Children's Products Containing Lead; Exemptions for Certain Electronic Devices, 3154-3159 [2010-877]
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Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations
(d) * * *
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(v) § 135.1—Applicability
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§ 120.117
program.
8. Revise paragraphs (a)(2) and (e)(2)
of § 120.117 to read as follows:
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Implementing a drug testing
(a) * * *
If you are ...
You must ...
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(2) An operator as defined in § 91.147 of this chapter ............................ Register with the FAA by contacting the Flight Standards District Office
nearest to your principal place of business.
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(e) * * *
(2) Send this information in the form
and manner prescribed by the
Administrator, in duplicate to the
appropriate address below:
(i) For § 91.147 operators: The Flight
Standards District Office nearest to your
principal place of business.
(ii) For all others: The Federal
Aviation Administration, Office of
Aerospace Medicine, Drug Abatement
Division (AAM–800), 800 Independence
Avenue, SW., Washington, DC 20591.
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■ 9. Revise paragraph (b) of § 120.119 to
read as follows:
§ 120.119
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Administrator, in duplicate to the
appropriate address below:
(i) For § 91.147 operators: The Flight
Standards District Office nearest to your
principal place of business.
(ii) For all others: The Federal
Aviation Administration, Office of
Aerospace Medicine, Drug Abatement
Division (AAM–800), 800 Independence
Avenue, SW., Washington, DC 20591.
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PART 135—OPERATING
REQUIREMENTS: COMMUTER AND
ON DEMAND OPERATIONS AND
RULES GOVERNING PERSONS ON
BOARD SUCH AIRCRAFT
Annual reports.
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(b) As an employer, you must use the
Management Information System (MIS)
form and instructions as required by 49
CFR part 40 (at 49 CFR 40.26 and
appendix H to 49 CFR part 40). You may
also use the electronic version of the
MIS form provided by DOT. The
Administrator may designate means
(e.g., electronic program transmitted via
the Internet) other than hard-copy, for
MIS form submission. For information
on where to submit MIS forms and for
the electronic version of the form, see:
https://www.faa.gov/about/office_org/
headquarters_offices/avs/offices/aam/
drug_alcohol.
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■ 10. Add paragraph (b)(5) to § 120.211
to read as follows:
12. The authority citation for part 135
continues to read as follows:
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Authority: 49 U.S.C. 106(g), 41706, 40113,
44701–44702, 44705, 44709, 44711–44713,
44715–44717, 44722, 45101–45105.
13. Revise paragraph (a)(5) of § 135.1
to read as follows:
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§ 135.1
Applicability.
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(b) * * *
(5) § 135.1—Applicability
■ 11. Revise paragraph (e)(2) of
§ 120.225 to read as follows:
(a) * * *
(5) Nonstop Commercial Air Tour
flights conducted for compensation or
hire in accordance with § 119.1(e)(2) of
this chapter that begin and end at the
same airport and are conducted within
a 25-statute-mile radius of that airport;
provided further that these operations
must comply only with the drug and
alcohol testing requirements in
§§ 120.31, 120.33, 120.35, 120.37, and
120.39 of this chapter; and with the
provisions of part 136, subpart A, and
§ 91.147 of this chapter by September
11, 2007.
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§ 120.225 How to implement an alcohol
testing program.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
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[FR Doc. 2010–908 Filed 1–19–10; 8:45 am]
§ 120.211
Applicable Federal regulations.
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(e) * * *
(2) Send this information in the form
and manner prescribed by the
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CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1500
Children’s Products Containing Lead;
Exemptions for Certain Electronic
Devices
AGENCY: Consumer Product Safety
Commission.
ACTION: Final rule.
SUMMARY: The Consumer Product Safety
Commission (CPSC or Commission) is
issuing a final rule concerning certain
electronic devices for which it is not
technologically feasible to meet the lead
limits as required under section 101 of
the Consumer Product Safety
Improvement Act of 2008 (CPSIA).1
DATES: Effective Date: This final rule is
effective on January 20, 2010.
