[Federal Register Volume 59, Number 90 (Wednesday, May 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11306]
[[Page Unknown]]
[Federal Register: May 11, 1994]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Proposed Rule; Requirements for Child-Resistant Packaging;
Mouthwash Packages Containing 3 Grams or More of Ethanol
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed rule.
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SUMMARY: Under the Poison Prevention Packaging Act of 1970, the
Commission is proposing a rule to require child-resistant packaging for
mouthwashes with 3 grams or more of absolute ethanol per package. 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 ingesting mouthwash.
DATES: Comments on the proposal should be submitted no later than July
25, 1994.
ADDRESSES: Comments should be mailed to the Office of the Secretary,
Consumer Product Safety Commission, Washington, DC 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.
FOR FURTHER INFORMATION CONTACT: Jacqueline Ferrante, Ph.D.,
Directorate for Health Sciences, Consumer Product Safety Commission,
Washington, DC 20207; telephone (301)504-0477 ext. 1199.
SUPPLEMENTARY INFORMATION:
A. Background
1. Relevant Statutes and Regulations
The Poison Prevention Packaging Act of 1970 (the ``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 packaging,'' is defined as packaging that 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. (It does not mean,
however, packaging which all such children cannot open, or obtain a
toxic or harmful amount from, within a reasonable time.)
Under the PPPA, effectiveness standards have been established for
special packaging (16 CFR 1700.15), as has a procedure for evaluating
the effectiveness (16 CFR 1700.20). Regulations have been issued
requiring special packaging for a number of household products (16 CFR
1700.14). The findings that the Commission must make in order to issue
a standard requiring child-resistant (``CR'') packaging for a product
are discussed below in Section D of this notice. For the purposes of
the PPPA, the amount of a substance ``in a single package'' that
triggers the requirement to place the product in CR packaging refers to
the total amount in a single retail unit of the substance.
The PPPA allows the Commission to require CR packaging for
household substances, which include 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). Mouthwashes are either drugs, if
they make medical claims, or cosmetics.
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 (1)
the manufacturer (or packer) also supplies the substance in CR packages
and (2) the non-CR packages bear conspicuous labeling stating: ``This
package for households without young children.'' 15 U.S.C. 1473(a). If
the package is too small to accommodate this label statement, the
package may bear a label stating: ``Package not child-resistant.'' 16
CFR 1700.5(b). The right of the manufacturer or packer to market a
single size of the product in noncomplying packaging under these
conditions is termed the ``single-size exemption.''
The Commission may restrict the right to market a single size in
noncomplying packaging if the Commission finds that the substance is
not also being supplied in popular size packages that comply with the
standard. 15 U.S.C. 1473(c). In this case, the Commission may, after
giving the manufacturer or packer an opportunity to comply with the
purposes of the PPPA and an opportunity for a hearing, order that the
substance be packaged exclusively in CR packaging. To issue such an
order, the Commission must find that the exclusive use of special
packaging is necessary to accomplish the purposes of the PPPA.
2. The Mouthwash Petition
On March 2, 1993, the Commission was petitioned to require child
resistant packaging for mouthwashes containing more than 5 percent
ethanol. The term ``mouthwash'' includes liquid products that are
variously called mouthwashes, mouthrinses, antiseptics, gargles,
fluoride rinses, anti-plaque rinses, and breath fresheners. It does not
include throat sprays or aerosol breath fresheners. The petition was
submitted by the American Academy of Pediatrics, the American
Association of Poison Control Centers, the Center for Science in the
Public Interest, and 28 states, Guam, and the Northern Mariana Islands.
The petitioners stated several reasons for their request: (1) Many
mouthwashes contain high percentages of ethanol, an extremely toxic
substance, in a package large enough to cause children serious injury
or death; (2) these mouthwashes are accessible to children because they
are generally considered innocuous and do not have CR packages; (3)
they are attractive to children because of their appealing taste,
color, and smell; and (4) data show that children have been seriously
injured or died from accidental ingestion of ethanol-containing
mouthwashes.
