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Consumer Product Safety: fluoride | Fluoride | Over The Counter Drug
Consumer Product Safety: fluoride
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CONSUMER PRODUCT S A F E T Y COMMISSION Washington, D.C. 20207
DATE : TO FROM : :
MN 6 1998
The Commission Sadye E. Dunn, Secretary Jeffrey Bromme, General Counsel Stephen Lemberg, Assistant Patricia M. Pollitzer, Attorney, Final PPPA Rule Requiring Child-Resistant Packaging for Household Products with Fluoride and Modifying Prescription Drug Exemption for Sodium Fluoride
Attached is a staff briefing package recommending that the Commission issue a final rule requiring child-resistant packaging under the Poison Prevention Packaging Act for household products containing the equivalent of more than 50 mg of elemental fluoride and more than the equivalent of 0.5 percent elemental fluoride. The staff also recommends that the Commission modify the current exemption for oral prescription drugs with sodium fluoride so that the exemption level would be consistent with the recommended level for household products. Tab G of the package contains a draft Federal Reqister notice that reflects both of the staff's recommendations. Please indicate your vote on the following options. I. Approve the Federal Resister notice as drafted.
NOTE: This document has not been
Approve the draft Federal Register notice with the following changes (please specify).
Final Rule to Require Child-Resistant Packaging for Household Products with Fluoride
For Information Contact: Jacqueline Ferrante, Ph.D. Directorate for Epidemiology & Health Sciences (301) 504-0477
NOTE: This document has not been reviewed or accented bv the Commission.
PAGE Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Briefing Memorandum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Public Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Updated Injury Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Regulatory Flexibility and Environmental Issues . . . . . . . . . . . . . . . . . Technical Feasibility, Practicability, and Appropriateness . . . . . . . . . . . Effective Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Recommendation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . T,4B A TAB B T,AB C 6 7 8 9 9 9 10 .10
Federal Register Notice, November 20, 1997 . . . . . . . . . . . a, . 11 Public Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, “Update on Injuries Due to Products Containing Fluoride,” October 9, 1997. . . . . . . . . . . . . 25 Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D.“Injuries Due to Products Containing Fluoride,” April 20, 1998 . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Memorandum from Marcia P. Robins, EC, to Jacqueline Ferrante, Ph.D., EH,” Final Rule: Child-Resistant Packaging for Household Products Containing Fluoride,” April 8, 1998 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Memorandum from Charles Wilbur, EH, to Jacqueline Ferrante, Ph.D., Technical Feasibility, Practicability, and Appropriateness Determination for the Final Rule to Require Special Packaging for Products Containing Fluoride,“March 10, 1998 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Draft Final Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Executive Summary On November 20, 1997, the Commission proposed a special packaging standard for household products with more than the equivalent of 50 mg of elemental fluoride and more than the equivalent of 0.5 percent elemental fluoride. The Commission also proposed to modify the exemption for oral prescription drugs with fluoride so that the exemption would be consistent with the proposed rule. The staff received four comments. None opposed the proposed rule or the proposed modification. Fluoride can cause severe penetrating bums and systemic effects. Deaths and serious injuries have resulted from toxic exposure to fluoride in both children and adults. Three deaths were reported within the last year, two involved children under five years old. The types of products that would be subject to a special packaging standard are those with high concentrations of fluoride in the form of hydrofluoric acid or soluble, inorganic salts, including various cleaners (e.g., metal, toilet, etc.), rust removers, and etching creams. Dental products would not be included because the concentration of elemental fluoride in currently marketed products is 0.5 percent or less. Special packaging is technically feasible, practicable., and appropriate for household products with fluoride. Some companies voluntarily use child-resistant packaging (CRP). A special packaging requirement for fluoride-containing products is not expected to have a significant impact on a substantial number of small businesses or have environmental effects. Senior-friendly CRP is readily available at competitive prices with non-CR-P. No comments were received from small businesses and no additional information was provided concerning glass etching creams. The staff recommends that the Commission issue a special packaging standard for all household products with 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) basis for liquids or a weight-to-weight (w/w) basis for nonliquids. The staff also recommends modifying the level for exemption for oral prescription drugs with sodium fluoride, to that for special packaging of other products with fluoride.
The Commissibn Sadye E. Dunn, Secretary Jeffrey S. Bromme, General Counsel Pamela Gilbert, Executive Director y&b L/
Ronald L. Medford, Assistant Executive Director for Hazard Identification toq and Reduction Jacqueline N. Ferrante, Ph.D., Pharmacologist, Directorate for Epidemiology/ and Health Sciences, Division of Health Sciences
Subject: Special Packaging Standard for Household Products with Fluoride Background On November 20, 1997, the Commission proposed a special packaging standard for household products with fluoride because these products may cause serious harm and death in young children (Tab A). Additionally, the Commission proposed to modi@ the exemption for oral prescription drugs with fluoride to be consistent with the proposed special packaging standard. Detailed information concerning this issue was provided to the Commission in a briefing package dated September 30, 1997. The acute toxicity of fluoride is well established. Hydrofluoric acid and fluoride salts found in products such as metal/toilet cleaners, rust removers, and etching creams, can dissociate fluoride ions (F‘ ) leading to penetrating tissue destruction and systemic poisoning. Deaths and serious injuries have been reported in children and adults following exposure to fluoride-containing products. The staff determined that products with both more than 50 milligrams (mg) and 0.5 percent elemental fluoride could potentially cause serious toxicity. Products that contain more than 50 mg per package, but have a concentration of 0.5 percent or less would not be subject to a special packaging standard. Dental products would be included in this category. This is consistent with the lack of injury data for both over-thecounter (OTC) and exempted prescription (Rx) fluoride-containing dental products. The following table clarifies which fluoride-containing products would be subject to a special packaging standard.
NOTE: This doknent has not been reviewed or accepted by th Commission. D t e q,f& / 7 f Initial $,,ka
Fluoride-containinp Products Subiect to a SDecial Packagiw Standard Product contains > 50 mg elemental fluoride Product contains > 0.5% elemental fluoride . Yes No Yes No Yes Yes No No Yes No No No . Subject to a special packaging standard
Public Comments The Commission received four comments in response to the proposed rule (Tab B). Colgate Oral Pharmaceuticals requested clarification regarding the exemption. The FR notice stated that the proposed exemption applies to sodium fluoride drug preparations that contain 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 weight to weight (w/w) or weight to volume (w/v) basis. The staff intended that products satisfying only one of these criteria would qualify for an exemption. Therefore, the wording for the exemption should be modified to exempt those sodium fluoride drug preparations that contain 50 mg or less of the equivalent of elemental fluoride (110 mg or less of sodium fluoride) per package or no more than the equivalent of 0.5 percent elemental fluoride on a w/w or w/v basis. The Chemical Manufacturers Association supports the proposed rule and the American Dental Association (ADA) had no objection to it. The ADA agrees that currently marketed OTC and Rx dental products with fluoride intended for home use have not been shown to pose a significant hazard to young children. Additionally, the ADA stated that “there are no currently marketed dental products that meet both of the proposed criteria for child-resistant packaging.” The Commission specifically requested information on the uses and marketing patterns of glass etching creams. No information was received related to this issue except that the Art and Creative Materials Institute, an international association of manufacturers of art and creative materials (including glass etching creams), support the proposed rule.
The staff sent letters to 65 companies that market or may market fluoride-containing products informing them of the proposed rule and requesting comments. Only two companies responded and neither markets fluoride-containing products. Five letters were returned with no forwarding address. Updated Injury Data ,
The staff updated injury data from fluoride-containing products since publication of the proposed rule (Tab A) which contained injury data from the medical literature, CPSC databases, and the American Association of Poison Control Centers (AAPCC). There were three additional deaths documented, two involved children under five years old (Tab C). These were not in the briefing package for the proposed rule, but were discussed at the public briefing in October 1997. In one case a 3-year-oId female ingested a wheel cleaner that contained ammonium fluoride and ammonium bifluoride salts. She vomited, her blood pressure dropped, and she became cyanotic. She died following cardiac arrest. The second death involved a 19-month-old female who ingested a rust remover with hydrofluoric acid and ammonium bifluoride. The third incident involved a 38-year-old male who unintentionally ingested one-half cup of rust remover with ammonium bifluoride. He died four hours postingestion from cardiac arrest. In another incident, an 18-month-old child ingested an unknown amount of rust remover. This child was examined in a hospital, but released the next day without any injuries. From June 1, 1997 to February 28, 1998, there were a number of injuries from fluoride-containing products reported in the National Electronic Injury Surveillance System (NEISS) database (Tab D). Six involved adults who experienced bums to the fingers, hands, or arms after using hydrofluoric acid (HF) cleaners. In another case, an 18-year-old female had chemical bums on her back and abdomen after she used a rust remover on a shirt, washed the shirt, and wore it. Five other NEISS cases reported during this period involved children under five years old. Three involved rust removers with HF. A 12-month-old male spilled some rust remover on his right leg causing bums and he also may have ingested some of the product. A 12month-old female was discovered pouring rust remover into a cup. Although the child had a blistered lip, the parents did not think the child ingested the product. In another case, a 2year-old male ingested an unknown quantity of rust remover. All three of these children were treated and released. The other two NEISS cases involved a wheel cleaning product with ammonium fluoride salts. In one case a 2-year-old male sprayed the cleaner in his mouth. This child was treated and released. In the second case, a 21 -month-old male was hospitalized after an accidental ingestion of this product. This incident is still under investigation.
The staff also reviewed data from the AAPCC for 1996 (Tab C). No fatalities or major’ injuries occurred in children under five years old exposed to HF products. One major injury was documented in a child following the ingestion of an electrolyte/mineral fluoride preparation. AAPCC data for all ages and all routes of exposure showed that moderate* to major outcomes developed in 14.2 percent of exposures to household products with HF compared to 0.5 percent of exposures to anti-caries products with fluoride. This is consistent with the lower concentration ‘of fluoride in the anti-caries product category. The draft Federal Register notice (Tab G, pp. 7 - 11) summarizes all of the injury data (incidents discussed in the notice of proposed rulemaking as well as the updated information). Regulatory Flexibility and Environmental Issues The staff concludes that a special packaging requirement for fluoride-containing products will not have a significant impact on a substantial number of small businesses (Tab E). Senior-friendly CRP is readily available at competitive prices with non-CRP. Some manufacturers of fluoride-containing products are voluntarily using senior-friendly CRP. The proposal will have no significant effects on the environment because the manufacture, use, and disposal of CR and non-CRP is virtually the same. Technical Feasibility, Practicability, and Appropriateness Available data support a conclusion that special packaging for fluoride-containing products is technically feasible (producible), practicable (lends itself to mass production techniques), and appropriate (compatible with the product) (Tab F). Senior-friendly CRP is available for products marketed in continuous threaded, snap, aerosols, and trigger spray packaging. Senior-friendly continuous threaded CRP is currently used by two manufacturers and another manufacturer uses a senior-friendly trigger mechanical pump mechanism for its product. E. Effective Date The PPPA provides that no regulation shall take effect sooner than 180 days or later than one year from the date such regulation is issued, unless the Commission determines that an earlier effective date is in the public interest. The Commission proposed that a final rule would take effect nine months after publication of the final rule since senior-friendly special packaging is commercially available for most types of CRP. Full commercial availability for senior-friendly mechanical pump packages and aerosol overcap packages could take from nine
‘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 is required. Symptoms were not life-threatening and the patient had no residual disability or disfigurement.
months to one year. The Commission proposed a nine month effective date and did not receive any comments related to this issue. Therefore, the staff concludes that an effective date of nine months after publication of the final rule is reasonable for most fluoridecontaining products. As stated in the draft Federal Register notice, companies needing more time can request a stay of enforcement for the minimum period needed to provide adequate supplies of senior-friendly CRP. Options 1. The Commission may issue a rule requiring special packaging for household products with more than the equivalent of 50 mg of elemental fluoride and more than the equivalent of 0.5 percent elemental fluoride (w/v or w/w) if the Commission preliminarily finds that: i) special packaging is required to protect young children from serious personal injury or illness from handling, using, or ingesting the product; and ii) special packaging is technically feasible, practicable, and appropriate. 2. The Commission may also issue a rule to amend the level for exemption for oral prescription drugs with sodium fluoride to be consistent with that for other products with fluoride. The Commission may decline to issue either or both of these rules if it is unable to make the necessary findings.
Recommendation The toxicity of fluoride is well established and exposure to fluoride-containing products has resulted in serious injuries and deaths. The staff recommends that the Commission issue a special packaging standard for all household products with more than the equivalent of 50 mg of elemental fluoride and more than the equivalent of 0.5 percent elemental fluoride on a w/v basis for liquids or a w/w basis for nonliquids. To maintain consistency within the PPPA regulations, the staff also recommends amending the level for exemption for oral prescription drugs with sodium fluoride. A draft final rule is at Tab G.
Federal Register / Vol. 62, No. 224 1 Thursday, November 20. 1997 / Proposed Rules
That a&space eKtendfng upward from 700 feet above the surface within a 6.4.mile mdhs of Tmcy Munkipal Airport and wlthh 2.2 miles each side of the Man- VORTAC 237’ radial, extending from the 6.4.milt radius to 4.9 milts southwest of the Manteca VORTAC and wlthfn 1.8 miles each side of the 117’ bearlng from the Tmcy Municipal Airpon. extending from the 6.4~mile radius to 8.4 miles southeast df the Tmcy Municipal Airpon and wHhln 1.8 miles each side of the 326’ bearlq from the Tmcy Municipal Airport, extending from the 6.4~miles mdius to 7.7 miles northwest of the Tmcy Municipal Airport, excluding that portron within the Stockton, CA, Class E and Livermore, CA, Class E airspace artas, and excluding-that &space within ResMcted
Area R2531A. ID * a lb l lsueci in Los Angeles, California, on November 7.1997. MichaeI&xunes, Acting Manager, Air Iliafnc DMsion.
