Sodium fluoride
CAS No. 7681-49-4
 
 

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Adverse Effects
Abstracts

ACTIVITY: Insecticide, Wood preservative, US EPA List 4B Inert

Inorganic

Adverse Effects:

The following
are listed below
in this section of Adverse Effects:

Due to length,
the following are presented
as separate sections

Cancer

Chemical Weapon
Precursor

CNS

Diabetes

Endocrine: Breast

Endocrine: Hypothalamus

Endocrine: Ovary

Endocrine: Uterus

Heart

Mesenteric artery

Pancreas

Salivary glands

Spleen

Teratogen

Apoptosis

Blood

Bone

Brain

Clastogenic • Cytotoxic • Fetotoxic • Genotoxic or Mutagenic

Endocrine: Pineal Gland

Endocrine: Testicular

G-Proteins

I.Q.

Kidney

Liver

Lung

Reproductive

Environmental effects:

In 1979-1980 the upstream migration of adult spring chinook salmon in the Columbia River were subject to unusally long delays. Investigators found high concentrations of fluoride in the vicinity of John Day Dam (0.3-0.5 mg/L in 1982) from discharges from an aluminum factory. Experiments concluded that the behavior of upstream-migrating adult salmon would be adversely affected by fluoride concentrations of about 0.5 mg/L.

Fine:
Feb 19, 1999: The US Commerce Department's Export Administration imposed a civil penalty of $750,000 on ALCOA for 100 violations of US export regulations involving shipments of potassium fluoride and
sodium fluoride. Potassium fluoride and sodium fluoride are controlled because they can be used to make chemical weapons.
Regulatory Information
(only comprehensive for the US)
US EPA Registered: Yes 
US EPA PC Code: 075202  
California Chemical Code 537  
Registered use in
(includes only a limited list of countries)

Australia, Canada, New Zealand, US, Vietnam 
Other Information
Molecular Formula: F Na
Inorganic
 
Manufacturers: ALCOA and other aluminum industries 

Other Names:

-- too many to list here

Alcoa Sodium Fluoride
Antibulit
Floridine
Fluorol
Flursol
FDA 0101
NCI-C55221
Pergantene Roach Salt
Sodium Hydrofluoride
Sodium Monofluoride
ADZ-PAD
Villiaumite
Hollow Heart Concentrate
Tie-Gard
Florocid
Tie-Gard
 
