studies on and design data from the hot spinning process are insufficient, this process has been performed based on trial and error and the experiences of field engineers. Changes in the inner diameter from the bottom to the top of the neck have occurred mainly because of the characteristics of the hot spinning process due to the high-speed rotation of the rollers. In this study, a theoretical and finite element analysis of the vessel is conducted with different material(Cr-13)-supplemented screw threads for tapping and to reduce shape errors. Based on the results, the structural safety under the operating conditions is evaluated.

Missouri Highway Safety Manual Recalibration

Science.gov (United States)

2018-05-01

The Highway Safety Manual (HSM) is a national manual for analyzing the highway safety of various facilities, including rural roads, urban arterials, freeways, and intersections. The HSM was first published in 2010, and a 2014 supplement addressed fre...

Cardiovascular Effects of Calcium Supplements

Directory of Open Access Journals (Sweden)

Ian R. Reid

2013-07-01

Full Text Available Calcium supplements reduce bone turnover and slow the rate of bone loss. However, few studies have demonstrated reduced fracture incidence with calcium supplements, and meta-analyses show only a 10% decrease in fractures, which is of borderline statistical and clinical significance. Trials in normal older women and in patients with renal impairment suggest that calcium supplements increase the risk of cardiovascular disease. To further assess their safety, we recently conducted a meta-analysis of trials of calcium supplements, and found a 27%–31% increase in risk of myocardial infarction, and a 12%–20% increase in risk of stroke. These findings are robust because they are based on pre-specified analyses of randomized, placebo-controlled trials and are consistent across the trials. Co-administration of vitamin D with calcium does not lessen these adverse effects. The increased cardiovascular risk with calcium supplements is consistent with epidemiological data relating higher circulating calcium concentrations to cardiovascular disease in normal populations. There are several possible pathophysiological mechanisms for these effects, including effects on vascular calcification, vascular cells, blood coagulation and calcium-sensing receptors. Thus, the non-skeletal risks of calcium supplements appear to outweigh any skeletal benefits, and are they appear to be unnecessary for the efficacy of other osteoporosis treatments.

Safety Evaluation Report related to the operation of Limerick Generating Station, Units 1 and 2 (Docket Nos. 50-352 and 50-353). Supplement 2

International Nuclear Information System (INIS)

1984-10-01

In August 1983 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0991) regarding the application of the Philadelphia Electric Company (the applicant) for licenses to operate the Limerick Generating Station, Units 1 and 2, located on a site in Montgomery and Chester Counties, Pennsylvania. This supplement addresses further issues that require resolution and closes them out

Safety Evaluation Report related to the operation of Limerick Generating Station, Units 1 and 2 (Docket Nos. 50-352 and 50-353). Supplement No. 5

International Nuclear Information System (INIS)

1985-07-01

In August 1983 the NRC issues its Safety Evaluation Report regarding the application for licenses to operate the Limerick Generating Station, Units 1 and 2 located on a site in Montgomery and Chester Counties, Pennsylvania. Supplement 1 was issued in December 1983 and addressed several outstanding issues. SSER 1 also contains the comments made by the Advisory Committee on Reactor Safeguards in its interim report dated October 18, 1983. Supplement 2 was issued in October 1984. Supplement 3 was issued in October 1984 and addressed the remaining issues that required resolution before issuance of the operating licence for Unit 1. On October 26, 1984 a license (NPF-27) for Unit 1 was issued which was restricted to a five percent power level and contained conditions which required resolution prior to proceeding beyond the five percent power level. Supplement 4 issued in May 1985 addressed some of the technical issues and their associated license conditions, which required resolution prior to proceeding beyond the five percent power level. SSER 4 also contained the comments made by the Advisory Committee on Reactor Safeguards in its report dated November 6, 1984. This Supplement 5 to the SER addresses further issues that require resolution prior to proceeding beyond the five percent power level

Calcium supplements as source of trace elements: Adequacy and safety of supplements with vitamin C, vitamin D and phosphate formulations

International Nuclear Information System (INIS)

Waheed, S.; Rahman, S.; Siddique, N.

2014-01-01

Instrumental neutron activation analysis and atomic absorption spectrometry were used to quantify trace elements in different national and multinational Ca supplements categorized on the basis of Ca with vitamin D, vitamin C and phosphate formulations. The supplements were found to contain low levels of Co, Cr and Cu with elevated amounts of Fe, K and Na. Toxic elements (As, Cd and Sb) were detected in very few samples at very low concentrations. The essential elements contribute to >3% of their respective Dietary Reference Intakes. - Highlights: • INAA and AAS were used to quantify trace elements in different national and multinational Ca supplements. • The essential elements contribute to >3% of their respective DRIs. • Toxic elements (As, Cd and Sb) were detected in very few samples at very low concentrations. • All supplements can be considered safe for human intake with respect to trace nutrients

Safety analysis report for packaging (Oak Ridge Y-12 Plant Model DT-14A package for enriched uranium), Y/DD-326 Supplement No. 1 (Rev. 0)

International Nuclear Information System (INIS)

Cadelli, G.; Kennedy, W.R. Jr.

1986-01-01

This Supplement to the Safety Analysis Report Y/DD-326 [1.4.1] was prepared in accordance with US NRC Regulatory Guide 7.9 to address the Naval Fuel contents to be shipped in the DT-14A packaging. New chapters were written for Shielding, Critcality and Quality Assurance. Independent reviews were obtained for each of these chapters and for a product leakage analysis referenced in Chapter 7.0 of this document. Other chapters invoke the Y/DD-326 SARP with minor changes or additions as indicated in the Supplement. All references to form or composition of the fuel are classified Confidential NNPI in the interest of national security

Athletes and Supplements: Prevalence and Perspectives.

Science.gov (United States)

Garthe, Ina; Maughan, Ronald J

2018-03-01

In elite sport, where opponents are evenly matched, small factors can determine the outcome of sporting contests. Not all athletes know the value of making wise nutrition choices, but anything that might give a competitive edge, including dietary supplements, can seem attractive. Between 40% and 100% of athletes typically use supplements, depending on the type of sport, level of competition, and the definition of supplements. However, unless the athlete has a nutrient deficiency, supplementation may not improve performance and may have a detrimental effect on both performance and health. Dietary supplements are classified as a subcategory of food, so manufacturers are not required to provide evidence of product safety and efficacy, nor obtain approval from regulatory bodies before marketing supplements. This creates the potential for health risks, and serious adverse effects have been reported from the use of some dietary supplements. Athletes who compete in sports under an anti-doping code must also realize that supplement use exposes them to a risk of ingesting banned substances or precursors of prohibited substances. Government systems of regulations do not include specific laboratory testing for banned substances according to the WADA list, so a separate regulatory framework to evaluate supplements for their risk of provoking a failed doping test is needed. In the high-performance culture typical of elite sport, athletes may use supplements regardless of possible risks. A discussion around medical, physiological, cultural, and ethical questions may be warranted to ensure that the athlete has the information needed to make an informed choice.

A review of dietary supplement-induced renal dysfunction.

Science.gov (United States)

Gabardi, Steven; Munz, Kristin; Ulbricht, Catherine

2007-07-01

Complementary and alternative medicine (CAM) is a multibillion-dollar industry. Almost half of the American population uses some form of CAM, with many using them in addition to prescription medications. Most patients fail to inform their health care providers of their CAM use, and physicians rarely inquire. Annually, thousands of dietary supplement-induced adverse events are reported to Poison Control Centers nationwide. CAM manufacturers are not responsible for proving safety and efficacy, because the Food and Drug Administration does not regulate them. However, concern exists surrounding the safety of CAM. A literature search using MEDLINE and EMBASE was undertaken to explore the impact of CAM on renal function. English-language studies and case reports were selected for inclusion but were limited to those that consisted of human subjects, both adult and pediatric. This review provides details on dietary supplements that have been associated with renal dysfunction and focuses on 17 dietary supplements that have been associated with direct renal injury, CAM-induced immune-mediated nephrotoxicity, nephrolithiasis, rhabdomyolysis with acute renal injury, and hepatorenal syndrome. It is concluded that it is imperative that use of dietary supplements be monitored closely in all patients. Health care practitioners must take an active role in identifying patients who are using CAM and provide appropriate patient education.

Safety analysis report: packages. GPHS shipping package supplement 2 to the PISA shipping package (packaging of fissile and other radioactive materials). Final report

International Nuclear Information System (INIS)

Chalfant, G. G.

1981-06-01

Safety Analysis Report DPST-78-124-1 is amended to permit shipment of 6 General Purpose Heat Source (GPHS) capsules (max.). Each capsule contains an average of 2330 curies of 238 Pu, and each pair of capsules is contained in a welded stainless steel primary containment vessel, all of which are doubly contained in a flanged secondary containment vessel. This is in addition to the forms discussed in DPST-78-124-1 and Supplement 1

Safety-evaluation report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323). Supplement No. 16

International Nuclear Information System (INIS)

1983-08-01

This supplement addresses certain allegations received by the staff concerning safety deficiencies at the Diablo Canyon project, specifically those relative to design aspects of the component cooling water system (CCWS), including its seismic classification, single failure considerations, and its heat removal capabilities. It is based on the staff's re-review of the Diablo Canyon Final Safety Analysis Report (FSAR); on a site walkdown conducted on January 12, 1983; on information obtained during meetings with the applicant dated March 15, 18, and 25, April 4, 7, and 15, and May 3 and 18, 1983

Reactor system safety assurance

International Nuclear Information System (INIS)

Mattson, R.J.

1984-01-01

The philosophy of reactor safety is that design should follow established and conservative engineering practices, there should be safety margins in all modes of plant operation, special systems should be provided for accidents, and safety systems should have redundant components. This philosophy provides ''defense in depth.'' Additionally, the safety of nuclear power plants relies on ''safety systems'' to assure acceptable response to design basis events. Operating experience has shown the need to study plant response to more frequent upset conditions and to account for the influence of operators and non-safety systems on overall performance. Defense in depth is being supplemented by risk and reliability assessment

Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

Science.gov (United States)

Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

2018-02-01

Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

47 CFR 80.651 - Supplemental eligibility requirements.

Science.gov (United States)

2010-10-01

... Section 80.651 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Maritime Support Stations § 80.651 Supplemental eligibility requirements. (a) An applicant for a maritime support station must demonstrate a requirement for training...

European regulations on nutraceuticals, dietary supplements and functional foods: A framework based on safety

International Nuclear Information System (INIS)

Coppens, Patrick; Fernandes da Silva, Miguel; Pettman, Simon

2006-01-01

This article describes the legislation that is relevant in the marketing of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication. Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation on dietetic foods, on food supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'nutraceuticals' in Europe. The cornerstone of EU legislation on food products, including

Safety Evaluation Report related to the operation of South Texas Project, Units 1 and 2 (Docket Nos. 50-498 and 50-499). Supplement No. 1

International Nuclear Information System (INIS)

1986-09-01

In April 1986 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0781) regarding the application of Houston Lighting and Power Company (applicant and agent for the owners) for a license to operate South Texas Project, Units 1 and 2 (Docket Nos. 50-498 and 50-499). The facility is located in Matagorda County, Texas, west of the Colorado River, 8 miles north-northwest of the town of Matagorda and about 89 miles southwest of Houston. This first supplement to NUREG-0781 reports the status of certain items that remained unresolved at the time the Safety Evaluation Report was published

Safety evaluation report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323). Supplement No. 26

International Nuclear Information System (INIS)

1984-07-01

Supplement 26 to the Safety Evaluation Report for Pacific Gas and Electric Company's application for licenses to operate Diablo Canyon Nuclear Power Plants, Units 1 and 2 (Docket Nos. 50-275 and 50-323), has been prepared jointly by the Office of Nuclear Reactor Regulation and the Region V Office of the US Nuclear Regulatory Commission. The supplement reports on the status of the staff's investigation, inspection and evaluation of those allegations or concerns that have been identified to the NRC as of July 8, 1984. The report specifically addresses those allegations which the staff determined must be satisfactorily resolved prior to full power operation of Diablo Canyon Unit 1

Safety Evaluation Report related to the operation of Seabrook Station, Units 1 and 2 (Docket Nos. 50-443 and 50-444). Supplement No. 5

International Nuclear Information System (INIS)

1986-07-01

This report is Supplement No. 5 to the Safety Evaluation Report (NUREG-0896, March 1983) for the application filed by the Public Service Company of New Hampshire, et al., for licenses to operate Seabrook Station, Units 1 and 2 Docket Nos. STN 50-443 and STN 50-444). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission and provides recent information on open items identified in the SER. The facility is located in Seabrook, New Hampshire. Subject to favorable resolution of the items discussed in this report, the staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public

West Valley Reprocessing Plant. Safety analysis plant, supplement 18

International Nuclear Information System (INIS)

1975-01-01

Supplement 18 contains the following additions to Appendix II--5.0 Geology and Seismology: Section 12 ''Seismic Investigations for Spent Fuel Reprocessing Facility at West Valley, New York,'' October 20, 1975, and Section 13 ''Earthquake Return Period Analysis at West Valley, New York, for Nuclear Fuel Services, Inc.'' November 5, 1975

Safety Evaluation Report related to the operation of Cartawba Nuclear Station, Units 1 and 2 (Docket Nos. 50-413 and 50-414). Supplement No. 5

International Nuclear Information System (INIS)

1986-02-01

This report supplements the Safety Evaluation Report (NUREG-0954) issued in February 1983 by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by Duke Power Company, North Carolina Municipal Power Agency Number 1, North Carolina Membership Corporation, Saluda River Electric Cooperative, Inc., and Piedmont Municipal Power Agency, as applicants and owners, for licenses to operate the Catawba Nuclear Station, Units 1 and 2 (Docket Nos. 50-413 and 50-414, respectively). The facility is located in York County, South Carolina, approximately 9.6 km (6 mi) north of Rock Hill and adjacent to Lake Wylie. This supplement provides additional information supporting the license for initial criticality and power ascension to full-power operation for Unit 2

Biological and chemical standardization of a hop (Humulus lupulus) botanical dietary supplement.

Science.gov (United States)

Krause, Elizabeth; Yuan, Yang; Hajirahimkhan, Atieh; Dong, Huali; Dietz, Birgit M; Nikolic, Dejan; Pauli, Guido F; Bolton, Judy L; van Breemen, Richard B

2014-06-01

Concerned about the safety of conventional estrogen replacement therapy, women are using botanical dietary supplements as alternatives for the management of menopausal symptoms such as hot flashes. Before botanical dietary supplements can be evaluated clinically for safety and efficacy, botanically authenticated and standardized forms are required. To address the demand for a standardized, estrogenic botanical dietary supplement, an extract of hops (Humulus lupulus L.) was developed. Although valued in the brewing of beer, hop extracts are used as anxiolytics and hypnotics and have well-established estrogenic constituents. Starting with a hop cultivar used in the brewing industry, spent hops (the residue remaining after extraction of bitter acids) were formulated into a botanical dietary supplement that was then chemically and biologically standardized. Biological standardization utilized the estrogen-dependent induction of alkaline phosphatase in the Ishikawa cell line. Chemical standardization was based on the prenylated phenols in hops that included estrogenic 8-prenylnaringenin, its isomer 6-prenylnaringenin, and pro-estrogenic isoxanthohumol and its isomeric chalcone xanthohumol, all of which were measured using high-performance liquid chromatography-tandem mass spectrometry. The product of this process was a reproducible botanical extract suitable for subsequent investigations of safety and efficacy. Copyright © 2014 John Wiley & Sons, Ltd.

CloudSat Safety Operations at Vandenberg AFB

Science.gov (United States)

Greenberg, Steve

2006-01-01

CloudSat safety operations at Vendenberg AFB is given. The topics include: 1) CloudSat Project Overview; 2) Vandenberg Ground Operations; 3) Delta II Launch Vehicle; 4) The A-Train; 5) System Safety Management; 6) CALIPSO Hazards Assessment; 7) CALIPSO Supplemental Safeguards; 8) Joint System Safety Operations; 9) Extended Stand-down; 10) Launch Delay Safety Concerns; and 11) Lessons Learned.

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446). Supplement No. 13

International Nuclear Information System (INIS)

1986-05-01

Supplement 13 to the Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station (CPSES), Units 1 and 2 (NUREG-0797), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission (NRC). The facility is located in Somervell County, Texas, approximately 40 miles southwest of Fort Worth, Texas. This supplement presents the staff's evaluation of the Comanche Peak Response Team (CPRT) Program Plan which was formulated by the applicant to resolve various construction and design issues raised by the Atomic Safety and Licensing Board, allegers, intervenor Citizens Association for Sound Energy (CASE), NRC inspections of various types, and Cygna Energy Services while conducting its independent design assessment. The NRC staff concludes that the CPRT Program Plan provides an overall structure for addressing all existing issues and any future issues which may be identified from further evaluations, and if properly implemented will provide important evidence of the design and construction quality of CPSES, and will identify any needed corrective action. The report identifies items to be addressed by the NRC staff during the implementation phase

Calcium and Vitamin D Supplementation in Men

Directory of Open Access Journals (Sweden)

Evelien Gielen

2011-01-01

Full Text Available Calcium and vitamin D supplements reverse secondary hyperparathyroidism and are widely prescribed to prevent osteoporotic fractures, with proven antifracture efficacy when targeted to individuals with documented insufficiencies. Men who should particularly be considered for calcium and vitamin D supplements include elderly or institutionalized individuals, patients with documented osteoporosis on antiresorptive or anabolic medication, and individuals receiving glucocorticoids. Benefits are most apparent when a daily dose of 1000–1200 mg calcium is complemented with 800 IU vitamin D. Compliance is the key to optimizing clinical efficacy. While (conventionally dosed vitamin D has not been associated with safety concerns, recent meta-analytic data have provided evidence to suggest that calcium supplements (without coadministered vitamin D may potentially be associated with cardiovascular risks.

21 CFR 814.39 - PMA supplements.

Science.gov (United States)

2010-04-01

..., modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of... 21 Food and Drugs 8 2010-04-01 2010-04-01 false PMA supplements. 814.39 Section 814.39 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES...

The impact of cGMP compliance on consumer confidence in dietary supplement products

International Nuclear Information System (INIS)

Crowley, Richard; FitzGerald, Libby Harvey

2006-01-01

The FDA estimates that US citizens spend more than $ 8.5 billion a year on dietary supplements and world wide the market is estimated at more than $ 60 billion. However, although a majority of consumers express confidence in the safety of these products, 74% believe the government should be more involved in ensuring that these products are safe and efficacious. Recent regulatory initiatives such as the imminent adoption of cGMPs for dietary supplements in the US, implementation of cGMPs in Canada and the recent EU dietary supplement initiative represent legislative and industry response to public clamor for more comprehensive oversight of dietary supplements. Regardless of mandated practices, the majority of dietary supplement manufacturers have done an excellent job of protecting the safety and quality of their products. The promulgation of these cGMPs will help ensure consumers that equal standards are followed throughout the industry. For some companies with established processes based on existing food or pharmaceutical cGMP regulations, the transition will be relatively painless while, for many, it will represent a significant increase in the level of documentation and testing. However, consumers deserve and demand that products meet standards for safety and quality and the implementation of cGMPs for these products are an important first step. Although the cGMPs are designed to ensure products are safe from a standpoint of identity, purity, quality, strength and composition, they do not address preclinical or clinical testing of ingredients for safety or efficacy. This would involve ingredients meeting the requirements of Generally Recognized as Safe (GRAS) status or going through the New Dietary Ingredient (NDI) process

Protecting military personnel from high risk dietary supplements.

Science.gov (United States)

Deuster, Patricia A; Lieberman, Harris R

2016-01-01

It is legal tomarketmost naturally occurring substances as dietary supplements in the USA without manufacturers demonstrating they are safe or effective, and an endless variety of ingredients, from esoteric botanicals to unapproved pharmaceuticals, can be found in dietary supplements. Use of certain supplements can pose a risk, but since a robust reporting systemdoes not exist in the USA it is difficult to know which are problematic and the number of adverse events (AE) resulting from their use. Certain populations, includingmilitary personnel, aremore likely to use dietary supplements than the general population. Approximately 70% of military personnel take dietary supplements while about 50% of civilians do. Service members prefer supplements purported to enhance physical performance such as supposedly natural stimulants, protein and amino acids, and combination products. Since some of thesemay be problematic, Servicemembers are probably at higher risk of injury than the general population. Ten percent of military populations appear to be taking potentially risky supplements, and the US Department of Defense (DoD) has taken variousmeasures to protect uniformed personnel including education, policy changes, and restricting sales. Actions taken include launching Operation Supplement Safety (OPSS), introducing a High Risk Supplement list, educating health care professionals on reporting AE thatmight be associated with dietary supplements, recommending policy for reporting AE, and developing an online AE reporting system. OPSS is a DoD-wide effort to educate service members, leaders, health care providers, military families, and retirees on how to safely select supplements

Calcium supplementation and cardiovascular risk: A rising concern.

Science.gov (United States)

Tankeu, Aurel T; Ndip Agbor, Valirie; Noubiap, Jean Jacques

2017-06-01

Over the past decade, the number of individuals taking calcium supplementation worldwide has been on the rise, especially with the emergence of new pharmaceutical companies specialized in the marketing of dietary supplements; with calcium supplementation being their main business axis. This is mostly because of the established role of calcium in the prevention and treatment of osteoporosis and, to a lesser extent, its role in the prevention of fractures. Recently, a rising body of evidence on the adverse effect of calcium supplementation on nonskeletal, especially cardiovascular, health has been a cause for concern. In fact, a significant number of studies have reported an association between calcium supplementation and adverse cardiovascular events, even though high dietary calcium intake was shown to have a protective effect. The mechanism by which calcium supplementation could cause a cardiovascular event was still unclear until a recent study published in the Journal of the American Heart Association. Combining this recent finding with available data associating calcium supplementation with cardiovascular mortality and all-cause mortality, we call on the need for an evidence-based approach to calcium supplementation, while stressing on the safety of dietary calcium intake over the former on cardiovascular health. ©2017 Wiley Periodicals, Inc.

HTGR safety philosophy

Energy Technology Data Exchange (ETDEWEB)

Joksimovic, V.; Fisher, C. R. [General Atomic Co., San Diego, CA (USA)

1981-01-15

The accident at the Three Mile Island has focused public attention on reactor safety. Many public figures advocate a safer method of generating nuclear electricity for the second nuclear era in the U.S. The paper discusses the safety philosophy of a concept deemed suitable for this second nuclear era. The HTGR, in the course of its evolution, included safety as a significant determinant in design philosophy. This is particularly evident in the design features which provide inherent safety. Inherent features cause releases from a wide spectrum of accident conditions to be low. Engineered features supplement inherent features. The significance of HTGR safety features is quantified and order-of-magnitude type of comparisons are made with alternative ways of generating electricity.

HTGR safety philosophy

International Nuclear Information System (INIS)

Joksimovic, V.; Fisher, C.R.

1981-01-01

The accident at the Three Mile Island has focused public attention on reactor safety. Many public figures advocate a safer method of generating nuclear electricity for the second nuclear era in the U.S. The paper discusses the safety philosophy of a concept deemed suitable for this second nuclear era. The HTGR, in the course of its evolution, included safety as a significant determinant in design philosophy. This is particularly evident in the design features which provide inherent safety. Inherent features cause releases from a wide spectrum of accident conditions to be low. Engineered features supplement inherent features. The significance of HTGR safety features is quantified and order-of-magnitude type of comparisons are made with alternative ways of generating electricity. (author)

HTGR safety philosophy

International Nuclear Information System (INIS)

Joskimovic, V.; Fisher, C.R.

1980-08-01

The accident at the Three Mile Island has focused public attention on reactor safety. Many public figures advocate a safer method of generating nuclear electricity for the second nuclear era in the US. The paper discusses the safety philosophy of a concept deemed suitable for this second nuclear era. The HTGR, in the course of its evolution, included safety as a significant determinant in design philosophy. This is particularly evident in the design features which provide inherent safety. Inherent features cause releases from a wide spectrum of accident conditions to be low. Engineered features supplement inherent features. The significance of HTGR safety features is quantified and order-of-magnitude type of comparisons are made with alternative ways of generating electricity

Regulations for the safe transport of radioactive material. 1985 ed. Supplement 1988

International Nuclear Information System (INIS)

1988-01-01

A major revision of the Agency's Regulations for the Safe Transport of Radioactive Material, Safety Series No. 6, was undertaken during a period of several years, culminating in the publication of the 1985 Edition. In order to consider minor problems in the new edition, the Agency convened a panel of experts in January 1986. This panel recommended some amendments which were subsequently published as Supplement 1986 to the Regulations. A further review panel meeting took place in June 1987. The amendments which were recommended for early adoption were themselves divided into two kinds. The first of these are designated as minor changes. The second kind of amendment recommended for early adoption comprises actual changes to regulatory provisions. Several changes of this second type were recommended by the panel and are included in this Supplement. The Supplement also contains the amended texts of the supporting documents, Safety Series Nos 7, 37 and 80, which are necessary to correct minor errors as well as to provide complementary information for the changes introduced to the Regulations themselves. In addition, the Supplement embodies the contents of Supplement 1986, which is consequently superseded.

Safety Evaluation Report related to the operation of Limerick Generating Station, Units 1 and 2 (Docket Nos. 50-352 and 50-353). Supplement No. 4

International Nuclear Information System (INIS)

1985-05-01

In August 1983 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0991) regarding the application of the Philadelphia Electric Company (the applicant) for licenses to operate the Limerick Generating Station, Units 1 and 2 located on a site in Montgomery and Chester Counties, Pennsylvania. A license (NPF-27) for the operation of Limerick Unit 1 was issued on October 26, 1984. The license, which was restricted to a five percent power level, contained conditions which required resolution prior to proceeding beyond the five percent power level. This Supplement 4 to the SER addresses some of those technical issues and their associated license conditions which require resolution prior to proceeding beyond the five percent power level. The remaining issues to be addressed prior to proceeding beyond the five percent power level will be addressed in a later supplement to this report. This Supplement 4 to the SER also contains the comments made by the Advisory Committee on Reactor Safeguards in its report dated November 6, 1984, regarding full power operation of Limerick Unit 1

Safety-barrier diagrams as a tool for modelling safety of hydrogen applications

DEFF Research Database (Denmark)

Duijm, Nijs Jan; Markert, Frank

2009-01-01

Safety-barrier diagrams have proven to be a useful tool in documenting the safety measures taken to prevent incidents and accidents in process industry. Especially during the introduction of new hydrogen technologies or applications, as e.g. hydrogen refuelling stations, safety-barrier diagrams...... are considered a valuable supplement to other traditional risk analysis tools to support the communication with authorities and other stakeholders during the permitting process. Another advantage of safety-barrier diagrams is that they highlight the importance of functional and reliable safety barriers in any...... system and here is a direct focus on those barriers that need to be subject to safety management in terms of design and installation, operational use, inspection and monitoring, and maintenance. Safety-barrier diagrams support both quantitative and qualitative approaches. The paper will describe...

Dietary supplement adverse events: report of a one-year poison center surveillance project.

Science.gov (United States)

Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

2008-06-01

The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

Safety Evaluation Report related to the operation of Catawba Nuclear Station, Units 1 and 2 (Docket Nos. 50-413 and 50-414). Supplement No. 6

International Nuclear Information System (INIS)

1986-05-01

This report supplements the Safety Evaluation Report (NUREG-0954) issued in February 1983 by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by Duke Power Company, North Carolina Municipal Power Agency Number 1, North Carolina Membership Corporation, Saluda River Electric Cooperative, Inc., and Piedmont Municipal Power Agency, as applicants and owners, for licenses to operate the Catawba Nuclear Station, Units 1 and 2 (Docket Nos. 50-413 and 50-414, respectively). The facility is located in York County, South Carolina, approximately 9.6 km (6 miles) north of Rock Hill and adjacent to Lake Wylie. This supplement provides additional information supporting the license for operation above 5% power and power ascension to full-power operation for Unit 2

Updates on chemical and biological research on botanical ingredients in dietary supplements.

Science.gov (United States)

Pawar, Rahul S; Tamta, Hemlata; Ma, Jun; Krynitsky, Alexander J; Grundel, Erich; Wamer, Wayne G; Rader, Jeanne I

2013-05-01

Increased use of dietary supplements is a phenomenon observed worldwide. In the USA, more than 40% of the population recently reported using complementary and alternative medicines, including botanical dietary supplements. Perceptions that such dietary supplements are natural and safe, may prevent disease, may replace prescription medicines, or may make up for a poor diet, play important roles in their increased use. Toxicity of botanical dietary supplements may result from the presence of naturally occurring toxic constituents or from contamination or adulteration with pharmaceutical agents, heavy metals, mycotoxins, pesticides, or bacteria, misidentification of a plant species in a product, formation of electrophilic metabolites, organ-specific reactions, or botanical-drug interactions. The topics discussed in this review illustrate several issues in recent research on botanical ingredients in dietary supplements. These include (1) whether 1,3-dimethylamylamine is a natural constituent of rose geranium (Pelargonium graveolens), (2) how analysis of the components of dietary supplements containing bitter melon (Momordica charantia) is essential to understanding their potential biological effects, and (3) how evolving methods for in vitro studies on botanical ingredients can contribute to safety evaluations. The virtual explosion in the use of botanical ingredients in hundreds of products presents a considerable challenge to the analytical community, and the need for appropriate methods cannot be overstated. We review recent developments and use of newer and increasingly sensitive methods that can contribute to increasing the safety and quality of botanical ingredients in dietary supplements.

Dietary supplement intake during pregnancy; better safe than sorry?

Science.gov (United States)

de Boer, Alie; Bast, Aalt; Godschalk, Roger

2018-06-01

Consumption of dietary supplements and specifically niche products such as supplements targeting pregnant women is increasing. The advantages of dietary supplementation during pregnancy with folic acid have been established, but health effects of many other supplements have not been confirmed. EU and US legislation on dietary supplements requires the product to be safe for the direct consumer, the mother. Long-term health effects for the fetus due to fetal programming (in utero adaptation of the fetal epigenome due to environmental stimuli such as supplementation) are not taken into account. Such epigenetic alterations can, however, influence the response to health challenges in adulthood. We therefore call for both conducting research in birth cohorts and animal studies to identify potential health effects in progeny of supplement consuming mothers as well as the establishment of a nutrivigilance scheme to identify favorable and adverse effects post-marketing. The acquired knowledge can be used to create more effective legislation on dietary supplement intake during pregnancy for safety of the child. Increasing knowledge on the effects of consuming supplements will create a safer environment for future mothers and their offspring to optimize their health before, during and after pregnancy. Copyright © 2018 Elsevier Inc. All rights reserved.

Laser safety tools and training

CERN Document Server

Barat, Ken

2008-01-01

Lasers perform many unique functions in a plethora of applications, but there are many inherent risks with this continually burgeoning technology. Laser Safety: Tools and Training presents simple, effective ways for users in a variety of facilities to evaluate the hazards of any laser procedure and ensure they are following documented laser safety standards.Designed for use as either a stand-alone volume or a supplement to Laser Safety Management, this text includes fundamental laser and laser safety information and critical laser use information rarely found in a single source. The first lase

The Content of Mercury in Herbal Dietary Supplements.

Science.gov (United States)

Brodziak-Dopierała, Barbara; Fischer, Agnieszka; Szczelina, Wioletta; Stojko, Jerzy

2018-01-17

The dietary supplement market in Poland has been growing rapidly, and the number of registered products and their consumption increases steadily. Among the most popular and the easiest to get are herbal supplements, available in any supermarket. The aim of this paper was to investigate the mercury content in the herbal supplements. The dietary supplements that have been examined (24) are available on the Polish market and contain one or more herbal ingredients. Supplements were pulverized in porcelain mortar and identified by AMA 254 atomic absorption spectrometer. The range of variations for all tested supplements was within 0.02-4293.07 μg/kg. The arithmetic mean of the total result was 193.77 μg/kg. A higher mercury content then this mean was found in preparations-bamboo shoots and alga Chlorella pyrenoidosa. The studies have shown that mercury is present in every examined herbal supplement, and its content exceeds in two preparations (with bamboo and alga) the permissible limit of 0.10 mg/kg. There were statistically significant differences in the occurrence of mercury depending on the herbal ingredient in the supplement. The lowest content was found in the preparation with Tanacetum parthenium and the highest with bamboo shoots. The mercury content in the tested herbal supplements was statistically significant in the form of a supplement-a tablet and a capsule. Daily, weekly, monthly, and yearly consumption of mercury with examined supplements was calculated-the results did not exceed the PTWI-provisional tolerable weekly intake of mercury. To increase consumer safety, it is imperative to conduct further research on dietary supplements and implement a stricter quality control of the dietary supplements.