On November 17, 1993, the Commission granted the petition. Although
the Nonprescription Drug Manufacturers Association (``NDMA'') and the
Cosmetic, Toiletry, and Fragrance Association (``CTFA'') had announced
plans to implement a voluntary program to place mouthwashes with more
than 5 percent ethanol in CR containers, the Commission found that
mandatory action still may be necessary. In April 1994, the NDMA and
CTFA notified the Commission that the products subject to their
voluntary program had been changed from mouthwashes with more than 5
percent ethanol to mouthwashes with 3 grams or more in a single
container.
B. Toxicity
The Commission's toxicity review indicates that mouthwashes with
ethanol can present a serious ingestion hazard to children. Most of the
popular adult mouthwashes contain between 14 percent and 27 percent
ethanol. By comparison, beer contains between 5 percent and 7 percent
ethanol and wine contains 12 to 14 percent ethanol.
Ethanol depresses the central nervous system. Symptoms of acute
ethanol poisoning in children include irritability, lethargy, and
unconsciousness which can lead to coma and death at high doses. Lethal
blood levels of ethanol in children are reported to range between 250
and 500 mg/dl, and the lethal dose of ethanol is 3 g/kg. Deaths or
serious injury could occur at lower doses due to other ethanol-induced
effects. Ethanol poisoning in children can produce certain metabolic
complications such as hypoglycemia, metabolic acidosis, and
hypokalemia.
A review of the relevant literature shows that three deaths of
children under 5 years of age have been reported. The most recent death
reported occurred in 1992 and involved a 3-year-old girl who ingested
an unknown amount of mouthwash that contained 18 percent ethanol.
Several other cases of ethanol-induced hypoglycemia or toxicity
following mouthwash ingestion are reported in the literature.
The National Electronic Injury Surveillance System (``NEISS'')
reported 36 cases of ethanol-containing mouthwash from January 1987
through November 1993. Based on these ingestions, it was estimated that
a total of 1,670 mouthwash poisoning cases were treated in hospital
emergency rooms in the United States during that time. An estimated 81
percent of these children were 1 or 2 years old, and about 5 percent of
the children were hospitalized.
In addition to these sources, the American Association of Poison
Control Centers' National Data Collection System (``AAPCC'') includes
cases reported by participating poison control centers. The AAPCC
received 10,193 reports of ingestions of ethanol-containing mouthwash
by children under 6 years of age during the 5-year period from 1987
through 1991. The AAPCC reported 1,847 ingestions of mouthwash with
ethanol by children under 5 years old in 1991. Of these ingestions, 181
resulted in minor or moderate outcomes (symptoms were not life-
threatening) and 1 resulted in a major, or life-threatening, outcome.
Most cases reported to poison control centers are managed in a non-
health-care facility, usually the patient's home.
C. Proposed Regulation
The mouthwash petition requested that the Commission require CR
packaging for mouthwash that contains more than 5 percent ethanol. The
Commission decided to propose that mouthwash products with 3 grams (g)
or more of absolute ethanol per package or retail-sale unit should be
subject to the regulation. This level is obtained by dividing the
lethal dose of ethanol (3 g/kg of body weight) for a 10-kg child (30 g)
by a safety factor of 10. This safety factor is needed because less
than the ``lethal'' dose can produce serious toxic effects, or even
death from hypoglycemia or other secondary effects. Three grams of
absolute ethanol are present in approximately 2.6 ounces of mouthwash
with 5 percent ethanol.
Regulating at the level requested by the petitioners (more than 5
percent ethanol) may not sufficiently protect children. This is because
relatively small amounts of mouthwash at a level of 5 percent or
somewhat below would exceed the 3 g limit that the Commission has
preliminarily determined is needed to protect children.
D. Statutory Considerations
1. Hazard to Children
As noted above, the toxicity data concerning children's ingestion
of ethanol-containing mouthwash demonstrate that the amount of ethanol
in available mouthwash preparations is sufficient to cause serious
illness and injury to children. These mouthwash preparations are
readily available to children. Even if the manufacturers of these
mouthwashes that are members of the NDMA and CFTA will voluntarily use
CR packaging for their products, the Commission concludes that a
regulation is needed to ensure that products subject to the regulation
will be placed in CR packaging by all mouthwash packagers. In addition,
the regulation will enable the Commission to enforce the CR packaging
requirement and ensure that effective CR packaging is used.
