Page 1 of 3 UNITED STATES ENVIRONMENTAL PROTECTI ON 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 (C hair), Rick L oranger, Leung Cheng, Mike Dohert y ( M inutes), 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 revision s. 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 pr eharvest 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 requi red 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 as surance 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 t olerances established under FFDCA are simpl y 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, thePage 2 of 3

pre - harvest use of a product on a crop or commodity that is approved onl y 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 p ossible to know whether a food
- borne chemical residue originated from a pre
- or a post harvest u se. 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 Imp orted 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 interes t 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 1⁄2 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 conditi ons and cultural practices for each crop in the affected areas of Mexico. I deall y, 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 exp ort 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 surfac tant in the remaining 75% w ould be selected in accordance with the localPage 3 of 3

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 surf actant). In formation on the use rates for the various surfactants should be included in the submission in order to meaningfull y 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 co nsensus was reached other than a noted need for a reliable source of up
- to - date names for active ingredients.