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

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700

Requirements for Child-Resistant Packaging; Mouthwash Packages

Containing 3 Grams or More of Ethanol

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: Under the Poison Prevention Packaging Act of 1970, the

Commission is issuing a rule to require child-resistant packaging for

mouthwashes with 3 grams or more of absolute ethanol per package. The

Commission has 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. The rule

exempts mouthwash products with nonremovable pump dispensers that

contain at least 7% on a weight-to-weight basis of mint or cinnamon

flavoring oils, that dispense no more than 0.03 grams of absolute

ethanol per pump actuation, and that contain less than 15 grams of

ethanol in a single package available to the consumer.

DATES: The effective date of the rule is July 24, 1995, and the rule

shall apply to products packaged on or after that date.

FOR FURTHER INFORMATION CONTACT: Michael Bogumill, Division of

Regulatory Management, Consumer Product Safety Commission, Washington,

DC 20207; telephone (301) 504-0400 ext. 1368.

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, standards have been established for special

packaging (16 CFR 1700.15), as has a test procedure for evaluating its

effectiveness (16 CFR 1700.20). Regulations requiring special packaging

for a number of household products are published at 16 CFR 1700.14. The

statutory findings that the Commission must make in order to issue a

standard requiring child-resistant (``CR'') packaging (``CRP'') for a

product are discussed below in Section D of this notice.

The PPPA allows the Commission to require CRP for household

substances, which include (among other specified 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).

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-CRP only if (1) the

manufacturer (or packer) also supplies the substance in CRP and (2) the

non-CRP bears 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 such cases, 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 CRP. 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 CRP for

mouthwashes containing more than 5% ethanol. 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. For the purposes

of this proceeding and the final rule, the term ``mouthwash'' includes

liquid products that are variously called mouthwashes, mouthrinses,

oral antiseptics, gargles, fluoride rinses, anti-plaque rinses, and

breath fresheners. It does not include throat sprays or aerosol breath

fresheners.

The petitioners stated several reasons for their request: (1) Many

mouthwashes [[Page 4537]] 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 CRP; (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.

By a letter dated June 3, 1993, the Nonprescription Drug

Manufacturers Association (``NDMA'') and the Cosmetic, Toiletry, and

Fragrance Association (``CTFA'') advised Commission staff of the

associations' plans to implement a voluntary program to place

mouthwashes with more than 5% ethanol in CR containers. [1, Tab

C.]1 On November 17, 1993, the Commission granted the petition.

Subsequently, 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% ethanol to mouthwashes with 3 grams

or more in a single container.

\1\ Numbers in brackets refer to the number of a document as

listed in App. 1 at the end of this notice.

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3. The Proposed Regulation

The mouthwash petition requested that the Commission require CRP

for mouthwash that contains more than 5% ethanol. However, after

analyzing the information before it, 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.

[10] 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 a small amount

(approximately 2.6 ounces) of mouthwash with 5% ethanol. The Commission

is concerned that regulating only products with more than 5% ethanol,

as requested in the petition, might not sufficiently protect children

because the quantity of ethanol available to be consumed is more

relevant to the safety issue than is the concentration of ethanol in a

mouthwash. Accordingly, the Commission proposed a regulatory threshold

of 3 g total ethanol in the package rather than the concentration of 5%

or more of ethanol in the product.

The proposed rule was published for public comment on May 11, 1994.

59 FR 24386.

B. Toxicity

[2, unless noted otherwise.] 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% and 27% ethanol. By comparison, beer contains between 5%

and 7% ethanol and wine can contain 12% to 14% 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 may 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% 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 40 mouthwash cases involving children under age 5 from January

1987 through July 1994. [14] Based on these ingestions, it was

estimated that a total of 1,840 mouthwash poisoning cases were treated

in hospital emergency rooms in the United States during that time, or

an average of about 240 per year. [14]

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

reported 1,966 ingestions of mouthwash with ethanol by children under 5

years old in 1992. [14] Of these ingestions, 182 were referred to a

health care facility by the poison control center. Another 64 cases

either were already in a health care facility or were on the way to one

when the poison control center was contacted.

