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At least 19 recordsLinked to original sources
PubMed1991

Environmental hazard and risk assessment under the United States Toxic Substances Control Act.

The Toxic Substances Control Act (TSCA) was enacted in 1976 and provides for the regulation of industrial chemicals. TSCA allows for regulation of a chemical if there is an unreasonable risk towards human health or the environment, and it allows for testing if a chemical may present an unreasonable risk or has significant exposure towards humans or the environment. Risk assessment under TSCA consists of the integration of the hazard assessment for a chemical with the chemical's exposure assessment. The environmental hazard assessment consists of identifying all of the effects of a chemical towards organisms in the environment, and towards the populations, communities, and ecosystems to which those organisms belong. Toxicity data for a chemical consists of effective concentrations (EC) which indicate the type of effect and the seriousness of that effect at a known concentration of chemical. Effective concentrations are either measured or predicted using structure activity relationships (SAR). SAR may consist of nearest analog analysis, member of a toxic chemical class, or quantitative SAR (QSAR). A collection of all of the ECs for a chemical is called a hazard profile or a toxicity profile. The environmental exposure assessment consists of measuring or predicting the environmental concentrations of a chemical from releases due to its production, processing, uses, and disposal. There are two types of exposure assessment most frequently used under TSCA: the Percentile Stream Flow Method and the Probability Dilution Model (PDM) Method. Environmental risk assessment under TSCA is performed by using the quotient method. This method simply compares an EC with the actual or predicted environmental concentrations (PEC). If the PEC is greater than the EC, then you have a potential risk. The risk assessment process usually consists of three steps: (i) worst case risk assessment, (ii) identification of the type or risk (e.g., acute and/or chronic risk), and (iii) quantification of the degree of environmental risk or the potential environmental impact expected for each type of risk. If the risk assessment determines that a chemical presents a potential risk to the environment, then the results of this assessment are integrated with the economic assessment, any relative risk factors, and governmental policy in order to decide whether a chemical may present an unreasonable risk to the environment.

Animals↗
PubMed1987

Application of the preliminary developmental toxicity screen for chemical hazard identification under the Toxic Substances Control Act.

The Office of Toxic Substances (OTS) within the U.S. Environmental Protection Agency (EPA) is authorized to carry forth the mandates of the Toxic Substances Control Act (TSCA). Included among the provisions of TSCA are the development of requirements for testing of "new" and "existing" chemicals that may present an unreasonable risk of injury to health or the environment. There are over 63,000 "existing" chemicals on the TSCA inventory, and EPA in recent years has been receiving an average of over 1,300 submissions for "new" chemicals a year. Since it is illogical and unrealistic to expect that all of these chemicals should be subjected to detailed testing for all potential adverse health and environmental effects, OTS views screening assays as highly useful tools to assign priorities to chemicals for further testing according to standard methodologies. The Chernoff/Kavlock assay (preliminary developmental toxicity screen) was specifically developed to address the need for a developmental toxicity assay to prioritize for further testing the large number of "new" and "existing" chemicals. OTS has been involved in seeking the development of data through the preliminary developmental toxicity screen for purposes of validating the screen and to obtain critical data necessary for evaluating chemicals. OTS believes that the screen has a role in the risk assessment process and has developed a testing protocol, which is included along with other OTS test guidelines; has provided internal guidance on when the screen may be recommended; and has discussed how the data may be applied in prioritizing chemicals for further study.

Animals↗
PubMed1977

Development of a chemical use classification system to facilitate reporting under the Toxic Substances Control Act.

A classification system was developed to enable manufacturers and processors of industrial chemicals to report categories of proposed categories of use of such chemicals to the Environmental Protection Agency in accordance with the Toxic Substances Control Act. To accommodate the two aspects of chemical use (i.e., function and application), a faceted classification scheme was designed. The function facet contains categories denoting the action for which a chemical is specially fitted or used, for example, adhesives or fuels. The application facet contains categories denoting the process or product in which a chemical is used, such as synthetic rubber manufacture. Linking these two facets in a single notation code provides a comprehensive indication of a chemical's use or uses. A variety of existing relevant classification schemes and reference tools were used as input sources for the chemical use classification. The practicability of the classification system was tested using a small sample of manufacturing and processing companies.

Chemical Phenomena↗
PubMed1992

Pushing the environmental regulatory focus a step back: controlling the introduction of new chemicals under the Toxic Substances Control Act.

Environmental destruction and its attendant effects on the animal world, including human beings, has moved to the forefront of United States and worldwide policy. The effect of this deterioration on human health is unclear. Much debate focuses on the cases of cancer, along with other diseases, that are environmentally induced. Congress has responded with various environmental laws. These laws focus primarily on controlling chemicals placed into the environment, largely by industry. This Note proposes that such a singular focus is inadequate and ultimately costly. A more sensible and efficient strategy to environmental protection places emphasis on controlling inputs to the productive process before the need arises to contain such substances. The Toxic Substances Control Act of 1976 ("TSCA") takes this approach. This Note reviews the means by which TSCA attempted to accomplish its goals and concludes that TSCA's implementation has largely been ineffective. The Note then discusses three possible explanations for TSCA's failure. Finally, the Note proposes how TSCA might be made more effective in regulating new chemicals.