Western-PactTic Regfon.
SIAP, GPS RWY 25 SIAP, and GPS RVW 29 SIAP and other IFR operaUons at Tracy Municipal Airport. Tracy. CA. Class E airspace designations are published in paragraph 6005 of FAA Order 7400.E dated September 10.1997, and effective September 16.1997, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subse uently in this Order. * The FAA has Betermined that this proposed regulation only fnvovles an established body of technid regulations for which frequent and routine amendments are nv to keep them operationally current. Therefore. this proposed ngulation-(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “signifkant rule” under DOT Regulatory Policies and Procedures (44 FR 11034: February 26.1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Aa. Listofsubjectsinl4cFRput71 Ahpace. Incorporation by reference, Navigation (air). TtrePIoposcdAroendmcnt in consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 7 1 as follows:
package and no more than the quivalent of 0.5 percent elemental fluoride on a w/v or w/w basis. The Commission has preliminarily determined that child-resistant children under 5 years of age from serious penond hjwy and serious illness resulting from handling or ingesting a toxic amount of elemental fluoride. The Commission takes this rction undu the authority of the Poison Prevention Packaging Act of 1970. DA=: Comments on the pf0~ should be submitted no later than February 3.1998. m: Comments should be mailed to the Office of the Secret2uy. Consumer Product Safety Commission, Washington, D.C. 20207, or delivered to the Office of the SecreUuy, Consumer Product Safety Commission, Room 502. 4330 East-West Highway, Bethesda, Maryland 208 146408, telephone (301)504-0800. Comments may also be filed by telefacsimile to (301) 504-0127 or by email to cpsc-os@cpsc.gov.
FOR FURTHER INFORMAlION COMTACT:
packaging is n-=uy to protect
(FR Dot. 97-30353 Filed 1 l-19-97; 8:45 am] ULLHC CooE 4mo4~ CONSUMER PRODUCT SAFEfY COMMISSION 16 CFR Part 1700
Many types of household products may contain fluoride in one form or another. Fluorides are ingredients in cleaning products for metal, tile. brick, CUYMARY: The Commission is proposing ?ART tl--JAMENDED] cement, wheels, radiators, siding. a mle to require child-resistant (“CR”) toilets, ovens and drains. Fluorides are 1. The authority citation for 14 CFR packaging for household products in mst and stain part 71 continues to read as follows: containing more than the equivalent of also found silver solderwaterother removers, and 50 mg of elemental fluoride and more Aulhorfty: 49 U.S.C. 106(s). 40103.40113. welding fluxes, etching compounds, 40120; E. 0.10854.24 FR 9565.3 CFR. 195% than the equivalent of 0.5 percent laundry sour, air conditioner coil 1963 Con+, p. 389. elemental fluoride (on a weight-tocleaners and floor polishes. The volume (“w/v”) or weight-to-weight fluorides that may be ingredients in (“w/w”) basis). Examples of such these products and are potentially toxic 2. The incorporation by reference in products are some rust removers, toilet are hydrofluoric acid (“HF”), 14 CFR 71.1 of the Federal Aviation cleaners, metal cleaners and etching ammonium bffluoride, ammonium Administration Order 7400.9E. Airspace products. Dental products. such as fluoride, potassium bifluoride, sodium Designations and Reporting Points, toothpaste, contain lower levels of dated September 10.1997, and effective fluoride and would not be affected. For bffluoride, sodium fluoride and sodium fluosilicate. 1 (3 j 2 September 16.1997, is amended as consistency, the Commission fs also Many dental products also contain follows: proposing to modify the oral fluorides, but at lower levels. prescription drug exemption for sodium fluoride preparations. Instead of 1 The percem@ of tleYwnut tluolide ln any allowing dnrgs with no more than 264 ampoundbdcrmminedbyditidin@molcculu mg of sodium fluoride per package to be wtlght of fiuoride (- 19 @molt) by the might of the cOrnpOund (e.g.. the in non-CR packaging as the current tule molecularwe&ht of mdium fluoride - 42 gunr! molecular does, the Commission proposes to allow mole). Sodlum fluotldc contains 45% eknental such drugs with only 50 mg or less of fluotidc (lW42 x 100 - 45%). oar. 37’41’15” N. long. 121~629”W ~Numkninbmcketsrrftrtodocumcnu~cd the equivalent of elemental fluoride Manttca VORTAC etthemdofthisnotln. (110 mg or less of sodium fluoride) per Qat. 37’50’01” N. long. 12lW’17” WI
Fbquimmnta for Chl-t Plckrging; Houwhold Product8 Wkh Mom Than 50 mg of ElomentA Fluoride rnd More man 0.5 Pwoent Elemental Fluoride: l d Modtfication of Exemption for Oral Prescription Dwgt With Sodium Fluoride AGENCY: Consumer hoduct safety Commission. ACTION: Proposed rule.
Jacqueline Ferrante, Ph.D., Division of Health Sciences, Directorate for Epidemiology and Health Sciences, Consumer koduct Safety Commission. Washington. D.C. 20207: telephone (301)504-0477 ext. 1199.
6UPPlEMENTARY UFoRMAT1ow: *
A. Background 1. Household products bxafnfng Nuonlde
Federal Register 1 Vol. 62. No. 224 1 Thursday, November 20, 1997 / Proposed Rules
Prescription dental products are available with fluoride contents of 0.125-0.5 me/ml for drops, OS- 1 mg per tablet. 1 mg per lozenge, 0.1-0.9 mg/g for topical rinses (O.OLO.09 percent and 5 mg/g (0.5 percent) for topical gels. Prescription vitamin preparations are also available contain!ng 0.25 to 1 mg elemental fluoride per ml. The highest concentrat!on of elemental fluor!de !n any such dental product available overthe-counter C’OTC”) is 0.15 percent for pastes and powders and 0.5 percent for liquids or gels. In contrast, some household products, particularly metal cleanets 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 !n household cleaners and surface preparation agents are 10 to 1 .OOO-fold higher than concentrations found in dental products. 12 ]
g.zr Statutory and Regulatory ..
CR packages of a popular size, and the non-CR packages bear conspicuous labeling stat!ng: ‘Th!s package for households without young children.” 15 USC. 1473(a), 16 CFR 1700.5.
3. Exlstfng Requhments for FluorideContaining Products
The Poison Prevention Packaging Act of 1970 (TPPA”). 15 U.S.C. 1471-1476. authorkes the Commission to establish standards for the “special packaging” of any mold substance !f (1) the degreeornatureofthehazardto ch!ldren m the availability of such substance. by reason of !u packaging. !s such that special packaging !s required to protect children from serious personal injury or serious illness result!ng from handling. using, or inguting such substance and (2) the special packaging !s technically feasible, practicable. and appropriate for such substance. Special packaging. also referred to as “child-resistant (CR) packaging.” is (1) designed or constructed to be significantly d!fiicult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and (2) not difficult for “nonn24l add&’ to use properly. 15 USC. 1471(4). Household substances for which the Commission may qu!re CR pack@ng !nclude (among other categories) foods, drugs, or cosmetics as these terms are defined In the Federal Food. Drug. and Cosmetic Act (21 USC. 321). 15 USC. 1471(2)(B). The Comm!ssion has performance rqufmnents for special packaging. 16 CFR 1700.15. 1700.20. Sect!on 4 (a) of the PPPA, 15 U.S.C. 1473(a). aRows the manufacturer or packer to package a nonprtscriptfon product stiject to special packaging standards in one size of non-CR packaging only’ !f the manufacturer (or packer) also supplies the substance in
The Commission currently requires CR packaging for oral prescription dntgs w!th fluoride, but it exempts those !n liquid or tablet form that contain no more than 264 mg of sodium fluoride (equivalent to 120 mg fluoride) per package. 16 CFR 1700.14(10)(v!i). In 1977, th& Commission f!rst exempted aqueous solutions of sodium fluoride at that level. In 1980, !n response to a petition, the Commission extended the exemption to include liquid and tablet forms. When it issued the exemption, the Commission believed that drugs with sodium fluoride below that level would not cause serious personal injury or illness to children under 5 years of age. The Commfssion based this decision on the lack of serious adverse human experience associated with such drugs at that time. The level was also partly based on a recommendatfon by the American Dental Association that no more than 264 mg of sodium fluoride should be dispensed at one tfrne. 45 FR 78630. Also at that time, the Food and Drug Administration (“FDA”) had determined that an acutely toxic dose of sodium fluoride for a 25 pound (- 11.4 kg+I child was in the range of 56 to 250 mgkg (equivalent to - 23 to 113 mg/kg of elemental fluoride) (42 FR 62363). As discussed below, the Commission is proposing a new level that !s based on current information concerning the toxicity of fluoride and would be consistent with the proposed CR requirement for fluoride-containing household products. The FDA limits OTC packages of toothpaste and tooth powder to no more than 276 mg total elemental fluoride per package. 21 CFR 310.545. However, preventative treatment r!nses and gels sold OTC must contain no more than 120 mg total elemental fluoride per package. 21 CFR 355.10. B. Toxidty of Fluoride Most available toxicity !nformst!on on fluoride relates to acute toxicity of hydrofluoric acid (,‘HF*‘). However, other water soluble fluoride-conta!n!ng compounds can cause fluoride poisoning. The fluoride ion !s system!cally absorbed almost !mmediately. It !s 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 t!ssues, causing burn!ng at sites deeper than the original exposure site. The process of t!ssue desuuct!on can continue for da .121 ystemic fluor!de po!son!ng after F ingestion or !nhalat!on occurs very rapidly as the fluoride is absorbed into the gastrointestinal (%I”) tract and lungs. Systemic fluoride po!son!ng can also result from dermal cxposwr !f the exposure is massive or the sk!n barrier has been destroyed. as with severe bums. Fluoride absorpt!on can produce hyperkalemfa (elevated serum potassium). hypocalcem!a (lowered m calcium), hypomagnesemia (lowered serum magnesium), and metabolic and mp!ratory ac!dos!s. These disturbances can then bring on cardiac arrhythmia, resp!ratory stimulation followed by resp!ratory depression. muscle spasms. convulsions, central nervous system (“CNS”) depression, possible respiratory paralysis or cardiac failure, and death. Fluoride may also inhibit cellular resp!rat!on and glycolys!s, alter membrane permeabflity and excitability, and cause neurotoxic and adverse CI effects. 121 When exposure !s through inhalation, fluorides can cause severe chem!cal burns to the resp!ratoty system. Inhalation can result in difficulty breathfng (dyspnea), bronchospasms, chemical pneumonitis, pulmonary edema, airway obstruction, and tracheobronchitfs. The severity of burns from dermal absorption can vary depending on the concentration of fluoride avaflable, duration of the exposure, the surface area exposed, and the penetrability of the exposed tissue. Dermal exposure to 6 to 10 percent HF !s the lowest concentration range known to cause skin injury !.n 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 oqxrnv~ to 70 percent HF over 2.5 percent of the body surface.[2] ocular exposure canmsult in serious eye injury. Exposure to concentrations of 0.5 percent can lead to mild conjunctiv!t!s and greater concentrations can lead to progressively awere results such as immediate comeal necrosis (20 rcent solution). ingestion of fluor!% can result in e m!ld to severe Cl symptoms. Reporrs suggest that ingestfng 3 to 5 milligrarms per Wlogram of fluoride cause vomiting, diarrhea, and l bdom!nal pain. Ingestion of more than 5 mg/kg may produce systemic toxicity. A retrospective poison control center study of fluoride ingestions reported
F&A Register / Vol. 62, No. 224 / Thursday. November 20. 1997 / Proposed Rules
Incident (TIPI”) flies, Death Certificate (‘WRY) database, and In-Depthinvestigation (“WDP”) fks. From 1988 to 1996, NESS 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 bums of the hands.(2] The INDP files contain numerous injury reports. For example. a SO-yearold woman was using a water stain remover with 6 percent HP 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 tier the incident she had only partial use of her arm and hand. In another case, an 180year-old man developed second and third degree bums on his hands after exposure to an automobile water spot remover with HF. His fingers became permanently flexed from damage to the muscle and connective tissue. A 200year-old male died of cardiac arrest after ingesting one to two ounces of a wheel cleaner with fluoride.121 Three reports in the INDP files involve children under 5 years old who died after ingesting fluoride-containing products. A -year-old child ingested an unknown product with HP. The second case involved a E-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 HP and 8 rcent phosphoric acid.121 Since 1r there have been six 95, additional reports of fluoride poisoning in children under 5 years of age from the wheel cleaning product involved in the death of the 20-year-old man described above. The product contains ammonium bffluoride and ammonium fluoride salts, reponedly 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.(2]
AAPCCDd!ta
that symptoms, primarily safely tolerated CI symptoms that tended to resolve within 24 hours. developed following ingestions of 4 to 8.4 mgkg of fluoride.(2] According to the medical literature. a safely tolerated dose (“STD.3 and a
cenainiy lethal dose (“CLD”) were
determined from 600 fluoride poisoning deaths. The CLD was determined to be 32to64mgkgandtheSTDwrs estimated at one fourth that, or 8 to 16 * mgikg. These values were statistically determined and do not correspond to the actual lowest t&c or lethal levels of fluoride. The lowest documented lethal dase for fluoride is 16 mgflrg in a 3-year-old child. There were complicating factors in this death. The child may have taken other m&cations and he suBemd from Crohn’s disease (an inflammatory disorder of the Gl tract) that may have contributed to his
death.[Z]
C. Injmy Data Medical Litemture 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 C’AAPCC”) of hydrofluoric acid burns from mt stain removers applied to clothing found 619 such casts in 1990. Five of these rquired hospitalization. Some of the burns occumcl even after the clothing had been washed.(2] Other reports included that of a 140 month-old child who developed hypocalcemia and hyperfkoridemia (elevated blood fluoride level) and went into cardiac arrest after exposure to a rust remover containing HF. A Zlh-yearold child developed respiratory failure and repeated episodes of ventricular tachycardia (rapid heart beat) and fibrillation after ing&ing a laundry sour (used in iaundry operations to neutmIi2z?aIkalis or decompose hypo&lo& bleach) with sodium fhmsfIia.e. A 280year-old man died after accidentally drinking floor polish that amtamed fluasilicate. A 56yearold man died after ingesting a spoonful of glass etching cream (20% ammonium bifIuoride and 13% sodium bffluoride). He had severe burns in his @sopand stomach, and he suffered cardiac amest 5 hours after the ingestionJ2) cPscbfabases CPSC has several databases for poison incidents. The staff reviewed cases from 1988 to May 1997 in the National Electronic IHII Surveillance System (“NEW”). the injury or Potential Injury
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 he determined because some products that contain fluoride are not identified as * such and therefore may be coded to generic categories such as acidic deaning products or other unknown .
