Federal Register / Vol. 63, No. 105 / Tuesday, June 2, 1998 / Rules and Regulations 29949

CONSUMER PRODUCT SAFETY compounds, laundry sour, air packer) also supplies the substance in COMMISSION conditioner coil cleaners and floor CR packages of a popular size, and the polishes. The fluorides that may be non-CR packages bear conspicuous 16 CFR Part 1700 ingredients in these products and are labeling stating: ‘‘This package for potentially toxic are hydrofluoric acid households without young children.’’ 15 Final Rule: Requirements for Child- (‘‘HF’’), ammonium bifluoride, U.S.C. 1473(a), 16 CFR 1700.5. Resistant Packaging; Household ammonium fluoride, potassium Products With More Than 50 mg of 3. Existing PPPA Requirements for bifluoride, sodium bifluoride, sodium Fluoride-Containing Products Elemental Fluoride and More Than 0.5 fluoride and sodium fluosilicate.1[1&3] 2 Percent Elemental Fluoride; and Many dental products also contain The Commission currently requires Modification of Exemption for Oral fluorides, but at lower levels. In general, CR packaging for oral prescription drugs Prescription Drugs with Sodium the concentrations of elemental fluoride with fluoride, but it exempts those in Fluoride in household cleaners and surface liquid or tablet form that contain no preparation agents are 10 to 1,000-fold more than 264 mg of sodium fluoride AGENCY: Consumer Product Safety (equivalent to 120 mg fluoride) per Commission. higher than concentrations found in dental products.[2] package. 16 CFR 1700.14(10)(vii). The ACTION: Final rule. Commission based this exemption level 2. Relevant Statutory and Regulatory on the lack of serious adverse human SUMMARY: The Commission is issuing a Provisions experience associated with such drugs rule to require child-resistant (‘‘CR’’) at that time and a recommendation by packaging for household products The Poison Prevention Packaging Act of 1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476, the American Dental Association that no containing more than the equivalent of more than 264 mg of sodium fluoride 50 mg of elemental fluoride and more authorizes the Commission to establish standards for the ‘‘special packaging’’ of should be dispensed at one time. 45 FR than the equivalent of 0.5 percent 78630. As discussed below, the elemental fluoride (on a weight-to- any household substance if (1) the degree or nature of the hazard to Commission is revising the exemption volume (‘‘w/v’’) or weight-to-weight to a new level that is based on current (‘‘w/w’’) basis). For consistency, the children in the availability of such substance, by reason of its packaging, is information concerning the toxicity of Commission is also modifying the oral fluoride and is consistent with the CR prescription drug exemption for sodium such that special packaging is required to protect children from serious requirement for fluoride-containing fluoride preparations. Instead of household products. exempting drugs with no more than 264 personal injury or serious illness mg of sodium fluoride per package as resulting from handling, using, or 4. The Proposed Rule ingesting such substance and (2) the the current rule does, the Commission On November 20, 1997, the special packaging is technically feasible, will exempt such drugs with either 50 Commission issued a notice of proposed practicable, and appropriate for such mg or less of the equivalent of elemental rulemaking (‘‘NPR’’) that would require fluoride (110 mg or less of sodium substance. Special packaging, also referred to as CR packaging for household products fluoride) per package or no more than containing more than the equivalent of the equivalent of 0.5 percent elemental ‘‘child-resistant (CR) packaging,’’ is (1) designed or constructed to be 50 mg of elemental fluoride and more fluoride on a w/v or w/w basis. The than the equivalent of 0.5 percent Commission determines that child- significantly difficult for children under 5 years of age to open or obtain a toxic elemental fluoride (w/v or w/w). The resistant packaging is necessary to Commission also proposed to adjust the protect children under 5 years of age or harmful amount of the substance contained therein within a reasonable oral prescription drug exemption so that from serious personal injury and serious it would be consistent. 62 FR 61928. illness resulting from handling or time and (2) not difficult for ‘‘normal adults’’ to use properly. 15 U.S.C. The Commission received four ingesting a toxic amount of elemental comments in response to the proposed fluoride. The Commission takes this 1471(4). Household substances for which the Commission may require CR rule. action under the authority of the Poison One commenter noted that the packaging include (among other Prevention Packaging Act of 1970. language of the revised exemption categories) foods, drugs, or cosmetics as needed to be clarified. The Commission DATES: The rule will become effective these terms are defined in the Federal intended that products satisfying either on March 2, 1999, and applies to Food, Drug, and Cosmetic Act (21 U.S.C. one of the criteria specified would products packaged on or after that date. 321). 