Air Pollution↗
PubMed1995

The use of plants for environmental monitoring and assessment.

This paper presents a critical review on phytotoxicity tests for environmental monitoring and assessment. Vascular macrophytes used in the laboratory testing are emphasized; algae are mentioned only for comparison. Several issues are discussed, including the rationale for and misconceptions about phytotoxicity tests, relation to regulation, status of phytotoxicity test protocols, advantages and disadvantages of phytotoxicity tests, and possible research directions. Aquatic and terrestrial macrophytes, along with algae, are essential components of ecosystems. Macrophytes are becoming more important for the monitoring and assessment of herbicides, effluents, and industrial chemicals. In the United States, Canada, and international organizations, phytotoxicity tests can be required for environmental monitoring and assessment in statutes such as Federal Insecticide, Fungicide, and Rodenticide Act; Toxic Substances Control Act; Water Quality Act; Canadian Pest Control Products Act; and Canadian Environmental Protection Act. Possible research directions for phytotoxicity tests are discussed relative to the role in regulations of industrial chemicals, effluents, hazardous waste sites, and pesticides.

Environmental Monitoring↗
PubMedDate not supplied

Role of exposure databases in risk assessment.

Risk assessments have assumed an increasingly important role in the management of risks in this country. The determination of which pollutants or public health issues are to be regulated, the degree and extent of regulation, and the priority assigned to particular problems are all areas of risk assessment that influence the country's $100 billion annual investment in environmental protection. Recent trends in public policy have brought the practice of risk assessment under greater scrutiny. As policy makers increasingly insist that specific numerical risk levels (so-called bright lines) be incorporated into regulatory decisions, the stakes for good risk assessment practice, already high, are raised even further. Enhancing the scientific basis of risk assessments was a major goal of the Workshop on Exposure Databases. In this article, we present the Risk Assessment Work Group's evaluation of the use of exposurerelated databases in risk assessment and the group's recommendations for improvement. The work group's discussion focused on the availability, suitability, and quality of data that underly exposure assessments, a critical component of risk assessment. The work group established a framework for evaluation, based on exposure scenarios typically used in regulatory decisions. The scenarios included examples from Superfund, the Clean Air Act, the Toxic Substances Control Act, and other regulatory programs. These scenarios were used to illustrate current use of exposure data, to highlight gaps in existing data sources, and to discuss how improved exposure information can improve risk assessments. The work group concluded that many of the databases available are designed for purposes that do not meet exposure and risk assessment needs. Substantial gaps exist in measurements of actual human exposure and in the data necessary to model exposures, to characterize distributions of exposure, to identify high-risk groups, and to identify possible environmental inequities in exposure. The work group, on the basis of its findings, made both short-term and longer-term recommendations for improving the collection of exposure data in the future.

Animals↗
PubMed1994

QAU verification: Ricerca's approach to EPA requirements for specimen disposition.

The U.S. Environmental Protection Agency (EPA) Federal Insecticide. Fungicide and Rodenticide Act and Toxic Substance Control Act Standards issued in 1989 presented a new task for the Quality Assurance Unit (QAU). Sections .190 and .195 of these Good Laboratory Practice (GLP) Standards require "quality assurance verification" prior to the disposal of certain specimens. These include "specimens from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids." QAU involvement in the specimen disposition process was a new concept. Other GLP Standards required specimen retention only as long as the quality of the preparation afforded evaluation: the QAU was not included in the procedure. The QAU verification step was included by the EPA to ensure that disposal of the prescribed specimens would not compromise the integrity of the study. A procedure to address verification of specimen disposition as required by the EPA GLP Standards has been implemented by Ricerca's QAU. This presentation provides a description of this approach to QAU verification.

Documentation↗
PubMedDate not supplied

Quality assurance responsibilities as defined by the EPA Good Automated Laboratory Practices (GALPs).

