[Federal Register Volume 63, Number 105 (Tuesday, June 2, 1998)]
[Rules and Regulations]
[Pages 29949-29953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14449]



[[Page 29949]]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Final 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

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: The Commission is issuing a rule to require child-resistant 
(``CR'') packaging for household products containing more than the 
equivalent of 50 mg of elemental fluoride and more than the equivalent 
of 0.5 percent elemental fluoride (on a weight-to-volume (``w/v'') or 
weight-to-weight (``w/w'') basis). For consistency, 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 March 2, 1999, 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 (``HF''), ammonium 
bifluoride, ammonium fluoride, potassium bifluoride, sodium bifluoride, 
sodium fluoride and sodium fluosilicate.<SUP>1</SUP>[1&3] <SUP>2</SUP>
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    \1\ The percentage of elemental fluoride in any compound is 
determined by dividing the molecular weight of fluoride 
(<difference>619 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.
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    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.[2]

2. Relevant Statutory and Regulatory Provisions

    The Poison Prevention Packaging Act of 1970 (``PPPA''), 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 ``normal 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 U.S.C. 1471(2)(B). The 
Commission has performance requirements for special packaging. 16 CFR 
1700.15, 1700.20.
    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.'' 15 
U.S.C. 1473(a), 16 CFR 1700.5.

3. Existing PPPA Requirements for Fluoride-Containing 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. 16 CFR 1700.14(10)(vii). 
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.

4. 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

[[Page 29950]]

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 (``HF''). However, other water soluble 
fluoride-containing compounds can cause fluoride poisoning. The 
fluoride ion is systemically absorbed almost immediately. It is highly 
penetrating and reactive and can cause both systemic poisoning and 
tissue destruction. Fluoride ions, once separated from either HF or 
fluoride salts, penetrate deep into tissues, causing burning at sites 
deeper than the original exposure site. The process of tissue 
destruction can continue for days.[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 arrhythmia, respiratory 
stimulation followed by respiratory depression, muscle spasms, 
convulsions, central nervous system (``CNS'') depression, possible 
respiratory paralysis or cardiac failure, and death. Fluoride may also 
inhibit cellular respiration and glycolysis, alter membrane 
permeability and excitability, and cause neurotoxic and adverse GI 
effects.[2]
    When exposure is through inhalation, fluorides can cause severe 
chemical burns to the respiratory system. Inhalation can result in 
difficulty breathing (dyspnea), bronchospasms, chemical pneumonitis, 
pulmonary edema, airway obstruction, and tracheobronchitis. The 
severity of burns from dermal absorption can vary depending on the 
concentration of fluoride available, duration of the exposure, the 
surface area exposed, and the penetrability of the exposed tissue. 
Ocular exposure can result in serious eye injury.[2]
    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. Ingestion of more than 5 mg/kg may produce systemic 
toxicity. 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 (``CLD'') 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 fluoride is 
16 mg/kg in a 3-year-old child. There were 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 (``AAPCC'') 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 Databases. CPSC has several databases for poison incidents. 
The staff reviewed cases from 1988 to May 1997 in the National 
Electronic Injury Surveillance System (``NEISS''), the Injury or 
Potential Injury Incident files, Death Certificate (``DCRT'') database, 
and In-Depth-Investigation (``INDP'') files.
    From 1988 to 1996, NEISS had reports of 31 incidents involving 
products documented to contain fluoride. Two of these were accidental 
ingestions by children under 5 years old. Most other injuries involved 
chemical burns of the hands.[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]
    The INDP files contain numerous injury reports. For example, a 50-
year-old woman was using a water stain remover with 6 percent HF when 
it leaked through her rubber gloves and to her skin. She developed 
intense pain 4 hours later when the fluoride ion penetrated through to 
the bones of her forearm. Four months after the incident she had only 
partial use of her arm and hand. Three reports in the INDP files 
involve children under 5 years old who died after ingesting fluoride-
containing products. A 3-year old child ingested an unknown product 
with HF. The second case involved a 2-year-old child who ingested a 
toilet bowl stain remover that contained 15.9 percent ammonium 
bifluoride. The most recent case was an 18-month-old child who ingested 
an unknown amount of air conditioner coil cleaner with 8 percent HF and 
8 percent phosphoric acid.[2]
    Since 1995, there were six reports of fluoride poisoning in 
children under 5 years of age from a wheel cleaning product. The 
product contains ammonium bifluoride and ammonium fluoride salts, 
reportedly containing at least 15 percent fluoride. Before December, 
1996, it was marketed for household use in non-CR packaging. Since that 
date it has been packaged in CR packaging, and in September 1997 it was 
recalled by the manufacturer.[2]
    Three deaths from fluoride-containing products were documented in 
1997 after the staff had completed the briefing package for the 
proposed rule. Two involved children under 5 years old. In one case, a 
3-year-old female died from cardiac arrest after ingesting the recalled 
wheel cleaner described above. The second death involved a 19-month-old 
female who ingested a rust remover with hydrofluoric acid and ammonium 
bifluoride. Finally, a 38-year-old male died from cardiac arrest after 
unintentional ingestion of a rust remover with ammonium bifluoride.[6]
    AAPCC Data. The staff reviewed AAPCC ingestion data involving 
children under 5 years old and products known to, or that may, contain 
fluoride. (The actual number of fluoride exposures cannot be determined 
because some products that contain fluoride are not identified as such 
and therefore may be coded to generic categories such as acidic 
cleaning products or other unknown cleaning products.) From 1993 to 
1995, there were no reported fatalities in this age group. Out of a 
total of 499 exposures to products known to contain HF, there were 2 
major \3\ outcomes and 24 moderate \4\ outcomes. The AAPCC data

