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Statement of Need: The Agency is in the process of updating its data requirements for pesticides. Since the current data requirements were first published in 1984, the information needed to support the registration of a pesticide has evolved along with the expanding knowledge base of pesticide chemical technology. Over the years, revisions and updates to the data requirements have been applied on a case-by-case basis. In 2007, the Agency promulgated data requirements for conventional, and biochemical and microbial pesticide chemicals. As part of this action, the 1984 data requirements were transferred intact to part 161 to provide continued regulatory coverage for antimicrobial pesticides until the Agency can promulgate a final regulation. This rule will update and revise the existing data requirements for antimicrobial pesticide products. These revisions build upon those previously proposed for conventional chemicals, but are tailored to the specific data needs of antimicrobial pesticides. The revisions will provide stakeholders with greater transparency and clarity to determine the data needed for an antimicrobial pesticide product without having extensive consultations with the Agency, more focused use patterns that reflect current practice, and a more efficient registration process. When the Agency promulgates the revised data requirements in part 158 subpart W, the current data requirements in part 161 will be removed.

Summary of the Legal Basis: 7 U.S.C. 136 to 136y

Alternatives: The Agency is required by its various statutory mandates to establish data requirements that support its regulatory decisions. The Agency re-evaluates those data requirements in light of scientific advances, analytical improvements, and new technology, to provide a sound scientific basis for those decisions. On a case by case basis, the Agency considers whether alternative regulatory methods, such as restrictions on use, would obviate the need for data, and explores means of introducing flexibility and clarity to reduce burdens on the regulated community. For this rule, EPA will analyze keeping the current data requirements as specified in part 161, using the data requirements promulgated for conventional chemicals, and promulgating new data requirements specifically for antimicrobials.

Anticipated Costs and Benefits: The Agency is conducting an economic analysis to support the rule. Anticipated benefits include less uncertainty and clearer understanding of the actual risk, increased clarity and transparency to the regulated community, improved scientific basis for pesticide regulatory decisions, and enhanced international harmonization with less duplication of data. The increased costs of the rule are estimated as greater than $3 million /year for the 72 companies that hold registrations or have applied for a registration for an antimicrobial product.

Risks: The revisions to the data requirements to be proposed, like the existing requirements in part 158, would require an applicant for pesticide registration to supply the Agency with information on the pesticide: composition, toxicity, potential human exposure, environmental properties and ecological effects, and, in certain cases, efficacy. This information is used to assess the human health and environmental risks associated with the product. The data that will be required by this regulation are the foundation of EPA's risk assessment for antimicrobial pesticides, and provide a sound scientific basis for any licensing decisions that impose requirements that mitigate or reduce risks. Under FIFRA, the applicant for registration must demonstrate to the Agency's satisfaction that the pesticide product will not cause "unreasonable adverse effects" to humans or to the environment.