EPA is revising the data requirements for antimicrobial pesticide products to reflect current scientific and regulatory practice, and to provide the regulated community with guidance on data needed to support pesticide registration decisions for antimicrobial products. The final rule is effective July 8, 2013.
This action will revise data requirements for antimicrobial pesticides currently found in Title 40 of the Code of Federal Regulations (CFR) in part 161, and which are being relocated as revised by the rule to subpart W of part 158. Subpart W sets out data requirements specific to antimicrobial products that are described by the antimicrobial use patterns and use exposure considerations particular to antimicrobials. With the promulgation of part 158, subpart W, EPA is removing part 161, entitled “Data Requirements for Registration of Antimicrobial Pesticides” as it is no longer needed.
The amendments contained in the final rule change the existing data requirements for antimicrobial pesticides:
- By changing some of the existing data requirements, such as a change from conditionally-required to required, a change in the number of test species, or expanding the number of use patterns for which the test is required.
- By adding newly codified data requirements, i.e., data requirements that are not currently identified in 40 CFR part 161, but are considered in current practice on a case-by-case basis.
- By 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.
- By eliminating the requirement for the chronic non-rodent study currently required in 40 CFR part 161.
- By 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.
Antimicrobial pesticides are used to control microbiological contamination in healthcare applications, and deterioration in industrial, commercial, and consumer products. Nearly 60 % of antimicrobial products are registered as public health products to control infectious microorganisms in hospitals and other health care environments, including common public health antimicrobial products such as sterilants, disinfectants, and sanitizers. Nonpublic health products are sold and distributed for use to control growth of algae, odor-causing bacteria, bacteria which cause spoilage, deterioration or fouling of materials and microorganisms infectious only to animals. Other examples of nonpublic health products include products used in cooling towers, jet fuel, paints, and treatments for textile and paper products. Within this final rule EPA is using the term antimicrobials to collectively refer to antimicrobial pesticides, antifoulant coatings and paints, and wood preservatives.