Test Guidelines for Data Requirements
Harmonized Test Guidelines
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 May 8, 2013).
Local Lymph Node Assay
Dermal sensitization guidelines (OPPTS 870.2600) now includes end-use pesticide products using the traditional (radiolabeled) Local Lymph Node Assay (LLNA). The policy expands the usefulness of the traditional LLNA protocol for assessment of dermal sensitization potential from technical grade active ingredients to end use products. See the details of the expanded protocol.
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 MethodsEPA 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 fall under the OECD Mutual Acceptance of Data decision, which calls for acceptance for regulatory use by all OECD member nations.
- Toxicology and ecotoxicology guidelines under development
U.S. experts are engaged in harmonization activities through OECD to revise toxicology and ecotoxicology test guidelines. These revisions will emphasize reduction, refinement, or replacement of animal testing, while incorporating the latest advances in science. Animal welfare concerns and international regulatory needs are being considered in the course of these revisions of the test guidelines. In addition, EPA is actively engaged in OECD’s development and harmonization efforts for guidelines to address environmental fate, endocrine disruptor screening, and efficacy of antimicrobial pesticides.
- Harmonization of residue chemistry guidelines
EPA is active in a multi-year OECD project to harmonize pesticide residue chemistry test guidelines and submission templates. As of October 2007, five test guidelines and three guidance documents have been published by OECD, with an additional two guidelines expected to be published later in 2007. These initial phase residue guidelines emphasize laboratory or contained studies, while the guidance documents emphasize technical policy frameworks for their use. The OECD is also working to develop a harmonized guideline and guidance document for crop field trials.