[Federal Register Volume 64, Number 117 (Friday, June 18, 1999)]
[Rules and Regulations]
[Pages 32799-32803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15580]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Final Rule: Requirements for Child-Resistant Packaging; Household
Products Containing Methacrylic Acid
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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[[Page 32800]]
SUMMARY: The Commission is issuing a rule to require child-resistant
(``CR'') packaging for liquid household products containing more than 5
percent methacrylic acid (weight-to-volume) in a single 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 handling or ingesting a toxic amount
of methacrylic acid. The Commission is specifically concerned about
nail care products containing methacrylic acid, the only household
product the Commission has confirmed contains methacrylic acid. The
Commission takes this action under the Poison Prevention Packaging Act
of 1970.
DATES: This rule will become effective on June 19, 2000 and applies to
methacrylic acid preparations packaged on or after that date.
FOR FURTHER INFORMATION CONTACT: Laura E. W. Noble, Directorate for
Compliance, U.S. Consumer Product Safety Commission, Washington, DC
20207; telephone (301) 504-0400 ext. 1452.
SUPPLEMENTARY INFORMATION:
A. Background
1. Relevant Statutory and Regulatory Provisions
The Poison Prevention Packaging Act of 1970 (``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'' (``CR'')
packaging, 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. 15 U.S.C.
1471(4). Household substances for which the Commission may require CR
packaging include (among other categories) foods, drugs, or cosmetics
that are ``customarily produced or distributed for sale for consumption
or use, or customarily stored, by individuals in or about the
household.'' 15 U.S.C. 1471(2). The Commission has performance
requirements for special packaging. 16 CFR 1700.15, 1700.20.
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 the
manufacturer (or packer) also supplies the substance in CR packages of
a popular size, and the non-CR packages bear conspicuous labeling
stating: ``This package for households without young children.'' 15
U.S.C. 1473(a), 16 CFR 1700.5.
2. Methacrylic Acid
Methacrylic acid (``MAA'') is used as a primer before applying
artificial fingernails. Nail products containing MAA are cosmetics
under the Food Drug and Cosmetic Act (``FDCA''). Although MAA is also
used as a chemical intermediate in making some other products, the
Commission does not believe that the rule would affect these products.
Nail primers help acrylic overlays adhere to the nail surface.
Primers may contain MAA exclusively, but some may have other
ingredients. Of the primers that the staff examined, those that do
contain MAA have at least 50 percent MAA. Most of the nail primers that
contain MAA are labeled ``For Professional Use Only.'' They are
generally distributed through wholesale distributors directly to nail
salons and to retail beauty supply stores. Some of these retail stores
sell to both professionals and consumers. According to industry
sources, there may be as many as 50 nail primer suppliers.
Approximately 90 percent of nail primers marketed to professionals
contain MAA. The Commission knows of 13 companies that market or have
marketed MAA-containing nail primers. Based on industry estimates, the
CPSC staff estimates annual unit sales of MAA-containing nail primers
at about 1.0 to 1.3 million units in \1/4\ oz., \1/2\ oz. and larger
sizes. These units have a retail value of $4-6.5 million. Their
wholesale value is about $2.9 to $4.6 million, based on a 40 percent
mark-up typical of the industry.
The industry could not estimate the number of consumers using MAA-
containing primers at home. It is clear, however, from the incident
data discussed below that these products are used in homes, and
children are obtaining access to them. The CPSC staff purchased these
primers at retail stores and by mail. This also shows that these
products are readily available to consumers.
3. The Proposed Rule
On December 30, 1998, the Commission issued a notice of proposed
rulemaking (``NPR'') requiring CR packaging for liquid household
products containing more than 5 percent MAA (weight-to-volume) in a
single package. 63 FR 71800.
The Commission also mailed copies of the NPR to 150 firms and trade
associations that might have an interest in the rulemaking. The
Commission received 5 comments in response to the proposed rule. No
commenters objected to the proposed rule; three expressed support, and
two expressed concern for the professionals applying the primers.