[[Page 29951]]

also show 23 major outcomes and 188 moderate outcomes for other acid 
household products. Some of these may have contained fluoride. The 
frequency of injury for dental treatments was much lower than that for 
household products containing HF. Of approximately 23,000 exposures to 
such dental products, there were 34 moderate outcomes, and the only 
documented major outcome was a miscoded incident where the child 
experienced an allergic reaction to the product rather than systemic 
toxicity from an overdose.[2]
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    \3\ Major outcome--The patient exhibited signs or symptoms which 
were life-threatening or resulted in significant residual disability 
or disfigurement.
    \4\ Moderate outcome--The patient exhibited signs and symptoms 
that were more pronounced, more prolonged, or more of a systemic 
nature. Usually some form of treatment was required. Symptoms were 
not life-threatening and the patient had no residual disability or 
disfigurement.
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    The 1996 AAPCC data report 136 exposures to products known to 
contain HF involving children under 5 years old. Four of these resulted 
in moderate outcomes. 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 outcomes and 275 in major outcomes. 
There were also injuries from dental products, fluoride mineral/
electrolyte products, and vitamins with fluoride. A total of 18 deaths 
were reported in the HF category. Two deaths involved children under 5 
years old. One ingested an ammonium bifluoride toilet stain remover 
(described above) and the other child died after ingesting a toilet 
cleaner with HF. Generally, these AAPCC data suggest that household 
products with HF pose a more serious risk of injury than other classes 
of fluoride products. Moderate to serious outcomes developed in 12.8 
percent of the exposures to HF compared to only 0.4 percent of the 
exposures to anticaries products.[2]
    The 1996 AAPCC data for all ages and all routes of exposure show 
that for 1996 there were about 2944 exposures to products containing 
HF. Of these, 742 resulted in moderate outcomes and 27 in major 
outcomes. Four deaths were reported involving HF.[7]

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.[1,2&5] This is the same level as the Commission proposed.
    There is no well defined lethal dose for fluoride. In the 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 too high based on documented 
cases of fluoride toxicity. There 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 8 mg/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.[1,2&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.[1] 
In its comment, the American Dental Association confirmed this.[5]

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 children in common 
household products. Although some products currently use CR packaging, 
others do not. The Commission concludes that a regulation is needed to 
ensure that products subject to the regulation will be placed in CR 
packaging by any current as well as future manufacturers.[1,2&5]
    The same hazard posed to children by toxic amounts of fluoride in 
household products also exists from such levels of fluoride in oral 
prescription drugs. Therefore, the Commission is modifying the existing 
exemption for such drugs with sodium fluoride to reflect current 
toxicity data and be consistent with the level for fluoride-containing 
household products.[1&2]
    Pursuant to section 3(a) of the PPPA, 15 U.S.C. 1472(a), the 
Commission finds that the degree and nature of the hazard to children 
from handling or ingesting fluoride is such that special packaging is 
required to protect children from serious illness. The Commission bases 
this finding on the toxic nature of these products, described above, 
and their accessibility to children in the home.

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 
``technically feasible, practicable, and appropriate.'' 15 U.S.C. 
1472(a)(2). Technical feasibility may be found when technology exists 
or can be readily developed and implemented to produce packaging that 
conforms to the standards. 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]

[[Page 29952]]

    Two manufacturers currently use senior-friendly continuous threaded 
CR packaging for their fluoride-containing household products. Another 
manufacturer uses a senior-friendly trigger mechanical pump mechanism 
for its product. This shows that these types of CR packages are 
technically feasible, practicable and appropriate for fluoride-
containing products. The Commission knows of at least one fluoride 
product that uses a non-CR aerosol package. The manufacturer of another 
regulated product is currently using a senior-friendly CR aerosol 
overcap. Thus, this kind of CR packaging could be used for fluoride-
containing products. Finally, various designs of senior-friendly snap 
type reclosable CR packaging that would be appropriate for non-liquid 
fluoride-containing products are available. Thus, appropriate senior-
friendly CR packaging is available for products marketed in continuous 
threaded, snap, aerosols, and trigger spray packaging.[4] Therefore, 
the Commission concludes that CR packaging for fluoride-containing 
products is technically feasible, practicable, and appropriate.

