Requirements for Child-Resistant Packaging; Household Products Containing Methacrylic Acid

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700

Requirements for Child-Resistant Packaging; Household Products

Containing Methacrylic Acid

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Commission is proposing a rule to require child-resistant

(``CR'') packaging for liquid household products containing more than 5

percent or more methacrylic acid (weight-to-volume) in a single

package. The Commission has preliminarily determined that child-

resistant packaging is necessary to protect children under 5 years of

age from serious personal injury and serious

[[Page 71801]]

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 to contain methacrylic acid. The

Commission takes this action under the authority of the Poison

Prevention Packaging Act of 1970.

DATES: Comments on the proposal should be submitted no later than March

15, 1999.

ADDRESSES: Comments should be mailed to the Office of the Secretary,

Consumer Product Safety Commission, Washington, D.C. 20207, or

delivered to the Office of the Secretary, Consumer Product Safety

Commission, Room 502, 4330 East-West Highway, Bethesda, Maryland 20814-

4408, telephone (301) 504-0800. Comments may also be filed by

telefacsimile to (301) 504-0127 or by email to [email protected].

FOR FURTHER INFORMATION CONTACT: Susan Aitken, Ph.D., Division of

Health Sciences, Directorate for Epidemiology and Health Sciences,

Consumer Product Safety Commission, Washington, D.C. 20207; telephone

(301) 504-0477 ext. 1195.

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 for cleaning,

degreasing, dehydrating and etching fingernails before applying

artificial nails. Nail products containing MAA are cosmetics under the

Food Drug and Cosmetic Act (``FDCA''). According to the FDCA,

``cosmetic'' includes ``articles intended to be rubbed, poured,

sprinkled, or sprayed on, introduced into, or otherwise applied to the

human body or any part thereof for cleansing, beautifying, promoting

attractiveness, or altering appearance.'' 15 U.S.C. 321(i). MAA is also

used as a chemical intermediate in making resins, paints, adhesives,

paper, polishes, plasticizers and dental fillings. However, the

Commission does not believe that these products would be affected by

the proposed rule because, in the process of manufacturing these

products, the bulk of MAA becomes polymerized and is no longer in the

form of the monomer MAA.

Nail primers are used to help acrylic overlays adhere to the nail

surface. Not all nail primers contain MAA. Primers that do contain MAA

may have as much as 100 percent MAA, but some may have other

ingredients. Of the primers examined by the staff, 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. To obtain samples, CPSC staff

visited several beauty supply retail stores, and purchased four nail

primers containing MAA. They were packaged in small bottles containing

\1/4\ oz. to \1/2\ oz. of primer. All were sold individually packaged,

none were CR and all were labeled ``Professional Use Only'' or ``For

Professional Use Only.'' The staff obtained an additional primer that

was confirmed to contain MAA by mail order purchase. It came in a non-

CR bottle labeled ``For Professional Use Only.''

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 is aware 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. The annual retail value of

these units amounts to $4-6.5 million. The wholesale value of these

products is about $2.9 to $4.6 million based on a 40 percent mark-up

typical of the industry.

Spokespersons for 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

the household, and children are obtaining access to them. The ability

of CPSC staff to purchase these primers at retail stores and by mail

also shows that these products are readily available for consumers to

purchase and bring home.

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 is a corrosive, meaning

that, when it comes into contact with living tissue, it causes

destruction of tissue by chemical action. 15 U.S.C. 1261(i).

MAA's effects are similar to those of other acids. Dermal burns can

destroy the surface of the epithelium and submucosa with damage to

blood vessels and connective tissue. Inhaling acid vapors may produce

nasal irritation, salivation, conjunctival irritation, difficulty

breathing, pleuritic chest pain, and bronchospasm. Ingestion generally

produces mild to severe oral and esophageal burns and GI bleeding,

perforation, edema, necrosis, stenosis (narrowing of the GI passage)

and fistulas (abnormal passages or outpocketings). Other intestinal

injuries may also occur. Areas of stricture may develop about 3 weeks

after ingestion. Eye exposure may cause pain, swelling, corneal

erosions, and blindness.

C. Incident Data

The staff reviewed several sources for information of adverse

health effects

[[Page 71802]]

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.

1. Medical Literature

A recent article in the medical literature analyzed data from the

Toxic Exposure Surveillance System (``TESS'') for 1993 through 1995.

