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EPA/OPPTS | RIN: 2070-AJ27 | Publication ID: Fall 2007 |
Title: Pesticides; Data Requirements for Plant-Incorporated Protectants (PIPs) | |
Abstract: EPA intends to propose codifying data requirements for the pesticide registration of plant-incorporated protectants (PIPs). These data requirements are intended to provide EPA with data and other information necessary for the registration of PIPs. These requirements would improve the Agencys ability to make regulatory decisions about the human health and environmental effects of these products. By codifying data requirements specific to PIPs, the regulated community would have a better understanding of and could better prepare for the registration process. This proposed rule is one in a series of proposals to update and clarify pesticide data requirements. | |
Agency: Environmental Protection Agency(EPA) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 40 CFR 158 and 174 | |
Legal Authority: 7 USC 136a 7 USC 136w |
Legal Deadline:
None |
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Statement of Need: There are currently no separate data requirements for plant-incorporated protectants (PIPs), a new type of pesticide first registered in the mid-1990s. Instead, the Agency has relied on the microbial pesticide data requirements tailored on a case-by-case basis. The information needed to support the registration of a PIP has evolved along with the expanding knowledge base of pesticide chemical technology. When established, these data requirements will reflect current scientific knowledge and understanding. Establishing these data requirements will provide stakeholders with greater transparency and clarity to determine the data needed for PIP pesticide product without having extensive consultations with the Agency and a more efficient registration process. Further, establishing these data requirements will improve the Agency's ability to make regulatory decisions about human health and environmental effects of PIP pesticides to better protect wildlife, the environment and people. |
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Summary of the Legal Basis: The final rule will describe data and information needed to support multiple pesticide mandates under two statutes: the registration, reregistration, registration review, and experimental use permit programs under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the tolerance-setting and reassessment program under the Federal Food, Drug and Cosmetic Act (FFDCA). These programs are authorized under FIFRA sections 3, 4, and 5 and FFDCA sec 408. |
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Alternatives: The Agency is required by its various statutory mandates to establish data requirements that support its regulatory decisions. On a case-by-case basis, the Agency considers whether alternative regulatory methods would obviate the need for data and explores the means of introducing flexibility and clarity to reduce burdens on the regulated community. For this rule, EPA will analyze several scenarios including establishing data requirements tailored specifically to PIP pesticides, not establishing any data requirements, and remaining status quo with relying on the microbial pesticide data requirements tailored on a case-by-case basis. |
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Anticipated Costs and Benefits: The Agency is conducting an economic analysis to support this rule. Anticipated benefits include greater certainty 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. However, since this rulemaking is currently under Agency workgroup discussion, the specific costs and benefits of the action have not yet been determined. The Agency expects this rule to result in decreased illness and death resulting from pesticide exposure. |
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Risks: The proposed revisions to the data requirements, 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. 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 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 resides in food meet the "reasonable certainty of no harm" risk standard of the Federal Food Drug and Cosmetic Act (FFDCA). |
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Timetable:
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Additional Information: SAN No. 5005 | |
Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Federal |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: No | |
Agency Contact: Kristen Brush Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7506P, Washington, DC 20460 Phone:703 308-0308 Email: brush.kristen@epa.gov William Schneider Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7511P, Washington, DC 20460 Phone:703 308-8683 Fax:703 308-7026 Email: schneider.william@epa.gov |