Adverse Effects Part 1:
Amyloidosis - Kidney
Blood
Body Weight Decrease
Bone
Brain
CNS
Deaths from Vikane fumigation
Endocrine: Adrenal
Endocrine: Hypothalmus
Endocrine: Thyroid

Adverse Effects Part 2:
Eye
Heart
Kidney
Liver
Lung
Tremors/Convulsions

US

• Too many to list, see tolerances for food commodities approved

US:
Dow Chemical, Pittsburg, California

March 22, 2006: The problem with ProFume. By Francesca Camillo. San Antonio Current (Texas).

... Although the EPA says it’s safe, fluoride activists believe that ProFume, a pesticide used to keep rodents and insects out of food-storage facilities, warehouses, and shipping containers, may contain levels of fluoride dangerous to humans. Elevated fluoride levels have been linked to reduced cognitive ability, pineal gland imbalance, and tooth decay.... Luddene Perry, author of A Field Guide to Buying Organic and an accredited organic inspector, said that much organic food is processed conventionally, so while crops may be grown organically they may be stored with conventionally grown crops that will be fumigated...

Februry 2006: EPA's wrote to FAN, EWG and Beyond Pesticides,and included their new human Helth Risk Assesment for sulfuryl fluroide. Incredibly, this is the first time that the public has had the opportunity to read this important document (both the draft and final versions) which EPA relied on (draft version) to set new tolerances. EPA's handling of the first-time tolerances for sulfuryl fluoride is becoming as much an issue as the science they have used to please Dow.

February 13, 2006 (received Feb. 22): EPA letter to FAN, EWG, Beyond Pesticides
January 18, 2006: Final Human Health Risk Assessment
June 2, 2005: Draft Human Health Risk Assessment

USEPA's "Waiver Justification of Inhalation Rat Developmental Neurotoxicity Study (DNT)"

January 23, 2006: In a telephone conversation with EPA's General Counsel, Jon Fleuchaus, we learned that USEPA waived the condition for Dow to perform an inhalation developmental neurotoxicity (DNT) study in APRIL 2004.

He said that EPA's July 15, 2005, Final Rule, was incorrect when it stated:

Based on the available evidence, the Agency is requiring an inhalation DNT 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.
http://www.epa.gov/fedrgstr/EPA-PEST/2005/July/Day-15/p13982.htm

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. The waiver was confirmed

Sulfuryl fluoride (ProFume®) in New York State

• January 9, 2006 - Press Release from FAN Pesticide Project: NYS approves pesticide despite unresolved health risks.

• January 4, 2006 - Letter from FAN Pesticide Project to NY Bureau of Pesticides requesting revocation of approval for the use of sulfuryl fluoride as a food fumigant.

• November 28, 2005 - Letter from the NY Bureau of Pesticides to Dow AgroSciences approving the use of ProFume® as a "Restricted Use Pesticide" product in NY state.

November 28, 2005 - New York State Bureau of Pesticides Management letter to Dow AgroSciences. Excerpts:

• The Department accepts ProFume ® Gas Fumigant (EPA Reg. No. 62719-376) for registration as a “Restricted Use Pesticide” product in New York State. On or before November 30, 2007, Dow Agro must submit to the Department certain United States Environmental Protection Agency (USEPA) Data Evaluation Reports or detailed reviews as specified in the following risk assessment.
• As conditions for federal registration of this pesticide product, USEPA requested that the registrant submit by January 26, 2006, the following information:
1) an inhalation developmental neurotoxicity study in rats;
2) data describing actual sulfuryl fluoride exposure to workers involved in fumigation and post-fumigation activities for various sites; and
3) data of sulfuryl fluoride residues in air from areas surrounding fumigation facilities. The New York State Department of Health (NYSDOH) requested that the registrant submit to the Department for NYSDOH review a copy of the USEPA Data Evaluation Record reports or if unavailable, a copy of the USEPA’s detailed reviews of this required information.
• DISCUSSION: On November 15, 2005, Dow Agro provided the Department with confirmation that USEPA had waived the inhalation rat developmental neurotoxicity study. Dow Agro also provided study summaries of the occupational and residential exposure data (ten studies) submitted to USEPA on May 18, 2004. Dow Agro estimates that USEPA will review the air monitoring studies during the next 12 to 18 months. Therefore, Dow Agro must provide the Department with USEPA Data Evaluation Reports or detailed reviews of these studies by November 30, 2007.
• There is a New York State drinking water standard for fluoride, which is 2.2 milligrams per liter (10 NYCRR Part 5, Public Water Systems).

July 15, 2005 - EPA letter to Dow AgroSciences on certain conditions not noted in the Final Rule of the same date.

1) Within two (2) years of the date of this letter, a study containing representative residue data must be submitted to reflect total post-treatment fluoride residues. The data must be of sufficient quantity and scope to allow re-evaluation of all tolerances, and should focus on agricultural commodities rather than finished foods. Prior to initiating this study, and within sixty (60 days) of the date of this letter, a protocol must be submitted to reflect the proposed study outline. Within this protocol, a validation method for the data must be specified.

2) Changes to the applicator's manual, which is considered a component of the product labeling for this product, must be made as follows:..

b) On page 9, the reference to "Milk" present in the section for Commodities That Can Be Fumigated must be revised to read "Milk, powdered"...

c) On page 26, within the section for Flames or Heating Elements, replace the term "SO2" with the words "sulfur dioxide". In addition, replace the term "HF" with the words "hydrofluoric acid".

