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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
- Interim guidance clarifying EPA's 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
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:
- Plants; and
- Surface water or ground water.
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.
Interim Guidance Clarifying EPA’s Toxicology Data Requirements for Antimicrobial Pesticides Used on Food Contact Surfaces
EPA issued interim guidance in 2015, clarifying EPA’s 2013 amendments to the data requirements for antimicrobial pesticides, to make the registration process for these pesticides more efficient and transparent. The interim guidance satisfies a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), which followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation (subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia.
EPA’s interim guidance states that, 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 interim guidance 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.
Under the ACC settlement agreement, EPA agreed to propose, by September 2, 2017, a correction to 40 CFR Part 158W to make the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) consistent with the U.S. Food and Drug Administration’s use of that same level. The proposal will clarify that the 200 ppb level established in the rule is based on total estimated daily dietary intake, and not on the amount of residue present on a single commodity.
For more information see the Settlement Agreement available at https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2008-0110-0139 or www.regulations.gov in Docket ID #EPA-HQ-OPP-2008-0110.
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.
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.
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