EPA Data Requirements for Registration of Antimicrobial Pesticides: Part 158W

This page explains recent changes to the data requirements for antimicrobial pesticides.

• Antimicrobial pesticide registration process
• Improved data requirements established in 2013
• Final rule clarifying toxicology data requirements for antimicrobial pesticides used on food contact surfaces
• Agency April 2015 letter to registrants of antimicrobial pesticides concerning recent changes in data requirements
• Antimicrobial Pesticides Use Site Index

Antimicrobial Pesticide Registration Process

With few exceptions, pesticide products must be approved by EPA prior to entering the market. Robust environmental, health and safety testing is required before these products can be sold or distributed. These data requirements apply to anyone or any company that seeks to register pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act or seeks a tolerance (maximum residue limit) or tolerance exemption for a pesticide in food or feed under the Federal Food, Drug and Cosmetic Act

In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product. Prospective registrants generally must generate scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide. The data allow EPA to evaluate whether a pesticide has the potential to cause unreasonable adverse effects on people or the environment, including:

• wildlife;
• plants; and
• surface water or ground water.

Learn more about antimicrobial pesticide registration.

Improved Data Requirements Established in 2013

In 2013, EPA revised the data requirements for antimicrobial pesticides in light of evolving science to ensure pesticide risk management decisions are founded on the best available sound science. The Agency’s purpose in updating these data requirements was to allow the pesticide industry to better understand and prepare for the pesticide registration process and to make the process more efficient and transparent.

Updates to the data requirements in 2013 include the following major changes:

• Changing from conditionally-required to required, changing the number of test species, or expanding the number of use patterns for which the test is required for some of the existing data requirements;
• Adding newly codified data requirements, i.e., data requirements that were not identified in 40 CFR part 161, but are considered in current practice on a case-by-case basis;
• Adding new data requirements, i.e., data requirements that have not been required or have rarely been required in current practice on a case-by-case basis, and have not been routinely considered during the Agency's evaluation of the data needed for the purpose of risk assessment;
• Eliminating the requirement for the chronic non-rodent study currently required in 40 CFR part 161; and
• Codifying the antimicrobial data requirements as finalized in this rule in 40 CFR part 158, subpart W, and removing the current requirements that appear in 40 CFR part 161.

EPA incorporated into the final rule many comments received from stakeholders, government agencies and the general public. Reflecting advances in science and technology since the EPA first published its data requirements in 1984, the revised antimicrobial pesticide data requirements improve the Agency’s ability to protect human health and the environment.

EPA has created training videos to provide guidance on data requirements for antimicrobial pesticides.

The final rule and other associated documents can be found at www.regulations.gov in Docket ID #EPA-HQ-OPP-2008-0110

Final Rule Clarifying Toxicology Data Requirements for Antimicrobial Pesticides Used on Food Contact Surfaces

In May 2019 EPA issued a final rule clarifying data requirements for antimicrobial pesticides in 40 CFR Part 158 Subpart W (158W), making the registration for these pesticides more efficient and transparent. View the final rule.

The final rule that states, in general, if pesticide residues in food resulting from use on food contact surfaces are 200 ppb or less, EPA requires certain toxicology data. If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results. The final rule also clarifies that the referenced 200 ppb level is based on total estimated daily dietary intake rather than on the amount of residue present on a single commodity. This interpretation is consistent with the U.S. Food and Drug Administration’s policy.

In 2017, EPA published the proposed rule and held a public comment period. The proposed rule satisfied a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC). Under the settlement agreement, EPA agreed to propose a change to the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) to make it consistent with the U.S. Food and Drug Administration’s use of that same level. For more information see the Settlement Agreement available at www.regulations.gov in Docket ID #EPA-HQ-OPP-2008-0110-0139.

Agency April 2015 letter to registrants of antimicrobial pesticides concerning recent changes in data requirements

EPA sent a letter to antimicrobial registrants with information about how the Agency has been implementing Part 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial pesticide applications.

Read EPA’s letter to registrants of antimicrobial pesticides concerning recent changes in data requirements.

Antimicrobial Pesticide Use Site Index

EPA developed an Antimicrobial Pesticide Use Site Index (USI) to assist applicants for antimicrobial pesticide registration by helping them identify the data requirements necessary to register a pesticide or support their product registrations and will likewise be used by Agency staff evaluating pesticide applications. Read the Antimicrobial Pesticides Use Site Index.

This document provides guidance about antimicrobial pesticide use sites and general antimicrobial pesticide use patterns and helps registrants determine if labeled uses require the establishment of a tolerance (maximum residue level for food or feed) or exemption from the requirement of a tolerance. The USI will be updated periodically, as needed. 

The Antimicrobial Pesticide Use Site Index, response to public comments and additional subpart 158W documents are available at www.regulations.gov  in docket EPA–HQ–OPP–2015–0302.

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