From July 2005 California report on Vikane: Environmental Fate - Volume III:

... 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. (pages 7-8)
http://www.fluorideaction.org/pesticides/sf.ca.epa.env.fate.july.05.pdf

CALIFORNIA: Public comment period up to Sept 5, 2005, on California's proposal to approve sulfuryl fluoride

The proposed regulatory action designates sulfuryl fluoride as a state restricted material. The proposed regulatory action would make permanent the emergency regulation that is now in effect. Comments received during the comment period will be considered and responded to in the Department's Final Statement of Reasons. It is in the Department's discretion whether to consider comments that are received after the close of the comment period.

• Notice of Proposed Action
http://www.cdpr.ca.gov/docs/legbills/rulepkgs/05-005/notice.pdf

• Proposed Text
http://www.cdpr.ca.gov/docs/legbills/rulepkgs/05-005/text.pdf

• Initial Statement of Reasons
http://www.cdpr.ca.gov/docs/legbills/rulepkgs/05-005/statement.pdf

• Economic and Fiscal Impact Statement
http://www.cdpr.ca.gov/docs/legbills/rulepkgs/05-005/399.pdf

• Comments can be emailed by going to this site
http://www.cdpr.ca.gov/docs/legbills/rulepkgs.htm

• Initial NOTICE OF PROPOSED DECISIONS TO REGISTER PESTICIDE PRODUCTS (Jan 31 2005)

2005 - Dow's special website for ProFume
FAQs: "Dow AgroSciences is aggressively generating data to support food tolerances for a wide range of food commodities."

See ProFume - specimen label revised 2/10/04

See ProFume Material Data Safety Sheet. Dow AgroSciences. Date: February 17, 2004

NEW YORK - January 31, 2005. ProFume (EPA Reg. No. 62719-376). NY State DEC letter to Dow. Denial of Application to Register a Major Change in Labeled Use Pattern.

"... Please be aware that ProFumeTM (EPA Reg. No. 62719-376) may not be sold, offered for sale, distributed, or used in New York State."

IOWA - 2004: ProFume (EPA Reg. No. 62719-376). Iowa Department of Agriculture and Land Stewardship. Pesticide Bureau. ProFume is listed with an "Active" Registration Status with an Expiration Date: Dec 31,2004 - check for updates.

SOUTH CAROLINA - Feb. 2005: Restricted Use Products: Profume. South Carolina Department of Pesticide Regulation.

TENNESSEE - 2004. "PROFUME, (sulfuryl fluoride), (DowAgroSciences LLC, EPA Reg. No. 62719-376) for control of postharvest insect and rodent pests. This product was registered conditionally effective August 27, 2004 after resolution of label issues and clarification of formulation methodology." Tennessee.

August 30,2004: Request to the California Air Resources Board (ARB) for "application-site monitoring" of sulfuryl fluoride as a food fumigant. The request is from Paul Gosselin, Acting Director of the California Department of Pesticide Regulation (DPR). Gosselin states:

We are requesting monitoring for sulfuryl fluoride because DPR may soon register this pesticide as a postharvest commodity fumigant. This use is significantly different from the structural fumigations ARB has monitored in the past. In addition, the registrant may change the method of application for structural fumigations and conduct air monitoring. Since the methodology for this pesticide is complicated and method performance can vary, DPR may need ARB to conduct quality control checks for the registrant monitoring andor monitor commodity fumigations.

Based on a preliminary assessment of the toxicology data, DPR requests the following target quantitation limits:

Acrolein	0.7 pg/m3
1,3-Dichloropropene	0.5 pg/m3
Methyl bromide	0.1 pg/m3
Sulfuryl fluoride	30.0 pg/m3

September 15, 2004: Gosselin writes another memo to the CA ARB. He states

It is likely that DPR will recommend monitoring one to two applications each for acrolein and sulfuryl fluoride, as well as ambient monitoring for 1,3-dichloropropene and methyl bromide. No breakdown products will be monitored.

Sulfuryl fluoride
EPA Toxic Release Inventory (TRI)
Facility Air Releases by Year
(Note: TRI statistics on Sulfuryl fluoride began in 1995. The latest statistics for 2003 were released in 2005. TRI does not include all industries or sources of air releases.)

"Fumigants -used to kill insects, insect eggs, and microorganisms- are the most acutely toxic pesticides used in agriculture. Because they are gases, fumigants are usually taken directly into the lungs, where they readily enter the blood and are distributed throughout the body. Although inhalation is the most serious source of exposure and can lead rapidly to death, absorption of fumigants through the skin can also be a significant hazard (103) [page 293]."
Ref: U.S. Congress, Office of Technology Assessment, Neurotoxicity: Identifying and Controlling Poisons of the Nervous System, OTA-BA-436 (Washington, DC: U.S. Government Printing Office, April 1990).
http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk2/1990/9031/9031.PDF

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.

2004 - US EPA maximum residue levels on food for Methyl Bromide. EPA lists 182 food commodities with tolerances for residues from the fumigant methyl bromide. This is of some interest as sulfuryl fluoride is touted as an alternative fumigant for methyl bromide. Methyl bromide is scheduled to be phased out of use by January 1, 2005 because it is a known to deplete the ozone layer. (Note the very high residue levels EPA has allowed on food for methyl bromide.)

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.