Sulfuryl fluoride - CAS No. 2699-79-8
Documents on ProFume®

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ProFume® is the name of the Dow AgroSciences fumigant that
was approved for first-time use on food by US EPA in January 2004.

It contains 99.8% sulfuryl fluoride.

Sulfuryl fluoride breaks down to the fluoride anion in the human body.

Fluoride is the toxicological endpoint of concern.

This compilation represents most of the essential documents that pertain to sulfuryl fluoride tolerances. A tolerance is the legal amount of a pesticide residue allowed in and/or on specific foods. US EPA approved the first-time use of sulfuryl fluoride as a fumigant on food in January 2004. Formal Objections to these tolerances and Requests for an Evidentiary Hearing have been submitted to EPA in 2002, 2004, and 2005. Three advocay groups have joined to revoke the use of sulfuryl fluoride as a food fumigant. They are: Fluoride Action Network, Environmental Working Group, and Beyond Pesticides. At EPA's request, the groups combined their objections into one document, which they submitted in December 2005.

(Note: US EPA first approved temporay tolerances for sulfuryl fluoride in an Experimental Use Permit (EUP) for Dow AgroSciences in 2002. However, Dow withdrew this EUP because it was not able to get approval for the conditions in the ProFume® label from the state of California.)

Submissions to EPA from FAN, Environmental Working Group, and Beyond Pesticides:

January 17, 2007. Memorandum to USEPA, Legal Standard for Grant of Hearings on Objections under Federal Food, Drug, and Cosmetic Act Section 408. This was submitted by the group's attorney, Perry Wallace, Esq., in response to Dow AgroSciences October 31, 2006, submission to USEPA, that argued against EPA granting an evidentiary hearing.

2006. November. Consolidated Objections submitted to EPA at their request.

2006. June. Petition to EPA to revoke all tolerances for sulfuryl fluoride.

2005. December 16. Submission to US EPA on the issues for an evidentiary hearing to revoke the tolerances approved for the use of sulfuryl fluoride.

2005. September 13. Objections and Request for Hearing. Sulfuryl fluoride; Pesticide Tolerance. Final Rule.

TABLES (included separately as Attachments to Submission)
1. Sulfuryl Fluoride: Brain effects from animal studies.
2. Sulfuryl Fluoride: Thyroid, Adrenal Cortex, Heart, Kidney, Lung effects from animal studies.
3. Fluoride Studies on Brain effects.
4. Fluoride Studies on IQ and Behavioral effects.
5. Fluoride Studies on G-Proteins.
6. Fluoride Studies on Male Reproductive System effects.

2005. September 13. Supplementary Objection and Request for Hearing. Submission by Chris Neuratth.

2005. April 19. Comments submitted to US EPA on Dow's petition for tolerances for over 600 food commodities.

2004. March 23. Written Objections and Request for Hearing in the matter of: Sulfuryl Fluoride; Pesticide Tolerance. Final Rule.

APPENDIXES (included separately as Attachments to Submission)
A. Summation of Data on Fluoride & Bone Damage (at Exposure Levels Relevant to EPA’s Current MCL).
B. Fluoride & Bone Damage: Published Data.
C. Translation of Chinese Fetal Bone Study.
D. FAN’s response to EPA’s criticisms of submitted health studies.
E. Translation of Bachinskii Paper.
F. A comparison of a review of animal studies on fluoride’s reproductive effects by Stan Freni (1994) and the DHHS (1991).
G. Adverse Effects on Male Reproductive System.

H . Adverse Effects on Brain.
J. Fluoride Ingestion from Toothpaste.
K. Objections based on OPP failure to adhere to statutes and guidelines.

1-L. Comparisons of Residue Tolerances: Final vs. Proposed.

2002. April 8. Written Objections and Request for Hearing in the matter of: Sulfuryl fluoride; Temporary Pesticide Tolerances. Final Rule.

2002. March 18,. SULFURYL FLUORIDE: comments submitted to US EPA on Dow AgroSciences petition to establish Fluoride and Sulfuryl fluoride tolerances for a large number (40) of raw and processed foods. Docket PF-1068.

2001. September 29. SULFURYL FLUORIDE: comments submitted to US EPA on Proposed Pesticide Temporary Tolerances by Ellen Connett. In response to petition published in the September 5, 2001, Federal Register. Docket OPP-301166.