&atmg products.) From 1993 to 1995, there were no reported fatalities Ln this rge group. Out of a total Of 499 ocpwm to products known to contain HF. there were 2 major’ outcomes and 24 moderate* outcomes. The AAPCC data &o 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,ooO exposures to such dental products, there were 34 moderate outcomes, and the only documented major outcome was a miscoded incident where the child ocpcrienced an allergic reaction to the product rather than systemic toxicity from an overdose. 121 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 HP. Of these, 2.88 1 resulted in moderate outcomes and 275 in major outcomes. The* were also injuries from dental products, fluoride mimral/electrolytt 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 bffluoride toilet stain remover (described above) and the other child died after ingesting a toilet cleaner with HF. Generally, these WCC 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 pKxiucts.[2] D. Level of Regulation for Household Products Containing Fluoride The Commission is proposing a tie that requires special 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”) basis for liquids or a weight-to-weight (“w/w”) basis for non-Uqui&.[l&Z] The Commission is especially interested in obtain@ information and receiving
Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Proposed Rules
comments on the uses and marketing patterns of glrss etching creams. There is no well defined Iethal dose for fluoride. ln the medical Iiterature, one source cites a minimum lethal dose in humansof mgkgandanother specifies a Iethal oral dose in the range of 70 to 140 mg/kg. The staff considers these values too high based on documented cases of fluoride toxicity. There is one documented death from * ingestion of 16 mgAcg fluoride. but as discussed alxwe. other medical factors may have contributed to that death. Most evidence suggests that the lower limit of the calculated cettaWly Iethal dose (CLD) of 32 mgflrs is a reasonable estimate for a minimum lethal dose. 12) Similarly, there is no established toxic dose for fluoride. Generally. greater than 6 percent HPcan cause dennal burns and more than 0.5 percent can lead to serious eye ini. Several reports suggest ingestion of 3 to 5 mgkg produces symptoms and that more than 5mg/kg(50sngina 10kgcNd)ca.n produce systemic toxicity. Additionally, some medical professionals advise medical obsuvation following ingestions of more than 5 to 8 mgkg. Based on this information, the Commission proposes a level for regulation that would include alI household products with more than 50 mg of elemental fluoride and more than 0.5 percent &mental fluoride on a w/ v basis for Iiquids or a w/w basis for non-liquids. There is no evidence that 50 mg or less of elemental fluoride or concentrations less than 0.5 percent cause serious systemic toxicity or
serious bums. (l&2]
E. Level of RqpxIation for OraI Prescription Drugs Containing Sodium Fluoride Based on the toxicity information discussed above, the Commission believes that the current exemption for oral presuiprion drugs with no more than 264 mg of sodium fluoride should be modified. To be consistent with the proposed level for househoId products containing fluoride. the Commission is proposing that the lwel for the oral prescription drug exemption be changed to allow no more than the quivalent of 50 mg of ekantal fluoride (110 mg sodium fluoride) per parLIpr and no more than a concentration of 0.5 percent elemental fluoride on a w/v hasis for Iiquids or a w/w basis for non-liquids. The proposed level provides a safety factor to protect sensitive individuak~M2) The Commission does not believe that changing the kvel of exemption for prescription dra.4~~ containing sodium fluoride will impact any of the currently
rdquately protect the integitv of the exempted denta products with more substance and not interfere with its than 50 mg of fluoride because these intended sto e or u~e.141 products have 0.5 percent or less Some OTC~uoride-containing fluoride. There is no evidence that any household products are packaged in of these products have caused serious containers with non-CR continuous injury. The Commission proposes modi@ing the exemption level so that it threaded &sums. The Commission also is aware of such products packaged in is consistent with the regulated level aerosoIs and mechanical pumps. proposed for household products and designs of senior vartous containing fluoride.1 1) R packaging can be redly friendly IT F. Statutory Considerations ObtaLne~I that would be suitable for flu0ri~rmining praducts.l3&4 1. Hstard to Children TWO manufacture currently use As noted above. the toxicity data senior-friendly amtinuous threaded CR concernbg children’s ingestion of pa&ging for their fluoride-containing Ruoride demonstrate that fluoride CM household products. Another cause serious illness and injury to manufacturer uses a senior-friendly children. Moreover, it is available to trigger mechanical pump mechanism for children in common household its product. This shows that these types products. Although some products of CR packages are technically feasible, currently use CR packaging, others do practicable and appropriate for fluoridenot. The Commission preliminarily containing products. The Commission concludes that a regulation is needed to knows of at least one fluoride product ensure that products subject to the that uses a non-CR aeroso1 package. The regulation will be placed in CR manufacturer of another regulated packaging by any current as well as new product is currently using a seniormanufacturers.( l&2] friendly CR aerosol overcap. Thus, this The same hazard posed to children by kind of CR packaging could be used for toxic amounts of fluoride in household fluoride-containing products. Finally, ‘products also exists from such levels of various designs of senior-friendly snap fluoride in oral prescription &gs. type reclosable CR packaging that would Therefore. the Commission is proposing be appropriate for non-Iiquid fluorideto modify the existing exemption for containing products are available. Thus, such drugs with sodium fluoride to appropriate senior-friendly CR reflect current toxicity data and be packaging is avaflable for products consistent with the proposed level for marketed in continuous threaded, snap, fluoride-containing household aerosols, and trigger spray packaging. 14 ] products.[ l&2] Therefore, the Commission concludes Pursuant to section 3(a) of the PPPA. - _that CR packaging for fluoride15 U.S.C. 1472(a), the Commission containing products is technically preliminarily finds that the degree and feasible, practicable. and appropriate. nature of the hazard to children from 3. orher conslduadons handling or ingesting fluoride is such that special packaging is required to in establishing a special packaging protect children from serious illness. standard under the PPPA, the The Commission bases this finding on Commission must consider the the toxic nature of these products, foIlowing: described above, and their accessibility a. The reasonabieness of the standard; to cNdren in the home. b. AvaiIable scientific, medical, and engineering data concerning special 2. Technical Fe&bf&y, PracticabiQ, packaging and concerning childhood and Approptiarenw accidental ingestions, iIIness, and injury in issuing a standard for special caused by household substances; packaging under the PPPA. the c. The manufacturing practices of Commission is required to find that the industries affected by the PPPA; and special packaging is l *technically d.Thenatureanduseofthe feasible, practicable, and appropriate.” household substance. 15 U.S.C. 1472(b). 15 U.S.C. 1472(a)(2). Technical The Co-ion has considered these feasibility may be found when factors withrespect to the various technology exists or can be readily determinations made in this notice, and developed and implemented by the preliminarily finds no reason to effective date to produce packaging that conclude that the rule is unreasonable conforms to the standards. Practicability or otherwise inappropriate. means that special packaging complying C. Efhcdvt D8te with the standards can utilize modem The PPPA provides that no regulation mass production and assembly line shall take effect sooner than 180 days or techniques. Packaging is appropriate later than one year from the date such when complying packaging will
Feded Register / Vol. 62, No. 224 1 Thursday. November 20, 1997 / Proposed Rules This asscisment reports that the staff is aware of 25 SuppliCrs of products that are in categories of products that may contain fluorides. Fourteen of these companies may be small businesses. It is unclear which of these products actually contain fluorides and are marketed directly to consumers rather than commercial markets. The staff is also aware of 40 suppliers of automotive and household cleaning chemicals and products. Some of these products may contafn fluoride.(3] The Commission quest5 comments fromcompanies that supply fluoride-containing household products. The Commission is particularly intehsted in comments and information on the likely effect of this proposed rule on small businesses. Several consumer products contafning fluoride are already in CR packaging. For example, senior friendly packaging is used by a small business marketer of a fluoride-containing mst remover packaged in a plastic container with a continuous turn closure. Another small, business, marketing a fluoridecontaining glass etching cream, also uses senior-friendly CR packaging. However, the small business marketer of another glass etching product is not currently using CR packaging. A variety of types of senior friendly CR packaging that would be suitable for such products are readily available at prices competitive with non-CR packaging. Similarly, of the three known marketers of fluoride-containing wheel cieanen. one (a large manufacturer) is using CR packaging, while another (a small business) is not. Senior-friendly trigger sprays like those used for this product are available. The incremental cost of a CR trigger to not likely to be large relative to the retail cost of the product.(3] Based on this assessment. the Commission concludes that the proposed requirement for fluoridecontaining household products would not have a signffrcant Impact on a substanthi number of small budmsses or other small cnti~es Furthermore, the proposed modffication in the level for exemption of oral prescription drugs containing sodium fluoride is not likely to affect any currently available prescription drugr, and if such w should become available in the future appropriate CR packaging is readily available at prices competitive with non-CR packaging. Therefore, the Commission concludes that the proposed modification to the exemption for oral prescription drugs containing sodium fluoride would not have a significant impact on a substantial number of small businesses or other small entities.
I. Ednmrnental Considemttons Punuant to the National Environmental Policy Act, and in accordance with the Councfl on Environmental Quality regulations and CPSC procedureS for environmental review, the CommMon has asse!ssed the possible environmental effects associated with the proposed PPPA requirements for fluoride-containing %~~mmiulon’s rtgulations state that rules rquirfng special packaging for consumer produCtS no&y have little or no potential for 8ffecting the human environment. 16 CFR 102 1 S(c) (3). Nothing in this proposed xule alters that expectation. Therefore, because the rule would have no adverse effect on the envtronment. neither an environmental assessment nor an environmental impact statement is squired. J. Exemd.ive Orden According to Executive Order 12988 (February 5,1996), agencies must state fn clear language the preemptive effect, if any, of new regulations. The PPPA provides that, generally, when a special packaging standard issued under the PPPA is in effect, “no State or political subdivision themf shall have any authotiv either to establish or continue in effect, with respect to such household substance, any standard for special packaging (and any exemption t.he!refrom and requirement related thereto) which is not identical to the (PPPA] standard.” 15 U.S.C. 1476(a). A State or local standard may be excepted from this preemptive effect if (1) the State or local standard provides a higher degree of protection from the risk of injury or illness than the PPPA standard; and (2) the State or political subdivision applies to the Commission for an exemption from the PPPA’s preemption clause and the Commission grants the exemption through a process specified at 16 CFR Part 1061.15 U.S.C. 1476(c)(I). In addition, the Federal govemment, or a State or local govemment, may establish and contfnue in effect a non-identical special packaging requirement that provides a higher degree of protection than the PPPA requirement for a household substance for the Federal. State or local government’s own use. 15 U.S.C. 1476(b), Thus, with the exception noted above, the proposed tie muting CR packaging for household pducu containing fluoride above the regulated level and modwing the exemption level for oral prescription drugs With sodium fluoride would preempt non-identical
final regulation is issued, except that, for good cause, the Commission may establish an earlier effective date if it determines an earlier date to be in the public interest. 15 U.S.C. 1471n. Senior-Mendiy special packaging is currently commercially available for most types of CR packaging. Aerosol and mechanical pump packages should be commercially available in senior- . Mendly CR designs within nine months ofafinalrule.(l,4&5]ThusJhe Commission proposes that a final rule would take effect nine months after publication of the final rule. Cumzntly available information indicates that full commercial availability for senior-friendly mechanical pump packages and aerosol ovetcap paewes could take from 9 to 12 months from the date a final ale is issued. If comments on this proposal indicate that manufacturers using mechanical pump packages and aerosol overcap packages need more than 9 months to comply with the rule, the Commission may (1) specify a i-year effective date for these types of packages only. or (2) provide that manufacturers may request a stay of enforcement so they m market their products in conventional packaging for the minimum period needed to obtain an adequate supply of senior-friendly P=kagw3* A fVra rule would apply to products that are packaged on or after the effective date. H. Regulatory Flexibility Act ceeific8tion When an agency undertakes a rulemaking proceeding, the Regulatory Flexibility Act. 5 U.S.C. 601 et seq., generally requires the agency to prepare proposed and final regulatory flexibility analyses describing the impact of the Nle on small businesses and other small entities. Section 605 of the Act provides that an agency is not required to prepare a regulatory flexibility analysis if the head of an agency certifies that the Nile will not have a significant economic impact on a substantial number of small entities. The Commission’s Directorate for Economic Analysis prepared a preliminary assessment of the impact of a mie to require special packaging for household products containing fluoride with more than 50 mg elemental fluoride and more than 0.5 percent elemental fluoride (w/v or w/w). The staff also considered the impact of a rule modi@ing the current exemption for oral prescription drugs containing sodium fluoride so that it would be constistent with the level proposed for household products. 131
Federal Register / Vol. 62, NO. 224 1 Thursday, November 20, 1997 / Proposed Rules
state Q local special packaging standards for such fluoride containing
pdUCtS.