15 U.S.C. 1471(2)(B). The qualify for the exemption. Accordingly, FOR FURTHER INFORMATION CONTACT: Commission has performance the Commission has clarified the final Laura Washburn, Office of Compliance, requirements for special packaging. 16 rule so that it exempts sodium fluoride Consumer Product Safety Commission, CFR 1700.15, 1700.20. drug preparations that contain no more Washington, D.C. 20207; telephone Section 4(a) of the PPPA, 15 U.S.C. than 50 mg of the equivalent of (301) 504–0400 ext. 1452. 1473(a), allows the manufacturer or elemental fluoride (110 mg or less of SUPPLEMENTARY INFORMATION: packer to package a nonprescription sodium fluoride) per package or no product subject to special packaging more than the equivalent of 0.5 percent A. Background standards in one size of non-CR elemental fluoride on a w/w or w/v 1. Household Products Containing packaging only if the manufacturer (or basis. Fluoride The Commission received a letter 1 The percentage of elemental fluoride in any Fluorides are ingredients in such compound is determined by dividing the molecular from the American Dental Association household products as cleaning weight of fluoride (∼619 grams/mole) by the stating that it does not object to the solutions for metal, tile, brick, cement, molecular weight of the compound (e.g., the proposed rule. The third comment came wheels, radiators, siding, toilets, ovens molecular weight of sodium fluoride = 42 grams/ from the Art and Creative Materials mole). Sodium fluoride contains 45% elemental and drains. Fluorides are also found in fluoride (19⁄42 × 100 = 45%). Institute, a non-profit association of rust and water stain removers, silver 2 Numbers in brackets refer to documents listed manufacturers of art and creative solder and other welding fluxes, etching at the end of this notice. materials, expressing support for the 29950 Federal Register / Vol. 63, No. 105 / Tuesday, June 2, 1998 / Rules and Regulations proposed rule. The Chemical fluoride.[2] According to the medical penetrated through to the bones of her Manufacturers Association also literature, a safely tolerated dose forearm. Four months after the incident commented in support of the proposed (‘‘STD’’) and a certainly lethal dose she had only partial use of her arm and rule. (‘‘CLD’’) were determined from 600 hand. Three reports in the INDP files fluoride poisoning deaths. The CLD was involve children under 5 years old who B. Toxicity of Fluoride determined to be 32 to 64 mg/kg and the died after ingesting fluoride-containing Most available toxicity information on STD was estimated at one fourth that, or products. A 3-year old child ingested an fluoride relates to acute toxicity of 8 to 16 mg/kg. These values were unknown product with HF. The second hydrofluoric acid (‘‘HF’’). However, statistically determined and are not case involved a 2-year-old child who other water soluble fluoride-containing identical to the actual lowest toxic or ingested a toilet bowl stain remover that compounds can cause fluoride lethal levels of fluoride. The lowest contained 15.9 percent ammonium poisoning. The fluoride ion is documented lethal dose for fluoride is bifluoride. The most recent case was an systemically absorbed almost 16 mg/kg in a 3-year-old child. There 18-month-old child who ingested an immediately. It is highly penetrating were complicating factors in this death. unknown amount of air conditioner coil and reactive and can cause both The child may have taken other cleaner with 8 percent HF and 8 percent systemic poisoning and tissue medications and he suffered from phosphoric acid.[2] destruction. Fluoride ions, once Crohn’s disease (an inflammatory Since 1995, there were six reports of separated from either HF or fluoride disorder of the GI tract) that may have fluoride poisoning in children under 5 salts, penetrate deep into tissues, contributed to his death.[2] years of age from a wheel cleaning causing burning at sites deeper than the C. Injury Data product. The product contains original exposure site. The process of ammonium bifluoride and ammonium tissue destruction can continue for Medical Literature. There are many fluoride salts, reportedly containing at days.[2] reports in the medical literature of least 15 percent fluoride. Before Fluoride absorption can produce deaths and injuries involving fluoride- December, 1996, it was marketed for hyperkalemia (elevated serum containing products. A retrospective household use in non-CR packaging. potassium), hypocalcemia (lowered study conducted by the American Since that date it has been packaged in serum calcium), hypomagnesemia Association of Poison Control Centers CR packaging, and in September 1997 it (lowered serum magnesium), and (‘‘AAPCC’’) of hydrofluoric acid burns was recalled by the manufacturer.