FOR FURTHER INFORMATION CONTACT:
Kristina Hatlelid, Ph.D., 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 Consumer Product Safety
Improvement Act of 2008 (CPSIA),
Public Law 110–314, 122 Stat. 3016,
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. The limit
1 The Commission voted 5–0 to publish this final
rule, with changes, in the Federal Register.
Chairman Inez M. Tenenbaum, and Commissioners
Thomas H. Moore, Nancy Nord, Robert Adler, and
Anne Northup voted to publish the notice with
changes. Commissioner Northup issued a statement,
and the statement can be found at https://
www.cpsc.gov/PR/northup01062010devices.pdf.
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will be further reduced to 100 ppm after
three years, or August 14, 2011, 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. Section 101
(b)(2)(B) of the CPSIA further provides
that the Commission shall promulgate a
rule providing guidance with respect to
what product components or classes of
components will be considered to be
inaccessible. An interpretative rule
providing guidance on inaccessibility
(inaccessibility rule) was published in
the Federal Register on August 7, 2009
(74 FR 39535).
In addition, if the Commission
determines that it is not technologically
feasible for certain electronic devices to
comply with the lead limits, section
101(b)(4) of the CPSIA provides that the
Commission shall issue requirements by
regulation to eliminate or minimize the
potential for exposure to and
accessibility of lead in such electronic
devices, and establish a schedule for
achieving full compliance unless the
Commission determines that full
compliance with the lead limits is not
technologically feasible within such a
schedule. Under section 101(d) of the
CPSIA, technological feasibility is based
on the commercial availability of
products, technology, or other practices
that will allow compliance with the lead
limits.
On January 15, 2009, the Commission
issued a notice of proposed rulemaking
on requirements for certain electronic
devices that could not comply with the
lead limits due to technological
infeasibility (74 FR 2435). The notice of
proposed rulemaking was withdrawn on
February 12, 2009 (74 FR 7021). On that
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date, the Commission issued an interim
final rule (74 FR 6991) to provide
certain exemptions for children’s
electronic devices including:
• Inaccessible lead-containing
component parts;
• Accessible lead-containing
components parts that cannot be
produced without lead due to the lack
of technologically feasible substitutions
and which require lead for the proper
functioning of the component part; and
• Lead-containing spare parts or other
removable components which are
inaccessible when the product is
assembled in functional form or is
otherwise granted an exemption.
The interim final rule also directed
Commission staff to reevaluate and
report to the Commission on the
technical feasibility of compliance with
the lead limits, including the
technological feasibility of making
accessible component parts
inaccessible, and the status of the
exemptions no less than every five years
after publication of a final rule in the
Federal Register. Comments on the
interim final rule were due on March
16, 2009.
C. Discussion of Comments to the
Interim Final Rule
The Commission received seven
comments from consumer groups,
electronics associations, companies, and
individuals. In general, most comments
sought to narrow or expand the scope of
the exemptions.
1. Summary of the Law—Section
1500.88(a)
Section 1500.88(a), in essence,
summarized the lead content limits in
children’s products under 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. Section 1500.88(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, we have, on
our own initiative, revised the last
sentence by adding, ‘‘Section 101(b)(2)
of the CPSIA further 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
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the product including swallowing,
mouthing, breaking, or other children’s
activities, and the aging of the product,
as determined by the Commission.’’
2. Technological Feasibility—Section
1500.88(b)
Section 1500.88(b) explained that if
the Commission determines that it is not
technologically feasible for certain
electronic devices, the Commission
must issue requirements by regulation
to eliminate or minimize the potential
for exposure to and accessibility of lead
in such electronic devices and establish
a schedule by which such electronic
devices shall be in full compliance
unless the Commission determines that
full compliance is not technologically
feasible for such devices within a
schedule set by the Commission.
We have, on our own initiative,
modified this section to add ‘‘within a
schedule set by the Commission’’ after
‘‘such devices.’’ This modification
reflects the statutory language at section
101(b)(4)(B) of the CPSIA.
One commenter requested guidance
regarding the definition of ‘‘electronic
devices.’’
The CPSIA does not provide a
definition for electronic devices.