In 8cc0dmce with Executive Order 12612 (October 26.1987). the Commission certifies that the proposed nrle does not have sufficient implicatiorrs for federalism to warrant a Fe&&sm Assessment. ListofSuQjec~in16CFRPa1t1709 * Consumer protection, Drugs. Infants and children. Packaging and containers, Poison prevention, Toxic substances. For the reasons given above. the Commission proposes to amend 16 CFR pan 1700 8s follows:
PART 17OO+AMENDED]
liquids or a weight-to-weight basis for non-liquids and containing no other substances subject to this 5 1700.14(a)(lO). * (27)*Ru&fe. kouse\old substances containing more than the equivalent of SO 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-liquids shall be packaged in accordance with c provisions of 5 1790.15 (a), (b) and
Sadye E. Dunn, Commission.
Dated: bvanbtr 17.1997.
secmary, consumer ProduaSafcty
List ofRelevant Documabts 1. Briefing memorandum from Jacqueline Fen-ante, Ph.D., EH. to the Commission, “Proposed Rule to Rquire Child-Resistant Packaging for Household Products with Fluoride.” September 30. 1997. 2. Memorandum from Susan C. Aitkm. 2. Section 1700.14 is amended to Ph.D.. EH, to Jacquclfne Fermnte, Ph.D.. EH, ‘Toxicity of Household Products Con-g revise paragraph (a) (10) (vii) and to add Fluoride,” Augur 4, 1997. pamgraph (a)(27) to read as follows 3. Memorandum from Marcia P. Robins, (although unchanged, the introductory EC, to jacqueline Fermnte. Ph.D., EH. text of pamgraphs (a) and (10) are “Market Data, Economic Considemtions and included klow for context) : Endrmmental Effects of a Proposal to Rqu!re Child-Resistant Packaging for Household Products Containing Fluoride,” junc 20.1997. (a) Substances. The Commission has 4. Memorandum from Charles Wilbur, EH, determined that the degree or nature of to Jacqueline Fenante, Ph.D., EH,,“‘Technkal the hazard to children in the availability Feasibility, Pmcticability. and of the following substances, by reason of Appropriateness Determfnation for the their packaging. is such that special Proposed Rule to Rquire Child-Resistant Packaging for OTC Products Containing packaging meeting the requirements of Fluoride,” June 27.1997. 5 1700.206) is required to protect childten from serious personal injury or [FR Dot. 97-30555 Filed 11-19-97: 8:45 am] serious illness resulting from handling. uLmGcoM~4 Autlmdty Pub. L. 91-601. sets. I-9.84 Stat. 1670-74.15 USC. 1471-76. Sets _-1700.1 and 1700.14 also Issued under Pub. L. 92-573.sec.3O(a). 88 Stat. 1231.15 USC. 2079b).
1. The authority citatfon for part 1700 continues to read as follows:
single prospectus, subm to certain conditions. The Commission is proposing similar amendments t0 the rides under the Securities Exchange Act of 1934 and the Investment Company Act of 1940 that govem the delivery of annual and (in the case of investment companies) semiannual reporU to shareholders. The proposed rule and de amendmentt seek to provide greater convenience for investon and cost savings for issues by reducing the amount of duplicative information that investors nccivc. DATES: Comments must & received on or before February 2.1998. m: Comments should be submitted in triplicate to Jonathan G. Katz. Seaetary. Securities and Exchange Commission, 450 5th Street, N.W., Stop 6-9, Washington. D.C. 20549. Comments also may be submitted electronically at the following E-mail address: rule-comments@sec.gov. All comment letters should refer to File No. S7-27-97: this file number should be included on the subject line if E-mail is used. Comment letters will be available for public inspection and copying in the Commission’s Public Reference Room, 450 5th Street, N.W.. Washington, D.C. 20549. Electronically submitted comment letters also will be posted on the Commission’s Internet web site
(http:hVWW.SeC.~OV).
FOR FURTHER WFORYATION CONTACT:
using. or ingesting such substances, and the special packaging herein required is technically feasible, practicable, and appropriatg for these substances: 0
Marilyn Mann. Senior Counsel, at (202) 942-0690, Office of Regulatory Policy, Division of Investment Management, Stop 10-2, or Elizabeth M. Murphy, Special Counsel, at (202) 942-2900, Mice of Chief Counsel, Division of Corporation Finance. Stop 4-2, Securities and Exchange Commission. 450 5th Street, N.W.. Washington, D.C.
SUPPLEMENTARY WFORMATION: The
humanusethatfsinadosagefonn fmaadd for oral administration and thatisrequ&edbyFederallawtobe dfspemd only by or upon an oral or w&ten prescription or a practitioner licmr#d by law to admfnister such dnrg shall be packaged in accordance with the provisions of 5 1790.15 (a). (b). and (c), except for the following: 8 (vii;sod;m fl;orid: drug preparations fnciuding liquid and tablet forms. containing not more than 110 mUgrams of sodium fluoride (the equivalent of 50 mg of elemental fluor&) per package and not more than a concenuazion of 0.5 percent elemental fluoride on a weight-to-volume basis for
Commission today is requesting public comment on proposed rule 154 under 17 CFR Part8 230,240 l d 270 the Securitks Act of 1933 (15 U.S.C. ~doRaa Nos. s3=74?6,3448321,l622884; 77a) (the “Securities Act’) and proposed amendments to rules 14a-3 Flk No. S74747j (17 CFR 240.14a-3), llc-3 (17 CFR RIN 323bACW 240.14~.3) and lJc-7 (17 CFR 240.14s 7) under the Securities Exchange Act of 0aliv.y of Dkclorurs Docunnntr to 1934 (15 U.S.C. 78a) (the “Exchange Houooholds Act”), and rules 3Od-1 (17 CFR AGENCY: Securities and Exchange 270,3Od-1) and 3Od-2 (17 CFR 270.304Commission. 2) under the Investment Company Act ACTION: Proposed tie. of 1940 (15 U.S.C. 8Oa) (the ‘Investment Company Act”). MIYYARY: The Commission is proposing Table of Contents for public comment a new rule under the Securities Act of 1933 to enable I. Dtscusk issuers and broker-dealers to satirj’ the A. Ddtv~ry of Prospectus= to a Household 1. Scope of Rule and c;maal Condwons Act’s prospectus delivery requirements, 2. Householding Without Wfitten C-of=m with respect to two or more investors 3. Revocation of Consent sharing the same address. by sending a
22 Januar)r 1998 Office of the Secretary Consumer Product Safety Commission Washingto% DC 20207 E-Mail: cpsc-os@cpsc.gov Reference: Proposed Rule: “Requirements for Child-Resistant Packaging; Household Products with More Than 50 mg of Elemental Fluoride and More Than 0.5% Percent Elemental Fluoride; and Modification of Exemption for Oral Prescription Drugs with Sodium Fluoride.” Dear Sir or Madam: I am writing to comment on the above mentioned proposed Consumer Product Safety Commission rulemaking. Inboththesummary and the text (16 CFR 1700.14( lO)(vii)) of this rulemaking. the Commission proposes to allow sodium fluoride drug preparations to be packaged in non Child Resistant Closure (CRC) packages if they contain 50 milligrams or less of the equivalent of elemental fluoride (110 milligrams 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. This wording would seem to indicate that both criteria (total elemental fluoride per package and elemental fluoride concentration) would have to be met in order to quaiifj for the exemption. However. in the preamble to the proposed rule (section E), the Commission states that it “. . . ..does not believe that changing the level of exemption for prescription drugs containing sodium fluoride will impact any of the currently exempted dental products with more than 50 mg of fluoride because these products have 0.5 percent or less fluoride ion. This statement indicates that only one (not both) of the criteria (total fluoride [F] ion or concentration) would have to be met in order to quAi@ for the exemption. Therefore, I contacted the Consumer Product Safety Commission for clarification. Dr. Jacqueline Ferrante clarified that only one (not both) of the criteria needs to be met to qu&fj for the exemption. Therefore, I would like to request that the wording in the te?ct of the rule be modified as follows at 16 CFR 1700.14(10)(vi.i): u.... sodium fluoride drug preparations.. . . containing not more than 110 mg sodium fluoride.. -per package and/or not more than a concentration of 0.5 percent elemental fluoride.. . .” Thank you for allowing me the opportunity to comment on this proposed rulemaking. Please feel free to contact me at (972) 720-6003 should you have any questions on this comment.
a subsidiary of ColgarePa/mo/ive CO. 14335 Gillis Road, Dallas, TX 75244
(972) 233-2800
Fax (972) 239-6854
Ms. EugCnie Acosta Manager. Regulatory Afhirs Colgate Oral Pharmaceuticals *
Amencan Deaal Association
Fcbmary 6, I998 sadye DUAA ScmaTy Commission 4330 East-West Highway, Room 502 Bethesda. Maryland 20814A408 Washington, DC 20207
U.S. COASUAZCT Product S8fq
SUBJECT: Consumer Product Safety Commission, 16 CFR Part 1700, Proposed Rule: Requirements For Child-Resistant Packaging; Household Products With More Than 50 mg of Elemental Fluoride and More than 0.5% ElcrnentaI Fluoride; and Modification of Exemption for Oral Prescription DNgs With Sodium Fluoride, Federal Register Vol. 62, No. 224, November 20,1997, pages 6192841933.
The official position of the American Dental Association (ADA) is that it dues not object to the Consumer Products Safety Commission (CPSC) changing its requirements for child-resistant pa&@ng for fluoride-containing products used in the home, as shown in the followiry two proposals outlined in the Proposed Ruic: Reposal 1. Rquiring child-resistant packaging for household Droducts (which inch& nondental and over-the-counter dental products) containing a) more than the equivalent of 50 mg of elemental fluoride (fluori& ion), und b) more than the quivalcnt of OS% elementai fluoride (on a w/w for a solid or w/v for a liquid basis). Both criteria must be met before child-resistant packaging would be mandated. P1~pfpl2. Modifying the oral pmritioa drug exemption for sodium fluoride mtions (c.g. fluoride supplements, fluoridchhamin preparations). Instead of doting drugs with no more than 264 mg sodium fluoride (120 mg elcmcntal fluoride) per package to bc in non-child-resistant packaging, as the curxnt rule does, the CPSC would require child-resistant packaging only for fluoride-containing products with a) rnox than the equivalent of 50 mg of elemental fluoride (fluoride ion), and b) more than tk equivalent of 0.5% elemental fluoride (on a w/w for a solid or w/v basis for a liquid). Both criteria must be met before child-resistant packaging would be mandated.
Sadye Dunn February 6.1998 Page 2
The CPSC states that dalti products contain lower levels of fluoride and therefore would
not be affected by these pmposals. The ADA is in agreement with the CPSC’s belief, as express& both in the background to the proposed rule and in the wording of Proposals 1 and 2 above. that curxntly~ma&etth fluoride-contain@, ovcr4eIcounter and prescription dental products, intended for hoa use, have not been shown to pose a significant safety hazard to young children, and tbst these dental products, thercforc, do not need child-resistant packagiq In addition, the -A notes that there arc no currrntly-marketed dental products that mtet both of the proposed criteria for child-resistant packaging.
The ADA understands the CPSC’s wish to rcguiatc non-dental, fluoride-containing products (such as cleaning products for metal, tile. brick, cement. wheels, radiators,
siding, toilets, ovens, aad drains, and other items including rust and water stain remova, silver solder and other welding fluxes, etching compounds, laundry sour, air conditioner coil clcancrs and floor polishes) used in the home to help prevent accidental injury to young children Because such products arc not related to dentisay, however, the ADA
will not comment on this aspect of the proposed rule.
David A. Whiston, D.D.S. prWi&ti DAW:m:pg
TIlTAL P-03
&~ntr Ptocerrd.
100 Boylston Street, Suite 1050 Boston, MA 02116 Tel. : 617 1326~6-IOO Fax: 61714266639
Deborah M. Fanning, CAE Executive Vice President
MATuuAlsINSTITUTE
Office of the Secretarj Consumer Product Safety Commission Room 502 4330 East-West Highwa! Bethesda, MD 208 14 RE: NOTICE OF PROPOSED RULEMAKING (NPR) FOR HOUSEHOLD PRODUCTS CONTAINTNG MORE THAN 50 MG OF ELEMENTAL FLUORIDE AND MORE T’HAIN 0.5% ELEMENTAL FLUORIDE 62 Federal Register, 61928 (November 20, 1997) In response to the Notice of Proposed Rulemaking (NPR) on the extension of the Poison Prevention Packaging Act (PPPA) by the Consumer Product Safety Commission (CPSC) to certain household products containing more than 50 mg of elemental fluoride and more than 0.5% elemental fluoride, The Art and Creative Materials Institute, Inc. (ACMI) is pleased to submit the following comments. ACMI is an - international non-profit association of manufacturers of art and creative materials who are committed to providing non-toxic products to children and products that have been evaluated for toxicity risks, and, if
any, labeled with cautionary warnings and safe use instructions for adult consumers. ACMI’s certification program began evaluating children’s art materials as non-toxic in 1940 and continues to this day; its program was espanded in 1982 to evaluate and properly label adult art materials.
