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 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 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 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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