[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