However, we believe a reasonable
definition of an electronic device is ‘‘a
device that generates, stores, distributes,
or converts electrical energy into
another energy form.’’ Examples of
children’s electronic devices include,
but are not limited to, products with
batteries or power cords (or that use
solar power or other power sources),
such as music players, headphones,
some toys and games, some calculators,
and certain computers or similar
electronic learning products.
3. Certain Lead-Containing Component
Parts—Section 1500.88(c)
Section 1500.88(c) provided that
certain lead-containing component parts
in electronic devices that are unable to
meet the lead limits would be granted
exemptions provided that the use of
lead is necessary for the proper
functioning of the component part and
it is not technologically feasible for the
component part to meet the lead content
limits.
On our own initiative, we have
modified this section to add the word
‘‘accessible’’ in between ‘‘certain’’ and
‘‘lead-containing component parts,’’ to
make clear that the exemptions in the
rule are applicable only to accessible
component parts. Inaccessible
component parts are already excluded
from the lead limits under section
101(b)(2) of the CPSIA.
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One commenter stated that the
exemptions should be narrowed to
cover only components of electrical
goods. This commenter asserted that the
language in the interim final rule could
be read to exclude general materials that
contain metal alloys and enable
manufacturers to add lead although it
may not be technologically necessary to
do so.
The rule was intended to be limited
to the materials and components
necessary for the electronic functioning
of children’s electronic devices. In
response to the comments, we have
revised § 1500.88(c) by adding the word
‘‘electronic’’ before the word
‘‘functioning.’’ In addition, we have
further clarified § 1500.88(d) to add the
word ‘‘electronic’’ before ‘‘component
parts’’ in the first sentence. Nonfunctional uses of lead in children’s
electronic devices remain subject to the
lead content limits under section 101(a)
of the CPSIA. For example, if the metal
component part was purely decorative,
such as a cell phone charm or wrist
accessory sold with, or attached to, a
child’s phone, that charm or accessory
is not necessary to the proper electronic
functioning of the component part and
is subject to the lead content limits.
Another commenter requested that
the exemptions for the metal alloy
components in children’s electronic
devices be extended to products whose
mechanical functions require the use of
material containing lead, such as a brass
collar on the wheel of a toy. The
commenter also asserted that the
electronic exemption for ‘‘lead-bronze
bearing shells and bushings’’ are not
primarily used for the transmission of
electrical current, but are mechanical
devices.
Section 101(b)(4) of the CPSIA allows
exemptions to the lead content limits if
the Commission finds that it is not
technologically feasible to remove the
lead from the electronic devices. This
section does not provide for exemptions
for other types of products that are
unrelated to electronic devices. The
exemptions under this rule include
bearing shells and bushings only when
those bearing shells and bushings are
integral to the operation of certain
electronic devices, such as electric
motors. For this reason, lead-bronze
bearing shells and bushings are allowed
in children’s electronic devices.
However, the exemption does not
extend to bearing shells and bushings in
children’s products that are unrelated to
electronic operations because they do
not fall within the scope of these
exemptions. Such components must
comply with the CPSIA’s lead content
limits. We note that if such components
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are inaccessible to a child, they would
not be subject to the CPSIA lead content
limits under 16 CFR 1500.87.
One commenter stated that the health
implications of lead exposure from the
electronic products have not been
considered and that the interim final
rule does not provide an incentive to
improve technology to reduce lead
content. The commenter also stated that
exempted products should be labeled as
to lead content. Another commenter
stated that no exemptions should be
granted given the dangerous effects of
lead in children.
As discussed in the preamble to the
interim final rule (74 FR at 6992), the
complete elimination of lead, or the
reduction in lead content to the lead
content limits specified in the CPSIA, is
currently not technologically feasible for
certain components of children’s
electronic products. Accordingly, the
final rule provides for exemptions from
the lead limits for a limited number of
components of electronic devices that
must be manufactured using lead,
including in certain metal alloys. Such
component parts could include power
cord pins, cathode-ray tubes, and
electrical connectors. Children are not
expected to experience significant
exposures to lead from these few
applications. The lead containing
components that are being exempted are
components that one would not expect
children to mouth, swallow, or handle
for significant periods under normal and
reasonably foreseeable conditions.
