Children's Products Containing Lead; Interpretative Rule on Inaccessible Component Parts, 39535-39540 [E9-18852]
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39535
Rules and Regulations
Federal Register
Vol. 74, No. 151
Friday, August 7, 2009
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[FR Doc. E9–18541 Filed 8–6–09; 8:45 am]
11 CFR Part 111
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Procedural Rules for Audit Hearings
BILLING CODE 6715–01–P
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AGENCY:
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ACTION:
SUMMARY: On July 10, 2009, the Federal
Election Commission published a
Procedural Rule (‘‘Commission’’)
instituting a program that provides
committees that are audited pursuant to
the Federal Election Campaign Act of
1971, as amended (‘‘FECA’’) with the
opportunity to have a hearing before the
Commission prior to the Commission’s
adoption of a Final Audit Report.
Procedural Rules for Audit Hearings, 74
FR 33140 (July 10, 2009). The
Commission is now adding a further
statement at the end of that procedural
rule to conform this statement to other
agency procedural rules.
DATES: Effective August 7, 2009.
FOR FURTHER INFORMATION CONTACT:
Joseph F. Stoltz, Assistant Staff Director,
Audit Division, 999 E Street, NW.,
Washington, DC 20463, (202) 694–1650
or (800) 424–9530.
SUPPLEMENTARY INFORMATION: On July
10, 2009, the Commission published a
Procedural Rule instituting a program
that provides committees that are
audited pursuant to the Federal Election
Campaign Act of 1971, as amended
(‘‘FECA’’) with the opportunity to have
a hearing before the Commission prior
to the Commission’s adoption of a Final
Audit Report. Procedural Rules for
Audit Hearings, The Commission is now
adding a statement to that procedural
rule to conform the rule to other agency
procedural rules and policy statements.
On page 33143, in the first column, at
the end of paragraph E, insert the
following:
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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: Final rule.
SUMMARY: The Consumer Product Safety
Commission (‘‘Commission’’) is issuing
a final rule providing guidance as to
what product components or classes of
components will be considered to be
‘‘inaccessible.’’ Section 101(b)(2)(A) of
the Consumer Product Safety
Improvement Act (‘‘CPSIA’’) provides
that the lead limits shall 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 requires the
Commission to issue, by August 14,
2009, a rule providing guidance with
respect to what product components, or
classes of components, will be
considered to be inaccessible. This final
rule satisfies the Commission’s statutory
obligation.
DATES: Effective Date: This
interpretative rule is effective on August
14, 2009.
FOR FURTHER INFORMATION CONTACT:
Kristina Hatlelid, PhD, M.P.H.,
Directorate for Health Sciences,
Consumer Product Safety Commission,
4330 East West Highway, Bethesda,
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Maryland 20814; e-mail
khatlelid@cpsc.gov; telephone 301–504–
7254.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA establishes specific lead
limits in children’s products. Section
101(a) of the CPSIA provides that, as of
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 meet this lower limit. Section
3(a)(16) of the Consumer Product Safety
Act, as amended by section 235(a) of the
CPSIA, defines ‘‘children’s product’’ as
a ‘‘consumer product designed or
intended primarily for children 12 years
of age or younger.’’
B. Statutory Authority
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 under section
101(b)(3) of the CPSIA.
C. Notice of Proposed Rulemaking
In the Federal Register of January 15,
2009 (74 FR 2439), the Commission
published a proposed interpretative rule
providing guidance with respect to what
product components or classes of
components will be considered to be
inaccessible. As stated in the preamble
to the proposed interpretative rule (74
FR at 2440), the Commission
preliminarily determined that:
• An accessible component part of a
children’s product is one that a child
may touch;
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• An inaccessible component part is
one that is located inside the product
and not capable of being touched or
mouthed by a child, whether or not
such part is visible to a user of the
product;
• An inaccessible part is one that may
be enclosed in any type of material, e.g.,
hard or soft plastic, rubber or metal.
However, the Commission requested
comments specifically on the use of
fabric as a barrier, and the impact of
aging on a children’s product;
• To assess whether a part is
inaccessible, the accessibility probes
defined in the Commission’s existing
regulations for evaluating accessibility
of sharp points or sharp metal or glass
edges (16 CFR 1500.48 and 1500.49)
could be used. An accessible leadcontaining 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; and
• 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. The 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. 16 CFR
1500.50–1500.53.
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D. Discussion of Comments to the
Proposed Rule and CPSC’s Responses
The Commission received comments
from trade associations, testing services,
consumer groups, electronic products
associations, youth recreational vehicle
companies, and textile groups. In
general, most comments, particularly
those from consumer groups, agreed
with most of the proposed interpretative
rule, whereas other comments,
particularly those from industry, sought
a narrower or different interpretation of
‘‘accessibility.’’
1. Summary of the Law—Section
1500.87(a)
Proposed § 1500.87(a), in essence,
summarized the lead limits in section
101 of the CPSIA and how, over time,
the limits decrease from 600 ppm to 100
ppm by August 14, 2011 unless the
Commission determines that it is not
technologically feasible to meet this
lower limit. Proposed § 1500.87(a) also
stated that, ‘‘Paint, coatings or
electroplating may not be considered a
barrier that would make the lead
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content of a product inaccessible to a
child.’’
We did not receive any comment on
this provision. However, on our own
initiative, we deleted the sentence
regarding paint, coatings, and
electroplating because the identical
sentence appears in § 1500.87(b).
2. Physical Accessibility—Section
1500.87(b)
Proposed § 1500.87(b) explained that
the lead limits do not apply to
component parts of a product that are
not accessible to a child. The proposal
explained 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. It added that 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.
Some commenters agreed with the
Commission’s determination that
accessibility is defined in the statute as
physical access and stressed that
exposure to lead such as through
leaching is not what was intended.
However, other commenters said the
Commission should explore other
inaccessibility scenarios, not just
physical inaccessibility, including
considering whether children using the
product could be exposed to the lead
that is present. Similarly, other
commenters stated that the physical
contact is only an example of
accessibility and said that evaluations of
accessibility focus on whether parts are
ingestible or mouthable, or alternatively,
consider whether a child will actually
touch the part during foreseeable use or
abuse of the product.
We decline to revise the rule as
suggested by the comments. The statute
refers to physical accessibility of
component parts of products, and this
reference is not simply an example of
how accessibility might be defined. The
proposed interpretative rule followed
the statutory language for determining
inaccessibility. Section 101(b)(2)(A) of
the CPSIA provides that, ‘‘[a]
component part is not accessible under
this subparagraph if such component
part 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’’ (emphasis added). The
statute goes on to state, ‘‘[r]easonably
foreseeable use and abuse shall include
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to, [sic] swallowing, mouthing,
breaking, or other children’s activities,
and the aging of the product.’’ Id.
