UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Subject:	Minutes of the 6/10/2009 ChemSAC Meeting 

	From:	Chemistry Science Advisory Council (ChemSAC)

		Office of Pesticide Programs (OPP)

		Health Effects Division (HED)

	To:	Residue Chemistry Interest Group

		Office of Pesticide Programs

Attendees:	Will Donovan (Chair), Rick Loranger, Leung Cheng, Mike
Doherty (Minutes), Julie Langsdale, Tom Bloem, Meheret Negussie, Bill
Drew, Nancy Dodd, Debra Rate, Chris Olinger, Bill Cutchin, Dave
Soderberg, Bernie Schneider, Barbara Madden, Sue Hummel, Mohsen
Sahafeyan

1.	Review Minutes from the 3 June 2009 Meeting

The minutes were approved with minor revisions.

2.	Removal of 40 CFR 180.1 Paragraph h (B. Schneider)

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 OPP has
been working to not put use information into the tolerance declarations
in 40 CFR 180.  With the language in 180.1(h), tolerances associated
with post-harvest uses of a pesticide are required to be designated as
such.  Revisions to the CFR will be made in connection with crop
grouping revisions and there is an opportunity to remove 180.1(h) from
the regulations.

In order to have 180.1(h) removed from the regulation, HED needs to
provide assurance that having tolerances decoupled from post-harvest-use
designations will not result in increased human health risk estimates or
in an expanded use profile for the active ingredient.  ChemSAC noted
that tolerances established under FFDCA are simply the maximum allowable
concentration of a compound in/on a food.  The tolerances themselves
have no bearing on the use pattern that resulted in the presence of
residues.  The allowed use patterns for a pesticide are enforceable via
FIFRA and are designated on the pesticide label.  Thus, the pre-harvest
use of a product on a crop or commodity that is approved only for
post-harvest use would be a violation of FIFRA and not necessarily FFDCA
(note that FFDCA violations are indicative of FIFRA violations). 
Therefore, removing 180.1(h) from the regulations does not imply the
approval of pre-harvest uses.  Since removing 180.1(h) does not
constitute an expanded use profile for compounds with
post-harvest-specific tolerances, risk estimates for those compounds are
not affected.  ChemSAC further noted that 180.1(h) was developed prior
to the current regulatory scheme and that, from a practical standpoint,
it is often not possible to know whether a food-borne chemical residue
originated from a pre- or a post-harvest use.  The SAC will issue a
memorandum to RD in support of having 40 CFR 180.1(h) removed from the
regulations, and this memo will be posted on the ChemSAC database.

3.   Substitution of U.S. for Mexican Crop Field Trials for Determining
a Tolerance on Imported Commodities (R. Loranger).

A consultant for a pesticide registrant has asked if we would accept
100% U.S. field trials for establishing an “import tolerance” for a
use in Mexico.  The request is based on conditions in Mexico related to
violence and swine flu.  The consultant noted that the Agency has
allowed Columbia to be excluded as a location due to violence and travel
advisories.  The proposal is that the Mexican trials be conducted in
Arizona and the southern part of Texas.  The crops of interest are
cucurbits, tomatoes, and peppers.  The consultant further states that of
the tomatoes grown in Mexico for export, 80% are grown in greenhouses. 
Current NAFTA guidelines allow for up to ½ of the trials to be
conducted outside of the exporting country.  

The SAC is willing to consider alternate study sites, provided such
sites can be shown to provide equivalent information.  In order to make
that determination, the SAC is requesting that more information be
provided regarding the environmental conditions and cultural practices
for each crop in the affected areas of Mexico.  Ideally, trials that are
proposed for the U.S. would be in the same NAFTA zone in which the crop
is grown in Mexico.  The SAC also noted that there may be other
countries that would be a more suitable surrogate than the U.S.

With regard to the extent of conducting 50-75% of the tomato trials in
greenhouses, the SAC noted that information available to the group
indicates that much less than 80% of the tomatoes in Mexico grown for
export come from greenhouses and that Mexican production data (field
versus greenhouse and % of each exported to the U.S.) are needed for all
crops of interest, not just tomato.

4.	Residue Testing with Surfactants (R. Loranger)

A registrant has asked for guidance regarding inclusion of surfactants
in residue field trials.  The registrant intends to include surfactants
in all trials for a new insecticide, with approximately 25% using MSO, a
blend of methylated seed oil and nonylphenol ethoxylate.  The surfactant
in the remaining 75% would be selected in accordance with the local
practices.

The SAC concluded that the proposed scheme is acceptable, provided that
the 75% address the other two major classes of surfactants (crop oil
concentrate and non-ionic surfactant).  Information on the use rates for
the various surfactants should be included in the submission in order to
meaningfully assess the impact of different surfactants on pesticide
residue levels.

5.  Chemical Names in Tolerance Expressions:  CAS vs. IUPAC.

The SAC discussed whether CAS or IUPAC names are preferred for inclusion
in the tolerance expression.  There appears to be no requirement for one
over the other and there were situations discussed where one might be
preferred vs. the other.  No consensus was reached other than a noted
need for a reliable source of up-to-date names for active ingredients.

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