[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Proposed Rules]
[Page 2439-2443]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja09-58]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Children's Products Containing Lead; Interpretative Rule on
Inaccessible Component Parts
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed interpretative rule.
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SUMMARY: On August 14, 2008, Congress enacted the Consumer Product
Safety Improvement Act of 2008 (CPSIA), Public Law 110-314, 122 Stat.
3016. Section 101(a) of the CPSIA provides for specific lead limits in
children's products. Section 101(b)(2) of the CPSIA provides that the
lead limits will not apply to any component part of a children's
product that is not accessible to a child through normal and reasonably
foreseeable use and abuse. Section 101(b)(2)(B) of the CPSIA further
directs the Commission to promulgate by August 14, 2009, a rule
providing guidance with respect to what product components or classes
of components will be considered to be inaccessible. In this document,
the Commission is proposing an interpretative rule providing guidance
on inaccessible component parts.
DATES: Written comments and submissions in response to this notice must
be received by February 17, 2009.
FOR FURTHER INFORMATION CONTACT: Comments should be e-mailed to
Sec101InaccessibleRule@cpsc.gov. Comments should be captioned ``Section
101 Inaccessible Component Parts.'' Comments may also be mailed,
preferably in five copies, to the Office of the Secretary, Consumer
Product Safety Commission, Room 502, 4330 East West Highway, Bethesda,
Maryland 20814, or delivered to the same address (telephone (301) 504-
7923). Comments also may be filed by facsimile to (301) 504-0127.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA provides for specific lead limits in children's products.
Section 101(a) of the CPSIA provides that by February 10, 2009,
products designed or intended primarily for children 12 and younger may
not contain more than 600 parts per million (ppm) of lead. After August
14, 2009, products designed or intended primarily for children 12 and
younger cannot contain more than 300 ppm of lead. On August 14, 2011,
the limit may be further reduced to 100 ppm, unless the Commission
determines that it is not technologically feasible to have this lower
limit. A children's product is defined as a consumer product designed
or intended primarily for children 12 years of age or younger under
section 235(a) of the CPSIA (to be codified at section 3(a)(2) of the
Consumer Product Safety Act). In determining whether a consumer product
is primarily intended for a child 12 years of age or younger, the
following factors will be considered:
A statement by the manufacturer about the intended use of
such product, including a label on such product if such statement is
reasonable.
Whether the product is represented in its packaging,
display, promotion or advertising as appropriate for use by children 12
years of age or younger.
Whether the product is commonly recognized by consumers as
being intended for use by a child 12 years of age or younger.
The Age Determination Guidelines issued by the Commission
in September 2002, and any successor to such guidelines.
Section 101(b)(2) of the CPSIA provides that the lead limits do not
apply to component parts of a product that are not accessible to a
child. This section specifies that a component part is not accessible
if it is not physically exposed by reason of a sealed covering or
casing and does not become physically exposed through reasonably
foreseeable use and abuse of the product including swallowing,
mouthing, breaking, or other children's activities, and the aging of
the product, as determined by the Commission. Paint, coatings, or
electroplating may not be considered to be a barrier that would render
lead in the substrate to be inaccessible to a child. Section
101(b)(2)(B) further provides that the Commission must promulgate a
rule providing guidance with respect to what product components or
classes of components will be considered to be inaccessible.
To the extent a component part is inaccessible to a child, that
component part would be relieved from the testing requirement of
section 102 of the CPSIA for purposes of supporting the required
certification. Of course even where a component part has been so
relieved of the testing requirement, other component parts that are
accessible must still meet the statutory lead level requirements, and
would be subject to the testing requirement of section 102. The
Commission will obtain and test products in the marketplace to assure
that this remains the case and will take appropriate enforcement action
in situations where the limits are exceeded in accessible parts.
[[Page 2440]]
In addition, if the Commission determines that it is not
technologically feasible for certain electronic devices to fully comply
with the lead limits, section 101(b)(4) of the CPSIA provides that the
Commission will issue requirements by regulation to eliminate or
minimize the potential for exposure to and accessibility of lead in
such electronic devices. A notice of proposed rulemaking on electronic
devices is published elsewhere in this Federal Register.
On September 26, 2008, the Commission staff requested comments on
the CPSC Web site on section 101(b)(2), Exception for Inaccessible
Component Parts, and section 101(b)(4), Certain Electronic Devices. In
particular, the staff requested comments and information on the
identification of any component part of any children's product that
currently contains lead in any concentration; whether any children's
product currently on the market contains lead-containing component
parts that are inaccessible, and the reasons why such component parts
are considered inaccessible; and whether test methods or processes
exist that are used or may be used to assess the accessibility by
children of component parts of products. Comments were due on October
31, 2009. The proposed interpretative rule provides guidance for
determining whether lead-containing components of children's products
are not accessible to children.
