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Statement of Need: Since the 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, updated data requirements have been applied on a case-by-case basis to support individual registration applications or imposed by data call-in on registrants of similar products. The codified data requirements have not been revised to keep pace with the updated data requirements. EPA will also propose to reformat the data requirements and revise procedures and policies for data submission. The changes to be proposed are intended to provide stakeholders with a more transparent and improved clarity of the potential data requirements, more focused use patterns that reflect current practice, and a more efficient registration process.

Summary of the Legal Basis: The planned proposed rule is intended to describe data and information needed to support multiple pesticide mandates under two statutes, specifically the registration, reregistration, registration review, experimental use permit programs under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the tolerance-setting program under the Federal Food, Drug and Cosmetic Act (FFDCA). FIFRA section 3(c) requires that applicants for registration provide the Agency a full description of tests made and the results that support the registration of a pesticide product, and requires the Agency to issue guidelines specifying the kinds of information needed to support registration. FIFRA section 3(g) requires the Agency to review every 15 years the registration of each pesticide, and determine that it continues to meet the registration standard. The data requirements established for registration will be the foundation of the Agency's registration review. FIFRA section 4 requires the Agency to reregister pesticides that were registered prior to 1984, and in so doing, to provide data and summaries of studies previously submitted to support registration. FIFRA section 5 authorizes the Agency to issue experimental use permits for which data may be required. FFDCA section 408 authorizes EPA to establish tolerances (or expemptions from tolerance) for pesticide residues in food, and prescribes generally the types of data that are to be submitted to support such tolerances.

Alternatives: The Agency is required by its various statutory mandates to establish data requirements that support its regulatory decisions. It is incumbent on the Agency to reevaluate those data requirements in light of scientific advances, analytical improvements, and new technology, in order to provide a sound scientific basis for those decisions. Accordingly, EPA sees no alternative to the overall need to update and revise its data requirements periodically. As it does so, however, each individual data requirement is evaluated against current scientific standards, value and cost, and undergoes an extensive review, including external and public participation, to assess the continued need for the data. The Agency also 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.

Anticipated Costs and Benefits: Although estimates may change before the proposal is published, the following estimates are based on the current draft Economic Analysis. Using the currently codified requirements as the baseline for the impact analysis, the total annual impact of the proposed revisions to the pesticide industry is estimated to be about $50 million. Of this estimated total annual impact, about $29 million per year represents new data requirements that were imposed over the years but were not specified in the existing CFR. As they have been applied to an increasing number of registrations, these data requirements have become more regularly required and will be proposed for codification. In addition, about $22 million represents the cost of the proposed modified or expanded existing data requirements for certain tests and use patterns, and about $2 million represents the cost of proposed new data requirements for data that have not yet been routinely sought. The benefits are difficult to quantify but were an important part of the Agency consideration in developing the proposal. The following parties are expected to benefit: consumers and the general public; farmers and other workers; registrants; animal welfare concerns; scientific, environmental and health communities; State and local governments; EPA and other Federal agencies; and governments outside the United states.

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 efficacy in certain cases. This information is used to assess the human health and environmental risks associated with the product. The data that would be required by this regulation in its current form, and as expected to be proposed, form the foundation of EPA's risk assessment for pesticides, and provide a sound scientific basis for any licensing decisions that impose requirements that mitigate or reduce risks, and that ensure that pesticide residues in food meet the "reasonable certainty of no harm" risk standard of the FFDCA.