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Test Guidelines for Pesticide Data Requirements

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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.

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Finding Test Guidelines

EPA recommends the pesticide registrant provide data from tests conducted according to EPA’s Test Guidelines. These guidelines meet the data requirements under 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).

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Implementing Alternative Approaches to Traditional Acute Toxicity Studies

We plan to continue to expand acceptance of alternative methods for acute toxicity testing for pesticides. The goals for alternative testing approaches include: 

  • assessing a broader range and potentially more human-relevant adverse effects,
  • generating data faster and at lower cost
  • reviewing data faster and at lower cost, and
  • reducing use of laboratory animals in regulatory testing.

We published a Process for Establishing and Implementing Alternative Approaches to Traditional in vivo Acute Toxicity Studies, which describes a transparent, stepwise process for evaluating and implementing alternative methods of testing for acute oral, dermal, inhalation toxicity, along with skin and eye irritation and skin sensitization (often referred to as the “six pack studies”). Included in this document is a discussion of the three major phases of this process and the implications for reporting information under section 6(a)(2) of FIFRA.

Additional Testing Options for Pesticides

Based on the efforts described below, applicants for pesticide registration have access to several test procedures that offer advantages over traditional test methods, such as using fewer test animals.

Guidance for EPA Staff on Studies and Their Review

  • Guidance for Identifying, Selecting and Evaluating Open Literature Studies

    This document provides guidance for Office of Pesticide Programs (OPP) staff to assist in their evaluation of open literature studies of pesticides. Consistent with the Open Government Initiative, this guidance is also intended to make transparent to the public how we identify, select and ensure that the data we use in pesticide risk assessments is of sufficient scientific quality.

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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. Read more about guideline harmonization.

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