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At least 19 recordsLinked to original sources
PubMed1992

Regulatory concerns of the United States Environmental Protection Agency.

The US Environmental Protection Agency, under 2 of its legislative mandates, has the authority to require the testing of industrial and pesticide chemicals. Among the testing requirements, particularly in chronic studies, are those relating to hematology, clinical chemistry, and urinalysis. Some of these requirements will be discussed in detail. Comments on the usefulness of the current requirements and recommendations for changes will be solicited from the meeting participants.

Animals↗
PubMed1986

The United States Environmental Protection Agency's guidelines for applicator exposure monitoring.

The Environmental Protection Agency (EPA)'s proposed guidelines for studies which estimate worker exposure to pesticides during application and related work activities are discussed. These guidelines are intended to aid pesticide registrants in conducting occupational exposure monitoring studies for pesticide applicators at indoor and outdoor sites. The Agency's rationale for requiring exposure to be monitored with passive dosimetry techniques or by biological monitoring is described. The practical and theoretical advantages and disadvantages of both approaches are also discussed.

Environmental Exposure↗
PubMed2004

Evaluating Oregon's beach sites for application to United States Environmental Protection Agency's BEACH Act criteria.

With the passage of the Beaches Environmental Assessment and Coastal Health (BEACH) Act in 2000, coastal states were mandated to assess and sample coastal recreational waters for bacterial ambient water quality parameters. The assessment of beach sites required the application of federal guidelines and a tiered approach to delineating the beaches. Eighty-seven beach sites in Oregon were evaluated and ranked by use, available information, pollution threats, sanitary survey and monitoring data results, exposure considerations, and economic/development factors. This ranking resulted in 19 high priority beaches (tier 1), five medium priority beaches (tier 2), 23 low priority beaches, and 40 beaches with a rank of none in Oregon.

Environmental Monitoring↗
PubMed2003

Modifications to United States Environmental Protection Agency methods 1622 and 1623 for detection of Cryptosporidium oocysts and Giardia cysts in water.

Collaborative and in-house laboratory trials were conducted to evaluate Cryptosporidium oocyst and Giardia cyst recoveries from source and finished-water samples by utilizing the Filta-Max system and U.S. Environmental Protection Agency (EPA) methods 1622 and 1623. Collaborative trials with the Filta-Max system were conducted in accordance with manufacturer protocols for sample collection and processing. The mean oocyst recovery from seeded, filtered tap water was 48.4% +/- 11.8%, while the mean cyst recovery was 57.1% +/- 10.9%. Recovery percentages from raw source water samples ranged from 19.5 to 54.5% for oocysts and from 46.7 to 70.0% for cysts. When modifications were made in the elution and concentration steps to streamline the Filta-Max procedure, the mean percentages of recovery from filtered tap water were 40.2% +/- 16.3% for oocysts and 49.4% +/- 12.3% for cysts by the modified procedures, while matrix spike oocyst recovery percentages ranged from 2.1 to 36.5% and cyst recovery percentages ranged from 22.7 to 68.3%. Blinded matrix spike samples were analyzed quarterly as part of voluntary participation in the U.S. EPA protozoan performance evaluation program. A total of 15 blind samples were analyzed by using the Filta-Max system. The mean oocyst recovery percentages was 50.2% +/- 13.8%, while the mean cyst recovery percentages was 41.2% +/- 9.9%. As part of the quality assurance objectives of methods 1622 and 1623, reagent water samples were seeded with a predetermined number of Cryptosporidium oocysts and Giardia cysts. Mean recovery percentages of 45.4% +/- 11.1% and 61.3% +/- 3.8% were obtained for Cryptosporidium oocysts and Giardia cysts, respectively. These studies demonstrated that the Filta-Max system meets the acceptance criteria described in U.S. EPA methods 1622 and 1623.

Animals↗
PubMed2001

Indirect exposure assessment at the United States Environmental Protection Agency.

In the early 1980s, exposures and subsequent health impact assessments from contaminants emitted into the air from stationary sources focused on the inhalation pathway. This 'direct' pathway of exposure was thought to be the most critical pathway, as it is for many contaminants. However, by the latter 1980s, the focus at the Environmental Protection Agency (EPA) shifted to contaminants that would persist in the environment and could bioaccumulate up the food chain. Consumption of impacted food products, and other 'indirect' pathways of exposure, such as soil-related exposures, were shown to result in exposures that exceeded inhalation exposures by two to up to four orders of magnitude. A historical background of indirect exposure assessment at EPA is provided in this paper, followed by an overview of modeling methodologies commonly used in indirect exposure assessments. These methodologies are demonstrated on a contaminant of primary focus for indirect exposure impact, dioxins. Two examples are provided. In the first, an air-to-beef model validation exercise is described. In the second, an indirect exposure assessment on a municipal solid waste incinerator in Ohio conducted by the EPA is summarized. This incinerator emitted very large amounts of dioxin, more than any single source known to EPA. Models were used to predict the movement of dioxins from the stack to a nearby hypothetical farm, where individuals in the farm family were exposed to dioxins from consumption of home-produced beef and milk. The predicted lifetime cancer risk of 2.8 x 10(-4) based on these food pathways was used by EPA's Region 5 to initiate regulatory activity on this incinerator.

