Page 1 of 1 UNITED STATES ENVIRONMENTAL PROTECTI ON AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES June 1 9 , 2009 MEMORANDUM SUBJECT: HED ChemSAC Request to Remove 40 CFR 180.1(h) . FROM: Bernard A. Schneider, Ph.D., Senior Plant Phy siologist

Chemistry

and Exposure Branch Health Effects Division (7509P) THR OUGH : William Donovan , Ph.D., and Michael Doherty, PhD , Chairperson s ,

HED Chemistry

Science Advisory

Council (ChemS AC) Health Effects Division (7509P) TO: Barbara Madden, Minor Use Officer

Minor Use, Inerts and Emergency Response Branch Registration Division (7505P) Conclusions As part of the ongoing Crop Group Revision P roject, periodic up dates are being made to 40 CFR §180 to include the recommended changes. This process has created an opportunity to implement another change that was identified b y the HED ChemSAC in its meeting of 6/10/2009: to remove section 180.1(h). This decision was arrived at due to the SAC’s unanimous agreement that 1) use information should generall y be avoided in the tolerance listings, 2) there is no safety benefit to be gained by

attempting to distinguish between residues arising from pre - or post - harvest treatm ent s , and 3 ) removal of 180.1(h) would not result in any increased exposure under existing tolerances due to expansion of post - harvest uses unless OPP first determined that increased exposure met the FFDCA safety standard. Detailed Considerations The Co de of Federal Regulations, Title 40, Part 180.1(h) states, “Unless otherwise specified, tolerances and exemptions established under the regulations in this part apply to residues from only preharvest application of the chemical. ” As a general policy , HED has recommended avoiding the addition of use information into the tolerance declarations in 40 CFR 180, preferring that this information be part of the product label directions for use . Use conditions in tolerances are difficult for FDA to enforce in the context of sampling residues in food. With thePage 2 of 2

language in 180.1(h), tolerances associated with post - harvest uses of a pesticide are required to be designated as such. T here is inconsistent practice within OPP on the inclusion of post - harvest language i n the 40 CFR §180 tolerance listings and this inconsistency has led to confusion regarding the coverage of certain tolerances . While in instances where there is a great disparity in residue levels between pre - and post - harvest use it may be wise to establ ish pre - and post harvest tolerances despite the enforcement difficulties. HED , however, expects this situation to the exception rather than the rule. Removing existing requirement in 180.1(h) will give HED the flexibility to draft tolerances in a manner that balances the needs of enforcement with appropriate restraints on the use of pesticides . Revisions to the CFR are being made in connection with crop grouping revisions and there is an opportunity to remove 180.1(h) from the regulations in that action . HED believes that removing section 180.1(h) will have no substantive impact on pesticide use or exposure under existing tolerances. Whether or not existing tolerances are limited to application to pre - harvest uses of pesticides, before a post - harvest u se could be added for a particular pesticide, the pesticide registrant would have to demonstrate to EPA that (1) the existing tolerance level was adequate to cover residues resulting from the post - harvest use; or (2) petition for an amended tolerance. In either case, EPA could not approve the new use until the applicant has shown that the FFDCA safety standard was met . Changes to FIFRA registration, including label changes such as the addition of a post - harvest use, can onl y be made if “all necessary [FF DCA] tolerances . . . have been issued . . . .” 40 CFR § 152.112(g). Applicants seeking to add post - harvest use to an existing pre - harvest use in their FIFRA registration would have to submit residue data demonstrating that the existing FFDCA tolerance w as set at a high enough level to cover residues from the post - harvest use or petition to raise the tolerance. If the applicant petitions under the FFDCA to raise the tolerance, EPA could only approve that modification of the tolerance if EPA concluded that the tolerance meets the FFDCA safety standard. If the residue data shows that no change in the tolerance is necessary , EPA can still not approve the amendment adding a post - harvest use to the FIFRA registration until EPA determines that dietary

risk fro m the pesticide is not “inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 346a).” 7 USC §136(bb). Thus, the removal of section 180.1(h) would not authorize post - harvest uses not previously allowed. Moreover, before such uses can be added to FIFRA labels, EPA would have to determine they

are safe under FFDCA section 408.

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