[Federal Register Volume 62, Number 224 (Thursday, November 20, 1997)]
[Proposed Rules]
[Pages 61928-61933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30555]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


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: Proposed rule.

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SUMMARY: The Commission is proposing 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). Examples of such products are some 
rust removers, toilet cleaners, metal cleaners and etching products. 
Dental products, such as toothpaste, contain lower levels of fluoride 
and would not be affected. For consistency, the Commission is also 
proposing to modify the oral prescription drug exemption for sodium 
fluoride preparations. Instead of allowing drugs with no more than 264 
mg of sodium fluoride per package to be in non-CR packaging as the 
current rule does, the Commission 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 Commission 
has preliminarily determined 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: Comments on the proposal should be submitted no later than 
February 3, 1998.

ADDRESSES: Comments should be mailed to the Office of the Secretary, 
Consumer Product Safety Commission, Washington, D.C. 20207, or 
delivered to the Office of the Secretary, Consumer Product Safety 
Commission, Room 502, 4330 East-West Highway, Bethesda, Maryland 20814-
4408, telephone (301)504-0800. Comments may also be filed by 
telefacsimile to (301) 504-0127 or by email to <a href="/cdn-cgi/l/email-protection#e182919282cc8e92a182919282cf868e97"><span class="__cf_email__" data-cfemail="7516050616581a0635160506165b121a03">[email protected]</span></a>.

FOR FURTHER INFORMATION CONTACT: Jacqueline Ferrante, Ph.D., Division 
of Health Sciences, Directorate for Epidemiology and Health Sciences, 
Consumer Product Safety Commission, Washington, D.C. 20207; telephone 
(301)504-0477 ext. 1199.

SUPPLEMENTARY INFORMATION:

A. Background

1. Household Products Containing Fluoride

    Many types of household products may contain fluoride in one form 
or another. Fluorides are ingredients in cleaning products 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> [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> 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.
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    Many dental products also contain fluorides, but at lower levels.

[[Page 61929]]

Prescription dental products are available with fluoride contents of 
0.125-0.5 mg/ml for drops, 0.5-1 mg per tablet, 1 mg per lozenge, 0.1-
0.9 mg/g for topical rinses (0.01-0.09 percent and 5 mg/g (0.5 percent) 
for topical gels. Prescription vitamin preparations are also available 
containing 0.25 to 1 mg elemental fluoride per ml. The highest 
concentration of elemental fluoride in any such dental product 
available over-the-counter (``OTC'') is 0.15 percent for pastes and 
powders and 0.5 percent for liquids or gels. In contrast, some 
household products, particularly metal cleaners 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 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 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). 
In 1977, the Commission first exempted aqueous solutions of sodium 
fluoride at that level. In 1980, in 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 Commission 
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 recommendation by the American Dental Association that no 
more than 264 mg of sodium fluoride should be dispensed at one time. 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 (<difference> 11.4 kg) child was in the range of 50 to 250 mg/kg 
(equivalent to <difference> 23 to 113 mg/kg of elemental fluoride) (42 
FR 62363). As discussed below, the Commission is proposing a new level 
that is 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 rinses and gels sold OTC must contain 
no more than 120 mg total elemental fluoride per package. 21 CFR 
355.10.

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]
    Systemic fluoride poisoning after ingestion or inhalation occurs 
very rapidly as the fluoride is absorbed into the gastrointestinal 
(``GI'') tract and lungs. Systemic fluoride poisoning can also result 
from dermal exposure if the exposure is massive or the skin barrier has 
been destroyed, as with severe burns. 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. 
Dermal exposure to 6 to 10 percent HF is the lowest concentration range 
known to cause skin injury in 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 exposure to 70 
percent HF over 2.5 percent of the body surface.[2]
    Ocular exposure can result in serious eye injury. Exposure to 
concentrations of 0.5 percent can lead to mild conjunctivitis and 
greater concentrations can lead to progressively severe results such as 
immediate corneal necrosis (20 percent solution).
    Ingestion of fluoride can result in mild to severe GI symptoms. 
Reports suggest that ingesting 3 to 5 milligrams per kilogram of 
fluoride 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

[[Page 61930]]

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 do not correspond 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. Some of the burns occurred even after the clothing had 
been washed.[2]
    Other reports included that of a 14-month-old child who developed 
hypocalcemia and hyperfluoridemia (elevated blood fluoride level) and 
went into cardiac arrest after exposure to a rust remover containing 
HF. A 2\1/2\-year-old child developed respiratory failure and repeated 
episodes of ventricular tachycardia (rapid heart beat) and fibrillation 
after ingesting a laundry sour (used in laundry operations to 
neutralize alkalis or decompose hypochlorite bleach) with sodium 
fluosilicate. A 28-year-old man died after accidentally drinking floor 
polish that contained fluosilicate. A 56-year-old man died after 
ingesting a spoonful of glass etching cream (20% ammonium bifluoride 
and 13% sodium bifluoride). He had severe burns in his esophagus and 
stomach, and he suffered cardiac arrest 5 hours after the ingestion.[2]

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 (``IIPI'') 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]
    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. In another case, an 18-year-old man 
developed second and third degree burns 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 
20-year-old male died of cardiac arrest after ingesting one to two 
ounces of a wheel cleaner with fluoride.[2]
    Three reports in the INDP files involve children under 5 years old 
who died after ingesting fluoride-containing products. A three-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 have been six 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 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]