B. Comments
Seventeen comments addressed issues related to accessibility or
inaccessibility of lead-containing component parts of children's
products, including methods for evaluating accessibility. Three
comments discussed fully enclosed parts that should be deemed
inaccessible. Four comments asserted that accessibility should refer to
exposure to lead, e.g., leaching of lead from the product, not physical
accessibility. Two comments suggested that only materials that
physically degrade or break down should be considered as resulting in
accessibility. Fourteen comments stated that accessible parts should be
only those that are ingestible, and refer to testing for small parts.
Seven comments stated that the use of tools should not be considered in
evaluating accessibility.
The CPSIA defines accessibility as physical exposure to lead-
containing component parts. Based on staff's review, the Commission
preliminarily determines that an accessible component part of a
children's product is one that a child may touch, and an inaccessible
component part is one that is located inside the product that a child
cannot touch. The Commission preliminarily accepts staff's
recommendation to assess inaccessibility through the use of
accessibility probes and use and abuse testing.
Further, based on staff's review, the Commission preliminarily
determines that an accessible component part includes a part that a
child may touch or place in the mouth, not just a component part that a
child might ingest, since exposure to lead may occur during direct
mouthing of an object or mouthing of fingers/hands. In addition, a
definition of accessibility that refers solely to exposure to lead,
e.g., resulting from leaching of lead from a part, or degradation of a
material, is not consistent with the definition of accessibility
provided in the CPSIA. The Commission also preliminarily finds that the
intentional disassembly of products by children through the use of
tools should not be considered in evaluating products for accessibility
of lead-containing components.
Several comments suggested that the accessibility probes defined in
the CPSC's regulations for evaluating accessibility of sharp points or
sharp metal or glass edges could be used to evaluate accessibility of
lead-containing components. The Commission preliminarily finds that
these accessibility probes could be used to determine whether a lead-
containing component part of a product is accessible to a child.
Three comments suggested that use and abuse tests could be used to
assess whether a product contains ingestible small parts. The
Commission preliminarily finds that appropriate use and abuse tests as
defined in current CPSC regulations could be part of an evaluation of
whether certain component parts of a product become accessible to a
child during normal and reasonably foreseeable use and abuse of the
product by a child. However, accessibility does not refer only to
ingestion of lead-containing components. Rather, the definition of
accessibility provided in the CPSIA is physical contact with lead-
containing component parts, and the Commission preliminarily finds that
this includes touching, placing in the mouth, or ingestion of a part of
a product.
C. Proposed Guidance for Inaccessible Component Parts
A component part of a product that contains lead at a level that
exceeds the lead limits specified in the CPSIA may be excluded from
compliance with the specified limits if the part is not accessible to a
child. The CPSIA specifies that accessibility is defined as physical
contact with lead-containing component parts.
Thus, the Commission accepts the staff's recommendation to consider
that an accessible component part of a children's product is one that a
child may touch, and an inaccessible component part is one that is
located inside the product and not capable of being touched by child,
whether or not such part is visible to a user of the product. While an
inaccessible part may be enclosed in any type of material, e.g., hard
or soft plastic, rubber or metal, the CPSIA prohibits the use of
surface treatments on a lead-containing component part in the form of
paint, coatings, or electroplating as a barrier that would render lead
in the substrate to be inaccessible to a child. The Commission seeks
comments on whether fabric coverings could be used as a barrier that
would make lead within the product inaccessible to a child.
Since a lead-containing component part may be inside a product and
not actually fully enclosed by another part of the product, children
may have opportunities to contact lead-containing component parts;
e.g., they might touch a part with their fingers or tongues. The
Commission's proposed approach to addressing section 101(b)(2) is to
describe means to test accessibility of potentially lead-containing
component parts through evaluation of whether children might touch a
lead-containing part.
Currently the Commission's regulations provide that sharp points
and sharp metal or glass edges on toys or other articles intended for
use by children under age eight years present a potential risk of
injury. 16 CFR 1500.48 and 1500.49 provide specific technical
requirements for determining accessibility of sharp points or edges
through use of accessibility probes specified in these regulations.
Both provisions require that a test of accessibility of sharp points or
edges shall be applied both before and after use and abuse tests
specified in 16 CFR sections 1500.50 through 1500.53. As defined in 16
CFR 1500.48 and 1500.49, an accessible sharp point or edge is present
in the product if the result of the test is that any part of the
specified portion of the accessibility probe contacts the sharp part.
The ASTM F963 Standard Consumer Safety Specification for Toy Safety
(ASTM F963 standard) also includes requirements for accessible sharp
points and sharp edges through references to the definitions at 16 CFR
1500.48 and 1500.49. As with the corresponding
[[Page 2441]]
regulations, the ASTM F963 standard indicates that accessibility is to
be determined both before and after use and abuse tests.