Moreover, with few exceptions, many
electronic devices will be in compliance
with the lead limits under the CPSIA
either because they already meet the
lead content limits or because the leadcontaining component part is
inaccessible (74 FR at 6992).
Furthermore, we do not believe that
labeling electronic devices for their lead
content would add to the safety of these
products. In the absence of the
exemptions provided for in the CPSIA
and this rule, certain electronics devices
would be banned if they were intended
primarily for children. The likely
substitute for some of these products
would be similar products that are
intended for general consumer use.
Thus, not providing these exemptions
could result in increases in the
children’s lead exposure from products
intended for general consumer use that
are not subject either to the lead
limitations in the CPSIA or the alternate
lead limits provided for in the
exemptions under this rule.
We also disagree with the
commenter’s assertion that the rule does
not provide incentives for technological
improvements. Congress recognized that
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certain electronic devices currently may
not be able to meet the lead content
limits. However, under section 101(b)(5)
of the CPSIA, the Commission
specifically was directed to periodically
review and revise the regulations, as
necessary, no less than every five years.
The Commission intends to continue to
evaluate the technological feasibility of
making accessible component parts
inaccessible, and to reevaluate the
exemptions within that time frame as
provided under § 1500.88(f) of this rule.
4. Exemptions for Lead—Section
1500.88(d)
This section set forth the specific
exemptions for lead as used in certain
component parts in children’s products.
As discussed in part C.3 of this
preamble, we have added the word
‘‘electronic’’ before ‘‘component parts’’ in
the first sentence of § 1500.88(d) to
make clear that this rule applies to
materials and components necessary for
the electronic functioning of children’s
electronic devices.
Additionally, on our own initiative,
we have revised § 1500.88(d)(1) to insert
a comma between ‘‘electronic
components’’ and ‘‘and fluorescent
tubes’’ to clarify that electronic
components and fluorescent tubes
should be considered as separate items
rather than as one item or as synonyms.
We also have revised § 1500.88(d)(2) to
replace ‘‘3,500 ppm’’ with ‘‘3,500 ppm,’’
for purposes of consistency with how
the ppm levels are expressed elsewhere
in the final rule. We also have revised
§ 1500.88(d)(8) to insert a comma
between ‘‘the seal frit and frit ring’’ and
‘‘as well as in print pastes’’ to clarify that
a seal frit and frit ring are distinct from
print pastes.
Commenters representing the
electronics industry manufacturers
asserted that the list of exempted
materials and components in the final
rule is too limited. They requested that
the rule incorporate all of the current
exemptions of the use of lead in the
European Union’s Restriction on
Hazardous Substances (EU RoHS)
directive to avoid inconsistencies and to
harmonize with other standards. They
claimed that while ongoing research
aims to find alternatives and eliminate
the use of lead, it is not yet
technologically feasible to avoid all uses
of lead. The commenters also asserted
that testing for lead in electronic
products is difficult and costly.
We do not believe that it is necessary
to incorporate into the rule all of the
exemptions listed in the EU RoHS
directive. (European Union Directive
2002/95/EC and amendments to the
directive are available at https://eur-
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lex.europa.eu/en/index.htm.) The
European Union and other countries
and authorities have adopted
restrictions on the use of lead and other
chemicals in electronic devices to
address concerns related to human
health and environmental impacts of
waste electrical and electronic
equipment. The EU RoHS directive
allows certain exemptions if
substitution is not possible from the
scientific and technical point of view or
if the negative environmental or health
impacts caused by substitution are
likely to outweigh the human and
environmental benefits of the
substitution. It also specifies that
exemptions must be reviewed at least
every four years with the aim of
removing such exemptions if it becomes
technologically or scientifically possible
to replace the lead in a particular
application. The list of exemptions
covered under the EU RoHS directive is
intended to cover all electric and
electronic equipment.
The list of exemptions provided
under this rule is intended to allow the
use of lead-containing components used
in children’s products that are necessary
for the electronic functioning of the
children’s electronic device.