3. 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;
    c. The manufacturing practices of industries affected by the PPPA; 
and
    d. The nature and use of the household substance. 15 U.S.C. 
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. 15 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 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 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 small 
businesses or other small entities. Despite making a specific request 
in the NPR, the Commission received no comments concerning the 
potential impact on small businesses, and the Commission is unaware of 
any information that would alter its conclusion that the rule will not 
have a significant impact on a substantial number of small entities.[8]
    The Commission reached the same conclusion concerning the proposed 
modification in the level for exemption of oral prescription drugs 
containing sodium fluoride.[3] No additional information was provided 
to alter the Commission's conclusion that the 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.[8]

I. Environmental Considerations

    Also in connection with the proposed rule and pursuant to the 
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] 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. No additional 
information alters this conclusion.[8]

J. Executive Orders

    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, generally, when a special packaging 
standard issued under the PPPA is in effect, ``no State or political 
subdivision thereof shall have any authority either to establish or 
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 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)(1). In 
addition, the Federal government, 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 CR 
packaging for household products containing fluoride above the 
regulated level and modifying the exemption level for oral prescription 
drugs with sodium fluoride would preempt non-identical state or local 
special packaging standards for such fluoride containing products.
    In accordance with Executive Order 12612 (October 26, 1987), the 
Commission certifies that the rule does

[[Page 29953]]

not have sufficient implications for federalism to warrant a Federalism 
Assessment.

List of Subjects in 16 CFR Part 1700

    Consumer protection, Drugs, Infants and children, Packaging and 
containers, Poison prevention, Toxic substances.

    For the reasons given above, the Commission amends 16 CFR part 1700 
as follows:

PART 1700--[AMENDED]

    1. The authority citation for part 1700 continues to read as 
follows:

    Authority: Secs 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 (the introductory text of 
paragraphs (a) and (10) are republished without change for context):


Sec. 1700.14  Substances requiring special packaging.

    (a) Substances. The Commission has determined that the degree or 
nature of the hazard to children in the availability of the following 
substances, by reason of their packaging, is such that special 
packaging meeting the requirements of Sec. 1700.20(a) is required to 
protect children from serious personal injury or serious illness 
resulting from handling, using, or ingesting such substances, and the 
special packaging herein required is technically feasible, practicable, 
and appropriate for these substances:
* * * * *
    (10) Prescription drugs. Any drug for human use that is in a dosage 
form intended for oral administration and that is required by Federal 
law to be dispensed only by or upon an oral or written prescription or 
a practitioner licensed by law to administer such drug shall be 
packaged in accordance with the provisions of Sec. 1700.15(a), (b), and 
(c), except for the following:
* * * * *
    (vii) Sodium fluoride drug preparations including liquid and tablet 
forms, containing not more than 110 milligrams of sodium fluoride (the 
equivalent of 50 mg of elemental fluoride) per package or not more than 
a concentration of 0.5 percent elemental fluoride on a weight-to-volume 
basis for liquids or a weight-to-weight basis for non-liquids and 
containing no other substances subject to this Sec. 1700.14(a)(10).
* * * * *
    (27) Fluoride. Household substances containing more than the 
equivalent of 50 milligrams of elemental fluoride per package and more 
than the equivalent of 0.5 percent elemental fluoride on a weight-to-
volume basis for liquids or a weight-to-weight basis for non-liquids 
shall be packaged in accordance with the provisions of Sec. 1700.15(a), 
(b) and (c).

* * * * *
    Dated: May 27, 1998.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.

List of Relevant Documents

    1. Briefing memorandum from Jacqueline Ferrante, Ph.D., EH, to 
the Commission, ``Proposed Rule to Require Child-Resistant Packaging 
for Household Products with Fluoride,'' September 30, 1997.
    2. Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline 
Ferrante, Ph.D., EH, ``Toxicity of Household Products Containing 
Fluoride,'' August 4, 1997.
    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,'' 
June 27, 1997.
    5. Briefing memorandum from Jacqueline Ferrante, Ph.D., EH, to 
the Commission, ``Final Rule to Require Child-Resistant Packaging 
for Household Products with Fluoride,'' May 6, 1998.
    6. 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.
    7. Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline 
Ferrante, Ph.D., EH, ``Injuries Due to Products Containing 
Fluoride,'' April 20, 1998.
    8. 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 Wilbur, EH, to Jacqueline Ferrante, 
Ph.D., EH, ``Technical Feasibility, Practicability, and 
Appropriateness Determination for the Final Rule to Require Special 
Packaging for Products Containing Fluoride,'' March 10, 1998.

[FR Doc. 98-14449 Filed 6-1-98; 8:45 am]
BILLING CODE 6355-01-P