Of special interest:
PAN BAD ACTOR - Acute Toxicity 
TOXNET Profile from the Hazardous Substances Data Bank - This profile has been updated and is available at Toxnet.  
December 10, 2007: Comments on EPA's Assessment for Wood Treatment Products from Fluoride Action Network.
August 1, 2005. Comments submitted to EPA on its proposal to revoke "tolerance exemptions" for sodium fluoride as an inert ingredien by FAN Pesticide Project. Federal Register Docket OPP-2005-0069.
Note: Currently sodium fluroide is classified as an EPA List 4B inert. All List 4 Inerts are approved for use in
the US National Organic Program. If EPA approves a Final Rule to revoke "tolerance exemptions," sodium fluoride will be removed from the "inerts" list. This is good news.
2005 - Schedule for Reregistration & Tolerance Reassessment (RED) is expected to be August 2008. Contact at EPA: Rebecca Miller (703) 305-0012; miller.rebecca@epa.gov . According to EPA:
Through the pesticide reregistration and tolerance reassessment programs, EPA is assessing risks and making risk management decisions for older pesticides. These decisions are summarized in documents known as REDs, IREDs, and TREDs. By making decisions according to the schedule below, EPA will meet its statutory deadlines for completing reregistration and tolerance reassessment.
Some of the decision dates presented in the schedule may change due to the dynamic nature of the review process. Any pesticide decisions that are not completed during the current fiscal year will be rescheduled for the following year. EPA is committed to meeting its reregistration and tolerance reassessment deadlines.
http://www.epa.gov/pesticides/reregistration/decision_schedule.htm
May 3, 2004. Submission to: National Research Council Committee: Toxicologic Risk of Fluoride in Drinking Water. From Ellen Connett. Title of Submission: Fluoride's adverse effects on the Male Reproductive system
April 19, 2004. Submission to National Research Council Committee: Toxicologic Risk of Fluoride in Drinking Water. From Ellen Connett. Title of Submission: Fluoride's effect on the brain.
2001 - US EPA "List 4 Inerts".
Uses: Not more than 0.25% of pesticide formulation. Stabilizer carrier for formulations used before crop emerges from soil. Ref: http://www.fintrac.com/gain/traderegs/usa/40P0180D.pdf
Material Safety Data Sheet. Sigma Chemical Co. 
Pesticide Products - partial list 
June 10, 2002 - European Directive on Food Supplements: Included for use are Fluoride, Potassium fluoride, and Sodium Fluoride. European Parliamment and the Council of the European Union.
February 19, 1999 - ALCOA Fined $750,000 by Commerce Department For Illegal Chemical Shipments - US Dept. of Commerce, Bureau of Export Administration --see also at: http://www.bxa.doc.gov/press/99/alcoa.htm 
October 1998 - Structural Pest Management pesticides. FAN's compilation of information cited on fluorine and organofluorine pesticides published in General Pest Management, Category 7A. A Guide for Commercial Applicators. Prepared by: Carolyn Randall, MSU Pesticide Education Program. Published by Michigan State University; MSU manual number: E-2048.  
March 1998 - Hazardous Substance Fact Sheet - NJ Department of Health and Senior Services 
April 9, 2001. Australia. Exemptions Listing
TECHNICAL GRADE ACTIVE CONSTITUENTS EXCLUDED FROM THE REQUIREMENTS OF NRA APPROVAL The list generally includes chemicals which have not been primarily developed as agricultural chemicals and thus for which an extensive package of data would not be readily available. Approval by the National Registration Authority for these TGACs is currently not required. Fluoride compounds exempted include: Cupro-ammonium Fluoroborate complex, Sodium fluoride, Sodium fluoroacetate, Sodium fluorosilicate.
  
Abstracts mainly from PubMed and TOXNET. Sodium fluoride is the substance of choice in animal studies to determine fluoride's adverse effects. Because of the number of studies performed, these abstracts, mainly dealing with Sodium fluoride, are listed by year. 
1999 - Recognition and Management of Pesticide Poisonings: Fluorides - US EPA Office of Pesticide Programs  
December 2000 - Sodium Fluoride Proposed for Inclusion in National Organic Standards  
National Toxicology Program. Drinking Water Study, number TR-393.
These studies, conducted by
Battlelle Columbus Laboratory in Ohio, are steeped in controversy. The union that represents EPA professionals in Washington DC have requested, in Congressional testimony, that these studies be redone. For more information search FAN's website at http://www.fluoridealert.org
Toxicology & Carcinogenesis study of rats and mice - 15 pages.
Toxicology & Carcinogenesis study of rats and mice - shorter report
Toxicology & Carcinogenesis study of rats and mice - Tables
 
Sodium Fluoride: A Classified Hazardous Waste California Code of Regulations, Title 22, Section 66261.126  

Sodium fluoride is a crystalline mineral once widely used in the United States for control of larvae and crawling insects in homes, barns, warehouses, and other storage areas. It is highly toxic to all plant and animal life. The only remaining use permitted is for wood treatement.
Ref: Recognition and Management of Pesticide Poisonings, 5th Edition,
The Office of Pesticide Programs, US EPA. Chapter 8

http://www.epa.gov/oppfead1/safety/healthcare/handbook/Chap08.pdf

Note from FAN:
Unfortunately the above is not correct. Sodium fluoride is allowed for use on food crops as a US EPA "List 4 Inert." "Inerts" are treated as confidential proprietary information by US EPA and the public is denied the right to know which pesticides contain them or on what food crops they are used. All "List 4 Inerts" (which includes Sodium fluoride) were approved for use in the US National Organic Program - (see last paragraph on page 248).