Glutamine Supplementation in Sick Children: Is It Beneficial?

Directory of Open Access Journals (Sweden)

Elise Mok

2011-01-01

Full Text Available The purpose of this review is to provide a critical appraisal of the literature on Glutamine (Gln supplementation in various conditions or illnesses that affect children, from neonates to adolescents. First, a general overview of the proposed mechanisms for the beneficial effects of Gln is provided, and subsequently clinical studies are discussed. Despite safety, studies are conflicting, partly due to different effects of enteral and parenteral Gln supplementation. Further insufficient evidence is available on the benefits of Gln supplementation in pediatric patients. This includes premature infants, infants with gastrointestinal disease, children with Crohn's disease, short bowel syndrome, malnutrition/diarrhea, cancer, severe burns/trauma, Duchenne muscular dystrophy, sickle cell anemia, cystic fibrosis, and type 1 diabetes. Moreover, methodological issues have been noted in some studies. Further mechanistic data is needed along with large randomized controlled trials in select populations of sick children, who may eventually benefit from supplemental Gln.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Statement on the safety of lacto-N-neotetraose and 2'-O-fucosyllactose as novel food ingredients in food supplements for children

DEFF Research Database (Denmark)

Poulsen, Morten

2015-01-01

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on the safety of lacto-N-neotetraose and 2'‑O-fucosyllactose as novel food ingredients in food supplements for children (excluding infants...... of 1.5 g for LNnT and 3 g for 2’-FL for children (4–18 years of age). In this scientific assessment, maximum daily intakes from food supplements for toddlers, children and teenagers are presented and two scenarios are calculated in which the maximum daily intakes from food supplements are added...... in intake levels which were reported to cause mild gastrointestinal symptoms in adults....

Food Safety: an Integral Part of Food Security

International Nuclear Information System (INIS)

Kilian, Lizette

2012-01-01

In recent years, many countries have developed integrated and harmonized food safety and quality control guidelines in accordance with national legislation and international standards to protect the health of consumers. But food safety standards alone are not enough. Radiation technology can complement and supplement existing technologies to ensure food security, safety and quality.

Safety evaluation report related to the operation of River Bend Station (Docket No. 50-458)

International Nuclear Information System (INIS)

1985-08-01

Supplement No. 3 to the Safety Evaluation Report on the application filed by Gulf States Utilities Company as applicant and for itself and Cajun Electric Power cooperative, as owners, for a license to operate River Bend Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in West Feliciana Parish, near St. Francisville, Louisiana. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report, Supplement No. 1, and Supplement No. 2

Construction safety program for the National Ignition Facility Appendix A: Safety Requirements

International Nuclear Information System (INIS)

Cerruti, S.J.

1997-01-01

These rules apply to all LLNL employees, non-LLNL employees (including contract labor, supplemental labor, vendors, personnel matrixed/assigned from other National Laboratories, participating guests, visitors and students) and construction contractors/subcontractors. The General Safety and Health rules shall be used by management to promote accident prevention through indoctrination, safety and health training and on-the-job application. As a condition for contracts award, all contractors and subcontractors and their employees must certify on Form S ampersand H A-1 that they have read and understand, or have been briefed and understand, the National Ignition Facility OCIP Project General Safety Rules

Construction safety program for the National Ignition Facility Appendix A: Safety Requirements

Energy Technology Data Exchange (ETDEWEB)

Cerruti, S.J.

1997-01-14

These rules apply to all LLNL employees, non-LLNL employees (including contract labor, supplemental labor, vendors, personnel matrixed/assigned from other National Laboratories, participating guests, visitors and students) and construction contractors/subcontractors. The General Safety and Health rules shall be used by management to promote accident prevention through indoctrination, safety and health training and on-the-job application. As a condition for contracts award, all contractors and subcontractors and their employees must certify on Form S & H A-1 that they have read and understand, or have been briefed and understand, the National Ignition Facility OCIP Project General Safety Rules.

Nutritional supplement for control of diabetes

Directory of Open Access Journals (Sweden)

Vladimir Vsevolodovich Sadovoy

2017-06-01

Full Text Available Analysis of diabetic patients’ dietary habits indicate that there is an imbalance of selected vitamins and minerals. A nutrient supplement composition; intended for prophylactic administration, was developed to correct this imbalance. It was composed of dried eggs and yeast component (60%, vitamin В1 (0.02% and nicotinamide (0.04%, chromium chelate (0.02%, “selen-active” (0.02% and lecithin (39.9%. The dried eggs and yeast component was prepared by homogenization of lysozyme rich chicken eggs and yeast followed by storage and drying at a pre-defined temperature and to a set water content respectively. The nutritional supplement was incorporated at 5% concentration into a cooked sausage recipe. An assessment of the safety and efficacy of the prophylactic nutritional supplement was performed in an alloxan induced diabetic rat model. The developed composition, as a part of feedstuff, improved metabolic processes, increased antioxidant activity, reduced lipid peroxidation, decreased blood cholesterol, and improved the carbohydrate metabolism.

Safety Cultural Competency Modeling in Nuclear Organizations

Energy Technology Data Exchange (ETDEWEB)

Kim, Sa Kil; Oh, Yeon Ju; Luo, Meiling; Lee, Yong Hee [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2014-05-15

The nuclear safety cultural competency model should be supplemented through a bottom-up approach such as behavioral event interview. The developed model, however, is meaningful for determining what should be dealt for enhancing safety cultural competency of nuclear organizations. The more details of the developing process, results, and applications will be introduced later. Organizational culture include safety culture in terms of its organizational characteristics.

Food supplements: survey of the ASL TO3.

Science.gov (United States)

Valfrè, R; Bioletti, L; Spagna, S; Rolle, M; Zucaro, D; Vietti, F; Laurenti, P

2014-01-01

In recent years, the increase of the consumption of supplements reveals problems concerning the safety of use. Current legislation states that supplements must be free of any therapeutic purpose and must have quality guarantees for the users' safety. The operators of the of Hygiene, Food and Nutrition Service (SIAN) of ASL TO 3 (province of Turin) conducted a surveillance in order to asses the situation on the territory, to know the use and consumption in local gyms. During the official control at the manufacturers / packers of supplements, located on the territory of the ASL TO 3, labels of supplement produced / packed were acquired, to analyze the components indicated, to carry out a deep evaluation of the individual product . Updating of the register of companies located in the territory of the ASL TO 3 was carried out; and during the period October 2011-March 2013 the labels of the products of these companies have been found and analyzed. The detailed content of the labels (ingredients, dose, method of recruitment, composition, etc. ..) was written in a database. It was also checked how many local gyms marketed supplements, and, in a small sample, a questionnaire was administered to visitors, in order to assess consumption. 355 labels were acquired and loaded on the database. 80% of them falls within the category of supplements based on ingredients derived from plants or similar. For these products was evaluated the presence on the label of not allowed plant extracts (according to the Ministerial Decree of 9 July 2012): only 2 products (of the same company) contained an ingredient not allowed. In all the examined labels was evaluated the presence of the substances for which there are specific warnings: 97% of the label is compliant and 3% are not in compliance. In the analyzed products the indications for use mainly found on the labels are related to increased demand and/or reduced intake, followed by antioxidant action. The study also evaluated the sale of

Supplements and other changes to an approved application. Final rule.

Science.gov (United States)

2004-04-08

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

Developing a research agenda for patient safety in primary care. Background, aims and output of the LINNEAUS collaboration on patient safety in primary care.

Science.gov (United States)

Esmail, Aneez; Valderas, Jose M; Verstappen, Wim; Godycki-Cwirko, Maciek; Wensing, Michel

2015-09-01

This paper is an introduction to a supplement to The European Journal of General Practice, bringing together a body of research focusing on the issue of patient safety in relation to primary care. The supplement represents the outputs of the LINNEAUS collaboration on patient safety in primary care, which was a four-year (2009-2013) coordination and support action funded under the Framework 7 programme by the European Union. Being a coordination and support action, its aim was not to undertake new research, but to build capacity through engaging primary care researchers and practitioners in identifying some of the key challenges in this area and developing consensus statements, which will be an essential part in developing a future research agenda. This introductory article describes the aims of the LINNEAUS collaboration, provides a brief summary of the reasons to focus on patient safety in primary care, the epidemiological and policy considerations, and an introduction to the papers included in the supplement.

An Evidence-Based Review of Fat Modifying Supplemental Weight Loss Products

Directory of Open Access Journals (Sweden)

Amy M. Egras

2011-01-01

Full Text Available Objective. To review the literature on fat modifying dietary supplements commonly used for weight loss. Methods. Recently published randomized, placebo-controlled trials were identified in PubMed, MEDLINE, International Pharmaceutical Abstracts, Cochrane Database, and Google Scholar using the search terms dietary supplement, herbal, weight loss, obesity, and individual supplement names. Discussion. Data for conjugated linoleic acid (CLA, Garcinia cambogia, chitosan, pyruvate, Irvingia gabonensis, and chia seed for weight loss were identified. CLA, chitosan, pyruvate, and Irvingia gabonensis appeared to be effective in weight loss via fat modifying mechanisms. However, the data on the use of these products is limited. Conclusion. Many obese people use dietary supplements for weight loss. To date, there is little clinical evidence to support their use. More data is necessary to determine the efficacy and safety of these supplements. Healthcare providers should assist patients in weighing the risks and benefits of dietary supplement use for weight loss.

Safety Evaluation Report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323). Supplement No. 33

International Nuclear Information System (INIS)

1986-05-01

Supplement 33 to the Safety Evaluation Report for the Pacific Gas and Electric Company's Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323) has been prepared jointly by the Office of Nuclear Reactor Regulation and the Region V Office of the US Nuclear Regulatory Commission. The supplement reports on the status of the staff's investigation, inspection, and evaluation of allegations and concerns that have been identified to the NRC through March 1986. The report includes a complete listing of all allegations and concerns, indicating the status of their resolution. The NRC staff concludes that the technical issues raised in the allegations with regard to the design, construction, and safe operation of Diablo Canyon Units 1 and 2 have been satisfactorily resolved and no further action is required

Safety Evaluation Report related to the operation of Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement No. 1

International Nuclear Information System (INIS)

1985-10-01

In June 1985, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1137) regarding the application of Georgia Power Company, Municipal Electric Authority of Georgia, Oglethorpe Power Corporation, and City of Dalton, Georgia, for a license to operate the Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). The facility is located in Burke County, Georgia, approximately 26 miles south-southeast of Augusta, Georgia, and on the Savannah River. This first supplement to NUREG-1137 provides recent information regarding resolution of some of the open and confirmatory items that remained unresolved at the time the Safety Evaluation Report was issued and provides the Advisory Committee on Reactor Safeguards letter dated August 13, 1985

A prioritization of generic safety issues. Supplement 21, Revision insertion instructions

Energy Technology Data Exchange (ETDEWEB)

None, None

1996-12-31

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative.

A prioritization of generic safety issues. Supplement 21, Revision insertion instructions

International Nuclear Information System (INIS)

1996-01-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative.

Evaluation of internet websites marketing herbal weight-loss supplements to consumers.

Science.gov (United States)

Jordan, Melanie A; Haywood, Tasha

2007-11-01

The aim of this study was to evaluate the quality and quantity of drug information available to consumers on Internet websites marketing herbal weight-loss dietary supplements in the United States. We conducted an Internet search using the search engines Yahoo and Google and the keywords "herbal weight loss." Website content was evaluated for the presence of active/inactive ingredient names and strengths and other Food and Drug Administration (FDA) labeling requirements. Information related to drug safety for the most common herbal ingredients in the products evaluated was compared against standard herbal drug information references. Thirty-two (32) websites were evaluated for labeling requirements and safety information. All sites listed an FDA disclaimer statement and most sites (84.4%) listed active ingredients, although few listed strengths or inactive ingredients. Based on the drug information for the most common ingredients found in the weight-loss dietary supplements evaluated, potential contraindications for cardiovascular conditions, pregnancy/nursing, and high blood pressure were listed most frequently (73%, 65.5%, and 37%, respectively), whereas few websites listed potential drug interactions or adverse reactions. Potential hazards posed by dietary supplements may not be accurately, if at all, represented on Internet websites selling these products. Since consumers may not approach their physicians or pharmacists for information regarding use of dietary supplements in weight loss, it becomes necessary for health care providers to actively engage their patients in open discussion regarding the use, benefits, and hazards of dietary supplements.

Safety effects of traffic signing for left turn flashing yellow arrow signals.

Science.gov (United States)

Schattler, Kerrie L; Gulla, Cody J; Wallenfang, Travis J; Burdett, Beau A; Lund, Jessica A

2015-02-01

In 2010, the left turn flashing yellow arrow (FYA) signal displays were installed at signalized intersections on state routes in the Peoria, Illinois, area. Supplemental traffic signs with text "Left Turn Yield on Flashing Yellow Arrow" were mounted on the mast arm adjacent to the left turn signal at over half of the FYA installations. The purpose of this paper is to present the results of the effectiveness evaluation of the FYA supplemental sign on safety. Analyses are presented on the effects of the FYA supplemental sign for all drivers and a subset of drivers age 65 and older. A crash-based comparison of 164 FYA approaches including 90 approaches with the sign and 74 approaches without the sign showed greater crash reductions when the supplemental FYA sign was present. The results also showed that crashes involving drivers age 65 and older did not experience the same magnitudes of crash reductions as compared to all drivers. The findings of this research indicate that supplemental FYA signs may help in improving safety for left-turning vehicles during the permissive interval. Thus, it is recommended that supplemental signs be used when initially implementing the FYA, and that effort to educate the driving public on new traffic control be made to further improve safety at signalized intersections. Copyright © 2014. Published by Elsevier Ltd.

Safety criteria for design of nuclear power plants

International Nuclear Information System (INIS)

1997-01-01

In Finland the general safety requirements for nuclear power plants are presented in the Council of State Decision (395/91). In this guide, safety principles which supplement the Council of State Decision and which are to be used in the design of nuclear power plants are defined

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

International Nuclear Information System (INIS)

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

Energy Technology Data Exchange (ETDEWEB)

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.

Caffeine and Creatine Content of Dietary Supplements Consumed by Brazilian Soccer Players.

Science.gov (United States)

Inácio, Suelen Galante; de Oliveira, Gustavo Vieira; Alvares, Thiago Silveira

2016-08-01

Caffeine and creatine are ingredients in the most popular dietary supplements consumed by soccer players. However, some products may not contain the disclosed amounts of the ingredients listed on the label, compromising the safe usage and the effectiveness of these supplements. Therefore, the aim of this study was to evaluate the content of caffeine and creatine in dietary supplements consumed by Brazilian soccer players. The results obtained were compared with the caffeine content listed on the product label. Two batches of the supplement brands consumed by ≥ 50% of the players were considered for analysis. The quantification of caffeine and creatine in the supplements was determined by a high-performance liquid chromatography system with UV detector. Nine supplements of caffeine and 7 supplements of creatine met the inclusion criteria for analysis. Eight brands of caffeine and five brands of creatine showed significantly different values (p soccer players present inaccurate values listed on the label, although most presented no difference among batches. To ensure consumer safety and product efficacy, accurate information on caffeine and creatine content should be provided on all dietary supplement labels.

Safety strategy and safety analysis of nuclear power plants

International Nuclear Information System (INIS)

Franzen, L.F.

1976-01-01

The safety strategy for nuclear power plants is characterized by the fact that the high level of safety was attained not as a result of experience, but on the basis of preventive accident analyses and the finding derived from such analyses. Although, in these accident analyses, the deterministic approach is predominant, it is supplemented by reliability analyses. The accidents analyzed in nuclear licensing procedures cover a wide spectrum from minor incidents to the design basis accidents which determine the design of the safety devices. The initial and boundary conditions, which are essentail for accident analyses, and the determination of the loads occurring in various states during regular operation and in accidents flow into the design of the individual systems and components. The inevitable residual risk and its origins are discussed. (orig.) [de

Pharmacokinetic Interactions between Drugs and Botanical Dietary Supplements

Science.gov (United States)

Sprouse, Alyssa A.

2016-01-01

The use of botanical dietary supplements has grown steadily over the last 20 years despite incomplete information regarding active constituents, mechanisms of action, efficacy, and safety. An important but underinvestigated safety concern is the potential for popular botanical dietary supplements to interfere with the absorption, transport, and/or metabolism of pharmaceutical agents. Clinical trials of drug–botanical interactions are the gold standard and are usually carried out only when indicated by unexpected consumer side effects or, preferably, by predictive preclinical studies. For example, phase 1 clinical trials have confirmed preclinical studies and clinical case reports that St. John’s wort (Hypericum perforatum) induces CYP3A4/CYP3A5. However, clinical studies of most botanicals that were predicted to interact with drugs have shown no clinically significant effects. For example, clinical trials did not substantiate preclinical predictions that milk thistle (Silybum marianum) would inhibit CYP1A2, CYP2C9, CYP2D6, CYP2E1, and/or CYP3A4. Here, we highlight discrepancies between preclinical and clinical data concerning drug–botanical interactions and critically evaluate why some preclinical models perform better than others in predicting the potential for drug–botanical interactions. Gaps in knowledge are also highlighted for the potential of some popular botanical dietary supplements to interact with therapeutic agents with respect to absorption, transport, and metabolism. PMID:26438626

Improving safety in small enterprises through an integrated safety management intervention.

Science.gov (United States)

Kines, Pete; Andersen, Dorte; Andersen, Lars Peter; Nielsen, Kent; Pedersen, Louise

2013-02-01

This study tests the applicability of a participatory behavior-based injury prevention approach integrated with safety culture initiatives. Sixteen small metal industry enterprises (10-19 employees) are randomly assigned to receive the intervention or not. Safety coaching of owners/managers result in the identification of 48 safety tasks, 85% of which are solved at follow-up. Owner/manager led constructive dialogue meetings with workers result in the prioritization of 29 tasks, 79% of which are accomplished at follow-up. Intervention enterprises have significant increases on six of eight safety-perception-survey factors, while comparisons increase on only one factor. Both intervention and comparison enterprises demonstrate significant increases in their safety observation scores. Interview data validate and supplement these results, providing some evidence for behavior change and the initiation of safety culture change. Given that over 95% of enterprises in most countries have less than 20 employees, there is great potential for adapting this integrated approach to other industries. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

Commonly Used Dietary Supplements on Coagulation Function during Surgery

Directory of Open Access Journals (Sweden)

Chong-Zhi Wang

2015-07-01

Full Text Available Background: Patients who undergo surgery appear to use dietary supplements significantly more frequently than the general population. Because they contain pharmacologically active compounds, dietary supplements may affect coagulation and platelet function during the perioperative period through direct effects, pharmacodynamic interactions, and pharmacokinetic interactions. However, in this regard, limited studies have been conducted that address the pharmacological interactions of dietary supplements. To avoid possible bleeding risks during surgery, information about the potential complications of dietary supplements during perioperative management is important for physicians. Methods: Through a systematic database search of all available years, articles were identified in this review if they included dietary supplements and coagulation/platelet function, while special attention was paid to studies published after 1990. Results: Safety concerns are reported in commercially available dietary supplements. Effects of the most commonly used natural products on blood coagulation and platelet function are systematically reviewed, including 11 herbal medicines (echinacea, ephedra, garlic, ginger, ginkgo, ginseng, green tea, kava, saw palmetto, St John’s wort, and valerian and four other dietary supplements (coenzyme Q10, glucosamine and chondroitin sulfate, fish oil, and vitamins. Bleeding risks of garlic, ginkgo, ginseng, green tea, saw palmetto, St John’s wort, and fish oil are reported. Cardiovascular instability was observed with ephedra, ginseng, and kava. Pharmacodynamic and pharmacokinetic interactions between dietary supplements and drugs used in the perioperative period are discussed. Conclusions: To prevent potential problems associated with the use of dietary supplements, physicians should be familiar with the perioperative effects of commonly used dietary supplements. Since the effects of dietary supplements on coagulation and platelet

Commonly Used Dietary Supplements on Coagulation Function during Surgery

Science.gov (United States)

Wang, Chong-Zhi; Moss, Jonathan; Yuan, Chun-Su

2015-01-01

Abstract Background Patients who undergo surgery appear to use dietary supplements significantly more frequently than the general population. Because they contain pharmacologically active compounds, dietary supplements may affect coagulation and platelet function during the perioperative period through direct effects, pharmacodynamic interactions, and pharmacokinetic interactions. However, in this regard, limited studies have been conducted that address the pharmacological interactions of dietary supplements. To avoid possible bleeding risks during surgery, information about the potential complications of dietary supplements during perioperative management is important for physicians. Methods Through a systematic database search of all available years, articles were identified in this review if they included dietary supplements and coagulation/platelet function, while special attention was paid to studies published after 1990. Results Safety concerns are reported in commercially available dietary supplements. Effects of the most commonly used natural products on blood coagulation and platelet function are systematically reviewed, including 11 herbal medicines (echinacea, ephedra, garlic, ginger, ginkgo, ginseng, green tea, kava, saw palmetto, St John’s wort, and valerian) and four other dietary supplements (coenzyme Q10, glucosamine and chondroitin sulfate, fish oil, and vitamins). Bleeding risks of garlic, ginkgo, ginseng, green tea, saw palmetto, St John’s wort, and fish oil are reported. Cardiovascular instability was observed with ephedra, ginseng, and kava. Pharmacodynamic and pharmacokinetic interactions between dietary supplements and drugs used in the perioperative period are discussed. Conclusions To prevent potential problems associated with the use of dietary supplements, physicians should be familiar with the perioperative effects of commonly used dietary supplements. Since the effects of dietary supplements on coagulation and platelet function are

Commonly Used Dietary Supplements on Coagulation Function during Surgery.

Science.gov (United States)

Wang, Chong-Zhi; Moss, Jonathan; Yuan, Chun-Su

2015-09-01

Patients who undergo surgery appear to use dietary supplements significantly more frequently than the general population. Because they contain pharmacologically active compounds, dietary supplements may affect coagulation and platelet function during the perioperative period through direct effects, pharmacodynamic interactions, and pharmacokinetic interactions. However, in this regard, limited studies have been conducted that address the pharmacological interactions of dietary supplements. To avoid possible bleeding risks during surgery, information of potential complications of dietary supplements during perioperative management is important for physicians. Through a systematic database search of all available years, articles were identified in this review if they included dietary supplements and coagulation/platelet function, while special attention was paid to studies published after 1990. Safety concerns are reported in commercially available dietary supplements. Effects of the most commonly used natural products on blood coagulation and platelet function are systematically reviewed, including 11 herbal medicines (echinacea, ephedra, garlic, ginger, ginkgo, ginseng, green tea, kava, saw palmetto, St John's wort, and valerian) and 4 other dietary supplements (coenzyme Q 10 , glucosamine and chondroitin sulfate, fish oil, and vitamins). Bleeding risks of garlic, ginkgo, ginseng, green tea, saw palmetto, St John's wort, and fish oil are reported. Cardiovascular instability was observed with ephedra, ginseng, and kava. Pharmacodynamic and pharmacokinetic interactions between dietary supplements and drugs used in the perioperative period are discussed. To prevent potential problems associated with the use of dietary supplements, physicians should be familiar with the perioperative effects of commonly used dietary supplements. Since the effects of dietary supplements on coagulation and platelet function are difficult to predict, it is prudent to advise their

Law regulations concerning food supplements, dietetic food and novel food containing herbal substances

Directory of Open Access Journals (Sweden)

Baraniak Justyna

2016-12-01

Full Text Available Food supplements are concentrated sources of nutrients and/or other substances with a nutritional or physiological effect. However, they often contain herbal substances or their preparations. Food supplements belong to category of food and for that reason are regulated by food legislation. European Union regulations and directives established general directions for dietary supplements, dietetic food, which due to their special composition or manufacturing process are prepared for specific groups of people with special nutritional needs, and novel food/novel food ingredients to ensure product safety, suitability and appropriate consumer information.

Safety-evaluation report related to the operation of Waterford Steam Electric Station, Unit No. 3. Docket No. 50-382

International Nuclear Information System (INIS)

1983-06-01

Supplement 5 to the Safety Evaluation Report for the application filed by Louisiana Power and Light Company for a license to operate the Waterford Steam Electric Station, Unit 3 (Docket No. 50-382), located in St. Charles Parish, Louisiana has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation Report by providing the staff's evaluation of information submitted by the applicant since the Safety Evaluation Report and its four previous Supplements were issued

Safety Evaluation Report related to the operation of Waterford Steam Electric Station, Unit No. 3 (Docket No. 50-382)

International Nuclear Information System (INIS)

1985-03-01

Supplement 10 to the Safety Evaluation Report for the application filed by Louisiana Power and Light Company for a license to operate the Waterford Steam Electric Station, Unit 3 (Docket No. 50-382), located in St. Charles Parish, Louisiana, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation Report by providing the staff's evaluation of information submitted by the licensee since the Safety Evaluation Report and its nine previous supplements were issued

Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements.

Science.gov (United States)

Schilter, B; Andersson, C; Anton, R; Constable, A; Kleiner, J; O'Brien, J; Renwick, A G; Korver, O; Smit, F; Walker, R

2003-12-01

There is a growing interest by both consumers and industry for the development of food products with 'functional' properties, or health benefits. These products may take the form of dietary supplements or of foods. The health benefits are given by particular ingredients, and in many cases these are derived from botanicals. The variety of plants providing these functions is large, ranging from staple food sources such as cereals, fruits and vegetables, to herbals as used in traditional medicine. The food or ingredient conferring health properties may consist of the plants themselves, extracts thereof, or more purified components. The scientific literature is abundant with articles not only on the beneficial properties, but also on possible adverse health effects of plants and their components. The present report discusses the data required to determine the safe use of these types of ingredients, and provides advice on the development of risk assessment strategies consistent with due diligence under existing food regulations. Product specifications, composition and characterisation of standardised and authentic materials, documented history of use and comparison to existing products (taking into account the effect of industrial processing), description of the intended use and consequent exposure are highlighted as key background information on which to base a risk evaluation. The extent of experimental investigation required, such as in vitro, animal, and/or human studies, depends on the adequacy of this information. A decision tree is presented as an aid to determine the extent of data requirements based on product comparison. The ultimate safety in use depends on the establishment of an adequate safety margin between expected exposure and identified potential hazards. Health hazards may arise from inherent toxicities or contaminants of the plant materials, including the mechanism of the intended beneficial effect. A lower safety margin may therefore be expected

Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis.

Science.gov (United States)

Liu, Xiaoqian; Machado, Gustavo C; Eyles, Jillian P; Ravi, Varshini; Hunter, David J

2018-02-01

To investigate the efficacy and safety of dietary supplements for patients with osteoarthritis. An intervention systematic review with random effects meta-analysis and meta-regression. MEDLINE, EMBASE, Cochrane Register of Controlled Trials, Allied and Complementary Medicine and Cumulative Index to Nursing and Allied Health Literature were searched from inception to April 2017. Randomised controlled trials comparing oral supplements with placebo for hand, hip or knee osteoarthritis. Of 20 supplements investigated in 69 eligible studies, 7 (collagen hydrolysate, passion fruit peel extract, Curcuma longa extract, Boswellia serrata extract, curcumin, pycnogenol and L-carnitine) demonstrated large (effect size >0.80) and clinically important effects for pain reduction at short term. Another six (undenatured type II collagen, avocado soybean unsaponifiables, methylsulfonylmethane, diacerein, glucosamine and chondroitin) revealed statistically significant improvements on pain, but were of unclear clinical importance. Only green-lipped mussel extract and undenatured type II collagen had clinically important effects on pain at medium term. No supplements were identified with clinically important effects on pain reduction at long term. Similar results were found for physical function. Chondroitin demonstrated statistically significant, but not clinically important structural improvement (effect size -0.30, -0.42 to -0.17). There were no differences between supplements and placebo for safety outcomes, except for diacerein. The Grading of Recommendations Assessment, Development and Evaluation suggested a wide range of quality evidence from very low to high. The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low. Some supplements with a limited number of studies and

Prescription Omega-3 Fatty Acid Products and Dietary Supplements Are Not Interchangeable.

Science.gov (United States)

Hilleman, Daniel; Smer, Aiman

2016-01-01

To provide an overview of prescription and dietary supplement omega-3 fatty acid (OM3-FA) products and considerations for clinical use. Narrative review. The PubMed database was searched for cardiovascular-related investigations focused on eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) (limit: English-only articles). Additional regulatory information on prescription and dietary supplements was obtained from United States Food and Drug Administration online sources. Prescription QM3-FA products are supported by robust clinical development and safety monitoring programs, whereas dietary supplements are not required to demonstrate safety or efficacy prior to marketing. There are no over-the-counter OM3-FA products available in the United States. Investigations of OM3-FA dietary supplements show that quantities of EPA and DHA are highly variable within and between brands. Dietary supplements also may contain potentially harmful components, including oxidized OM3-FA, other lipids, cholesterol, and toxins. Prescription OM3-FA products may contain DHA and EPA or EPA alone. All prescription OM3-FA products have demonstrated statistically significant triglyceride reduction as monotherapy or in combination with statins in patients with hypertriglyceridemia. Differential effects between products containing EPA and DHA compared with a high-purity EPA product (icosapent ethyl) have clinical implications: Increases in low-density lipoprotein cholesterol associated with DHA have the potential to confound strategies for managing patients with dyslipidemia. Cardiovascular outcomes studies of prescription CM3-FA products are ongoing. OM3-FA dietary supplements should not be substituted for prescription products, and prescription OM3-FA products that contain DHA are not equivalent to or interchangeable with high-purity EPA (icosapent ethyl) and should not be substituted for it.

Safety evaluation report related to the operation of Millstone Nuclear Power Station, Unit No. 3 (Docket No. 50-423)

International Nuclear Information System (INIS)

1985-09-01

The Safety Evaluation Report issued in August 1984 provided the results of the NRC staff review of Northeast Nuclear Energy Company's application for a license to operate the Millstone Nuclear Power Station, Unit No. 3. Supplement No. 1 to that report, issued in March 1985 updated the information contained in the Safety Evaluation Report and addressed the ACRS Report issued on September 10, 1984. The Report, Supplement No. 2 updates the information contained in the Safety Evaluation Report and Supplement No. 1 and addresses prior unresolved items. The facility is located in Waterford Township, New London, Connecticut. 11 refs., 9 tabs

Probiotics Supplementation Therapy for Pathological Neonatal Jaundice: A Systematic Review and Meta-Analysis

OpenAIRE

Chen, Zhe; Zhang, Lingli; Zeng, Linan; Yang, Xiaoyan; Jiang, Lucan; Gui, Ge; Zhang, Zuojie

2017-01-01

Background: Neonatal jaundice is a relatively prevalent disease and affects approximately 2.4–15% newborns. Probiotics supplementation therapy could assist to improve the recovery of neonatal jaundice, through enhancing immunity mainly by regulating bacterial colonies. However, there is limited evidence regarding the effect of probiotics on bilirubin level in neonates. Therefore, this study aims at systematically evaluating the efficacy and safety of probiotics supplement therapy for patholog...

Pharmacokinetic Interactions between Drugs and Botanical Dietary Supplements.