Swallowing and mouthing are examples
of use and abuse actions to be
considered, but the language of the
statute does not limit consideration to
ingestible or mouthable products.
Courts have routinely found that use of
the word ‘‘including’’ in a statute before
a list of items demonstrates that the list
is illustrative, and not meant to be
exhaustive. See, e.g., West v Gibson, 527
U.S. 212, 217 (1999) (holding that
‘‘including’’ in section 717(b) of Title
VII of the Civil Rights Act which sets
forth the EEOC’s authority to enforce the
antidiscrimination standard ‘‘makes
clear that the authorization is not
limited to the specified remedies there
mentioned * * *’’); Federal Land Bank
of St. Paul v Bismarck Lumbar Co., 314
U.S. 95, 99–100 (1941) (holding that
‘‘the term ‘including’ is not one of allembracing definition, but connotes
simply an illustrative application of the
general principle.’’); Puerto Rico
Maritime Shipping Auth. v ICC, 645
F.2d 1102, 1112 n.26 (DC Cir. 1981) (‘‘It
is hornbook law that the use of the word
‘including’ indicates that the specified
list * * * that follows is illustrative, not
exclusive.’’ (internal citation omitted)).
‘‘Other children’s activities’’ could
reasonably include touching, grasping,
and handling that can lead to physical
exposure to the lead containing parts.
Accordingly, the final rule construes
accessibility to be physical contact with
lead-containing component parts, and
mouthing and swallowing, along with
touching, among the children’s
activities that can result in contact with
the lead-containing parts.
3. Testing and Certification
Requirements for Inaccessible
Component Parts
Some commenters recommended that
the rule explicitly state that inaccessible
component parts are relieved of the
testing requirement of section 102 of the
CPSIA. One commenter said that the
rule should state clearly that no
certificate is required when no
provision of CPSIA or any other rule or
standard applies. In addition, the
commenters requested that the rule
provide that third-party testing is not
required to demonstrate compliance
with section 101 of the CPSIA when the
lead in the product is deemed to be
inaccessible.
In general, inaccessible component
parts do not have to comply with the
lead content limits or be tested and
certified as to lead content. The
accessible portions of a product, unless
specifically excluded from lead content
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requirements or the testing
requirements, would require testing and
certification to the lead content limits.
Currently, third-party testing and
certification is required for toys and
children’s products under the small
parts regulations (16 CFR Part 1501 and
1500.50–53 and 16 CFR 1500(18)(a)(9)),
as well as under the toy safety standard,
ASTM–F963. Accordingly, some of the
tests proposed for evaluating
accessibility are already being
conducted by manufacturers for small
parts evaluations. In addition, toys and
games that are or contain small parts
that are intended for use by children
from 3 to 6 years old are subject to the
labeling requirements of 16 CFR
1500.19. With respect to other
children’s products that do not fall
within the scope of the small parts
regulations, but that contain
inaccessible parts, the manufacturer
currently is not required to provide
third-party testing to demonstrate
inaccessibility. The Commission intends
to address certification requirements
and the establishment of protocols and
standards for ensuring that children’s
products are tested for compliance with
applicable children’s products safety
rules in a separate rulemaking.
4. Rulemaking Authority—Section
1500.87(c)
Proposed § 1500.87(c) cited section
101(b)(2)(B) of the CPSIA as the legal
authority to promulgate the
interpretative rule and stated that the
rulemaking is to be conducted by
August 14, 2009.
We received no comments on this
provision and have finalized it without
change.
5. Use of Accessibility Probes—Section
1500.87(d)
Proposed § 1500.87(d) stated that:
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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 leadcomponent 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.
In general, most commenters agree
with the proposed approach of using
accessibility probes to evaluate whether
certain parts of a product might be
accessible to a child. However, one
commenter stated that probes should be
unnecessary for products that are sealed
and have no accessible cavities.
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The Commission agrees that, for
products that are effectively sealed so
that there is no point of entry to any
internal parts that contain lead, use of
the probes would not be necessary to
demonstrate that the parts are not
accessible. However, it would be
necessary to test the material which
encases or encloses the inaccessible
lead-containing part, unless it is a
material that the Commission has
specifically determined falls below the
lead content limits of the CPSIA. The
Commission established procedures for
a Commission determination that a
specific material or product does not
exceed the lead content limits specified
under section 101(a) of the CPSIA (74
FR 10475 (March 11, 2009)). In addition,
the Commission has issued a notice of
proposed rulemaking regarding lead
content limits on certain materials or
products which have been preliminarily
determined to fall below the lead
content limits of the CPSIA (74 FR 2433
(January 15, 2009)).
Some commenters stated that
accessibility probes could be used to
evaluate products, but they questioned
whether existing test fixtures are
appropriate for the entire age range of
children’s products. The commenters
argued that older children have
developed their motor skills and have
increased agility compared to younger
children for which the probes were
designed.
In considering reasonably foreseeable
use and abuse, the Commission finds
that the accessibility probes are
appropriate for testing the wider range
of products for children through age
twelve years. The probes are used to
evaluate possible gaps or holes in a
product through which a young child’s
finger might physically contact a leadcontaining component part. Because
older children’s larger fingers generally
would have more limited access to gaps
that would be accessible to smaller
children, the Commission believes that,
in most cases, the probes will indicate
whether access is possible.
Some commenters claimed that the
use of accessibility probes for evaluating
accessibility is inappropriate; these
commenters said that the proper method
for determining inaccessibility would
evaluate mouthing and swallowing
behaviors. The commenters argued that
the possibility of simple physical
contact with a lead-containing
component part does not necessarily
lead to mouthing or swallowing, or that
the lead-containing component parts are
not touched during normal and
reasonably foreseeable use and abuse of
the component part.
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We disagree with the comments. The
statute provides for inaccessibility of
component parts based on physical
exposure to the part. Therefore, the
Commission must assess accessibility
based on whether a child may touch a
component part that contains lead above
the lead limits, not simply on whether
a child might ingest or mouth a part of
a product. In addition, we have deemed
that, in the context of an exclusion
request for all-terrain vehicles, the
normal and reasonably foreseeable
contact with lead-containing parts by
children using motorized recreational
vehicles would not be extensive but
would occur. For example, in the
regular use of the product, users will
have to touch the brake and clutch
levers and the throttle controls. It is
reasonable to assume that children will
not be washing their hands immediately
after touching these parts. Average users
(6–12 year olds) do not typically engage
in hand-to-mouth behavior; however, it
is not unreasonable to assume they may
wipe their mouth or face with their
hands while using or right after using
the recreational vehicle. (See Human
Factors Response to Request for
Motorized Recreational Vehicles Group
Request for Exclusion from Lead Limits
under Section 101(b)(1) of the Consumer
Product Safety Improvement Act dated
April, 2009.) Accordingly, the
Commission finds that the accessibility
probes provide an objective means for
evaluating accessibility based on such
physical access.