EPA Health Risk Assessments (HRA):

2006. January 18. Final HRA

2005. June 2. Draft HRA.

2004. January 20. HRA.
Docket No. OPP-2003-0373-0002

2003. October 31. Second Report of the Hazard Identification Assessment Review Committee.
Docket No. OPP-2003-0373-0004

Federal Register FINAL RULES:

2005. July 15. Final Rule. -- With this Final Rule EPA approved tolerances for ALL PROCESSED FOOD. Unless specifically stated, the tolerance for fluroide residues is 70 ppm fluoride. See box at bottom: "Facilities approved to use sulfuryl fluoride as a fumigant."

2004. January 23. Final Rule - first-time approval of sulfuryl fluoride use as a fumigant on food.

2002. February 7. Three-year Experimental Use Permit (EUP) that allows Dow to use Sulfuryl fluoride as a fumigant on Raisins and Walnuts.
-- Two years after this EUP was issued EPA stated that sulfuryl fluoride was not used on walnuts and raisins because the California Department of Pesticide Regulation did not issue the necessary state authorization to allow the EUP to proceed. Dow Agrosciences requested that its EUP for sulfuryl fluoride use on walnuts and raisins be withdrawn.

Federal Register PROPOSALS:.

2005. March 4. Dow petition to EPA.

2002. March 27. Dow. Issuance of 3-Year Experimental Use Permit for "ProFume Gas Fumigant."

2002. Feb 15. Pesticide petition to establish Fluoride and Sulfuryl fluoride tolerances for a large number (40) of raw and processed foods.

2001. Sept 5. Proposed Pesticide Temporary Tolerances for residues resulting from the post harvest treatment with sulfuryl fluoride.

2001. June 21. Petition to establish a Tolerance for fluoride and sulfuryl fluoride on walnuts; petition for an Exemption of fluoride tolerances on raisins.


2006: Federal Register notice of Petition for a stay of sulfuryl fluoride tolerances. EPA solicits public comments. See some of the comments received

2005: July 14. Response to publc comments concerning the use of sulfuryl fluoride in food handling facilities.

2004. April 22. EPA "Waiver Justification of Inhalation Rat Developmental Neurotoxicity Study (DNT)"
- This waiver is dated April 22, 2004. However, the first time the public learned of the waiving of the DNT study was in a November 2005 letter from the NYS Bureau of Pesticides to Dow.

2004. January 16. EPA Response to public comments concerning the use of sulfuryl fluorde as a post-harvest fumigant.
Docket No. OPP-2003-0373-0006

2004. January 8. EPA Review of five recent papers on fluoride aubmitted by the Fluoride Action Network,

2003. Nov 18. EPA: 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

1993. Sulfuryl fluoride RED (Reregistration Eligibility Decision)

EPA Letters to Objectors (FAN, Environmental Working Group, Beyond Pesticides):

2006. February 13. Re: Objections and request for a Hearing concerning sulfuryl fluoride.

2005. June 2. Re: Objections and request for a hearing concerning sulfuryl fluoride tolerances.

Dow AgroSciences submissions to EPA:

2006: October 31. Dow's arguments on why EPA should not grant a request for an evidentiary hearing.

2006: August 4. Dow's arguments on why EPA should reject Petition to stay all tolerances for sulfuryl fluoride.

ProFume® labels etc.

Current: Dow's website for ProFume®.

2005: August. Dow: Container Label and Applicator Manual for ProFume® gas fumigant.
- The new label has been changed so that a 1:10 diluting of fumigated food products with non-fumigated products is no longer required.

2005: July 15. EPA letter to Dow AgroSciences.

2004: February 10. Specimen label.
- The 2004 label included a 1:10 dilution factor

2004. April 13. Revised ProFume® Material Safety Data Sheet.

2004. February 17. ProFume® Material Safety Data Sheet.

Also see:

Fluoride pesticide residue tolerances approved by US EPA, as of July 15, 2005.

2006. March 22. National Research Council report on toxicity of fluoride at
• See also excerpts from Chapter 7: Neuroxicity and Neurobehavioral Effects

2006. January 20. Dispute Over Methyl Bromide Alternative Prompts Debate On Fluoride.
By Manu Raju. Inside EPA. Read full report.

Current - Compilation of Health Effects from animal studies: PART 1 and Part 2

The following are Risk Characterization Documents for VIKANE prepared by the California EPA.
2005. June 1. Volume I Health Risk Assessment.
2005. June 1. Volume II Exposure Assessment.
2005. July. Volume III: Environmental Fate - Volume III.
2005. June 1. Volume IV DPR Responses to Comments.