Agriculture↗
PubMed1978

Analytical determination of N-nitroso compounds in pesticides by the United States Environmental Protection Agency--a preliminary study.

Lijinsky, Eisenbrand and others have demonstrated the formation of N-nitroso derivatives of certain secondary amine pesticides under specified experimental conditions. Partly based on these studies and on reports of the industrial discharge of N-nitrosos compounds from several chemical manufacturing facilities the Environmental Protection Agency (EPA) has issued several reports on the nitroso problem, including a report by a special ad hoc committee under the Administrator's Science Advisory Board (1976). Unexpectedly high N-nitrosoalkylamine residues found in several pesticide products (Fine et al., 1976) have prompted EPA to conduct a survey, initially of approximately 70-80 pesticides that potentially were representative of the following three routes of contamination: 1. industrial process formation and carryover; 2. in situ (container) nitrosation and 3. utilization of contaminated amines in the manufacturing process. Environmental formation was not studied in this survey. Duplicate samples were analysed by two different laboratories using GC and HPLC interfaced with Hall, UV and chemiluminescent (TEA) detectors. Results of some analyses of this continuing survey are presented. Based partly on the results of this study, the Agency has decided to conduct risk-benefit analyses on pesticides suspected of containing N-nitroso contaminants, with special consideration given to oncogenic and mutagenic potential. The analytical results of the study are discussed, as is the cooperative effort within the Agency.

Chromatography, Gas↗
PubMedDate not supplied

Advances in dietary exposure research at the United States Environmental Protection Agency-National Exposure Research Laboratory.

The United States Environmental Protection Agency-National Exposure Research Laboratory's (USEPA-NERL) dietary exposure research program investigates the role of diet, including drinking water, as a potential pathway of human exposure to environmental contaminants. A primary program goal is to establish measurement methods for ingestion that are consistent with approaches used by the USEPA to measure inhalation and dermal exposures, and, hence, total exposure. Research has focused on developing and field-testing measurement methods for personal dietary monitoring, known as duplicate-diet methodology, and on the methods to support analyses of environmental contaminants in foods and beverages. Guidance for measuring personal dietary exposure has been developed for the researcher performing measurements in which there is an established or potential route of exposure to environmental contaminants from foods consumed. Useful information for other types of dietary exposure assessment can be found in existing food consumption and food residue databases. Several of the major food databases have been integrated into an exposure model that provides estimates of potential dietary exposure and identifies potentially highly exposed people for guidance in exposure monitoring. Another component of this research program explores priority, diet-related issues to identify and reduce exposures from foods and beverages. The methods of preparing mercury-contaminated fish by Native Americans and children exposed to lead-laden environments are currently under investigation. Other research is designed to improve our understanding of the process of excess food contamination and the reduction of dietary exposure. Additional research needs are summarized. An overview of the USEPA-NERL dietary exposure program is presented and research discussed in this paper is described in the following papers in this issue.

Databases, Factual↗
PubMedDate not supplied

A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions.

Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data interchange (EDI) guidelines: 1) the EPA Electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also available at: www.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, "Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, "Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway." The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, "Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999." This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, "FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997." This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm.

Authorship↗
PubMed1990

EPA's intervention into workplace health and safety--the other OSHA.

Primarily but not exclusively through the Toxic Substance Control Act (TSCA) and the Superfund Amendment Reauthorization Act Title III, EPA's involvement is significant because they are now a "key player" in providing regulatory direction to those responsible for workplace health and safety. A comparative matrix is presented as a database demonstration of the similarities and differences between OSHA and EPA in the standards setting, compliance, and public policy areas. This matrix demonstrates the impact that EPA now has on specific aspects of workplace health and safety and on the conduct of United States business activity. EPA's restrictive powers are clearly greater than those of OSHA. Conclusions derived from specific interventions of the EPA into workplace health and safety are (1) the industrial hygienist has no choice but to get involved in the compliance and regulatory process evolving from EPA. (2) Industrial hygiene professional societies must likewise become equally aware and involved. (3) There is a strong need for coordination and cooperation between OSHA and EPA leading to effective regulations and avoidance of redundancy. (4) National and global impacts must be optimized to enhance worker health and safety and not be barriers to technical and economic advances. (5) Private sector risk management functions must be integrated to avoid redundancies and omissions. (6) Finally, compliance initiatives can be leveraged to build strong relations with the public and employees.

Environmental Health↗