In previous comments, ACM1 supporred the extension of PPPA regulations to petroleum distillates, hydrocarbons and terpenes that present an aspiration risk as listed in the NPR at the percentage compositions contained in the FHSA regulations and at a viscosity of less than 100 SUS at 100” F. In the case of art materials, this would extend PPPA regulations to any art material containing 10% or more of xylene, toluene, petroleum distillates, and D-Limonene. FHSA and its regulations also require DANGER warnings for materials that are corrosive or highly toxic. We also reccmmended the extension to products that require such a DANGER warning and that present an aspiration hazard. Art materials that are currently labeled with a DANGER warning because they are corrosive or are considered highly toxic contain 0.075% or more ammonium bifluoride. 30% or more of calcium chloride, or 0.25% or more of sodium fluoroborosilicate and include glass etching creams, some ceramic glazes. and some ceramic thickeners. Therefore, we certainly support the current NPR to extend the PPPA regulations to cover household products containing more than 50 mg of elemental fluoride and more than 0.5% elemental fluoride. As a major contributor to the development of ASTM D-4236, the pioneering chronic hazard labeling standard for art materials. the development of LHAMA. and a member of the Poison Prevention Week Council, ACMI is committed to the provision of safe products and information to consumers of its members’ products and is pleased to submit these comments for consideration by CPSC. ACMI appreciates the extension granted to submit these comments. Respectfully submitted, Deborah M. Fanning, CAE Executive Vice President a Of CounseI: Neville. Peterson & Williams 80 Broad Street, 34th Floor New York, NY 10004
Woodhall Stopford, M.D. Jacqueline Ferrante
C O U R T N E Y M. PRICE
Office of the Secretary Consumer Products Safety Commission 4330 East West Highway Room 502 Bethesda, MD 20814
Proposed Rule: Child-Restraint Packaging for Household Products with Fluoride
Dear Sir/Madam: The Chemical Manufacturers Association Hydrogen Fluoride (HF Panel) is pleased to submit these comments in response to the Consumer Product Safety Commission’s (CPSC) proposa1 to establish child-restraint packaging requirements for household products containing elemental fluoride above specified amounts or concentrations. 62 Fed. Reg. 61928 (Nov. 20, 1997). The HF Panel is an industry group concerned with issues relating to the safe use and handling of anhydrous hydrogen fluoride and hydrofluoric acid. Our membership is composed of manufacturers, transporters, and industrial users of HF.1 The CPSC is proposing to require child-restraint (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 include rust removers, toilet cleaners, metal cleaners and etching products. The CPSC also is proposing to modify the oral prescription drug exemption for sodium fluoride preparations. Current rules allow drugs with no more than 264 mg of sodium fluoride per package to be in non-CR packaging. To be consistent, the CPSC now 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 CPSC has made a preliminary determination that child-resistant packaging is necessary to protect children under 5 years of age from injury and illness resulting from handling or ingesting toxic amounts of elemental fluoride.
The Hydrogen Ruoxide Panel indudes 3M Company, AlliedSignal, Inc., Aluminum Company of America, Chemtech Products, Inc., Da&en American Inc., DuPont, Elf Atochem, N.A., General Chemical, Industrial Quimica de Mexico, S.A. de C.V., LaRoche Industries Inc., LCI/Norfluor, Occidental Chemical Corporation, OSRAM Sylvania Ix., and Quimica Fluor S.A.
1 INNOVATION , T ECHNOLOGY
R ESPONSIBLE CARET A T WORK
pg$*
CPSC March 30,1998 Page 2
The HF Panel supports the CPSC’s efforts to encourage the safe handling and use of products containing fluoride. More specifically, the Panel supports the CPSC’s current proposed rule and believes it may help prevent injuries to small children from the mishandling of certain fluoride-containing consumer products. The Panel appreciates the work that the CPSC has done relating to the proposed rule. If you have any questions concerning these comments, please call Elizabeth Festa Watson, Manager of the Hydrogen Fluoride Panel at (703) 741-5629.
Courtney M. Price Vice President, CHEMSTAR
U.S. CONSUMER PRODUCT SAFETY COMMlSSlON WASHINGTON, D.C. 20207 OR-9 I997
TO . THROUGH
: Jacqueline Ferrante, Ph.D., Pharmacologist, Division of Health Sciences : Mary Ann Danello, Ph.D., Associate Executive Director, for Epidemiology. and Health Sciences (EH) Marilyn 1. Wind, Ph.D., Director, Division of Health Sciences*m& Scientific Coordination
/CR : Susan C. Aitken, Ph.D., Pharmacologist, Division of Health Sciences 2 : Update on Injuries Due to Products Containing Fluoride
Staff recently learned of additional injuries due to household products containing fluoride salts or hydrofluoric acid. One fatal incident involved the ingestion of a wheel cleaner containing ammonium fluoride and ammonium bifluoride salts by a 3-year-old girl (August 9, 1997). A series of injuries due to this same wheel cleaner were reported in a previous memorandum discussing the toxicity of products containing elemental fluoride (CPSC, 1997). An In-Depthinvestigation (IDI) of this case is complete with the exception of the coroner’s report. A second incident involved the death of a 38-year-old male following the unintentional ingestion of one-half cup of rust remover containing ammonium bifluoride (Litowitt et.al., 1997). A third incident involved the lethal ingestion of a rust remover containing hydrofluoric acid and ammonium bifluoride by a 1 g-monthold girl (July 22, 1997). An IDI in this third case is complete with the exception of some official records. A fourth incident involved the ingestion of a small quantity of a rust remover, bearing the same trade name as the product implicated in the third incident and with a similar description of the dispenser, by an 18-month-old girl. A briefing package recommending a special packaging standard under the Poison Prevention Packaging Act (PPPA) for products containing more than 0.5 percent elemental fluoride and more than 50 mg elemental fluoride per package is now before the Commission. The incidents reported here support the need for such a special packaging standard to protect young children from serious personal injury and illness due to handling, using, or ingesting household products containing amounts of elemental fluoride exceeding the recommended levels for regulation. Details of these incidents are reported below. fncident 1. A previously healthy 3-year-old girl accessed an 8 ounce (02) pump spray bottle of wheel cleaner momentarily left on the kitchen counter after use. Both parents were outside for a brief period and the actual ingestion was
2 unwitnessed. Although the poison control information indicates the child obtained the solution from a cup, the testimony of the father indicates the child obtained the liquid from the original container. It is unknown whether the child, who was reportedly clever, unscrewed the pump spray, drank some of the liquid from the container, and then replaced the pump; the child sprayed liquid directly into her mouth; or the child spray’ed liquid into another container and then drank it. The pump was still on the bottle after the ingestion. However, when the bottle was photographed at the time of the CPSC investigation, the pump was missing. The child complained of stomach pain and a sibling indicated she drank some of the wheel cleaner. After administering water, the child vomited. The *ather immediately transported her to an emergency room (ER), arriving about 20 minutes post-ingestion. By that time, the child was vomiting intermittently, experiencing a drop in blood pressure, was cyanotic, and minimally reactive. The emergency staff immediately intubated to maintain respiration. However, blood pressure continued to fall and no pulse was detected. About 20 minutes after arrival, the ER personnel consulted with 4he local poison control center, confirmed that the ingested product appeared to be a fluoride solution, and, while continuously administering cardio-pulmonary resuscitation (CPR), the staff commenced an intravenous infusion of calcium gluconate and calcium chloride. Continued aggressive treatment failed to restore a pulse, heart rhythm and breathing were irregular, and the child was increasingly cyanotic. The child went into cardiac arrest, attempts to revive her were not successful, and CPR was terminated approximately one hour after arrival at the ER. Although the laboratory conducting post-mortem toxicology tests did not have the capability of measuring serum or urinary fluoride, other autopsy results will become available in the near future. Incident 2. After ingesting approximately one-half cup of rust remover containing ammonium bifluoride, the 38-year-old victim presented to an emergency room hospital facility. After one episode of vomiting, he was asymptomatic at l-1/2 hours post-exposure. However, 3-‘l/2 hours post-ingestion, he experienced sudden cardiac arrest. Although resuscitation efforts were transiently successful and calcium chloride was administered, a series of subsequent cardiac arrests resulted in death approximately 4 hours post-ingestion. Incident 3. The parents were in the process of moving into a mobile home. A bottle of carpet tust remover containing hydrofluoric acid and ammonium bifluoride had been left in the mobile home by the previous owner along with other cleaning chemicals. The parents had packed the chemicals left behind in a box, and placed this box in a closet. However, the bottle of rust remover was overlooked and was left in a box on the living room floor. Apparently the 19-month-old child awoke at about 9 AM while the parents were aslee and drank an undetermined amount from the bottle. The child, crying and coughing, awoke her parents and a 3-yearold brother told them she had drunk from the bottle. The parents took the child to
3 a neighbor’s home where the neighbor attempted to give her some milk. However, after learning what she had ingested, the neighbor suggested the child should be taken to the hospital. The child died shortly after. This incident is currently under investigation by the local Sheriff’s Department and the container is being held in evidence for possible criminal proceedings. The container is described as a whitish plastic bottle about 6-l /2 inches high and 2-5/8 inches in diameter with a protrusion about 1 inch high and 1 inch in diameter for dispensing. The sheriff’s investigative report indicated the protrusion resembled that of an infant’s drinking cup. The sheriff’s full report includes a description of the labeling on the rust remover, and this report plus additional information is expected shortly. Staff also expects further information on the product formulation to become available. Incident 4. The parents of an 18-month-old-child were building an addition on their home, and placed some of their tools and supplies on the kitchen counter the evening prior to the incident. While waiting for breakfast the next morning, the victim climbed onto a chair to access the counter and found a bottle of rust remover (the same trade name as reported in incident 3)., The container is described as a plastic bottle having a long narrow plastic spout for dispensing the product. The cap covering the spout was not in place when the child drank an unknown amount of the rust remover. The child began to cough, her mother rushed in from the next room, and a 5-year-old sibling informed the mother that the victim drank some of the rust remover. Poison Control advised the mother to give the child water and take her to a hospital. Treatment involved an unspecified blood test, an x-ray to ascertain if any of the product had entered the lungs, and observation for a short time. The child was released the next day. The mother believed the child ingested less than 1 ounce. One ounce equals approximately 30 milliliters (ml). However, if the product was in fact identical to the toxic product that proved fatal in incident 3, staff suspects the child ingested much less than 30 ml and probably took no more than one swallow (approximately 5 ml). The child may also have spit out some of the material. References: CPSC (1997). Memorandum from Susan C. Aitken, Ph.D., EHHS to Jacqueline Ferrante, Ph.D., EHHS, “Toxicity of Household Products Containing Fluoride”, July 28, 1997. Liiowitz, L., M. Smilkstein, L. Felberg, W. Klein-Schwartz, R. Berlin, and J.L. Morgan (1997). Amer, A Emer. Med. x:447-447-500. 1996 Annual Report of the American Association of Poison Control Centers. -c;”
: Jacqueline Ferrante, Ph.D., Pharmacologist, Division of Health Sciences . : Mary Ann Datiello, Ph.D., Associate Executive Director, Directorate for Epidemiology and Health Sciences (EH)m &!& Marilyn L. Wind, Ph.D., Director, Division of Health Sciencesm&/l Scientific Coordination
: Susan C. Aitken, Ph.D., Pharmacologist, Division of Health Sciences : Injuries Due to Products Containing Fluoride
The Commission recently published a notice of proposed rulemaking (NPR)’ under the Poison Prevention Packaging Act (PPPA) which would establish a special padkaging standard for household products containing more than 0.5 percent and more than 50 milligrams elemental fluoride. The briefing package “Proposed Rule to Require Child-Resistant Packaging for Household Products with Fluoride”2 and an addendum to the briefing package “Update on Injuries Due to Products Containing Fluoride”3 documented several injuries that provided support for the NPR. This memorandum provides additional injury information acquired since the staff prepared the addendum. In this memorandum, staff of the Division of Health Sciences (HS) review CPSC data bases (June 1, 1997 through February 28, 1998) and the 1996 Toxic Exposure Surveillance System (TESS) data base maintained by the American Association of Poison Control Centers (AAPCC) for reports of exposures to products containing elemental fluoride. NEISS Incidents - Burns CPSC’s Injury and Potential Injury (IPII), In-Depth Investigation (INDP), and Death Certificate (DTHS) data bases contained no reports of incidents involving household products containing elemental fluoride. However, CPSC’s National Electronc Injury Surveillance System (NEISS) data base contained several reports of injuries due to either hydrofluoric acid (HF) or soluble fluoride salts. The toxicities of these forms of fluoride are almost identical and essentially are dependent only on the actual amount of elemental fluoride present. NEISS data show six adults experienced burns to fingers, hands, or arms following use of HF-containing cleaners. A 52-year-old female suffered chemical burns to both hands when using rust remover to clean windows and a >6-year-old male, a 42-year-old male, a 43-year-old male, and a 49-year-old male suffered similar burns after using various cleaners containing HF. One 50-year-old woman was
hospitalized overnight due to burns to her fingers after using a rust remover to clean the metal legs of a table. In this case, and at least one of the other cases, the individuals were not using gloves. In addition to these incidents, an 18-year-old female suffered chemical burns to her abdomen and back after using rust remover to remove stains from a shirt, washing the shirt, and wearing it.
NEISS Incidents - Ingestions
Three NEISS incidents involved accidental ingestion of rust removers containing HF by children less than 5-years-old. A 12-month-old male may have ingested some material from an open can of rust remover. He also spilled some on his right leg, causing burns. A 12-month-old female was found pouring rust remover into a cup. Although the parents did not believe the child actually ingested any of the product, the child did experience a blistered lip. In the third case, a 2-year-old male ingested an undetermined amount of rust remover. All three individuals were treated and released. Two NEISS incidents involving a wheel cleaner containing ammonium fluoride salts were identified. The wheel cleaner in question was recalled in August, 1997 following the death of a three-year-old child after accidental ingestion of the product. In the first case, a 2-year-old male sprayed the cleaner in his mouth. The child was treated and released. In a second case, a 21-month-old male was hospita!ized after an accidental ingestion. The staff is investigating this incident for more details. In addition, an investigation of another incident could not establish whether the product in question was the wheel cleaner. The product may have the same brand name but actually be a solvent-based cleaner used on vinyl and tires. Apparently, the sibling of the 3-year-old victim sprayed the cleaner on the child’s hair and hands and possibly into her mouth. However, the parent indicated the child was not burned but was hospitalized overnight for observation after becoming slightly ill. Three other NEISS injuries to children less than 5-years-old involved products which may or may not have contained HF. All three incidents are now under investigation. At this time, no further details are available.’ The types of injuries reported above are similar to those reported in previous memorLnda2’ 3. Adults tend to experience burns to the hands during planned use of products containing elemental fluoride. Injuries to children tend to be associated with attempted ingestions which can result in accidental burns.