Some commenters asked that we
clarify that access to a component
containing smaller components that
may, themselves, contain leadcontaining parts does not mean that a
lead-containing component is accessible
if the lead is fully enclosed within the
larger component which can be touched
by an accessibility probe.
The Commission interprets a leadcontaining component part to mean the
material used to construct the part
includes lead in its formulation, not that
the part contains smaller parts that
contain lead. For example, assume that
the product is a sealed ball made of
plastic and that the sealed ball has a
lead content that complies with the
CPSIA lead limits. Inside the sealed ball
are metal beads that contain lead. In this
example, the metal beads are leadcontaining component parts, but the ball
is not. If the sealed ball does not provide
access to the beads inside it, through a
hole or a crevice, or after being subject
to use and abuse testing, then the leadcontaining parts would be deemed
inaccessible. The Commission also
notes that, for certain electronic devices
that contain accessible lead-containing
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parts, there is an interim final rule
which provides exemptions for such
parts for which it is not technologically
feasible to comply with the lead content
limits (74 FR 6990 (February 12, 2009)).
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6. Use of Use and Abuse Tests—Section
1500.87(e) and (f)
Proposed § 1500.87(e) explained that
the use and abuse tests 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 leadcontaining 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.
Proposed § 1500.87(f) was similar to
proposed § 1500.87(e), except that it
referred to use and abuse tests 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 being 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.
In general, most commenters agreed
with the proposed approach of using
existing use and abuse tests to evaluate
the 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.
Some commenters agreed that the use
and abuse tests are appropriate for
evaluating whether ingestible or
mouthable parts might come loose from
a product, but said that intentional
disassembly or destruction by older
children, including use of tools, should
not be considered in evaluating
accessibility. Other commenters
questioned whether the tests are
appropriate for older children given
their increased strength and dexterity.
We acknowledge that older children
have advanced motor skills compared to
younger children. However, older
children also have advanced cognitive
skills and the ability to properly care for
their belongings. For the purposes of
evaluating product integrity, the
Commission believes that the existing
use and abuse tests are appropriate for
revealing inherent characteristics or
possible defects in products that could
result in accessibility of components
and will expose potential hazards that
might result from use and abuse for
most children’s products.
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The test methods in 16 CFR 1500.50–
1500.53 are used to simulate the normal
and reasonably foreseeable use, damage,
or abuse of toys and other articles
intended for children in three separate
age groups. Accordingly, revised
§§ 1500.87(e),(f), and (g) make clear that
the use and abuse tests at 16 CFR
1500.50–1500.53 will be used to
evaluate accessibility of lead-containing
component parts of a children’s product
for the specific age group the product is
intended. In addition, § 1500.87(h) is
revised to make clear that the test under
§ 1500.87(g) will apply to products
intended for children that are over 96
months through 12 years of age.
Accordingly, we have revised
§§ 1500.87(e) through (h) to read as
follows:
(e) For products intended for children
that are 18 months of age or less, the use
and abuse tests set forth under the
Commission’s regulations at 16 CFR
1500.50 and 16 CFR 1500.51 (excluding
the bite test of 1500.51(c)), will be used
to evaluate accessibility of leadcontaining component parts of a
children’s product as a result of normal
and reasonably foreseeable use and
abuse of the product.
(f) For products intended for children
that are over 18 months but not over 36
months of age, the use and abuse tests
set forth under the Commission’s
regulations at 16 CFR 1500.50 and 16
CFR 1500.52 (excluding the bite test of
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.
(g) For products intended for children
that are over 36 months but not over 96
months of age, the use and abuse tests
set forth under the Commission’s
regulations at 16 CFR 1500.50 and 16
CFR 1500.53 (excluding the bite test of
1500.53(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.
(h) For products intended for children
over 96 months through 12 years of age,
the use and abuse tests set forth under
the Commission’s regulations at 16 CFR
1500.50 and 16 CFR 1500.53 (excluding
the bite test of 1500.53(c)) intended for
children aged 37–96 months will be
used to evaluate accessibility of leadcontaining 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.
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7. The Exclusion of the Bite Test From
Use and Abuse Testing
Proposed § 1500.87(e) and (f) referred
to the ‘‘bite tests of 1500.51(c) and
1500.52(c).’’
Some commenters requested an
explanation for the exclusion of the bite
test. One commenter pointed out that
the proposed rule excludes the bite test
from 16 CFR 1500.51 and 1500.52, but
not § 1500.53, and stated that the bite
test from all three sections should be
excluded.
Currently, the Commission does not
use the bite test specified in the three
CFR sections, as a result of a court case
(Clever Idea Co., Inc. v Consumer
Products Safety Commission, 385 F.
Supp. 688 (E.D. N.Y. 1974)) that
questioned the appropriateness of this
test. This requirement may be modified
in a future proceeding.
Because the bite test currently is not
applied as part of use and abuse testing
in general, it will not be applied for the
purposes of evaluating whether leadcontaining component parts are
accessible. Nevertheless, the inclusion
of the bite test in 16 CFR 1500.53 was
inadvertent in the proposed rule, and
we have revised §§ 1500.87(g) and (h) to
exclude the bite test of 16 CFR
1500.53(c).
8. Fabric Coverings Used as Barrier—
Section 1500.87(g)
Several commenters claimed that
fabric coverings are appropriate barriers.
Some commenters gave examples of a
fabric-covered button or base of a zipper
that would form a barrier to a leadcontaining part, such as a metal button
or zipper base, thus rendering it
inaccessible to a child. The commenters
said that such use of fabric must
withstand wear and tear and remain
intact through the life of a garment. In
addition, the commenters noted that
fabrics in footwear applications must be
durable and able to withstand abrasion
and other abuse and must not wear out
over the expected life of a shoe. They
asserted that fabrics are barriers
especially given that the use of tools is
not to be considered in an accessibility
evaluation. Another commenter said
that fabric coverings surrounding the
inner parts of mattresses and
foundations are barriers for which there
is no point of entry and which must
withstand normal use of these products.
Conversely, other commenters stated
that the Commission must evaluate the
possibility that lead could leach from
components that are fabric-covered and
must evaluate the ability of fabric
barriers to hold up to use and abuse.
Although test data was not submitted
that specifically address the possibility
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of leaching of lead through fabric
coverings, leaching involves a liquid
dissolving a portion of a material or
otherwise extracting a chemical from
the material. Because fabrics, in general,
cannot be considered to be impervious
to liquids such as saliva and stomach
acid, we believe that leaching of lead
from an underlying material is possible.
