Published: Jan 2003
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The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(3)(B)(i)(I) requires the Office of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA) as expeditiously as possible to review and act on any application received proposing initial or amended registration of an end-use product that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently registered pesticide identified in the application, or that would differ in composition and labeling from such currently registered pesticide only in ways that would not significantly increase the risk of unreasonable effects on the environment. OPP is proposing some definitions, specifications, and product chemistry data requirements for identical or substantially similar pesticide products, applicable to all pesticides regulated by the EPA. They are required in part to regulate pesticide registrations, reregistrations, and amendments for repacks, alternate formulations, and “me-too” registrations, all require similarity determination by the Agency. The criteria used in the review and decision-making process on initial or amended registration and reregistration of a pending product claimed to be identical or substantially similar to a registered product are based on the chemical composition, physical/chemical properties, and labeling. The purpose of the paper is to make it easier for regulators and the regulated pesticide industry to follow the proposed guidance when applying for “me-too” registration in compliance with FIFRA Section 3(c)(3)(B)(i)(I) and for “alternate formulations” as per the regulations of 40 CFR Part 152.43. The present regulations are general and contain several caveats. Regulations pertaining to acute toxicology, risk assessment, toxicological, ecotoxicological, environmental fate, minor formulation amendments regulated by PR Notice 98-10, are not within the scope of this guidance.
Alternate formulation, CFR, FIFRA, FQPA, Guidelines, Identical, “me-too” registration, PR Notice substantially similar
Senior Scientist, Environmental Protection Agency, Office of Pesticide Programs (7505C), Washington, DC