[Federal Register Volume 60, Number 15 (Tuesday, January 24, 1995)]
[Rules and Regulations]
[Pages 4536-4541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1691]
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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