[2] metabolic and respiratory acidosis. from rust stain removers applied to Three deaths from fluoride-containing These disturbances can then bring on clothing found 619 such cases in 1990. products were documented in 1997 after cardiac arrhythmia, respiratory Five of these required hospitalization.[2] the staff had completed the briefing stimulation followed by respiratory Other reports gathered from the medical package for the proposed rule. Two depression, muscle spasms, literature are discussed in the notice of involved children under 5 years old. In convulsions, central nervous system proposed rulemaking and the one case, a 3-year-old female died from (‘‘CNS’’) depression, possible accompanying briefing package. 62 FR cardiac arrest after ingesting the recalled respiratory paralysis or cardiac failure, 61928. wheel cleaner described above. The and death. Fluoride may also inhibit CPSC Databases. CPSC has several second death involved a 19-month-old cellular respiration and glycolysis, alter databases for poison incidents. The staff female who ingested a rust remover membrane permeability and excitability, reviewed cases from 1988 to May 1997 with hydrofluoric acid and ammonium and cause neurotoxic and adverse GI in the National Electronic Injury bifluoride. Finally, a 38-year-old male effects.[2] Surveillance System (‘‘NEISS’’), the died from cardiac arrest after When exposure is through inhalation, Injury or Potential Injury Incident files, unintentional ingestion of a rust fluorides can cause severe chemical Death Certificate (‘‘DCRT’’) database, remover with ammonium bifluoride.[6] burns to the respiratory system. and In-Depth-Investigation (‘‘INDP’’) AAPCC Data. The staff reviewed Inhalation can result in difficulty files. AAPCC ingestion data involving breathing (dyspnea), bronchospasms, From 1988 to 1996, NEISS had reports children under 5 years old and products chemical pneumonitis, pulmonary of 31 incidents involving products known to, or that may, contain fluoride. edema, airway obstruction, and documented to contain fluoride. Two of (The actual number of fluoride tracheobronchitis. The severity of burns these were accidental ingestions by exposures cannot be determined from dermal absorption can vary children under 5 years old. Most other because some products that contain depending on the concentration of injuries involved chemical burns of the fluoride are not identified as such and fluoride available, duration of the hands.[2] In addition, 1997 NEISS therefore may be coded to generic exposure, the surface area exposed, and reports show six adults experienced categories such as acidic cleaning the penetrability of the exposed tissue. burns while using fluoride-containing products or other unknown cleaning Ocular exposure can result in serious products. In 1997, NEISS had reports of products.) From 1993 to 1995, there eye injury.[2] an additional five cases involving were no reported fatalities in this age Ingestion of fluoride can result in children under 5 years old ingesting group. Out of a total of 499 exposures mild to severe GI symptoms. Reports products containing fluoride. For 1997, to products known to contain HF, there suggest that ingesting 3 to 5 milligrams NEISS also reported an additional three were 2 major 3 outcomes and 24 of fluoride per kilogram of body weight cases of children under 5 years old moderate 4 outcomes. The AAPCC data (mg/kg) causes vomiting, diarrhea, and involving products that might have abdominal pain. Ingestion of more than contained fluoride.[7] 3 Major outcome—The patient exhibited signs or 5 mg/kg may produce systemic toxicity. The INDP files contain numerous symptoms which were life-threatening or resulted A retrospective poison control center injury reports. For example, a 50-year- in significant residual disability or disfigurement. study of fluoride ingestions reported old woman was using a water stain 4 Moderate outcome—The patient exhibited signs that symptoms, primarily safely remover with 6 percent HF when it and symptoms that were more pronounced, more prolonged, or more of a systemic nature. Usually tolerated GI symptoms that tended to leaked through her rubber gloves and to some form of treatment was required. Symptoms resolve within 24 hours, developed her skin. She developed intense pain 4 were not life-threatening and the patient had no following ingestions of 4 to 8.4 mg/kg of hours later when the fluoride ion residual disability or disfigurement. Federal Register / Vol. 63, No. 105 / Tuesday, June 2, 1998 / Rules and Regulations 29951 also show 23 major outcomes and 188 one source cites a minimum lethal dose F. Statutory Considerations moderate outcomes for other acid in humans of 71 mg/kg and another 1. Hazard to Children household products. Some of these may specifies a lethal oral dose in the range have contained fluoride. The frequency of 70 to 140 mg/kg. The staff considers As noted above, the toxicity data of injury for dental treatments was these values too high based on concerning children’s ingestion of much lower than that for household documented cases of fluoride toxicity. fluoride demonstrate that fluoride can products containing HF. Of There is one documented death from cause serious illness and injury to approximately 23,000 exposures to such ingestion of 16 mg/kg fluoride, but as children. Moreover, it is available to dental products, there were 34 moderate discussed above, other medical factors children in common household outcomes, and the only documented may have contributed to that death. products. Although some products major outcome was a miscoded incident Most evidence suggests that the lower currently use CR packaging, others do where the child experienced an allergic limit of the calculated CLD of 32 mg/kg not. The Commission concludes that a reaction to the product rather than is a reasonable estimate for a minimum regulation is needed to ensure that systemic toxicity from an overdose.