AAPCC Incidents
Staff also reviewed the 1996 TESS data. These data only isolate fluoridecontaining products for hydrofluoric acid, rust removers containing hydrofluoric acid, and various types of anti-caries treatments such as fluoride toothpastes, fluoride mouthwashes, prophylactic treatments with tablets, pastes, and powders (captured as fluoride under electrolytes/minerals), and vitamin supplements (captured as various types of vitamins containing fluoride). Several other classes of products, notably cleaners, may contain unspecified acids or fluoride salts and may be coded as acidic cleaning products or other/unknown cleaning products. Therefore, these data represent only an estimate and possible lower bound and cannot establish the actual number of ingestions of fluoride products. Injuries due to fluoride-containing products are shown in Table 1 (children < 5-years-old, ingestions) and Table 2 (all ages, all routes of exposure). No fatalities or major injuries occurred in children less than 5-years-old who were exposed to HF or HF-containing rust removers. One major injury was reported due to ingestion of fluoride in the form of electrolytes/minerals In general, household products containing HF or fluoride salts appear to pose a more serious risk to the population as a whole than do anti-caries treatments containing fluoride. Table 2 indicates that moderate to major consequences developed in 14.2 percent of exposures to household products containing elemental fluoride in the form of HF as opposed to 0.5 percent of exposures to anti-caries treatments containing elemental fluoride. This pattern is almost identical to that reported in the original toxicity review of fluoride-containing products (12.8 percent for household products c#ontaining HF versus 0.4 percent for anti-caries treatments)3. HS staff reemphasizes that the form of elemental fluoride, whether HF or soluble fluoride salt, is irrelevant to degree of toxicity. In either case, toxicity is determined by the absolute amount of elemental fluoride. Previous memoranda provided data supporting the conclusion that products containing more than 0.5 percent and more than 50 mg elemental fluoride could cause serious personal injury or illness to children less than 5-years-old. This memorandum provides additional evidence supporting both the toxicity of household products containing concentrations and amounts of elemental fluoride above the proposed level for regulation and the general lack of toxicity of anti-caries products that contain 0.5 percent or less elemental fluoride.
TABLE 1. AAPCC TESS DATA (1996, accidental ingestions by children C 5) OUTCOME Total HF Household Products Hydrofluoric Acid U-W Rust Remover U-W Total HF Household Products Anti-caries Treatments Mouthwash + F Toothpaste + F Electrolytes/ Minerals Vitamins + F Total Anti-caries Treatments 904 4,099 2,374 35 501 237 3 i3 2 48 88 14 20 1 3 0 0 minor moderate . maror death
1,367 8,744
Ingestion refers to cases where the material enters the mouth, and includes ingestions accompanied by aspiration. Minor Symptoms - The patient exhibited some minimal signs or symptoms which resolved rapidly. Moderate Symptoms The patient exhibited signs or symptoms that were more pronounced, prolonged, or of a systemic nature which usually required some form of treatment. Symptoms were not life threatening and the patient returned to a pre-exposure state of <well-being with no residual disability or disfigurement. Major Symptoms - The patient exhibited some symptoms which were life-threatening or resulted in disfigurement or residual disability.
TABLE 2. AAPCC TESS Data (1996, all ages, all routes of exposure) Death
Total HF Household Products HF HF Rust Remover Total HF Household Products 1,480 1,464
Anti-caries Treatments Mouthwash + F Toothpaste + F E!ectrolytes! Mixrals Vitar?ins 7 F Total Anti-caries Treatments 1,483 5,442 1,061 4,454 82 892 5 37 0 1 0 0
3,741 1,921
3,283 1,535
Definitions of outcome are as previously described in Table 1.
6 REFERENCES: ’ CPSC. Proposed Rule “Requirements for Child-Resistant Packaging; Household Products With More than.50 mg of Elemental Fluoride and More Than 0.5 Percent Elemental Fluoride; and Modification of Exemption for Oral Prescription Drugs With Sodium Fluoride”. Federal Register 62(224):61928-61933. November 20, 1997. 2 Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, “Update on Injuries Due to Products Containing Fluoride”, October 9,1997. I3 Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, “Toxicity of Household Products Containing Fluoride”, August 4, 1997.
United States Washington, D.C. 20207
CONSIJMERPRODUCTSAFETY COMMMION
DATE= 0 8 APR 1998
Jacqueline N. Ferrante, Ph.D., EH Project Manager, Fluorides Warren J. Prunella, AED, EC d mm Y Marcia P. Robins, EC (504-0962) Final Rule: Child-Resistant Packaging For Household Products Containing Fluorides
The Regulatory Flexibility Act (RFA [PL 96-34511) generally requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis describing the impact of the rule on small businesses and other small entities, when a general notice of proposed rulemaking is published in the Federal Register. However, under section 605, no such analysis is required if the Commission certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities. On November 20, 1997, CPSC published a Notice of Proposed Rulemaking (NPR) 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 or weight-to-weight basis per package.) In this notice the Commission concluded that the proposal would not have a significant economic effect on a substantial number of small businesses or other small entities. This conclusion was based primarily on the fact that various types of senior-friendly CR packaging suitable for household products containing fluorides are available at prices competitive with nonCR packaging. Thus, costs should not be burdensome to current manufacturers of fluoride-containing products or an entry barrier for future small business marketers. The CPSC staff had observed a number of consumer products containing fluorides in senior friendly CR packaging. The requirement would not affect costs for companies that are already voluntarily providing such CR packaging. Finally, there are no recordkeeping or reporting requirements under the PPPA.
As proposed, the final rule would also modify the current exemption for oral prescription drugs containing sodium fluoride so that it would be consistent with the level proposed for household products. This modification is not likely to affect any currently available prescription drugs. If such drugs should become available in the future, appropriate CR packaging is readily available at . prices competitive with nonCR packaging. A copy of the proposed rule was sent to individual businesses, many of which were small, that may sell fluoridecontaining products. However, the public comments on the proposed rule provided no additional information regarding potential adverse impacts on small businesses or other small entities. Therefore, the staff concludes that the rule is not expected to have any significant adverse economic effects on industry or the public.
U.S. CONSUMER PRODUCT SAFETY COMMISSION WASHINGTON, D.C. 20207 3/10/98
TO: THROUGH:
Jacqueline N. Ferrante, Ph.D., Project Manager, Fluoride, Division of Health Sciences Mary Ann Danello, Ph.D., Associate Executive Director for Epidemiology and Health Sciences-&-. . Marilyn L. Wind, Ph.D., Director, Division of Health")%& Sciences, Directorate for Epidemiology & Health Sciences
FROM: SUBJECT :
Charles Wilbur, Consumer Safety Officer .F Division of Health Sciences, (504-0477, ext. 1204) Technical Feasibility, Practicability, and Appropriateness Determination for the Final Rule to Require Special Packaging for Products Containing Fluoride.
The attached evaluation summarizes the Health Sciences determinations of technical feasibility, practicability, and appropriateness for the final rule for fluoride containing household products.
FLUORIDE TECHNICAL FEASIBILITY, PRACTICABILITY,
APPROPRIATENESS Charles J. Wilbur MARCH 1998
DIRECTORATE FOR EPIDEMIOLOGY & HEALTH SCIENCES DIVISION OF HEALTH SCIENCES
SUMMARY . . . . . . . . . . . . . ..*.......*..*............................ 1 INTRODUCTION................................................... TECHNICAL FEASIBILITY.......................................... CONTINUOUS THREADED (CT) RECLOSABLE CRP, ASTM TYPE I SNAP REXLOSABLE CRP, ASTM TYPE III AEROSOL MULTIPLE APPLICATION CRP, ASTM TYPE VII TRIGGER SPRAYER MECHANICAL DISPENSERS CRP, ASTM TYPE IX PRACTICABILITY................................................. CONTINUOUS THREADED (CT) AND SNAP RECLOSABLE CRP AEROSOL MULTIPLE APPLICATION CRP TRIGGER SPRAYER MECHANICAL DISPENSERS CRP APPROPRIATENESS..............................................,. CONTINUOUS THREADED (CT), SNAP RECLOSABLE AND TRIGGER SPRAYER MECBANICAL DISPENSERS CRP AEROSOL MULTIPLE APPLICATION CRP EFFECTIVE DATE................................................. CONCLUSION..................................................... 4 5 4 3 1 2
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Directorate for Epidemiology and Health Sciences staff conclude that findings can be supported that special packaging requirements for products containing fluoride are technically feasible (can be produced), practicable (lends itself to techniques of mass production), and appropriate (compatible with the substances contained within the package), for the following: Products using continuous threaded, snap reclosable, aerosol, and trigger sprayer dispensing child-resistant packaging (,CRP) require an effective date of nine months. A temporary stay of enforcement can be requested if additional time is needed to provide adequate commercial quantities or for small companies converting to senior friendly CRP. Some Poison Prevention Packaging Act (PPPA) regulated substances presently are in these types of Senior Adult Use Effectiveness (SAUE) special packaging. Adequate supplies of CRP are available or can be made available. Currently PPPA regulations exempt oral prescription drugs, in liquid and tablet forms, that contain no more then 264 mg sodium fluoride. To maintain consistency with the proposed level the staff recommends the exemption level be changed to no more than 110 mg sodium fluoride or no more than a concentration of 0.5 percent on a w/v basis for liquids or a w/w basis for nonliquids. This change is not expected to affect the technical feasibility, practicability and appropriateness findings, as it is not expected to impact currently exempted prescription dental products or OTC dental products. INTRODUCTION To require that fluoride containing products at the proposed level be packaged in CRP the Commission must find that CRP is: o Technically Feasible - Technology exists to produce packaging conforming to the standards, see 16 CFR 1700.15. Products that must be in aerosol form may be exempt from the senior adult use effectiveness requirements, see 16 CFR 1700.15(b),(2), ii. o Practicable - Special packaging complying with the standards, can be produced using modern mass production and assembly line techniques. o Appropriate - Packaging complying with the standards, adequately protects the integrity of the substance and does not interfere with its intended storage or use.
Fluoride containing oral Rx drugs are presently regulated under the PPPA. Most Over-The-Counter (OTC) fluoride containing products are packaged in various sizes of containers with non-CR continuous threaded closures. Other known products are packaged in aerosols and mechanical pumps. Various types and designs of senior friendly CR packaging can be obtained, see ASTM D3475, Standard Classification of Child-Resistant Packages'. Each type of packaging is addressed below: .
CONTINUOUS THREADED RECLOSABLE CR PACKAGING: Two manufacturers are presently using a senior friendly ASTM IA design package'? In addition various designs of senior friendly continuous threaded (screw) type reclosable CR packaging are readily available. ASTM in its Standard Classification of ChildResistant Packages lists several designs of type I packages that are senior friendly. The majority of fluoride products use or can use this type of CRP.
There is at least one powdered fluoride containing product. We don't know what type of packaging it is in as we were unable to obtain a sample. However, the snap type of CRP is typically used for OTC nonliquid products, i.e., tablets, capsules, powders, etc. There are available various designs of senior friendly snap type reclosable CR packaging. ASTM in its Standard Classification of ChildResistant Packages lists several designs of type III packages that are senior friendly.
SNAP RECLOSABLE CR PACKAGING:
We know at AEROSOL MULTIPLE APPLICATION CR PACKAGING: least one fluoride product uses a non-CR aerosol type package4. One product manufacturer of another regulated product is presently using a CR aerosol overcap that is senior friendly'. Two overcap manufacturers have supplied SF protocol test data6#' and are in various stages of developing additional sizes of a senior friendly package*,'. There are other designs of aerosol overcaps that may be made senior friendly. ASTM in its Standard Classification of Child-Resistant Packages lists designs of type VII packages that can be made senior friendly.
TRIGGER SPRAYER BfEXHANIcAL DISPENSER CR PACKAGING: We
know of some fluoride products that use non-CR trigger mechanical pump dispensing mechanismslot". One product uses a senior friendly CR trigger mechanical pump mechanism that can be The supplier of senior permanently attached to the bottle2. friendly CR trigger mechanical pumps supplied the Commission with passing SF protocol test results13. This CRP manufacturer can There are provide this packageto the product manufacturers14. other designs of trigger sprayers that may be made senior friendly. ASTM in its Standard Classification of Child-Resistant Packages lists designs of type IX packages that can be made senior friendly. The staff believe that data support the finding that special packaging for fluoride containing products that require CR continuous threaded (screw), snap, aerosol and trigger sprayer packaging are technically feasible.
Information is available to support the finding that the special packaging of fluoride containing products is practicable.
CONTINUOUS THREADED (CT) AND SNAP RECLOSABLE CR PACKAGING:
These types of senior friendly CRP are presently being used by some companies for regulated products, i.e., two fluoride products use CT special packaging. Companies have implemented assembly line and mass production techniques in their manufacturing process for both the CT and snap CRP. This shows that it is practicable to package regulated products in special packaging. No major problems are anticipated in this change from the manufacturing standpoint. Frequently manufacturers can incorporate CR packaging into their existing packaging lines. Two known AEROSOL MULTIPLE APPLICATION CR PACKAGING: product manufacturers are in commercial production with a senior Information is available from two CR friendly aerosol overcap. packaging manufacturers that this type of senior friendly special packaging can be made commercially available. Both manufacturers supply their CR overcap commercially for other similar products. This special package can be implemented into most product manufacturers assembly line. No major problems are anticipated in using special packaging from the production manufacturing process. One TRIGGER SPRAYER MECHANICAL DISPENSER CR PACKAGING: known fluoride product manufacturer is currently using a senior friendly CR trigger sprayer for their product. No changes are necessary to the assembly line and mass production technique in the manufacturing process. This shows that it is practicable to package fluoride containing products in trigger sprayer type special packaging. No major problems are anticipated in using CR packaging from the manufacturing standpoint. 3
CONTINUOUS THREADED, SNAP RECLOSABLE AND TRIGGER SPRAYER Some companies are presently using these DISPENSER CR PACKAGING:
types of senior friendly special packaging for their products, i.e., two fluoride products use a CT and one a trigger sprayer type special package. Most companies can use existing CR packaging designs and materials that have proven not to be detrimental to the integrity of the substance and have not interfered with its storage or use for these types of CRP. Product shelf-life, and integrity would not be expected to change, as it is anticipated that the same packaging materials could be used in contact with the product. The CR overcap AEROSOL MULTIPLE APPLICATION CR PACKAGING: method of packaging has successfully been used by other product manufacturers for their products, and two have a senior friendly overcap. The overcap CR concept does not affect the integrity of the substance or interfere with its storage or use. The CR overcap is separate from the product container. Product shelflife, and integrity would not be expected to change, as it is anticipated that the same packaging materials could be used in contact with the product. Staff, therefore, believe that the data support the finding that special packaging for fluoride containing products are appropriate. EFFECTIVE DATE Information received from the packaging manufacturers confirm that most fluoride-containing products can be packaged in senior-friendly CRP in nine months.