The American Association of Poison Control Centers (``AAPCC'') collects

reports of exposures to toxic chemicals (drugs, household products,

poisonous plants, etc.) made to participating poison control centers

within the United States in the TESS data base. The TESS data base

contains 759 reports of exposures to MAA-containing nail products. Most

of the exposures to children less than 6-years-old occurred in the home

and involved either ingestion or both dermal contact and ingestion.

Children less than 6-years-old accounted for 564 exposures. Two-year-

old children were most at risk (approximately 330 exposures).

Approximately 10 percent of young children suffered moderate to major

injuries.1

---------------------------------------------------------------------------

\1\ ``Minor symptoms'' means that the patient exhibited some

minimal signs or symptoms that resolved rapidly. ``Moderate

symptoms'' means the patient exhibited signs or symptoms that were

more pronounced, prolonged, or of a systemic nature which usually

required some form of treatment (symptoms were not life threatening

and there was no residual disability or disfigurement). ``Major

symptoms'' means the patient exhibited some symptoms that were life-

threatening or resulted in disfigurement or residual disability.

---------------------------------------------------------------------------

A second recent 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. In the first case, a 21-

month-old male accidentally ingested approximately 3-5 ml of a product

containing at least 98 percent MAA. The child began drooling, gagging,

and vomiting. Physicians at the emergency room (``ER'') of a local

hospital observed that the child was in great distress on arrival 30

minutes after ingestion. He required endotracheal intubation to

maintain the airway and upper GI endoscopy. The upper GI tract,

pharynx, and airways showed severe tissue damage. He developed

bilateral pneumonia and respiratory distress with stridor (a harsh,

high-pitched respiratory sound often associated with acute laryngeal

obstruction). He required positive pressure ventilation for 6 days and

parenteral nutrition for 15 days. A regular diet was resumed only after

he was discharged from the hospital 28 days after he was admitted.

Although x-rays of the esophagus and stomach appeared normal one month

after discharge, the child experienced intermittent episodes of choking

and vomiting. One year later, x-rays confirmed a stricture of the

esophagus. Skin burns on the lips, chin, and neck resolved without

permanent scarring.

A 2\1/2\-year-old male spilled approximately 5-7 ml of a product

containing at least 98.5 percent MAA onto his face, right arm, and

chest. He immediately began screaming. The affected areas were

immediately rinsed with water, and he was treated at a nearby hospital

20 minutes later. ER personnel noted patchy erythema of the face,

chest, right arm, and flank. Blisters developed on his chest. Treatment

included rinsing his body and applying silver sulfadiene and aloe to

burn areas. All burn areas healed without scarring.

A 27-year-old female ingested two artificial nail products. The

first contained MAA and methylethyl ketone. The second product

contained ethyl methacrylate (an ester of MAA), proprietary modifiers,

and polymerization accelerators. The woman arrived at the ER 30 minutes

after ingestion with symptoms of lethargy and cyanosis (a bluish color

of the skin). She also exhibited lesions of the pharynx, mucosal injury

in the mouth and pharynx, and ulcerated areas in the upper esophagus.

Areas of persistent ulceration in the esophagus were still present

after 7 days. She was able to eat a normal diet only after 14 days of

hospitalization. These corrosive injuries were due to the MAA as none

of the other ingredients in these products were known to be corrosives.

2. CPSC Databases

CPSC has several databases for poison incidents--the National

Electronic Injury Surveillance System (``NEISS'') (January 1988--

September 30, 1998), the Injury and Potential Injury Incident

(``IPII'') data base (January 1980--September 30, 1998), the In-Depth

Investigations (``INDP'') data base (January 1980--September 30, 1998),

and the Children and Poisonings (``CAP'') data base (1978-1987). The

staff reviewed these databases for incidents involving nail primers.

Between 1988 and September 30, 1998, the staff identified 85 cases

as exposures to nail products specifically identified as primers or as

containing MAA. It is possible that other incidents may have implicated

primers and that some of the primers involved in these incidents did

not contain MAA.

NEISS is a stratified probability sample of ER hospitals in the

United States and its territories. The staff computed both the national

estimates and sampling errors for ER visits by children less than 5

years old due to exposures to nail primers. Approximately 2,723

estimated ER visits due to exposures to nail primers occurred between

January 1988 and September 1998. The lower and upper 95 percent

confidence limits of this estimate were 1,756 and 3,690 respectively.

