Household Products Containing Fluoride
Excerpts from US Federal Register: June 2, 1998
(Volume 63, Number 105)]
U.S. Consumer Product Safety Commission
Fluorides are ingredients in such household products as cleaning solutions 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.
B. 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.
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.
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.
Ocular exposure can result in serious eye injury.
Ingestion of fluoride can result in mild to severe GI symptoms.
C. Injury Data
Medical Literature. There are many reports in the medical literature of deaths and injuries involving fluoride-containing products. A retrospective study conducted by the American Association of Poison Control Centers (“AAPCC”) of hydrofluoric acid burns from rust stain removers applied to clothing found 619 such cases in 1990. Five of these required hospitalization.
Other reports gathered from the medical literature are discussed in the notice of proposed rulemaking and the accompanying briefing package.
From 1988 to 1996, NEISS had reports of 31 incidents involving products documented to contain fluoride. Two of these were accidental ingestions by children under 5 years old. Most other injuries involved chemical burns of the hands. In addition, 1997 NEISS reports show six adults experienced burns while using fluoride-containing products. In 1997, NEISS had reports of an additional five cases involving children under 5 years old ingesting products containing fluoride. For 1997, NEISS also reported an additional three cases of children under 5 years old involving products that might have contained fluoride.
The INDP files contain numerous injury reports. For example, a 50- year-old woman was using a water stain remover with 6 percent HF when it leaked through her rubber gloves and to her skin. She developed intense pain 4 hours later when the fluoride ion penetrated through to the bones of her forearm. Four months after the incident she had only partial use of her arm and hand. Three reports in the INDP files involve children under 5 years old who died after ingesting fluoride- containing products. A 3-year old child ingested an unknown product with HF. The second case involved a 2-year-old child who ingested a toilet bowl stain remover that contained 15.9 percent ammonium bifluoride. The most recent case was an 18-month-old child who ingested an unknown amount of air conditioner coil cleaner with 8 percent HF and 8 percent phosphoric acid.
Since 1995, there were six reports of fluoride poisoning in children under 5 years of age from a wheel cleaning product. The product contains ammonium bifluoride and ammonium fluoride salts, reportedly containing at least 15 percent fluoride. Before December, 1996, it was marketed for household use in non-CR packaging. Since that date it has been packaged in CR packaging, and in September 1997 it was recalled by the manufacturer.
Three deaths from fluoride-containing products were documented in 1997 after the staff had completed the briefing package for the proposed rule. Two involved children under 5 years old. In one case, a 3-year-old female died from cardiac arrest after ingesting the recalled wheel cleaner described above. The second death involved a 19-month-old female who ingested a rust remover with hydrofluoric acid and ammonium bifluoride. Finally, a 38-year-old male died from cardiac arrest after unintentional ingestion of a rust remover with ammonium bifluoride.
AAPCC Data. The staff reviewed AAPCC ingestion data involving children under 5 years old and products known to, or that may, contain fluoride. (The actual number of fluoride exposures cannot be determined because some products that contain fluoride are not identified as such and therefore may be coded to generic categories such as acidic cleaning products or other unknown cleaning products.) From 1993 to 1995, there were no reported fatalities in this age group. Out of a total of 499 exposures to products known to contain HF, there were 2 major \3\ outcomes and 24 moderate \4\ outcomes. The AAPCC data also show 23 major outcomes and 188 moderate outcomes for other acid household products. Some of these may have contained fluoride. The frequency of injury for dental treatments was much lower than that for household products containing HF. Of approximately 23,000 exposures to such dental products, there were 34 moderate outcomes, and the only documented major outcome was a miscoded incident where the child experienced an allergic reaction to the product rather than systemic toxicity from an overdose.
Major outcome--The patient exhibited signs or symptoms which were life-threatening or resulted in significant residual disability or disfigurement.
Moderate outcome--The patient exhibited signs and symptoms that were more pronounced, more prolonged, or more of a systemic nature. Usually some form of treatment was required. Symptoms were not life-threatening and the patient had no residual disability or disfigurement.