The Commission proposes that the accessibility probes specified for
determining accessibility of sharp points or edges be designated as
appropriate for determining whether a lead-component part of a product
is accessible to a child. An accessible lead-containing component part
would be defined as one that contacts any portion of the specified
segment of the accessibility probe. An inaccessible lead-containing
component part would be defined as one that cannot be contacted by any
portion of the specified segment of the accessibility probe. Under the
provisions of the CPSIA, a lead-containing component part is not
subject to the lead limits if it is not accessible to a child.
1. Description of Accessibility Probes
16 CFR sections 1500.48 and 1500.49 provide identical technical
requirements for two accessibility probes applicable to two categories
of children's products, based on the age of the intended consumer. A
detailed drawing of the probes is reproduced below as Figure 1.
The two probes differ by size for use with products intended for
children aged three years or less (Probe A) or for children up to eight
years (Probe B). The probe section of the test fixture is a jointed,
three-segment cylindrical piece (the part of the probe on the right
side of the illustration in Figure 1) attached to a larger collared
section. Under 16 CFR 1500.48, for example, an accessible point is one
that can be contacted by any portion forward of the collar. For
children aged three years and younger, the probe section is 0.220
inches in diameter with each of the three sections 0.577 inches in
length, for a total length of 1.731 inches.
[GRAPHIC] [TIFF OMITTED] TP15JA09.000
2. Use and Abuse Tests
16 CFR 1500.50 through 1500.53 (excluding the bite tests of
1500.51(c) and 1500.52(c)) provide specific test methods for simulating
normal use of toys and other articles intended for use by children as
well as the reasonably foreseeable damage or abuse to which the
articles may be subjected. The test methods are for use in exposing
potential hazards that would result from the normal use or the
reasonably foreseeable damage or abuse of such articles intended for
children.
The first of these four sections (16 CFR sections 1500.50)
describes the objective, general application of the tests, and
definitions; the next three sections detail the test methods for
articles intended for specified age groups of children: 18 months of
age or less, over 18 months but not over 36 months of age, and over 36
months but not over 96 months of age. Products for each of the age
groups may be subject to up to five different tests (impact test,
flexure test, torque test, tension test, and compression test)
depending on the specifications of the regulations and the
characteristics of the product.\1\
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\1\ The staff's toy testing manual, which is on the Commission's
Web site at http://www.cpsc.gov/BUSINFO/testtoys.pdf, explains in
greater detail the sharp point accessibility test and the use and
abuse testing currently conducted by Commission staff.
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The Commission preliminarily concludes that these use and abuse
tests are appropriate for evaluating whether lead-containing component
parts of a product become accessible to a child during normal and
reasonably foreseeable use and abuse of the product by a child, since
the stated purpose of the tests is to simulate use and damage or abuse
of a product by children and to expose potential hazards that might
result from use and abuse. However, the Commission is interested in
obtaining comment on the effect, if any, of product aging on the use
and abuse evaluation.
3. Testing Products for Children Aged 12 Years and Under
The existing testing paradigms for accessibility of sharp points
and edges are intended for products for use by children in designated
age groups up to age eight years. The Commission preliminarily
concludes that the application of the current accessibility tests is
sufficient for products intended for children older than age eight
years, given that the accessibility probes are designed to test whether
children's relatively small fingers might enter small holes, gaps, or
recesses where they could physically contact certain components, and
considering that older children's larger fingers would likely have more
limited access to such small holes, gaps, or recesses.
Use and abuse testing is also designated for products for children
up to age eight years. While the Commission recognizes that as children
age they gain strength and dexterity and participate in a greater range
of
[[Page 2442]]
activities that could lead to inaccessible components eventually
becoming accessible, older children (ages 9 through 12 years) also gain
cognitive skills and knowledge that they use to care for and
appropriately use their toys and other articles. The Commission
preliminarily determines, therefore, that applying the use and abuse
tests described for products for children up to age eight years to
products for children through age 12 years will appropriately reveal
inherent characteristics or possible defects in products that could
result in accessibility of components.
Further, the Commission recognizes that as children 12 years of age
or younger grow and mature, they become, in many respects,
indistinguishable from children older than 12 years, and even adults.
Consequently, the Commission preliminary determines that intentional
disassembly or destruction of products by children older than age 8
years by means or knowledge not generally available to younger children
should not be considered in evaluating products for accessibility of
lead-containing components. For example, accessibility arising from the
use of tools, such as a screwdriver, should not be considered in
accessibility and use and abuse testing.