However, unlike other children’s
products that have lead-containing
components that are accessible, children
will not touch the lead-containing
component with the hands or fingers if
the component is enclosed or encased in
fabric. Thus, leaching of lead from such
a product is not likely to occur except
in the case of mouthing or swallowing
an item that is completely encased or
enclosed in fabric. Whether a fabriccovered product or a fabric-covered
component part of a product can be
mouthed or swallowed should be
determined through appropriate testing.
The Commission has reviewed section
108 of the CPSIA, which addresses
phthalate content of certain products,
for a definition for toys that can be
placed in a child’s mouth. Section
108(e)(2)(B) of the CPSIA provides that
‘‘if a toy or part of toy in one dimension
is smaller than 5 centimeters, it can be
placed in the mouth.’’ Although the
CPSIA provisions for lead apply to all
children’s products, not just toys, the
definition in section 108 of the CPSIA
is helpful in assessing whether a part of
any children’s product can be placed in
a child’s mouth. Accordingly, fabriccovered components that are used in
children’s products, including toys,
should be evaluated for the potential to
be placed in the mouth according to this
definition to assess whether the fabriccovered part is accessible.
The Commission believes that, in
general, fabric coverings may be
considered barriers to physical contact
with underlying materials for products
such as mattresses because they cannot
be mouthed or swallowed. However, the
appropriate use and abuse tests, such as
for the integrity of seams, should be
used to evaluate the coverings. Smaller
items or small components of children’s
products should be evaluated for the
potential for mouthing or swallowing
using the small parts test. For fabriccovered children’s products, an
additional test to determine whether
any part in one dimension is smaller
than 5 centimeters should be performed
to see if it can be placed in the mouth.
If mouthing or swallowing of a
component part could occur, the
material beneath the fabric covering is
considered to be accessible to a child.
Therefore, the Commission has revised
the final interpretative rule by adding a
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new § 1500.87(i) to explain that a
children’s product that is or contains a
lead-containing part which is enclosed,
encased, or covered by fabric and passes
the appropriate use and abuse tests on
such covers, is inaccessible to a child
unless the product or part of the product
in one dimension is smaller than 5
centimeters. The Commission also has
renumbered proposed § 1500.87(g),
which pertained to the intentional
disassembly or destruction of products
by children, as § 1500.87(j).
9. Intentional Disassembly and
Destruction—Section 1500.87(j)
(Formerly Section 1500.87(g))
Proposed § 1500.87(g) (now
renumbered as § 1500.87(j)), explained
that 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
products for accessibility of leadcontaining components.
For the reasons stated in section D.6
of this preamble, we have retained the
text for this provision without change,
but have renumbered the provision as
§ 1500.87(j).
10. Miscellaneous Comments
Some commenters said that, if aging
and wear and tear exposes leadcontaining parts, the components
should be considered accessible.
Conversely, other commenters said
that, with respect to textile products, the
necessary durability of such products
already incorporates consideration of
aging and wear and tear. Another
commenter claimed that additional
testing to account for aging for their type
of products does not need to be done,
because the product lifespan of
children’s electronics is shorter than for
other children’s products, and aging
leads to products becoming unusable.
Section 101(b)(2)(A) of the CPSIA
provides that aging of the product may
be considered in the evaluation of the
accessibility of component parts.
However, because of the wide range of
products and product types subject to
the lead content requirements of the
CPSIA, the Commission believes that
such evaluations are necessarily specific
to individual products or product types
and may not be generalized. Currently,
the Commission does not have specific
requirements on the effects of aging on
children’s products. Testing for aging on
children’s products is similar to normal
use testing. Section 8.5 of ASTM–F963
provides that normal use testing would
entail tests intended to simulate normal
use conditions so as to ensure that
PO 00000
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Fmt 4700
Sfmt 4700
39539
hazards are not generated through
normal wear and deterioration of the
product. Such tests would be used to
uncover hazards rather than to
demonstrate the reliability of the toy.
However, ASTM–F963 does not specify
requirements because it would not be
possible to define such requirements in
view of the wide range of children’s
products in the marketplace. Since any
evaluation on the effects of aging on the
integrity of product must be conducted
on product by product basis, the
Commission will continue to review the
effects of aging of the integrity of the
children’s products and will issue
further guidance on this issue in the
future if it deems such guidance is
necessary.
11. Compact Disks and DVDs
One commenter specifically requested
that the final interpretive rule address
compact disks and DVDs. These
products are composed of acrylic
polymer layers that encase the data part
of the product. Because the law does not
allow for coatings to be used as a barrier
that would render lead in the substrate
inaccessible to a child, this commenter
asked that the rule state that the acrylic
part of a disk is not a ‘‘coating.’’ The
commenter was concerned that if the
acrylic polymer layer is not clearly
determined to not be a coating, then
manufacturers would have to test the
layer of material within the polymer
part of the product.
Acrylic polymer layers of a compact
disk or DVD are not considered to be a
coating within the definition of section
1303 because the acrylic polymer layers
are not a surface coating that is
separable from the substrate through
scraping. If the internal metallic layer of
a disk is not accessible to a child, testing
and certification would not be required.
The Commission notes that the issue of
whether there is any lead in compact
disks or DVDs has been raised in
various proceedings. However, we have
not received any test data or information
regarding lead content in CDs or DVDs
and would require further information
before we can evaluate these products
properly. Moreover, given the very large
numbers of children’s products in the
market, an interpretative rule on
accessibility is not the appropriate
forum for the Commission to address
such product-specific issues. Rather, the
interpretative rule is intended to
provide guidance to allow
manufacturers of children’s products to
assess whether their own products or
component parts of their products are
inaccessible for purposes of section
101(b)(2) of the CPSIA. Product-specific
requests should be made under the rule
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39540
Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations
on procedures and requirements for a
Commission determination or exclusion
(74 FR 10475 (March 11, 2009)).
E. Effective Date
The CPSIA requires the Commission
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
interpretative rule will take effect on
August 14, 2009.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous
materials, Hazardous substances,
Imports, Infants and children, Labeling,
Law enforcement, and Toys.
F. Conclusion
For the reasons stated above, the
Commission amends 16 CFR chapter II
as follows:
■
PART 1500—HAZARDOUS
SUBSTANCES AND ARTICLES:
ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority citation for part 1500
continues to read as follows:
■
Authority: 15 U.S.C. 1261–1278, 122 Stat.
3016.
2. Add a new § 1500.87 to read as
follows:
■
pwalker on DSK8KYBLC1PROD with RULES
§ 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.
(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
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15:59 Aug 06, 2009
Jkt 217001
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
Commissions’ 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 leadcontaining component part would be
considered accessible if it can be
contacted by 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) For products intended for children
that are 18 months of age or less, the use
and abuse tests set forth under the
Commission’s regulations at 16 CFR
1500.50 and 16 CFR 1500.51 (excluding
the bite test of § 1500.51(c)), will be
used to evaluate accessibility of leadcontaining component parts of a
children’s product as a result of normal
and reasonably foreseeable use and
abuse of the product.
