40 CFR 152.85 - Formulators' exemption.
(a) Statutory provision. FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to any pesticide contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another person. This provision is commonly referred to as the formulators' exemption.
(b) Applicability of the formulators' exemption.
(1) The formulators' exemption applies only to data concerning the purchased product or its ingredients. These data may include, but are not limited to, product chemistry, toxicology, residue chemistry, exposure, environmental fate, and ecological effects.
(2) The data to which the formulators' exemption applies usually will concern the safety of one or more of the product's active ingredients, specifically, those active ingredients which are contained in the purchased product. In general, data for which the required test substance is the technical grade of the active ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product are eligible for the formulators' exemption.
(3) The formulators' exemption generally does not apply to data on the applicant's product itself, including the safety or efficacy of the product, unless the composition of the product is identical to the purchased product. In general, data for which the required test substance is the product proposed for registration are not eligible for the formulators' exemption.
(c) Limitation of the formulators' exemption. EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant to use the formulators' exemption with respect to data concerning an ingredient of his product only if:
(1) The application indicates that the ingredient's presence in the product is attributable solely to the purchase from another person of an identified, registered product containing that ingredient and the use of the purchased product in formulating the product; and
(2) The purchased product is a registered manufacturing-use product whose label does not prohibit its use for making an end-use product labeled for any use for which the applicant's product will be labeled; or
(3) The purchased product is a registered end-use product labeled for each use for which the applicant's product will be labeled.
(d) Claiming eligibility for the exemption.
(1) If the product contains one or more ingredients eligible for the formulators' exemption, the applicant need not comply with the requirements of §§ 152.90 through 152.96 with respect to any data requirement pertaining to such ingredient, provided that he submits to the Agency a certification statement containing the following information (a form for this purpose is available from the Agency):
(i) Identification of the applicant, and of the product by EPA registration number or file symbol.
(ii) Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the EPA registration number of the product that is the source of that ingredient.
(iii) A statement that the listed ingredients meet the requirements for the formulators' exemption.
(iv) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula.
(v) The name, title and signature of the applicant or his authorized representative and the date of signature.
(2) An applicant for amended registration is not required to submit a new formulators' exemption statement, if the current statement in Agency files is complete and accurate.
(e) Approval of registration. Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve an application unless there are available to EPA for its review all data that are necessary to make the required risk/benefit finding under FIFRA section 3(c)(5) or section 3(c)(7).