C. Comments on the Proposal

The Commission received nine comments in response to the proposed

rule. [13] The New York State Consumer Protection Board, the American

Dental Association, and several students from Florida International

University expressed strong support for the rule. The university

students also submitted the results of an informal survey of mouthwash

use.

The NDMA/CTFA Joint Oral Care Task Group and several industry

members also favor the proposed rule. However, these and other

commenters disagreed with the proposed effective date, and questions

were raised about the application of the rule. The issues raised by the

comments are discussed below.

Exemption for Certain Pump Dispensers

The manufacturer of one product that otherwise would have been

subject to the proposed rule requested an exemption. [15] This product

is an oral rinse concentrate marketed in a 2-oz (59 ml) glass bottle

containing 24% ethanol by weight, for a total of 14.16 g of ethanol per

package. This product utilizes a screw-on metered pump to dispense the

product, and has a protective overcap. The use instructions call for

five actuations of the pump (for a total of 0.6 ml, or less than 0.025

oz) into a small cup supplied with the product. This amount is then

diluted with up to 1 oz of water for use. The Commission is unaware of

any other manufacturer of a product subject to the rule that uses this

type of package.

In 1987, one ingestion of a mouthwash made by this manufacturer was

reported in the NEISS database. The child involved in that incident was

treated and released. However, it cannot be determined from the report

whether this incident involved the concentrated spray product or

another, non-concentrated mouthwash that may have been available from

that manufacturer at that time.

Human experience data submitted by the manufacturer show that from

January 1990 to September 1994 there were 117 known cases of accidental

ingestion of this product by children under 5 years old. [15] All cases

resulted in either no effects or only minor ones. All but one of these

cases were treated at home. In that one case, the child was taken to a

health care facility at the insistence of the parents. These cases all

involve product packaged in the current screw-on pump dispenser.

[[Page 4538]]

The case reports indicate that 102 of the children (87%) gained

access to the product by unscrewing the top of the bottle. None of the

reports indicated that the child gained access to the product by using

the pump, but 12 reports did not specify the way in which the child

accessed the product.

If the product were marketed in a nonremovable pump, which the

manufacturer has stated it intends to do in July 1995, the only way a

child could access a regulated amount of the mouthwash concentrate

would be to spray the product at least 100 times into the mouth and

swallow the sprayed product. One study shows that many children

physically could activate the pump this many times. However, the study

did not note that any of the children sprayed the contents of the

package (in this test, water) into their mouths. If they had, it likely

would have been documented in the study.

Since this product is intended to be used in a diluted form, the

packaged form contains a very high concentration of flavoring oils. The

CPSC staff examined this aspect and concluded that the irritant

properties of this concentrated flavoring would create unpleasant or

painful sensations. [18] CPSC's Human Factors staff have concluded that

it is highly unlikely that children would ingest a significant quantity

of the product by means of repeated sprays. [18]

Based upon all of the above information, the Commission has decided

that this rule should not apply to mouthwash products with nonremovable

pump dispensers that contain at least 7% on a weight-to-weight basis of

mint or cinnamon flavoring oils, that dispense no more than 0.03 grams

of absolute ethanol per pump actuation, and that contain less than 15

grams of ethanol in a single unit.

Effective Date

The proposed rule specified that the rule should become effective

on May 1, 1995, or 6 months after the rule is published in the Federal

Register, whichever is earlier. A number of comments were received

opposing an effective date any earlier than May 1, 1995. This issue is

now moot, since May 1, 1995, is now the earlier of the two dates. The

time needed to analyze issues concerning the requested exemption and

how the effective date should apply to special situations, described

below, prevented earlier publication of the final rule.

Manufacturers that claim to be responsible for over 95% of the

production of ethanol-containing mouthwash are committed to be in

compliance by May 1, 1995. This commitment, however, was based on there

being no change in the Commission's PPPA test protocol. [8] However,

the Commission has proposed to modify the test protocol by which CRP is

evaluated in order to make the packaging easier for adults to open

(referred to as ``senior-friendly'' packaging). 59 FR 13264 (March 21,

1994). Accordingly, the Commission's staff contacted five companies

that will be subject to the rule for mouthwash containing ethanol to

see how the possibility that the PPPA protocol may be amended to

require senior-friendly packaging would affect these companies. [20]

Three of the companies contacted belong to the groups that are

sponsoring the implementation of voluntary CRP for mouthwash containing

ethanol by May 1, 1995. These three companies expect to have their

products in packaging that meets the present protocol by that date.

