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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

June 19, 2009

MEMORANDUM 

SUBJECT: HED ChemSAC Request to Remove 40 CFR 180.1(h).

 

FROM: Bernard A. Schneider, Ph.D., Senior Plant Physiologist

Chemistry and Exposure Branch 

Health Effects Division (7509P) 

THROUGH: William Donovan, Ph.D., and Michael Doherty, PhD, Chairpersons,

HED Chemistry Science Advisory Council (ChemSAC)

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 Project, periodic updates 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 by 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 generally 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 treatments, 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 Code 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 the 
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language in 180.1(h), tolerances associated with post-harvest uses of a pesticide are required to 

be designated as such. There is inconsistent practice within OPP on the inclusion of post-harvest 

language in 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 establish pre- and postharvest 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 use 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 only be made if “all necessary 

[FFDCA] 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 was 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 from 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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