Science.gov (United States)

Sprouse, Alyssa A; van Breemen, Richard B

2016-02-01

The use of botanical dietary supplements has grown steadily over the last 20 years despite incomplete information regarding active constituents, mechanisms of action, efficacy, and safety. An important but underinvestigated safety concern is the potential for popular botanical dietary supplements to interfere with the absorption, transport, and/or metabolism of pharmaceutical agents. Clinical trials of drug-botanical interactions are the gold standard and are usually carried out only when indicated by unexpected consumer side effects or, preferably, by predictive preclinical studies. For example, phase 1 clinical trials have confirmed preclinical studies and clinical case reports that St. John's wort (Hypericum perforatum) induces CYP3A4/CYP3A5. However, clinical studies of most botanicals that were predicted to interact with drugs have shown no clinically significant effects. For example, clinical trials did not substantiate preclinical predictions that milk thistle (Silybum marianum) would inhibit CYP1A2, CYP2C9, CYP2D6, CYP2E1, and/or CYP3A4. Here, we highlight discrepancies between preclinical and clinical data concerning drug-botanical interactions and critically evaluate why some preclinical models perform better than others in predicting the potential for drug-botanical interactions. Gaps in knowledge are also highlighted for the potential of some popular botanical dietary supplements to interact with therapeutic agents with respect to absorption, transport, and metabolism. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

Review of the safety and efficacy of vitamin A supplementation in the treatment of children with severe acute malnutrition.

Science.gov (United States)

Iannotti, Lora L; Trehan, Indi; Manary, Mark J

2013-09-12

World Health Organization (WHO) guidelines recommend for children with severe acute malnutrition (SAM), high-dose vitamin A (VA) supplements be given on day 1 of admission, and on days 2 and 14 in the case of clinical signs of vitamin A deficiency (VAD). Daily low-dose VA follows, delivered in a premix added to F-75 and F-100. This study aimed to systematically review the evidence for safety and effectiveness of high-dose VA supplementation (VAS) in treatment of children with SAM. A comprehensive literature review was undertaken for all relevant randomized controlled trials (RCT) and observational studies from 1950 to 2012. Studies identified for full review were evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology using a set of pre-defined criteria: indirectness; inconsistency; imprecision; and study limitations. A quality rating of high, moderate, or low was then assigned to each study, and only those attaining moderate to high were considered in making recommendations. Of the 2072 abstracts screened, 38 met criteria for full review, and 20 were rated moderate to high quality. Only one study replicated the WHO VA protocol in children with SAM. Indirectness was a critical limitation, as studies were not exclusive to children with SAM. There was inconsistency across trials for definitions of malnutrition, morbidities, and ages studied; and imprecision arising from sub-group analyses and small sample sizes. Evidence showed improved outcomes associated with low-dose compared to high-dose VAS, except in cases presenting with signs of VAD, measles, and severe diarrhea or shigellosis. Adverse outcomes related to respiratory infection, diarrhea, and growth were associated with high-dose VAS in children who were predominantly adequately nourished. No adverse effects of the high dose were found in children with SAM in the trial that replicated the WHO VA guideline. This is the first systematic review of the safety and

Safety Evaluation Report Restart of K-Reactor Savannah River Site

International Nuclear Information System (INIS)

1991-10-01

In April 1991, the Department of Energy (DOE) issued DOE/DP-0084T, ''Safety Evaluation Report Restart of K-Reactor Savannah River Site.'' The Safety Evaluation Report (SER) documents the results of DOE reviews and evaluations of the programmatic aspects of a large number of issues necessary to be satisfactorily addressed before restart. The issues were evaluated for compliance with the restart criteria included in the SER. The results of those evaluations determined that the restart criteria had been satisfied for some of the issues. However, for most of the issues at least part of the applicable restart criteria had not been found to be satisfied at the time the evaluations were prepared. For those issues, open or confirmatory items were identified that required resolution. In August 1991, DOE issued DOE/DP-0090T, ''Safety Evaluation Report Restart of K-Reactor Savannah River Site Supplement 1.'' That document was the first Supplement to the April 1991 SER, and documented the resolution of 62 of the open items identified in the SER. This document is the second Supplement to the April 1991 SER. This second SER Supplement documents the resolution of additional open times identified in the SER, and includes a complete list of all remaining SER open items. The resolution of those remaining open items will be documented in future SER Supplements. Resolution of all open items for an issue indicates that its associated restart criteria have been satisfied, and that DOE concludes that the programmatic aspects of the issue have been satisfactorily addressed

Safety evaluation report related to the operation of Waterford Steam Electric Station, Unit No. 3 (Docket No. 50-382). Suppl.6

International Nuclear Information System (INIS)

1984-06-01

Supplement 6 to the Safety Evaluation Report for the application filed by Louisiana Power and Light Company for a license to operate the Waterford Steam Electric Station, Unit 3 (Docket No. 50-382), located in St. Charles Parish, Louisiana, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation Report by providing the staff's evaluation of information submitted by the applicant since the Safety Evaluation Report and its five previous supplements were issued

Social Media Listening for Routine Post-Marketing Safety Surveillance.

Science.gov (United States)

Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

2016-05-01

Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

Safety on the Job. Some Guidelines for Working Safely. Instructor's Edition.

Science.gov (United States)

Oklahoma State Dept. of Vocational and Technical Education, Stillwater. Curriculum and Instructional Materials Center.

This teacher's guide was developed to help teachers (especially in Oklahoma) promote safe practices on the job. As a supplement to existing programs in the requirements for job safety, this book can also promote same basic safety attitudes and help support basic safety concepts, with an emphasis on accident prevention. The guide contains eight…

EXPERIENCE OF USING THE “DE ALEX” DIETARY SUPPLEMENT: RESULTS OF A SINGLE CENTER STUDY

Directory of Open Access Journals (Sweden)

A. O. Vasil’ev

2017-01-01

Full Text Available Introduction. Since their first appearance and through present day, dietary supplements remain popular among customers. In medical practice, dietary supplements are used as an additional source of nutrients and biologically active compounds aimed at optimization of various types of metabolism as well as normalization and/or improvement of functional state of organs and systems.Objective: is to evaluate effectiveness and safety of a dietary supplement “De Alex” in patients with benign prostatic hyperplasia (BPH.Materials and methods. The study included 35 volunteers who signed the informed consent form and received treatment at urology departments of the S.I. Spasokukotsky Municipal Clinical Hospital. The main group included 20 men, the control group included 15 men. “De Alex” dietary supplement was administered according to the following scheme: 1 tablet 3 times a day for the first 3 months, then 4 tablets a day for 2 more months. Clinical, laboratory and instrumental data were evaluated as well as validated questionnaires filled out by the patients.Results. There weren’t any allergic reactions or individual intolerance to the “De Alex”  dietary supplement in the main group. The total IPSS score decreased in all patients, and symptoms of the lower urinary tract were less pronounced. “De Alex” administration didn’t affect the levels of prostate-specific antigen and testosterone. In the studied subgroups, a moderate decrease of the prostate volume was observed. Conclusions. The “De Alex” dietary supplement has a satisfactory safety profile. In patients with BPH the supplement causes a moderate decrease of the prostate volume.

Progress of nuclear safety research-2004

International Nuclear Information System (INIS)

Anoda, Yoshinari; Ebine, Noriya; Chuto, Toshinori; Sato, Satoshi; Ishikawa, Jun; Yamamoto, Toshihiro; Munakata, Masahiro; Asakura, Toshihide; Yamaguchi, Tetsuji; Kida, Takashi; Matsui, Hiroki; Haneishi, Akihiro; Araya, Fumimasa

2005-03-01

JAERI is conducting nuclear safety research primarily at the Nuclear Safety Research Center in close cooperation with the related departments in accordance with the Long Term Plan for Development and Utilization of Nuclear Energy and Annual Plan for Safety Research issued by the Japanese government. The fields of conducting safety research at JAERI are the engineering safety of nuclear power plants and nuclear fuel cycle facilities, and radioactive waste management as well as advanced technology for safety improvement or assessment. Also, JAERI has conducted international collaboration to share the information on common global issues of nuclear safety and to supplement own research. Moreover, when accidents occurred at nuclear facilities, JAERI has taken a responsible role by providing technical experts and investigation for assistance to the government or local public body. This report summarizes the nuclear safety research activities of JAERI from April 2002 through March 2004 and utilized facilities. (author)

Evaluation of negative and positive health effects of n-3 fatty acids as constituents of food supplements and fortified foods

OpenAIRE

Norwegian Scientific Committee for Food Safety

2011-01-01

The Norwegian Scientific Committee for Food Safety (VKM) has on request from The Norwegian Food Safety Authority evaluated negative and positive human health effects from intake of n-3 fatty acids from food supplements and fortified foods. The evidence presented in this evaluation show that it is possible to obtain positive health effects in the Norwegian population from intake of EPA and DHA, including from food supplements, without any appreciable risk of negative or adverse health ...

[Recommendations on vitamin D and calcium supplements for adults in Spain].

Science.gov (United States)

Rigueira García, Ana Isabel

2012-10-01

Calcium supplements and vitamin D are involved in current debates of health, as cardiovascular safety of calcium, and correction of vitamin levels. The aim is to review the possibilities of making better use of supplements marketed in Spain, depending on their availability, information and related epidemiology. Analysis of comercial offer and available information about pharmacological aspects of Spanish medicinal supplements in data-sheets (39), guides and reports current institutional and professional, with additional search of this information and epidemiological data related Spanish in Cochrane Database of Systematic Reviews ®, PubMed ® (tool "Clinical Queries"), Dialnet database and hand search of Spanish journals directly related. There is no uniformity in terms of indication, expression of content, dosages, precautions and safety in data sheets or technical reports. The literature search found more recent publications volume for vitamin D than calcium, No evidence was found to establish appropriate dosing regimens indisputable or universal, or cholecalciferol bioavailability tests with aqueous vehiculización. In Spain nutritional situation is found generally suitable for the calcium but a status mostly unsuitable for vitamin D with several references for insufficiency and vitamin deficiency in adults. Corrective treatments primarily affect calcium supplements. There is an ample supply of calcium and vitamin D in Spain, whose drug design should rethink because don't respond to the needs identified or correction possibilities currently recommended. It should also improve and update their information, with particular interest in health status related to hypovitaminosis D.

Safety Evaluation Report related to the operation of Beaver Valley Power Station, Unit 2 (Docket No. 50-412)

International Nuclear Information System (INIS)

1987-05-01

This report, Supplement No. 5 to the Safety Evaluation Report for the application filed by the Duquesne Light Company et al. (the applicant) for a license to operate the Beaver Valley Power Station, Unit 2 (Docket No. 50-412), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved when the Safety Evaluation Report and its Supplements 1, 2, 3, and 4 were published

Safety evaluation report related to the operation of Beaver Valley Power Station, Unit 2 (Docket No. 50-412)

International Nuclear Information System (INIS)

1987-03-01

This report, Supplement No. 4 to the Safety Evaluation Report for the application filed by the Duquesne Light Company et al. (the applicant) for a license to operate the Beaver Valley Power Station, Unit 2 (Docket No. 50-412), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved when the Safety Evaluation Report and its Supplements 1, 2, and 3 were published

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Unit 2 (Docket No. 50-446)

International Nuclear Information System (INIS)

1992-09-01

This document supplement 25 to the Safety Evaluation Report related to the operation of the Comanche Peak Steam Electric Station (CPSES), Unit 2 (NUREG-0797), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission (NRC). The facility is located in Somervell County, Texas, approximately 40 miles southwest of Fort Worth, Texas. This supplement reports the status of certain issues that had not been resolved when the Safety Evaluation Report and Supplements 1, 2, 3, 4, 6, 12, 21, 22, 23, and 24 to that report were published. This supplement deals primarily with Unit 2 issues; however, it also references evaluations for several Unit 1 licensing items resolved since Supplement 24 was issued

The Nordic programme for nuclear safety 1990-1993

International Nuclear Information System (INIS)

Soerensen, H.C.

1993-04-01

The supplement contains a name-and-address list relevant to the Nordic Nuclear Safety Programme 1990-1993 and covering consortiums, reference groups, programme coordinators, project leaders and project participants. (AB)

The Nordic programme for nuclear safety 1990-1993

International Nuclear Information System (INIS)

Soerensen, H.C.

1992-03-01

The supplement contains a name-and-address list relevant to the Nordic Nuclear Safety Programme 1990-1993 and covering consortiums, reference groups, programme coordinators, project leaders and project participants. (AB)

Nuclear Law Bulletin: Index + supplement no.56

International Nuclear Information System (INIS)

Anon.

1995-01-01

This book deals with the status of legislation governing the peaceful uses of nuclear energy in Central and Eastern European Countries. Readers are informed about regulatory and institutional developments in these countries. The Supplement to this Bulletin reproduces the Ukraine fundamental nuclear law of the 8 february 1995 on the use of nuclear energy and radiation safety. It shall establish the priority of human and environmental safety and the rights and responsibilities of citizens with regard to the use of nuclear energy, it shall regulate activities connected with the use of nuclear installations and ionizing radiation sources, and, as well, establish the legal basis for Ukraine's international commitments with respect to the use of nuclear energy. (authors). 71 refs

Safety Evaluation Report related to the operation of WPPSS Nuclear Project No. 2 (Docket No. 50-397)

International Nuclear Information System (INIS)

1984-04-01

This report, Supplement No. 5 to the Safety Evaluation Report (SSER 5) on the Washington Public Power Supply System application for a license to operate WNP-2 (Docket No. 50-397), located in Benton County, Washington, approximately 12 miles north of Richland, Washington, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplements No. 1, 2, 3, and 4

Total embolization of the main splenic artery as a supplemental treatment modality for hypersplenism

OpenAIRE

He, Xin-Hong; Li, Wen-Tao; Peng, Wei-Jun; Li, Guo-Dong; Wang, Sheng-Ping; Xu, Li-Chao

2011-01-01

AIM: To study the safety and feasibility of total embolization of the main splenic artery as a supplemental treatment modality for hypersplenism with thrombocytopenia or leukocytopenia accompanying liver cirrhosis.

Effects of eight weeks of an alleged aromatase inhibiting nutritional supplement 6-OXO (androst-4-ene-3,6,17-trione on serum hormone profiles and clinical safety markers in resistance-trained, eugonadal males

Directory of Open Access Journals (Sweden)

Kreider Richard

2007-10-01

Full Text Available Abstract The purpose of this study was to determine the effects of 6-OXO, a purported nutritional aromatase inhibitor, in a dose dependent manner on body composition, serum hormone levels, and clinical safety markers in resistance trained males. Sixteen males were supplemented with either 300 mg or 600 mg of 6-OXO in a double-blind manner for eight weeks. Blood and urine samples were obtained at weeks 0, 1, 3, 8, and 11 (after a 3-week washout period. Blood samples were analyzed for total testosterone (TT, free testosterone (FT, dihydrotestosterone (DHT, estradiol, estriol, estrone, SHBG, leutinizing hormone (LH, follicle stimulating hormone (FSH, growth hormone (GH, cortisol, FT/estradiol (T/E. Blood and urine were also analyzed for clinical chemistry markers. Data were analyzed with two-way MANOVA. For all of the serum hormones, there were no significant differences between groups (p > 0.05. Compared to baseline, free testosterone underwent overall increases of 90% for 300 mg 6-OXO and 84% for 600 mg, respectively (p 0.05 and clinical safety markers were not adversely affected with ingestion of either supplement dose (p > 0.05. While neither of the 6-OXO dosages appears to have any negative effects on clinical chemistry markers, supplementation at a daily dosage of 300 mg and 600 mg for eight weeks did not completely inhibit aromatase activity, yet significantly increased FT, DHT, and T/E.

MedWatch Safety Alerts for Human Medical Products

Data.gov (United States)

U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...

Safety evaluation report related to the operation of Enrico Fermi Atomic Power Plant, Unit No. 2. Docket No. 50-341

International Nuclear Information System (INIS)

1983-01-01

Supplement No. 3 to the Safety Evaluation Report related to the operation of the Enrico Fermi Atomic Power Plant, Unit 2, provides the staff's evaluation of additional information submitted by the applicant regarding outstanding review issues identified in Supplement No. 2 to the Safety Evaluation Report, dated January 1982

Safety evaluation report related to the operation of Beaver Valley Power Station, Unit 2 (Docket No. 50-412)

International Nuclear Information System (INIS)

1987-08-01

This report, Supplement No. 6 to the Safety Evaluation Report for the application filed by the Duquesne Light Company et al. (the licensee) for a license to operate the Beaver Valley Power Station, Unit 2 (Docket No. 50-412), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved when the Safety Evaluation Report and its Supplements 1, 2, 3, 4, and 5 were published

Timing criteria for supplemental BWR emergency response equipment

International Nuclear Information System (INIS)

Bickel, John H.

2015-01-01

The Great Tohuku Earthquake and subsequent Tsunami represented a double failure event which destroyed offsite power connections to Fukushima-Daiichi site and then destroyed on-site electrical systems needed to run decay heat removal systems. The accident could have been mitigated had there been supplemental portable battery chargers, supplemental pumps, and in-place piping connections to provide alternate decay heat removal. In response to this event in the USA, two national response centers, one in Memphis, Tennessee, and another in Phoenix, Arizona, will begin operation. They will be able to dispatch supplemental emergency response equipment to any nuclear plant in the U.S. within 24 hours. In order to define requirements for supplemental nuclear power plant emergency response equipment maintained onsite vs. in a regional support center it is necessary to confirm: (a) the earliest time such equipment might be needed depending on the specific scenario, (b) the nominal time to move the equipment from a storage location either on-site or within the region of a nuclear power plant, and (c) the time required to connect in the supplemental equipment to use it. This paper describes an evaluation process for a BWR-4 with a Mark I Containment starting with: (a) severe accident simulation to define best estimate times available for recovery based on the specific scenario, (b) identify the key supplemental response equipment needed at specific times to accomplish recovery of key safety functions, and (c) evaluate what types of equipment should be warehoused on-site vs. in regional response centers. (authors)

The Interactive Trampoline - Safety and Enjoyment

DEFF Research Database (Denmark)

Karoff, Helle Skovbjerg; Elbæk, Lars; Rytz, Sigrid Alison

2013-01-01

This paper addresses the use of technology as a supplement to traditional and well-known dynamics of play. By examining the use of the Interactive Trampoline in the development process of play activities, this paper seeks to emphasise the relationship between physical activity, safety, enjoyment ...

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Unit 2 (Docket No. 50-446)

International Nuclear Information System (INIS)

1993-02-01

Supplement 26 to the Safety Evaluation Report related to the operation of the Comanche Peak Steam Electric Station (CPSES), Unit 2, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission (NRC). The facility is located in Somervell County, Texas, approximately 40 miles southwest of Fort Worth, Texas. This supplement reports the status of certain issues that had not been resolved when the Safety Evaluation Report and Supplements 1, 2, 3, 4, 6, 12, 21, 22, 23, 24, and 25 to that report were published. This supplement deals primarily with Unit 2 issues; however, it also references evaluations for several licensing issues that relate to Unit 1, which have been resolved since Supplement 25 was issued

Creatine supplementation with specific view to exercise/sports performance: an update

Directory of Open Access Journals (Sweden)

Cooper Robert

2012-07-01

Full Text Available Abstract Creatine is one of the most popular and widely researched natural supplements. The majority of studies have focused on the effects of creatine monohydrate on performance and health; however, many other forms of creatine exist and are commercially available in the sports nutrition/supplement market. Regardless of the form, supplementation with creatine has regularly shown to increase strength, fat free mass, and muscle morphology with concurrent heavy resistance training more than resistance training alone. Creatine may be of benefit in other modes of exercise such as high-intensity sprints or endurance training. However, it appears that the effects of creatine diminish as the length of time spent exercising increases. Even though not all individuals respond similarly to creatine supplementation, it is generally accepted that its supplementation increases creatine storage and promotes a faster regeneration of adenosine triphosphate between high intensity exercises. These improved outcomes will increase performance and promote greater training adaptations. More recent research suggests that creatine supplementation in amounts of 0.1 g/kg of body weight combined with resistance training improves training adaptations at a cellular and sub-cellular level. Finally, although presently ingesting creatine as an oral supplement is considered safe and ethical, the perception of safety cannot be guaranteed, especially when administered for long period of time to different populations (athletes, sedentary, patient, active, young or elderly.

Safety Evaluation Report related to the operation of River Bend Station (Docket No. 50-458)

International Nuclear Information System (INIS)

1984-10-01

Supplement No. 1 to the Safety Evaluation Report on the application filed by Gulf States Utilities Company as applicant and for itself and Cajun Electric Power Cooperative, as owners, for a license to operate River Bend Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

Science.gov (United States)

Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

2015-01-01

Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress

Cardiovascular and Metabolic Consequences of Testosterone Supplements in Young and Old Male Spontaneously Hypertensive Rats: Implications for Testosterone Supplements in Men.

Science.gov (United States)

Dalmasso, Carolina; Patil, Chetan N; Yanes Cardozo, Licy L; Romero, Damian G; Maranon, Rodrigo O

2017-10-17

The safety of testosterone supplements in men remains unclear. In the present study, we tested the hypothesis that in young and old male spontaneously hypertensive rats (SHR), long-term testosterone supplements increase blood pressure and that the mechanism is mediated in part by activation of the renin-angiotensin system. In untreated males, serum testosterone exhibited a sustained decrease after 5 months of age, reaching a nadir by 18 to 22 months of age. The reductions in serum testosterone were accompanied by an increase in body weight until very old age (18 months). Testosterone supplements were given for 6 weeks to young (12 weeks-YMSHR) and old (21-22 months-OMSHR) male SHR that increased serum testosterone by 2-fold in young males and by 4-fold in old males. Testosterone supplements decreased body weight, fat mass, lean mass, and plasma leptin, and increased plasma estradiol in YMSHR but had no effect in OMSHR. Mean arterial pressure (MAP) was significantly higher in OMSHR than in YMSHR and testosterone supplements decreased MAP in OMSHR, but significantly increased MAP in YMSHR. Enalapril, the angiotensin-converting enzyme inhibitor, reduced MAP in both control and testosterone-supplemented YMSHR, but had a greater effect on MAP in testosterone-treated rats, suggesting the mechanism responsible for the increase in MAP in YMSHR is mediated at least in part by activation of the renin-angiotensin system. Taken together with previous studies, these data suggest that testosterone supplements may have differential effects on men depending on age, cardiovascular and metabolic status, and dose and whether given long-term or short-term. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

A new era of safety at CERN

CERN Multimedia

CERN Bulletin

2014-01-01

CERN is modernising its safety policy and organisational structure in matters of Safety with the introduction of new reference documents that have come into force on 29 September. These texts adapt the Organization’s safety policy to take account of how the Laboratory has evolved and to include best practice in Safety matters.   Safety is a priority at CERN, so it’s no coincidence that the Organization’s anniversary has been chosen as the time to launch a modernised approach to its Safety policy and how Safety matters are organised. On the day of CERN’s 60th anniversary, the SAPOCO 42 document, which covered both policy and organisational aspects, was replaced by a more concise general policy statement. The organisational structure and responsibilities in matters of Safety are now set out in a Safety Regulation, that is supplemented by subsidiary documents. Together these documents will replace the corresponding parts of the former SAPOCO 42 as well as Saf...

Sports Supplements

Science.gov (United States)

... Staying Safe Videos for Educators Search English Español Sports Supplements KidsHealth / For Teens / Sports Supplements What's in ... really work? And are they safe? What Are Sports Supplements? Sports supplements (also called ergogenic aids ) are ...

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446)

International Nuclear Information System (INIS)

1990-01-01

Supplement 22 to the Safety Evaluation Report related to the operation of the Comanche Peak Steam Electric Station, Units 1 and 2 (NUREG-0797), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Somervell County, Texas, approximately 40 miles southwest of Fort Worth, Texas. This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplements 1, 2, 3, 4, 6, 12, and 21 to that report. This supplement also includes the evaluations for licensing items resolved since Supplement 21 was issued. Supplement 5 has been cancelled. Supplements 7 through 11 were limited to the staff evaluation of allegations investigated by the NRC Technical Review Team. Supplement 13 presented the staff's evaluation of the Comanche Peak Response Team (CPRT) Program Plan, which was formulated by the applicant to resolve various construction and design issues raised by sources external to the applicant. Supplements 14 through 20 presented the staff's evaluation of the applicant's Corrective Action Program and CPRT activities. Items identified in Supplements 7, 8, 9, 10, 11, 13, 14, and 15 through 20 are not included in this supplement, except to the extent that they affect the applicant's Final Safety Analysis Report. 154 refs., 24 figs., 8 tabs

The clinical content of preconception care: nutrition and dietary supplements.

Science.gov (United States)

Gardiner, Paula M; Nelson, Lauren; Shellhaas, Cynthia S; Dunlop, Anne L; Long, Richard; Andrist, Sara; Jack, Brian W

2008-12-01

Women of child-bearing age should achieve and maintain good nutritional status prior to conception to help minimize health risks to both mothers and infants. Many women may not be aware of the importance of preconception nutrition and supplementation or have access to nutrition information. Health care providers should be knowledgeable about preconception/pregnancy-related nutrition and take the initiative to discuss this information during preconception counseling. Women of reproductive age should be counseled to consume a well-balanced diet including fruits and vegetables, iron and calcium-rich foods, and protein-containing foods as well as 400 microg of folic acid daily. More research is critically needed on the efficacy and safety of dietary supplements and the role of obesity in birth outcomes. Preconception counseling is the perfect opportunity for the health care provider to discuss a healthy eating guideline, dietary supplement intake, and maintaining a healthy weight status.

MAPLE-X10 reactor safety assessment

International Nuclear Information System (INIS)

Cotnam, K.D.; Lounsbury, R.I.; Gillespie, G.E.

1990-01-01

This paper reports on the safety assessment of the 10 MW MAPLE-X10 reactor which has involved a substantial component of PSA analysis to supplement deterministic analysis. Initiating events are identified through the use of a master logic diagram. The events are then examined through event sequence diagrams, at the concept design stage, followed by a set of reliability analyses that are coordinated with the event sequence diagrams. Improvements identified through the reliability analyses are incorporated into the design to ensure that safety objectives are attained

West Valley Reprocessing Plant. Safety analysis report, supplement 20

International Nuclear Information System (INIS)

1976-01-01

Supplement 20 is comprised of changed pages for the SAR which reflect: (1) the change in design basis fuel fed to the process from a minimum of 180 days after reactor discharge to a minimum of 210 days and an effective 24 months after reactor discharge; (2) the design objective of NFS that the concentrations of radionuclides, other than tritium, will not exceed the concentration limits of 10 CFR 20, Appendix B, Table II, column 2, when measured at the discharge from NFS' lagoon system to the on-site waterway; (3) incorporation of modifications to fuel receiving and storage area; (4) an updating of the general information presented in Chapter 1.0; and (5) additional data from the new meteorological tower at West Valley and recent changes in demographic projections

Surgical Safety Training of World Health Organization Initiatives.

Science.gov (United States)

Davis, Christopher R; Bates, Anthony S; Toll, Edward C; Cole, Matthew; Smith, Frank C T; Stark, Michael

2014-01-01

Undergraduate training in surgical safety is essential to maximize patient safety. This national review quantified undergraduate surgical safety training. Training of 2 international safety initiatives was quantified: (1) World Health Organization (WHO) "Guidelines for Safe Surgery" and (2) Department of Health (DoH) "Principles of the Productive Operating Theatre." Also, 13 additional safety skills were quantified. Data were analyzed using Mann-Whitney U tests. In all, 23 universities entered the study (71.9% response). Safety skills from WHO and DoH documents were formally taught in 4 UK medical schools (17.4%). Individual components of the documents were taught more frequently (47.6%). Half (50.9%) of the additional safety skills identified were taught. Surgical societies supplemented safety training, although the total amount of training provided was less than that in university curricula (P < .0001). Surgical safety training is inadequate in UK medical schools. To protect patients and maximize safety, a national undergraduate safety curriculum is recommended. © 2013 by the American College of Medical Quality.

Safety evaluation report related to the operation of WPPSS Nuclear Project No. 2, Docket No. 50-397, Washington Public Power Supply System

International Nuclear Information System (INIS)

1982-12-01

Supplement 2 to the Safety Evaluation Report for Washington Public Power Supply System's application for a license to operate WNP-2 (Docket No. 50-397), located in Benton County, Washington, approximately 12 miles north of Richland, Washington, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement 1

Safety Evaluation Report related to the operation of Clinton Power Station, Unit No. 1, Docket No. 50-461

International Nuclear Information System (INIS)

1983-05-01

Supplement No. 2 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement No. 1

Dietary supplements: What's in a name? What's in the bottle?

Science.gov (United States)

Marcus, Donald M

2016-01-01

The Dietary Supplement Health and Education Act of 1994 (DSHEA), which arbitrarily classified herbals and other medicinal products as dietary supplements, obscured fundamental differences between two classes of products. Authentic supplements to the diet, such as multivitamins or calcium, have nutritional value and are safe. Herbals are used worldwide as medicines, they do not supplement the diet, they may cause severe adverse events, and they should be regulated as medicines. DSHEA also prevented the Food and Drug Administration (FDA) from effectively regulating herbal supplements as medicines. One consequence of weak FDA regulatory oversight is the poor quality of herbals. FDA inspections of manufacturing facilities have revealed violations of good manufacturing practices in over half of facilities inspected, including unsanitary conditions and lack of product specifications. Moreover, many "all natural" herbals marketed for weight loss, enhancement of sexual health and improving sports performance are adulterated with prescription and over-the-counter medications that have caused adverse cardiovascular events. New procedures to authenticate the identity of plants used in herbals will neither detect adulteration by medications nor provide assurance of appropriate pharmacological activity or safety. Nonvitamin, nonmineral "supplements" should be regulated as medicines, but revision or repeal of DSHEA faces strong opposition in Congress. The marketing of botanical supplements is based on unfounded claims that they are safe and effective. Health professionals need to inform patients and the public that there is no reason to take herbal medicines whose composition and benefits are unknown, and whose risks are evident. Copyright © 2015 John Wiley & Sons, Ltd.

Vitamin C supplementation in pregnancy.

Science.gov (United States)

Rumbold, Alice; Ota, Erika; Nagata, Chie; Shahrook, Sadequa; Crowther, Caroline A

2015-09-29

Vitamin C supplementation may help reduce the risk of pregnancy complications such as pre-eclampsia, intrauterine growth restriction and maternal anaemia. There is a need to evaluate the efficacy and safety of vitamin C supplementation in pregnancy. To evaluate the effects of vitamin C supplementation, alone or in combination with other separate supplements on pregnancy outcomes, adverse events, side effects and use of health resources. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies. All randomised or quasi-randomised controlled trials evaluating vitamin C supplementation in pregnant women. Interventions using a multivitamin supplement containing vitamin C or where the primary supplement was iron were excluded. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Twenty-nine trials involving 24,300 women are included in this review. Overall, 11 trials were judged to be of low risk of bias, eight were high risk of bias and for 10 trials it was unclear. No clear differences were seen between women supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control for the risk of stillbirth (risk ratio (RR) 1.15, 95% confidence intervals (CI) 0.89 to 1.49; 20,038 participants; 11 studies; I² = 0%; moderate quality evidence), neonatal death (RR 0.79, 95% CI 0.58 to 1.08; 19,575 participants; 11 studies; I² = 0%), perinatal death (average RR 1.07, 95% CI 0.77 to 1.49; 17,105 participants; seven studies; I² = 35%), birthweight (mean difference (MD) 26.88 g, 95% CI -18.81 to 72.58; 17,326 participants; 13 studies; I² = 69%), intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06; 20,361 participants; 12 studies; I² = 15%; high quality evidence), preterm birth (average RR 0.99, 95% CI 0.90 to 1.10; 22,250 participants; 16 studies; I² = 49%; high quality evidence

Nuclear criticality safety handbook. Version 2

International Nuclear Information System (INIS)

1999-03-01

The Nuclear Criticality Safety Handbook, Version 2 essentially includes the description of the Supplement Report to the Nuclear Criticality Safety Handbook, released in 1995, into the first version of Nuclear Criticality Safety Handbook, published in 1988. The following two points are new: (1) exemplifying safety margins related to modelled dissolution and extraction processes, (2) describing evaluation methods and alarm system for criticality accidents. Revision is made based on previous studies for the chapter that treats modelling the fuel system: e.g., the fuel grain size that the system can be regarded as homogeneous, non-uniformity effect of fuel solution, and burnup credit. This revision solves the inconsistencies found in the first version between the evaluation of errors found in JACS code system and criticality condition data that were calculated based on the evaluation. (author)

Lepreau 2 environmental impact statement. Supplemental information

International Nuclear Information System (INIS)

1984-09-01

This report contains supplemental information to the Environmental Impact Statement that was issued on the proposed second nuclear generating station Point Lepreau-2 in New Brunswick, Canada. Some issues dealt with here are the terrestrial and aquatic impacts of radioactive and thermal releases to the environment, radiation safety for the human population, socio-economic impacts on the region in regards to housing, social services and employment, and monitoring programs for all aspects of the development, construction and operation of the plant

Will the new Consumer Protection Act prevent harm to nutritional supplement users?