Hospitalization was necessary in approximately 10 percent of estimated

ER visits (262). The home was the location of exposure in 83 percent of

the estimated ER visits (2,272). Primers accounted for 11 of the total

15 hospitalizations associated with nail products.

The INDP files provide additional details on some of these

incidents. In one incident, a 2-year-old female spilled a bottle of

nail primer containing MAA when she climbed a chair to reach the

container placed on a table. On opening the bottle, the child spilled

about 1\1/2\ to 2 ounces on her thigh. After trying to rub it off with

her hand she then rubbed her face. The child was quickly rinsed off in

a shower and taken to the ER. She was treated and released. The child

suffered first and second degree burns to her right thigh and both

sides of her face from her eyebrows to the bottom of her cheeks.

A 2-year-old male gained access to an artificial nail kit left on a

living room table. The child was about to ingest the bonding agent

(primer), possibly MAA, when he spilled about one and one-half ounces

on his shirt and around his mouth and nose. He began screaming, turned

pale, appeared lethargic, and his eyes were described as glassy. He was

immediately taken to the ER where his burns were treated. He remained

in the hospital under observation for two nights, was transferred to

another hospital for an endoscopy because of difficulty swallowing, and

was released after a total of four nights in the hospital.

A 12-month-old male experienced chemical burns to his hands and

mouth from a fingernail primer. The child removed the cap of the primer

bottle, and about one ounce of the primer spilled on his hand. The

child then rubbed his mouth with his hand and began drooling and

frothing. He was immediately taken to the hospital. His chemical burns

were treated, and he was released the same day.

[[Page 71803]]

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. This incident is discussed below. There were 32

poisoning outcomes coded as moderate (10.7 percent) and 137 poisonings

(39.3 percent) coded as having minor outcomes.

The AAPCC also provided additional information on some exposures

reported to, and collected by individual poison control centers. All

these exposures involved MAA-containing nail primers. All incidents

except one occurred in the child's own residence or in someone else's

residence. A summary of the more significant cases from the collection

follows below.

In an incident coded as having a major medical outcome (1997), a 3-

year-old female experienced burns to her lips and cheeks when she

attempted to ingest a nail primer at a beauty salon. She also suffered

an anaphylactic reaction, presumably to the MAA in the primer. She

remained in a pediatric intensive care unit (ICU) for 2 days. On the

third day, she was transferred to a regular bed and her open cheek

blisters had healed sufficiently to allow treatment with antibiotic

ointment. An endoscopy on day 4 revealed no GI burns, and she was

discharged on day 5.

A 1\1/2\-year-old female experienced burns over half her chest

after spilling a bottle of primer on herself. The child required

outpatient treatment at a burn center for the next 3 weeks and remained

in pain for much of that period. According to the parents, her

physician at the Center was considering skin grafts. The burns required

approximately 4 weeks to heal.

A 20-month-old female spilled some primer in the process of

attempting to ingest it. Blisters formed on the skin and most of the

face within 30 minutes and the child was in evident pain. The pain

persisted several days, and the burns did not begin to resolve for

another week. The primary physician originally recommended consultation

with a plastic surgeon; however, the burns eventually healed without

scarring.

4. FDA Database

The FDA's CVRP database 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 proposing a rule that would require special

packaging for household products containing more than 5 percent

methacrylic acid.

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. The severity of burns to a human

from corrosive chemicals is dependent on duration of exposure, site of

contact, area of contact, volume and concentration of the product, and

the chemical characteristics of the product. 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; in terms of acidity, acetic acid is

1.3-fold stronger than MAA when concentration is expressed in percent

units. 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.

