July 15, 2005

OPP-2005-0174

DOW AGROSCIENCES. Pesticide Tolerance. FINAL RULE.
• EPA is requiring an inhalation developmental neurotoxicity study in rats (OPPTS Harmonized Guideline 870.6300) as a condition of registration in order to more clearly and fully characterize the potential for neurotoxic effects in young animals.
• See: EPA's response to Public Comments (Docket OPP-2005-0067-0020)
• See EPA's Addendum to Public Comments (Docket OPP-2005-0067-0021)
• See: Comparison of this Final Rule to Dow's March 4, 2005 Petition for new tolerances.
• There is too much to comment on to give a fair representation of FAN's concerns. The residue tolerances EPA approved with this Final Rule are:

With this action, tolerances are established in association with the use of sulfuryl fluoride for the above commodities as a result of the treatment of areas and equipment within food and feed processing plants with sulfuryl fluoride for the control of insects. The term food and feed processing plant includes those facilities specifically listed under the Food and Feed Processing Plants subgroup within pesticide use site group 12 in Appendix A to 40 CFR part 158.

DOW AGRO. Petition for new food tolerances.

DOW AGRO. Pesticide Tolerance for the first food use of sulfuryl fluoride in the US. FINAL RULE.
• This regulation establishes tolerances for residues of sulfuryl fluoride and inorganic fluoride from postharvest fumigation uses of sulfuryl fluoride in or on stored commodities.
• Sulfuryl fluoride is considered to be a methyl bromide replacement for some of these post-harvest fumigation uses.
• Because Dow Agrosciences has now requested that its EUP for sulfuryl fluoride use on walnuts and raisins be withdrawn EPA, in today's action, is establishing permanent tolerances for sulfuryl fluoride on walnuts and raisins, these temporary tolerances are being revoked, also as a part of today's action. The Agency received a Hearing Request dated April 8, 2002 in response to the temporary tolerance final rule from Fluoride Action Network. Because the tolerances that were objected to have now been revoked, the objections are moot and are denied on that ground.
• Objections and requests for hearings, identified by docket ID number OPP-2003-0373, must be received on or before March 23, 2004.

US EPA Documents released in support of this Final Rule:

1. October 31, 2003. MEMORANDUM. SUBJECT: SULFURYL FLUORIDE - Second Report of the Hazard Identification Assessment Review Committee. Docket No. OPP-2003-0373-0004 - 31 pages

2. November 18, 2003. A Preliminary Evaluation of Articles Related to Fluoride Cited by the Fluoride Action Network (FAN) as Objections to the Sulfuryl Fluoride Pesticide Tolerance Rule. Docket No. OPP-2003-0373-0003 - 55 pages

3. January 8, 2004. MEMORANDUM. SUBJECT: Review of Five Recent Papers on Fluoride Submitted by the Fluoride Action Network. Docket No. OPP-2003-0373-0005- 3 pages

4. January 16, 2004.RESPONSE TO PUBLIC COMMENTS CONCERNING THE USE OF SULFURYL FLUORIDE AS A POST-HARVEST FUMIGANT. Docket No. OPP-2003-0373-0006 - 47 pages

5. January 20, 2004. MEMORANDUM. Subject: Human Health Risk Assessment for Sulfuryl Fluoride and Fluoride Anion Addressing the Section 3 Registration of Sulfuryl Fluoride Post-Harvest Fumigation of Stored Cereal Grains, Dried Fruits and Tree Nuts and Pest Control in Grain Processing Facilities. PP# 1F6312. Docket No. OPP-2003-0373-0002 - 51 pages

DOW AGRO - Pesticide petition to establish Fluoride and Sulfuryl fluoride tolerances for a large number (40) of raw and processed foods. As Fluoride is the endpoint of toxicological concern, it is these tolerances that are of concern. The highest tolerance for Fluoride residues in this petition is for processed Wheat Germ at 98 parts per million. Other Fluoride tolerances vary for a variety of foods which include Nuts: Almond, Beechnut, Brazil, Butternut, Cashew, Chestnut, Chinquapin, Filbert, Macadamia, Pecan, Pistachio, Walnut; Fruits: Date, Fig, Dried fruits, Raisin, Prune; and Grains: Barley, Corn, Millet, Oat, Rice, Sorghum, Triticale, Wheat.

This is the second request made by Dow for fluoride tolerances. Both requests are due to the effort to replace the banned fumigant Methyl Bromide, a known ozone depleter. Dow's first request for an Experimental Use Permit was approved by EPA on Feb 7, 2002 (see below).

It is important to read the health assessment on Fluoride prepared by EPA and published in the Federal Register on September 5, 2002.

At first reading there appears to be several discrepancies between this petition and the Final Rule approved by EPA for an Experimental Use Permit (EUP) on Feb 7, 2002. Two of these discrepancies:

No Developmental Neurotoxicity study has been performed for Sulfuyl fluoride. EPA did not require this study because Sulfuryl fluoride had no food uses (it was used as structural fumigant). EPA approved Dow's request for the EUP without this study due to the nature of an Experimental Use Permit. However, EPA stated in its Final Rule for the EUP on Feb 7th that for "unconditional registration," which Dow is requesting in this petition, that a developmental neurotoxicity study "is warranted." Citizens must ensure than EPA defer consideration of Dow's request until a Developmental Neurotoxicity study for Sulfuryl fluoride is performed. The second discrepancy of interest relates to tolerances:

DOW AGRO - Three-year Experimental Use Permit that allows Dow to use Sulfuryl fluoride as a fumigant on Raisins and Walnuts. - FINAL RULE. This permit allows very high tolerances of inorganic fluoride: 30 ppm in or on raisins and 12 ppm in or on walnuts. EPA notes that they received 86 responses to this proposal. EPA's justification for allowing these high tolerance levels are of some interest.

Proposed Pesticide Temporary Tolerances for residues resulting from the post harvest treatment with sulfuryl fluoride:

-- INORGANIC FLUORIDE residues in or on RAISINS at 30 ppm; in or on WALNUTS at 12 ppm.
-- SULFURYL FLUORIDE residues in or on RAISINS at 0.004 ppm; and in or on WALNUTS at 2 ppm. Expiration date: April 1, 2006.

DOW AGRO - Petition to establish a Tolerance for FLUORIDE and Sulfuryl fluoride on Walnuts; petition for an Exemption of FLUORIDE tolerances on Raisins.