[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