Pesticide Registration Policy and Guidance
Antimicrobial Policies and Guidance
- Antimicrobial Policies and Guidance - Guidance, science policy and protocols for registering antimicrobial pesticides.
- Efficacy Requirements for Antimicrobial Pesticides - In addition to data requirements that apply to all pesticides, pesticides designed to control microbial pests such as viruses and bacteria must have data proving their ability to kill these pests (known as efficacy).
Toxicity Testing Topics and Guidance
- Process for Evaluating & Implementing Alternative Approaches to Traditional in Vivo Acute Toxicity Studies for FIFRA Regulatory Use
- Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products
- Guidance for Thyroid Assays in Pregnant Animals, Fetuses and Postnatal Animals, and Adult Animals
- Advances in Genetic Toxicology and Integration of in vivo Testing into Standard Repeat Dose Studies
- Strategic Direction for New Testing and Assessment Approaches for Pesticides - EPA is developing and evaluating new technologies in molecular, cellular, and computational sciences to supplement or replace more traditional methods of toxicity testing and risk assessment.
- Bridging or waiving data requirements - We have two related documents to assist registrants in determining if waivers to data requirements may apply:
- Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products - criteria that can be cited by registrants to bridge data for or support a waiver of the requirement for mammalian acute toxicity data for pesticide technical active ingredients and pesticide end use formulations (Acute Oral, Acute Dermal, Acute Inhalation, Primary Eye, Primary Dermal, and Dermal Sensitization).
- Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations and Supporting Retrospective Analysis," published in 2016, expands the potential for data waivers for acute dermal studies for formulated products. The document includes a policy statement to waive all acute lethality dermal studies for formulated pesticide products (see section 3.0).
- EPA is requesting GHS calculations paired with acute oral and acute inhalation toxicity study data to support the evaluation of pesticide product formulations. The GHS dose additive mixtures equation, used to classify the toxicity of mixtures based on the available data on the individual ingredients in them, could be an alternative to animal testing of pesticide formulations. OPP will use submissions under this pilot to evaluate the utility and acceptability of the GHS dose additive mixtures equation as an alternative to oral and inhalation toxicity studies for pesticide formulations. For information on how to submit data for the pilot and an example submission template, visit our Mixtures Equation Pilot Program page.
- Guidance for Identifying, Selecting and Evaluating Open Literature Studies - OPP considers multiple sources of information when conducting risk assessments for pesticides, not just studies conducted specifically to support pesticide registration. This page provides guidance for OPP staff to assist in their evaluation of open literature studies of pesticides.
Protection of Human Test Subjects
- Protection for Human Test Subjects - EPA released the final rule on ways to strengthen protection for participants involved with human subjects research. This page includes this notice and background information related to its development.
- EPA Settles Human Studies Lawsuit. Search EPA Archive
Additional Guidance and Policy Information
- Pesticide registration notices
- TRAC Science Policy Issues and Documents - In 1998, EPA began releasing science policy documents related to implementation of the Food Quality Protection Act (FQPA) for public comment. The initial framework and list of documents was developed in consultation with the EPA Tolerance Reassessment Advisory Committee (TRAC). The Agency continues to identify guidance and policy documents to make available to the public. Search EPA Archive
- Determining If Insect Repellent Skin Patch Products Must Be Registered Under FIFRA
- Nitrogen Stabilizer Products that Must Be Registered under FIFRA