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Harmonized Test Guidelines

The Office of Prevention, Pesticides and Toxic Substances (OPPTS) 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.

Test guidelines are documents that specify methods that EPA recommends be used to generate data to support the registration of a pesticide, setting of a tolerance or tolerance exemption for pesticide residues, or the decision making process for an industrial chemical. These data are used by the Agency to perform risk assessments and make regulatory decisions.

Studies conducted according to these test guidelines may be required under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136) for pesticide registration. The guidelines may also be useful 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 section 408 the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a).

Test guidelines used in regulatory actions as bases for test standards under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601) 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 Final OPPTS Harmonized Test Guidelines are organized in the following series:

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