Pursuant to section 3(a) of the PPPA, 15 U.S.C. 1472(a), the
Commission finds preliminarily that the degree and nature of the hazard
to children from ingesting ethanol-containing mouthwashes is such that
special packaging is required to protect children from serious illness.
The Commission bases this preliminary finding on the toxic nature of
such mouthwashes, described above, and the accessibility of such
preparations 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 by section 3(a)(2) of the PPPA, 15 U.S.C.
1472(a)(2), to find that the special packaging is ``technically
feasible, practicable, and appropriate.'' Technical feasibility exists
when technology exists or readily can be 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. Appropriateness exists when packaging complying with the
standards will adequately protect the integrity of the substance and
not interfere with the intended storage or use.
CR packages are mass produced for products that contain ethanol and
have similar properties to mouthwashes. Two industry groups have
indicated that their members can have CR packages for one size of their
mouthwashes by August 31, 1994, with their entire lines converted by
May 1, 1995. In addition, one major manufacturer of mouthwash has
introduced a popular size of its product in packaging that is not only
child resistant, but is easier for adult consumers (and especially
older adults) to open. Therefore, the Commission preliminarily
concludes that CR packaging for mouthwashes is technically feasible,
practicable, and appropriate.
3. Other Considerations
In establishing a special packaging standard, section 3(b) of the
PPPA, 15 U.S.C. 1472(b), requires the Commission to 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).
These items have been considered with respect to the various
determinations made in this notice.
E. Effective Date
The PPPA provides that no regulation shall take effect sooner than
180 days or later than one year from the date such regulation is
issued, 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.
Because of their voluntary program, members of the NDMA and the
CFTA are already implementing assembly line and mass production
techniques to package ethanol-containing mouthwashes with CR packages.
These groups have indicated that their program will be fully
implemented by May 1, 1995, and will involve at least 95 percent of the
industry's sales. Furthermore, these groups have indicated that each of
their members will have at least one size of product in CR packaging by
August 31, 1994. Thus, it appears that the manufacturers will be
phasing in CR packaging over various product sizes.
Therefore, it appears that as the end of the industry's phase-in
period approaches, there will be a relatively small portion of
production that would not be in CR packaging. At least one major
manufacturer has already started using CR packaging on what reportedly
is a major portion of its production. The Commission concludes that
even the few packagers of mouthwash products containing 3 grams or more
of ethanol that are not participating in the voluntary program should
be able to implement CR packaging for their products by 6 months after
the issuance of a final rule, or by May 1, 1995, whichever is sooner,
without serious adverse economic effects. Any packagers that did not
have their assembly lines for CR packaging fully operational by that
time could obtain appropriate packaging on an interim basis from
contract packers.
Accordingly, the final rule is proposed to become effective 180
days after issuance of a final rule, or May 1, 1995, whichever is
sooner, as to all products subject to the rule that are packaged on or
after that date. It is possible, therefore, that the effective date
will be less than 180 days after issuance of the final rule. The
Commission finds that there is good cause for preliminarily determining
that an effective date of less than 180 days is in the public interest.
This determination is based on (1) the desirability of having CR
packaging for this product on the market as soon as practicable in
order to reduce the risk of ethanol poisonings to children from a
widely distributed product and (2) the fact that, under the industry's
voluntary program, at least 95 percent of the industry will be in
compliance by May 1, 1995.
F. 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.
The purpose of the Regulatory Flexibility Act, as stated in section
2(b) (5 U.S.C. 602 note), is to require agencies, consistent with their
objectives, to fit the requirements of regulations to the scale of the
businesses, organizations, and governmental jurisdictions subject to
the regulations. 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 Economics has prepared a
preliminary economic assessment of a rule to require special packaging
for mouthwash preparations with 3 g or more of ethanol in a single
package. Based on this assessment, the Commission concludes that such a
requirement would not have a significant impact on a substantial number
of small businesses or other small entities because of the widespread
acceptance of the voluntary CR packaging program. CR packaging for
mouthwash preparations is readily available at an incremental cost of
one-half to two cents per closure, and the PPPA permits manufacturers
to market preparations in one non-CR size. The relatively low costs of
CR packages should not be a burden to current small business
manufacturers or an entry burden for future marketers. Manufacturers
would be given enough time to use up existing supplies of non-CR
packages and to obtain suitable CR packaging and incorporate its use
into their packaging lines.