Accordingly, the list of exemptions does
not include exemptions for uses of lead
in components that have no application
to, or would not otherwise be used in
children’s products. For example,
adopting the EU RoHS directive would
result in the inclusion of EU RoHS
directive exemption 23, ‘‘Lead alloys as
solder for transducers used in highpowered (designed to operate for several
hours at acoustic power levels of 125dB
SPL and above) loudspeakers’’ into the
final rule. Such high powered speakers
may be appropriate for use in a stadium,
but are not a children’s product.
Because the commenters did not
identify any specific exemption under
the EU RoHS directive or similar
directives that may, in fact, require the
use of lead in a component of children’s
electronic devices and that also is not
listed as an exemption under this rule,
we decline to revise the list of
exemptions at this time. We note that
this rule does not preclude the
commenters from complying with the
EU RoHS directive if they choose to do
so. However, if commenters need
additional exemptions for leadcontaining component parts in
children’s electronic devices, they can
submit a petition under the procedures
set forth under 16 CFR part 1051 with
the supporting documentation. A
general request for regulatory action
which does not reasonably specify the
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type of action requested is not sufficient
for purposes of a petition request. 16
CFR 1051.6(a)(5).
Commenters also requested that the
rule explicitly state that exempted or
inaccessible parts are not subject to the
testing requirement of section 102 of the
CPSIA.
With regard to inaccessible
component parts, the preamble to the
inaccessibility rule stated that a
manufacturer currently is not required
to provide third-party testing to
demonstrate inaccessibility (74 FR at
39537). In addition, many of the
exemptions provided under this rule do
not require testing under section 102 of
the CPSIA because there are no lead
limits associated with the exemptions.
However, the exemptions for the metal
alloys are not blanket or absolute
exemptions. Instead, they are presented
as alternate lead limits. As such, those
components, i.e., copper (less than 4
percent lead by weight), steel (less than
0.35 percent lead by weight), and
aluminum (less than 0.4 percent lead by
weight), must still be tested by the
manufacturer to verify that these
component parts comply with these
higher lead limits under section 102 of
the CPSIA.
The Commission intends to address
component part testing 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 an upcoming rulemaking.
As for the other specific exemptions
mentioned in § 1500.88(d), such as lead
used in compliant pin connector
systems (§ 1500.88(d)(6)), lead used in
optical and filter glass (§ 1500.88(d)(7)),
lead oxide in plasma display panels and
surface conduction electron emitter
displays used in structural elements
(§ 1500.88(d)(8)), and lead oxide in the
glass envelope of Black Light Blue
lamps (§ 1500.88(d)(9)), we did not
receive comments on those provisions.
Consequently, the final rule retains
those provisions without change.
5. Removable or Replaceable Parts—
Section 1500.88(e)
This section provided that
components of electronic devices that
are removable or replaceable, such as
battery packs and light bulbs, are not
subject to the lead content limits if they
were otherwise granted an exemption,
or are inaccessible when the product is
assembled in functional form.
On our own initiative, we have added
commas after ‘‘replaceable’’ and
‘‘exemption’’ to clarify that section for
readability.
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Several commenters addressed
removable and replaceable parts. Some
commenters supported the exemption
from the lead content limits for such
parts on the basis that replacing or
installing parts of a children’s electronic
device is not a children’s activity. Other
commenters opposed the exemption
because children could access the leadcontaining parts when they are not
installed.
We decline to revise the rule as
suggested by some commenters. We
have determined that removable or
replaceable parts, such as battery packs
and light bulbs, that are inaccessible
when installed in the product, are not
subject to the lead content requirements.
When installed, such parts are
inaccessible under 16 CFR 1500.87. In
addition, these types of spare parts or
replacement parts, including battery
pack and light bulbs, are not intended
primarily for children since such parts
are available for general use by the
public. While spare parts may
sometimes be included with a children’s
product, in many instances, the parts,
necessary for the functioning of the
electronic device, are to be installed by
adults, and are inaccessible to children
once installed.
