Sodium Fluoride
CAS No. 7681-49-4
US Federal Register

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Adverse Effects

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


US Federal Register
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

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).

Nov 20, 1997

Requirements for Child-Resistant Packaging. Federal Register.
SUMMARY: The The Consumer Product Safety Commission is proposing a rule to require child-resistant (``CR'') packaging for household products containing more than the equivalent of 50 mg of elemental fluoride and more than the equivalent of 0.5 percent elemental fluoride (on a weight-to-volume (``w/v'') or weight-to-weight (``w/w'') basis). Examples of such products are some rust removers, toilet cleaners, metal cleaners and etching products. Dental products, such as toothpaste, contain lower levels of fluoride and would not be affected. For consistency, the Commission is also proposing to modify the oral prescription drug exemption for sodium fluoride preparations. Instead of allowing drugs with no more than 264 mg of sodium fluoride per package to be in non-CR packaging as the current rule does, the Commission proposes to allow such drugs with only 50 mg or less of the equivalent of elemental fluoride (110 mg or less of sodium fluoride) per package and no more than the equivalent of 0.5 percent elemental fluoride on a w/v or w/w basis. The Commission has preliminarily determined that child-resistant packaging is necessary to protect children under 5 years of age from serious personal injury and serious illness resulting from handling or ingesting a toxic amount of elemental fluoride. The Commission takes this action under the authority of the Poison Prevention Packaging Act of 1970.

Many types of household products may contain fluoride in one form or another. Fluorides are ingredients in cleaning products for metal, tile, brick, cement, wheels, radiators, siding, toilets, ovens and drains. Fluorides are also found in rust and water stain removers, silver solder and other welding fluxes, etching compounds, laundry sour, air conditioner coil cleaners and floor polishes. The fluorides that may be ingredients in these products and are potentially toxic are hydrofluoric acid (``HF''), ammonium bifluoride, ammonium fluoride, potassium bifluoride, sodium bifluoride, sodium fluoride and sodium fluosilicate.

... some household products, particularly metal cleaners and rust removers containing hydrofluoric acid and/or soluble fluoride salts, can have as much as 57 percent elemental fluoride. In general, the concentrations of elemental fluoride in household cleaners and surface preparation agents are 10 to 1,000-fold higher than concentrations found in dental products.

Toxicity of Fluoride. Most available toxicity information on fluoride relates to acute toxicity of hydrofluoric acid (``HF''). However, other water soluble fluoride-containing compounds can cause fluoride poisoning. The fluoride ion is systemically absorbed almost immediately. It is highly penetrating and reactive and can cause both systemic poisoning and tissue destruction. Fluoride ions, once separated from either HF or fluoride salts, penetrate deep into tissues, causing burning at sites deeper than the original exposure site. The process of tissue destruction can continue for days.

Systemic fluoride poisoning after ingestion or inhalation occurs very rapidly as the fluoride is absorbed into the gastrointestinal (``GI'') tract and lungs. Systemic fluoride poisoning can also result from dermal exposure if the exposure is massive or the skin barrier has been destroyed, as with severe burns. Fluoride absorption can produce hyperkalemia (elevated serum potassium), hypocalcemia (lowered serum calcium), hypomagnesemia (lowered serum magnesium), and metabolic and respiratory acidosis. These disturbances can then bring on cardiac arrhythmia, respiratory stimulation followed by respiratory depression, muscle spasms, convulsions, central nervous system (``CNS'') depression, possible respiratory paralysis or cardiac failure, and death. Fluoride may also inhibit cellular respiration and glycolysis, alter membrane permeability and excitability, and cause neurotoxic and adverse GI effects.[2]

When exposure is through inhalation, fluorides can cause severe chemical burns to the respiratory system. Inhalation can result in difficulty breathing (dyspnea), bronchospasms, chemical pneumonitis, pulmonary edema, airway obstruction, and tracheobronchitis. The severity of burns from dermal absorption can vary depending on the concentration of fluoride available, duration of the exposure, the surface area exposed, and the penetrability of the exposed tissue. Dermal exposure to 6 to 10 percent HF is the lowest concentration range known to cause skin injury in humans. Destruction of tissue under the skin may occur, as may decalcification and erosion of bone. Death from systemic fluoride toxicity has resulted from dermal exposure to 70 percent HF over 2.5 percent of the body surface.[2]

Ocular exposure can result in serious eye injury. Exposure to concentrations of 0.5 percent can lead to mild conjunctivitis and greater concentrations can lead to progressively severe results such as immediate corneal necrosis (20 percent solution).

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