[2] lethal dose.[2] products subject to the regulation will The 1996 AAPCC data report 136 Similarly, there is no established toxic be placed in CR packaging by any exposures to products known to contain dose for fluoride. Generally, greater than current as well as future HF involving children under 5 years 6 percent HF can cause dermal burns manufacturers.[1,2&5] old. Four of these resulted in moderate and more than 0.5 percent can lead to The same hazard posed to children by outcomes. There were no major serious eye injury. Several reports toxic amounts of fluoride in household outcomes or deaths reported with this suggest ingestion of 3 to 5 mg/kg products also exists from such levels of age group in 1996.[7] produces symptoms and that more than fluoride in oral prescription drugs. The staff also compiled data from 5 mg/kg (50 mg in a 10 kg child) can Therefore, the Commission is modifying AAPCC annual reports for all ages and produce systemic toxicity. Additionally, the existing exemption for such drugs all routes of exposure for the years 1985 some medical professionals advise with sodium fluoride to reflect current to 1995. During this time period, there medical observation following toxicity data and be consistent with the were about 25,000 exposures to ingestions of more than 5 to 8 mg/kg. level for fluoride-containing household products containing HF. Of these, 2,881 Based on this information, the products.[1&2] resulted in moderate outcomes and 275 Commission determined a level for Pursuant to section 3(a) of the PPPA, in major outcomes. There were also regulation that would include all 15 U.S.C. 1472(a), the Commission finds injuries from dental products, fluoride household products with more than 50 that the degree and nature of the hazard mineral/electrolyte products, and mg of elemental fluoride and more than to children from handling or ingesting vitamins with fluoride. A total of 18 0.5 percent elemental fluoride on a w/ fluoride is such that special packaging deaths were reported in the HF category. v basis for liquids or a w/w basis for is required to protect children from Two deaths involved children under 5 non-liquids. There is no evidence that serious illness. The Commission bases years old. One ingested an ammonium 50 mg or less of elemental fluoride or this finding on the toxic nature of these bifluoride toilet stain remover concentrations less than 0.5 percent products, described above, and their (described above) and the other child cause serious systemic toxicity or accessibility to children in the home. died after ingesting a toilet cleaner with serious burns.[1,2&5] 2. Technical Feasibility, Practicability, HF. Generally, these AAPCC data E. Level of Regulation for Oral and Appropriateness suggest that household products with Prescription Drugs Containing Sodium HF pose a more serious risk of injury In issuing a standard for special Fluoride than other classes of fluoride products. packaging under the PPPA, the Moderate to serious outcomes Based on the toxicity information Commission is required to find that the developed in 12.8 percent of the discussed above, the Commission special packaging is ‘‘technically exposures to HF compared to only 0.4 believes that the current exemption for feasible, practicable, and appropriate.’’ percent of the exposures to anticaries oral prescription drugs with no more 15 U.S.C. 1472(a)(2). Technical products.[2] than 264 mg of sodium fluoride should feasibility may be found when The 1996 AAPCC data for all ages and be modified. To be consistent with the technology exists or can be readily all routes of exposure show that for level for household products containing developed and implemented to produce 1996 there were about 2944 exposures fluoride, the Commission is revising the packaging that conforms to the to products containing HF. Of these, 742 level for the oral prescription drug standards. Practicability means that resulted in moderate outcomes and 27 exemption to exempt products that have special packaging complying with the in major outcomes. Four deaths were either no more than the equivalent of 50 standards can utilize modern mass reported involving HF.