Test Guidelines for Pesticide Data Requirements
- Data requirements for pesticide registration
- Implementing alternative approaches to traditional acute toxicity studies
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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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).
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.
- Test Guidelines/Acute Toxicity - Acute Oral Toxicity Up-And-Down-Procedure
The Up-and-Down Procedure is an alternative acute toxicity test that provides a way to determine the toxicity of chemicals with fewer test animals by using sequential dosing steps. It is used in the Series 870 Health Effects Test Guidelines for acute toxicity testing and by the Organisation for Economic Co-operation and Development member nations. It replaces the traditional acute oral toxicity test formerly used to characterize industrial chemicals, pesticides, and their mixtures.
- Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products
This updated guidance document describes a testing framework for assessing eye irritation potential of EPA-registered antimicrobial cleaning products using three in vitro/ex vivoassays (non-animal tests).
- Update on the Use of the Local Lymph Node Assay for End Use Pesticide Products and Adoption of the Reduced Dose Protocol for LLNA (rLLNA)
Applicants for pesticide registration may use the existing OPPTS 870.2600 dermal sensitization guideline for both the technical grade active ingredients and end use pesticide products with the radiolabeled (or traditional) Local Lymph Node Assay (LLNA). The “reduced or limit dose” LLNA (rLLNA) radiolabeled assay is also available, which further reduces the number of animals used in laboratory tests by 40% when compared to the multi-dose LLNA.
- Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products
This paper integrates information from various Agency documents and other memoranda, as relevant, into one document that can be used as a single reference source for acute toxicity waiver guidance as well as criteria for bridging of acute toxicity data.
- Guidance for Neurotoxicity Battery, Subchronic Inhalation, Subchronic Dermal and Immunotoxicity Studies
Provide guidance on the weight of the evidence-based (WOE) determination of data needs for neurotoxicity, subchronic inhalation, subchronic, dermal and immunotoxicity studies and provide guidance on how to consider the data needs determination in risk assessment. Evaluation of waiver requests and development of registration review cases are typical situations in which OPP reviewers will make data need determinations.
- Genetic Toxicology: Integration of in vivo Testing into Standard Repeat Dose Studies
There have been a number of recent advances in the area of genetic toxicity testing that would reduce animal usage and still provide the necessary information for an assessment of the genotoxic potential of substances. The integration of the cytogenetic tests into repeated dose toxicity studies can be used to satisfy the in vivo cytogenetic data requirement in CFR Part 158.
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.
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.