The staff also compiled data from AAPCC annual reports for all ages and all routes of exposure for the years 1985 to 1995. During this time period, there were about 25,000 exposures to products containing HF. Of these, 2,881 resulted in moderate outcomes and 275 in major outcomes.
There were also injuries from dental products, fluoride mineral/electrolyte products, and vitamins with fluoride. A total of 18 deaths were reported in the HF category. Two deaths involved children under 5 years old. One ingested an ammonium bifluoride toilet stain remover (described above) and the other child died after ingesting a toilet cleaner with HF. Generally, these AAPCC data suggest that household products with HF pose a more serious risk of injury than other classes of fluoride products. Moderate to serious outcomes developed in 12.8 percent of the exposures to HF compared to only 0.4 percent of the exposures to anticaries products.
The 1996 AAPCC data for all ages and all routes of exposure show that for 1996 there were about 2944 exposures to products containing HF. Of these, 742 resulted in moderate outcomes and 27 in major outcomes. Four deaths were reported involving HF.
Hazard to Children
As noted above, the toxicity data concerning children's ingestion of fluoride demonstrate that fluoride can cause serious illness and injury to children. Moreover, it is available to children in common household products. Although some products currently use CR packaging, others do not. The Commission concludes that a regulation is needed to ensure that products subject to the regulation will be placed in CR packaging by any current as well as future manufacturers.[1,2&5]
The same hazard posed to children by toxic amounts of fluoride in household products also exists from such levels of fluoride in oral prescription drugs. Therefore, the Commission is modifying the existing exemption for such drugs with sodium fluoride to reflect current toxicity data and be consistent with the level for fluoride-containing household products.[1&2]
Pursuant to section 3(a) of the PPPA, 15 U.S.C. 1472(a), the Commission finds that the degree and nature of the hazard to children from handling or ingesting fluoride is such that special packaging is required to protect children from serious illness. The Commission bases this finding on the toxic nature of these products, described above,and their accessibility to children in the home.
Some OTC fluoride-containing household products are packaged in containers with non-CR continuous threaded closures. The Commission also is aware of such products packaged in aerosols and mechanical pumps. Various types and designs of senior friendly CR packaging can be readily obtained that would be suitable for fluoride-containing products.[3&4]
Two manufacturers currently use senior-friendly continuous threaded CR packaging for their fluoride-containing household products. Another manufacturer uses a senior-friendly trigger mechanical pump mechanism for its product. This shows that these types of CR packages are technically feasible, practicable and appropriate for fluoride-containing products. The Commission knows of at least one fluoride product that uses a non-CR aerosol package. The manufacturer of another regulated product is currently using a senior-friendly CR aerosol overcap. Thus, this kind of CR packaging could be used for fluoride-containing products. Finally, various designs of senior-friendly snap type reclosable CR packaging that would be appropriate for non-liquid fluoride-containing products are available. Thus, appropriate senior-friendly CR packaging is available for products marketed in continuous threaded, snap, aerosols, and trigger spray packaging. Therefore, the Commission concludes that CR packaging for fluoride-containing products is technically feasible, practicable, and appropriate.
Sec. 1700.14 Substances requiring special packaging.
(a) Substances. The Commission has determined that the degree or nature of the hazard to children in the availability of the following substances, by reason of their packaging, is such that special packaging meeting the requirements of Sec. 1700.20(a) is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substances, and the special packaging herein required is technically feasible, practicable, and appropriate for these substances:
(10) Prescription drugs. Any drug for human use that is in a dosage form intended for oral administration and that is required by Federal law to be dispensed only by or upon an oral or written prescription or a practitioner licensed by law to administer such drug shall be packaged in accordance with the provisions of Sec. 1700.15(a), (b), and (c), except for the following:
(vii) Sodium fluoride drug preparations including liquid and tablet
forms, containing not more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental fluoride) per package or not more than a concentration of 0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids and containing no other substances subject to this Sec. 1700.14(a)(10).
(27) Fluoride. Household substances containing more than the equivalent of 50 milligrams of elemental fluoride per package and more than the equivalent of 0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquidsshall be packaged in accordance with the provisions of Sec. 1700.15(a),(b) and (c).