Federal Register/Vol. 63, No. 105/Tuesday, June 2, 1998/Rules
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Federal Register / Vol. 63, No. 105 / Tuesday, June 2, 1998 / Rules and Regulations 29949 CONSUMER PRODUCT SAFETY compounds, laundry sour, air packer) also supplies the substance in COMMISSION conditioner coil cleaners and floor CR packages of a popular size, and the polishes. The fluorides that may be non-CR packages bear conspicuous 16 CFR Part 1700 ingredients in these products and are labeling stating: ``This package for potentially toxic are hydrofluoric acid households without young children.'' 15 Final Rule: Requirements for Child- (``HF''), ammonium bifluoride, U.S.C. 1473(a), 16 CFR 1700.5. Resistant Packaging; Household ammonium fluoride, potassium Products With More Than 50 mg of 3. Existing PPPA Requirements for bifluoride, sodium bifluoride, sodium Fluoride-Containing Products Elemental Fluoride and More Than 0.5 fluoride and sodium fluosilicate.1[1&3] 2 Percent Elemental Fluoride; and Many dental products also contain The Commission currently requires Modification of Exemption for Oral fluorides, but at lower levels. In general, CR packaging for oral prescription drugs Prescription Drugs with Sodium the concentrations of elemental fluoride with fluoride, but it exempts those in Fluoride in household cleaners and surface liquid or tablet form that contain no preparation agents are 10 to 1,000-fold more than 264 mg of sodium fluoride AGENCY: Consumer Product Safety (equivalent to 120 mg fluoride) per Commission. higher than concentrations found in dental products.[2] package. 16 CFR 1700.14(10)(vii). The ACTION: Final rule. Commission based this exemption level 2. Relevant Statutory and Regulatory on the lack of serious adverse human SUMMARY: The Commission is issuing a Provisions experience associated with such drugs rule to require child-resistant (``CR'') at that time and a recommendation by packaging for household products The Poison Prevention Packaging Act of 1970 (``PPPA''), 15 U.S.C. 1471±1476, the American Dental Association that no containing more than the equivalent of more than 264 mg of sodium fluoride 50 mg of elemental fluoride and more authorizes the Commission to establish standards for the ``special packaging'' of should be dispensed at one time. 45 FR than the equivalent of 0.5 percent 78630. As discussed below, the elemental fluoride (on a weight-to- any household substance if (1) the degree or nature of the hazard to Commission is revising the exemption volume (``w/v'') or weight-to-weight to a new level that is based on current (``w/w'') basis). For consistency, the children in the availability of such substance, by reason of its packaging, is information concerning the toxicity of Commission is also modifying the oral fluoride and is consistent with the CR prescription drug exemption for sodium such that special packaging is required to protect children from serious requirement for fluoride-containing fluoride preparations. Instead of household products. exempting drugs with no more than 264 personal injury or serious illness mg of sodium fluoride per package as resulting from handling, using, or 4. The Proposed Rule ingesting such substance and (2) the the current rule does, the Commission On November 20, 1997, the special packaging is technically feasible, will exempt such drugs with either 50 Commission issued a notice of proposed practicable, and appropriate for such mg or less of the equivalent of elemental rulemaking (``NPR'') that would require fluoride (110 mg or less of sodium substance. Special packaging, also referred to as CR packaging for household products fluoride) per package or no more than containing more than the equivalent of the equivalent of 0.5 percent elemental ``child-resistant (CR) packaging,'' is (1) designed or constructed to be 50 mg of elemental fluoride and more fluoride on a w/v or w/w basis. The than the equivalent of 0.5 percent Commission determines that child- significantly difficult for children under 5 years of age to open or obtain a toxic elemental fluoride (w/v or w/w). The resistant packaging is necessary to Commission also proposed to adjust the protect children under 5 years of age or harmful amount of the substance contained therein within a reasonable oral prescription drug exemption so that from serious personal injury and serious it would be consistent. 62 FR 61928. illness resulting from handling or time and (2) not difficult for ``normal adults'' to use properly. 15 U.S.C. The Commission received four ingesting a toxic amount of elemental comments in response to the proposed fluoride. The Commission takes this 1471(4). Household substances for which the Commission may require CR rule. action under the authority of the Poison One commenter noted that the packaging include (among other Prevention Packaging Act of 1970. language of the revised exemption categories) foods, drugs, or cosmetics as needed to be clarified. The Commission DATES: The rule will become effective these terms are defined in the Federal intended that products satisfying either on March 2, 1999, and applies to Food, Drug, and Cosmetic Act (21 U.S.C. one of the criteria specified would products packaged on or after that date. 321). 