One commenter requested guidance
regarding whether a metal key sold with
electrical electronic equipment would
be subject to the lead content limits.
According to the commenter, keys are
made with copper alloy and aluminum
and contain lead of up to 0.4%. The
commenter stated that substitutes
containing lead below 300 ppm are
unavailable.
The definition of ‘‘children’s product’’
means a consumer product designed or
intended primarily for children 12 years
of age. A key used in connection with
a child’s electronic device does not
necessarily make the key a children’s
product if the key is intended for an
adult to use in safeguarding or
monitoring the use of the electronic
equipment. In such instances, the key
would be in the possession of the adult
at all times, and would not be
considered a children’s product. In
other instances, if a key is to be used
primarily by a child in connection with
an electronic device, an exemption from
the lead content limits under the CPSIA
would apply only in instances where
such a key is necessary for the
electronic functioning of the device.
6. Review Period—Section 1500.88(f)
This section provides that the
Commission staff will reevaluate and
report to the Commission on the
technological feasibility of compliance
with the lead content limits for
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children’s electronic devices, including
the technological feasibility of making
accessible component part inaccessible,
and the status of the exemptions no less
than every five years.
One commenter stated that the EU
RoHS directive specifies that
exemptions must be reviewed every four
years. The commenter requested that the
Commission adopt the same four year
review cycle.
As discussed in part C.4 of this
preamble, we are not adopting all of the
exemptions in the EU RoHS directive.
Accordingly, the Commission’s review
of the exemptions provided under this
rule will be based on the application of
lead in children’s electronic devices.
Section 101(b)(5) of the CPSIA provides
that reviews and possible revision must
occur no less frequently than every five
years. Thus, we do not believe that the
rule needs to be revised at this time.
However, to the extent technological
advances are made in the next few
years, such that the existing exemptions
warrant revision or rescission, we will
review such changes and consider
revisions prior to the five year review
period.
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D. Impact on Small Businesses
Under the Regulatory Flexibility Act
(RFA), when an agency issues a
proposed rule, it generally must prepare
an initial regulatory flexibility analysis
describing the impact the proposed rule
is expected to have on small entities. 5
U.S.C. 603. The RFA does not require a
regulatory flexibility analysis if the head
of the agency certifies that the rule will
not have a significant effect on a
substantial number of small entities.
In the preamble to the interim final
rule (74 FR at 6992), the Commission’s
Directorate for Economic Analysis
determined that the exemption for
certain specified materials from the
requirements of section 101(a) of the
CPSIA will not result in any increase in
the costs of production for any firm. Its
only effect on businesses, including
small businesses, will be to reduce the
costs associated with compliance with
the lead content limits of the CPSIA.
Based on the foregoing assessment, the
Commission certifies that the rule
would not have a significant impact on
a substantial number of small entities.
E. Environmental Considerations
Generally, CPSC rules are considered
to ‘‘have little or no potential for
affecting the human environment,’’ and
environmental assessments are not
usually prepared for these rules (see 16
CFR 1021.5(c)(1)). The final rule is not
expected to have an adverse impact on
the environment, thus, the Commission
VerDate Nov<24>2008
15:59 Jan 19, 2010
Jkt 220001
concludes that no environment
assessment or environmental impact
statement is required in this proceeding.
F. Executive Orders
According to Executive Order 12988
(February 5, 1996), agencies must state
in clear language the preemptive effect,
if any, of new regulations. The
preemptive effect of regulations such as
this final rule is stated in section 18 of
the Federal Hazardous Substances Act.
15 U.S.C. 1261n.
G. Effective Date
The Administrative Procedure Act
requires that a substantive rule must be
published not less than 30 days before
its effective date, unless the rule relieves
a restriction. 5 U.S.C. 553(d)(1). Because
the final rule provides relief from
existing testing requirements under the
CPSIA and is virtually identical to an
interim final rule that has been in effect
since February 10, 2009, the effective
date for the final rule is January 20,
2010.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous
materials, Hazardous substances,
Imports, Infants and children, Labeling,
Law enforcement, and Toys.