Science.gov (United States)

Gabriels, Gary; Lambert, Mike; Smith, Pete; Hiss, Donavon

2011-07-25

BACKGROUND. There is no clear distinction between the regulation of food, supplements and medicines in South Africa. Consequently, grey areas exist in implementing the legislation, particularly in the supplement industry. The increase in supplement sales in South Africa can be attributed to aggressive marketing by manufacturers whose claims are not always supported by published peer-reviewed evidence. Such claims often go unchecked, resulting in consumers being mislead about the role of supplements. As a result of poor regulation, contaminants or adulterants in supplements may also cause insidious effects unrelated to the listed ingredients. AIM. To assess the regulations, legislation, and claims associated with nutritional supplement products in South Africa. METHOD. Peer-reviewed literature and the relevant South African statutes were consulted. RESULTS. The National Health Act incorporates the Medicine Control Council, which is charged with ensuring the safety, quality and effectiveness of medicines, and related matters, including complementary/alternative medicines. The South African Institute for Drug-Free Sport and Amendment Act provides for testing athletes for using banned substances, but currently does not concern itself with monitoring nutritional supplements for contaminants or adulterants that may cause a positive drug test, which has implications for sports participants and also the health of the general population. The implementation of the Consumer Protection Act 68 of 2008 (CPA) could protect consumer rights if it is administered and resourced appropriately. CONCLUSION. The CPA should promote greater levels of policy development, regulatory enforcement, and consumer education of South Africa's supplement industry.

Randomized controlled trial to determine the effectiveness of an interactive multimedia food safety education program for clients of the special supplemental nutrition program for women, infants, and children.

Science.gov (United States)

Trepka, Mary Jo; Newman, Frederick L; Davila, Evelyn P; Matthew, Karen J; Dixon, Zisca; Huffman, Fatma G

2008-06-01

Pregnant women and the very young are among those most susceptible to foodborne infections and at high risk of a severe outcome from foodborne infections. To determine if interactive multimedia is a more effective method than pamphlets for delivering food safety education to Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients. A randomized controlled trial of WIC clients was conducted. Self-reported food safety practices were compared between pre- and postintervention questionnaires completed >or=2 months after the intervention. Pregnant WIC clients or female caregivers (usually mothers) of WIC clients who were 18 years of age or older and able to speak and read English were recruited from an inner-city WIC clinic. Participants were randomized to receive food safety pamphlets or complete an interactive multimedia food safety education program on a computer kiosk. Change from pre- to postintervention food safety scores. A mean food safety score was determined for each participant for the pre- and postintervention questionnaires. The scores were used in a two-group repeated measures analysis of variance. Of the 394 participants, 255 (64.7%) completed the postintervention questionnaire. Satisfaction with the program was high especially among those with no education beyond high school. When considering a repeated measures analysis of variance model with the two fixed between-subject effects of group and age, a larger improvement in score in the interactive multimedia group than in the pamphlet group (P=0.005) was found, but the size of the group effect was small (partial eta(2)=0.033). Women aged 35 years or older in the interactive multimedia group had the largest increase in score. The interactive multimedia was well-accepted and resulted in improved self-reported food safety practices, suggesting that interactive multimedia is an effective option for food safety education in WIC clinics.

Safety-related incidents at the Finnish nuclear power plants

International Nuclear Information System (INIS)

Lehtinen, P.

1986-03-01

This report contains detailed descriptions of operating incidents and other safety-related matters at the Finnish nuclear power plants regarded as significant by the regulatory authority, the Finnish Centre for Radiation and Nuclear Safety. In this connection, an account is given of the practical actions caused by the incidents, and their significance to reactor safety is evaluated. The main features of the incidents are also described in the general Quartely Reports, Operation of Finnish Nuclear Power Plants, which are supplemented by this report intended for experts. (author)

Safety-related incidents at the Finnish nuclear power plants

International Nuclear Information System (INIS)

Lehtinen, P.

1985-01-01

This report contains detailed descriptions of operating incidents and other safety-related matters at the Finnish nuclear power plants regarded as significant by the regulatory authority, the Finnish Centre for Radiation and Nuclear Safety. In this connection, an account is given of the practical actions caused by the incidents, and their significance to reactor safety is evaluated. The main features of the incidents are also described in the general Quartely Reports, Operation of Finnish Nuclear Power Plants, which are supplemented by this report intended for experts. (author)

Biochemical and Anthropometric Effects of a Weight Loss Dietary Supplement in Healthy Men and Women

Directory of Open Access Journals (Sweden)

Cameron G. McCarthy

2012-01-01

Full Text Available Background We have recently noted an acute increase in circulating free fatty acids and glycerol, as well as resting metabolic rate, when men and women ingested the dietary supplement OxyELITE Pro™ in a single dose. We have also noted a reduction in appetite when subjects were treated with this supplement for 14 consecutive days. It is possible that such findings may favor body weight and fat loss over time. Therefore, the purpose of the present study was to determine the effects of this dietary supplement on weight loss and associated markers using an eight week intervention. Methods Exercise-trained subjects were randomly assigned in double blind manner to ingest either the dietary supplement (n = 16; aged 22.8 ± 0.7 or a placebo (n = 16; 22.5 ± 0.5 every day for eight weeks. Body weight, body composition, skinfold thickness, serum lipids, and appetite were measured as the primary outcome variables. As measures of supplement safety, a complete blood count and comprehensive metabolic panel were performed, and resting heart rate and blood pressure were measured (pre and post intervention. Results No interactions or main effects were noted for our primary outcome measures ( P > 0.05. However, when comparing pre and post intervention values for the supplement, significant decreases were noted in appetite, body weight, body fat percentage, and skinfold thickness ( P 0.05, with the exception of an increase in HDL-C ( P 0.05, with the exception of monocytes, for which an interaction effect was noted ( P = 0.04. Conclusion These data indicate that the dietary supplement OxyELITE Pro™ may assist in weight and body fat loss in a sample of exercise-trained men and women. The supplement does not result in any adverse effects pertaining to resting blood pressure or bloodborne markers of safety; however a small increase in resting heart rate is observed.

Determinants of dietary supplement use--healthy individuals use dietary supplements.

Science.gov (United States)

Kofoed, Christina L F; Christensen, Jane; Dragsted, Lars O; Tjønneland, Anne; Roswall, Nina

2015-06-28

The prevalence of dietary supplement use varies largely among populations, and previous studies have indicated that it is high in the Danish population compared with other European countries. The diversity in supplement use across countries indicates that cultural and environmental factors could influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54,948 Danes, aged 50-64 years, who completed self-administrated questionnaires on diet, dietary supplements and lifestyle between 1993 and 1997. A health index including smoking, physical activity, alcohol and diet, and a metabolic risk index including waist circumference, urinary glucose and measured hypertension were constructed. Logistic regression was used to investigate these determinants in relation to the intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher likelihood of being user of any, more common and less common supplements, respectively. In the metabolic risk index, one additional point was associated with 17 and 16 % lower likelihood of being user of any supplement and more common supplements, respectively. No significant association was found for less common supplement use. In conclusion, those with the healthiest lifestyle were more likely to use dietary supplements. Thus, lifestyle and dietary composition should be considered as confounders on supplement use and health outcomes.

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2, Docket Nos. 50-390 and 50-391

International Nuclear Information System (INIS)

1992-01-01

Supplement No. 8 to the Safety Evaluation Report for the application filed by the Tennessee Valley Authority for license to operate Watts Bar Nuclear plant, Units 1 and 2, Docket Nos. 50-390 and 50-391, located in Rhea County, Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation of (1) additional information submitted by the applicant since Supplement No. 7 was issued, and (2) matters that the staff had under review when Supplement No. 7 was issued

Effect of carotenoid supplementation on plasma carotenoids, inflammation and visual development in preterm infants.

Science.gov (United States)

Rubin, L P; Chan, G M; Barrett-Reis, B M; Fulton, A B; Hansen, R M; Ashmeade, T L; Oliver, J S; Mackey, A D; Dimmit, R A; Hartmann, E E; Adamkin, D H

2012-06-01

Dietary carotenoids (lutein, lycopene and β-carotene) may be important in preventing or ameliorating prematurity complications. Little is known about carotenoid status or effects of supplementation. This randomized controlled multicenter trial compared plasma carotenoid levels among preterm infants (n=203, lutein, lycopene and β-carotene with human milk (HM)-fed term infants. We assessed safety and health. Plasma carotenoid levels were higher in the supplemented group at all time points (Plutein levels correlated with the full field electroretinogram-saturated response amplitude in rod photoreceptors (r=0.361, P=0.05). The supplemented group also showed greater rod photoreceptor sensitivity (least squares means 6.1 vs 4.1; Plutein on preterm retina health and maturation.

Prioritization of generic safety issues

International Nuclear Information System (INIS)

Emrit, R.; Minners, W.; VanderMolen, H.

1983-12-01

This report presents the priority rankings for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated at Unresolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative

Guidelines for nuclear power plant safety issue prioritization information development. Supplement 2

International Nuclear Information System (INIS)

Andrews, W.B.; Gallucci, R.H.V.; Konzek, G.J.; Heaberlin, S.W.; Fecht, B.A.; Allen, C.H.; Allen, R.D.; Bickford, W.E.; Carbaugh, E.H.; Lewis, J.R.

1983-12-01

This is the third in a series of reports to document the use of a methodology developed by the Pacific Northwest Laboratory to calculate, for prioritization purposes, the risk, dose and cost impacts of implementing resolutions to reactor safety issues (NUREG/CR-2800, Andrews et al. 1983). This report contains results of issue-specific analyses for 31 issues. Each issue was considered within the constraints of available information as of summer 1983, and two staff-weeks of labor. The results are referenced, as one consideration in setting priorities for reactor safety issues, in NUREG-0933, A Prioritization of Generic Safety Issues

The role of calcium supplementation in healthy musculoskeletal ageing: an expert consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases ...

Science.gov (United States)

The place of calcium supplementation, with or without concomitant vitamin D supplementation, has been much debated in terms of both efficacy and safety. There have been numerous trials and meta-analyses of supplementation for fracture reduction, and associations with risk of myocardial infarction ha...

Safety Evaluation Report: Restart of K-Reactor, Savannah River Site

International Nuclear Information System (INIS)

1991-08-01

In April 1991, the Department of Energy (DOE) issued DOE/DP-0084T, ''Safety Evaluation Report Restart of K-Reactor Savannah River Site.'' The Safety Evaluation Report (SER) documents the results of DOE reviews and evaluations of the programmatic aspects of a large number of issues which need to be satisfactorily addressed before restart. The issues were evaluated for compliance with the restart criteria included in the SER. The results of those evaluations determined that the restart criteria had been satisfied for some of the issues. However, for most of the issues at least part of the applicable restart criteria had not been found to be satisfied a the time the evaluations were prepared. For those issues, open or confirmatory items were identified that required resolution. This document supplements the April 1991 SER. The SER Supplement documents the resolution of several of the open items identified in the SER. Only those issues (sections) for which at least one open item identified in the SER has now been closed are addressed in this Supplement. Additionally, some SER sections had no open items identified. Therefore, this Supplement does not include all sections that were addressed in the SER. If there are any open items remaining to be resolved for the sections included in this Supplement, that is so identified at the end of the section. The resolution of those remaining open times, and all remaining open items for those SER sections not included in this first Supplement, will be documented in future SER Supplements. Resolution of all open items for an issue indicates that its associated restart criteria have been satisfied, and that DOE concludes that the programmatic aspects of the issue have been satisfactorily addressed

Leveraging corporate social responsibility to improve consumer safety of dietary supplements sold for weight loss and muscle building.

Science.gov (United States)

Kulkarni, Anvita; Huerto, Ryan; Roberto, Christina A; Austin, S Bryn

2017-03-01

The potential dangers associated with dietary supplements sold for weight loss and muscle building are well documented and increasingly garnering the attention of the media, public, and government leaders. Public health professionals have an opportunity to improve population health in the context of dietary supplement use by translating scientific evidence into action. In this commentary, we discuss the potential to motivate corporate social responsibility (CSR) among manufacturers and retailers of dietary supplements sold for weight loss and muscle building. We examine levers available to public health professionals for generating voluntary corporate self-regulation by reviewing examples from successful CSR initiatives in other domains of public health and offering recommendations highlighting effective advocacy strategies. We encourage public health professionals to use one or multiple advocacy strategies to improve consumer protections for dietary supplements sold for weight loss and muscle building.

Progress of nuclear safety research. 2002

Energy Technology Data Exchange (ETDEWEB)

Anoda, Yoshinari; Kudo, Tamotsu; Tobita, Tohru (eds.) [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment] (and others)

2002-11-01

JAERI is conducting nuclear safety research primarily at the Nuclear Safety Research Center in close cooperation with the related departments in accordance with the Long Term Plan for Development and Utilization of Nuclear Energy and Annual Plan for Safety Research issued by the Japanese government. The fields of conducting safety research at JAERI are the engineering safety of nuclear power plants and nuclear fuel cycle facilities, and radioactive waste management as well as advanced technology for safety improvement or assessment. Also, JAERI has conducted international collaboration to share the information on common global issues of nuclear safety and to supplement own research. Moreover, when accidents occurred at nuclear facilities, JAERI has taken a responsible role by providing technical experts and investigation for assistance to the government or local public body. This report summarizes the nuclear safety research activities of JAERI from April 2000 through April 2002 and utilized facilities. This report also summarizes the examination of the ruptured pipe performed for assistance to the Nuclear and Industrial Safety Agency (NISA) for investigation of the accident at the Hamaoka Nuclear Power Station Unit-1 on November, 2001. (author)

Progress of nuclear safety research - 2005

International Nuclear Information System (INIS)

Anoda, Yoshinari; Amaya, Masaki; Saito, Junichi; Sato, Atsushi; Sono, Hiroki; Tamaki, Hitoshi; Tonoike, Kotaro; Nemoto, Yoshiyuki; Motoki, Yasuo; Moriyama, Kiyofumi; Yamaguchi, Tetsuji; Araya, Fumimasa

2006-03-01

The Japan Atomic Energy Research Institute (JAERI), one of the predecessors of the Japan Atomic Energy Agency (JAEA), had conducted nuclear safety research primarily at the Nuclear Safety Research Center in close cooperation with the related departments in accordance with the Long Term Plan for Development and Utilization of Nuclear Energy and Five-Years Program for Safety Research issued by the Japanese government. The fields of conducting safety research at JAERI were the engineering safety of nuclear power plants and nuclear fuel cycle facilities, and radioactive waste management as well as advanced technology for safety improvement or assessment. Also, JAERI had conducted international collaboration to share the information on common global issues of nuclear safety and to supplement own research. Moreover, when accidents occurred at nuclear facilities, JAERI had taken a responsible role by providing experts in assistance to conducting accident investigations or emergency responses by the government or local government. These nuclear safety research and technical assistance to the government have been taken over as an important role by JAEA. This report summarizes the nuclear safety research activities of JAERI from April 2003 through September 2005 and utilized facilities. (author)

Requirements of safety and reliability

International Nuclear Information System (INIS)

Franzen, L.F.

1977-01-01

The safety strategy for nuclear power plants is characterized by the fact that the high level of safety was attained not as a result of experience, but on the basis of preventive accident analyses and the findings derived from such analyses. Although, in these accident analyses, the deterministic approach is predominant it is supplemented by reliability analyses. The accidents analyzed in nuclear licensing procedures cover a wide spectrum from minor incidents to the design basis accidents which determine the design of the safety devices. The initial and boundary conditions, which are essential for accident analyses, and the determination of the loads occuring in various states during regular operation and in accidents flow into the design of the individual systems and components. The inevitable residual risk and its origins are discussed. (orig./HP) [de

Safety-related occurrences at the Finnish nuclear power plants

International Nuclear Information System (INIS)

Reponen, H.; Viitasaari, O.

1985-04-01

This report contains detailed descriptions of operating incidents and other safety-related matters at the Finnish nuclear power plants regarded as significant by the regulatory authority, the Finnish Centre for Radiation and Nuclear Safety. In this connection, an account is given of the practical actions caused by the incidents, and their significance to reactor safety is evaluated. The main features of the incidents are also described in the general Quartely Report for this period, Operation of Finnish Nuclear Power Plants (STUK-B-YTO 7), which is supplemented by this report intended for experts. (author)

Safety Evaluation Report related to the operation of LaSalle County Station, Units 1 and 2. Docket Nos. 50-373 and 50-374

International Nuclear Information System (INIS)

1984-03-01

This supplement to the Safety Evaluation Report of Commonwealth Edison Company's application for a license to operate its La Salle County Station, Unit 2, located in Brookfield Township, La Salle County, Illinois, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement is to update evaluations on Unit 2 issues identified in the previous Safety Evaluation Report and Supplements that need resolution prior to issuance of the full power operating license for Unit 2

Safety Evaluation Report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323)

International Nuclear Information System (INIS)

1984-02-01

Supplement 17 to the Safety Evaluation Report for Pacific Gas and Electric Company's application for licenses to operate Diablo Canyon Nuclear Power Plants, Units 1 and 2 (Docket Nos. 50-275 and 50-323) has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and the previous supplements

Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

Science.gov (United States)

McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R

2014-10-01

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Safety evaluation of the nuclear power plant at Cattenom

International Nuclear Information System (INIS)

Anon.

1987-01-01

This is a systematic compilation of the material which was dealt with at the level of the German-French Commission (on questions of the safety of nuclear installations) in this discussions about the nuclear power plant at Cattenom. As a supplement to the report published already in 1982, the Commission has officially released its deliberation results on the subjects constructive safety measures, radiological effects, and precautions in case of an emergency. The allegations according to which the installation is wanting in safety are countered by the joint statement of the chairmen of GPR (Permanent Group on Reactors) and RSK (German Commission on Reactor Safety) of August 29, 1986. (HSCH) [de

Vitamin B supplementation for diabetic peripheral neuropathy.

Science.gov (United States)

Jayabalan, Bhavani; Low, Lian Leng

2016-02-01

Vitamin B12 deficiency has been associated with significant neurological pathology, especially peripheral neuropathy. This review aims to examine the existing evidence on the effectiveness of vitamin B12 supplementation for the treatment of diabetic peripheral neuropathy. A search of PubMed and the Cochrane Central Register of Controlled Trials for all relevant randomised controlled trials was conducted in December 2014. Any type of therapy using vitamin B12 or its coenzyme forms was assessed for efficacy and safety in diabetics with peripheral neuropathy. Changes in vibration perception thresholds, neuropathic symptoms and nerve conduction velocities, as well as the adverse effects of vitamin B12 therapy, were assessed. Four studies comprising 363 patients met the inclusion criteria. This review found no evidence that the use of oral vitamin B12 supplements is associated with improvement in the clinical symptoms of diabetic neuropathy. Furthermore, the majority of studies reported no improvement in the electrophysiological markers of nerve conduction. Copyright © Singapore Medical Association.

SPORT SUPPLEMENTATION

OpenAIRE

Alexandаr Marinkov

2016-01-01

Sport supplementation is essential for athletes performance and achievements. The well balanced and structured supplementation is a challenge for sport medicine because must be done a balance between potential benefits and potential risks (anti-doping rule violations and others). In this review are structured the most used categories sport supplementations. Nutritional supplements used in sport could be divided in some main categories like: amino acids, vitamins, proteins and antioxidants. Fo...

Safety evaluation report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410)

International Nuclear Information System (INIS)

1986-07-01

This report supplements the Safety Evaluation Report (NUREG-1047, February 1985) for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate the Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. Supplement 1 to the Safety Evaluation Report was published in June 1985 and contained the report from the Advisory Committee on Reactor Safeguards as well as the resolution to a number of outstanding issues from the Safety Evaluation Report. Supplement 2 was published in November 1985 and contained the resolution to a number of outstanding and confirmatory issues. Subject to favorable resolution of the issues discussed in this report, the NRC staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public

Safety evaluation report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461). Suppl. 3

International Nuclear Information System (INIS)

1984-05-01

Supplement No. 3 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report and Supplements No. 1 and 2

Marketing dietary supplements in the United States: A review of the requirements for new dietary ingredients

International Nuclear Information System (INIS)

Noonan, Chris; Patrick Noonan, W.

2006-01-01

Since the passage of the Dietary Supplement Health and Education Act in 1994, the marketplace for dietary supplements has experienced dramatic growth. New products have redefined the entire marketplace, and new ingredients are introduced to consumers at lightning speed. As part of this act, laws were passed to ensure the safety of new dietary ingredients introduced into the United States marketplace. But more than 11 years later, these laws are frequently misunderstood, and more frequently ignored. This article reviews the regulatory landscape of new dietary ingredients and defines the issues manufacturers must contend with to legally market dietary supplements with new dietary ingredients in the U.S

41 CFR 128-1.8005 - Seismic safety standards.

Science.gov (United States)

2010-07-01

... the model building codes that the Interagency Committee on Seismic Safety in Construction (ICSSC...) Uniform Building Code (UBC); (2) The 1992 Supplement to the Building Officials and Code Administrators International (BOCA) National Building Code (NBC); and (3) The 1992 Amendments to the Southern Building Code...

Safety evaluation report related to the operation of Beaver Valley Power Station, Unit 2 (Docket No. 50-412)

International Nuclear Information System (INIS)

1986-05-01

This report, Supplement No. 1 to the Safety Evaluation Report for the application filed by the Duquesne Light Company et al. (the applicant) for a license to operate the Beaver valley Power Station, Unit 2 (Docket No. 50-412), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time the Safety Evaluation Report was published

Engineering design guidelines for nuclear criticality safety

International Nuclear Information System (INIS)

Waltz, W.R.

1988-08-01

This document provides general engineering design guidelines specific to nuclear criticality safety for a facility where the potential for a criticality accident exists. The guide is applicable to the design of new SRP/SRL facilities and to major modifications Of existing facilities. The document is intended an: A guide for persons actively engaged in the design process. A resource document for persons charged with design review for adequacy relative to criticality safety. A resource document for facility operating personnel. The guide defines six basic criticality safety design objectives and provides information to assist in accomplishing each objective. The guide in intended to supplement the design requirements relating to criticality safety contained in applicable Department of Energy (DOE) documents. The scope of the guide is limited to engineering design guidelines associated with criticality safety and does not include other areas of the design process, such as: criticality safety analytical methods and modeling, nor requirements for control of the design process

Safety and environmental health handbook

Science.gov (United States)

,

1989-01-01

This Safety Handbook (445-1-H.) supplements the Geological Survey Safety Management Program objectives set forth in Survey Manual 445.1. Specifically, it provides a compact source of basic information to assist management and employees in preventing motor vehicle accidents, personal injuries, occupational diseases, fire, and other property damage or loss. All work situations incidental to the Geological Survey cannot be discussed in a handbook, and such complete coverage is not intended in this document. However, a wide range of subjects are covered in which a "common sense" approach to safety has been expressed. These subjects have been organized such that Chapters 1-5 address administrative issues, Chapters 6-12 address activities usually conducted within a facility, and Chapters 13-20 address field activities. No information contained in the Handbook is intended to alter any provision of any Federal law or executive order, Department of the Interior or Survey directive, or collective bargaining agreement. Questions or suggestions regarding the content of the Safety Handbook may be directed to the Survey Safety Manager, Administrative Division, Office of Facilities and Management Services, National Center, Reston, Virginia, Mail Stop 246. The previous edition of the Safety Handbook is superseded.

Regulations for the safe transport of radioactive material. 1985 ed. Supplement 1986

International Nuclear Information System (INIS)

1986-01-01

Following a six-year effort, a major revision to the Agency's Regulations for the Safe Transport of Radioactive Material (Safety Series No. 6) was issued in 1985. In order to address minor problems with the 1985 Edition of Safety Series No. 6, a panel of experts convened by the International Atomic Energy Agency met from 13 to 17 January 1986. This panel considered minor inconsistencies, omissions or errors that had occurred in the course of preparing the 1985 Edition of Safety Series No. 6, and recommended that two types of change be made. First, changes which will correct errors in the presentation of the text, translation errors (in the French, Russian and Spanish versions of the 1985 Edition), and drafting which failed to express the intent of the panels which reviewed the previous edition of the Regulations; these minor changes are promulgated herewith by the authority of the Director General. Secondly, changes of detail which can only be introduced in accordance with the procedure approved by the Board of Governors on 22 September 1972, which authorizes the Director General to promulgate such changes after giving Governments not less than ninety days' notice and taking into account any comments that they make. Three changes of this second type were recommended by the panel, and were circulated according to the 'ninety-day rule' amendment procedure on 3 February 1986. Those changes which received unanimous support by Member States are included in this Supplement. Corrected text to the 1985 Edition of Safety Series No. 6 (paragraphs, tables, etc.) is provided in this Supplement, and this corrected text supersedes the corresponding portions of the 1985 Edition of Safety Series No. 6.

The incidence of vitamin, mineral, herbal, and other supplement use in facial cosmetic patients.

Science.gov (United States)

Zwiebel, Samantha J; Lee, Michelle; Alleyne, Brendan; Guyuron, Bahman

2013-07-01

Dietary supplement use is common in the United States. Some herbal supplements may cause coagulopathy, hypertension, or dry eyes. The goal of this study is to reveal the incidence of herbal supplement use in the cosmetic surgery population. A retrospective chart review of 200 patients undergoing facial cosmetic surgery performed by a single surgeon was performed. Variables studied included patient age, sex, surgical procedure, herbal medication use, and intraoperative variables. Exclusion criteria were age younger than 15 years, noncosmetic procedures such as trauma, and incomplete preoperative medication form. Patients were subdivided into the supplement user group (herbal) and the supplement nonuser group (nonherbal). Statistical analysis included descriptive statistics, t test, and chi-square analysis. The incidence of supplement use was 49 percent in the 200 patients; 24.5 percent of patients used only vitamins or minerals, 2.5 percent of patients used only animal- and plant-based (nonvitamin/mineral) supplements, and 22 percent of patients used both types of supplements. In the herbal group, patients used an average of 2.8 supplements. The herbal and nonherbal groups differed significantly in sex (herbal, 89.8 percent female; nonherbal, 77.5 percent; p use is prevalent in the facial cosmetic surgery population, especially in the older female population. Considering the potential ill effects of these products on surgery and recovery, awareness and careful documentation and prohibiting the patients from the consumption of these products will increase the safety and reduce the recovery following cosmetic procedures.

Integrated Plant Safety Assessment, Systematic Evaluation Program, Palisades Plant (Docket No. 50-255)

International Nuclear Information System (INIS)

1983-11-01

This report documents the review completed under the SEP for those issues that required refined engineering evaluations or the continuation of ongoing evaluations after the Final IPSAR for the Palisades Plant was issued. The review has provided for (1) an assessment of the significance of differences between current technical positions on selected safety issues and those that existed when the Palisades Plant was licensed, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety when the supplement to the Final IPSAR and the Safety Evaluation Report for converting the license from a provisional to a full-term license have been issued. The Final IPSAR and its supplement will form part of the bases for considering the conversion of the provisional operating license to a full-term operating license

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2

International Nuclear Information System (INIS)

1995-09-01

This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985). Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992). Supplement No. 9 (June 1992), Supplement No. 10 (October 1992), Supplement No. 11 (April 1993), Supplement No. 12 (October 1993). Supplement No. 13 (April 1994), Supplement No. 14 (December 1994), and Supplement No. 15 (June 1995) issued by the Office of Nuclear Reactor Regulation of the U.S. Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos, 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items, and proposed license conditions identified in the SER

Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework.

Science.gov (United States)

Abdel-Tawab, Mona

2018-04-01

Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission. Georg Thieme Verlag KG Stuttgart · New York.

Safety issues of botanicals and botanical preparations in functional foods

International Nuclear Information System (INIS)

Kroes, R.; Walker, R.

2004-01-01

Although botanicals have played a role in the marketing of health products for ages, there is an increased interest today due to their perceived health benefits. Not only do consumers increasingly take charge of their health, but the scientific information and understanding of the beneficial health effects of bioactive substances in food, functional foods and food supplements have improved. Increasing use of these products has also led to concerns about their actual safety. Recorded cases of intoxications have triggered such concerns. The safety assessment of these substances is complicated by, amongst others, the variability of composition. Furthermore, consumption of such functional products is expected to produce physiological effects, which may lead to low margins of safety as the margin between exposure of such products and the safe level of intake are likely to be small. The safety assessment of botanicals and botanical preparations in food and food supplement should at least involve: - the characterisation and quality of the material, its quality control; - the intended use and consequent exposure; - history of use and exposure; - product comparison(s); - toxicological information gathering; - Risk characterisation/safety assessment; As a guidance tool, a decision tree approach is proposed to assist in determining the extent of data requirements based on the nature of the such product. This guidance tool in safety assessment was developed by an expert group of the International Life Sciences Institute (ILSI), European Branch, and is currently in press. In this paper a summarised version of this tool is presented

The effect and safety of highly standardized Ginger (Zingiber officinale) and Echinacea (Echinacea angustifolia) extract supplementation on inflammation and chronic pain in NSAIDs poor responders. A pilot study in subjects with knee arthrosis.

Science.gov (United States)

Rondanelli, Mariangela; Riva, Antonella; Morazzoni, Paolo; Allegrini, Pietro; Faliva, Milena Anna; Naso, Maurizio; Miccono, Alessandra; Peroni, Gabriella; Degli Agosti, Irene; Perna, Simone

2017-06-01

The study aimed to evaluate the effect of Zingiber officinale and Echinacea angustifolia extract supplementation (25 mg of ginger and 5 mg of Echinacea) for 30 days on inflammation and chronic pain in knee osteoarthritis (OA). Consecutive nonsteroidal anti-inflammatory-drugs (NSAIDs) poor responders with chronic inflammation and pain due to knee arthrosis were assessed (15 subjects, age: 67.2 ± 7.9, body mass index: 30.6 ± 7.1, men/women:2/13). The primary endpoint was to determine pain improvement from baseline to Day 30 by Tegner Lysholm Knee Scoring. The secondary endpoints were the assessment of Visual Analog Scale for Pain, health-related quality of life, by the ShortForm36 (SF-36), anthropometric parameters, hydration. After supplementation, a significant improvement of 12.27 points was observed for Lysholm scale score (p < 0.05), SF-36 (p < 0.05), and a decrease in -0.52 cm in knee circumference (left) (p < 0.01). This pilot study provides feasibility and safety data for the use of highly standardised ginger and Echinacea extract supplementation in people with knee OA.

Safety-evaluation report related to the final design of the Standard Nuclear Steam Supply Reference System - CESSAR System 80. Docket No. STN 50-470

International Nuclear Information System (INIS)

1983-03-01

Supplement No. 1 to the Safety Evaluation Report for the application filed by Combustion Engineering, Inc. for a Final Design Approval for the Combustion Engineering Standard Safety Analysis Report (STN 50-470) has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation by providing: (1) the evaluation of additional information submitted by the applicant since the Safety Evaluation Report was issued, (2) the evaluation of the matters the staff had under review when the Safety Evaluation Report was issued, and (3) the response to comments made by the Advisory Committee on Reactor Safeguards

A prioritization of generic safety issues

International Nuclear Information System (INIS)

Emrit, R.; Riggs, R.; Milstead, W.; Pittman, J.