[7] mg of elemental fluoride (110 mg production and assembly line sodium fluoride) per package or no techniques. Packaging is appropriate D. Level of Regulation for Household more than a concentration of 0.5 percent when complying packaging will Products Containing Fluoride elemental fluoride on a w/v basis for adequately protect the integrity of the The Commission is issuing a rule that liquids or a w/w basis for non- substance and not interfere with its requires special packaging for liquids.[1,2&5] intended storage or use.[4,9] household products containing more The Commission does not believe that Some OTC fluoride-containing than the equivalent of 50 mg of changing the level of exemption for household products are packaged in elemental fluoride and more than the prescription drugs containing sodium containers with non-CR continuous equivalent of 0.5 percent elemental fluoride will impact any of the currently threaded closures. The Commission also fluoride on a w/v basis for liquids or a exempted dental products with more is aware of such products packaged in w/w basis for non-liquids.[1,2&5] This than 50 mg of fluoride because these aerosols and mechanical pumps. is the same level as the Commission products have 0.5 percent or less Various types and designs of senior proposed. fluoride.[1] In its comment, the friendly CR packaging can be readily There is no well defined lethal dose American Dental Association confirmed obtained that would be suitable for for fluoride. In the medical literature, this.[5] fluoride-containing products.[3&4] 29952 Federal Register / Vol. 63, No. 105 / Tuesday, June 2, 1998 / Rules and Regulations

Two manufacturers currently use comments on this issue. If companies do I. Environmental Considerations senior-friendly continuous threaded CR find that they need more time, they can Also in connection with the proposed packaging for their fluoride-containing request a stay of enforcement for the rule and pursuant to the National household products. Another minimum period needed to obtain Environmental Policy Act, the Council manufacturer uses a senior-friendly adequate supplies of senior-friendly CR on Environmental Quality regulations trigger mechanical pump mechanism for packaging. and CPSC procedures for environmental its product. This shows that these types A final rule would apply to products review, the Commission assessed the of CR packages are technically feasible, that are packaged on or after the possible environmental effects practicable and appropriate for fluoride- effective date. associated with the proposed PPPA containing products. The Commission requirements for fluoride-containing knows of at least one fluoride product H. Regulatory Flexibility Act Certification products.[3] The Commission that uses a non-CR aerosol package. The concluded that the proposed rule would manufacturer of another regulated When an agency undertakes a have no adverse effect on the product is currently using a senior- rulemaking proceeding, the Regulatory environment, and neither an friendly CR aerosol overcap. Thus, this Flexibility Act, 5 U.S.C. 601 et seq., environmental assessment nor an kind of CR packaging could be used for generally requires the agency to prepare environmental impact statement would fluoride-containing products. Finally, proposed and final regulatory flexibility be required. No additional information various designs of senior-friendly snap analyses describing the impact of the alters this conclusion.[8] type reclosable CR packaging that would rule on small businesses and other small be appropriate for non-liquid fluoride- entities. Section 605 of the Act provides J. Executive Orders containing products are available. Thus, that an agency is not required to prepare According to Executive Order 12988 appropriate senior-friendly CR a regulatory flexibility analysis if the (February 5, 1996), agencies must state packaging is available for products head of an agency certifies that the rule in clear language the preemptive effect, marketed in continuous threaded, snap, will not have a significant economic if any, of new regulations. aerosols, and trigger spray packaging.[4] impact on a substantial number of small The PPPA provides that, generally, Therefore, the Commission concludes entities. when a special packaging standard that CR packaging for fluoride- In connection with the proposed rule, issued under the PPPA is in effect, ‘‘no containing products is technically the Commission’s Directorate for State or political subdivision thereof feasible, practicable, and appropriate. Economic Analysis prepared a shall have any authority either to 3. Other Considerations preliminary assessment of the impact of establish or continue in effect, with a rule to require special packaging for respect to such household substance, In establishing a special packaging household products containing fluoride any standard for special packaging (and standard under the PPPA, the with more than 50 mg elemental any exemption therefrom and Commission must consider the fluoride and more than 0.5 percent requirement related thereto) which is following: elemental fluoride (w/v or w/w). The not identical to the [PPPA] standard.’’ a. The reasonableness of the standard; staff also considered the impact of a rule 15 U.S.C. 1476(a). A State or local b. Available scientific, medical, and modifying the current exemption for engineering data concerning special standard may be excepted from this oral prescription drugs containing preemptive effect if (1) the State or local packaging and concerning childhood sodium fluoride so that it would be accidental ingestions, illness, and injury standard provides a higher degree of consistent with the level proposed for protection from the risk of injury or caused by household substances; household products.[3] c. The manufacturing practices of illness than the PPPA standard; and (2) industries affected by the PPPA; and Based on this assessment, the the State or political subdivision applies d. The nature and use of the Commission concluded that the to the Commission for an exemption household substance. 15 U.S.C. 1472(b). proposed requirement for fluoride- from the PPPA’s preemption clause and The Commission has considered these containing household products would the Commission grants the exemption factors with respect to the various not have a significant impact on a through a process specified at 16 CFR determinations made in this notice, and substantial number of small businesses part 1061. 15 U.S.C. 1476(c)(1). In finds no reason to conclude that the rule or other small entities. Despite making addition, the Federal government, or a is unreasonable or otherwise a specific request in the NPR, the State or local government, may establish inappropriate. Commission received no comments and continue in effect a non-identical concerning the potential impact on special packaging requirement that G. Effective Date small businesses, and the Commission provides a higher degree of protection The PPPA provides that no regulation is unaware of any information that than the PPPA requirement for a shall take effect sooner than 180 days or would alter its conclusion that the rule household substance for the Federal, later than one year from the date such will not have a significant impact on a State or local government’s own use. 15 final regulation is issued, except that, substantial number of small entities.[8] U.S.C. 1476(b). for good cause, the Commission may The Commission reached the same Thus, with the exceptions noted establish an earlier effective date if it conclusion concerning the proposed above, the rule requiring CR packaging determines an earlier date to be in the modification in the level for exemption for household products containing public interest. 15 U.S.C. 1471n. of oral prescription drugs containing fluoride above the regulated level and Senior-friendly special packaging is sodium fluoride.[3] No additional modifying the exemption level for oral currently commercially available for information was provided to alter the prescription drugs with sodium fluoride most types of CR packaging.[9] Commission’s conclusion that the would preempt non-identical state or Therefore, the Commission believes that modification to the exemption for oral local special packaging standards for an effective date of 9 months after prescription drugs containing sodium such fluoride containing products. publication of the final rule is fluoride would not have a significant In accordance with Executive Order reasonable. The Commission proposed a impact on a substantial number of small 12612 (October 26, 1987), the 9 month effective date and received no businesses or other small entities.[8] Commission certifies that the rule does Federal Register / Vol. 63, No. 105 / Tuesday, June 2, 1998 / Rules and Regulations 29953 not have sufficient implications for 50 milligrams of elemental fluoride per DEPARTMENT OF THE TREASURY federalism to warrant a Federalism package and more than the equivalent of Assessment. 0.5 percent elemental fluoride on a Customs Service weight-to-volume basis for liquids or a List of Subjects in 16 CFR Part 1700 19 CFR Part 10 weight-to-weight basis for non-liquids Consumer protection, Drugs, Infants shall be packaged in accordance with [T. D. 98±52] and children, Packaging and containers, the provisions of § 1700.15(a), (b) and RIN 1515±AC18 Poison prevention, Toxic substances. (c). For the reasons given above, the Procedural Change Regarding Commission amends 16 CFR part 1700 * * * * * American Shooks and Staves as follows: Dated: May 27, 1998. Sadye E. Dunn, AGENCY: Customs Service, Department PART 1700Ð[AMENDED] Secretary, Consumer Product Safety of the Treasury. 1. The authority citation for part 1700 Commission. ACTION: Final rule. continues to read as follows: List of Relevant Documents SUMMARY: This document amends the Authority: Secs 1700.1 and 1700.14 also 1. Briefing memorandum from Jacqueline Customs Regulations by requiring the issued under Pub. L. 92–573, sec. 30(a), 88 Ferrante, Ph.D., EH, to the Commission, submission of a Customs Form (CF) Stat. 1231. 