■ For the reasons stated above, the
Commission amends chapter II of title
16 of the Code of Federal Regulations 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. Revise § 1500.88 to read as follows:
§ 1500.88 Exemptions from lead limits
under section 101 of the Consumer Product
Safety Improvement Act for Certain
Electronic Devices.
(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 will be further
reduced to 100 ppm, unless the
Commission determines that it is not
technologically feasible to meet this
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
lower limit. Section 101(b)(2) of the
CPSIA further 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.
(b) Section 101(b)(4) of the CPSIA
provides that if the Commission
determines that it is not technologically
feasible for certain electronic devices to
comply with the lead limits, the
Commission must issue requirements by
regulation to eliminate or minimize the
potential for exposure to and
accessibility of lead in such electronic
devices and establish a compliance
schedule unless the Commission
determines that full compliance is not
technologically feasible within a
schedule set by the Commission.
(c) Certain accessible lead-containing
component parts in children’s electronic
devices unable to meet the lead limits
set forth in paragraph (a) of this section
due to technological infeasibility are
granted the exemptions that follow in
paragraph (d) of this section below,
provided that use of lead is necessary
for the proper electronic functioning of
the component part and it is not
technologically feasible for the
component part to meet the lead content
limits set forth in paragraph (a) of this
section.
(d) Exemptions for lead as used in
certain electronic components parts in
children’s electronic devices include:
(1) Lead blended into the glass of
cathode ray tubes, electronic
components, and fluorescent tubes.
(2) Lead used as an alloying element
in steel. The maximum amount of lead
shall be less than 0.35% by weight
(3,500 ppm).
(3) Lead used in the manufacture of
aluminum. The maximum amount of
lead shall be less than 0.4% by weight
(4,000 ppm).
(4) Lead used in copper-based alloys.
The maximum amount of lead shall be
less than 4% by weight (40,000 ppm).
(5) Lead used in lead-bronze bearing
shells and bushings.
(6) Lead used in compliant pin
connector systems.
(7) Lead used in optical and filter
glass.
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Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations
(8) Lead oxide in plasma display
panels (PDP) and surface conduction
electron emitter displays (SED) used in
structural elements; notably in the front
and rear glass dielectric layer, the bus
electrode, the black stripe, the address
electrode, the barrier ribs, the seal frit
and frit ring, as well as in print pastes.
(9) Lead oxide in the glass envelope
of Black Light Blue (BLB) lamps.
(e) Components of electronic devices
that are removable or replaceable, such
as battery packs and light bulbs that are
inaccessible when the product is
assembled in functional form or are
otherwise granted an exemption, are not
subject to the lead limits in paragraph
(a) of this section.
(f) Commission staff is directed to
reevaluate and report to the Commission
on the technological feasibility of
compliance with the lead limits in
paragraph (a) of this section for
children’s electronic devices, including
the technological feasibility of making
accessible component parts
inaccessible, and the status of the
exemptions, no less than every five
years after publication of a final rule in
the Federal Register on children’s
electronic devices.