1991-07-01

This report presents the priority rankings for generic safety issues and related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated as Un-resolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are High, Medium, Low, and Drop and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. 1310 refs

Safety-related occurrences at the Finnish nuclear power plants

International Nuclear Information System (INIS)

Viitasaari, O.; Rantavaara, A.

1984-03-01

This report contains detailed descriptions of operating incidents and other safety-related matters at the Finnish nuclear power plants regarded as significant by the regulatory authority, the Finnish Centre for Radiation and Nuclear Safety. In this connection, an account is given of the practical actions caused by the incidents, and their significance to reactor safety is evaluated. The main features of the incidents are also described in the general Quartely Report for this period, Operation of Finnish Nuclear Power Plants (STL-B-RTO-83/7), which is supplemented by this report intended principally for experts. (author)

[Marketability of food supplements - criteria for the legal assessment].

Science.gov (United States)

Breitweg-Lehmann, Evelyn

2017-03-01

To be placed on the market legally, food supplements have to meet national and European food law regulations. This is true for all substances used as well as for the labeling on the packaging of and the advertising for food supplements. The food business operator is responsible for its compliance with all regulations. Therefore, in this article, a concise step-by-step assessment is presented, covering all necessary legal requirements to market food supplements. Additionally, all steps are visualized in a flow chart. All vitamins, minerals and other substances used have to meet the legal conditions. Food business operators have to make sure that their products do not contain medicinal ingredients based on their pharmacologic effect. It is prohibited to place medicinal products as food supplements on the market. Furthermore, food business operators have to make sure that their products are not non-authorized novel foods according to the novel food regulation (EC) no. 258/97. Also, food supplements have to meet the requirements of article 14 of Regulation (EC) No. 178/2002 concerning the safety of foodstuff. Food shall not be placed on the market if it is unsafe. For food supplements that fail the German food-related legal standards but are legally manufactured in another EU member state or are legally put into circulation, the importer requires the so-called general disposition, which must be applied for at the BVL according to § 54 of the German Food and Feed Act. Another possibility for food which fails to meet German food law is to apply for a certificate of exemption according to § 68 of the Food and Feed Act. The food business operator has to meet the harmonized regulations concerning maximum and minimum levels of additives, flavors and enzymes. The packaging has to meet the compulsory labeling as well the voluntary labeling, like health claims. The BVL is also the relevant authority for other tasks concerning food supplements. A figure shows all

Complementarity in dietary supplements and foods: are supplement users vegetable eaters?

Science.gov (United States)

Kang, Hyoung-Goo; Joo, Hailey Hayeon; Choi, Kyong Duk; Lee, Dongmin; Moon, Junghoon

2017-01-01

Background : The consumption of fruits, vegetables, and dietary supplements correlate. Most previous studies have aimed to identify the determinants of supplement uses or the distinct features of supplement users; this literature lacks a discussion on dietary supplement consumption as a predictor of fruit and vegetable consumption. Objective : This study examines how dietary supplement consumption correlates with fruit and vegetable consumption by combining scanner data and surveys of Korean household grocery shopping. Methods : Propensity score matching (PSM) is used to identify the relationship between dietary supplement consumption and fruit and vegetable consumption in a household. A logit regression using supplement consumption as the dependent variable is used. Then, the supplement takers (the treatment group) are matched with non-takers (the control group) based on the propensity scores estimated in the logit regression. The fruit and vegetable consumption levels of the groups are then compared. Results : We found that dietary supplement use is associated with higher fruit and vegetable consumption. This supports the health consciousness hypothesis based on attention bias, availability heuristics, the focusing effect, and the consumption episode effect. It rejects the health substitute hypothesis based on economic substitutes and mental accounting. Conclusions : Future research on the health benefits of dietary supplements should address the complementary consumption of fruits/vegetables and their health benefits to avoid misstating the health effects of supplements.

77 FR 74820 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplemental Motor...

Science.gov (United States)

2012-12-18

... Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday... maintenance plan to increase the safety margin as a result of new emissions model, VMT projection models, and... Promulgation of Implementation Plans; Tennessee: Knox County Supplemental Motor Vehicle Emissions Budget Update...

Maternal creatine supplementation affects the morpho-functional development of hippocampal neurons in rat offspring.

Science.gov (United States)

Sartini, S; Lattanzi, D; Ambrogini, P; Di Palma, M; Galati, C; Savelli, D; Polidori, E; Calcabrini, C; Rocchi, M B L; Sestili, P; Cuppini, R

2016-01-15

Creatine supplementation has been shown to protect neurons from oxidative damage due to its antioxidant and ergogenic functions. These features have led to the hypothesis of creatine supplementation use during pregnancy as prophylactic treatment to prevent CNS damage, such as hypoxic-ischemic encephalopathy. Unfortunately, very little is known on the effects of creatine supplementation during neuron differentiation, while in vitro studies revealed an influence on neuron excitability, leaving the possibility of creatine supplementation during the CNS development an open question. Using a multiple approach, we studied the hippocampal neuron morphological and functional development in neonatal rats born by dams supplemented with 1% creatine in drinking water during pregnancy. CA1 pyramidal neurons of supplemented newborn rats showed enhanced dendritic tree development, increased LTP maintenance, larger evoked-synaptic responses, and higher intrinsic excitability in comparison to controls. Moreover, a faster repolarizing phase of action potential with the appearance of a hyperpolarization were recorded in neurons of the creatine-treated group. Consistently, CA1 neurons of creatine exposed pups exhibited a higher maximum firing frequency than controls. In summary, we found that creatine supplementation during pregnancy positively affects morphological and electrophysiological development of CA1 neurons in offspring rats, increasing neuronal excitability. Altogether, these findings emphasize the need to evaluate the benefits and the safety of maternal intake of creatine in humans. Copyright © 2015 IBRO. Published by Elsevier Ltd. All rights reserved.

The safety of available treatment options for iron-deficiency anemia.

Science.gov (United States)

Muñoz, Manuel; Gómez-Ramírez, Susana; Bhandari, Sunil

2018-02-01

Iron deficiency (ID), with or without anemia, is highly prevalent worldwide and has clinical consequences. The prevention and treatment of ID is a major public health goal. Accurate diagnosis, selection of the appropriate iron replacement therapy and addressing the underlying cause, remain as the main challenges in ID management. Areas covered: This review aims to provide a narrative review of current available evidence on iron supplementation options regularly used to treat ID, including oral and intravenous (IV) iron formulations, with emphasis on safety issues. Analyzed safety concerns include gastrointestinal side effects (oral iron) and risks of hypotension, anaphylaxis, infection, hypophosphatemia, oxidative stress and mortality (IV iron). Expert opinion: Low-to-moderate doses of oral iron supplementation remains as first line therapy for uncomplicated ID, but it has been scarcely discussed in the setting of inflammation. Confirmatory studies on the efficacy of newer oral iron formulations in this setting are needed. Compared with oral iron, short-term IV iron administration is more efficacious in ID correction, without significant safety concerns. However, long-term safety of IV iron maintenance therapy, head to head comparisons of IV iron preparations, pharmacological modulation of hepcidin and HIF, and extra-erythropoietic effects of iron are among the important areas of research.

Progress of nuclear safety research. 2003

International Nuclear Information System (INIS)

Anoda, Yoshinari; Amagai, Masaki; Tobita, Tohru

2004-03-01

JAERI is conducting nuclear safety research primarily at the Nuclear Safety Research Center in close cooperation with the related departments in accordance with the Long Term Plan for Development and Utilization of Nuclear Energy and Annual Plan for Safety Research issued by the Japanese government. The fields of conducting safety research at JAERI are the engineering safety of nuclear power plants and nuclear fuel cycle facilities, and radioactive waste management as well as advanced technology for safety improvement or assessment. Also, JAERI has conducted international collaboration to share the information on common global issues of nuclear safety and to supplement own research. Moreover, when accidents occurred at nuclear facilities, JAERI has taken a responsible role by providing technical experts and investigation for assistance to the government or local public body. This report summarizes the nuclear safety research activities of JAERI from April 2001 through March 2003 and utilized facilities. This report also summarizes the examination of the ruptured pipe performed for assistance to the Nuclear and Industrial Safety Agency (NISA) for investigation of the accident at the Hamaoka Nuclear Power Station Unit-1 on November, 2001, and the integrity evaluation of cracked core shroud of BWRs of the Tokyo Electric Power Company performed for assistance to the Nuclear Safety Commission in reviewing the evaluation reports by the licensees. (author)

Function and safety assessment of Lactococus lactis subsp. lactis ...

African Journals Online (AJOL)

the characterizations of the strain, such as acid-tolerance, bile-tolerance, antimicrobial activity, antibiotic sensitivity and safety were also examined. The serum total cholesterol, triglyceride and bile acid levels significantly decreased of mice given a high-cholesterol diet supplemented with yogurt fermented by Lactococus ...

International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine

OpenAIRE

Kreider, Richard B.; Kalman, Douglas S.; Antonio, Jose; Ziegenfuss, Tim N.; Wildman, Robert; Collins, Rick; Candow, Darren G.; Kleiner, Susan M.; Almada, Anthony L.; Lopez, Hector L.

2017-01-01

Creatine is one of the most popular nutritional ergogenic aids for athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations which may help explain the observed improvements in high intensity exercise performance leading to greater training adaptations. In addition to athletic and exercise improvement, research has shown that creatine supplementation may enhance post-exercise recovery, injury prevention, thermoregulation, rehabilit...

Safety and Efficacy of Glucomannan for Weight Loss in Overweight and Moderately Obese Adults

Directory of Open Access Journals (Sweden)

Joyce K. Keithley

2013-01-01

Full Text Available Background. Few safe and effective dietary supplements are available to promote weight loss. We evaluated the safety and efficacy of glucomannan, a water-soluble fiber supplement, for achieving weight loss in overweight and moderately obese individuals consuming self-selected diets. Methods. Participants were randomly assigned to take 1.33 grams of glucomannan or identically looking placebo capsules with 236.6 mL (8 ounces of water one hour before breakfast, lunch, and dinner for 8 weeks. The primary efficacy outcome was change in body weight after 8 weeks. Other efficacy outcomes were changes in body composition, hunger/fullness, and lipid and glucose concentrations. Safety outcomes included gastrointestinal symptoms/tolerance and serum liver enzymes and creatinine levels. Results. A total of 53 participants (18–65 years of age; BMI 25–35 kg/m2 were enrolled and randomized. The two groups did not differ with respect to baseline characteristics and compliance with the study supplement. At 8 weeks, there was no significant difference between the glucomannan and placebo groups in amount of weight loss (−.40±.06 and −.43±.07, resp. or other efficacy outcomes or in any of the safety outcomes. Conclusions. Glucomannan supplements administered over 8 weeks were well tolerated but did not promote weight loss or significantly alter body composition, hunger/fullness, or lipid and glucose parameters. This trial is registered with NCT00613600.

Efficacy and Safety of Leucine Supplementation in the Elderly.

Science.gov (United States)

Borack, Michael S; Volpi, Elena

2016-12-01

Leucine supplementation has grown in popularity due to the discovery of its anabolic effects on cell signaling and protein synthesis in muscle. The current recommendation is a minimum intake of 55 mg ⋅ kg -1 . d -1 Leucine acutely stimulates skeletal muscle anabolism and can overcome the anabolic resistance of aging. The value of chronic leucine ingestion for muscle growth is still unclear. Most of the research into leucine consumption has focused on efficacy. To our knowledge, very few studies have sought to determine the maximum safe level of intake. Limited evidence suggests that intakes of ≤1250 mg ⋅ kg -1 . d -1 do not appear to have any health consequences other than short-term elevated plasma ammonia concentrations. Similarly, no adverse events have been reported for the leucine metabolite β-hydroxy-β-methylbutyrate (HMB), although no studies have tested HMB toxicity in humans. Therefore, future research is needed to evaluate leucine and HMB toxicity in the elderly and in specific health conditions. © 2016 American Society for Nutrition.

Antioxidant Supplementation Reduces Genomic Aberrations in Human Induced Pluripotent Stem Cells

Directory of Open Access Journals (Sweden)

Junfeng Ji

2014-01-01

Full Text Available Somatic cells can be reprogrammed to induced pluripotent stem cells (iPSCs using oncogenic transcription factors. However, this method leads to genetic aberrations in iPSCs via unknown mechanisms, which may limit their clinical use. Here, we demonstrate that the supplementation of growth media with antioxidants reduces the genome instability of cells transduced with the reprogramming factors. Antioxidant supplementation did not affect transgene expression level or silencing kinetics. Importantly, iPSCs made with antioxidants had significantly fewer de novo copy number variations, but not fewer coding point mutations, than iPSCs made without antioxidants. Our results suggest that the quality and safety of human iPSCs might be enhanced by using antioxidants in the growth media during the generation and maintenance of iPSCs.

78 FR 13606 - Defense Federal Acquisition Regulation Supplement; Unallowable Fringe Benefit Costs (DFARS Case...

Science.gov (United States)

2013-02-28

... indirect cost is expressly unallowable under a cost principle in the FAR, or an executive agency supplement... economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563... have a significant economic impact on a substantial number of small entities within the meaning of the...

Determinants of dietary supplement use - healthy individuals use dietary supplements

DEFF Research Database (Denmark)

Kofoed, Christina L F; Christensen, Jane; Dragsted, Lars Ove

2015-01-01

influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54 948 Danes, aged 50-64 years, who completed self-administrated questionnaires on diet, dietary supplements...... and lifestyle between 1993 and 1997. A health index including smoking, physical activity, alcohol and diet, and a metabolic risk index including waist circumference, urinary glucose and measured hypertension were constructed. Logistic regression was used to investigate these determinants in relation...... to the intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher...

Safety Evaluation Report related to the operation of Hope Creek Generating Station (Docket No. 50-354)

International Nuclear Information System (INIS)

1985-10-01

Supplement No. 3 to the Safety Evaluation Report on the application filed by Public Service Electric and Gas Company on its own behalf as co-owner and as agent for the other co-owner, the Atlantic City Electric Company, for a license to operate Hope Creek Generating Station has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lower Alloways Creek Township in Salem County, New Jersey. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report. 6 tabs

Supplemental environmental impact statement - defense waste processing facility

International Nuclear Information System (INIS)

1994-11-01

This document supplements the Final Environmental Impact Statement (EIS) DOE Issued in 1982 (DOE/EIS-0082) to construct and operate the Defense Waste Processing Facility (DWPF) at the Savannah River Site (SRS), a major DOE installation in southwestern South Carolina. That EIS supported the decision to construct and operate the DWPF to immobilize high-level waste generated as a result of nuclear materials processing at SRS. The DWPF would use a vitrification process to incorporate the radioactive waste into borosilicate glass and seal it in stainless steel canisters for eventual disposal at a permanent geologic repository. The DWPF is now mostly constructed and nearly ready for full operation. However, DOE has made design changes to the DWPF since the 1982 EIS to improve efficiency and safety of the facility. Each of these modifications was subjected to appropriate NEPA review. The purpose of this Supplemental EIS is to assist DOE in deciding whether and how to proceed with operation of the DWPF as modified since 1982 while ensuring appropriate consideration of potential environmental effects. In this document, DOE assesses the potential environmental impacts of completing and operating the DWPF in light of these design changes, examines the impact of alternatives, and identifies potential actions to be taken to reduce adverse impacts. Evaluations of impacts on water quality, air quality, ecological systems, land use, geologic resources, cultural resources, socioeconomics, and health and safety of onsite workers and the public are included in the assessment

Nagra thermochemical data base. II. Supplement data 05/92

International Nuclear Information System (INIS)

Pearson, F.J.; Berner, U.; Hummel, W.

1992-05-01

Chemical thermodynamic data for aqueous species, minerals, and gases are required by Nagra for geochemical modelling. The Nagra thermochemical data base contains core and supplemental data. Core data for well-characterised entities were individually carefully selected and given by Pearson and Berner (1991). Supplemental data are for less common entities and for elements principally of safety assessment concern. They were selected in groups from other data bases for geochemical modelling and did not receive individual scrutiny. This report gives tables with the Nagra thermochemical data as of 5/92. It includes the core data described in the earlier report with supplemental data for the elements aluminium, silicon, iron, and manganese, the actinides thorium, uranium, neptunium, plutonium, and americium, and elements found as fission or activation products in nuclear waste, including nickel, zirconium, niobium, molybdenum, technetium, palladium, tin, selenium and iodine. Aqueous complexes of four representative organic anions are also included. The sources of these supplemental data are described in the text. Other compilations of data were examined during the selection on the supplemental data. These included the data bases used at the Paul Scherrer Institut with the geochemical programs MINEQL as of 3/91, PHREEQE as of 4/91, and the HATCHES 3.0 data base. This report also gives tables comparing selected data in these three data bases with values from the Nagra data base. This data base has not yet been tested for a full range of nuclear waste management applications, although such work is in progress. It should thus be regarded as a reference fixed point for quality assurance purpose and not critically reviewed standard. (author) tabs., refs

Formal testing and utilization of streaming media to improve flight crew safety knowledge.

Science.gov (United States)

Bellazzini, Marc A; Rankin, Peter M; Quisling, Jason; Gangnon, Ronald; Kohrs, Mike

2008-01-01

Increased concerns over the safety of air medical transport have prompted development of novel ways to increase safety. The objective of our study was to determine if an Internet streaming media safety video increased crew safety knowledge. 23 out of 40 crew members took an online safety pre-test, watched a safety video specific to our program and completed immediate and long-term post-testing 6 months later. Mean pre-test, post-test and 6 month follow up test scores were 84.9%, 92.3% and 88.4% respectively. There was a statistically significant difference in all scores (p Streaming media proved to be an accessible and effective supplement to safety training in our study.

Is Nutrient Content and Other Label Information for Prescription Prenatal Supplements Different from Nonprescription Products?

Science.gov (United States)

Saldanha, Leila G; Dwyer, Johanna T; Andrews, Karen W; Brown, LaVerne L; Costello, Rebecca B; Ershow, Abby G; Gusev, Pavel A; Hardy, Constance J; Pehrsson, Pamela R

2017-09-01

Prenatal supplements are often recommended to pregnant women to help meet their nutrient needs. Many products are available, making it difficult to choose a suitable supplement because little is known about their labeling and contents to evaluate their appropriateness. To determine differences between prescription and nonprescription prenatal supplements available in the United States regarding declared nutrient and nonnutrient ingredients and the presence of dosing and safety-related information. Using two publicly available databases with information about prenatal supplement products, information from prescription and nonprescription product labels were extracted and evaluated. For the 82 prescription and 132 nonprescription products, declared label amounts of seven vitamins and minerals, docosahexaenoic acid (DHA), the presence of other nonnutrient components, and the presence of key safety and informational elements as identified in two Department of Health and Human Services Office of Inspector General (OIG)'s 2003 reports were compiled and compared. Compared with nonprescription products, prescription products contained significantly fewer vitamins (9±0.2 vs 11±0.3; P≤0.05) and minerals (4±0.1 vs 8±0.3; P≤0.05). Declared amounts of folic acid were higher in prescription products, whereas vitamin A, vitamin D, iodine, and calcium were higher in the nonprescription products. Amounts of iron, zinc, and DHA were similar. Virtually all products contained levels of one or more nutrients that exceeded the Recommended Dietary Allowances for pregnant and/or lactating women. Product type also influenced ingredients added. Fewer prescription products contained botanical ingredients (6% prescription vs 33% nonprescription) and probiotics (2% prescription vs 8% nonprescription). Only prescription products contained the stool softener docusate sodium. Our analysis of prenatal supplements indicates that prescription and nonprescription supplements differ in terms

Evaluation of heavy metals content in dietary supplements in Lebanon

Directory of Open Access Journals (Sweden)

Korfali Samira

2013-01-01

Full Text Available Abstract Background The consumption of dietary supplements is widely spread and on the rise. These dietary supplements are generally used without prescriptions, proper counseling or any awareness of their health risk. The current study aimed at analyzing the metals in 33 samples of imported dietary supplements highly consumed by the Lebanese population, using 3 different techniques, to ensure the safety and increase the awareness of the citizen to benefit from these dietary supplements. Results Some samples had levels of metals above their maximum allowable levels (Fe: 24%, Zn: 33%, Mn: 27%, Se: 15%, Mo: 12% of samples, but did not pose any health risk because they were below permitted daily exposure limit and recommended daily allowance except for Fe in 6% of the samples. On the other hand, 34% of the samples had Cu levels above allowable limit where 18% of them were above their permitted daily exposure and recommended daily allowance. In contrast, all samples had concentration of Cr, Hg, and Pb below allowable limits and daily exposure. Whereas, 30% of analyzed samples had levels of Cd above allowable levels, and were statistically correlated with Ca, and Zn essential minerals. Similarly 62% of the samples had levels of As above allowable limits and As levels were associated with Fe and Mn essential minerals. Conclusion Dietary supplements consumed as essential nutrients for their Ca, Zn, Fe and Mn content should be monitored for toxic metal levels due to their natural geochemical association with these essential metals to provide citizens the safe allowable amounts.

Evaluation of heavy metals content in dietary supplements in Lebanon.

Science.gov (United States)

Korfali, Samira Ibrahim; Hawi, Tamer; Mroueh, Mohamad

2013-01-18

The consumption of dietary supplements is widely spread and on the rise. These dietary supplements are generally used without prescriptions, proper counseling or any awareness of their health risk. The current study aimed at analyzing the metals in 33 samples of imported dietary supplements highly consumed by the Lebanese population, using 3 different techniques, to ensure the safety and increase the awareness of the citizen to benefit from these dietary supplements. Some samples had levels of metals above their maximum allowable levels (Fe: 24%, Zn: 33%, Mn: 27%, Se: 15%, Mo: 12% of samples), but did not pose any health risk because they were below permitted daily exposure limit and recommended daily allowance except for Fe in 6% of the samples. On the other hand, 34% of the samples had Cu levels above allowable limit where 18% of them were above their permitted daily exposure and recommended daily allowance. In contrast, all samples had concentration of Cr, Hg, and Pb below allowable limits and daily exposure. Whereas, 30% of analyzed samples had levels of Cd above allowable levels, and were statistically correlated with Ca, and Zn essential minerals. Similarly 62% of the samples had levels of As above allowable limits and As levels were associated with Fe and Mn essential minerals. Dietary supplements consumed as essential nutrients for their Ca, Zn, Fe and Mn content should be monitored for toxic metal levels due to their natural geochemical association with these essential metals to provide citizens the safe allowable amounts.

Safety-evaluation report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322)

International Nuclear Information System (INIS)

1983-09-01

Supplement 4 (SSER 4) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

Safety evaluation report related to the operation of Shoreham Nuclear Power Station, Unit No. 1. Docket No. 50-322

International Nuclear Information System (INIS)

1983-02-01

Supplement No. 3 to the Safety Evaluation Report of Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have come to light since the previous supplement was issued

Safety Evaluation Report related to the operation of Shoreham Nuclear Power Station, Unit No. 1 (Docket No. 50-322)

International Nuclear Information System (INIS)

1989-04-01

Supplement 10 (SSER 10) to the Safety Evaluation Report on Long Island Lighting Company's application for a license to operate the Shoreham Nuclear Power Station, Unit 1, located in Suffolk County, New York, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement addresses several items that have been reviewed by the staff since the previous supplement was issued

Safety evaluation report related to the operation of South Texas Project, Units 1 and 2 (Docket Nos. 50-498 and 50-499)

International Nuclear Information System (INIS)

1987-07-01

In April 1986 the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0781) regarding the application of Houston Lighting and Power Company (applicant and agent for the owners) for a license to operate South Texas Project, Units 1 and 2 (Docket Nos. 50-498 and 50-499). The facility is located in Matagorda County, Texas, west of the Colorado River, 8 miles north-northwest of the town of Matagorda and about 89 miles southwest of Houston. The first supplement to NUREG-0781 was issued in September 1986, the second supplement in January 1987, and the third supplement in May 1987. This fourth supplement reports on the status of unresolved items in the Safety Evaluation Report and resolves all the issues necessary to support the issuance of a low-power license

Safety Evaluation Report, related to the operation of Byron Station, Units 1 and 2 (Docket Nos. STN 50-454 and STN 50-455)

International Nuclear Information System (INIS)

1983-11-01

Supplement No. 3 to the Safety Evaluation Report related to Commonwealth Edison Company's application for licenses to operate the Byron Station, Units 1 and 2, located in Rockvale Township, Ogle County, Illinois, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

Safety Evaluation Report related to the operation of Byron Station, Units 1 and 2 (Docket Nos. STN 50-454 and STN 50-455)

International Nuclear Information System (INIS)

1984-05-01

Supplement No. 4 to the Safety Evaluation Report related to Commonwealth Edison Company's application for licenses to operate the Byron Station, Units 1 and 2, located in Rockvale Township, Ogle County, Illinois, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

Safety evaluation report related to the operation of Byron Station, Units 1 and 2. Docket Nos. STN 50-454 and STN 50-455

International Nuclear Information System (INIS)

1983-01-01

Supplement No. 2 to the Safety Evaluation Report related to Commonwealth Edison Company's application for licenses to operate the Byron Station, Units 1 and 2, located in Rockvale Township, Ogle County, Illinois, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report

Interactions of commonly used dietary supplements with cardiovascular drugs: a systematic review

Directory of Open Access Journals (Sweden)

Kanji Salmaan

2012-05-01

Full Text Available Abstract Background The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. Methods The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed. Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s with the drug(s alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Results Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Conclusions Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets and garlic (plus nitrates or warfarin on triglycerides and HDL-C, respectively. Safety concerns, however, persist.

Site and Regional Data for Biosphere Assessment BSA-2009 Supplement to Olkiluoto Biosphere Description 2009

International Nuclear Information System (INIS)

Aro, L.; Haapanen, R.; Puhakka, L.; Hjerpe, T.; Kirkkala, T.; Koivunen, S.; Lahdenperae, A.-M.; Salo, T.; Ikonen, A.T.K.; Helin, J.

2010-06-01

The safety case for a spent nuclear fuel repository at Olkiluoto includes a computational safety assessment. A site-specific biosphere assessment is an integral part of them both. In 2009 an assessment was conducted to demonstrate preparedness to apply for construction license to the repository in 2012. As a part of the biosphere assessment, the present conditions at the site are described in Olkiluoto biosphere description report for an analogue of the future conditions being simulated in the safety assessment. This report is a supplement to the biosphere description report of 2009 and documents the site and regional data used in the biosphere assessment 'BSA-2009' with respective rationales. (orig.)

Safety evaluation report related to the operation of Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425)

International Nuclear Information System (INIS)

1986-12-01

In June 1985, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1137) regarding the application of Georgia Power Company, Municipal Electric Authority of Georgia, Oglethorpe Power Corporation, and City of Dalton, Georgia, for licenses to operate the Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement 1 to NUREG-0737 was issued by the staff in October 1985, Supplement 2 was issued in May 1986, and Supplement 3 was issued in August 1986. The facility is located in Burke County, Georgia, approximately 26 miles south-southeast of Augusta, Georgia, and on the Savannah River. This fourth supplement to NUREG-1137 provides recent information regarding resolution of some of the open and confirmatory items that remained unresolved at the time the Safety Evaluation Report was issued. This supplement also discusses some new items

Safety evaluation report related to the operation of Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425)

International Nuclear Information System (INIS)

1987-01-01

In June 1985, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1137) regarding the application of Georgia Power Company, Municipal Electric Authority of Georgia, Oglethorpe Power Corporation, and the City of Dalton, Georgia, for licenses to operate the Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement 1 to NUREG-1137 was issued by the staff in October 1985, Supplement 2 was issued in May 1986, Supplement 3 was issued in August 1986, and Supplement 4 was issued in December 1986. The facility is located in Burke County, Georgia, approximately 26 miles south-southeast of Augusta, Georgia, and on the Savannah River. This fifth supplement to NUREG-1137 provides recent information regarding resolution of some of the open and confirmatory items that remained unresolved at the time the Safety Evaluation Report was issued

Hemorrhagic Stroke in a Young Healthy Male Following Use of Pre-Workout Supplement Animal Rage XL.

Science.gov (United States)

Harris, Brandon F; Winn, Coty; Ableman, Thomas B

2017-09-01

So-called "pre-workout" supplements are substances marketed as natural dietary supplements with claims of helping athletes achieve more focused and intense workouts. The use of such products remains popular among American youth as a whole, but is especially high among active duty service members. Supplements are minimally regulated by the Food and Drug Administration (FDA), and unlike pharmaceuticals, supplements are often brought to market without any testing to show neither efficacy nor safety. Several case reports have documented serious adverse events and raise the question of whether supplement use was a causative factor. Reported events occurring after use of pre-workout supplements include, among others, ischemic stroke, hemorrhagic stroke, myocardial infarction, hepatitis, and death. Here, we present the case of a healthy 25-year-old active duty male who experienced a bilateral cerebellar hemorrhagic stroke occurring shortly after taking a supplement named Animal Rage XL. Hemorrhagic stroke occurring in a healthy 25-year-old male with no risk factors is exceedingly rare. This is the first known case of stroke temporally associated with this particular supplement, which is currently available for purchase at military exchanges. Additionally, several of the active ingredients in this supplement have been shown to cause hypertension, tachycardia, and vasospasm. All of these effects could increase the likelihood and severity of a hemorrhagic stroke. The investigated ingredients in this abstract include β-phenethylamine, creatine-monophosphate, and caffeine. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

Dietary fat intake, supplements, and weight loss

Science.gov (United States)

Dyck, D. J.

2000-01-01

Although there remains controversy regarding the role of macronutrient balance in the etiology of obesity, the consumption of high-fat diets appears to be strongly implicated in its development. Evidence that fat oxidation does not adjust rapidly to acute increases in dietary fat, as well as a decreased capacity to oxidize fat in the postprandial state in the obese, suggest that diets high in fat may lead to the accumulation of fat stores. Novel data is also presented suggesting that in rodents, high-fat diets may lead to the development of leptin resistance in skeletal muscle and subsequent accumulations of muscle triacylglycerol. Nevertheless, several current fad diets recommend drastically reduced carbohydrate intake, with a concurrent increase in fat content. Such recommendations are based on the underlying assumption that by reducing circulating insulin levels, lipolysis and lipid oxidation will be enhanced and fat storage reduced. Numerous supplements are purported to increase fat oxidation (carnitine, conjugated linoleic acid), increase metabolic rate (ephedrine, pyruvate), or inhibit hepatic lipogenesis (hydroxycitrate). All of these compounds are currently marketed in supplemental form to increase weight loss, but few have actually been shown to be effective in scientific studies. To date, there is little or no evidence supporting that carnitine or hydroxycitrate supplementation are of any value for weight loss in humans. Supplements such as pyruvate have been shown to be effective at high dosages, but there is little mechanistic information to explain its purported effect or data to indicate its effectiveness at lower dosages. Conjugated linoleic acid has been shown to stimulate fat utilization and decrease body fat content in mice but has not been tested in humans. The effects of ephedrine, in conjunction with methylxanthines and aspirin, in humans appears unequivocal but includes various cardiovascular side effects. None of these compounds have been

States Stepping up Mandates for School Safety Drills

Science.gov (United States)

Shah, Nirvi

2013-01-01

Hundreds of U.S. schools will supplement fire drills and tornado training next fall with simulations of school shootings. In response to the December shootings by an intruder at Sandy Hook Elementary School in Newtown, Connecticut, several states have enacted or are considering laws that require more and new types of school safety drills, more…

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446)

International Nuclear Information System (INIS)

1990-02-01

Supplement 23 to the Safety Evaluation Report related to the operation of the Comanche Peak Steam Electric Station (CPSES), Units 1 and 2 (NUREG-0797), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission (NRC). The facility is located in Somervell County, Texas, approximately 40 miles southwest of Fort Worth, Texas. This supplement reports the status of certain issues that had not been resolved when the Safety Evaluation Report and supplements 1, 2, 3, 4, 6, 12, 21, and 22 to that report were published. This supplement also includes the evaluations for licensing items resolved since Supplement 22 was issued. Supplement 5 has not been issued. Supplements 7, 8, 9, 10, and 11 were limited to the staff evaluation of allegations investigated by the NRC Technical Review Team. Supplement 13 presented the staff's evaluation of the Comanche Peak Response Team (CPRT) Program Plan, which was formulated by the applicant to resolve various construction and design issues raised by sources external to TU Electric. Supplements 14 through 19 presented the staff's evaluation of the CPSES Corrective Action Program: large- and small-bore piping and pipe supports (Supplement 14); cable trays and cable tray hangers (Supplement 15); conduit supports (Supplement 16); mechanical, civil/structural, electrical, instrumentation and controls, and systems portions of the heating, ventilation, and air conditioning (HVAC) system workscopes (Supplement 17); HVAC structural design (Supplement 18); and equipment qualification (Supplement 19). Supplement 20 presented the staff's evaluation of the Comanche Peak Response Team implementation of the CPRT Program

Safety and performance indicators for the assessment of long-term safety of deep geological disposal of radioactive waste

International Nuclear Information System (INIS)

Hugi, M.; Schneider, J.W.; Dorp, F. van; Zuidema, P.