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 <SUP>3</SUP> 
outcomes and 24 moderate <SUP>4</SUP> outcomes. The AAPCC data also 
show 23 major outcomes and 188 moderate outcomes for other acid 
household products. Some of these may have contained fluoride. The 
frequency of injury for dental treatments was much lower than that for 
household products containing HF. Of approximately 23,000 exposures to 
such dental products, there were 34 moderate outcomes, and the only 
documented major outcome was a miscoded incident where the child 
experienced an allergic reaction to the product rather than systemic 
toxicity from an overdose.[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 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]

D. Level of Regulation for Household Products Containing Fluoride

    The Commission is proposing 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 weight-to-volume (``w/v'') basis for liquids or 
a weight-to-weight (``w/w'') basis for non-liquids.[1&2] The Commission 
is especially interested in obtaining information and receiving

[[Page 61931]]

comments on the uses and marketing patterns of glass etching creams.
    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 certainly lethal dose (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 proposes 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]

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 proposed level for household products containing 
fluoride, the Commission is proposing that the level for the oral 
prescription drug exemption be changed to allow no more than the 
equivalent of 50 mg of elemental fluoride (110 mg sodium fluoride) per 
package and 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. The 
proposed level provides a safety factor to protect sensitive 
individuals.[1&2]
    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. 
There is no evidence that any of these products have caused serious 
injury. The Commission proposes modifying the exemption level so that 
it is consistent with the regulated level proposed for household 
products containing fluoride.[1]

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 preliminarily 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 new 
manufacturers.[1&2]
    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 proposing to modify 
the existing exemption for such drugs with sodium fluoride to reflect 
current toxicity data and be consistent with the proposed level for 
fluoride-containing household products.[1&2]
    Pursuant to section 3(a) of the PPPA, 15 U.S.C. 1472(a), the 
Commission preliminarily 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 by the effective date 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]
    Some OTC fluoride-containing household products are packaged in 
containers with non-CR continuous threaded closures. The Commission 
also is aware of such products packaged in aerosols and mechanical 
pumps. Various types and designs of senior friendly CR packaging can be 
readily obtained that would be suitable for fluoride-containing 
products.[3&4]
    Two manufacturers currently use senior-friendly continuous threaded 
CR packaging for their fluoride-containing household products. Another 
manufacturer uses a senior-friendly trigger mechanical pump mechanism 
for its product. This shows that these types of CR packages are 
technically feasible, practicable and appropriate for fluoride-
containing products. The Commission knows of at least one fluoride 
product that uses a non-CR aerosol package. The manufacturer of another 
regulated product is currently using a senior-friendly CR aerosol 
overcap. Thus, this kind of CR packaging could be used for fluoride-
containing products. Finally, various designs of senior-friendly snap 
type reclosable CR packaging that would be appropriate for non-liquid 
fluoride-containing products are available. Thus, appropriate senior-
friendly CR packaging is available for products marketed in continuous 
threaded, snap, aerosols, and trigger spray packaging.[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 preliminarily 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

[[Page 61932]]

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. Aerosol and mechanical pump 
packages should be commercially available in senior-friendly CR designs 
within nine months of a final rule.[1,4 & 5] Thus, the Commission 
proposes that a final rule would take effect nine months after 
publication of the final rule.
    Currently available information indicates that full commercial 
availability for senior-friendly mechanical pump packages and aerosol 
overcap packages could take from 9 to 12 months from the date a final 
rule 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 1-year effective date for these types of 
packages only, or (2) provide that manufacturers may request a stay of 
enforcement so they can market their products in conventional packaging 
for the minimum period needed to obtain an adequate supply of senior-
friendly 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.
    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]
    This assessment reports that the staff is aware of 25 suppliers 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 contain fluoride.[3] The 
Commission requests comments from companies that supply fluoride-
containing household products. The Commission is particularly 
interested in comments and information on the likely effect of this 
proposed rule on small businesses.
    Several consumer products containing fluoride are already in CR 
packaging. For example, senior friendly packaging is used by a small 
business marketer of a fluoride-containing rust remover packaged in a 
plastic container with a continuous turn closure. Another small 
business, marketing a fluoride-containing 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 cleaners, 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 is 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 fluoride-containing household products would 
not have a significant impact on a substantial number of small 
businesses or other small entities.
    Furthermore, the proposed modification in the level for exemption 
of oral prescription drugs containing sodium fluoride is not likely to 
affect any currently available prescription drugs, and if such drugs 
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. Environmental Considerations

    Pursuant to the National Environmental Policy Act, and in 
accordance with the Council on Environmental Quality regulations and 
CPSC procedures for environmental review, the Commission has assessed 
the possible environmental effects associated with the proposed PPPA 
requirements for fluoride-containing products.
    The Commission's regulations state that rules requiring special 
packaging for consumer products normally have little or no potential 
for affecting the human environment. 16 CFR 1021.5(c)(3). Nothing in 
this proposed rule alters that expectation. Therefore, because the rule 
would have no adverse effect on the environment, neither an 
environmental assessment nor an environmental impact statement is 
required.

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 proposed 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

[[Page 61933]]

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 proposed rule does 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 proposes to amend 16 
CFR part 1700 as follows:

PART 1700--[AMENDED]

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

    Authority: Pub. L. 91-601, secs. 1-9, 84 Stat. 1670-74, 15 
U.S.C. 1471-76. 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 (although unchanged, the 
introductory text of paragraphs (a) and (10) are included below 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 and 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: November 17, 1997.
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.

[FR Doc. 97-30555 Filed 11-19-97; 8:45 am]
BILLING CODE 6355-01-P


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