For more information on the issue of "Inerts" see: Toxic Secrets: "Inert" Ingredients in Pesticides1987-1997, published by Northwest Coalition for Alternatives to Pesticides.

Sodium fluoride is currently registered for use as a wood preservtive in Canada. In 2000, 12 tonnes of NaF were used for this purpose. Nearly all of this amount came from sales of a wood preservative paste applied to the groundline portion of in-service utility poles. The only registration for sodium fluoride as an insecticide expired December 2000 (p 4).
Ref: Canadian Water Quality Guidelines for the Protection of Aquatic Life: Inorganic Fluorides. Environment Canada. August 2001.


US EPA List of Inerts. This substance is on List 4B

EPA's List 4A & 4B Inerts have been approved for use in the new US National Organic Standards. Sodium Fluoride as a List 4B Inert is allowed for use in organic agriculture in the US.

Note: US EPA allows so-called "Inert" ingredients to be commonly mixed with the "active" pesticidal ingredient to create a formulated pesticide product. According to EPA, "The term `inert' is not intended to imply nontoxicity; the ingredient may or may not be chemically active." "Inert" ingredients include solvents, emulsifiers, spreaders, and other substances mixed into pesticide products to increase the effectiveness of the active ingredients, make the product easier to apply, or to allow several active ingredients to mix in one solution. Both US EPA and California Department of Pesticide Regulation require pesticide manufacturers to identify inert ingredients in their products but do not disclose this information to the general public because the pesticide industry considers product formulations trade secrets, protected by law and by the US EPA. The US EPA category of Inerts (as of September 2003):

List 1 - Of Toxicological Concern
List 2 - Potentially Toxic / High Priority for Testing
List 3 - Of Unknown Toxicity
List 4A - Generally Regarded as Safe
List 4B - EPA states it has Sufficient Information to Reasonably Conclude that the Current Use Pattern in Pesticide Products will not Adversely Affect Public Health or the Environment
List 4 (all)


*USES: This chemical is used as an insecticide, a constituent of vitreous enamel and glass mixtures and as a steel degassing agent. It is used in electroplating fluxes, heat treating salt compositions and fluoridation of drinking water. It is also used as a disinfectant for brewery apparatus, for preserving wood, pastes and mucilage, in the manufacture of coated paper in frosting glass and in the removal of hydrogen fluoride from exhuast gases. It is used as a dental caries prophylactic. In veterinary medicine, it is used as an anthelmintic [an agent that destroys or expels intestional worms], a pediculicide [an agent used to destroy lice] and an acaricide [commonly used to denote chemicals that kill ticks]. It is also used as a preservative for toothpastes, in laundry soap and in cryolite manufacture. Single crystals are used as windows in ultraviolet and infrared radiation detecting devices.

*ACUTE/CHRONIC HAZARDS: This compound is toxic by ingestion, inhalation and skin contact. It may cause irritation. When heated to decomposition it emits toxic fumes of hydrogen fluoride gas and sodium oxide. It is corrosive.

Ref: National Toxicology Program, Health and Safey, H&S: SODIUM FLUORIDE 7681-49-4 (updated on 13 August 2001. Available at: http://ntp-server.niehs.nih.gov/cgi/iH_Indexes/ALL_SRCH/iH_ALL_SRCH_Frames.html
[Note: definitions from Stedman's Concise Medical Dictionary for the Health Professions, 4th edition.]


Fluoride/fluorinated substances identified in Agreement between Canada and the United States on Great Lakes Water Quality, 1978.
Appendix 1 - Hazardous Polluting Substances:

Ammonium Bifluoride * Ammonium Fluoborate * Ammonium Fluoride * Ammonium Silicofluoride * Antimony Trifluoride * Beryllium Fluoride * Ferric Fluoride * Hydrofluoric Acid * Lead Fluoborate * Lead Fluoride * Sodium Bifluoride * Sodium Fluoride * Zinc Fluoride * Zinc Silicofluoride * Zirconium Potassium Fluoride.
Appendix 2 - Potential Hazardous Polluting Substances:
Aluminum Fluoride * Antimony Pentafluoride * Benfluralin * Chlorflurazole * Cobaltous Fluoride * Stannous Fluoride


US Federal Register

•• Note: Due to length, the following is a partial list. Click here to see full list of FR entries.