15 U.S.C. 2079(a). ‘‘Proposed Rule to Require Child-Resistant 4455, Certificate of Registration, rather 2. Section 1700.14 is amended to Packaging for Household Products with than a CF 3311, Declaration for Free revise paragraph (a)(10)(vii) and to add Fluoride,’’ September 30, 1997. Entry of Returned American Products, paragraph (a)(27) to read as follows (the 2. Memorandum from Susan C. Aitken, when shooks and staves produced in the introductory text of paragraphs (a) and Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, United States are exported from the (10) are republished without change for ‘‘Toxicity of Household Products Containing United States with the intention that context): Fluoride,’’ August 4, 1997. they will be returned to the United 3. Memorandum from Marcia P. Robins, States, exempt from duty, in the form of § 1700.14 Substances requiring special EC, to Jacqueline Ferrante, Ph.D., EH, complete boxes or barrels in use as packaging. ‘‘Market Data, Economic Considerations and usual containers of merchandise. When (a) Substances. The Commission has Environmental Effects of a Proposal to boxes or barrels made from the exported determined that the degree or nature of Require Child-Resistant Packaging for American shooks and staves, for which the hazard to children in the availability Household Products Containing Fluoride,’’ a CF 4455 has been submitted, are of the following substances, by reason of June 20, 1997. imported, the importer of the boxes or their packaging, is such that special 4. Memorandum from Charles Wilbur, EH, barrels must use the CF 4455 as well to packaging meeting the requirements of to Jacqueline Ferrante, Ph.D., EH, ‘‘Technical make such a claim. Shooks and staves § 1700.20(a) is required to protect Feasibility, Practicability, and produced in the United States that are children from serious personal injury or Appropriateness Determination for the exported and so returned are exempt serious illness resulting from handling, Proposed Rule to Require Child-Resistant from customs duties provided their using, or ingesting such substances, and Packaging for OTC Products Containing identity is established by the proper the special packaging herein required is Fluoride,’’ June 27, 1997. submission of the CF 4455. The technically feasible, practicable, and 5. Briefing memorandum from Jacqueline amendment helps to clarify the appropriate for these substances: Ferrante, Ph.D., EH, to the Commission, procedures regarding the free entry of * * * * * ‘‘Final Rule to Require Child-Resistant such American produced shooks and (10) Prescription drugs. Any drug for Packaging for Household Products with staves returned to the United States. Fluoride,’’ May 6, 1998. human use that is in a dosage form EFFECTIVE DATE: July 2, 1998. 6. Memorandum from Susan C. Aitken, intended for oral administration and FOR FURTHER INFORMATION CONTACT: that is required by Federal law to be Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, ‘‘Update on Injuries Due to Products Thomas Wygant, Office of Field dispensed only by or upon an oral or Operations, 202–927–1167. written prescription or a practitioner Containing Fluoride,’’ October 9, 1997. SUPPLEMENTARY INFORMATION: licensed by law to administer such drug 7. Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH, shall be packaged in accordance with Background ‘‘Injuries Due to Products Containing the provisions of § 1700.15(a), (b), and Fluoride,’’ April 20, 1998. Section 10.5, Customs Regulations (19 (c), except for the following: 8. Memorandum from Marcia P. Robins, CFR 10.5) provides that shooks and * * * * * EC, to Jacqueline Ferrante, Ph.D., EH, ‘‘Final staves produced in the United States (vii) Sodium fluoride drug Rule: Child-Resistant Packaging for and returned in the form of complete preparations including liquid and tablet Household Products Containing Fluorides,’’ boxes or barrels in use as the usual forms, containing not more than 110 April 8, 1998. containers of merchandise are exempt milligrams of sodium fluoride (the 9. Memorandum from Charles Wilbur, EH, from any duties imposed by the tariff equivalent of 50 mg of elemental to Jacqueline Ferrante, Ph.D., EH, ‘‘Technical laws upon similar containers made of fluoride) per package or not more than Feasibility, Practicability, and foreign shooks or staves, provided their a concentration of 0.5 percent elemental Appropriateness Determination for the Final identity is established under the fluoride on a weight-to-volume basis for Rule to Require Special Packaging for regulations. liquids or a weight-to-weight basis for Products Containing Fluoride,’’ March 10, Paragraph (d) of § 10.5 provides that non-liquids and containing no other 1998. an exporter of shooks or staves in substances subject to this [FR Doc. 98–14449 Filed 6–1–98; 8:45 am] respect of which free entry is to be § 1700.14(a)(10). claimed when returned as boxes or BILLING CODE 6355±01±P * * * * * barrels shall file a notice of intent to (27) Fluoride. Household substances export on a Customs Form (CF) 3311 in containing more than the equivalent of triplicate with the director of the port of