15 U.S.C. 1471(2)(B). The qualify for the exemption. Accordingly, FOR FURTHER INFORMATION CONTACT: Commission has performance the Commission has clarified the final Laura Washburn, Office of Compliance, requirements for special packaging. 16 rule so that it exempts sodium fluoride Consumer Product Safety Commission, CFR 1700.15, 1700.20. drug preparations that contain no more Washington, D.C. 20207; telephone Section 4(a) of the PPPA, 15 U.S.C. than 50 mg of the equivalent of (301) 504±0400 ext. 1452. 1473(a), allows the manufacturer or elemental fluoride (110 mg or less of SUPPLEMENTARY INFORMATION: packer to package a nonprescription sodium fluoride) per package or no product subject to special packaging more than the equivalent of 0.5 percent A. Background standards in one size of non-CR elemental fluoride on a w/w or w/v 1. Household Products Containing packaging only if the manufacturer (or basis. Fluoride The Commission received a letter 1 The percentage of elemental fluoride in any Fluorides are ingredients in such compound is determined by dividing the molecular from the American Dental Association household products as cleaning weight of fluoride (∼619 grams/mole) by the stating that it does not object to the solutions for metal, tile, brick, cement, molecular weight of the compound (e.g., the proposed rule. The third comment came wheels, radiators, siding, toilets, ovens molecular weight of sodium fluoride = 42 grams/ from the Art and Creative Materials mole). Sodium fluoride contains 45% elemental and drains. Fluorides are also found in fluoride (19¤42 × 100 = 45%). Institute, a non-profit association of rust and water stain removers, silver 2 Numbers in brackets refer to documents listed manufacturers of art and creative solder and other welding fluxes, etching at the end of this notice. materials, expressing support for the 29950 Federal Register / Vol. 63, No. 105 / Tuesday, June 2, 1998 / Rules and Regulations proposed rule. The Chemical fluoride.[2] According to the medical penetrated through to the bones of her Manufacturers Association also literature, a safely tolerated dose forearm. Four months after the incident commented in support of the proposed (``STD'') and a certainly lethal dose she had only partial use of her arm and rule. (``CLD'') were determined from 600 hand. Three reports in the INDP files fluoride poisoning deaths. The CLD was involve children under 5 years old who B. Toxicity of Fluoride determined to be 32 to 64 mg/kg and the died after ingesting fluoride-containing Most available toxicity information on STD was estimated at one fourth that, or products. A 3-year old child ingested an fluoride relates to acute toxicity of 8 to 16 mg/kg. These values were unknown product with HF. The second hydrofluoric acid (``HF''). However, statistically determined and are not case involved a 2-year-old child who other water soluble fluoride-containing identical to the actual lowest toxic or ingested a toilet bowl stain remover that compounds can cause fluoride lethal levels of fluoride. The lowest contained 15.9 percent ammonium poisoning. The fluoride ion is documented lethal dose for fluoride is bifluoride. The most recent case was an systemically absorbed almost 16 mg/kg in a 3-year-old child. There 18-month-old child who ingested an immediately. It is highly penetrating were complicating factors in this death. unknown amount of air conditioner coil and reactive and can cause both The child may have taken other cleaner with 8 percent HF and 8 percent systemic poisoning and tissue medications and he suffered from phosphoric acid.[2] destruction. Fluoride ions, once Crohn's disease (an inflammatory Since 1995, there were six reports of separated from either HF or fluoride disorder of the GI tract) that may have fluoride poisoning in children under 5 salts, penetrate deep into tissues, contributed to his death.[2] years of age from a wheel cleaning causing burning at sites deeper than the C. Injury Data product. The product contains original exposure site. The process of ammonium bifluoride and ammonium tissue destruction can continue for Medical Literature. There are many fluoride salts, reportedly containing at days.[2] reports in the medical literature of least 15 percent fluoride. Before Fluoride absorption can produce deaths and injuries involving fluoride- December, 1996, it was marketed for hyperkalemia (elevated serum containing products. A retrospective household use in non-CR packaging. potassium), hypocalcemia (lowered study conducted by the American Since that date it has been packaged in serum calcium), hypomagnesemia Association of Poison Control Centers CR packaging, and in September 1997 it (lowered serum magnesium), and (``AAPCC'') of hydrofluoric acid burns was recalled by the manufacturer.[2] metabolic and respiratory acidosis.