(f) For products intended for children
that are over 18 months but not over 36
months of age, the use and abuse tests
set forth under the Commission’s
regulations at 16 CFR 1500.50 and 16
CFR 1500.52 (excluding the bite test of
§ 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.
(g) For products intended for children
that are over 36 months but not over 96
months of age, the use and abuse tests
set forth under the Commission’s
regulations at 16 CFR 1500.50 and 16
CFR 1500.53 (excluding the bite test of
§ 1500.53(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.
(h) For products intended for children
over 96 months through 12 years of age,
the use and abuse tests set forth under
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Frm 00006
Fmt 4700
Sfmt 4700
the Commission’s regulations at 16 CFR
1500.50 and 16 CFR 1500.53 (excluding
the bite test of § 1500.53(c)) intended for
children aged 37–96 months will be
used to evaluate accessibility of leadcontaining component parts of a
children’s product as a result of normal
and reasonably foreseeable use and
abuse of the product.
(i) A children’s product that is or
contains a lead-containing part which is
enclosed, encased, or covered by fabric
and passes the appropriate use and
abuse tests on such covers, is
inaccessible to a child unless the
product or part of the product in one
dimension is smaller than 5 centimeters.
(j) 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
products for accessibility of leadcontaining components.
Dated: July 31, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. E9–18852 Filed 8–6–09; 8:45 am]
BILLING CODE 6335–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 174
[EPA–HQ–OPP–2009–0101; FRL–8428–7]
Bacillus thuringiensis Cry1A.105
Protein; Time Limited Exemption From
the Requirement of a Tolerance;
Correction
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule, correction.
SUMMARY: On May 20, 2009 EPA
published a Final Rule that established
an 18–month, time-limited exemption
from the requirement of a tolerance for
residues of the Bacillus thuringiensis
Cry1A.105 protein in or on the food and
feed commodities cotton seed, cotton
seed oil, cotton seed meal, cotton hay,
cotton hulls, cotton forage and cotton
gin byproducts when used as a plantincorporated protectant. Subsequent to
the publication of the May 20, 2009
Final Rule, the Agency identified an
error in the Analytical Methods section
of that Rule’s preamble. Through this
action, EPA is republishing the
tolerance exemption with a new
effective date and opportunity to request
a hearing, and a corrected Analytical
Methods section. The conditions of the
E:\FR\FM\07AUR1.SGM
07AUR1
Agencies
[Federal Register Volume 74, Number 151 (Friday, August 7, 2009)]
[Rules and Regulations]
[Pages 39535-39540]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18852]
=======================================================================
-----------------------------------------------------------------------
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (``Commission'') is
issuing a final rule providing guidance as to what product components
or classes of components will be considered to be ``inaccessible.''
Section 101(b)(2)(A) of the Consumer Product Safety Improvement Act
(``CPSIA'') provides that the lead limits shall 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 requires the Commission to issue, by August
14, 2009, a rule providing guidance with respect to what product
components, or classes of components, will be considered to be
inaccessible. This final rule satisfies the Commission's statutory
obligation.
DATES: Effective Date: This interpretative rule is effective on August
14, 2009.
FOR FURTHER INFORMATION CONTACT: Kristina Hatlelid, PhD, M.P.H.,
Directorate for Health Sciences, Consumer Product Safety Commission,
4330 East West Highway, Bethesda, Maryland 20814; e-mail
khatlelid@cpsc.gov; telephone 301-504-7254.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA establishes specific lead limits in children's products.
Section 101(a) of the CPSIA provides that, as of 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 meet this lower
limit. Section 3(a)(16) of the Consumer Product Safety Act, as amended
by section 235(a) of the CPSIA, defines ``children's product'' as a
``consumer product designed or intended primarily for children 12 years
of age or younger.''
B. Statutory Authority
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 under section
101(b)(3) of the CPSIA.
C. Notice of Proposed Rulemaking
In the Federal Register of January 15, 2009 (74 FR 2439), the
Commission published a proposed interpretative rule providing guidance
with respect to what product components or classes of components will
be considered to be inaccessible. As stated in the preamble to the
proposed interpretative rule (74 FR at 2440), the Commission
preliminarily determined that:
An accessible component part of a children's product is
one that a child may touch;
[[Page 39536]]
An inaccessible component part is one that is located
inside the product and not capable of being touched or mouthed by a
child, whether or not such part is visible to a user of the product;
An inaccessible part is one that may be enclosed in any
type of material, e.g., hard or soft plastic, rubber or metal. However,
the Commission requested comments specifically on the use of fabric as
a barrier, and the impact of aging on a children's product;
To assess whether a part is inaccessible, the
accessibility probes defined in the Commission's existing regulations
for evaluating accessibility of sharp points or sharp metal or glass
edges (16 CFR 1500.48 and 1500.49) could be used. 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; and
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. The 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. 16 CFR 1500.50-1500.53.
D. Discussion of Comments to the Proposed Rule and CPSC's Responses
The Commission received comments from trade associations, testing
services, consumer groups, electronic products associations, youth
recreational vehicle companies, and textile groups. In general, most
comments, particularly those from consumer groups, agreed with most of
the proposed interpretative rule, whereas other comments, particularly
those from industry, sought a narrower or different interpretation of
``accessibility.''
1. Summary of the Law--Section 1500.87(a)
Proposed Sec. 1500.87(a), in essence, summarized the lead limits
in section 101 of the CPSIA and how, over time, the limits decrease
from 600 ppm to 100 ppm by August 14, 2011 unless the Commission
determines that it is not technologically feasible to meet this lower
limit. Proposed Sec. 1500.87(a) also stated that, ``Paint, coatings or
electroplating may not be considered a barrier that would make the lead
content of a product inaccessible to a child.''
We did not receive any comment on this provision. However, on our
own initiative, we deleted the sentence regarding paint, coatings, and
electroplating because the identical sentence appears in Sec.
1500.87(b).
2. Physical Accessibility--Section 1500.87(b)
Proposed Sec. 1500.87(b) explained that the lead limits do not
apply to component parts of a product that are not accessible to a
child. The proposal explained 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. It added that 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.
Some commenters agreed with the Commission's determination that
accessibility is defined in the statute as physical access and stressed
that exposure to lead such as through leaching is not what was
intended.
However, other commenters said the Commission should explore other
inaccessibility scenarios, not just physical inaccessibility, including
considering whether children using the product could be exposed to the
lead that is present. Similarly, other commenters stated that the
physical contact is only an example of accessibility and said that
evaluations of accessibility focus on whether parts are ingestible or
mouthable, or alternatively, consider whether a child will actually
touch the part during foreseeable use or abuse of the product.
