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Test Guidelines for Data Requirements

Harmonized Test Guidelines
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Current as of December 2014

Before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA grants a “registration” or license that permits a pesticide’s distribution, sale, and use only after the company meets the scientific and regulatory requirements.

In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product. Potential registrants must generate scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide.

Harmonized test guidelines meet multiple data requirements

EPA recommends the pesticide registrant provide data from tests conducted according to EPA’s Harmonized Test Guidelines. The purpose for harmonizing these guidelines into a single set of guidelines is to minimize variations among the testing procedures that must be performed to meet the data requirements under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.).

Information about the specific scientific studies required for pesticide registration is located in the Code of Federal Regulations: 40 CFR 158. EPA’s 340 test guidelines for use in data development for the assessment of pesticides are based on the data requirements outlined in Part 158. (Read about data requirement revisions for antimicrobial pesticides, which became effective on July 8, 2013).

Other guideline harmonization efforts

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, namely for acute lethality, sensitization, and skin and 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 Exit EPA disclaimer fall under the OECD Mutual Acceptance of Data decision, which calls for acceptance for regulatory use by all OECD member nations.

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