Published date Docket Identification Number

Details

October 10, 2007 EPA-HQ-OPP-2007-0833

Sodium Fluoride Risk Assessment; Notice of Availability and Risk Reduction Options. This notice announces the availability of EPA's risk assessment, and related documents for the pesticide Sodium Fluoride and opens a public comment period on these documents. Comments on the following documents are due by December 10.

Sodium Fluoride Preliminary Risk Assessment for the Reregistration Eligibility Decision (RED) Document . Sept. 30, 2007 (87 pages)
Revised Occupational and Residential Exposure Chapter for the Sodium Fluoride Reregistration Eligibility Decision (RED). Oct. 1, 2007 (12 pages)
Environmental Fate Science Chapter for the Sodium Fluoride Reregistration Eligibility Decision (RED) Document. Sept. 25, 2007 (8 pages)
Sodium Fluoride Toxicology Chapter for Issuance of the Reregistration Eligibility Decision (RED) Document. Sept. 30, 2007 (78 pages)
Product Chemistry Science Chapter For: Sodium Fluoride Reregistration Eligibility Decision (RED). Sept. 25, 2007 (2 pages)
Revised Ecological Hazard and Environmental Risk Assessment Science Chapter for the Sodium Fluoride Reregistration Eligibility Decision (RED). Sept. 25, 2007 (13 pages)
Sodium Fluoride – Incident Report Summary. Aug. 3, 2007 (11 pages)

Sept 21, 2005 OPP-2005-0069 Revocation of Pesticide "Inert" Tolerance Exemption. FINAL RULE.
Sodium fluoride is one of 34 exemptions that EPA is revoking from the requirement of a tolerance that were identified in the Federal Register of June 1, 2005 (see below). EPA says it is revoking sodium fluoride because it is not contained in any product as an "inert" ingredient. However, sodium fluoride is used as an active ingredient in wood preservatives and is used on "right of ways" - see FAN comments submitted to EPA.
August 8, 2005 OPP-2005-0069

Proposed rule; reopening of comment period.
This document reopens the public comment period established in the Federal Register issued on June 1, 2005 (see below). In that document, EPA sought comment on a proposed rule revoking 34 exemptions from the requirement of a tolerance that are associated with 31 inert ingredients because, according to Agency records, these substances are no longer contained in active FIFRA pesticide product registrations. The following are the comments submitted on this proposal. The comments are relevant to the "inerts" issue, and not sodium fluoride. FAN's comments are relevant to both.

Date of Letter Letter from Details Docket No.
July 18, 2005

Inerts Steering Committee

A joint effort of CropLife America and the Chemical Producers and Distributors Assoc.

Requests a 30-day extenstion OPP-2005-0069-0003
July 27, 2005 Monsanto Monsanto states that their pesticide products "do not list any of the specific chemicals." However, they submitted 5 interesting questions to EPA. OPP-2005-0069-0004
July 27, 2005 Dow AgroSciences In their support for this proposal Dow submits questions on inerts to EPA. OPP-2005-0069-0005
July 27, 2005 Dow AgroSciences This letter from Dow contains Confidential Business Information which has been deleted from this document. OPP-2005-0069-0006
August 1, 2005 Fluoride Action Network Pesticide Project FAN supports the proposal and submits several questions to EPA on the use of sodium fluoride. OPP-2005-0069-0007 


June 1, 2005 OPP-2005-0069

EPA proposes to revoke sodium fluoride (40 CFR 180.920) as an inert ingredient.
EPA is proposing to revoke 34 exemptions from the requirement of a tolerance that are associated with 31 inert ingredients because these substances are no longer contained in active Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide product registrations. These ingredients are subject to reassessment by August 2006 under section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). Upon the issuance of the final rule revoking the tolerance exemptions, the 34 tolerance exemptions will be counted as ``reassessed'' for purposes of FFDCA's section 408(q). Comments must be received on or before August 1, 2005.

