About Test Guidelines for Pesticides and Toxic Substances
EPA's test guidelines for pesticides and toxic substances specify EPA-recommended methods to generate data that is submitted to EPA to support:
- The registration of a pesticide under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136);
- Setting of a tolerance or tolerance exemption for pesticide residues under section 408 the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a); or
- The decision making process supporting potential regulation of an industrial chemical under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601).
Studies conducted according to these test guidelines may be used for satisfying FIFRA data requirements in 40 CFR part 158, data-call-ins issued pursuant to FIFRA section 3(c)(2)(B), as needed to satisfy data requirements appropriate for specific pesticide registration applications, or for satisfying data requirements to demonstrate the safety of a tolerance or tolerance exemption under FFDCA section 408.
Test guidelines used in regulatory actions as bases for test standards under TSCA are typically promulgated in 40 CFR part 799, or may be written into specific TSCA rules (such as test rules under TSCA section 4). Note that where data will be required under a TSCA rule (such as a test rule under TSCA section 4), EPA may promulgate a TSCA-specific version of the applicable guideline as a rule. You can find examples at 40 CFR part 799, subparts E and H.
The test guidelines may also be used as part of voluntary testing.
These test guidelines were developed by EPA scientists and non-EPA individuals with a particular interest or expertise in the subject matter covered, including representatives from:
- The scientific community,
- Non-profit organizations, and
- Other governments.
Some of these guidelines blend EPA's data requirements with test guidelines established by the Organization for Economic Cooperation and Development (OECD), an international organization whose membership includes most industrialized nations which maintain comprehensive testing requirements for pesticides and industrial chemicals. When necessary, EPA presented significant scientific issues for external peer review to the FIFRA Scientific Advisory Panel (SAP) or to another group of scientific experts for that particular topic.
In general, when substantive or significant changes need to be made or new guidelines issued, EPA intends to submit the revision or new guideline for external peer review by the FIFRA SAP or another panel of scientific experts before it is included as a final test guideline in this library. When changes to a guideline are not significant, EPA will not subject the revision to external peer review before the revised guideline is published as part of this library.
Before being available in final form, drafts of new or revised guidelines may undergo external peer review and be available for public review and comment prior to issuing a final guideline for peer review and comment.
EPA is engaged in several activities to develop new and revised testing methods and guidelines that take full advantage of scientific and technical advances in an expeditious manner.
U.S. Interagency Coordinating Committee for the Validation of Alternative Methods
EPA is an active member of the U.S. Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM). The mission of ICCVAM is to facilitate the development, validation, and regulatory acceptance of new and revised toxicology test methods that reduce, refine, or replace animal use in testing, while maintaining scientific quality and protecting human and animal health and the environment.
ICCVAM has reviewed more than 185 alternative test methods and recommended alternatives for the four most commonly used product safety tests:
- Acute lethality.
- Skin corrosion.
- Eye corrosion.
ICCVAM collaborates with the Japanese Center for the Validation of Alternative methods (JaCVAM) and the European Center for the Validation of Alternative Methods (ECVAM). ICCVAM has also developed a Five-Year Strategy for its work.
Organisation for Economic Co-operation and Development
EPA’s test guidelines are harmonized with those established by the Organisation for Economic Co-operation and Development (OECD). EPA works closely with other government agencies and with other countries through the OECD to facilitate the harmonization of test guidelines. Harmonized test guidelines reduce the burden on chemical producers and conserve scientific resources, including the minimal use of laboratory test animals. They also form a basis for work sharing and cooperation among all OECD countries.
All harmonized OECD test guidelines fall under the OECD Mutual Acceptance of Data decision, which calls for acceptance for regulatory use by all OECD member nations.
Toxicology and Ecotoxicology Guidelines under Development
U.S. experts are engaged in harmonization activities through OECD to revise toxicology and ecotoxicology test guidelines. These revisions will emphasize reduction, refinement, or replacement of animal testing, while incorporating the latest advances in science. Animal welfare concerns and international regulatory needs are being considered in the course of these revisions of the test guidelines. In addition, EPA is actively engaged in OECD’s development and harmonization efforts for guidelines to address environmental fate, endocrine disruptor screening, and efficacy of antimicrobial pesticides.
Harmonization of Residue Chemistry Guidelines
EPA is active in a multi-year OECD project to harmonize pesticide residue chemistry test guidelines and submission templates. As of October 2007, five test guidelines and three guidance documents have been published by OECD, with an additional two guidelines expected to be published later in 2007. These initial phase residue guidelines emphasize laboratory or contained studies, while the guidance documents emphasize technical policy frameworks for their use. The OECD is also working to develop a harmonized guideline and guidance document for crop field trials.