scholarly journals Good Laboratory Practices: A Comparison of the Regulations

1985 ◽  
Vol 4 (6) ◽  
pp. 339-345
Author(s):  
S. K. Keener ◽  
B. K. Hoover
Keyword(s):  
Quality Assurance ◽  
Environmental Protection Agency ◽  
Toxic Substances ◽  
Protection Agency ◽  
Laboratory Practice ◽  
Environmental Testing ◽  
Federal Food ◽  
Good Laboratory ◽  
Similarities And Differences ◽  
Toxic Substances Control Act

Recently, the Environmental Protection Agency (EPA) issued Good Laboratory Practice (GLP) Regulations under the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act (and under some sections of the Federal Food, Drug, and Cosmetic Act). Quality assurance professionals, toxicologists, and laboratory managers are now confronted with complying with two new sets of regulations in addition to those promulgated by the Food and Drug Administration (FDA) in 1979. Immediately questions arose concerning the similarities and differences in the FDA and EPA requirements. Therefore, an analysis was performed to determine whether there were significant differences. The findings indicated that 19 sections were similar to the FDA requirements, 5 sections had minor differences, and 4 had major differences. In addition, new sections were added to the EPA regulations addressing compliance statements and the consequences of noncompliance for sponsors and laboratory personnel. The Toxic Substances GLP also incorporated a new subpart covering environmental testing.

REGULATING RISK: OVERSIGHT OF MICROBIAL PRODUCTS OF BIOTECHNOLOGY UNDER THE U.S. TOXIC SUBSTANCES CONTROL ACT

1999 ◽  
Vol 01 (03) ◽  
pp. 329-347 ◽  
Author(s):  
REBECCA A. EFROYMSON
Keyword(s):  
Environmental Protection ◽  
Environmental Protection Agency ◽  
Genetically Engineered ◽  
Institutional Constraints ◽  
Toxic Substances ◽  
Protection Agency ◽  
Microbial Products ◽  
Toxic Substances Control Act ◽  
Risk Oversight ◽  
The U.S

The Toxic Substances Control Act (TSCA) is the legislation used by the U.S. Environmental Protection Agency to regulate releases of genetically engineered microorganisms. The rule defining the scope of the notification requirements for releases of microbial products of biotechnology was published in April 1997. The Environmental Protection Agency (EPA) had some latitude regarding the extent to which various categories of microorganisms would be regulated, but the agency was constrained by requirements of TSCA and an interagency agreement about how to regulate products of biotechnology. This paper investigates the extent to which the scope of oversight is based on risk. A risk-based rule is defined as one where the reporting requirements are based on potential for exposure or expected adverse effects. The evolution of the rule is described, and risk-based components are discussed. In conclusion, the scope of oversight of microbial releases is determined to be based on risk to the extent that legislation and institutional constraints permit.

U.S. Chemical Program: Purpose, Challenges, and Evolution

2001 ◽  
Vol 20 (2) ◽  
pp. 175-187 ◽  
Author(s):  
Odelia Funke
Keyword(s):  
Environmental Protection Agency ◽  
International Negotiations ◽  
Toxic Chemicals ◽  
Toxic Substances ◽  
Protection Agency ◽  
Testing Program ◽  
Toxic Substances Control Act ◽  
Chemical Testing ◽  
The U.S

This article explores long-term issues and problems that have seriously undermined the U.S. Chemical Testing Program established by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act. This program is meant to gather information needed to protect human health and the environment from damaging exposure to toxic chemicals. Despite seemingly broad and impressive authority under the statute, there are a number of inherent difficulties, as well as substantial political constraints, that impede comprehensive oversight of chemicals in U.S. commerce. The article discusses several approaches that EPA has adopted to overcome statutory and political limitations and increase chemical testing information. The most recent and promising of these efforts has involved international negotiations to harmonize testing approaches with OECD nations and to cooperate on an agenda that will better share the testing burden on an international level.

potential risk of cancer to humans; and chemicals which CAG reviewed because one or more of three organizations (The International Agency for Research on Cancer, the National Toxicology Program Bioassay Program, and the Food and Drug Administration of the U.S. Department of Health and Human Services) concluded that these chemicals are potential human carcinogens. Report of the TSCA Interagency Testing Committee to the Administrator, Environmental Protection Agency Section 4(e) of the Toxic Substances Control Act (TSCA) (P.L. 94469) established the TSCA Interagency Testing Committee (lTC) with representation from many of the Federal research and regulatory agencies. This Committee has the continuing responsibility to identify and recommend to the Administrator of the Environmental Protection Agency, chemical substances or mixtures which should be tested to determine their hazard to human health or the environment. In the ITC review and recommendation of selected chemicals, priority attention given to those individual or groups of chemical substances or mixtures which are known to cause or contribute to, or which are suspected of causing or contributing to cancer, gene mutations, or birth defects. The list, and reasons for making each recommendation, are required to be published in the Federal Register. Since 1977, the lTC has published eight reports which contain a total of 46 chemical substances or categories of chemicals. One chemical has been removed from the 4( e) Priority List because EPA responded to the Committee's recommendation for testing. Toxic Substances Control Act: Substantial Risk Notification Under Section 8(e) of the Toxic Substances Control Act of 1976 (TSCA), anyone who obtains information which reasonably supports the conclusion that a substance presents a substantial risk of injury to human health or the environment must notify the Environmental Protection Agency within days. These notices are then reviewed by the Office of Pesticides and Toxic Substances. An initial evaluation of the substance is prepared containing, if appropriate, followup questions to the submitter, referrals

1994 ◽  
pp. 20-20
Keyword(s):  
Environmental Protection ◽  
Human Health ◽  
Environmental Protection Agency ◽  
Gene Mutations ◽  
Toxic Substances ◽  
Protection Agency ◽  
Chemical Substances ◽  
Section 8 ◽  
Substantial Risk ◽  
Toxic Substances Control Act

Benefits of Good Laboratory Practice as a Tool to Improve Testing

1993 ◽  
Vol 12 (6) ◽  
pp. 528-532
Author(s):  
Dian Turnheim
Keyword(s):  
Quality Assurance ◽  
Information Exchange ◽  
Economic Cooperation ◽  
Good Laboratory Practice ◽  
Compliance Monitoring ◽  
Laboratory Practice ◽  
International Harmonisation ◽  
Good Laboratory

The Organization for Economic Cooperation and Development (OECD) has promoted Good Laboratory Practice (GLP) since the mid 1970s. This paper describes the development of the concept through international harmonisation, Quality Assurance (QA), and compliance monitoring. Ultimately this process permits Mutual Acceptance of Data (MAD). An important aspect of the OECD's programme is the promotion of related training and information exchange.

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