Human evidence does not associate exposures to commercial vinegar

(4 to 6 percent acetic acid) with skin burns but suggests these

concentrations cause mild skin irritation. The Toxicological Advisory

Board (U.S. CPSC, 1982) similarly concluded that 5 percent acetic acid

is a weak skin irritant. However, doubling the acetic acid

concentration to 10 percent results in classification as a strong skin

irritant. Doubling the acetic acid concentration yet again to 20

percent requires labeling as a poison under Section 3(b) of the FHSA,

16 CFR 1500.129.

Similarly, concentrations of 4.8 percent MAA cause no irritation

(in aqueous solution) or only mild irritation (in acetone solution) to

the skin of mice. Doubling that concentration to 9.6 percent in an

acetone solution results in epithelial necrosis (tissue destruction)

and adverse effects in the dermis of the skin. This degree of injury

constitutes a second degree burn to the skin and can best be

characterized as severe irritation. Doubling the MAA concentration

again to 19.2 percent causes visible destruction to skin epithelium and

injury throughout all layers of the skin, including the dermis and

submucosal musculature. These skin injuries, if not overtly corrosive,

border on corrosive, causing ``visible destruction or irreversible

alterations in the tissue at the site of contact'' as defined under the

FHSA, 16 CFR 1700.3(c)(3).

Increasing degrees of injury can also be predicted to the eyes with

corresponding changes in MAA concentration (4.8, 9.6, and 19.2

percent). In general, acid solutions with a pH of 2.5 or above cause

little damage to the eye (the lower the pH, the stronger the acid). For

example, the Toxicological Advisory Board classified a solution of 3

percent acetic acid, pH 2.53, as a moderate eye irritant. A 4.8 percent

solution of MAA has a pH of 2.46, and probably would also be considered

a moderate eye irritant, causing reversible inflammatory changes in the

eye and its surrounding mucous membranes. Doubling the MAA

concentration to 9.6 percent produces a solution with a pH of 2.3. This

pH has the potential to produce more serious eye injury with

inflammation of the iris and opacity of the cornea. Doubling the MAA

concentration yet again to 19.2 percent results in a solution of 2.15,

well within the range capable of causing corrosive eye injuries.

The use of organic solvents such as acetone or ethyl acetate in MAA

solutions is likely to increase the degree of injury to eyes, mucous

membranes of the GI and respiratory tract, and skin. MAA is soluble in

aqueous solutions only to a limited extent (10% maximum). Any

concentration of MAA exceeding 9 percent would only dissolve in organic

solvents such as acetone that not only cause mild irritation in their

own right but exacerbate the toxic effects of MAA itself.

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 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. The weight of the evidence indicates

that solutions containing 5 percent MAA

[[Page 71804]]

will not cause serious personal harm or illness in young children.

Because the staff is not aware of data defining the precise point

between 5 and 10 percent at which injury becomes serious, the staff

recommends that child-resistant packaging be required for products

containing more than 5 percent MAA to protect children from potential

serious injury. The Commission solicits comments on this level.

E. Statutory Considerations

1. Hazard to Children

As noted above, the toxicity data concerning ingestion of MAA

demonstrate that MAA can cause serious illness and injury to children.

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 preliminarily finds that the degree and nature of the hazard

to children from handling and ingesting household products containing

MAA is such that special packaging is required 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

In issuing a standard for special packaging under the PPPA, the

Commission is required to find that the special packaging is

``technically feasible, practicable, and appropriate.'' 15 U.S.C.

1472(a)(2). Technical feasibility may be found when technology exists

or can be readily developed and implemented 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. Packaging is appropriate when complying

packaging will adequately protect the integrity of the substance and

not interfere with its intended storage or use.

The staff evaluated the packaging of ten nail primer products. Five

of these nail primers contained MAA. Four of the five were packaged in

0.25 to 2 ounce brown or tinted glass bottles with 13-20 millimeter

(``mm'') non-CR continuous threaded (``CT'') plastic closures. One was

in a brown plastic bottle with a non-CR plastic closure. Three of the

five packages included a built-in applicator brush, one had a separate

applicator brush, and one completely lacked an applicator brush. One

primer was packaged in a plastic marker pen with a fiber applicator

tip, preventing any substantial flow or spillage of free liquid from

the device. The staff is aware of a similar device used for an MAA-

containing primer sold through a mail order catalog.

Packaging for MAA-containing nail primers that is senior friendly

(``SF'') and CR is technically feasible. There are currently available

20 mm 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 has

indicated to staff that it could develop a 20 mm CR and SF cap with a

built-in applicator brush suitable for use with MAA within 6 months to

a 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. However, this should not present a problem since some of the

smallest sizes of bottles used for MAA-containing primers (0.25 ounces)

already have a 20 mm finish. Manufacturers of MAA-containing primers

concerned with spillage have the additional option of using a variety

of commercially available restrictive inserts to decrease the inside

diameter of the bottle opening in conjunction with CR 20 mm finishes.