One of the other companies contacted originally had intended to

comply with the rule by reducing its ethanol concentration below the

greater-than-5-percent level specified in the first version of the

voluntary program and in the petition to the Commission. When the

Commission proposed to regulate 3 grams or more in a single package,

this manufacturer was no longer able to comply by reducing its ethanol

content. Thus, this manufacturer had a late start in converting to CRP.

This manufacturer now estimates that it may have CRP by July 1995. [21]

The remaining manufacturer contacted recently by the staff is a

small company that estimates it will not be ready with a package that

would satisfy either the current protocol or the proposed senior-

friendly protocol until December 1995. The company states that this

length of time is required because it must change its bottle molds, in

addition to its capping equipment, in order to accept either current or

senior-friendly CRP.

All five of these companies are aware of the proposed senior-

friendly protocol. None of these companies anticipates major problems

from a subsequent regulation requiring CRP to be senior-friendly. Of

these manufacturers, one is already marketing its product in senior-

friendly packaging, which it is purchasing from a supplier. Three

others intend to purchase commercially available CRP. One of these

intends to begin production by May 1, 1995. The other two of these

manufacturers intend to have senior-friendly packaging in production by

July 1995 and December 1995, respectively. The fifth contacted

manufacturer is developing packages that it intends to ultimately be

senior-friendly. This manufacturer intends to have the new package in

production by May 1, 1995. That manufacturer states that, if its design

is not senior-friendly initially, it can be modified to be so.

None of the manufacturers contacted stated that it would have to

design an additional package if there are changes to the CRP protocol.

The manufacturers contacted, together with another manufacturer known

to be marketing its mouthwash in senior-friendly CRP, represent an

estimated 70 percent of mouthwash sales. Thus, it appears that the

possibility of changes to the test protocol to ensure that CRP is

senior-friendly is not a significant factor in the choice of effective

date for the CRP standard for mouthwash containing ethanol.

The Commission has learned of a few small manufacturers of

concentrated mouthwash products, marketed in bottles with continuous-

threaded (CT) caps. One of these manufacturers filed a late comment on

the proposed rule. [13, No. CP94-2-9] That commenter's product contains

70% ethanol and is marketed in 2-, 4-, 8- and 16-oz sizes. The other

manufacturers' products are believed to also have high ethanol

concentrations. The commenter expressed concern about the proposed May

1, 1995, effective date, but did not expressly ask for a later date or

say how long it would take to convert to CRP.

Some of the bottles used by these manufacturers can use existing CR

or senior-friendly CR caps without modification; others will require a

long-skirted cap, e.g., a 415 finish, to fit their existing bottles.

[17] For the manufacturers needing a long-skirted cap, a major CRP

manufacturer has said that senior-friendly caps in 20mm, 24mm, and 28mm

sizes with a long-skirt special 415 finish have been commercially

available since October 1994. [17] For those manufacturers that have to

change caps, the capping equipment will need to be modified to account

for the larger diameter of the CR cap. This is not a complicated or

expensive modification. [17]

The only known manufacturer of the oral rinse concentrate that will

be exempt from the rule if marketed in a nonremovable pump has

indicated that it will switch to a crimped-on nonremovable pump in July

1995. [Telephone conversation, September 8, 1994.]

After considering the currently available information, the

Commission concludes that an effective date of [insert date that is 6

months after [[Page 4539]] publication], which is 6 months after

publication of the final rule, is reasonable. The vast majority of

manufacturers are committed to being in compliance before this, by May

1, 1995. The one company that states it needs until December 1995 to

comply may be able to do so much sooner. Moreover, this company may

have sufficient inventory to cover the period of time between the

effective date and the date complying packaging can be provided.

Furthermore, revenue from mouthwash does not constitute the major

portion of its sales.

For the instances where modifications to the bottles or development

of special caps for these bottles are required, the manufacturers may

not be able to incorporate them into production by July 24, 1995. In

this event, these manufacturers may have to use other bottle/cap

combinations from contract packagers until other arrangements can be

made.

