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Harmonized Test Guidelines

The Office of Chemical Safety and Pollution Prevention (OCSPP) has developed a series of harmonized test guidelines for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency. The OCSPP Harmonized Test Guidelines are organized in the following series:

Note - the name change from "Office of Prevention, Pesticides and Toxic Substances" and "OPPTS" to "Office of Chemical Safety and Pollution Prevention" and "OCSPP" does not affect the Guidelines.

The OCSPP harmonized test guidelines are documents that specify methods that EPA recommends be used 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 for 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 and part 161, 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). The test guidelines may also be used as part of voluntary testing. Note that where data will be required under a TSCA rule (such as a test rule under TSCA section 4), a TSCA-specific version of the applicable guideline may be promulgated as a rule. Examples may be found at 40 CFR part 799, subparts E and H.

The OCSPP harmonized test guideline library is intended to provide a compilation of guidelines for conducting the studies routinely used for generating data on pesticides and industrial chemicals regulated under FIFRA and TSCA, but may also be useful for voluntary testing purposes.  Data submitted to EPA are used by the Agency to perform risk assessments and make regulatory decisions. 

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, industry, non-profit organizations, and other governments.  Some of these guidelines harmonize EPA's data requirements with 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, significant scientific issues were presented 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 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, DRAFT guidelines may undergo external peer review and be available for public review and comment.

A Master List (PDF) (28 pp, 80K, About PDF) of the OCSPP Harmonized Test Guidelines is available | Microsoft Excel Version (84K) (Excel viewer Exit EPA Disclaimer)

 


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