One manufacturer of MAA-containing primers currently uses such a

restriction.

Special packaging for MAA-containing household products is

practicable. CT caps that meet the senior friendly and CR testing

requirements have been in mass production for many years. A 20 mm

continuous threaded closure that is CR and SF but lacks an insert for a

brush is now in mass production. Similarly, a 28 mm continuous threaded

closure that is CR and SF and does have an insert for a brush is in

mass production. 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 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).

The Commission has considered these factors with respect to the

various determinations made in this notice, and preliminarily 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. An overcap covers the applicator

tip. Several manufacturers market this type of device for applying nail

primer. Some of these primers contain MAA.

The Commission believes that MAA-containing primers packaged in

this type of device 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).

Although it might be possible to develop a lug finish CR closure to

overcap these devices, based on the design of these devices and

available injury information, the Commission

[[Page 71805]]

does not believe that a CR cap is necessary. 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 proposes to exempt 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.

The Commission proposes 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. This includes time for closure manufacturers to produce the

20 mm closures and for product manufacturers to change existing

assembly lines to accommodate these closures. Some manufacturers may

need to change the bottles currently in use to bottles with 20 mm

finishes. A year provides time to produce commercial quantities of the

20 mm CR and SF closures, adjust assembly lines to a different bottle

size, and conduct testing following the PPPA protocol.

Thus, the Commission proposes that a rule would take effect 12

months after publication of a final rule and would 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 a

preliminary assessment of the impact of a rule to require special

packaging for household products containing more than 5 percent

methacrylic acid.

As noted above, the Commission is aware of 13 companies that market

nail primers containing MAA. Seven of these may be small businesses. As

discussed above, the technology exists to produce CR packaging suitable

for use with MAA-containing nail primers. Requiring special packaging

for these nail primers may affect many small suppliers. However, the

impact on any individual supplier is expected to be small. Generally,

incremental costs for CR packaging are low relative to the retail cost

of the product. Moreover, these incremental costs would likely be

passed on to users (professional nail technicians and consumers who

purchase these nail primers). Thus, based on current information, the

Commission certifies that the proposed rule is not likely to have a

substantial effect on a significant number of small businesses. The

Commission requests suppliers, particularly small businesses, to

provide information on the impact the proposed rule would have on them.

I. Environmental Considerations

Pursuant to the National Environmental Policy Act, and in

accordance with the Council on Environmental Quality regulations and

CPSC procedures for environmental review, the Commission has assessed

the possible environmental effects associated with the proposed PPPA

requirements for MAA-containing products.

The Commission's regulations state that rules requiring special

packaging for consumer products normally have little or no potential

for affecting the human environment. 16 CFR 1021.5(c)(3). Nothing in

this proposed rule alters that expectation. Therefore, because the rule

would have no adverse effect on the environment, neither an

environmental assessment nor an 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.

The PPPA provides that, generally, when a special packaging

standard issued under the PPPA is in effect, ``no State or political

subdivision thereof shall have any authority either to establish or

continue in effect, with respect to such household substance, any

standard for special packaging (and any exemption therefrom and

requirement related thereto) which is not identical to the [PPPA]

standard.'' 15 U.S.C. 1476(a). Upon application to the Commission, a

State or local standard may be excepted from this preemptive effect if

the State or local standard (1) provides a higher degree of protection

from the risk of injury or illness than the PPPA standard and (2) does

not unduly burden interstate commerce. In addition, the Federal

government, or a State or local government, may establish and continue

in effect a non-identical special packaging requirement that provides a

higher degree of protection than the PPPA requirement for a household

substance for the Federal, State or local government's own use. 15

U.S.C. 1476(b).

Thus, with the exceptions noted above, the proposed 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 proposed 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 proposes to amend 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 republishing the introductory text

of paragraph (a) and adding new paragraph (a)(29) 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

[[Page 71806]]

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: the methacrylic acid is contained

by the absorbent material so that no free liquid is within the device;

and under any reasonably foreseeable conditions of use the methacrylic

acid will emerge only through the tip of the device.

* * * * *

Dated: December 21, 1998.

Sadye E. Dunn,

Secretary, Consumer Product Safety Commission.

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.

[FR Doc. 98-34345 Filed 12-29-98; 8:45 am]

BILLING CODE 6355-01-P