To Test or Not to Test: Tools, Rules, and Corporate Data in US Chemicals Regulation

2021 ◽  
pp. 016224392110133
Author(s):  
Angela N. H. Creager
Keyword(s):  
Environmental Protection Agency ◽  
Reagan Administration ◽  
Nixon Administration ◽  
Environmental Data ◽  
Toxic Substances ◽  
Industrial Chemicals ◽  
Public Data ◽  
History Of ◽  
Draft Bill ◽  
Toxic Substances Control Act

When the Toxic Substances Control Act (TSCA) was passed by the US Congress in 1976, its advocates pointed to new generation of genotoxicity tests as a way to systematically screen chemicals for carcinogenicity. However, in the end, TSCA did not require any new testing of commercial chemicals, including these rapid laboratory screens. In addition, although the Environmental Protection Agency was to make public data about the health effects of industrial chemicals, companies routinely used the agency’s obligation to protect confidential business information to prevent such disclosures. This paper traces the contested history of TSCA and its provisions for testing, from the circulation of the first draft bill in the Nixon administration through the debates over its implementation, which stretched into the Reagan administration. The paucity of publicly available health and environmental data concerning chemicals, I argue, was a by-product of the law and its execution, leading to a situation of institutionalized ignorance, the underside of regulatory knowledge.

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.

History of EPI Suite™ and future perspectives on chemical property estimation in US Toxic Substances Control Act new chemical risk assessments

2017 ◽  
Vol 19 (3) ◽  
pp. 203-212 ◽  
Author(s):  
Marcella L. Card ◽  
Vicente Gomez-Alvarez ◽  
Wen-Hsiung Lee ◽  
David G. Lynch ◽  
Nerija S. Orentas ◽  
...  
Keyword(s):  
Chemical Property ◽  
Risk Assessments ◽  
Toxic Substances ◽  
Future Perspectives ◽  
Qsar Modeling ◽  
Chemical Risk ◽  
The Past ◽  
Property Estimation ◽  
History Of ◽  
Toxic Substances Control Act

A discussion of the past developments, current practices, and future opportunities in QSAR modeling for new chemical risk assessments.

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.

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.

scholarly journals A Cumulative Framework for Identifying Overburdened Populations under the Toxic Substances Control Act: Formaldehyde Case Study

2021 ◽  
Vol 18 (11) ◽  
pp. 6002
Author(s):  
Kristi Pullen Fedinick ◽  
Ilch Yiliqi ◽  
Yukyan Lam ◽  
David Lennett ◽  
Veena Singla ◽  
...  
Keyword(s):  
Low Income ◽  
Environmental Protection Agency ◽  
Access To Health Care ◽  
Formal Education ◽  
Indigenous Communities ◽  
Health Care Facilities ◽  
Mitigation Strategies ◽  
Toxic Substances ◽  
Toxic Substances Control Act ◽  
Susceptible Subpopulations

Extensive scholarship has demonstrated that communities of color, low-income communities, and Indigenous communities face greater environmental and health hazards compared to communities with more White or affluent people. Low-income, Indigenous, Black, and/or other populations of color are also more likely to lack access to health care facilities, healthy food, and adequate formal education opportunities. Despite the mountains of evidence that demonstrate the existence and significance of the elevated toxic social and environmental exposures experienced by these communities, the inclusion of these factors into chemical evaluations has been scarce. In this paper, we demonstrate a process built with publicly available data and simple geospatial techniques that could be utilized by the U.S. Environmental Protection Agency (USEPA) to incorporate cumulative approaches into risk assessments under the Toxic Substances Control Act. The use of these approaches, particularly as they relate to identifying potentially exposed and susceptible subpopulations, would help USEPA develop appropriate risk estimates and mitigation strategies to protect disproportionately burdened populations from the adverse effects of chemical exposures. By utilizing such approaches to inform risk evaluation and mitigation, USEPA can identify and protect those most burdened and impacted by toxic chemicals, and finally begin to close the gap of environmental health inequities.

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

Immunological mechanisms of chronic liver lesions under the influence of chemicals

2020 ◽  
pp. 536-537
Author(s):  
G. S. Agzamova ◽  
M. M. Abdullaeva
Keyword(s):  
The Body ◽  
Chronic Liver ◽  
Toxic Substances ◽  
Liver Lesions ◽  
Industrial Chemicals ◽  
Toxic Agent ◽  
Chronic Poisoning ◽  
Immunological Mechanisms ◽  
T System

The immunological profile of chronic liver lesions depending on the toxic agent was studied. It was revealed that chronic poisoning by industrial toxic substances causes changes in the functional state of the T-system of immunity, long-term contact with industrial chemicals leads to increased sensitization to autoantigens of the body.

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