FIFRA—

The tria2ine family of herbicides appeared in and after 1955, and the bipyridiniums in 1960. In 1967, two new chemical herbicides (1) were registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The number of new registrations swelled to 11 in 1975 and subsequendy dropped to three in 1990 and two in 1991. 

FIFRA Sections 3 and 4 pertain to registration and reregistration of pesticides, with clearly defined data requirements as outlined in Tide 40 of the US. Code of federal Regulations (51). About 120 different studies are Hsted, most of which are to be done on technical-grade active ingredients (TGAIs). 

Subdivision O guidelines for residue chemistry data were originally pubHshed by the EPA in 1982. These have been supplemented to improve the rate of acceptance by EPA reviewers of the many reports submitted by registrants in support of tolerances for pesticides in foods. The residue chemistry studies most frequently rejected include metaboHsm in plants, food processing (qv) studies, and studies on storage stabHity of residues in field samples (57). AH tolerances (maximum residue levels) estabHshed under FIFRA are Hsted in 40 CFR under Sections 180 for individual pesticides in/on raw agricultural commodities, 180 for exemptions from tolerances, 185 for processed foods, and 186 for animal feeds. 

US. Federal Insecticide, Fungicide, and Kodenticide Hct as Hmended, FIFRA as passed in 1947 amended as the Federal Environmental Pesticide ControlA.ct (1972), 540/09-89-012, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C., rev. Oct. 1988. 

U. S. Code of Federal Regulations, Tide 40 Protection of Environment, Subchapter E FIFRA—Pesticide Programs, Parts 150—189, rev. July 1,1994, pubHshed by the Office of the Federal Register as a Special Edition, distributed by Government Institutes, Inc., Rockville, Md., 680 pp. 

The two main federal agencies involved in the protection of human health and the environment are the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA). EPA s principal concern is the protection of the environment, in most cases, the area outside of an industrial faciUty. There are 10 regional offices that carry out the regulatory functions of the agency (Table 1). Primary laws covered by EPA are the Clean Air Act Amendments (CAAA), the Clean Water Act (CWA), Resource Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation, and LiabiUty Act (CERCLA), Toxic Substances Control Act (TSCA), and Eederal Insecticide, Eungicide, and Rodenticide Act (FIFRA). 

In addition to conventional pesticides such as insecticides, herbicides, and fungicides, there are other chemicals classified as pesticides and regulated under FIFRA. These chemicals include wood preservatives, disinfectants (excluding chlorine), and sulfur. In the United States these chemicals have aimual usage of about 500,000 t, which is equal to conventional pesticides. 

Another section of the EPA, the Office of Prevention, Pesticides, and Toxic Substances (OPPT), has recently updated and harmonized its testing guidelines for evaluating the developmental and reproductive effects of pesticides and industrial chemicals to include an assessment of endocrine disrupting properties. These guidelines will be used in future testing of pesticides under both the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). 

EPA s decision to register a pesticide is based in part on the risk of adverse elfects on endangered species as well as the environmental fate (how a pesticide will affect the habitat), Under FIFRA, EPA can issue emergency suspensions of certain pesticides to cancel, or restrict their use if an endangered species will be adversely affected. Under a new program, EPA, FWS, and USDA are distributing hundreds of county bulletins which include habitat maps, pe.sticide use limiiiiions,, md other actions required to protect listed species. 

When EPA became aware almost five years ago that N-nitroso contaminants occurred in a number of pesticide products, the Agency immediately acted on the authority of Section 3 of FIFRA to place a moratorium on new registrations of pesticides suspected to contain N-nitroso contaminants at detectable levels (this term is defined and explained later in the text). As has been discussed in other papers of the Symposium, many N-nitroso compounds are animal carcinogens and, consequently, suspected human carcinogens. 

The primary focus of FIFRA is to provide federal control of pesticide distribution, sale, and use. Under FIFRA, the ERA was given authority to study the consequences of pesticide usage. FIFRA requires that all pesticide uses in the United States be registered by ERA. Registration assmes that pesticides will be properly labeled and that if produced and used in accordance with specifications, pesticides will not cause unreasonable harm to the environment. ... 

The FQPA is another important statute for regulating pesticides. The FQPA amendments to FIFRA changed the way ERA regulates pesticides. The requirements included a new safety standard - reasonable certainty of no harm - which must be applied to all pesticides used on foods. ... 

The processing report contains a summary of the processing data. An outline of each report element is presented in the following sections with clarifications added as needed. The processing report may be included as an appendix in the final report of the processing study to satisfy the FIFRA GLP Standards 40 CFR 160.185(a)(12). 

United States Environmental Protection Agency Web site www.epa.gov/region5/defs/htm]/ fifra.htm. 

The emphasis that the FQPA placed on the assessment of pesticide residues in drinking water, for example, led to the collection and analysis of data on the effects of drinking water treatment processes on pesticide residues. These data were presented to the FIFRA Science Advisory Board to highlight the variability in the effects of treatment on different kinds of pesticides and the products formed and the variability of treatment processes employed at different locations and at different collection time intervals at an individual location. These complexities led to the current proposal... 

A Case Study Advancing Ecological Risk Assessment Methods in the EPA, Office of Pesticide Programs, Final Report from FIFRA Scientific Advisory Panel. USEPA, Washington, DC (2001). Also available on the World Wide Web http //www.epa.gov/scipoly/sap 001/index.htm, accessed September 2002. 

FIFRA Scientific Advisory Panel Meeting Report, Review of Proposed Revised Guidehnes for Conducting Terrestrial Field Dissipation Studies , SAP Report No. 90-01, United States Environmental Protection Agency, Washington, DC, p. 32 (1998). 

Some data submitters were concerned about whether the supplemental files would be archived along with the data, and whether the supplemental files would be subject to Freedom of Information Act (FOIA) requests. OPP expects to maintain the CD provided as the electronic data submission, and archive the supplemental files on CD along with the rest of the electronic data submission. However, the official archive format at the present time is paper, and the supplemental files duplicate material in the paper submission. Supplemental files may be released upon FOIA requests after the first registration for the pesticide active ingredient, subject to the requirements of FIFRA 10(g), which include an affirmation statement from the requestor and a notice to the data owner, and exclude any FIFRA CBI. 

Table 2 Possible FIFRA GLP citations that apply to electronic data systems...

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