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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.
fluoride breaks down to the fluoride anion in the human body.
is the toxicological endpoint of concern.
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.
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.
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
Fluoride: Brain effects from animal studies.
Fluoride: Thyroid, Adrenal Cortex, Heart, Kidney, Lung effects
from animal studies.
Studies on Brain effects.
Studies on IQ and Behavioral effects.
Studies on G-Proteins.
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)
of Data on Fluoride & Bone Damage (at Exposure Levels Relevant
to EPA’s Current MCL).
& Bone Damage: Published Data.
of Chinese Fetal Bone Study.
FAN’s response to EPA’s criticisms of submitted
of Bachinskii Paper.
comparison of a review of animal studies on fluoride’s
reproductive effects by Stan Freni (1994) and the DHHS (1991).
Effects on Male Reproductive System.
H . Adverse
Effects on Brain.
Ingestion from Toothpaste.
Objections based on OPP failure to adhere to statutes and guidelines.
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):
18. Final HRA
2. Draft HRA.
Docket No. OPP-2003-0373-0002
31. Second Report of the Hazard Identification Assessment Review
Docket No. OPP-2003-0373-0004
Federal Register FINAL RULES:
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."
23. Final Rule - first-time approval of sulfuryl fluoride
use as a fumigant on food.
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:.
4. Dow petition to EPA.
27. Dow. Issuance of 3-Year Experimental Use Permit for "ProFume
15. Pesticide petition to establish Fluoride and Sulfuryl fluoride
tolerances for a large number (40) of raw and processed foods.
5. Proposed Pesticide Temporary Tolerances for residues resulting
from the post harvest treatment with sulfuryl fluoride.
21. Petition to establish a Tolerance for fluoride and sulfuryl
fluoride on walnuts; petition for an Exemption of fluoride tolerances
OTHER EPA DOCUMENTS:
Register notice of Petition for a stay of sulfuryl fluoride tolerances.
EPA solicits public comments. See
some of the comments received
14. Response to publc comments concerning the use of sulfuryl
fluoride in food handling facilities.
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.
16. EPA Response to public comments concerning the use of sulfuryl
fluorde as a post-harvest fumigant.
Docket No. OPP-2003-0373-0006
8. EPA Review of five recent papers on fluoride aubmitted by the
Fluoride Action Network,
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
fluoride RED (Reregistration Eligibility Decision)
EPA Letters to Objectors (FAN, Environmental
Working Group, Beyond Pesticides):
13. Re: Objections and request for a Hearing concerning sulfuryl
2. Re: Objections and request for a hearing concerning sulfuryl
Dow AgroSciences submissions to EPA:
2006: October 31. Dow's
arguments on why EPA should not grant a request for an evidentiary
2006: August 4. Dow's
arguments on why EPA should reject Petition to stay all tolerances
for sulfuryl fluoride.
ProFume® labels etc.
website for ProFume®.
Dow: Container Label and Applicator Manual for ProFume® gas
- The new label has been changed so that a 1:10 diluting of fumigated
food products with non-fumigated products is no longer required.
15. EPA letter to Dow AgroSciences.
10. Specimen label.
- The 2004 label included a 1:10 dilution factor
April 13. Revised ProFume® Material Safety Data Sheet.
17. ProFume® Material Safety Data Sheet.
pesticide residue tolerances approved by US EPA, as of July 15,
March 22. National
Research Council report on toxicity of fluoride at http://www.nap.edu/catalog/11571.html
• See also excerpts
from Chapter 7: Neuroxicity and Neurobehavioral Effects
January 20. Dispute Over Methyl Bromide Alternative
Prompts Debate On Fluoride.
By Manu Raju. Inside EPA.
Read full report.
- Compilation of Health Effects from animal studies: PART
1 and Part
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.
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
2004 - Summary
of Toxicology Data. Sulfuryl fluoride. California Environmental
Protection Agency. Department of Pesticide Regulation. Medical
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 http://www.nap.edu/books/0309091691/html/
Reregistration Eligibility Decision (RED). US EPA.
approved to use sulfuryl fluoride as a fumigant:
July 15, 2005, US EPA approved a 70 ppm residue tolerance
for fluoride on ALL processed food. Fumigation is
Food and feed processing plants
• 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
• 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
Rationale for US EPA to add Sulfuryl Fluoride to the Toxic
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.
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.
Online at http://www.epa.gov/tri/frnotices/59fr1788.htm