§152.85 Formulators' exemption.

(a) FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to the safety of any ingredient (or mixture of ingredients) contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another producer.

(b) 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 requirements pertaining to the safety of any 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):

(1) Identification of the applicant, and of the product by EPA registration number or file symbol;

(2) 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;

(3) A statement that the listed ingredients meet the requirements for the formulators' exemption;

(4) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula; and

(5) The name, title and signature of the applicant or his authorized representative and the date of signature.

(c) 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.

[49 FR 30903, Aug. 1, 1984, as amended at 58 FR 34203, June 23, 1993; 60 FR 32096, June 19, 1995]