The American Academy of Pediatrics (``AAP''), the American Beauty
Association (``ABA'') and the Methacrylate Producers Association
(``MPA'') all wrote in support of the rule. The AAP noted the potential
harm to children exposed to MAA and its common use in the home. The
ABA, a non-profit trade association representing manufacturers selling
more than 80 percent of professional-use beauty salon products, stated
that the Commission had fairly weighed the hazards to children and
conducted a ``fair analysis of the practicality and feasibility of
protecting children against the hazards.'' The MPA, an association of
manufacturers of MAA and MAA esters, noted that with the corrosive
properties of MAA and the widespread use of primers in the home, the
Commission's special packaging proposal is appropriate.
No Lift Nails, a manufacturer of MAA-containing nail primers,
expressed concern that no available CR caps would fit a 15 mm bottle
finish, and larger bottles would expose more cosmetologists to MAA
because of spills. The commenter suggested that the Commission require
that bottles be both no larger than \1/2\ ounce, and that they have a
small orifice. The commenter also suggested that the Commission require
a restricted flow feature in addition to the small orifice. Under the
PPPA, the Commission cannot prescribe a particular packaging design or
size. 15 U.S.C. 1472(d). The Commission can require restricted flow.
The Commission is not doing so here because of the small volume applied
in a single use and because applicators are commonly inserted into the
containers.
Beatrice Kaye Cosmetics commented that MAA poses a serious health
problem for professional cosmetologists and their patrons. The PPPA
provides the Commission with authority to require CR packaging for
substances that pose a hazard to children in the home.
[[Page 32801]]
It does not give the Commission jurisdiction over hazards unique to
professionals in the workplace.
B. Toxicity of Methacrylic Acid
MAA is readily absorbed through mucous membranes of the lungs and
gastrointestinal (``GI'') tract as well as through the skin. It is
rapidly distributed to all major tissues, with the highest
concentrations in the liver and kidneys. It destroys tissue by chemical
action. This makes it a ``corrosive'' substance as defined in the
Federal Hazardous Substances Act. 15 U.S.C. 1261(i).
MAA's effects are similar to those of other acids. As discussed in
the NPR, dermal burns, inhalation of acid vapors, ingestion, and eye
exposure all can be harmful.
C. Incident Data
The staff reviewed several sources for information of adverse
health effects from nail products containing MAA. These sources are
published reports in the medical literature, the American Association
of Poison Control Centers (``AAPCC''), the FDA Cosmetic Voluntary
Registration Program (``CVRP''), and reports from the injury
surveillance databases maintained by the Commission. The NPR discusses
incident data from those sources in detail.
1. Medical Literature
As discussed in the NPR, two recent articles in the medical
literature reviewed relevant data. The first analyzed data from the
Toxic Exposure Surveillance System (``TESS''), a database that AAPCC
maintains, for 1993 through 1995. Of the 759 reports of exposures to
MAA-containing nail products, 564 exposures involved children less than
6 years old. Most of these occurred at home. Approximately 10 percent
of young children suffered moderate to major injuries.
The second article reviewed the hazard of nail care products, among
them nail primers containing MAA, and reported the medical consequences
of ingestion of and/or dermal exposure to primers in two children less
than 5 years old and one adult. The NPR provides details of these
incidents.
2. CPSC Databases
The staff reviewed CPSC's databases for poison incidents involving
nail primers. As recounted in the NPR, between 1988 and September 30,
1998, the staff identified 85 cases as exposures to nail products
specifically identified as primers or as containing MAA. Five of these
involved serious injuries resulting from ingestion or dermal exposure
to MAA in nail primers. Since publication of the NPR, three additional
injuries were reported to CPSC. None of the three children was
hospitalized. One incident involved a nail primer that was not
confirmed to contain MAA. The other two children suffered burns on
their legs after spilling bottles of nail primers known to contain MAA.
3. AAPCC Data
The staff obtained AAPCC data isolating nail products containing
MAA for the years 1996 and 1997. The data include 467 exposures,
including 341 poisonings (ingestion, ingestion/dermal), 11 ocular
exposures, and 115 dermal exposures to children less than 5 years old.