From Enviromental Fate - Volume III:
... pages 7-8: A search of the open science literature produced no citations relevant to the fate of sulfuryl fluoride in the atmosphere ... Little or no data on sulfuryl fluoride’s environmental and atmospheric loss processes are available. There are no experimental data to confirm that it photolyzes in the troposphere or reacts with OH radicals, NO3 radicals, or O3. It is entirely possible that sulfuryl fluoride has a long or very long atmospheric lifetime and should therefore be considered a greenhouse gas.

2004 - Summary of Toxicology Data. Sulfuryl fluoride. California Environmental Protection Agency. Department of Pesticide Regulation. Medical Toxicology Branch.

2004. See Chapter 4: Water -- on recommended and estimated amounts that various subsets drink. Dietary Reference Intakes for Water, Potassium, Sodium Cloride, and Sulfate. Panel on Dietary Reference Intakes for Electrolytes and Water. Food and Nutrition Board. The National Academies Press. Washington DC. ONLINE EDITION

1996: CRYOLITE: Reregistration Eligibility Decision (RED). US EPA.

Facilities approved to use sulfuryl fluoride as a fumigant:

On July 15, 2005, US EPA approved a 70 ppm residue tolerance for fluoride on ALL processed food. Fumigation is approved in:

• Food and feed processing plants
• Bakeries
• Bottlers
• Canneries
• Dairies, creameries, milk processing plants
• Feed mills, feed stores
• Fresh fruit packing and processing
• Meat processing
• Poultry processing
• Wineries, wine cellars
• Flour mills, machinery, warehouses, bins, elevators
• Egg processing
• Candy and confectionary plants
• Sugar processing, cane mills, etc.
• Cider mills
• Dry food products plants
• Tobacco processing
• Air treatment for processing and transportation of foods
• Beverage processing
• Nut processing
• Cereal processing
• Seafood processing
• Vegetable oil processing
• Spice mills
• Vinegar processing
• Farinaceous processing (noodles, etc.)
• Mushroom processing
• Dried fruit processing
• Pickle processing
• Ice plants
• Chocolate processing
• Fruit juice processing

1994: Rationale for US EPA to add Sulfuryl Fluoride to the Toxic Release Inventory

The primary effects of sulfuryl fluoride in humans are respiratory irritation and central nervous system depression, followed by excitation and possibly convulsions. Rabbits exposed via inhalation (6 hours/day, 5 days/week, for 2 weeks) to sulfuryl fluoride showed hyperactivity, convulsions and vacuolation of the cerebrum at 600 ppm (2.5 mg/L). Renal lesions were present in all rats exposed by inhalation (6 hours/day, 5 days/week, for 2 weeks) to 600 ppm (2.5 mg/ L) sulfuryl fluoride. Minimal renal changes were noted in rats exposed to 300 ppm (1252 mg/L), whereas no effects occurred at 100 ppm (4.2 mg/ L). Convulsions at near lethal concentrations were reported in rabbits, mice, and rats. In a 30-day inhalation study, loss of control, tremors of the hind quarters, and histopathological changes in the lung, liver, and kidney were reported in rabbits exposed to 400 ppm (1.6 mg/L) for 7 hours/day, 5 days/week for 5 weeks. The NOEL was 200 ppm (0.83 mg/L). Cerebral vacuolation and/or malacia and inflammation of nasal tissues were observed in rabbits exposed by inhalation to 100 or 300 ppm (0.4 or 1.25 mg/L) for 13 weeks. The NOEL was 30 ppm (0.125 mg/L). Rats exposed by inhalation to 100 to 600 ppm (0.4 to 0.25 mg/L) sulfuryl fluoride for 13 weeks developed mottled teeth (indicative of fluoride toxicity), renal and respiratory effects, and cerebral vacuolation. EPA believes that there is sufficient evidence for listing sulfuryl fluoride on EPCRA section 313 pursuant to EPCRA section 313(d)(2)(B) based on the available neurological, renal, and respiratory toxicity data for this chemical.

Ref: USEPA/OPP. Support Document for the Addition of Chemicals from Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) Active Ingredients to EPCRA Section 313. U. S. Environmental Protection Agency, Washington, DC (1993). As cited by US EPA in: Federal Register: January 12, 1994. Part IV. 40 CFR Part 372. Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Proposed Rule.

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