On the other hand, testing of products should consider the normal
and expected children's interactions with products. For example,
children may be expected to operate zippers or snaps, open unsealed and
unsecured compartments, or remove unsecured covers. Products with such
features should be evaluated for accessibility in all the intended and
likely configurations of the product during use by children.
D. Effective Date
The Commission was directed by the CPSIA to promulgate a rule
providing guidance on inaccessible component parts by August 14, 2009.
Although interpretative rules do not require a particular effective
date under the Administrative Procedure Act, 5 U.S.C. 553(d)(2), the
Commission recognizes the need for providing the guidance
expeditiously. Accordingly, the proposed interpretative rule would take
effect upon publication of a final interpretative rule in the Federal
Register.
E. Request for Comments
Interested persons are invited to submit comment on the proposed
rule. Comments should be e-mailed to Sec101InaccessibleRule@cpsc.gov.
Comments should be captioned ``Section 101 Inaccessible Component
Parts.'' Comments may also be mailed, preferably in five copies, to the
Office of the Secretary, Consumer Product Safety Commission, Room 502,
4330 East West Highway, Bethesda, Maryland 20814, or delivered to the
same address (telephone (301) 504-7923). Comments also may be filed by
facsimile to (301) 504-0127.
F. List of Relevant Documents
Memorandum from Kristina M. Hatlelid, Ph.D., M.P.H., Toxicologist,
Directorate for Health Sciences ``Consumer Product Safety Improvement
Act of 2008 (CPSIA) Exclusions and Exemptions from Compliance with
Limits for Lead: Inaccessibility and Certain Electronic Devices.''
December 2008.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
G. Conclusion
For the reasons stated above, the Commission amends Title 16 of the
Code of Federal Regulations as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority for part 1500 is amended to read as follows:
Authority: 15 U.S.C. 1261-1278, 122 Stat. 3016.
2. Add a new Sec. 1500.87 to read as follows:
Sec. 1500.87 Children's Products Containing Lead: Inaccessible
Component Parts.
(a) The Consumer Product Safety Improvement Act (CPSIA) provides
for specific lead limits in children's products. Section 101(a) of the
CPSIA provides that by February 10, 2009, products designed or intended
primarily for children 12 and younger may not contain more than 600 ppm
of lead. After August 14, 2009, products designed or intended primarily
for children 12 and younger cannot contain more than 300 ppm of lead.
On August 14, 2011, the limit may be further reduced to 100 ppm after
three years, unless the Commission determines that it is not
technologically feasible to have this lower limit. Paint, coatings or
electroplating may not be considered a barrier that would make the lead
content of a product inaccessible to a child.
(b) Section 101(b)(2) of the CPSIA provides that the lead limits do
not apply to component parts of a product that are not accessible to a
child. This section specifies that a component part is not accessible
if it is not physically exposed by reason of a sealed covering or
casing and does not become physically exposed through reasonably
foreseeable use and abuse of the product including swallowing,
mouthing, breaking, or other children's activities, and the aging of
the product, as determined by the Commission. Paint, coatings, or
electroplating may not be considered to be a barrier that would render
lead in the substrate to be inaccessible to a child.
(c) Section 101(b)(2)(B) of the CPSIA directs the Commission to
promulgate by August 14, 2009, this interpretative rule to provide
guidance with respect to what product components or classes of
components will be considered to be inaccessible.
(d) The accessibility probes specified for sharp points or edges
under the Commission's regulations at 16 CFR 1500.48-1500.49 will be
used to assess the accessibility of lead-component parts of a
children's product. A lead-containing component part would be
considered accessible if it contacts any portion of the specified
segment of the accessibility probe. A lead-containing component part
would be considered inaccessible if it cannot be contacted by any
portion of the specified segment of the accessibility probe.
(e) The use and abuse tests set forth under the Commission's
regulations at 16 CFR 1500.50-1500.53 (excluding the bite tests of
1500.51(c) and 1500.52(c)) will be used to evaluate accessibility of
lead-containing component parts of a children's product as a result of
normal and reasonably foreseeable use and abuse of the product by
children that are 18 months of age or less, over 18 months but not over
36 months of age, and over 36 months but not over 96 months of age.
(f) The use and abuse tests set forth under the Commission's
regulations at 16 CFR 1500.50-1500.53 (excluding the bite tests of
1500.51(c) and 1500.52(c)) intended for children aged 37-96 months will
be used to evaluate accessibility of lead-containing component parts of
a children's product as a result of normal and reasonably foreseeable
use and abuse of the product by a child through 12 years of age.
(g) The intentional disassembly or destruction of products by
children older than age 8 years by means or knowledge not generally
available to younger children, including use of tools, will not be
considered in evaluating
[[Page 2443]]
products for accessibility of lead-containing components.
Dated: January 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-717 Filed 1-14-09; 8:45 am]
BILLING CODE 6335-01-P