2005-01-01

The evaluation of the ability to isolate radioactive waste and the assessment of the long-term safety of a deep geological repository is usually done in terms of the calculated dose and/or risk for an average individual of the population which is potentially most affected by the potential impacts of the repository. At present, various countries and international organisations are developing so-called complementary indicators to supplement such calculations. These indicators are called ''safety indicators'' if they refer to the safety of the whole repository system; if they address the isolation capability of individual system components or the whole system from a more technical perspective, they are called ''performance indicators''. The need for complementary indicators follows from the long time frames which characterise the safety assessment of a geological repository, and the corresponding uncertainty of the calculated radiation dose. The main reason for these uncertainties is associated with the uncertain long-term prognosis of the surface environment and the related human behaviour. (orig.)

Implementation of safety goals in NRC's regulatory process

International Nuclear Information System (INIS)

Murley, T.E.

1985-01-01

In May 1983 the Nuclear Regulatory Commission issued a policy statement on Safety Goals For Nuclear Power Plant Operation. The Commission at the same time judged that a two-year evaluation period was necessary to judge the effectiveness of the goals and design objectives, and directed the staff to develop information and understanding as to how to further define and use the design objectives and the cost-benefit guidelines. In carrying out the Commission's mandate, the staff framed three major questions to be addressed during the safety goal evaluation period. These three questions are: 1) to what extent is it practical to use safety goals in the regulatory process. 2) Should the quantitative design objectives be modified or supplemented. If so, how. 3) How should the safety goals be implemented at the end of the evaluation period. The staff's conclusions are discussed

Safety evaluation report related to the operation of Midland Plant, Units 1 and 2. Docket Nos. 50-329 and 50-330. Consumers Power Company

International Nuclear Information System (INIS)

1982-06-01

This report supplements the Safety Evaluation Report, NUREG-0793, issued with respect to the application filed for licenses to operate the Midland Plant, Units 1 and 2 (Docket Nos. 50-329 and 50-330). This supplement provides recent information regarding resolution of some of the open items identified in the Safety Evaluation Report and discusses recommendations of the Advisory Committee on Reactor Safeguards in its interim report dated June 8, 1982

Towards an international regime on radiation and nuclear safety

International Nuclear Information System (INIS)

Gonzalez, A.J.

2000-01-01

The 1990s have seen the de facto emergence of what might be called an 'international regime on nuclear and radiation safety'. It may be construed to encompass three key elements: legally binding international undertakings among States; globally agreed international safety standards; and provisions for facilitating the application of those standards. While nuclear and radiation safety are national responsibilities, governments have long been interested in formulating harmonised approaches to radiation and nuclear safety. A principal mechanism for achieving harmonisation has been the establishment of internationally agreed safety standards and the promotion of their global application. The development of nuclear and radiation safety standards is a statutory function of the IAEA, which is unique in the United Nations system. The IAEA Statute expressly authorises the Agency 'to establish standards of safety' and 'to provide for the application of these standards'. As the following articles and supplement in this edition of the IAEA Bulletin point out, facilitating international conventions; developing safety standards; and providing mechanisms for their application are high priorities for the IAEA. (author)

Safety Evaluation Report related to the operation of Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-275 and 50-323). Supplement No. 30

International Nuclear Information System (INIS)

1985-04-01

Supplement 30 to the Safety Evaluation Report for the application by the Pacific Gas and Electric Company (PG and E) to operate the Diablo Canyon Nuclear Power Plant - Unit 2 (Docket No. 50-323) has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. SSER 30 reports on the staff's technical review and evaluation of the design and analysis of Unit 2 piping systems and pipe supports. The staff effort includes an evaluation of PG and E's treatment of issues raised during the Unit 1 design verification, actions resulting from low power License Condition 2.C.(11) in the Unit 1 low power license DPR-76 and the Unit 2 applicability and resolution of certain allegations related to piping and supports

Nuclear Criticality Safety Handbook, Version 2. English translation

International Nuclear Information System (INIS)

2001-08-01

The Nuclear Criticality Safety Handbook, Version 2 essentially includes the description of the Supplement Report to the Nuclear Criticality Safety Handbook, released in 1995, into the first version of the Nuclear Criticality Safety Handbook, published in 1988. The following two points are new: (1) exemplifying safety margins related to modeled dissolution and extraction processes, (2) describing evaluation methods and alarm system for criticality accidents. Revision has been made based on previous studies for the chapter that treats modeling the fuel system: e.g., the fuel grain size that the system can be regarded as homogeneous, non-uniformity effect of fuel solution, an burnup credit. This revision has solved the inconsistencies found in the first version between the evaluation of errors found in JACS code system and the criticality condition data that were calculated based on the evaluation. This report is an English translation of the Nuclear Criticality Safety Handbook, Version 2, originally published in Japanese as JAERI 1340 in 1999. (author)

In-class Active Video Game Supplementation and Adherence to Cardiac Rehabilitation.

Science.gov (United States)

Ruivo, Jorge Manuel Arsénio Dos Santos; Karim, Kay; OʼShea, Roisin; Oliveira, Rosa Celeste Santos; Keary, Louis; OʼBrien, Claire; Gormley, John Patrick

2017-07-01

The application of active video games (AVGs) during cardiac rehabilitation (CR) sessions could potentially facilitate patient adherence. The feasibility, safety, and efficacy of in-class AVG supplementation as an alternative to conventional phase 2 programs were investigated. A pilot, evaluator-blinded, intention-to-treat, randomized controlled trial recruited 32 low-moderate risk CR participants and allocated them to conventional or AVG-supplemented exercise. Both groups experienced equal exercise loads for 6 weeks. Patients were assessed at baseline, end of the program, and after an 8-week followup. Adherence and safety-related outcomes were the primary endpoints. Secondary outcomes included change in exercise capacity, daily physical activity (PA), energy expenditure (EE), and psychometric profiling. Patients (males 81%; 60 ± 10 years) presented with typical cardiovascular risk factors and similar baseline characteristics. Participants did not perceive an increased risk of injury and were more interactive. At the end of the program, there was a lower tendency for dropping out (6% vs 19%, P > .05), a significant improvement in PA (322 vs 247 arbitrary acceleration units/min, P = .047) and related EE per body weight (13 vs 11 kcal/kg/d, P = .04) among AVG participants compared with controls. No significant differences between groups for adverse medical events, exercise capacity, affect toward exercise, anxiety, depression, or quality-of-life changes were reported. The additional use of AVGs during CR sessions is feasible, safe, and significantly improved daily PA and EE. A dropout reduction trend among its users, which needs to be confirmed in a larger trial, raises awareness to AVG supplementation as a promising strategy to increase CR adherence.

Vitamin D supplementation for women during pregnancy

Science.gov (United States)

De-Regil, Luz Maria; Palacios, Cristina; Ansary, Ali; Kulier, Regina; Peña-Rosas, Juan Pablo

2013-01-01

involving 414 women consistently show that women who received vitamin D supplements had higher concentrations of vitamin D in serum at term than those women who received no intervention or a placebo; however the magnitude of the response was highly heterogenous. Data from three trials involving 463 women suggest that women who receive vitamin D supplements during pregnancy less frequently had a baby with a birthweight below 2500 grams than those women receiving no treatment or placebo; statistical significance was borderline (RR 0.48; 95% CI 0.23 to 1.01). In terms of other conditions, there were no significant differences in adverse side effects including nephritic syndrome (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women); stillbirths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) or neonatal deaths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) between women who received vitamin D supplements in comparison with women who received no treatment or placebo. No studies reported on preterm birth, maternal death, admission to neonatal intensive care unit/special nursery or Apgar scores. Authors' conclusions Vitamin D supplementation in a single or continued dose during pregnancy increases serum vitamin D concentrations as measured by 25-hydroxyvitamin D at term. The clinical significance of this finding and the potential use of this intervention as a part of routine antenatal care are yet to be determined as the number of high quality trials and outcomes reported is too limited to draw conclusions on its usefulness and safety. Further rigorous randomised trials are required to evaluate the role of vitamin D supplementation in pregnancy. PMID:22336854

An evaluation of a supplementary road safety package.

Science.gov (United States)

Guria, Jagadish; Leung, Joanne

2004-09-01

A Supplementary Road Safety Package (SRSP) was developed in New Zealand in 1995/1996 to supplement the compulsory breath test (CBT) and speed camera programmes introduced in 1993. A major feature of the package was the use of emotion and shock advertising campaigns not only to affect high risk driving attitudes and behaviours towards speeding and drink-driving but also to encourage the use of safety belts. Furthermore, the SRSP also emphasised targeting enforcement to these three areas. This package continued for 5 years. This paper estimates the effect of the package on road trauma. The analysis shows that the Package made substantial impact on road safety and saved over 285 lives over the 5-year period. Copyright 2003 Elsevier Ltd.

Effect of HMB supplementation on body composition, fitness, hormonal profile and muscle damage indices.

Science.gov (United States)

Portal, Shawn; Eliakim, Alon; Nemet, Dan; Halevy, Orna; Zadik, Zvi

2010-07-01

There is a huge market for ergogenic supplements for athletes. However, only a few products have been proven to have ergogenic effects and to be effective at improving muscle strength and body composition. One such supplement is beta-hydroxy beta-methylbutyrate (HMB). Derived from the amino acid leucine and its keto acid alpha-ketoisocaproate (KIC), HMB has been well documented as an oral ergogenic supplement commonly used by athletes. Several studies have shown that combining exercise training with HMB supplementation leads to increased muscle mass and strength, and there is some anecdotal evidence of aerobic improvement. However, HMB supplementation has been found to be effective mainly for untrained individuals. While previous reviews have emphasized three main pathways for HMB's mode of action: 1) enhancement of sarcolemmal integrity via cytosolic cholesterol, 2) inhibition of protein degradation via proteasomes, and 3) increased protein synthesis via the mTOR pathway, more recent studies have suggested additional possible mechanisms for its physiological effects. These include decreased cell apoptosis and enhanced cell survival, increased proliferation, differentiation and fusion via the MAPK/ERK and PI3K/Akt pathways, and enhanced IGF-I transcription. These are described here, and hormonal interactions are discussed, along with HMB dosage and safety issues.

Calcium supplements

Science.gov (United States)

... this page: //medlineplus.gov/ency/article/007477.htm Calcium supplements To use the sharing features on this page, please enable JavaScript. WHO SHOULD TAKE CALCIUM SUPPLEMENTS? Calcium is an important mineral for the ...

Use of dietary supplements by female seniors in a large Northern California health plan

Directory of Open Access Journals (Sweden)

Schaffer Donna M

2005-02-01

education, good health, belief that health practices have at least a moderate effect on health, and having arthritis or depression significantly increased likelihood of NVNM use, while having diabetes decreased likelihood. Conclusions An extremely high proportion of older women are using dietary supplements other than multivitamins and calcium, many in combination with multiple prescription medications. Increased resources should be devoted to helping clinicians, pharmacists, supplement vendors, and consumers become more aware of the safety, effectiveness, and potential side effects of dietary supplements.

Safety climate and injuries: an examination of theoretical and empirical relationships.

Science.gov (United States)

Beus, Jeremy M; Payne, Stephanie C; Bergman, Mindy E; Arthur, Winfred

2010-07-01

Our purpose in this study was to meta-analytically address several theoretical and empirical issues regarding the relationships between safety climate and injuries. First, we distinguished between extant safety climate-->injury and injury-->safety climate relationships for both organizational and psychological safety climates. Second, we examined several potential moderators of these relationships. Meta-analyses revealed that injuries were more predictive of organizational safety climate than safety climate was predictive of injuries. Additionally, the injury-->safety climate relationship was stronger for organizational climate than for psychological climate. Moderator analyses revealed that the degree of content contamination in safety climate measures inflated effects, whereas measurement deficiency attenuated effects. Additionally, moderator analyses showed that as the time period over which injuries were assessed lengthened, the safety climate-->injury relationship was attenuated. Supplemental meta-analyses of specific safety climate dimensions also revealed that perceived management commitment to safety is the most robust predictor of occupational injuries. Contrary to expectations, the operationalization of injuries did not meaningfully moderate safety climate-injury relationships. Implications and recommendations for future research and practice are discussed.

Systematic review of herbs and dietary supplements for glycemic control in diabetes.

Science.gov (United States)

Yeh, Gloria Y; Eisenberg, David M; Kaptchuk, Ted J; Phillips, Russell S

2003-04-01

To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre, Aloe vera, vanadium, Momordica charantia, and nopal.

Resveratrol food supplements

DEFF Research Database (Denmark)

Aschemann-Witzel, Jessica; Grunert, Klaus G

2015-01-01

Background: Consumers increasingly choose food supplements in addition to their diet. Research on supplement users finds they are likely to be female, older and well-educated; Furthermore, supplement users are often characterised as being especially health-oriented, an observation which is termed...... the ‘inverse supplement hypothesis’. However, results are dependent on the substance in question. Little is known so far about botanicals in general, and more specifically, little is known about resveratrol. The psychographic variables of food supplement users are yet relatively underexplored. By comparing US...... and Danish respondents, we aimed to identify whether sociodemographic variables, health status, health beliefs and behaviour and interest in food aspects specifically relevant to resveratrol (e.g., naturalness, indulgence, and Mediterranean food) explain favourable attitudes and adoption intentions toward...

Identifying and assessing views among physically-active adult gym members in Israel on dietary supplements.

Science.gov (United States)

Druker, Inbal; Gesser-Edelsburg, Anat

2017-01-01

Sports dietary supplements are available for sale in public places including sports clubs. Although there is uncertainty regarding their safety, many gym members who regularly work out consume them. The present study aimed to identify the approaches and perspectives of the public who work out in gyms and take dietary supplements. It examined how professionals view sports dietary supplement consumption, and how they communicate this issue to gym members. The literature discusses the prevalence of SDS use among athletes, but rarely discusses or compares between the risk perceptions of gym members, trainers, and dietitians, who represent the physically-active general public, regarding SDS. We conducted constructivist qualitative research in semi-structured one-on-one interviews ( n  = 34). We held in-depth interviews ( n  = 20) with a heterogeneous population of adult gym members who take dietary supplements, and ( n  = 14) with dietitians and fitness trainers. The main finding was a gap in risk perception of dietary supplement use between dietitians, gym members and fitness trainers. There was low risk perception among dietary supplements consumers. Trainers believed that benefits of supplement consumption exceeded risk, and therefore they did not convey a message to their clients about risk. In contrast, dietitians interviewed for this study renounced general use of sports dietary supplements and doubted whether trainers had proper nutritional knowledge to support it. Lack of awareness of risks suggests that there is a need for communication on this issue. We recommend that professionals (physicians and dietitians) be present in sports clubs that sell such products in an uncontrolled way.

Guidelines for nuclear power plant safety issue prioritization information development. Supplement 5

International Nuclear Information System (INIS)

Daling, P.M.; Lavender, J.C.

1996-07-01

This is the sixth in a series of reports to document the development and use of a methodology developed by the Pacific Northwest Laboratory (PNL) to calculate, for prioritization purposes, the risk, dose, and cost impacts of implementing potential resolutions to reactor safety issues (see NUREG/CR-2800, Andrews, et al., 1983). This report contains the results of issue-specific analyses for 34 generic issues. Each issue was considered within the constraints of available information at the time the issues were examined and approximately 2 staff-weeks of labor. The results are referenced as one consideration in NUREG-0933, A Prioritization of Generic Safety Issues (Emrit, et al., 1983)

Guidelines for nuclear power plant safety issue prioritization information development. Supplement 5

Energy Technology Data Exchange (ETDEWEB)

Daling, P.M.; Lavender, J.C. [Pacific Northwest National Lab., Richland, WA (United States)

1996-07-01

This is the sixth in a series of reports to document the development and use of a methodology developed by the Pacific Northwest Laboratory (PNL) to calculate, for prioritization purposes, the risk, dose, and cost impacts of implementing potential resolutions to reactor safety issues (see NUREG/CR-2800, Andrews, et al., 1983). This report contains the results of issue-specific analyses for 34 generic issues. Each issue was considered within the constraints of available information at the time the issues were examined and approximately 2 staff-weeks of labor. The results are referenced as one consideration in NUREG-0933, A Prioritization of Generic Safety Issues (Emrit, et al., 1983).

Safety evaluation report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446)

International Nuclear Information System (INIS)

1990-04-01

Supplement 24 to the Safety Evaluation Report related to the operation of the Comanche Peak Steam Electric Station (CPSES), Units 1 and 2 (NUREG-0797), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission (NRC). The facility is located in Somervell County, Texas, approximately 40 miles southwest of Fort Worth, Texas. This supplement reports the status of certain issues that had not been resolved when the Safety Evaluation Report and Supplements 1, 2, 3, 4, 6, 12, 21, 22, and 23 to that report were published. This supplement also includes the evaluations for licensing items resolved since Supplement 23 was issued. Supplement 5 has not been issued. Supplements 7, 8, 9, 10, and 11 were limited to the staff evaluation of allegations investigated by the NRC Technical Review Team. Supplement 13 represented the staff's evaluation of the Comanche Peak Response Team (CPRT) Program Plan, which was formulated by the applicant to resolve various construction and design issues raised by sources external to TU Electric. Supplements 14 through 19 presented the staff's evaluation of the CPSES Corrective Action Program: large- and small-bore piping and pipe supports (Supplement 14); cable trays and cable tray hangers (Supplement 15); conduit supports (Supplement 16); mechanical, civil/structural, electrical, instrumentation and controls, and systems portions of the heating, ventilation, and air conditioning (HVAC) system workscopes (Supplement 17); HVAC structural design (Supplement 18); and equipment qualification (Supplement 19). Supplement 20 presented the staff's evaluation of the CPRT implementation of its Program Plan and the issue-specific action plans, as well as the CPRT's investigations to determine the adequacy of various types of programs and hardware at CPSES

Knowledge and characteristics of herbal supplement usage among community pharmacy customers in a Malaysian population.

Science.gov (United States)

Yeong, S W; Choong, Y C

2017-12-01

We investigated the knowledge and characteristics of herbal supplement usage of the customers of community pharmacies in a Malaysian population. Self-administered questionnaires (in English, Malay, or Chinese) were provided to customers at three community pharmacies in Malaysia (Ipoh, Perak). Questionnaire validation and translation validation were performed. A pilot study was conducted before actual questionnaire distribution. Informed consent was obtained from all participants. Total number of participants was 270 (99 males and 171 females) with majority from the 31-50 age group (41.5%). Among the participants, 45.6% were herbal users. The most commonly used herbal supplements were evening primrose oil (17.9%), ginkgo biloba (13.0%), and milk thistle (8.5%). The participants seemed to have sufficient knowledge regarding herbal supplements including safety, quality, and indication of use from medical literature. Participants obtained information about herbal supplements from pharmacists (26.9%), package inserts (25.2%), friends (20.5%), and the Internet (13.3%) more often than from their doctors (9.8%). Most herbal users did not inform their doctors about their usage of herbal supplements (68.3%) or the side effects (61.5%). Herbal supplement users also tended to be women, >50-year-old, and those with higher monthly household incomes. Community pharmacists have a vital role in educating their customers about the safe use of herbal supplements. The participants had sufficient knowledge about herbal supplement usage; therefore, customers of these community pharmacies may have benefitted from the advice of the pharmacists. Further studies could be carried out in future on the knowledge, skills and roles of community pharmacists in the safe use of herbal supplements. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446)

International Nuclear Information System (INIS)

1985-10-01

This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplements 1, 2, 3, 4, and 6 to that report. This supplement also lists the new issues that have been identified since Supplement 6 was issued and includes the evaluations for licensing items resolved in this interim period. Supplement 5 has not been issued. Supplements 7, 8, 9, 10, and 11 were limited to the staff evaluations of allegations investigated by the NRC Technical Review Team, and items identified therein are not included in this supplement

Safety Evaluation Report related to the operation of Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Docket Nos. STN 50-528, STN 50-529, and STN 50-530)

International Nuclear Information System (INIS)

1984-10-01

Supplement No. 6 to the Safety Evaluation Report for the application filed by Arizona Public Service Company, et al., for licenses to operate the Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Docket Nos. STN 50-528/529/530), located in Maricopa County, Arizona, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation Report by providing an evaluation of (1) additional information submitted by the applicant since Supplement No. 5 was issued and (2) matters that the staff had under review when Supplement No. 5 was issued

The application of reporter gene assays for the detection of endocrine disruptors in sport supplements

International Nuclear Information System (INIS)

Plotan, Monika; Elliott, Christopher T.; Scippo, Marie Louise; Muller, Marc; Antignac, Jean-Philippe; Malone, Edward; Bovee, Toine F.H.; Mitchell, Samuel; Connolly, Lisa

2011-01-01

The increasing availability and use of sports supplements is of concern as highlighted by a number of studies reporting endocrine disruptor contamination in such products. The health food supplement market, including sport supplements, is growing across the Developed World. Therefore, the need to ensure the quality and safety of sport supplements for the consumer is essential. The development and validation of two reporter gene assays coupled with solid phase sample preparation enabling the detection of estrogenic and androgenic constituents in sport supplements is reported. Both assays were shown to be of high sensitivity with the estrogen and androgen reporter gene assays having an EC 50 of 0.01 ng mL -1 and 0.16 ng mL -1 respectively. The developed assays were applied in a survey of 63 sport supplements samples obtained across the Island of Ireland with an additional seven reference samples previously investigated using LC-MS/MS. Androgen and estrogen bio-activity was found in 71% of the investigated samples. Bio-activity profiling was further broken down into agonists, partial agonists and antagonists. Supplements (13) with the strongest estrogenic bio-activity were chosen for further investigation. LC-MS/MS analysis of these samples determined the presence of phytoestrogens in seven of them. Supplements (38) with androgen bio-activity were also selected for further investigation. Androgen agonist bio-activity was detected in 12 supplements, antagonistic bio-activity was detected in 16 and partial antagonistic bio-activity was detected in 10. A further group of supplements (7) did not present androgenic bio-activity when tested alone but enhanced the androgenic agonist bio-activity of dihydrotestosterone when combined. The developed assays offer advantages in detection of known, unknown and low-level mixtures of endocrine disruptors over existing analytical screening techniques. For the detection and identification of constituent hormonally active compounds the

Evaluation of congruence among dietary supplement use and motivation for supplementation in young, Canadian athletes.

Science.gov (United States)

Parnell, Jill A; Wiens, Kristin; Erdman, Kelly Anne

2015-01-01

Dietary supplement use is endemic in young athletes; however, it is unclear if their choices are congruent with their motivation for supplementation and the established benefits of the dietary supplements. The aim of this study was to evaluate the relationships between dietary supplement use and self-reported rationale in young athletes. Canadian athletes (n = 567; 11-25 years; 76% club or provincial level, 24% national or higher) completed a questionnaire designed to assess supplementation patterns and motivation for supplementation. Chi square tests examined associations between dietary supplements and self-reported rationale for use. Vitamin and mineral supplements, including vitamin-enriched water, were associated with several health- and performance- related reasons (p performance reasons, as were performance foods (protein powder, sport bars, sport gels, etc.). Plant extracts and fatty acids were primarily associated with health reasons, particularly immune support (p performance rationales and supplementation for common ergogenic aids, however, less so for vitamin and mineral supplements, vitamin-enriched water, and plant extracts. Incongruences were found between fatty acids, protein supplements, vitamin and mineral supplements, vitamin-enriched water, and plant extracts and health motivators for supplementation. Educational interventions are essential to ensure young athletes are using dietary supplements safely and effectively.

Nuclear waste information in supplements of local newspapers

International Nuclear Information System (INIS)

Ryhaenen, Veijo

1995-01-01

Full text: The utility Teollisuuden Voima Oy (TVO) is conducting site investigations in Finland to select a final disposal site for spent nuclear fuel. Site selection studies, including deep drillings and other field investigations, have been carried out in different parts of the country since 1987. Now there are three areas in which detailed studies are continued. The programme aims at site selection in the year 2000. Before the construction of the final disposal facility can be started around the year 2010 a precondition in the Finnish legislation is that the council of the local municipality accepts the facility. Hence, an essential task is to distribute information of the studies and of the principles of final disposal to the local decision-makers and public. Information work has an important role already now in order to make people familiar with the long-term project and to build confidence on the safety of final disposal. TVO's information programme includes several types of actions to different target groups, such as press conferences, contact group meetings, open houses, exhibitions, lectures to different groups, visits to the drilling sites and to the existing nuclear waste facilities as well as use of various written material. In January 1994 a new method was applied in the distribution of TVO's written information directly to local public. Four-page supplements were prepared to the local newspapers to inform public of the stage of the site investigations and other topical issues. After that, new supplements have been published in six months intervals. Own supplements have been made for different municipalities in which the candidate areas are situated. The form of the supplement is same as that of the newspaper. As a matter of fact, TVO's information forms a special advertising section in a single issue of a newspaper. The topics handled in the supplements are for example present status of the local bedrock studies, other topical information of TVO

Safety Evaluation Report related to the operation of Byron Station, Units 1 and 2 (Dockets Nos. STN 50-454 and STN 50-455)

International Nuclear Information System (INIS)

1984-10-01

Supplement No. 5 to the Safety Evaluation Report related to Commonwealth Edison Company's application for licenses to operate the Byron Station, Units 1 and 2, located in Rockvale Township, Ogle County, Illinois, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. This supplement reports the status of certain items that had not been resolved at the time of publication of the Safety Evaluation Report. Because of the favorable resolution of the items discussed in this report, the staff concludes that there is reasonable assurance that the facility can be operated by the applicant without endangering the health and safety of the public

Swine plasma immunoglobulins for prevention and treatment of post-weaning diarrhoea: Safety and Preliminary results

DEFF Research Database (Denmark)

Hedegaard, Chris Juul; Strube, Mikael Lenz; Bendix Hansen, Marie

. coli F4+ induced PWD, we observed that piglets given IgG as a feed supplement cleared the E coli infection significantly faster than control weaner piglets not receiving an immunoglobulin feed supplement. Furthermore, deep sequencing of the ileal microbiota showed a significantly lowered colonization...... their adhesion to porcine epithelial cells in vitro. As the immunoglobulin fraction is intended for oral use as a feed supplement, we also tested the safety of feeding 4 grams of natural immunoglobulins to 4-5 week old weaner piglets for 14 days and observed no adverse effects. In an experimental model of E...

Safety culture competition - expectations of a regulatory authority

International Nuclear Information System (INIS)

Keil, D.; Gloeckle, W.

2000-01-01

The accident at the Chernobyl nuclear power station on April 26, 1986 influenced the development of reactor safety and promulgated two basic concepts especially in Germany. On the one hand, extensive measures of in-plant accident management have greatly reduced the so-called residual risk. On the other hand, a comprehensive safety approach has been initiated which comprises the nuclear power plant as a system together with people, technology, and organization and also includes safety culture. In a modern regulatory concept based on the dynamic development of safety, the authority's classical regulatory function of controlling is supplemented by the objective of promoting safety. While preserving the division of responsibilities between the regulatory authority and plant operators, the authority uses 'constructive critical dialog' as a tool to enhance safety. Besides the regulatory assessment of safety culture on the basis of indications or indicators, also the continuous promotion of safety culture in a dialog with plant operators is seen as one of the duties of a regulatory authority. Continued efforts are necessary to maintain the high level of safety culture in German nuclear power plants. Operators are expected to establish a safety management which assigns top priority to safety issues, and which pursues the goal of supervising and promoting safety culture. Developments on the deregulated electricity markets must not lead to safety aspects ranking second to economic aspects. Moreover, also under changed boundary conditions, only the safe operation of nuclear power plants ensures economic viability. (orig.) [de

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2. Docket Nos. 50-445 and 50-446

International Nuclear Information System (INIS)

1983-03-01

Supplement No. 3 to the Safety Evaluation Report (SER) related to the operation of the Comanche Peak Steam electric Station, Units 1 and 2, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. the facility is located in Somervell County, Texas. Subject to favorable resolution of the items identified in this supplement, the staff concludes that the facility can be operated by the applicatn without endangering the health and safety of the public. This document provides the NRC staff's evaluation of the outstanding and confirmatory issues that have been resolved since Supplement No. 2 was issued in January 1982, and addresses changes to the SER and its earlier supplements which have resulted from the receipt of additonal information from the applicant during the period of January throught October 1982

Health claims made on multivitamin and mineral supplements

Directory of Open Access Journals (Sweden)

Jelena Jovičić

2011-12-01

Full Text Available Introduction: Basic purpose of health claims is consumers' benefit by providing information about healthy eating habits. It is necessary for health claims to be scientifically substantiated and truthful. Health claims should not attribute to food the property of preventing, treating or curing a human disease. Use of health claims should be followed by a statement indicating the importance of a varied and balanced diet and a healthy lifestyle. The objective of this research was to examine the compliance of health claims made on multivitamin and mineral dietary supplements' labels on the Serbian market with national regulation concerning health safety of dietary products.Methods: An assessment of labels of MVMs was done in two privately owned pharmacies in Novi Sad, Serbia in August 2010.Results: In total, 48 MVMs were sampled and 22 health claims were detected. Seven out of 22 health claims were in compliance with the national regulation. The main reason for health claims on foreign MVMs not to be compliant with the regulation in Serbia was inadequate or nonexistent translation of original labels.Conclusion: Detected use of terms such as "prevention", "treatment" and "indications" on vitamin and mineral dietary supplements' labels is both forbidden and misleading to consumers. Coupled with inadequate or nonexistent translation of the labels, it leads to a low level of protection of Serbian consumers. It is necessary to establish an effective monitoring system for dietary supplements' labeling on a national scale in order toprotect consumers and their wellbeing.

Botanical supplements: detecting the transition from ingredients to supplements

Science.gov (United States)

Methods were developed using flow injection mass spectrometry (FIMS) and chemometrics for the comparison of spectral similarities and differences of 3 botanical ingredients and their supplements: Echinacea purpurea aerial samples and solid and liquid supplements, E. purpurea root samples and solid s...

Intermittent oral iron supplementation during pregnancy (Review)

Science.gov (United States)

Peña-Rosas, Juan Pablo; De-Regil, Luz Maria; Dowswell, Therese; Viteri, Fernando E

2014-01-01

Background Anaemia is a frequent condition during pregnancy, particularly among women from developing countries who have insufficient iron intake to meet increased iron needs of both the mother and the fetus. Traditionally, gestational anaemia has been prevented with the provision of daily iron supplements throughout pregnancy, but adherence to this regimen due to side effects, interrupted supply of the supplements, and concerns about safety among women with an adequate iron intake, have limited the use of this intervention. Intermittent (i.e. one, two or three times a week on non-consecutive days) supplementation with iron alone or in combination with folic acid or other vitamins and minerals has recently been proposed as an alternative to daily supplementation. Objectives To assess the benefits and harms of intermittent supplementation with iron alone or in combination with folic acid or other vitamins and minerals to pregnant women on neonatal and pregnancy outcomes. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (23 March 2012). We also searched the WHO International Clinical Trials Registry Platform (ICTRP) for ongoing studies and contacted relevant organisations for the identification of ongoing and unpublished studies (23 March 2012). Selection criteria Randomised or quasi-randomised trials. Data collection and analysis We assessed the methodological quality of trials using standard Cochrane criteria. Two review authors independently assessed trial eligibility, extracted data and conducted checks for accuracy. Main results This review includes 21 trials from 13 different countries, but only 18 trials (with 4072 women) reported on our outcomes of interest and contributed data to the review. All of these studies compared daily versus intermittent iron supplementation. Three studies provided iron alone, 12 iron+folic acid and three more iron plus multiple vitamins and minerals. Their methodological quality was mixed

Final Safety Analysis Report (FSAR) for Building 332, Increment III

Energy Technology Data Exchange (ETDEWEB)

Odell, B. N.; Toy, Jr., A. J.