We decline to revise the rule as suggested by the comments. The
statute refers to physical accessibility of component parts of
products, and this reference is not simply an example of how
accessibility might be defined. The proposed interpretative rule
followed the statutory language for determining inaccessibility.
Section 101(b)(2)(A) of the CPSIA provides that, ``[a] component part
is not accessible under this subparagraph if such component part 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'' (emphasis added). The statute goes on to state,
``[r]easonably foreseeable use and abuse shall include to, [sic]
swallowing, mouthing, breaking, or other children's activities, and the
aging of the product.'' Id. Swallowing and mouthing are examples of use
and abuse actions to be considered, but the language of the statute
does not limit consideration to ingestible or mouthable products.
Courts have routinely found that use of the word ``including'' in a
statute before a list of items demonstrates that the list is
illustrative, and not meant to be exhaustive. See, e.g., West v Gibson,
527 U.S. 212, 217 (1999) (holding that ``including'' in section 717(b)
of Title VII of the Civil Rights Act which sets forth the EEOC's
authority to enforce the antidiscrimination standard ``makes clear that
the authorization is not limited to the specified remedies there
mentioned * * *''); Federal Land Bank of St. Paul v Bismarck Lumbar
Co., 314 U.S. 95, 99-100 (1941) (holding that ``the term `including' is
not one of all-embracing definition, but connotes simply an
illustrative application of the general principle.''); Puerto Rico
Maritime Shipping Auth. v ICC, 645 F.2d 1102, 1112 n.26 (DC Cir. 1981)
(``It is hornbook law that the use of the word `including' indicates
that the specified list * * * that follows is illustrative, not
exclusive.'' (internal citation omitted)).
``Other children's activities'' could reasonably include touching,
grasping, and handling that can lead to physical exposure to the lead
containing parts. Accordingly, the final rule construes accessibility
to be physical contact with lead-containing component parts, and
mouthing and swallowing, along with touching, among the children's
activities that can result in contact with the lead-containing parts.
3. Testing and Certification Requirements for Inaccessible Component
Parts
Some commenters recommended that the rule explicitly state that
inaccessible component parts are relieved of the testing requirement of
section 102 of the CPSIA. One commenter said that the rule should state
clearly that no certificate is required when no provision of CPSIA or
any other rule or standard applies. In addition, the commenters
requested that the rule provide that third-party testing is not
required to demonstrate compliance with section 101 of the CPSIA when
the lead in the product is deemed to be inaccessible.
In general, inaccessible component parts do not have to comply with
the lead content limits or be tested and certified as to lead content.
The accessible portions of a product, unless specifically excluded from
lead content
[[Page 39537]]
requirements or the testing requirements, would require testing and
certification to the lead content limits.
Currently, third-party testing and certification is required for
toys and children's products under the small parts regulations (16 CFR
Part 1501 and 1500.50-53 and 16 CFR 1500(18)(a)(9)), as well as under
the toy safety standard, ASTM-F963. Accordingly, some of the tests
proposed for evaluating accessibility are already being conducted by
manufacturers for small parts evaluations. In addition, toys and games
that are or contain small parts that are intended for use by children
from 3 to 6 years old are subject to the labeling requirements of 16
CFR 1500.19. With respect to other children's products that do not fall
within the scope of the small parts regulations, but that contain
inaccessible parts, the manufacturer currently is not required to
provide third-party testing to demonstrate inaccessibility. The
Commission intends to address certification requirements and the
establishment of protocols and standards for ensuring that children's
products are tested for compliance with applicable children's products
safety rules in a separate rulemaking.
4. Rulemaking Authority--Section 1500.87(c)
Proposed Sec. 1500.87(c) cited section 101(b)(2)(B) of the CPSIA
as the legal authority to promulgate the interpretative rule and stated
that the rulemaking is to be conducted by August 14, 2009.
We received no comments on this provision and have finalized it
without change.
5. Use of Accessibility Probes--Section 1500.87(d)
Proposed Sec. 1500.87(d) stated that:
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.
In general, most commenters agree with the proposed approach of
using accessibility probes to evaluate whether certain parts of a
product might be accessible to a child. However, one commenter stated
that probes should be unnecessary for products that are sealed and have
no accessible cavities.
The Commission agrees that, for products that are effectively
sealed so that there is no point of entry to any internal parts that
contain lead, use of the probes would not be necessary to demonstrate
that the parts are not accessible. However, it would be necessary to
test the material which encases or encloses the inaccessible lead-
containing part, unless it is a material that the Commission has
specifically determined falls below the lead content limits of the
CPSIA. The Commission established procedures for a Commission
determination that a specific material or product does not exceed the
lead content limits specified under section 101(a) of the CPSIA (74 FR
10475 (March 11, 2009)). In addition, the Commission has issued a
notice of proposed rulemaking regarding lead content limits on certain
materials or products which have been preliminarily determined to fall
below the lead content limits of the CPSIA (74 FR 2433 (January 15,
2009)).
Some commenters stated that accessibility probes could be used to
evaluate products, but they questioned whether existing test fixtures
are appropriate for the entire age range of children's products. The
commenters argued that older children have developed their motor skills
and have increased agility compared to younger children for which the
probes were designed.
In considering reasonably foreseeable use and abuse, the Commission
finds that the accessibility probes are appropriate for testing the
wider range of products for children through age twelve years. The
probes are used to evaluate possible gaps or holes in a product through
which a young child's finger might physically contact a lead-containing
component part. Because older children's larger fingers generally would
have more limited access to gaps that would be accessible to smaller
children, the Commission believes that, in most cases, the probes will
indicate whether access is possible.
Some commenters claimed that the use of accessibility probes for
evaluating accessibility is inappropriate; these commenters said that
the proper method for determining inaccessibility would evaluate
mouthing and swallowing behaviors. The commenters argued that the
possibility of simple physical contact with a lead-containing component
part does not necessarily lead to mouthing or swallowing, or that the
lead-containing component parts are not touched during normal and
reasonably foreseeable use and abuse of the component part.
We disagree with the comments. The statute provides for
inaccessibility of component parts based on physical exposure to the
part. Therefore, the Commission must assess accessibility based on
whether a child may touch a component part that contains lead above the
lead limits, not simply on whether a child might ingest or mouth a part
of a product. In addition, we have deemed that, in the context of an
exclusion request for all-terrain vehicles, the normal and reasonably
foreseeable contact with lead-containing parts by children using
motorized recreational vehicles would not be extensive but would occur.