Applicability of the Effective Date

In the proposal, the effective date would apply to products

packaged after the effective date. A commenter requests that the

effective date should apply to products shipped on or after that date.

The commenter's request that the effective date should apply to the

shipping date would tend to reduce any potential motivation for

stockpiling noncomplying product packaged before the effective date.

This request cannot be granted, however, because PPPA Sec. 8, 15 U.S.C.

1471n, mandates ``[n]o [special packaging] standard shall be effective

as to household substances subject to this Act packaged prior to the

effective date of such final regulation.''

Definition of ``Single Retail Unit''

The proposal specified that the rule applied to products containing

3 g or more in a single package. The proposal explained that the

``single package'' to be covered by the rule was a ``single retail

unit.'' A commenter stated that the term ``single retail unit'' should

be defined as ``a package intended to be made available to consumers

for direct retail purchase.''

The use of the term ``single retail unit'' was intended to clarify

that a regulated substance supplied in a retail package which contained

smaller packages that, considered individually, would not be subject to

the rule because each of the smaller packages contained less than the

regulated amount, would be subject to the CRP standard if the total

amount of the regulated substance in the retail package exceeded the

regulated amount. The proposal did not intend to limit the

applicability of the standard to packages sold at retail.

In view of this comment, the Commission concludes that the term

``single retail unit'' is confusing in this context. Rather, the

Commission considers the term ``package'' to mean the container or

wrapping in which a household substance is supplied for consumption,

use, or storage by individuals in or about the household. This

includes, but is not limited to, any package intended to be made

available to consumers for retail purchase. This definition is not

intended to be the same as the statutory definition of ``packaging'' at

PPPA Sec. 2(3), 15 U.S.C. 1471(3).

Definition of ``Household Substance''

A commenter contended that ``amenities'' do not fall within the

definition of ``household substance'' in 15 U.S.C. 1471(2). Amenities

are small quantities of substances, such as soap, shampoo, or

mouthwash, that are placed in hotel rooms or other accommodations for

use by the room's occupants. If the commenter's contention were

correct, amenities would not be subject to an otherwise applicable PPPA

standard.

The PPPA's definition of household substance includes ``any

substance which is customarily produced or distributed for sale for

consumption or use * * * by individuals in or about the household and

which is * * * a hazardous substance as [defined in the Federal

Hazardous Substances Act (``FHSA'')] * * * [or] a food, drug, or

cosmetic [as defined in the Federal Food, Drug, & Cosmetic Act].'' PPPA

Sec. 2(2), 15 U.S.C. 1471(2). Mouthwash subject to the proposed rule

clearly is either a hazardous substance or a drug or cosmetic. How the

other elements of this definition apply to mouthwash distributed as

amenities in hotel rooms is discussed below.

1. Mouthwash amenities are ``sold'' for use by individuals. If a

hotel purchases prepackaged units of mouthwash to place in hotel rooms,

such packages clearly are sold to the hotel for use by individuals. In

the unlikely event that hotel employees repackage mouthwash from a

larger container to a smaller one to be left in the room, the mouthwash

is nevertheless sold to the hotel for use by individuals since only

individuals can use mouthwash. In addition, the mouthwash amenity can

be viewed as being sold to the hotel occupants, since the amount paid

by the hotel guests for lodging also pays for providing the mouthwash.

2. Items used in hotel rooms are used ``in or about the

household.'' One definition of the term household is ``the home and its

affairs.'' ``Home'' in turn is defined as ``the house, apartment, etc.,

where one lives or is living temporarily; living quarters.'' Webster's

New World Dictionary. Hotels and other places that provide amenities

are places where people live, however temporarily. Therefore, hotels

are households.

Another definition of household is ``those who dwell under the same

roof and compose a family: A domestic establishment; specif: A social

unit comprised of those living together in the same dwelling.''

Webster's Third New International Dictionary of the English Language

Unabridged, 1986 Ed. (``Webster's Unabridged''). Thus, under this

definition, a household refers to a group of people rather than to any

particular type of building. Accordingly, if a hotel rents rooms where

more than one member of a household may stay at a time, amenities used

in those rooms are used ``in or about the household.''

