[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.1[1&3] 2
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\1\ The percentage of elemental fluoride in any compound is
determined by dividing the molecular weight of fluoride
(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