For example, in the regular use of the product, users will have to
touch the brake and clutch levers and the throttle controls. It is
reasonable to assume that children will not be washing their hands
immediately after touching these parts. Average users (6-12 year olds)
do not typically engage in hand-to-mouth behavior; however, it is not
unreasonable to assume they may wipe their mouth or face with their
hands while using or right after using the recreational vehicle. (See
Human Factors Response to Request for Motorized Recreational Vehicles
Group Request for Exclusion from Lead Limits under Section 101(b)(1) of
the Consumer Product Safety Improvement Act dated April, 2009.)
Accordingly, the Commission finds that the accessibility probes provide
an objective means for evaluating accessibility based on such physical
access.
Some commenters asked that we clarify that access to a component
containing smaller components that may, themselves, contain lead-
containing parts does not mean that a lead-containing component is
accessible if the lead is fully enclosed within the larger component
which can be touched by an accessibility probe.
The Commission interprets a lead-containing component part to mean
the material used to construct the part includes lead in its
formulation, not that the part contains smaller parts that contain
lead. For example, assume that the product is a sealed ball made of
plastic and that the sealed ball has a lead content that complies with
the CPSIA lead limits. Inside the sealed ball are metal beads that
contain lead. In this example, the metal beads are lead-containing
component parts, but the ball is not. If the sealed ball does not
provide access to the beads inside it, through a hole or a crevice, or
after being subject to use and abuse testing, then the lead-containing
parts would be deemed inaccessible. The Commission also notes that, for
certain electronic devices that contain accessible lead-containing
[[Page 39538]]
parts, there is an interim final rule which provides exemptions for
such parts for which it is not technologically feasible to comply with
the lead content limits (74 FR 6990 (February 12, 2009)).
6. Use of Use and Abuse Tests--Section 1500.87(e) and (f)
Proposed Sec. 1500.87(e) explained that the use and abuse tests 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.
Proposed Sec. 1500.87(f) was similar to proposed Sec. 1500.87(e),
except that it referred to use and abuse tests 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 being 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.
In general, most commenters agreed with the proposed approach of
using existing use and abuse tests to evaluate the 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.
Some commenters agreed that the use and abuse tests are appropriate
for evaluating whether ingestible or mouthable parts might come loose
from a product, but said that intentional disassembly or destruction by
older children, including use of tools, should not be considered in
evaluating accessibility. Other commenters questioned whether the tests
are appropriate for older children given their increased strength and
dexterity.
We acknowledge that older children have advanced motor skills
compared to younger children. However, older children also have
advanced cognitive skills and the ability to properly care for their
belongings. For the purposes of evaluating product integrity, the
Commission believes that the existing use and abuse tests are
appropriate for revealing inherent characteristics or possible defects
in products that could result in accessibility of components and will
expose potential hazards that might result from use and abuse for most
children's products.
The test methods in 16 CFR 1500.50-1500.53 are used to simulate the
normal and reasonably foreseeable use, damage, or abuse of toys and
other articles intended for children in three separate age groups.
Accordingly, revised Sec. Sec. 1500.87(e),(f), and (g) make clear that
the use and abuse tests at 16 CFR 1500.50-1500.53 will be used to
evaluate accessibility of lead-containing component parts of a
children's product for the specific age group the product is intended.
In addition, Sec. 1500.87(h) is revised to make clear that the test
under Sec. 1500.87(g) will apply to products intended for children
that are over 96 months through 12 years of age. Accordingly, we have
revised Sec. Sec. 1500.87(e) through (h) to read as follows:
(e) For products intended for children that are 18 months of age or
less, the use and abuse tests set forth under the Commission's
regulations at 16 CFR 1500.50 and 16 CFR 1500.51 (excluding the bite
test of 1500.51(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.
(f) For products intended for children that are over 18 months but
not over 36 months of age, the use and abuse tests set forth under the
Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.52
(excluding the bite test of 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.
(g) For products intended for children that are over 36 months but
not over 96 months of age, the use and abuse tests set forth under the
Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.53
(excluding the bite test of 1500.53(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.
(h) For products intended for children over 96 months through 12
years of age, the use and abuse tests set forth under the Commission's
regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite
test of 1500.53(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.
7. The Exclusion of the Bite Test From Use and Abuse Testing
Proposed Sec. 1500.87(e) and (f) referred to the ``bite tests of
1500.51(c) and 1500.52(c).''
Some commenters requested an explanation for the exclusion of the
bite test. One commenter pointed out that the proposed rule excludes
the bite test from 16 CFR 1500.51 and 1500.52, but not Sec. 1500.53,
and stated that the bite test from all three sections should be
excluded.
Currently, the Commission does not use the bite test specified in
the three CFR sections, as a result of a court case (Clever Idea Co.,
Inc. v Consumer Products Safety Commission, 385 F. Supp. 688 (E.D. N.Y.
1974)) that questioned the appropriateness of this test. This
requirement may be modified in a future proceeding.
Because the bite test currently is not applied as part of use and
abuse testing in general, it will not be applied for the purposes of
evaluating whether lead-containing component parts are accessible.
Nevertheless, the inclusion of the bite test in 16 CFR 1500.53 was
inadvertent in the proposed rule, and we have revised Sec. Sec.
1500.87(g) and (h) to exclude the bite test of 16 CFR 1500.53(c).
8. Fabric Coverings Used as Barrier--Section 1500.87(g)
Several commenters claimed that fabric coverings are appropriate
barriers. Some commenters gave examples of a fabric-covered button or
base of a zipper that would form a barrier to a lead-containing part,
such as a metal button or zipper base, thus rendering it inaccessible
to a child. The commenters said that such use of fabric must withstand
wear and tear and remain intact through the life of a garment. In
addition, the commenters noted that fabrics in footwear applications
must be durable and able to withstand abrasion and other abuse and must
not wear out over the expected life of a shoe. They asserted that
fabrics are barriers especially given that the use of tools is not to
be considered in an accessibility evaluation. Another commenter said
that fabric coverings surrounding the inner parts of mattresses and
foundations are barriers for which there is no point of entry and which
must withstand normal use of these products.
Conversely, other commenters stated that the Commission must
evaluate the possibility that lead could leach from components that are
fabric-covered and must evaluate the ability of fabric barriers to hold
up to use and abuse.
Although test data was not submitted that specifically address the
possibility
[[Page 39539]]
of leaching of lead through fabric coverings, leaching involves a
liquid dissolving a portion of a material or otherwise extracting a
chemical from the material. Because fabrics, in general, cannot be
considered to be impervious to liquids such as saliva and stomach acid,
we believe that leaching of lead from an underlying material is
possible. However, unlike other children's products that have lead-
containing components that are accessible, children will not touch the
lead-containing component with the hands or fingers if the component is
enclosed or encased in fabric. Thus, leaching of lead from such a
product is not likely to occur except in the case of mouthing or
swallowing an item that is completely encased or enclosed in fabric.