No deaths were reported. One poisoning with major medical consequences
was reported in 1997. There were 32 poisoning outcomes coded as
moderate (10.7 percent) and 137 poisonings (39.3 percent) coded as
having minor outcomes. Approximately 90 percent of poisonings occurred
in the home.
4. FDA Database
The FDA's CVRP data base contains four reports of injuries from
nail primers. One of these reports indicates that a 2-year-old male was
brought to the ER after a nail primer splashed in his face and caused
burns to the cornea of the eye and the face (1988).
D. Level for Regulation
The Commission is issuing a rule that requires special packaging
for household products containing more than 5 percent methacrylic acid
in a single package.
At this time, there is no evidence establishing the lowest
concentration or amount of MAA capable of causing severe personal
injury or illness to young children. Burn severity from corrosive
chemicals depends on exposure duration, contact site and product
volume, concentration, and chemical characteristics. These chemical
characteristics include pH, physical nature, viscosity, titratable
acidity or alkalinity, molarity, oxidation-reduction potential, and
complexing affinity for bivalent ions. MAA is a weak organic acid
closely resembling acetic acid; acetic acid is 1.3-fold more acidic
than MAA when concentration is expressed in percent units. As discussed
in detail in the NPR, the Commission arrived at a level for regulation
based on mutually supportive evidence derived from a report of
concentration-related skin injury in mice due to MAA, the calculated pH
of various concentrations of MAA, and the effects of acetic acid on
humans at various concentrations.
The actual degree of irritancy or corrosion at 1 to 20 percent
concentrations would probably depend on the volume of acid in contact
with tissues, the surface area and site affected, and duration of the
contact. A concentration of approximately 5 percent MAA does not cause
serious injury to mouse skin. It is not likely to be more than a
moderate irritant to the eyes of humans, or a mild irritant to the skin
of humans. It is equivalent to a 4 percent concentration of acetic acid
(about the same as vinegar). That concentration is not associated with
serious personal injury or illness in young children. However,
concentrations of approximately 10 percent MAA are, at the very least,
severe skin irritants in a mouse model and, judging from calculated pH
values, are capable of serious eye injury. Because the Commission is
not aware of data defining the precise point between 5 and 10 percent
at which injury becomes serious, the Commission is requiring child-
resistant packaging for products containing more than 5 percent MAA to
protect children from potential serious injury. The Commission received
no comments on this level.
E. Statutory Considerations
1. Hazard to Children
As noted above, the toxicity data demonstrate that MAA can cause
serious illness and injury to children when ingested. Moreover, it is
available to children in the form of nail primers that are accessible
in the home. These packages are not CR.
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 handling and ingesting household products containing MAA requires
special packaging to protect children from serious illness. The
Commission bases this finding on the toxic nature of MAA-containing
products and their accessibility to children in the home.
2. Technical Feasibility, Practicability, and Appropriateness
To issue a standard for special packaging under the PPPA, the
Commission must find that the special packaging is ``technically
feasible, practicable, and appropriate.'' 15 U.S.C. 1472(a)(2). The
Commission may find technical feasibility when technology exists or can
be readily developed and implemented to produce packaging that conforms
to the standards. Practicability
[[Page 32802]]
means that special packaging complying with the standards can utilize
modern mass production and assembly line techniques. Packaging is
appropriate when complying packaging will adequately protect the
integrity of the substance and not interfere with its intended storage
or use.
Packaging for MAA-containing nail primers that is senior friendly
(``SF'') and CR is technically feasible. There are currently available
20 millimeter (``mm'') continuous-threaded (``CT'') caps without built-
in applicator brushes that are SF and CR. The manufacturer of this cap
also manufactures a 28 mm CT closure that is CR and SF and has a built
in applicator brush. This manufacturer told staff that it could develop
a 20 mm CR and SF cap with a built-in applicator brush suitable for use
with MAA within one year. Manufacturers of bottles with smaller
finishes (the part of a bottle that receives the cap) may have to
change to bottles with 20 mm finishes. Some of the smallest sizes of
bottles used for MAA-containing primers (0.25 ounces) already have a 20
mm finish. Alternatively, manufacturers could use a restrictive insert
to decrease the inside diameter of the bottle opening in conjunction
with CR 20 mm finishes.