CONTINUOUS THREADED AND SNAP RECLOSABE CR PACKAGING:
Adequate supplies of Senior Friendly special packaging are available for products requiring continuous threaded and snap reclosable packaging. Two major aerosol overcap CRP manufacturers have supplied the Commission with information indicating that their aerosol overcap CRP has passed the senior friendly requirements under the PPPA. Both have supplied confirming protocol test data. One supplier confirmed the need for nine months to one year to make available commercial quantities for the market. Time is needed to provide additional sizes and provide adequate commercial quantities for the market.
AEROSOL MULTIPLE APPLICATION CR PACKAGING:
One major acturer has prov ided the Commiss ion mechan ical trigger pump manuf CRP with p rotocol test data indic.ating that their mechanical pump ess y and child -resi stant effectiven has pa ssed the senior friend1 requir ements under the Poison, Prevention Pack aging Act (PPPA) Howeve r, they need nine monthIS to one ye ar to make available commermcial quantities for the! market. T ime i s required for sts, obtaining new tools, purchasi ng molds, c onduc ting protocol te etc. Senior friendly CRP, e.g., mechanical pump, aerosol overcap, snap and continuous threaded CRP, is available to,meet an effective date of nine months for most fluoride containing products. If some individual companies have difficulties in obtaining adequate senior friendly CRP, they can applyto the Commission for a stay of enforcement for a minimum period to market their products in conventional packaging until they can obtain an adequate supply of senior friendly CRP. CONCLUSION The staff concludes that data support the findings that ASTM types I, III, VII and IV special packaging for fluoride products are technically feasible, practicable, and appropriate. To achieve senior friendly CRP it may be necessary sometimes to use a different ASTM type special packaging.
CONTINUOUS THREADED (ASTM I), SNAP (ASTM III) RECLOSABLE AND TRIGGER SPRAYER (ASTM IX) DISPENSER CR PACKAGING:
TRIGGER SPRAYER DISPEN‘SER CR PACKAGING
There are regulated PPPA products on the market with ASTM type I, III, and IX, CRP that comply with SAUE requirements. Supplies of senior friendly CRP are available.
AEROSOL (ASTM VIII) MULTIPLE APPLICATION CR PACKAGING:
A _~ _- senior friendly overcap is being used by one product . _ indicated with with manufacturer. CR overcap manufacturers have indicated, ial commercial adequate time, they can make available suitable commer uired for additional time is re time is required special packaging. In this case, additional this case, CR overcap companies to implement new sizes, redesign, obtain overcap companies to implement sizes, redesign, ob;;kn molds, protocol test, and start commercial production. e IS Ninenew months to one year is needed to insure adequate suppli insure adequate supplies of new of senior friendly and child resistant special packaging. The same findings relating to technical feasibility, practicability, and appropriateness can be made for the fluoride exemption as for the final rule for fluoride containing products.
1. ASTM, Standard Classification Child-Resistant Packages, D-3475, ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, Telephone 610-832-9739. 21 . Tewabe, A., Wilbur, C., Laboratory Report, Form 221, ASTM IA, Reclosable Continuous Threaded, Push Down and Turn Closure on a 6 oz. Plastic Container with an Internal Neck Plug Dispenser Insert, 97-594-0292, No. 2929, CPSC, Health Sciences, June 9, 1997. 3. Tewabe, A., Wilbur, C., Laboratory Report, Form 221, ASTM IA, Reclosable Continuous Threaded, Push Down and Turn Closure on a 3 oz. Cream Plastic Container, 97-594-0293, No. 2930, CPSC, Health Sciences, June 9, 1997. 4. Wilbur, C., Laboratory Report, Form 221, Non-CR Aerosol, Conventional Snap Type Overcap on a 212 x 804 Metal Can, 16 oz., 97-860-5515, No. 2397, CPSC, Health Sciences, November 12, 1996. 5. Tewabe, A., Wilbur, C., Laboratory Report, Form 221, CR & Senior Friendly Overcap 202 on a Aerosol Container, 97-594-0314, No. 2957, 97-594-0315, No. 2958, 97-594-03164, No. 2959, CPSC, Health Sciences, July 1, 1997. 6. Tewabe, A., Wilbur, C., CR & Senior Friendly 211 Overcap ASTM Type VII A on a A-z-rosol Metal Container, 98-594-0348, No. 3001, Laboratory Report, Form 221, CPSC, Health Sciences, October 8, 1997. 7. Tewabe, A., Wilbur, C., Laboratory Report, Form 221, CR & Senior Friendly Overcap SP 211 on a Aerosol Container, 97-594-0335, No. 2980, CPSC, Health Sciences, December 1, 1997. 8. One Major Child Resistant Packaging Aerosol Overcap Manufacturer, Confidential Communication, CPSC Form, 247, March 3, 1998. 9. A Second Major Child Resistant Packaging Aerosol Overcap Manufacturer, Confidential Communication, CPSC Form, 247, March 3, 1998. 10. Tewabe, A., Wilbur, C., Laboratory Report, Form 221, Non-CR Mechanical Pump Trigger Sprayer Dispenser with Non-CR Screw Cap attachment to a 20 oz. Plastic Handled Bottle, CPSC, Health Sciences, 97-400-0196, No. 2360, October 1, 1996, and 97-8605514, No. 2396, November 11, 1996. 11. Tewabe, A., Wilbur, C., Laboratory Report, Form 221, Non-CR Mechanical Pump Trigger Sprayer Dispenser with Non-CR Screw Cap attachment to a 18 oz. Plastic Handled Bottle, 97-594-0289, No. 2929, CPSC, Health Sciences, May 30, 1997. 6
12. Tewabe, A., Wilbur, C., Laboratory Report, Form 221, ASTM IX B (1) CR Mechanical Pump Trigger Sprayer Dispenser with CR Screw Cap attachment to a 17 oz. Plastic Handled Bottle, 97-594-0291, No. 2928, CPSC, Health Sciences, June 9, 1997. 13. Tewabe, A., Wilbur, C., CR Mechanical Pump Trigger Sprayer Dispenser, ASTM IX B (l), with CR Screw Cap attachment to a 17 oz. Plastic Handled ,Bottle, Laboratory Report, Form 221, CPSC, Health Sciences, 97-594-0291, No. 2928, June 9, 1997, and Child/Senior Protocol Test Data, October 15, 1997. 14. Child Resistant Packaging Mechanical Finger Pump Dispenser Manufacturer, Confidential Communication, CPSC Form, 247, March 11, 1998.
Draft 5/4/90
Billing Code 6355-01 CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1700
Final Rule: Requirements for Child-Resistant Packaging; 1 Household Products With More Than 50 mg of Elemental Fluoride and More Than 0.5 Percent Elemental Fluoride; and Modification of Exemption for Oral Prescription Drugs with Sodium Fluoride AGENCY: ACTION: SUMMARY: Consumer Product Safety Commission. Final rule. The Commission is issuing a rule to require child-
resistant (VRll> 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-tovolume (IIW/V~I) or weight-to-weight (rr~/w") basis). consistency, For
the Commission is also modifying the oral
prescription drug exemption for sodium fluoride preparations. Instead of exempting drugs with no more than 264 mg of sodium fluoride per package as the current rule does, the Commission will exempt such drugs with either 50 mg or less of the equivalent of elemental fluoride (110 mg or less of sodium fluoride) per package or no more than the equivalent of 0.5 percent elemental fluoride on a w/v or w/w basis. The Commission
determines 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. DATES: The rule will become effective on I 1998 [insert
date that is 9 months after publication in the FEDERAL REGISTER], and applies to products packaged on or after that date. FOR FURTHER INFORMATION CONTACT: Laura Washburn, office of
Compliance, Consumer Product Safety Commission, Washington, D.C. 20207; telephone (301)504-0400 ext. 1452. SUPPLEMENTARY INFORMATION: A. Background 1. . Household Products Containing Fluoride 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 (I~HFII), ammonium bifluoride, ammonium fluoride, potassium bifluoride, sodium bifluoride, sodium fluoride and sodium fluosilicate.'[l&312
The percentage of elemental fluoride in any compound is determined by dividing the molecular weight of fluoride (- 19 grams/mole) by the molecular weight of the compound (e.g., the molecular weight of sodium fluoride = 42 grams/mole). Sodium fluoride contains 45% elemental fluoride (19/42 x 100 = 45%). 2 Numbers in brackets refer to documents listed at the end of this notice. -2-
Many dental products also contain fluorides, but at lower levels. 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. 121 2. Relevant Statutory and Requlatorv Provisions The Poison Prevention Packaging Act of 1970 (IlPPPAll), 15 U.S.C. 1471-1476, authorizes the Commission to establish standards for the “special packaging" of any household substance if (1) the degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance and (2) the special packaging is technically feasible, practicable, and appropriate for such substance. Special packaging, also referred to as “child-resistant (CR) packaging," is (1) designed or constructed to be significantly
difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and (2) not difficult for Wormal adults" to use properly. 15 U.S.C. 1471(4). Household substances for which
the Commission may require CR packaging include (among other categories) foods, drugs, or cosmetics as these terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 15
The Commission has performance requirements 16 CFR 1700.15, 1700.20.
for special packaging. ,
Section 4(a) of the PPPA, 15 U.S.C. 1473(a), allows the manufacturer or packer to package a nonprescription product subject to special packaging standards in one size of non-CR packaging only if the manufacturer (or,packer) also supplies the substance in CR packages of a popular size, and the non-CR packages bear conspicuous labeling stating: “This package for households without young children." 1700.5. 3. Existinq PPPA Requirements for Fluoride-Containinq Products The Commission currently requires CR packaging for oral prescription drugs with fluoride, but it exempts those in liquid or tablet form that contain no more than 264 mg of sodium fluoride (equivalent to 120 mg fluoride) per package. 1700.14(10) (vii). 16 CFR 15 U.S.C. 1473(a), 16 CFR
The Commission based this exemption level.on
the lack of serious adverse human experience associated with such drugs at that time and a recommendation by the American Dental Association that no more than 264 mg of sodium fluoride should be dispensed at one time. 45 FR 78630. As discussed below, the
Commission is revising the exemption to a new level that is based on current information concerning the toxicity of fluoride and is consistent with the CR requirement for fluoride-containing household products.
The Proposed Rule On November 20, 1997, the Commission issued a notice of
proposed rulemaking ("NPR") that would require 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 (w/v or w/w). The Commission also proposed to
adjust the oral prescription drug exemption so that it would be consistent. 62 FR 61928. The Commission received four comments
in response to the proposed rule. One commenter noted that the language of the revised exemption needed to be clarified. The Commission intended that
products satisfying either one of the criteria specified would qualify for the exemption. Accordingly, the Commission has
clarified the final rule so that it exempts sodium fluoride drug preparations that contain no more than 50 mg of the equivalent of elemental fluoride (110 mg or less of sodium fluoride) per package or no more than the equivalent of 0.5 percent elemental fluoride on a w/w or w/v basis. The Commission received a letter from the American Dental Association stating that it does not object to the proposed rule. The third comment came from the Art and Creative Materials Institute, a non-profit association of manufacturers of art and creative materials, expressing support for the proposed rule. The Chemical Manufacturers Association also commented in support of the proposed rule.
B. Toxicity of Fluoride
Most available toxicity information on fluoride relates to acute toxicity of hydrofluoric acid ("HP). However, other water
soluble fluoride-containing compounds can cause fluoride poisoning. immediately. The fluoride ion is systemically absorbed almost It is highly penetrating and reactive and can cause Fluoride ions,
both systemic poisoning and tissue destruction.
once separated from either HF or fluoride salts, penetrate deep into tissues, causing burning at sites deeper than the original exposure site. for days.[2] 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 The process of tissue destruction can continue
arrhythmia, respiratory stimulation followed by respiratory depression, muscle spasms, convulsions, central nervous system (VNSI) 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 -6-
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 injuryJ21 . Ingestion of fluoride can result in mild to severe GI symptoms. Reports suggest that ingesting 3 to 5 milligrams of
fluoride per kilogram of body weight (mg/kg) causes vomiting, diarrhea, and abdominal pain. produce systemic toxicity. Ingestion of more than 5 mg/kg may
A retrospective poison control center
study of fluoride ingestions reported that symptoms, primarily safely tolerated GI symptoms that tended to resolve within 24 hours, developed following ingestions of 4 to 8.4 mg/kg of fluoride.[2] According to the medical literature, a safely "
tolerated dose (~STD~~> and a certainly lethal dose (llCLDll> were determined from 600 fluoride poisoning deaths. The CLD was
determined to be 32 to 64 mg/kg and the STD was estimated at one fourth that, or 8 to 16 mg/kg. These values were statistically
determined and are not identical to the actual lowest toxic or lethal levels of fluoride. The lowest documented lethal dose for There were
fluoride is 16 mg/kg in a 3-year-old child. complicating factors in this death.