The Commission's regulations under the FHSA state that an ``article

is suitable for use in or around the household * * * [if] under any

reasonably foreseeable condition of purchase, storage or use the

article may be found in or around a dwelling.'' 16 C.F.R.

1500.3(c)(10)(i). The term ``dwelling'' means ``a building or

construction used for residence: ABODE, HABITATION.'' Webster's

Unabridged. This term is not limited to a permanent home or primary

residence. Thus, the Commission's rules lend support to the

interpretation that items used in hotels are used ``in or about the

household.''

Finally, even if a hotel room were not a household, it is

customary, and expected, that amenities will be removed from hotel

rooms by guests for use at home. Thus, for this independent reason,

amenities are ``customarily produced or distributed for sale for

consumption or use * * * in or about the household.''

For the reasons given above, the Commission concludes that

amenities supplied in hotel rooms and the like are household

substances, as that term is used in the PPPA.

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 though the

[[Page 4540]] manufacturers of these mouthwashes that are members of

the NDMA and CFTA will voluntarily use CRP for their products, the

Commission concludes that a regulation is needed to ensure that

mouthwash will be placed in CRP by all mouthwash packagers. In

addition, the regulation will enable the Commission to enforce the CRP

requirement and ensure that effective CRP is used.

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 ingesting ethanol-containing mouthwashes is such that special

packaging is required to protect children from serious illness. The

Commission bases this finding on the toxic nature of such mouthwashes,

described above, the accessibility of such preparations to children in

the home, and the existing incident data involving ingestions by young

children.

2. Technical Feasibility, Practicability, and Appropriateness

[17] 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 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.

CRP are mass produced for products that contain ethanol and have

similar properties to mouthwashes. Two industry groups have indicated

that their members would have CRP 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 concludes that CRP 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, and the Commission finds no basis

for concluding that the rule is unreasonable.

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.

As discussed above in Section C of this notice, the Commission has

established the effective date for this rule as July 24, 1995, which is

6 months after publication of the final rule.

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 prepared an economic

assessment of this rule to require special packaging for mouthwash

preparations with 3 g or more of ethanol in a single package. [16]

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 CRP program. CRP for mouthwash preparations

is readily available at a relatively low incremental cost, and the PPPA

permits manufacturers to market preparations in one non-CR size. The

relatively low costs of CRP should not be a burden to current small

business manufacturers or an entry burden for future marketers.

Manufacturers are given enough time to use up existing supplies of non-

CRP and to obtain suitable CRP and incorporate its use into their

packaging lines.

Individual firms and associations representing businesses affected

by the proposed rule commented that impacts would not be significant as

long as the effective date was no sooner than May 1, 1995, and there

was no change in the PPPA test protocol. That date was originally

proposed by the industry trade association in a voluntary program to

provide CRP for mouthwash; the date was based on the length of time

determined by the members to be reasonable and workable. Many

commenters advised the Commission that an effective date of May 1,

1995, would allow sufficient time to complete package development,

modify equipment, conduct protocol and stability testing, and implement

marketing programs.

The Commission has decided to exempt from this regulation mouthwash

products using nonremovable pumps that contain at least 7% on a weight-

to-weight basis of mint or cinnamon flavoring oils, that dispense no

more than 0.03 g of absolute ethanol per pump actuation, and that

contain less than 15 g of ethanol in a single unit. This will

potentially reduce the adverse impacts of the rule. However, the only

known manufacturer of a product that would qualify for the exemption,

except that its current pump is removable, is not a small entity.

[Manufacturing USA, 2nd Ed. (1992), Gale Research, Detroit, p. 677.]

Based on a comment to the proposal, the Commission has learned that

there are about four or five small businesses that market mouthwash

products that will need CRP. If these marketers do not reformulate to

eliminate ethanol from their products, they may incur incremental costs

for CRP, compared to the non-CRP now used. They may also incur costs to

modify equipment to accommodate new packaging components. However,

these costs are not expected to be high. In any event, the Commission

could grant a temporary enforcement exemption to companies--in this

case, most likely only a few small companies--who demonstrate that,

despite reasonable efforts, they are unable to meet the effective date.