Whether a fabric-covered product or a fabric-covered component part of
a product can be mouthed or swallowed should be determined through
appropriate testing.
The Commission has reviewed section 108 of the CPSIA, which
addresses phthalate content of certain products, for a definition for
toys that can be placed in a child's mouth. Section 108(e)(2)(B) of the
CPSIA provides that ``if a toy or part of toy in one dimension is
smaller than 5 centimeters, it can be placed in the mouth.'' Although
the CPSIA provisions for lead apply to all children's products, not
just toys, the definition in section 108 of the CPSIA is helpful in
assessing whether a part of any children's product can be placed in a
child's mouth. Accordingly, fabric-covered components that are used in
children's products, including toys, should be evaluated for the
potential to be placed in the mouth according to this definition to
assess whether the fabric-covered part is accessible.
The Commission believes that, in general, fabric coverings may be
considered barriers to physical contact with underlying materials for
products such as mattresses because they cannot be mouthed or
swallowed. However, the appropriate use and abuse tests, such as for
the integrity of seams, should be used to evaluate the coverings.
Smaller items or small components of children's products should be
evaluated for the potential for mouthing or swallowing using the small
parts test. For fabric-covered children's products, an additional test
to determine whether any part in one dimension is smaller than 5
centimeters should be performed to see if it can be placed in the
mouth. If mouthing or swallowing of a component part could occur, the
material beneath the fabric covering is considered to be accessible to
a child. Therefore, the Commission has revised the final interpretative
rule by adding a new Sec. 1500.87(i) to explain that a children's
product that is or contains a lead-containing part which is enclosed,
encased, or covered by fabric and passes the appropriate use and abuse
tests on such covers, is inaccessible to a child unless the product or
part of the product in one dimension is smaller than 5 centimeters. The
Commission also has renumbered proposed Sec. 1500.87(g), which
pertained to the intentional disassembly or destruction of products by
children, as Sec. 1500.87(j).
9. Intentional Disassembly and Destruction--Section 1500.87(j)
(Formerly Section 1500.87(g))
Proposed Sec. 1500.87(g) (now renumbered as Sec. 1500.87(j)),
explained that 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 products for accessibility of lead-containing
components.
For the reasons stated in section D.6 of this preamble, we have
retained the text for this provision without change, but have
renumbered the provision as Sec. 1500.87(j).
10. Miscellaneous Comments
Some commenters said that, if aging and wear and tear exposes lead-
containing parts, the components should be considered accessible.
Conversely, other commenters said that, with respect to textile
products, the necessary durability of such products already
incorporates consideration of aging and wear and tear. Another
commenter claimed that additional testing to account for aging for
their type of products does not need to be done, because the product
lifespan of children's electronics is shorter than for other children's
products, and aging leads to products becoming unusable.
Section 101(b)(2)(A) of the CPSIA provides that aging of the
product may be considered in the evaluation of the accessibility of
component parts. However, because of the wide range of products and
product types subject to the lead content requirements of the CPSIA,
the Commission believes that such evaluations are necessarily specific
to individual products or product types and may not be generalized.
Currently, the Commission does not have specific requirements on the
effects of aging on children's products. Testing for aging on
children's products is similar to normal use testing. Section 8.5 of
ASTM-F963 provides that normal use testing would entail tests intended
to simulate normal use conditions so as to ensure that hazards are not
generated through normal wear and deterioration of the product. Such
tests would be used to uncover hazards rather than to demonstrate the
reliability of the toy. However, ASTM-F963 does not specify
requirements because it would not be possible to define such
requirements in view of the wide range of children's products in the
marketplace. Since any evaluation on the effects of aging on the
integrity of product must be conducted on product by product basis, the
Commission will continue to review the effects of aging of the
integrity of the children's products and will issue further guidance on
this issue in the future if it deems such guidance is necessary.
11. Compact Disks and DVDs
One commenter specifically requested that the final interpretive
rule address compact disks and DVDs. These products are composed of
acrylic polymer layers that encase the data part of the product.
Because the law does not allow for coatings to be used as a barrier
that would render lead in the substrate inaccessible to a child, this
commenter asked that the rule state that the acrylic part of a disk is
not a ``coating.'' The commenter was concerned that if the acrylic
polymer layer is not clearly determined to not be a coating, then
manufacturers would have to test the layer of material within the
polymer part of the product.
Acrylic polymer layers of a compact disk or DVD are not considered
to be a coating within the definition of section 1303 because the
acrylic polymer layers are not a surface coating that is separable from
the substrate through scraping. If the internal metallic layer of a
disk is not accessible to a child, testing and certification would not
be required. The Commission notes that the issue of whether there is
any lead in compact disks or DVDs has been raised in various
proceedings. However, we have not received any test data or information
regarding lead content in CDs or DVDs and would require further
information before we can evaluate these products properly. Moreover,
given the very large numbers of children's products in the market, an
interpretative rule on accessibility is not the appropriate forum for
the Commission to address such product-specific issues. Rather, the
interpretative rule is intended to provide guidance to allow
manufacturers of children's products to assess whether their own
products or component parts of their products are inaccessible for
purposes of section 101(b)(2) of the CPSIA. Product-specific requests
should be made under the rule
[[Page 39540]]
on procedures and requirements for a Commission determination or
exclusion (74 FR 10475 (March 11, 2009)).
E. Effective Date
The CPSIA requires the Commission 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 interpretative rule will take effect on August 14,
2009.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
F. Conclusion
0
For the reasons stated above, the Commission amends 16 CFR chapter II
as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1500 continues to read as follows:
Authority: 15 U.S.C. 1261-1278, 122 Stat. 3016.
0
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.
(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 Commissions' 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 can be contacted by 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) For products intended for children that are 18 months of age or
less, the use and abuse tests set forth under the Commission's
regulations at 16 CFR 1500.50 and 16 CFR 1500.51 (excluding the bite
test of Sec. 1500.51(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.
(f) For products intended for children that are over 18 months but
not over 36 months of age, the use and abuse tests set forth under the
Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.52
(excluding the bite test of Sec. 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.
(g) For products intended for children that are over 36 months but
not over 96 months of age, the use and abuse tests set forth under the
Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.53
(excluding the bite test of Sec. 1500.53(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.
(h) For products intended for children over 96 months through 12
years of age, the use and abuse tests set forth under the Commission's
regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite
test of Sec. 1500.53(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.
(i) A children's product that is or contains a lead-containing part
which is enclosed, encased, or covered by fabric and passes the
appropriate use and abuse tests on such covers, is inaccessible to a
child unless the product or part of the product in one dimension is
smaller than 5 centimeters.
(j) 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 products for accessibility of lead-containing
components.
Dated: July 31, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-18852 Filed 8-6-09; 8:45 am]
BILLING CODE 6335-01-P