Special packaging for MAA-containing household products is
practicable. CT caps that meet the senior friendly and CR testing
requirements have been mass-produced for many years. A 20 mm continuous
threaded closure that is CR and SF but lacks an insert for a brush is
now mass-produced. Similarly, a 28 mm continuous threaded closure that
is CR and SF and does have an insert for a brush is mass-produced. The
mass production and assembly line techniques used for the 28 mm CR and
SF closure with insert can be adapted to those used for the 20 mm non-
CR closure with an insert and brush.
Special packaging is appropriate when it will protect the integrity
of the substance and not interfere with intended storage or use. Nail
primers containing MAA are currently packaged in both glass and plastic
bottles. Thus, both glass and plastic containers are suitable for MAA-
containing products. One packaging manufacturer uses identical
materials to produce a 28 mm continuous threaded CR and SF closure
(equipped with an insert for attaching a brush) and a 20 mm continuous
threaded non-CR closure that is currently used for MAA-containing
primers and is equipped with an insert and attached brush. Plastic
bottle neck restriction devices should also be compatible with MAA
since at least one is already in use. Therefore, the same materials
used for non-CR packages of MAA-containing products, with or without
brushes or inserts, are used or can be used for CR-packages.
3. Other Considerations
In establishing a special packaging standard under the PPPA, the
Commission must consider the following:
a. The reasonableness of the standard;
b. Available scientific, medical, and engineering data concerning
special packaging and childhood accidental ingestions, illness, and
injury caused by household substances;
c. The manufacturing practices of affected industries; and
d. The nature and use of the household substance. 15 U.S.C.
1472(b).
The Commission has considered these factors with respect to this
rule, and finds no reason to conclude that the rule is unreasonable or
otherwise inappropriate.
F. Exemption
The Commission is aware of one MAA-containing primer that is
packaged in a tube with a fiber applicator tip. The container looks
like a plastic marker pen. The fiber strand holds the MAA so that no
free liquid flows through the device. A cap covers the applicator tip.
Several manufacturers market this type of device for applying nail
primer. Some of these primers contain MAA.
As stated in the NPR, the Commission believes that MAA-containing
primers packaged this way do not pose a risk of serious injury. For
this type of package not to pose a risk to children, the Commission
believes that two conditions must be met: (1) the absorbent material
must hold the MAA so that no free liquid is in the device, and (2)
through reasonably foreseeable use the MAA will be released only
through the tip of the device. Reasonably foreseeable use would include
reasonably foreseeable abuse by children. These conditions are grounded
in an existing exemption from FHSA labeling for porous-tip ink-marking
devices. 16 CFR 1500.83(a)(9).
The volume of MAA available and accessible is extremely small
(total amount of material in the devices is reportedly less than \1/2\
gram). The only possible route of serious injury would be from direct
contact of the felt tip with the eye. The staff has not identified any
incidents involving these types of devices. Thus, the Commission is
exempting MAA-containing primers contained in these marker-like devices
if they meet the conditions discussed above.
G. Effective Date
The PPPA provides that no regulation shall take effect sooner than
180 days or later than one year from the date such final 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 proposed, the Commission is providing a one-year effective date.
Currently, 20 mm CT caps that are CR and senior friendly are available.
However, these caps are not available with a built-in applicator brush.
Thus, manufacturers will need to make some modifications to provide a
CR cap with a built-in applicator. Such closures should be available
within one year. The Commission received no comments respecting the
effective date.
Thus, the rule will take effect 12 months after publication and
will apply to products that are packaged on or after the effective
date.
H. 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.
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 Economic Analysis prepared an
assessment of the impact of a rule to require special packaging for
household products containing more than 5 percent methacrylic acid. As
discussed in the NPR, based on this assessment the Commission certified
that the rule is not likely to have a substantial effect on a
significant number of small businesses. The Commission requested
suppliers, particularly small businesses, to provide information on the
impact the proposed rule would have on them, but did not receive any
such comments.