[[Page 4541]]

Accordingly, for the reasons given above, the Commission concludes

that the number of small entities that market products subject to the

rule requiring special packaging for mouthwashes containing 3 g or more

of ethanol is not substantial. Also, the economic effects on such firms

will not be significant.

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 Poison

Prevention Packaging Act (PPPA) packaging requirements for ethanol-

containing products. [4]

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. Analysis of

the impact of this rule indicates that CRP for these mouthwash

preparations will have no significant effects on the environment. This

is because the rule will not significantly increase the total amount of

CRP in use and, in any event, the manufacture, use, and disposal of CRP

presents the same environmental effects as do the currently used non-

CRP.

Therefore, because the rule will 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),

reading as follows (although unchanged, the introductory text of

paragraph (a) is included below for context):

Sec. 1700.14 Substances requiring special packaging.

(a) Substances. The Commission has determined that the degree or

nature of the hazard to children in the availability of the following

substances, by reason of their packaging, is such that special

packaging 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. Except as provided in the following sentence,

mouthwash preparations for human use and containing 3 g or more of

ethanol in a single package shall be packaged in accordance with the

provisions of Sec. 1700.15 (a), (b), and (c). Mouthwash products with

nonremovable pump dispensers that contain at least 7% on a weight-to-

weight basis of mint or cinnamon flavoring oils, that dispense no more

than 0.03 grams of absolute ethanol per pump actuation, and that

contain less than 15 grams of ethanol in a single unit are exempt from

this requirement. The term ``mouthwash'' includes liquid products that

are variously called mouthwashes, mouthrinses, oral antiseptics,

gargles, fluoride rinses, anti-plaque rinses, and breath fresheners. It

does not include throat sprays or aerosol breath fresheners.

* * * * *

Dated: January 18, 1995.

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 Child-Resistant

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 CRP 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 21, 1994.

10. Memorandum from Harleigh Ewell, GCRA, to the Commission,

transmitting a revised Federal Register notice, April 21, 1994.

11. Letter from Eric A. Rubel, CPSC General Counsel, to Ms.

Doris S. Freedman, Acting Chief Counsel for Advocacy, Small Business

Administration, transmitting Regulatory Flexibility Act finding, May

4, 1994.

12. Proposed rule, 59 FR 24386 (May 11, 1994).

13. Public comments on proposed rule, Nos. CP94-2-1 through

CP94-2-9.

14. Memorandum from Dr. Terry Kissinger, EPHA, to Jacqueline

Ferrante, Ph.D., HSPS, ``Update of injury Data Related to the

Toxicity of Ethanol-Containing Mouthwash,'' September 1, 1994.

15. Letter from David J. Aupperlee, Amway Corporation, to

Jacqueline Ferrante, Ph.D., requesting an exemption for Amway

Glister Anti-Plaque Oral Rinse [contains some claimed confidential

information], October 19, 1994.

16. Memorandum from Marcia P. Robins, ECSS, to Jacqueline

Ferrante, Ph.D., HSPS, ``Final Regulatory Flexibility Analysis:

Child-Resistant Packaging for Mouthwash Containing Ethanol,''

October 27, 1994.

17. Memorandum from Charles Wilbur, HSPS, ``Technical

Feasibility, Practicability, and Appropriateness Determination for

the Final Rule to Require Child-Resistant Packaging for Mouthwash

Preparations Containing Ethanol,'' November 1, 1994.

18. Memorandum from Catherine A. Sedney, EPHF, to Jacqueline

Ferrante, Ph.D., HSPS, ``Request for Exemption from Requirements for

Special Packaging for Mouthwash,'' November 17, 1994.

19. Briefing paper from Jacqueline Ferrante, Ph.D., HSPS, to the

Commission, with Tabs A-G, November 29, 1994.

20. Memorandum from Jacqueline Ferrante, Ph.D., to the

Commission, ``Supplemental information concerning a PPPA requirement

for mouthwash with ethanol,'' December 12, 1994.

21. Letter from George Andrassy, Dep Corporation, to Sadye Dunn,

Secretary of the CPSC, November 14, 1994.

[FR Doc. 95-1691 Filed 1-23-95; 8:45 am]

BILLING CODE 6355-01-P