In December 1990, the Environmental Protection Agency's (EPA) Office of Information Resources Management (OIRM) issued a draft of the Good Automated Laboratory Practices (GALP). The GALPs developed from a union of existing Federal and EPA regulations and policies, including: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) & Toxic Substance Control Act (TSCA), Good Laboratory Practices (GLP), the EPA Information Resources Management Policy (IRMP), and the Computer Security Act of 1987. The GALPs consolidate the regulations and policies to provide a single source of reference, and sever as an extension of the GLP standards (40 CFR 160 & 792). Whereas the GLPs describe acceptable laboratory management practices, the GALPs describe acceptable automated data management practices, and give guidance for standardizing and implementing procedures to ensure the quality and integrity of automated data collection and storage. The GALPs have been formatted to parallel the structure of the GLPs. Just as the GLPs define the responsibilities of the Quality Assurance Unit (QAU) in maintaining good laboratory practices, the GALPs define the responsibilities of the QAU in maintaining good automated data practices. The QAU is charged with (i) maintaining copies of written procedures for the automated data collection system, (ii) performing inspections of laboratory operations utilizing the automated data collection system and reporting findings, (iii) ensuring authorization and documentation of deviations from written procedures, (iv) auditing data and reports from the automated data collection system to ensure they accurately represent the raw data, and (v) maintaining records of the above-defined QAU functions.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Information Systems↗
PubMed1993

Role of the U.S. Congress in setting goals and priorities for research on nutrition and aging.

The U.S. Congress plays an important role in setting the broad research agenda for research agencies. It often does so by articulating major goals for federally-supported activities. Goals, longer-term objectives that agencies should work towards, should not be confused with priorities, near-term resource allocations designed to support efforts to achieve goals. Typically, federal research priorities are established by individual departments, agencies, and other organizations within the executive branch; however, when the funding levels are particularly large or public concern about an issue is particularly intense, Congress may become involved in the process of setting specific priorities. Congress influences the directions of research on aging primarily through the activities of authorization, appropriations, and special or select committees. The Special Committee on Aging in the Senate, and the Select Committee on Aging in the House of Representatives focus their attention exclusively on elderly Americans. Periodically, the activities of these committees are directed to research issues. Congress indirectly influences the directions of research on aging and nutrition through laws that establish science-based regulatory programs such as the Food, Drug, and Cosmetic Act, and the Toxic Substances Control Act. In setting priorities Congress relies on information, analysis, and advice from the four congressional support agencies, particularly the Office of Technology Assessment (OTA). OTA has undertaken a number of studies in recent years which address aging and nutrition issues. It is useful to try to devise mechanisms to encourage the establishment of national and international long-range goals and near-term priorities for research on aging and nutrition.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1995

U.S. EPA challenges and review--highlights of the Fiscal Year 1994 Inspection Program and EPA's laboratory accreditation considerations.

The reorganization and consolidation of the United States Environmental Protection Agency's (EPA's) Headquarters Enforcement and Compliance programs into a new Office of Enforcement and Compliance Assurance (OECA) is now complete. The Good Laboratory Practice (GLP) inspection program is now part of the Office of Compliance, one of the principal offices in this new organization. The role of the Office of Compliance and the implications of these changes for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) GLP programs are addressed. Highlights of the fiscal year 1994 inspection program are reviewed. The status of the Agency's consideration of laboratory accreditation is discussed.

Accreditation↗
PubMed1991

EPA use of in vivo germ cell mutagenicity data.

The Toxic Substances Control Act (TSCA) provides the U.S. Environmental Protection Agency, Office of Toxic Substances (EPA, OTS) with the authority to regulate chemical use by requiring testing and use restrictions as appropriate to protect human health. Regulation on the basis of heritable mutation induction is specifically mentioned in the Test Rule section of the law and has also been pursued for new chemical substances. A tiered scheme of mutagenicity testing has been employed and recently revised to assess mutagenicity hazard. In vivo assay systems play key roles at all three levels in the scheme, beginning with the first level of determining intrinsic mutagenicity hazard. Once intrinsic mutagenicity has been identified, the revised scheme requires an assay or assays to assess chemical interaction with gonadal DNA. Finally, the scheme contains tests that permit risk assessment for a chemical. The recently-revised Office of Pesticide Programs (OPP) mutagenicity testing requirements closely parallel those of OTS.

Animals↗
PubMed2000

Regulatory framework for the thermal treatment of various waste streams.

Since 1990, regulations and standards have changed considerably. This article is an update of the regulatory requirements for the thermal treatment of various waste streams. The waste categories covered, along with the laws they are governed under, include: Hazardous waste under Subtitle C of the Resource Conservation and Recovery Act (RCRA) and under the Clean Air Act; municipal solid waste under Subtitle D of the RCRA; medical waste under Subtitle J of the RCRA; Superfund waste under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA); toxic waste under the Toxic Substances Control Act (TSCA); and sludge waste under the Clean Water Act (CWA).

Humans↗
PubMed1995

The new chemicals process at the Environmental Protection Agency (EPA): structure-activity relationships for hazard identification and risk assessment.

Section 5 of the Toxic Substances Control Act (TSCA) does not require any toxicity testing as a prerequisite for submission of a Premanufacturing Notice (PMN) for a new chemical. In order to compensate for the lack of actual test data, a process involving structure-activity relationships (SAR) for assessing hazard potential was constructed. The hazard assessment is then coupled with an estimation of potential exposure to determine potential risk. This process involves the use of multiple interdisciplinary teams that work within a 90-day time frame to complete approximately 2000 risk assessments per year.

Animals↗