EPA is aware that inert ingredients are also contained in pesticide adjuvant products which are not subject to registration under FIFRA. The Agency does not keep records of currently used adjuvants or their ingredients, therefore, it has been unable to conclusively confirm the use of adjuvants containing one of these inert ingredients. Parties who know of currently used adjuvant products that contain an inert ingredient subject to this proposal are encouraged to submit documentation to EPA in the form of the adjuvant product's current label and/or documentation of the registration of the adjuvant product with a State adjuvant registration program.

Also, inert ingredient tolerance exemptions will be retained if the tolerances or exemptions (which EPA refers to as ``import'' tolerances) are necessary to allow importation into the United States of food containing such residues. Through this proposed rule, the Agency is inviting individuals who need these import tolerance exemptions to identify those exemptions that are needed to cover imported commodities.

Parties interested in the retention of any of the tolerance exemptions subject to this notice should be aware that because these ingredients are currently subject to reassessment under section 408(q) of FFDCA, additional data may be needed to support retention of the exemption. Reassessment activities for such ingredients must be completed by August 2006. If the Agency is unable to determine that the exemptions for these ingredients meet the FFDCA standard for reassessment, the Agency will revoke the exemptions.

B. When Do These Actions Become Effective?
EPA is proposing that revocation of these tolerance exemptions become effective on the day the final rule revoking these tolerance exemptions is published in the Federal Register...

April 28, 2004 OPP-2003-0368 Pesticides; Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing Solutions). FINAL RULE.
-- Stabilizer carrier for formulations used before crop emerges from soil.  Not more than 0.25% of pesticide formulation. For use in pesticide formulations applied to growing crops only:
July 30, 2003 OPP-2002-0327 US EPA's Pesticide Reregistration Performance Measures and Goals.
Candidate for Reregistration Eligibility Decision (RED) in Fiscal Year 2004
  which runs from October 1, 2003, through September 30, 2004.
April 16, 2003 OPP-2003-0116.

Requests to voluntarily cancel certain pesticide registrations. EPA is issuing a notice of receipt of request by registrants to voluntarily cancel certain pesticide registrations. Unless a request is withdrawn by October 13, 2003, or May 16, 2003 for EPA Registration Numbers: 003008-00021, 075341-00001, and 075341-00007, orders will be issued canceling these registrations.

Product Registration Number Company Name and Address
Hollow Heart Concentrate 075341-00001 Osmose Utilities Services, Inc.
980 Ellicott Street,
Buffalo, NY 14209.
Osmoplastic SD Wood Preserving Compound 075341-00007
Sept 5, 2001 OPP-301166

Proposed Pesticide Temporary Tolerances for residues resulting from the post harvest treatment with sulfuryl fluoride:
It is important to read the updated toxicological risk assessment on inorganic fluoride prepared by EPA and published in this issue of the FR.

Dec 21, 2000 TMD-00-02
(USDA)

Approved for use in US National Organic Standards. USDA National Organic Program. - FINAL RULE.
The National Organic Program allows the use of all US EPA "List 4 Inerts" in organic agriculture. Sodum fluoride is a "List 4 Inert." Because "Inerts" are considered confidential proprietary information, the public is denied the right to know which crops they are used on. The Final Rule states:

"In this final rule, only EPA List 4 Inerts are allowed as ingredients in formulated pesticide products used in organic crop and livestock production. The allowance for EPA List 4 Inerts only applies to pesticide formulations..." (see last paragraph on page 248).

•• Note: Due to length, the above is a partial list. Click here to see full list of FR entries.

 
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