Accordingly, for the reasons given above, the Commission
preliminarily concludes that the rule to require special packaging for
mouthwashes containing 3 g or more of ethanol would not have any
significant economic effect on a substantial number of small entities.
G. 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 Poison
Prevention Packaging Act (PPPA) packaging requirements for ethanol-
containing products.
The Commission's regulations at 16 CFR 1021.5(c)(3) state that
rules requiring special packaging for consumer products normally have
little or no potential for affecting the human environment. Preliminary
analysis of the potential impact of this proposed rule indicates that
CR packages for certain mouthwash preparations would have no
significant effects on the environment. This is because the rule will
not significantly increase the number of CR packages in use and, in any
event, the manufacture, use, and potential disposal of the CR packages
present the same potential environmental effects as do the currently
used packages.
Therefore, because the proposed rule would have no adverse effect
on the environment, neither an environmental assessment nor an
environmental impact statement is required.
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: 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 by adding new paragraph (a)(22) and
republishing the introductory text of paragraph (a) to read as follows:
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 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:
* * * * *
(22) Mouthwash. Mouthwash preparations for human use and containing
3 g or more of ethanol in a single package (i.e., retail unit) shall be
packaged in accordance with the provisions of Sec. 1700.15 (a), (b),
and (c).
Dated: May 5, 1994.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
(Note. This list of relevant documents will not be printed in
the Code of Federal Regulations.)
1. Briefing Memorandum with attached briefing package, September
30, 1993.
2. Memorandum from Jacqueline Ferrante, Ph.D., HSPS, to James F.
Hoebel, Acting Associate Executive Director for Health Sciences,
``Recommendation for the level of regulation of mouthwash with
ethanol'', January 10, 1994.
3. Memorandum from Terry Kissinger, Ph.D., EPHA, to Jacqueline
Ferrante, Ph.D., HSPS, ``Injury Data Related to the Toxicity of
Ethanol-containing Mouthwash'', January 31, 1994.
4. Memorandum from Marcia P. Robins, ECSS, to Jacqueline
Ferrante, Ph.D., HSPS, ``Preliminary Assessment of Economic and
Environmental Effects of a Proposal to Require CR Packaging for
Mouthwash Containing Ethanol'', February 24, 1994.
5. Memorandum from Charles Wilbur, HSPS, to Jacqueline Ferrante,
Ph.D., HSPS, ``Technical Feasibility, Practicability, and
Appropriateness Determination for the Proposal to Require CR
Packaging for Mouthwash Preparations Containing Ethanol'', February
24, 1994.
6. Memorandum from Marcia P. Robins, ECSS, to Ronald L. Medford,
EXHR, ``Economic Effects of an Earlier Effective Date for CR
Packaging of Mouthwash Preparations Containing Ethanol,'' April 6,
1994.
7. Briefing memorandum from Jacqueline N. Ferrante, Ph.D., HSPS,
to the Commission, ``Proposed Special Packaging Standard for
Mouthwash Products with Ethanol,'' with Tabs A-E, April 11, 1994.
8. NDMA/CTFA Joint Voluntary Program on Child Resistant
Packaging for Alcohol Containing Mouthwashes (Revised).
9. Memorandum from Jacqueline Ferrante, Ph.D., HSPS, to the
Commission, ``Revised industry voluntary program for child-resistant
packaging of mouthwashes with ethanol,'' April 20, 1994.
10. Memorandum from Harleigh Ewell, GCRA, to the Commission,
transmitting a revised Federal Register notice, April 20, 1994.
[FR Doc. 94-11306 Filed 5-10-94; 8:45 am]
BILLING CODE 6355-01-P