I. Environmental Considerations
As noted in the NPR, the Commission assessed the possible
environmental effects associated with the proposed PPPA requirements
for MAA-containing products and found that the rule would have little
or no potential for affecting the human environment. The Commission
concluded that neither an environmental assessment nor an
[[Page 32803]]
environmental impact statement is required.
J. Executive Orders
According to Executive Order 12988 (February 5, 1996), agencies
must state in clear language the preemptive effect, if any, of new
regulations. As explained in the NPR, the rule requiring CR packaging
for household products containing more than 5 percent MAA would preempt
non-identical state or local special packaging standards for such MAA-
containing products.
In accordance with Executive Order 12612 (October 26, 1987), the
Commission certifies that the rule does not have sufficient
implications for federalism to warrant a Federalism Assessment.
List of Subjects in 16 CFR Part 1700
Consumer protection, Cosmetics, 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. In Sec. 1700.14 the introductory text of paragraph (a) is
republished and paragraph (a)(29) is added 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 meeting the requirements of Sec. 1700.20(a) 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:
* * * * *
(29) Methacrylic acid. Except as provided in the following
sentence, liquid household products containing more than 5 percent
methacrylic acid (weight-to-volume) in a single retail package shall be
packaged in accordance with the provisions of Sec. 1700.15(a),(b) and
(c). Methacrylic acid products applied by an absorbent material
contained inside a dispenser (such as a pen-like marker) are exempt
from this requirement provided that: (i) the methacrylic acid is
contained by the absorbent material so that no free liquid is within
the device, and (ii) under any reasonably foreseeable conditions of use
the methacrylic acid will emerge only through the tip of the device.
Dated: June 15, 1999.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
Note: The following list will not appear in the Code of Federal
Regulations.
List of Relevant Documents
1. Briefing memorandum from Susan Aitken, Ph.D., EH, to the
Commission, ``Proposed Special Packaging Standard for Household
Products Containing Methacrylic Acid,'' November 23, 1998.
2. Memorandum from Susan Aitken, Ph.D., EH, to Mary Ann Danello,
Ph.D., Associate Executive Director, EH, ``Toxicity of Methacrylic
Acid'' August 12, 1998.
3. Memorandum from Susan C. Aitken, Ph.D., EH, to Mary Ann Danello,
Ph.D., EH, ``Human Injuries from Nail Products Containing Methacrylic
Acid,'' August 12, 1998.
4. Memorandum from Marcia P. Robins, EC, to Susan Aitken, Ph.D.,
EH, ``Economic Considerations: Proposal to Require Child-Resistant
Packaging for Household Products Containing Methacrylic Acid,'' August
17, 1998.
5. Memorandum from Tewabe A. Asebe, EH, to Susan Aitken, Ph.D., EH,
``Technical Feasibility, Practicability, and Appropriateness
Determination for Proposed Rule to Require Special Packaging for
Methacrylic Acid-Containing Products,'' August 17, 1998.
6. Memorandum from Bhooshan Bharat, Ph.D., LS, and Bhavi K. Jain,
MS, LS, ``Report on the Testing of Nail Products for Titratable Acid
Reserve (``TAR''), Quantification of Methacrylic Acid, and pH,'' August
20, 1998.
7. Briefing memorandum from Susan Aitken, Ph.D., EH, to the
Commission, ``Final Rule to Require Child-Resistant Packaging for
Household Products Containing More Than 5 Percent Methacrylic Acid in a
Single Package,'' May 21, 1999.
8. Memorandum from Marcia P. Robins, EC, to Susan Aitken, Ph.D.,
EH, ``Final Rule for Child-Resistant Packaging for Household Products
Containing Methacrylic Acid: Regulatory Flexibility Issues,'' April 8,
1999.
9. Memorandum from Tewabe A. Asebe, EH, to Susan Aitken, Ph.D., EH,
``Assessment of Technical Feasibility, Practicability, and
Appropriateness for the Final Rule to Require Child-Resistant Packaging
for Methacrylic Acid Products,'' April 23, 1999.
[FR Doc. 99-15580 Filed 6-17-99; 8:45 am]
BILLING CODE 6355-01-P