The child may have taken
other medications and he suffered from Crohn's disease (an inflammatory disorder of the GI tract) that may have contributed to his death.[2]
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 (WAPCC") of hydrofluoric acid burns from rust stain removers applied to clothing found 619 such cases in 1990. Five of these required hospitalization.[2]
Other reports gathered from the medical literature are discussed in the notice of proposed rulemaking and the accompanying briefing package. 62 FR 61928. CPSC has several databases for poison
CPSC Databases. incidents.
The staff reviewed cases from 1988 to May 1997 in the
National Electronic Injury Surveillance System (IINEISSl), the Injury or Potential Injury Incident files, Death Certificate (rrDCRTUl) database, and In-Depth-Investigation (llINDPll) files. From 1988 to 1996, NEISS had reports of 31 incidents involving products documented to contain fluoride. Two of these Most
were accidental ingestions by children under 5 years old. other injuries involved chemical burns of the hands.[2] 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.[7] -8-
The INDP files contain numerous injury reports.
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
when the fluoride Four months
ion penetrated through to the bones of her forearm.
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 3year old child ingested an unknown product with HF. The second
case involved a 2-year-oldchild who ingested a toilet bowl stain remover that contained 15.9 percent ammonium bifluoride. 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.[2] Since 1995, there were six reports of fluoride poisoning in children under 5 years of age from a wheel cleaning product. The The
p:roduct c ontains 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.[2] Three deaths from fluoride-containing products were d#ocumented in 1997 after the staff had completed the briefing package for the proposed rule. years old. Two involved children under 5
In one case, a 3-year-old female died from cardiac
arrest after ingesting the recalled wheel cleaner described -9-
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 bifluorideJ61 . 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 Out of a total of 499
reported fatalities in this age group.
exposures to products known to contain HF, there were 2 major outcomes and 24 moderate4 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
3Major outcome - The patient exhibited signs or symptoms which were life-threatening or resulted in significant residual disability or disfigurement. 4Moderate outcome - The patient exhibited signs and symptoms that were more pronounced, more prolonged, or more of a systemic Usually some form of treatment was required. nature. Symptoms were not life-threatening and the patient had no residual disability or disfigurement. -lO-
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.[2] The 1996 AAPCC data report 136 exposures to products known to contain HF involving children under 5 years old. these resulted in moderate outcomes. Four of
There were no major
outcomes or deaths reported with this age group in 1996.[7] 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 There were also injuries
outcomes and 275 in major outcomes.
from dental products, fluoride mineral/electrolyte products, and vitamins with fluoride. the HF category. A total of 18 deaths were reported in
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 productsJ21 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 Four deaths were reported involving HF.[7]
27 in major outcomes.
D. Level of Regulation for Household Products Containing Fluoride
The Commission is issuing a rule that requires special 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 w/v basis for liquids or a w/w basis for non-liquids.[l,2&5] level as the Commission proposed. There is no well defined lethal dose for fluoride. In the This is the same
medical literature, one source cites a minimum lethal dose in humans of 71 mg/kg and another specifies a lethal oral dose in the range of 70 to 140 mg/kg. The staff considers these values There
too high based on documented cases of fluoride toxicity.
is one documented death from ingestion of 16 mg/kg fluoride, but as discussed above, other medical factors may have contributed to that death. Most evidence suggests that the lower limit of the
calculated CLD of 32 mg/kg is a reasonable estimate for a minimum lethal dose.[2] Similarly, there is no established toxic dose for fluoride. Generally, greater than 6 percent HF can cause dermal burns and more than 0.5 percent can lead to serious eye injury. Several
reports suggest ingestion of 3 to 5 mg/kg produces symptoms and that more than 5 mg/kg (50 mg in a 10 kg child) can produce systemic toxicity. Additionally, some medical professionals
advise medical observation following ingestions of more than 5 to -12-
w/kg=
Based on this information, the Commission determined a
level for regulation that would include all household products with more than 50 mg of elemental fluoride and more than 0.5 percent elemental fluoride on a w/v basis for liquids or a w/w basis for non-liquids. There is no evidence that 50 mg or less
of elemental fluoride or concentrations less than 0.5 percent cause serious systemic toxicity or serious burns.[1,2&5]
E* Level of Regulation for Oral Prescription Drugs Containing Sodium Fluoride
Based on the toxicity information discussed above, the Commission believes that the current exemption for oral prescription drugs with no more than 264 mg of sodium fluoride should be modified. To be consistent with the level for
household products containing fluoride, the Commission is revising the level for the oral prescription drug exemption to exempt products that have either no more than the equivalent of 50 mg of elemental fluoride (110 mg sodium fluoride) per package or no more than a concentration of 0.5 percent elemental fluoride on a w/v basis for liquids or a w/w basis for non-liquids.[l,2&5] The Commission does not believe that changing the level of exemption for prescription drugs containing sodium fluoride will impact any of the currently exempted dental products with more than 50 mg of fluoride because these products have 0.5 percent or less fluoride.[l] In its comment, the American Dental
Association confirmed this. [53
F. Statutory Considerations
1. 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 Although some products The Commission
children in common household products.
currently use CR packaging, others do not.
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.[i&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. 2. Technical Feasibility, Practicability, and Appropriateness In issuing a standard for special packaging under the PPPA, the Commission is required to find that the special packaging is -14-
“technically feasible, practicable, and appropriate." 1472(a)(2).
exists or can be readily developed and implemented to produce packaging that conforms to the standards. P Practicability means
that special packaging complying with the standards can utilize modern mass production and assembly line techniques. Packaging
is appropriate when complying packaging will adequately protect the integrity of the substance and not interfere with its intended storage or use.[4,9] 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 This shows that these
mechanical pump mechanism for its product.
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 Thus, this
currently using a senior-friendly CR aerosol overcap.
kind of CR packaging could be used for fluoride-containing products. Finally, various designs of senior-friendly snap type -15-
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 I packaging.141 Therefore, the Commission concludes that CR packaging for fluoride-containing products is technically feasible, practicable, and appropriate. 13 . Other Considerations In establishing a special packaging standard under the PPPA, the Commission must consider the following: a. The reasonableness of the standard; b. Available scientific, medical, and engineering data concerning special packaging and concerning childhood accidental ingestions, illness, and injury caused by household substances;
1472 (b) .
The Commission has considered these factors with respect to the various determinations made in this notice, and finds no reason to conclude that the rule is unreasonable or otherwise inappropriate. G. Effective Date The PPPA provides that no regulation shall take effect sooner than 180 days or later than one year from the date such final regulation is issued, except that, for good cause, the
Commission may establish an earlier effective date if it determines an earlier date to be in the public interest. I5 U.S.C. 1471n. Senior-friendly special packaging is currently commercially available for most types of CR packaging.[9] Therefore, the
Commission believes that an effective date of 9 months after publication of the final rule is reasonable. The Commission
proposed a 9 month effective date and received no comments on this issue. If companies do find that they need more time, they
can request a stay of enforcement for the minimum period needed to obtain adequate supplies of senior-friendly CR packaging. A final rule would apply to products that are packaged on or after the effective date.
H. Regulatory Flexibility Act Certification
When an agency undertakes a rulemaking proceeding, the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., generally requires the agency to prepare proposed and final regulatory flexibility analyses describing the impact of the rule on small businesses and other small entities. Section 605 of the Act
provides that an agency is not required to prepare a regulatory flexibility analysis if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. In connection with the proposed rule, the Commission's Directorate for Economic Analysis prepared a preliminary assessment of the impact of a rule to require special packaging -17-
for household products containing fluoride with more than 50 mg eilemental fluoride and more than 0.5 percent elemental fluoride (w/v or w/w> . The staff also considered the impact of a rule
modifying the current exemption for oral prescription drugs containing sodium fluoride so that it would be consistent with the level proposed for household products.[3] Based on this assessment, the Commission concluded that the proposed requirement for fluoride-containing household products would not have a significant impact on a substantial number of 1 smal A businesses or other small entities. Despite making a
specific request in the NPR, the Commission re'ceived no comments .concerning the potential impact on small businesses, and the Ce3mmission is unaware of any information that ,would alter its
r?'7C]ly~Cye
'q--t t* G
tk;,e
b7jJ.i
s-~-+t~--i~l number of small entiLies.[8] F- _A- Com-nission reach& the same conclusion concerning the - ,- h proposed modification in the level for exemption of 0ra.l
CX-leCCX-lCL-ion drugs containing sodium fluoride. [3]
informLation was pro-\-ided to alter the Commission's conclusion
that, the rr,odification to the exemption for oral prescription
drugs containing sodium fluoride would not have a significant impact on a substantial number of small businesses or other small
c=nri+les.[8] e-L I. Environmental Considerations
Also in connection with the proposed rule and pursuant to c he National Environmental Policy Act, the Council on
Environmental Quality regulations and CPSC procedures for environmental review, the Commission assessed the possible environmental effects associated with the proposed PPPA requirements for fluoride-containing products.[3] j\ The Commission
concluded that the proposed rule would have no adverse effect on the environment, and neither an environmental assessment nor an environmental impact statement would be required. information alters this conclusion.[8] J. Executive
According to Executive Order 12988 (February 5, 1996), agencies must state in clear language the preemptive effect, if any , of new regulations. The PPPA provides that, generaily, when a special packaging standard issued under the PPPA is in effect, T)oliticai -c "no State or
subdivision thereof shall have any authority either tc
establish cr continue in effect, with respect to such household substance, any standard for special packaging (and any exemption
therefrom and requirement related thereto) which is not identical to the [PPPA] standard." 15 U.S.C. 1476(a). A State or local
standard may be excepted from this preemptive effect if (1) the State or local standard provides a higher degree of protection from the risk of in-jury or illness than the PE?PA standard; and (2) the State or political subdivision applies to the Commission for an exemption from the PPPA's preemption clause and the Commission grants the exemption through a process specified at 16 CFR Part 1061. 15 U.S.C. 1476(c)(l). -19In addition, the Federal
or a State or local government, may establish and
continue in effect a non-identical special packaging requirement that provides a higher degree of protection than the PPPA requirement for a household substance for the Federal, State or local government's own use. 15 U.S.C. 1476(b).
Thus, with the exceptions noted above, the rule requiring packaging for household products containing fluoride above the regulated
and modifying the exemption level for oral
prescript ion drugs with sodium fluoride would preempt nonidentical state or local special packaging standards for such fy~~;ovi 4jp containing -LUG products 19873,
I n accordance with Executive Order 12612 (October 26,
the Commission certifies that the rule does not have sufficient i_mpL i cations for federalism to warrant a Federalism Assessment.
List of Subjects in 16 CFR Part 1700 Consumer torotection, Drugs, Infants and children, Packaging
and containers, Poison prevention, Toxic substances.
For the reasons given above, the Commission amends 16 CFR part 1700
2s fOliOWS:
PART 1700--[AMENDED] 1. The authority citation for part 1700 continues to read as foliows:
Authority: Pub. L. 91-601, sets. 1-9, 84 Stat. 1670-74, 15 U.S.C. 1471-76.
Sets 1700.1 and 1700.14 also issued under Pub. L. 92-
573, sec. 30(a), 88 Stat. 1231. 15 U.S.C. 2079(a). 2. Section 1700.14 is amended to revise paragraph (a) (10) (vii) and to add paragraph (a)(27) to read as follows (although unchanged, the introductory text of paragraphs (a) and (10) are included below for context):
1700.14 (a)
Substances Substances.
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 s 1700.2O(a,! 1s required tc protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such suztancec, and the special packaging herein required is - --Cf-“?7 ~a-.--- re asibie, practicable, and appropriate for these CL-*--*SLlbS Lances : x r + * 3:
<iOj 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 b)y 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 : 170&15(a),(b), and (c), except for the f:ollowinc: : -21-
(-qii) Sodium fluoride drug preparations including liquid and tablet forms, containing not more than 110 milligrams of sodium fluoride (the equiva,lent cf 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-toweight basis for non-liquids and containing no other substances subject to this § 1700.14(a)(10). * * (27) * * j: 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-vciume basis lis:~ids or a weight-to-weight basis for _
fey ncn-liquids shall be packaged in accordance with the z:lfo-b-isions of s 17CO.15(a),(b) and (cj.
Sadye E. Dunn, Secretary, Consumer Product Safety Commission
1. Briefing memorandum from Jacqueline Ferrante, Ph.D., EH, c.c the Commission, “Proposed Rule to Require Child-Resistant L E'ackaging for Household Products with Fluoride," September 30, 1.997.
3 &. D/emorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, "Toxicity of Household Products Containing Fluoride,'" August 4, 1997. -22-
3. Memorandum from Marcia P. Robins, EC, to Jacqueline Ferrante, Ph.D., EH, “Market Data, Economic Considerations and Environmental Effects of a Proposal to Require Child-Resistant Packaging for Household Products Containing Fluoride," June 20, 1997. 4. Memorandum,from Charles Wilbur, EH, to Jacqueline Ferrante, Ph.D., EH, "Technical Feasibility, Practicability, and Appropriateness Determination for the Proposed Rule to Require Child-Resistant Packaging for OTC Products Containing Fluoride," LJune 27, 1997. 5. Briefing memorandum from Jacqueline Ferrante, Ph.D., EH, to the Commission, “Final Rule to Require Child-Resistant Elackaging for Household Products with Fluoride," April , 1998. 6. Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, “Update on Injuries Due to Products Ccntaining Fluoride," October 9, 199'7. 7. Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, “Injuries Due to Products Containing
1~1~0~id~
," Agrii 20, L
P i). Memorandum from Marcia P. Robins, EC, to Jacqueline Ferrante, Ph.D., EH, "Final Rule: Child-Resistant Packaging for Household Products Containing Fluorides," April 8, 1998.
9. Memorandum from Charles p?ilbur, EH, to Jacqueline Ferrante, Ph.D., EH, "Technical Feasibility, Practicability, and ApprCpriEi eness Determination for the Final Rule to Require Special Packaging for Products Containing Fluoride," March 10, 1.991.
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