Proposed Rule; Requirements for Child-Resistant Packaging; Mouthwash Packages Containing 3 Grams or More of Ethanol

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]

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