1977-08-31

This Final Safety Analysis Report (FSAR) supplements the Preliminary Safety Analysis Report (PSAR), dated January 18, 1974, for Building 332, Increment III of the Plutonium Materials Engineering Facility located at the Lawrence Livermore Laboratory (LLL). The FSAR, in conjunction with the PSAR, shows that the completed increment provides facilities for safely conducting the operations as described. These documents satisfy the requirements of ERDA Manual Appendix 6101, Annex C, dated April 8, 1971. The format and content of this FSAR complies with the basic requirements of the letter of request from ERDA San to LLL, dated March 10, 1972. Included as appendices in support of th FSAR are the Building 332 Operational Safety Procedure and the LLL Disaster Control Plan.

A Dietary Supplement Containing and Velvet Bean Improves Sleep Quality in Men and Women

Directory of Open Access Journals (Sweden)

Cameron G. McCarthy

2012-01-01

Full Text Available Background Impaired sleep quality is commonplace within industrialized societies, as evidenced by the increasing number of prescription sleep aids available. Certain herbal preparations have been suggested to provide a natural benefit to sleep; however, limited controlled data are available documenting this benefit. In the present study we tested the effect of an experimental dietary supplement, containing the active ingredients Chlorophytum borivilianum and Velvet bean, on sleep quality using the Pittsburgh Sleep Quality Index (PSQI. Methods Eighteen healthy and active men and women, with evidence of impaired sleep quality, consumed the supplement daily for 28 days. The PSQI was administered before and after the intervention period. As indicators of safety, resting heart rate and blood pressure were measured, and a complete blood count, comprehensive metabolic panel, and lipid panel were determined. Results Sleep quality was influenced by the supplement, as evidenced by an improvement in every category of the PSQI questionnaire ( P < 0.05, with most category scores improving approximately 50% from pre to post intervention. No adverse outcomes were noted with use of the supplement, as indicated by no change in resting heart rate, blood pressure, or any bloodborne parameter. Conclusions An investigational dietary supplement containing the active ingredients Chlorophytum borivilianum and Velvet bean improves sleep quality in men and women. Additional placebo controlled trials are needed to corroborate these findings in individuals with self-reported sleeping difficulty.

Developing safety culture in nuclear activities. Practical suggestions to assist progress

International Nuclear Information System (INIS)

2000-01-01

The term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG) in Summary Report on the Post-Accident Review Meeting on the Chernobyl Accident published by the IAEA as Safety Series No. 75-INSAG-1 in 1986, and expanded in Basic Safety Principles for Nuclear Power Plants, Safety Series No. 75-INSAG-3 in 1988. This publication supplements INSAG-4 published in 1991 which includes the definition and concept of safety culture describing practices valuable in establishing and maintaining a sound safety culture in a number of countries. It is intended for those who design, construct, manufacture, operate, maintain or decommission nuclear facilities. It should be practically useful for all those involved in operating nuclear facilities. It will also provide a reference for groups such as regulators who have an interest in developing, improving and evaluating safety culture training and individuals engaged in nuclear activities, and for bodies such as ethics review committees who should take into account safety culture issues for certifying professional excellence in the medical field

Developing safety culture in nuclear activities. Practical suggestions to assist progress

International Nuclear Information System (INIS)

1998-01-01

The term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG) in Summary Report on the Post-Accident Review Meeting on the Chernobyl Accident published by IAEA as safety Series No. 75-INSAG-1 in 1986, and expanded in Basic Safety principles for Nuclear Power Plants, Safety Series No. 75-INSAG-3 in 1988. This publication supplements INSAG-4 published in 1991 which includes the definition and concept of safety culture describing practices valuable in establishing and maintaining a sound safety culture in a number of countries. It is intended for those who design, construct, manufacture, operate, maintain or decommission nuclear facilities. It should be practically useful for all those involved in operating nuclear facilities. It will also provide a reference for groups such as regulators who have an interest in developing, improving and evaluating safety culture training and individuals engaged in nuclear activities, and for bodies such as ethics review committees who should take into account safety culture issues for certifying professional excellence in the medical field

Evaluation of Glycerol and Waste Alcohol as Supplemental Carbon Sources for Denitrification

OpenAIRE

Uprety, Kshitiz

2013-01-01

Supplemental carbon has been successfully added and implemented at biological nutrient removal treatment plants all around the world in order to reach low nitrogen discharge limits. Although, methanol has been the most prevalent external electron donor used due to its low cost and effectiveness, many utilities are moving away from it due to cost volatility, safety issues, and hindered performance in cold weather conditions. Many sustainable and alternative sources are being researched, such a...

Safety program of the Oak Ridge National Laboratory: a different approach

International Nuclear Information System (INIS)

Burger, G.H.

1981-01-01

The uniqueness and therefore different approach to Oak Ridge National Laboratory's safety program is not a result of elimination of the usual industrial safety organization, but results from the three organizations which supplement it and the areas of safety concerns that they cover. While industrial safety is primarily concerned with day-to-day routine worker activities (wearing of safety glasses and hard hats, adherence to electrical safety work procedures, proper safety lockout and tagout of equipment for maintenance activities, etc.), the other organizations, the Office of Operational Safety, Division Safety Officers and Radiation Control Officers, and the Laboratory director's Review Committees, are concerned with themuch broader spectrum of the total work environment. These organizations are concerned not only with the day-to-day worker activities but the design and conduction of all operations from a process viewpoint. The emphasis of these groups is assuring first that operations, experiments, facilities, etc., are designed properly and then secondly operated properly to assure safety of the operators, Laboratory population, and the public. Responsibilities of the three safety organizations constituting operational or process safety are described and discussed

Does folic acid supplementation prevent or promote colorectal cancer? Results from model-based predictions.

Science.gov (United States)

Luebeck, E Georg; Moolgavkar, Suresh H; Liu, Amy Y; Boynton, Alanna; Ulrich, Cornelia M

2008-06-01

Folate is essential for nucleotide synthesis, DNA replication, and methyl group supply. Low-folate status has been associated with increased risks of several cancer types, suggesting a chemopreventive role of folate. However, recent findings on giving folic acid to patients with a history of colorectal polyps raise concerns about the efficacy and safety of folate supplementation and the long-term health effects of folate fortification. Results suggest that undetected precursor lesions may progress under folic acid supplementation, consistent with the role of folate role in nucleotide synthesis and cell proliferation. To better understand the possible trade-offs between the protective effects due to decreased mutation rates and possibly concomitant detrimental effects due to increased cell proliferation of folic acid, we used a biologically based mathematical model of colorectal carcinogenesis. We predict changes in cancer risk based on timing of treatment start and the potential effect of folic acid on cell proliferation and mutation rates. Changes in colorectal cancer risk in response to folic acid supplementation are likely a complex function of treatment start, duration, and effect on cell proliferation and mutations rates. Predicted colorectal cancer incidence rates under supplementation are mostly higher than rates without folic acid supplementation unless supplementation is initiated early in life (before age 20 years). To the extent to which this model predicts reality, it indicates that the effect on cancer risk when starting folic acid supplementation late in life is small, yet mostly detrimental. Experimental studies are needed to provide direct evidence for this dual role of folate in colorectal cancer and to validate and improve the model predictions.

Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid.

Science.gov (United States)

Stegelmeier, Bryan L; Brown, Ammon W; Welch, Kevin D

2015-12-01

In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids and other potential carcinogens can contaminate these products. As herbal and food supplement producers are left to their own means to determine the safety and purity of their products prior to marketing, disturbingly often good marketing practices currently in place are ignored and content is largely undocumented. Historical examples of poisoning and health issues relating to plant material containing dehydopyrrolizidine alkaloids and aristolochic acids were used as examples to demonstrate the risk and potential toxicity of herbal products, food supplements, or traditional medicines. More work is needed to educate consumers of the potential risk and require the industry to be more responsible to verify the content and insure the safety of their products. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

Safety Evaluation Report related to the operation of South Texas Project, Unit 2 (Docket No. 50-499)

International Nuclear Information System (INIS)

1989-01-01

In April 1986 the staff of the US Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0781) regarding the application of Houston Lighting and Power Company (applicant and agent for the owners) for a license to operate South Texas Project, Units 1 and 2 (Docket Nos. 50-498 and 50-499). The facility is located in Matagorda County, Texas, west of the Colorado River, 8 miles north-northwest of the town of Matagorda and about 89 miles southwest of Houston. The first supplement to NUREG-0781 was issued in September 1986, the second supplement in January 1987, the third supplement in May 1987, the fourth supplement in July 1987 and the fifth supplement in March 1988. This sixth supplement provides updated information on the issues that had been considered previously as well as the evaluation of issues that have arisen since the fifth supplement was issued. The evaluation resolves all the issues necessary to support the issuance of a low-power license for Unit 2

Safety Evaluation Report related to the operation of Comanche Peak Steam Electric Station, Units 1 and 2 (Docket Nos. 50-445 and 50-446)

International Nuclear Information System (INIS)

1984-11-01

This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement 1, 2, 3, and 4 of that report. (Supplement 5, currently in preparation, will document the staff's evaluation findings pertaining solely to an independent design verification, conducted for the applicant by the CYGNA Corporation in late 1983-early 1984, and does not update the status of issues since the release of Supplement 4.)

Military-specific application of nutritional supplements: a brief overview [v1; ref status: indexed, http://f1000r.es/548

Directory of Open Access Journals (Sweden)

Kyle Hoedebecke

2015-03-01

Full Text Available The Soldiers of America's military endure numerous physical and mental challenges that demand strict physical fitness regimens, extreme mental agility, and a perpetual readiness to deploy at a moment's notice. The chronicity of these stressors has the potential to dramatically reduce performance - both directly and indirectly.  Because of this risk, many Soldiers turn to nutritional supplements with hopes of optimizing performance. Increasing amounts of research have demonstrated that various supplements may enhance overall physical prowess, health, and offer quicker recovery in the face of corporal or psychological extremes. Most individuals, including many medical and nutrition professionals, possess only an elementary comprehension of nutritional supplements and their effect on Soldiers in training or combat environments. Nevertheless, a grasp of these details is required for safety and optimal benefits. Various compounds have been evaluated - to include evidence within the military setting - and found to augment endurance, increase cognitive function, decrease knee pain, or offer hearing or lung protection in the face of high-energy impulses. These efficacious outcomes may serve to augment the health and longevity of these Soldiers; however, continued research is needed for efficacy and long-term safety within specific environments.

Safety-licensing assessment of NASAP reactor concepts and fuel cycle facilities

International Nuclear Information System (INIS)

Lipinski, W.C.; Prohammer, F.G.; van Erp, J.B.; Seefeldt, W.B.

1978-06-01

Assessments are presented of the safety/licensability of reactor concepts based on information supplied by the Nonproliferation Alternative Systems Assessment Program (NASAP) characterization contractors in their updated responses to the data package for NASAP Rolling Report II. The assessment of the LMFBR includes information from a characterization contractor on alternate fuel cycles but does not include information provided by a characterization contractor on plant-related safety issues. The information provided by the characterization contractors was supplemented by assessments provided by the U. S. Nuclear Regulatory Commission

Patient Safety Movement: History and Future Directions.

Science.gov (United States)

Lark, Meghan E; Kirkpatrick, Kay; Chung, Kevin C

2018-02-01

Despite progress within the past 15 years, improving patient safety in health care remains an important public health issue. The history of safety policies, research, and development has revealed that this issue is more complex than initially perceived and is pertinent to all health care settings. Solutions, therefore, must be approached at the systems level and supplemented with a change in safety culture, especially in higher risk fields such as surgery. To do so, health care agents at all levels have started to prioritize the improvement of nontechnical skills such as teamwork, communication, and accountability, as reflected by the development of various checklists and safety campaigns. This progress may be sustained by adopting teamwork training programs that have proven successful in other high-risk industries, such as crew resource management in aviation. These techniques can be readily implemented among surgical teams; however, successful application depends heavily on the strong leadership and vigilance of individual surgeons. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2004-01-01

This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2005-01-01

This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

West Valley UF6 Facility. Environmental report and safety evaluation, supplement 1

International Nuclear Information System (INIS)

1975-01-01

Revised pages are provided for the Environmental Report and the Safety Evaluation Report which reflect design changes and more detailed information on the items requested in the USAEC letter to NFS dated September 6, 1974

Management of Radioactive Waste from the Mining and Milling of Ores. Safety Guide (Spanish ed.)

International Nuclear Information System (INIS)

2010-01-01

This Safety Guide provides recommendations and guidance on the safe management of radioactive waste resulting from the mining and milling of ores, with the purpose of protecting workers, the public and the environment from the consequences of these activities. It supplements Safety Standards Series No. WS-R-1, Near Surface Disposal of Radioactive Waste. Contents: 1. Introduction; 2. Administrative, legal and regulatory framework; 3. Protection of human health and the environment; 4. Strategy for waste management; 5. Safety considerations in different phases of operations; 6. Safety assessment; 7. Quality assurance; 8. Monitoring and surveillance; 9. Institutional control for the post-closure phase.

Licensed reactor nuclear safety criteria applicable to DOE reactors

International Nuclear Information System (INIS)

1991-04-01

The Department of Energy (DOE) Order DOE 5480.6, Safety of Department of Energy-Owned Nuclear Reactors, establishes reactor safety requirements to assure that reactors are sited, designed, constructed, modified, operated, maintained, and decommissioned in a manner that adequately protects health and safety and is in accordance with uniform standards, guides, and codes which are consistent with those applied to comparable licensed reactors. This document identifies nuclear safety criteria applied to NRC [Nuclear Regulatory Commission] licensed reactors. The titles of the chapters and sections of USNRC Regulatory Guide 1.70, Standard Format and Content of Safety Analysis Reports for Nuclear Power Plants, Rev. 3, are used as the format for compiling the NRC criteria applied to the various areas of nuclear safety addressed in a safety analysis report for a nuclear reactor. In each section the criteria are compiled in four groups: (1) Code of Federal Regulations, (2) US NRC Regulatory Guides, SRP Branch Technical Positions and Appendices, (3) Codes and Standards, and (4) Supplemental Information. The degree of application of these criteria to a DOE-owned reactor, consistent with their application to comparable licensed reactors, must be determined by the DOE and DOE contractor

Monitoring of polycyclic aromatic hydrocarbons (PAH) in food supplements containing botanicals and other ingredients on the Dutch market

NARCIS (Netherlands)

Martena, M.J.; Grutters, M.; Groot, de H.N.; Konings, E.J.M.; Rietjens, I.

2011-01-01

Food supplements can contain polycyclic aromatic hydrocarbons (PAH). The European Food Safety Authority (EFSA) has defined 16 priority PAH that are both genotoxic and carcinogenic and identified eight priority PAH (PAH8) or four of these (PAH4) as good indicators of the toxicity and occurrence of

Effects of Dietary Supplementation of Astaxanthin and Sesamin on Daily Fatigue: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study

Directory of Open Access Journals (Sweden)

Ayano Imai

2018-02-01

Full Text Available Severe fatigue can negatively affect quality of life, and oxidative stress may play a role in its mechanism. The aim of this study was to evaluate the effect of dietary supplementation of astaxanthin and sesamin (AS, strong food-derived antioxidants, on fatigue. Twenty-four healthy volunteers were supplemented with AS and placebo, each for four weeks. After each supplementation period, participants underwent tasks inducing mental and physical fatigue (visual display terminal task and ergometer task, respectively. Subjective fatigue was evaluated using a visual analogue scale during and after the mental and physical tasks, and daily subjective fatigue was evaluated by the Chalder fatigue questionnaire. Secondary outcomes included other subjective feelings, work efficiency, autonomic nerve activity, levels of an oxidative stress marker (plasma phosphatidylcholine hydroperoxide (PCOOH and safety. AS supplementation was associated with significantly improved recovery from mental fatigue compared with placebo. Increased PCOOH levels during mental and physical tasks were attenuated by AS supplementation. No differences between AS and placebo were detected in secondary outcomes, and no adverse effects of AS supplementation were observed. In conclusion, AS supplementation may be a candidate to promote recovery from mental fatigue which is experienced by many healthy people.

Safety evaluation report related to the operation of Clinton Power Station, Unit No. 1 (Docket No. 50-461)

International Nuclear Information System (INIS)

1987-03-01

Supplement No. 8 to the Safety Evaluation Report on the application filed by Illinois Power Company, Soyland Power Cooperative, Inc., and Western Illinois Power Cooperative, Inc., as applicants and owners, for a license to operate the Clinton Power Station, Unit No. 1, has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Harp Township, DeWitt County, Illinois. This supplement reports the status of items that have been resolved by the staff since Supplement No. 7 was issued

Isoflavones in food supplements: chemical profile, label accordance and permeability study in Caco-2 cells.

Science.gov (United States)

Almeida, I M C; Rodrigues, F; Sarmento, B; Alves, R C; Oliveira, M B P P

2015-03-01

Consumers nowadays are playing an active role in their health-care. A special case is the increasing number of women, who are reluctant to use exogenous hormone therapy for the treatment of menopausal symptoms and are looking for complementary therapies. However, food supplements are not clearly regulated in Europe. The EFSA has only recently begun to address the issues of botanical safety and purity regulation, leading to a variability of content, standardization, dosage, and purity of available products. In this study, isoflavones (puerarin, daidzin, genistin, daidzein, glycitein, genistein, formononetin, prunetin, and biochanin A) from food supplements (n = 15) for menopausal symptoms relief are evaluated and compared with the labelled information. Only four supplements complied with the recommendations made by the EC on the tolerable thresholds. The intestinal bioavailability of these compounds was investigated using Caco-2 cells. The apparent permeability coefficients of the selected isoflavonoids across the Caco-2 cells were affected by the isoflavone concentration and product matrix.

A cocktail of synthetic stimulants found in a dietary supplement associated with serious adverse events.

Science.gov (United States)

Venhuis, Bastiaan; Keizers, Peter; van Riel, Antoinette; de Kaste, Dries

2014-06-01

Food supplements are regularly found to contain pharmacologically active substances. Recently, the food supplement Dexaprine was removed from the Dutch market because it was associated with severe adverse events. Reports to the Dutch Poisons Information Center (DPIC) showed that ingestion of as little as half a tablet caused several cases of nausea, agitation, tachycardia, and palpitations and even one case of cardiac arrest. The remaining tablets of four patients were sent in by different healthcare professionals. Analysis by ultra-performance liquid chromatography quadrupole time of flight mass-spectrometry (UPLC-QTOF-MS) confirmed the presence of synephrine, oxilofrine, deterenol, yohimbine, caffeine, and theophylline. Two more compounds were found which were tentatively identified as β-methyl-β-phenylethylamines. This incident is only the next in a series of similar incidents involving dietary supplements with (undeclared) active substances that are either unsafe or have no known safety profile. Copyright © 2014 John Wiley & Sons, Ltd.

Safety Evaluation Report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391)

International Nuclear Information System (INIS)

Tam, P.S.

1992-10-01

This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), Supplement No. 8 (January 1992), and Supplement No. 9 (June 1992) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units I and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items, and proposed license conditions identified in the SER

Site Decommissioning Management Plan. Supplement 1

International Nuclear Information System (INIS)

Fauver, D.N.; Weber, M.F.; Johnson, T.C.; Kinneman, J.D.

1995-11-01

The Nuclear Regulatory Commission (NRC) staff has identified 51 sites contaminated with radioactive material that require special attention to ensure timely decommissioning. While none of these sites represent an immediate threat to public health and safety, they have contamination that exceeds existing NRC criteria for unrestricted use. All of these sites require some degree of remediation, and several involve regulatory issues that must be addressed by the Commission before they can be released for unrestricted use and the applicable licenses terminated. This report contains the NRC stairs strategy for addressing the technical, legal, and policy issues affecting the timely decommissioning of the 51 sites and describes the status of decommissioning activities at the sites. This is supplement number one to NUREG-1444, which was published in October 1993

The application of reporter gene assays for the detection of endocrine disruptors in sport supplements

Energy Technology Data Exchange (ETDEWEB)

Plotan, Monika; Elliott, Christopher T. [Institute of Agri-Food and Land Use, School of Biological Sciences, Queen' s University Belfast, Belfast BT95AG, Northern Ireland (United Kingdom); Scippo, Marie Louise [Department of Food Sciences, University of Liege, 4000 Liege (Belgium); Muller, Marc [Molecular Biology and Genetic Engineering GIGA-R, University of Liege, 4000 Liege (Belgium); Antignac, Jean-Philippe [LABERCA, ENVN, USC INRA 2013, BP 50707, 44 307, Nantes (France); Malone, Edward [The State Laboratory, Young' s Cross, Celbridge, Co. Kildare (Ireland); Bovee, Toine F.H. [RIKILT Institute of Food Safety, P.O. Box 230, AE Wageningen 6700 (Netherlands); Mitchell, Samuel [Agri-Food and Biosciences Institute, Belfast BT9 5PX (United Kingdom); Connolly, Lisa, E-mail: l.connolly@qub.ac.uk [Institute of Agri-Food and Land Use, School of Biological Sciences, Queen' s University Belfast, Belfast BT95AG, Northern Ireland (United Kingdom)

2011-08-26

The increasing availability and use of sports supplements is of concern as highlighted by a number of studies reporting endocrine disruptor contamination in such products. The health food supplement market, including sport supplements, is growing across the Developed World. Therefore, the need to ensure the quality and safety of sport supplements for the consumer is essential. The development and validation of two reporter gene assays coupled with solid phase sample preparation enabling the detection of estrogenic and androgenic constituents in sport supplements is reported. Both assays were shown to be of high sensitivity with the estrogen and androgen reporter gene assays having an EC{sub 50} of 0.01 ng mL{sup -1} and 0.16 ng mL{sup -1} respectively. The developed assays were applied in a survey of 63 sport supplements samples obtained across the Island of Ireland with an additional seven reference samples previously investigated using LC-MS/MS. Androgen and estrogen bio-activity was found in 71% of the investigated samples. Bio-activity profiling was further broken down into agonists, partial agonists and antagonists. Supplements (13) with the strongest estrogenic bio-activity were chosen for further investigation. LC-MS/MS analysis of these samples determined the presence of phytoestrogens in seven of them. Supplements (38) with androgen bio-activity were also selected for further investigation. Androgen agonist bio-activity was detected in 12 supplements, antagonistic bio-activity was detected in 16 and partial antagonistic bio-activity was detected in 10. A further group of supplements (7) did not present androgenic bio-activity when tested alone but enhanced the androgenic agonist bio-activity of dihydrotestosterone when combined. The developed assays offer advantages in detection of known, unknown and low-level mixtures of endocrine disruptors over existing analytical screening techniques. For the detection and identification of constituent hormonally

Nutrient supplementation approaches in the treatment of ADHD.

Science.gov (United States)

Rucklidge, Julia J; Johnstone, Jeanette; Kaplan, Bonnie J

2009-04-01

Attention-deficit/hyperactivity disorder (ADHD) is a chronic, debilitating psychiatric illness that often co-occurs with other common psychiatric problems. Although empirical evidence supports pharmacological and behavioral treatments, side effects, concerns regarding safety and fears about long-term use all contribute to families searching for alternative methods of treating the symptoms of ADHD. This review presents the published evidence on supplementation, including single ingredients (e.g., minerals, vitamins, amino acids and essential fatty acids), botanicals and multi-ingredient formulas in the treatment of ADHD symptoms. In most cases, evidence is sparse, mixed and lacking information. Of those supplements where we found published studies, the evidence is best for zinc (two positive randomized, controlled trials); there is mixed evidence for carnitine, pycnogenol and essential fatty acids, and more research is needed before drawing conclusions about vitamins, magnesium, iron, SAM-e, tryptophan and Ginkgo biloba with ginseng. To date, there is no evidence to support the use of St John's wort, tyrosine or phenylalanine in the treatment of ADHD symptoms. Multi-ingredient approaches are an intriguing yet under-researched area; we discuss the benefits of this approach considering the heterogeneous nature of ADHD.

Health aspects of Spirulina (Arthrospira microalga food supplement

Directory of Open Access Journals (Sweden)

Sotiroudis Theodore G.

2013-01-01

Full Text Available Spirulina, now named Arthrospira, is a microscopic and filamentous cyanobacterium that has a long history of use as a safe food lacking toxicity. It is commercially produced in large outdoor ponds under controlled conditions. The aim of this review article is to summarize available recent information concerning human clinical potential and applications of Spirulina, as well as clinical data related to the safety and side effects of Spirulina. Potential health benefits of Spirulina are mainly due to its chemical composition, which includes proteins (the highest protein content of any natural food, 55%-70%, carbohydrates, essential amino acids, minerals (especially iron, essential fatty acids, vitamins, and pigments. In this respect, three major bioactive components of Spirulina, the protein phycocyanin (a biliprotein pigment, sulfated polysaccharides and gamma linolenic acid seem to play significant role in imparting improved human body functions. Furthermore, new experimental evidence supports the immunomodulation and antiviral effects of Spirulina supplementation. According to the Dietary Supplements Information Expert Committee of United States Pharmacopeial Convention the available clinical evidence does not indicate a serious risk to health or other public health concerns for Spirulina. However, a few cases of severe side-effects have been reported.

Vitamin and Mineral Supplement Fact Sheets

Science.gov (United States)

... website Submit Search NIH Office of Dietary Supplements Vitamin and Mineral Supplement Fact Sheets Search the list ... Supplements: Background Information Botanical Dietary Supplements: Background Information Vitamin and Mineral Fact Sheets Botanical Supplement Fact Sheets ...

Phytotherapy and Nutritional Supplements on Breast Cancer

Directory of Open Access Journals (Sweden)

C. M. Lopes

2017-01-01

Full Text Available Breast cancer is the most frequent type of nonskin malignancy among women worldwide. In general, conventional cancer treatment options (i.e., surgery, radiotherapy, chemotherapy, biological therapy, and hormone therapy are not completely effective. Recurrence and other pathologic situations are still an issue in breast cancer patients due to side effects, toxicity of drugs in normal cells, and aggressive behaviour of the tumours. From this point of view, breast cancer therapy and adjuvant methods represent a promising and challenging field for researchers. In the last few years, the use of some types of complementary medicines by women with a history of breast cancer has significantly increased such as phytotherapeutic products and nutritional supplements. Despite this, the use of such approaches in oncologic processes may be problematic and patient’s health risks can arise such as interference with the efficacy of standard cancer treatment. The present review gives an overview of the most usual phytotherapeutic products and nutritional supplements with application in breast cancer patients as adjuvant approach. Regardless of the contradictory results of scientific evidence, we demonstrated the need to perform additional investigation, mainly well-designed clinical trials in order to establish correlations and allow for further validated outcomes concerning the efficacy, safety, and clinical evidence-based recommendation of these products.

Instrumentation and control systems important to safety in nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2005-01-01

This Safety Guide was prepared under the IAEA programme for establishing safety standards for nuclear power plants. It supplements Safety Standards Series No. NS-R-1: Safety of Nuclear Power Plants: Design (the Requirements for Design), which establishes the design requirements for ensuring the safety of nuclear power plants. This Safety Guide describes how the requirements should be met for instrumentation and control (I and C) systems important to safety. This publication is a revision and combination of two previous Safety Guides: Safety Series Nos 50-SG-D3 and 50-SG-D8, which are superseded by this new Safety Guide. The revision takes account of developments in I and C systems important to safety since the earlier Safety Guides were published in 1980 and 1984, respectively. The objective of this Safety Guide is to provide guidance on the design of I and C systems important to safety in nuclear power plants, including all I and C components, from the sensors allocated to the mechanical systems to the actuated equipment, operator interfaces and auxiliary equipment. This Safety Guide deals mainly with design requirements for those I and C systems that are important to safety. It expands on paragraphs of Ref in the area of I and C systems important to safety. This publication is intended for use primarily by designers of nuclear power plants and also by owners and/or operators and regulators of nuclear power plants. This Safety Guide provides general guidance on I and C systems important to safety which is broadly applicable to many nuclear power plants. More detailed requirements and limitations for safe operation specific to a particular plant type should be established as part of the design process. The present guidance is focused on the design principles for systems important to safety that warrant particular attention, and should be applied to both the design of new I and C systems and the modernization of existing systems. Guidance is provided on how design

Food Safety Education Using an Interactive Multimedia Kiosk in a WIC Setting: Correlates of Client Satisfaction and Practical Issues

Science.gov (United States)

Trepka, Mary Jo; Newman, Frederick L.; Huffman, Fatma G.; Dixon, Zisca

2010-01-01

Objective: To assess acceptability of food safety education delivered by interactive multimedia (IMM) in a Supplemental Nutrition Program for Women, Infants and Children Program (WIC) clinic. Methods: Female clients or caregivers (n = 176) completed the food-handling survey; then an IMM food safety education program on a computer kiosk.…

Joint convention on the safety of spent fuel management and on the safety of radioactive waste management. First national report on the implementation by France of the obligations of the Convention

International Nuclear Information System (INIS)

2003-03-01

The Joint Convention on the safety of spent fuel management and on the safety of radioactive waste management is supplementing the Convention of Nuclear Safety. it was approved by France on february 22, 2000 and it entered into force on June 18,2001. Article 32 obliges each contracting Party to present at the review meetings (every three years) a report on the way in which it implements the obligations of the Convention (full text of the Convention and additional information on the web site of the IAEA, its director General being the depository of the Convention. (author)

Management of osteoarthritis (OA) with the pharma-standard supplement FlexiQule (Boswellia): a 12-week registry.

Science.gov (United States)

Belcaro, G; Dugall, M; Luzzi, R; Ledda, A; Pellegrini, L; Hu, S; Ippolito, E

2015-10-22

This registry study assessed the pharma-standard supplement FlexiQule (Boswellia extract in capsules) in the management of symptoms associated to osteoarthritis (OA) also managed with the 'standard management' (SM) in comparison with a group of patients managed only with SM. The 12- week registry included patients with symptomatic knee arthrosis. They were able to walk on a treadmill for a walking test and to complete the WOMAC questionnaire. 32 patients used the supplement and 34 acted as controls (SM). No safety problems were observed. At 12 weeks, the Karnofsky scale was significantly improved in both groups: the variation was higher (p<0.05) in the supplement group. The WOMAC score was decreased significantly more in the supplement+SM group in comparison with controls considering pain, stiffness and physical functions (p<0.05). For social and emotional functions the decrease in score was also more evident in the supplement group (p<0.05). Both groups improved in pain-free and total walking distance at 12 weeks. Pain-free walking distance (treadmill) was higher (p<0.05) with the supplement (from 93.4;11.6 m to 271.3;19.3 m) than in controls (from 90.5;13.5 m to 158.3;22.3)(p<0.05). The improvement in total walking distance was also higher in the supplement group (p<0.05) (from 164.3;23.2 to 322.3;22.3 m) in comparison with the SM- only group ( from 158.3;18,4 to 240.2;19.3 m). The need for concomitant drugs and medical attention during the registry was reduced more in the supplement group (p<0.05). In conclusion the difference between SM and the Flexiqule+SM was in favor of the management with the supplement for all target measurements. The product is safe and well tolerated.

Safety Evaluation Report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391)

International Nuclear Information System (INIS)

Tam, P.S.

1991-04-01

This report supplements the Safety Evaluation Report (SER), NUREG- 0847 (June 1982), Supplement No. 1' (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), and Supplement No. 5 (November 1990) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50--390 and 50--391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items, and proposed license conditions identified in the SER

MICROBIOLOGICAL QUALITY OF FOOD SUPPLEMENTS.

Science.gov (United States)

Ratajczak, Magdalena; Kubicka, Marcelina M; Kamińska, Dorota; Długaszewska, Jolanta

2015-01-01

Many specialists note that the food offered today - as a result of very complex technological processing - is devoid of many components that are important for the organism and the shortages have to be supplemented. The simplest for it is to consume diet supplements that provide the missing element in a concentrated form. In accordance with the applicable law, medicinal products include all substances or mixtures of substances that are attributed with properties of preventing or treating diseases with humans or animals. Permits to admit supplements to the market are issued by the Chief Sanitary Inspector and the related authorities; permits for medicines are issued by the Chief Pharmaceutical Inspector and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Therefore, admittance of a supplement to the market is less costly and time consuming_than admittance of a medicine. Supplements and medicines may contain the same component but medicines will have a larger concentration than supplements. Sale of supplements at drug stores and in the form of tablets, capsules, liquids or powders makes consumer often confusing supplements with medicines. Now there are no normative documents specifying limits of microbiological impurities in diet supplements. In Polish legislation, diet supplements are subject to legal acts concerning food. Medicines have to comply with microbiological purity requirements specified in the Polish Pharmacopeia. As evidenced with the completed tests, the proportion of diet supplement samples with microbiological impurities is 6.5%. Sales of diet supplements have been growing each year, they are consumed by healthy people but also people with immunology deficiencies and by children and therefore consumers must be certain that they buy safe products.

Keto acid-supplemented low-protein diet for treatment of adult patients with hepatitis B virus infection and chronic glomerulonephritis.

Science.gov (United States)

Mou, Shan; Li, Jialin; Yu, Zanzhe; Wang, Qin; Ni, Zhaohui

2013-02-01

An open-label, randomized, controlled, single-centre clinical trial to evaluate the effects of low-protein intake, with or without keto acid supplementation, on nutritional status and proteinuria, in patients with hepatitis B virus (HBV) and early stage chronic glomerulonephritis. Patients with chronic glomerulonephritis and HBV infection were randomized to receive a low-protein diet (0.6-0.8 g/kg ideal body weight [IBW] per day) either without (LP group) or with (sLP group) keto acid supplementation (0.1 g/kg IBW per day), for 12 months. Nutritional, clinical and safety parameters were recorded. The study included 17 patients (LP group n = 9; sLP group n = 8). Proteinuria and microalbuminuria were significantly lower in the sLP group at 6 and 12 months compared with baseline, and at 12 months compared with the LP group. There were no significant differences in serum creatinine level or estimated glomerular filtration rate. Nutritional parameters (serum albumin and prealbumin) were significantly improved at 12 months, compared with baseline, in the sLP group. Restriction of dietary protein intake to 0.6-0.8 g/kg IBW per day appears to have an acceptable safety profile. Supplementation with keto acids is associated with decreased urine protein excretion.

Supplementation with a combination of beta-hydroxy-beta-methylbutyrate (HMB), arginine, and glutamine is safe and could improve hematological parameters.

Science.gov (United States)

Rathmacher, J A; Nissen, S; Panton, L; Clark, R H; Eubanks May, P; Barber, A E; D'Olimpio, J; Abumrad, N N

2004-01-01

Combining the amino acids arginine and glutamine with the leucine metabolite beta-hydroxy-beta-methylbutyrate (HMB) has been shown to reverse lean tissue loss in cancer and acquired immunodeficiency syndrome (AIDS) patients. Although each of these nutrients has been shown to be safe, the safety of this mixture has not been reported. Three double-blind studies examined the safety of the combination of HMB, arginine and glutamine on blood chemistries, hematology, emotional profile, and adverse events. Study 1 was conducted in healthy adult males (n = 34), study 2 was in HIV patients with AIDS-associated weight loss (n = 43), and study 3 was in cancer patients with wasting (n = 32). Volunteers were assigned to either a placebo or a mixture of 3 g HMB, 14 g arginine, and 14 g glutamine per day. Across the 3 studies, HMB, arginine, and glutamine supplementation was not associated with any adverse indicators of health. The only significant changes noted were positive indicators of health status. HMB, arginine, and glutamine supplementation was associated with an improvement in emotional profile (p = .05), a decreased feeling of weakness (p = .03), and increased red blood cells, hemoglobin, hematocrit, lymphocytes, and eosinophils (p HMB, arginine, and glutamine supplementation, which was possibly caused by the additional nitrogen consumed or to the fact that ureagenesis is influenced by arginine and glutamine supplementation. These results show that HMB, arginine, and glutamine can be safely used to treat muscle wasting associated with AIDS and cancer.

Periodic safety review of operational nuclear power plants. A publication within the NUSS programme

International Nuclear Information System (INIS)

1994-01-01

This Safety Guide which supplements the IAEA Safety Fundamentals: The Safety of Nuclear Installations and the Code on the Safety of Nuclear Power Plants: Operation, forms part of the Agency's programme, referred to as the NUSS programme, for establishing Codes and Guides relating to nuclear power plants. A list of NUSS publications is given at the end of this book. This Guide was drafted on the basis of a systematic review approach that was endorsed by the IAEA Conference on the Safety of Nuclear Power: Strategy for the Future. The purpose of this Safety Guide is to provide guidance on the conduct of Periodic Safety Reviews (PSRs) for an operational nuclear power plant. The Guide is directed at both owners/operators and regulators. This Safety Guide deals with the PSR of an operational nuclear power plant. A PSR is a comprehensive safety review addressing all important aspects of safety, carried out at regular intervals. 22 refs, 4 figs

Maternal supplementation for prevention and treatment of vitamin D deficiency in exclusively breastfed infants.

Science.gov (United States)

Haggerty, Linda L

2011-06-01

Current research links newborn and infant vitamin D deficiency with various clinical outcomes, including rickets, failure to thrive, type 1 diabetes, and other immune-related diseases. Breastfed infants are often at a greater risk of developing deficiency due to their mothers' low vitamin D status. Human milk reflects the vitamin D status of the mother and often contains inadequate levels of 25-hydroxyvitamin D for infant nutrition. In 2008 the American Academy of Pediatrics (AAP) recommended 400 IU of vitamin D supplementation of all infants. However, research has indicated low levels of compliance of vitamin D supplementation of breastfed infants and a high incidence of vitamin D deficiency in the United States. Many breastfeeding advocates believe that the AAP's recommendations undermine breastfeeding, implying that human milk is inadequate for infant nutrition. Lactating mothers are also reluctant to add any supplements to their breastmilk. The literature review will examine the effectiveness and safety of maternal vitamin D supplementation for prevention and/or treatment of vitamin D deficiency in breastfed infants and lactating mothers. This method of prevention and intervention provides pediatric providers and certified lactation consultants with an alternative approach for education, counseling, promotion of breastfeeding, and treatment to improve maternal and infant health.

Resistance Training and Co-supplementation with Creatine and Protein in Older Subjects with Frailty.

Science.gov (United States)

Collins, J; Longhurst, G; Roschel, H; Gualano, B

2016-01-01

Studies assessing the effects co-supplementation with creatine and protein, along with resistance training, in older individuals with frailty are lacking. This is an exploratory trial from the Pro-Elderly study ("Protein Intake and Resistance Training in Aging") aimed at gathering knowledge on the feasibility, safety, and efficacy of co-supplementation with creatine and protein supplementation, combined with resistance training, in older individuals with frailty. A 14-week, double-blind, randomized, parallel-group, placebo controlled exploratory trial. The subjects were randomly assigned to whey protein and creatine co-supplementation (WHEY+CR) or whey protein supplementation (WHEY) group. All subjects undertook a supervised exercise training program and were assessed at baseline and after 14 weeks. Muscle function, body composition, blood parameters, and self-reported adverse events were assessed. No interaction effects (between-group differences) were observed for any dependent variables (p > 0.05 for all). However, there were main time-effects in handgrip (WHEY+CR = 26.65 ± 31.29; WHEY = 13.84 ± 14.93 Kg; p = 0.0005), timed-up-and-go (WHEY+CR = -11.20 ± 9.37; WHEY = -17.76 ± 21.74 sec; p = 0.006), and timed-stands test (WHEY+CR = 47.50 ± 35.54; WHEY = 46.87 ± 24.23 reps; p = 0.0001), suggesting that WHEY+CR and WHEY were similarly effective in improving muscle function. All of the subjects showed improvements in at least two of the three functional tests, regardless of their treatments. Body composition and blood parameters were not changed (p > 0.05). No severe adverse effects were observed. Co-supplementation with creatine and whey protein was well-tolerable and free of adverse events in older subjects with frailty undertaking resistance training. Creatine supplementation did not augment the adaptive effects of resistance training along with whey protein on body composition or muscle function in this population. Clinicaltrials.gov: NCT01890382.

Safety Evaluation Report related to the operation of Braidwood Station, Units 1 and 2 (Docket Nos. 50-456 and 50-457)

International Nuclear Information System (INIS)

1987-05-01

In November 1983, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1002) regarding the application filed by the Commonwealth Edison Company, as applicant and owner, for a license to operate Braidwood Station, Units 1 and 2 (Docket Nos. 50-456 and 50-457). The first supplement to NUREG-1002 was issued in September 1986; the second supplement to NUREG-1002 was issued in October 1986. This third supplement to NUREG-1002 reports the status of certain items that remained unresolved at the time Supplement 2 was published. The facility is located in Reed Township, Will County, Illinois

Taking iron supplements

Science.gov (United States)

... medlineplus.gov/ency/article/007478.htm Taking iron supplements To use the sharing features on this page, ... levels. You may also need to take iron supplements as well to rebuild iron stores in your ...

75 FR 69360 - Defense Federal Acquisition Regulation Supplement; Award-Fee Reductions for Health and Safety...

Science.gov (United States)

2010-11-12

... acts with gross negligence or reckless disregard for health or safety, causing serious bodily injury or... which actions of gross negligence or reckless disregard of health or safety by the contractor or its... or death of any civilian or military personnel of the Government through gross negligence or with...

Use and perception of herbal and dietary supplements in the Hutterites of South Dakota.

Science.gov (United States)

Peters, Stacy; Shiyanbola, Olayinka

2013-12-01

South Dakota is home to 6,000 Hutterites, the largest population of Hutterites in the United States. Observation of frequent supplement use by this population prompted the current survey based study. Use of supplements is on the rise with around 53 percent of Americans reporting at least one herbal and dietary supplement (HDS). Use and perception of HDS has not previously been evaluated in the Hutterite population. Participants were 18 years of age and older and had to be present at the time of survey administration. Surveys were administered before and after an educational presentation at five colonies to volunteer participants. Survey data was analyzed using descriptive analysis and chi-square tests. One-hundred and six surveys were completed with 81.1 percent being female. Approximately 78 percent reported using at least one type of HDS, with an average of 2.7 (SD = 1.4) supplements per person. Women were more likely to report supplement use than men. Hutterites reported they felt HDS were safer than prescription medications. Education was effective on some aspects such as telling their doctor if they are taking HDS. Some study limitations included small sample size, possible lack of survey understanding, and the limited number of male participants. The frequency of HDS use in South Dakota Hutterites appears to be very high. Baseline knowledge on the safety and regulation of HDS reveals that education of this population is needed. Further investigation of HDS use in Hutterites is warranted.

Vitamin supplementation for preventing miscarriage.

Science.gov (United States)

Balogun, Olukunmi O; da Silva Lopes, Katharina; Ota, Erika; Takemoto, Yo; Rumbold, Alice; Takegata, Mizuki; Mori, Rintaro

2016-05-06

Miscarriage is a common complication of pregnancy that can be caused by a wide range of factors. Poor dietary intake of vitamins has been associated with an increased risk of miscarriage, therefore supplementing women with vitamins either prior to or in early pregnancy may help prevent miscarriage. The objectives of this review were to determine the effectiveness and safety of any vitamin supplementation, on the risk of spontaneous miscarriage. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (6 November 2015) and reference lists of retrieved studies. All randomised and quasi-randomised trials comparing supplementation during pregnancy with one or more vitamins with either placebo, other vitamins, no vitamins or other interventions. We have included supplementation that started prior to conception, periconceptionally or in early pregnancy (less than 20 weeks' gestation). Three review authors independently assessed trials for inclusion, extracted data and assessed trial quality. We assessed the quality of the evidence using the GRADE approach. The quality of evidence is included for numerical results of outcomes included in the 'Summary of findings' tables. We included a total of 40 trials (involving 276,820 women and 278,413 pregnancies) assessing supplementation with any vitamin(s) starting prior to 20 weeks' gestation and reporting at least one primary outcome that was eligible for the review. Eight trials were cluster-randomised and contributed data for 217,726 women and 219,267 pregnancies in total.Approximately half of the included trials were assessed to have a low risk of bias for both random sequence generation and adequate concealment of participants to treatment and control groups. Vitamin C supplementation There was no difference in the risk of total fetal loss (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.92 to 1.40, seven trials, 18,949 women; high-quality evidence); early or late miscarriage (RR 0.90, 95% CI 0.65 to 1

Safety Evaluation Report related to the operation of Perry Nuclear Power Plant, Units 1 and 2, (Docket Nos. 50-440 and 50-441)

International Nuclear Information System (INIS)

1984-02-01

Supplement No. 4 to the Safety Evaluation Report on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO), as applicants and owners, for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio. This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1, 2 and 3 to that report

Safety evaluation report related to the operation of Perry Nuclear Power Plant, Units 1 and 2: Docket Nos. 50-440 and 50-441

International Nuclear Information System (INIS)

1983-01-01

Supplement No. 2 to the Safety Evaluation Report on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group (CAPCO)), as applicants and owners, for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440 and 50-441), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio. This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement No. 1 to that report

Safety evaluation report related to the operation of Perry Nuclear Power Plant, Units 1 and 2. Docket Nos. 50-440 and 50-441

International Nuclear Information System (INIS)

1983-04-01

Supplement No. 3 to the Safety Evaluation Report on the application filed by the Cleveland Electric Illuminating Company on behalf of itself and as agent for the Duquesne Light Company, the Ohio Edison Company, the Pennsylvania Power Company, and the Toledo Edison Company (the Central Area Power Coordination Group or CAPCO), as applicants and owners, for a license to operate the Perry Nuclear Power Plant, Units 1 and 2 (Docket Nos. 50-440/441), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in Lake County, Ohio. This supplement reports the status of certain issues that had not been resolved at the time of publication of the Safety Evaluation Report and Supplement Nos. 1 and 2 to that report

Description of the retest instruction for the safety injection system in a German PWR

International Nuclear Information System (INIS)

Buettner, W.E.

1982-01-01

This report is a detailed supplement to the report 'Retests for a Safety System in a German Nuclear Power Plant' presented at the CSNI Meeting of the Group of Experts on Human Error Data and Assessment, Paris, Sept. 1979. (orig./RW)

Issues in Nutrition: Dietary Supplements.

Science.gov (United States)

Thompson, Margaret E; Noel, Mary Barth

2017-01-01

The majority of American adults report use of one or more dietary supplements every day or occasionally. The Dietary Supplement Health and Education Act of 1994 defines dietary supplements and regulates their manufacture and distribution. One of the most commonly used supplements is vitamin D. Measurement of serum levels of vitamin D must be undertaken with the caveats that different laboratories define normal levels differently, and that there is rarely a clinical correlation with the actual level. Patients should understand that supplements should not be used to excess, as there are toxicities and other adverse effects associated with most of them. There currently is considerable research being performed on probiotics and how the gut microbiome affects health and disease states. Protein supplements may be useful in reducing mortality rates in elderly patients but they do not appear to increase quality of life. If used, protein supplements should contain essential amino acids. Casein and whey supplements, derived from dairy sources, help transport essential amino acids to tissues. Although there have been many studies investigating the role of vitamin supplements in disease prevention, there have been few conclusive positive results. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

Lead in calcium supplements (abstract)

International Nuclear Information System (INIS)

Rehman, S.; Khalid, N.

2011-01-01

Lead present in calcium supplements is of grave concern as some lead levels have been measured up to the extent of regulatory limit set by the United States. Calcium supplements inevitably get contaminated with lead as both are naturally occurring elements. Therefore, it is imperative to indicate its level in these supplements in order to create awareness among consumers. In this study, a sophisticated analytical technique, atomic absorption spectrometry was used to analyze Pb contents in 27 commonly consumed Ca supplements manufactured by different national and multinational companies. The daily intake of lead through these supplements was calculated. Only 10% of the calcium supplements analyzed met the criteria of acceptable Pb levels (1.5 mu g/daily dose) in supplements/consumer products set by the United States. It was also found that Pb intake was highest in chelated calcium supplements 28.5 mu g/daily dose, whereas lowest 0.47 mu g/daily dose through calcium supplements with vitamin D formulation. In order to validate our results from the study conducted, IAEA-certified reference material (animal bone, H-5) was analyzed for its Pb levels. The levels of Pb determined were quite in good agreement with the certified values. (author)

Physician-Patient Communication about Dietary Supplements

Science.gov (United States)

Tarn, Derjung M.; Paterniti, Debora A.; Good, Jeffrey S.; Coulter, Ian D.; Galliher, James M.; Kravitz, Richard L.; Karlamangla, Arun; Wenger, Neil S.

2013-01-01

Objective Describe the content and frequency of provider-patient dietary supplement discussions during primary care office visits. Methods Inductive content analysis of 1477 transcribed audio-recorded office visits to 102 primary care providers was combined with patient and provider surveys. Encounters were collected in Los Angeles, California (2009–2010), geographically-diverse practice settings across the United States (2004–2005), and Sacramento, CA (1998–1999). Results Providers discussed 738 dietary supplements during encounters with 357 patients (24.2% of all encounters in the data). They mentioned: 1) reason for taking the supplement for 46.5% of dietary supplements; 2) how to take the supplement for 28.2%; 3) potential risks for 17.3%; 4) supplement effectiveness for 16.7%; and 5) supplement cost or affordability for 4.2%. Of these five topics, a mean of 1.13 (SD=1.2) topics were discussed for each supplement. More topics were reviewed for non-vitamin non-mineral supplements (mean 1.47 (SD=1.2)) than for vitamin/mineral supplements (mean 0.99 (SD=1.1); psupplements are occurring, it is clear that more discussion might be needed to inform patient decisions about supplement use. Practice Implication Physicians could more frequently address topics that may influence patient dietary supplement use, such as the risks, effectiveness, and costs of supplements. PMID:23466249

Role of young child formulae and supplements to ensure nutritional adequacy in U.K. young children

DEFF Research Database (Denmark)

Vieux, Florent; Brouzes, Chloé M C; Maillot, Matthieu

2016-01-01

The European Food Safety Authority (EFSA) states that young child formulae (YCFs) “cannot be considered as a necessity to satisfy the nutritional requirements” of children aged 12–36 months. This study quantifies the dietary changes needed to ensure nutritional adequacy in U.K. young children who...... consume YCFs and/or supplements and in those who do not. Dietary data from 1147 young children (aged 12–18 months) were used to identify, using linear programming models, the minimum changes needed to ensure nutritional adequacy: (i) by changing the quantities of foods initially consumed by each child....../day, respectively). Increasing YCF and supplement consumption was the shortest way to cover the EFSA nutrient requirements of U.K. children....

Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations.

Science.gov (United States)

Finley, John Weldon; Finley, John Wescott; Ellwood, Kathleen; Hoadley, James

2014-01-01

Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. New foods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.

Nutritional Supplements for Strength Power Athletes

Science.gov (United States)

Wilborn, Colin

Over the last decade research involving nutritional supplementation and sport performance has increased substantially. Strength and power athletes have specific needs to optimize their performance. Nutritional supplementation cannot be viewed as a replacement for a balanced diet but as an important addition to it. However, diet and supplementation are not mutually exclusive, nor does one depend on the other. Strength and power athletes have four general areas of supplementation needs. First, strength athletes need supplements that have a direct effect on performance. The second group of supplements includes those that promote recovery. The third group comprises the supplements that enhance immune function. The last group of supplements includes those that provide energy or have a direct effect on the workout. This chapter reviews the key supplements needed to optimize the performance and training of the strength athlete.

Impact of supplemental instruction leader on the success of supplemental instruction model

Science.gov (United States)

Mahabaduge, Hasitha; Haslam, Jeanne

Supplemental instruction utilizes peer-assisted study sessions to provide review sessions on course material and an opportunity to discuss and work out problems. The impact of supplemental instruction on student performance is well researched and used in a large number of universities around the world due to its proven success. However, the impact of the student leader who plays a significant role in this model is rarely discussed in the literature. We present a case study on the impact of student leader on the success of supplemental instruction model. This case study was done for an Introductory Physics course correlating student performance and the supplemental instruction sessions they attended. Further analysis revealed that the academic performance and work ethics of the student leader has a significant impact on the success of the supplemental instruction model. Important factors to consider when selecting a student leader, the challenges and possible remedies will also be discussed.

Safety evaluation report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan

International Nuclear Information System (INIS)

1991-01-01

This safety evaluation report (SER) was prepared by the US Nuclear Regulatory Commission (NRC) staff and represents the second and last supplement (SSER 2) to the staff's original SER published as Volume 3 of NUREG-1232 in April 1989. Supplement 1 of Volume 3 of NUREG-1232 (SSER 1) was published in October 1989. Like its predecessors, SSER 2 is composed of numerous safety evaluations by the staff regarding specific elements contained in the Browns Ferry Nuclear Performance Plan (BFNPP), Volume 3 (up to and including Revision 2), submitted by the Tennessee Valley Authority (TVA) for the Browns Ferry Nuclear Plant (BFN). The Browns Ferry Nuclear Plant consists of three boiling-water reactors (BWRs) at a site in Limestone County, Alabama. The BFNPP describes the corrective action plans and commitments made by TVA to resolve deficiencies with its nuclear programs before the startup of Unit 2. The staff has inspected and will continue to inspect TVA's implementation of these BFNPP corrective action plans that address staff concerns about TVA's nuclear program. SSER 2 documents the NRC staff's safety evaluations and conclusions for those elements of the BFNPP that were not previously addressed by the staff or that remained open as a result of unresolved issues identified by the staff in previous SERs and inspections

Hepatotoxicity Associated with Use of the Weight Loss Supplement Garcinia cambogia: A Case Report and Review of the Literature

Directory of Open Access Journals (Sweden)

Jiten P. Kothadia

2018-01-01

Full Text Available The use of herbal and dietary supplements for weight loss is becoming increasingly common as obesity is becoming major health problem in the United States. Despite the popularity of these natural supplements, there are no guidelines for their therapeutic doses and their safety is always a concern. Garcinia cambogia extract with its active ingredient “hydroxycitric acid” is a component of many weight loss regimens. It suppresses fatty acid biosynthesis and decreases appetite. However, its prolonged use in weight maintenance is unknown. Here we describe a case of acute hepatitis after the use of Garcinia cambogia for weight loss.

Safety evaluation report related to the operation of Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425)

International Nuclear Information System (INIS)

1989-03-01

In June 1985, the staff of the Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-1137) regarding the application of Georgia Power Company, Municipal Electric Authority of Georgia, Oglethorpe Power Corporation, and the City of Dalton, Georgia, for licenses to operate the Vogtle Electric Generating Plant, Units 1 and 2 (Docket Nos. 50-424 and 50-425). Supplement 1 to NUREG-1137 was issued by the staff in October 1985, Supplement 2 was issued in May 1986, Supplement 3 was issued in August 1986, Supplement 4 was issued in December 1986, Supplement 5 was issued in January 1987, Supplement 6 was issued in March 1987, Supplement 7 was issued in January 1988, and Supplement 8 was issued in February 1989. The facility is located in Burke County, Georgia, approximately 26 miles south-southeast of Augusta, Georgia, and on the Savannah River. This ninth supplement to NUREG-1137 provides recent information regarding resolution of conditional items following issuance of Supplement 8

Monitoring of polycyclic aromatic hydrocarbons (PAH) in food supplements containing botanicals and other ingredients on the Dutch market.

Science.gov (United States)

Martena, M J; Grutters, M M P; De Groot, H N; Konings, E J M; Rietjens, I M C M

2011-01-01

Food supplements can contain polycyclic aromatic hydrocarbons (PAH). The European Food Safety Authority (EFSA) has defined 16 priority PAH that are both genotoxic and carcinogenic and identified eight priority PAH (PAH8) or four of these (PAH4) as good indicators of the toxicity and occurrence of PAH in food. The current study aimed to determine benzo[a]pyrene and other EFSA priority PAH in different categories of food supplements containing botanicals and other ingredients. From 2003 to 2008, benzo[a]pyrene exceeded the limit of quantification (LOQ) in 553 (44%) of 1258 supplements with a lower-bound mean of 3.37 µg kg(-1). In 2008 and 2009, benzo[a]pyrene and 12 other EFSA priority PAH were determined in 333 food supplements. Benzo[a]pyrene exceeded the LOQ in 210 (63%) food supplements with a lower-bound mean of 5.26 µg kg(-1). Lower-bound mean levels for PAH4 and PAH8(-indeno[1,2,3-cd]pyrene) were 33.5 and 40.5 µg kg(-1), respectively. Supplements containing resveratrol, Ginkgo biloba, St. John's wort and propolis showed relatively high PAH4 levels in 2008 and 2009. Before 2008, supplements with these ingredients and also dong quai, green tea or valerian contained relatively high benzo[a]pyrene levels. On average, PAH4 intake resulting from food supplement use will be at the lower end of the range of contributions of main food groups to PAH4 exposure, although individual food supplements can contribute significantly to PAH4 exposure. Regular control of EFSA indicator PAH levels in food supplements may prove a way forward to reduce further the intake of PAH from food.

Safety evaluation report related to the operation of South Texas Project, Unit 2 (Docket No. 50-499)

International Nuclear Information System (INIS)

1989-03-01

In April 1986 the staff of the US Nuclear Regulatory Commission issued its Safety Evaluation Report (NUREG-0781) regarding the application of Houston Lighting and Power Company (applicant and agent for the owners) for a license to operate South Texas Project, Units 1 and 2 (Docket Nos. 50-498 and 50-499). The facility is located in Matagorda County, Texas, west of the Colorado River, 8 miles north-northwest of the town of Matagorda and about 89 miles southwest of Houston. The first supplement to NUREG-0781 was issued in September 1986, the second supplement in January 1987, the third supplement in May 1987, the fourth supplement in July 1987, the fifth supplement in March 1988, and the sixth supplement in January 1989. This seventh supplement, which supports the issuance of a full-power license for Unit 2, provides updated information on the issues that had been considered previously as well as the evaluation of issues that have arisen since the sixth supplement was issued. The evaluation resolves all the issues necessary to support the issuance of a full-power license for Unit 2. 2 refs., 2 figs., 1 tab

Inclusion and Exclusion in the safety culture at sea

DEFF Research Database (Denmark)

Grøn, Sisse

The acceleration of the globalization faces us as a nation with the challenge of adjusting our procedures and policies to accommodate foreign citizens working in Danish workplaces. In this paper I analyse data from field work voyages at sea. The data is presented in categories of bonding, bridging...... and linking acts inspired from research in social capital, and supplemented with acts of exclusion, all to describe the power conflicts which includes and excludes members in the unitary, divided or fragmented safety cultures that I met on board. The data shows that foreign seafarers are treated equally...... as long as the basic structures are not addressed. They are however treated equally on the majority´s terms, which still lead to a minority position even in the safety culture. A shared safety culture is therefore difficult to achieve....

The effect of 12-month dehydroepiandrosterone supplementation on the menstrual pattern, ovarian reserve markers, and safety profile in women with premature ovarian insufficiency.

Science.gov (United States)

Wong, Queenie Ho Yan; Yeung, Tracy Wing Yee; Yung, Sofie Shuk Fei; Ko, Jennifer Ka Yee; Li, Hang Wun Raymond; Ng, Ernest Hung Yu

2018-03-09

To evaluate the effect of 12-month DHEA supplementation on menstrual pattern and ovarian reserve markers in women with premature ovarian insufficiency (POI) METHODS: This is a prospective observational study. Women with POI were given DHEA supplements (25 mg three times daily) for 12 months. Sonographic assessment for ovarian volume and antral follicle count (AFC) and serum measurement for anti-Mullerian hormone (AMH), follicle stimulating hormone (FSH), estradiol, testosterone, liver function, and hemoglobin level were performed at baseline and monthly for 13 months after the supplementation. Menstrual pattern, ovarian reserve markers, and side-effects were recorded. Between August 2011 and July 2014, 38 women with POI were recruited and 31 completed the study. The median age of women was 36 years, and the median baseline FSH and AMH concentrations were 82.2 IU/L and 0.01 ng/ml, respectively. No women had resumption of regular menstruation after DHEA supplementation. AMH, FSH, and AFC did not change significantly. No serious side effects were reported. Our results do not support any significant improvement in ovarian function by 12-month DHEA supplementation in women with POI.

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50--390 and 50--391)

International Nuclear Information System (INIS)

1990-11-01

This report supplements the Safety Evaluation Report (SER), NUREG-0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), and Supplement No. 4 (March 1985), issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee, near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items and proposed license conditions identified in the SER

The potential for social media to educate farm families about health and safety for children.

Science.gov (United States)

Gualtieri, Lisa

2012-01-01

Social media has the potential to reach farm families to educate them about health and safety for children. It offers advantages over traditional approaches because of the shorter time between creation and distribution and because of the greater reach and engagement possible. Recommendations are provided for how government agencies and the private sector can learn about and use social media to promote health and safety for children as a supplement to traditional approaches.

Safety evaluation report related to the operation of Watts Bar Nuclear Plant, Units 1 and 2, (Docket Nos. 50-390 and 50-391), Tennessee Valley Authority

International Nuclear Information System (INIS)

1992-06-01

This report supplements the Safety Evaluation Report (SER), NUREG- 0847 (June 1982), Supplement No. 1 (September 1982), Supplement No. 2 (January 1984), Supplement No. 3 (January 1985), Supplement No. 4 (March 1985), Supplement No. 5 (November 1990), Supplement No. 6 (April 1991), Supplement No. 7 (September 1991), and Supplement No. 8 (January 1992) issued by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission with respect to the application filed by the Tennessee Valley Authority, as applicant and owner, for licenses to operate the Watts Bar Nuclear Plant, Units 1 and 2 (Docket Nos. 50-390 and 50-391). The facility is located in Rhea County, Tennessee near the Watts Bar Dam on the Tennessee River. This supplement provides recent information regarding resolution of some of the outstanding and confirmatory items, and proposed license conditions identified in the SER

Dietary supplements for football.

Science.gov (United States)

Hespel, P; Maughan, R J; Greenhaff, P L

2006-07-01

Physical training and competition in football markedly increase the need for macro- and micronutrient intake. This requirement can generally be met by dietary management without the need for dietary supplements. In fact, the efficacy of most supplements available on the market is unproven. In addition, players must be cautious of inadequate product labelling and supplement impurities that may cause a positive drug test. Nonetheless, a number of dietary supplements may beneficially affect football performance. A high endurance capacity is a prerequisite for optimal match performance, particularly if extra time is played. In this context, the potential of low-dose caffeine ingestion (2 - 5 mg . kg body mass(-1)) to enhance endurance performance is well established. However, in the case of football, care must be taken not to overdose because visual information processing might be impaired. Scoring and preventing goals as a rule requires production of high power output. Dietary creatine supplementation (loading dose: 15 - 20 g . day(-1), 4 - 5 days; maintenance dose: 2 - 5 g g . day(-1)) has been found to increase muscle power output, especially during intermittent sprint exercises. Furthermore, creatine intake can augment muscle adaptations to resistance training. Team success and performance also depend on player availability, and thus injury prevention and health maintenance. Glucosamine or chondroitin may be useful in the treatment of joint pain and osteoarthritis, but there is no evidence to support the view that the administration of these supplements will be preventative. Ephedra-containing weight-loss cocktails should certainly be avoided due to reported adverse health effects and positive doping outcomes. Finally, the efficacy of antioxidant or vitamin C intake in excess of the normal recommended dietary dose is equivocal. Responses to dietary supplements can vary substantially between individuals, and therefore the ingestion of any supplement must be assessed