Dated: January 12, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2010–877 Filed 1–19–10; 8:45 am]
BILLING CODE 6355–01–P
List of Subjects in 21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 510 is amended as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Change of
Sponsor’s Name and Address
AGENCY:
Food and Drug Administration,
pwalker on DSK8KYBLC1PROD with RULES
Drug labeler
code
*
*
*
*
Fort Dodge Animal Health,
Division of Wyeth Holdings Corp., a wholly
owned subsidiary of
Pfizer, Inc., 235 East 42d
St., New York, NY 10017
Fort Dodge Animal Health,
Division of Wyeth, a
wholly owned subsidiary
of Pfizer, Inc., 235 East
42d St., New York, NY
10017
*
*
*
*
053501
000856
*
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Fort
Dodge Animal Health, A Division of
Wyeth Holdings Corp. to Fort Dodge
Animal Health, Division of Wyeth
Holdings Corp., a wholly owned
subsidiary of Pfizer, Inc. In a separate
action, FDA is amending the animal
drug regulations to reflect a change of
sponsor’s name from Fort Dodge Animal
Health, Division of Wyeth to Fort Dodge
Animal Health, Division of Wyeth, a
Jkt 220001
*
(2) * * *
Drug labeler
code
*
Firm name and address
*
000856
*
*
*
Fort Dodge Animal Health,
Division of Wyeth, a
wholly owned subsidiary
of Pfizer, Inc., 235 East
42d St., New York, NY
10017
*
053501
*
*
*
*
*
Fort Dodge Animal Health,
Division of Wyeth Holdings Corp., a wholly
owned subsidiary of
Pfizer, Inc., 235 East 42d
St., New York, NY 10017
*
*
*
*
Dated: January 8, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–930 Filed 1–19–10; 8:45 am]
1. The authority citation for 21 CFR
part 510 continues to read as follows:
SUMMARY:
15:59 Jan 19, 2010
Firm name and address
PART 510—NEW ANIMAL DRUGS
DEPARTMENT OF THE TREASURY
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Internal Revenue Service
2. In § 510.600, in the table in
paragraph (c)(1), revise the entries for
‘‘Fort Dodge Animal Health, A Division
of Wyeth Holdings Corp.’’ and ‘‘Fort
Dodge Animal Health, Division of
Wyeth’’; and in the table in paragraph
(c)(2), revise the entries for ‘‘000856’’
and ‘‘053501’’ to read as follows:
26 CFR Part 1
■
Final rule.
VerDate Nov<24>2008
(c) * * *
(1) * * *
BILLING CODE 4160–01–S
HHS.
ACTION:
wholly owned subsidiary of Pfizer, Inc.
In each case, the sponsor’s mailing
address will be changed.
DATES: This rule is effective January 20,
2010.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, A Division of
Wyeth Holdings Corp., P.O. Box 1339,
Fort Dodge, IA 50501 has informed FDA
of a change of name and mailing address
to Fort Dodge Animal Health, Division
of Wyeth Holdings Corp., a wholly
owned subsidiary of Pfizer, Inc., 235
East 42d St., New York, NY 10017. In
a separate action, Fort Dodge Animal
Health, Division of Wyeth, 800 Fifth St.
NW., Fort Dodge, IA 50501 has
informed FDA of a change of name and
mailing address to Fort Dodge Animal
Health, Division of Wyeth, a wholly
owned subsidiary of Pfizer, Inc., 235
East 42d St., New York, NY 10017.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to
reflect these changes.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
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*
*
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*
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[TD 9475]
RIN 1545–BF83
Corporate Reorganizations;
Distributions Under Sections
368(a)(1)(D) and 354(b)(1)(B);
Correction
AGENCY: Internal Revenue Service (IRS),
Treasury.
*
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]]>Agencies
[Federal Register Volume 75, Number 12 (Wednesday, January 20, 2010)]
[Rules and Regulations]
[Pages 3154-3159]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-877]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Children's Products Containing Lead; Exemptions for Certain
Electronic Devices
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is
issuing a final rule concerning certain electronic devices for which it
is not technologically feasible to meet the lead limits as required
under section 101 of the Consumer Product Safety Improvement Act of
2008 (CPSIA).\1\
---------------------------------------------------------------------------
\1\ The Commission voted 5-0 to publish this final rule, with
changes, in the Federal Register. Chairman Inez M. Tenenbaum, and
Commissioners Thomas H. Moore, Nancy Nord, Robert Adler, and Anne
Northup voted to publish the notice with changes. Commissioner
Northup issued a statement, and the statement can be found at https://www.cpsc.gov/PR/northup01062010devices.pdf.
DATES: Effective Date: This final rule is effective on January 20,
---------------------------------------------------------------------------
2010.
FOR FURTHER INFORMATION CONTACT: Kristina Hatlelid, Ph.D., 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 Consumer Product Safety Improvement Act of 2008 (CPSIA), Public
Law 110-314, 122 Stat. 3016, 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. The limit
[[Page 3155]]
will be further reduced to 100 ppm after three years, or August 14,
2011, 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. Section 101
(b)(2)(B) of the CPSIA further provides that the Commission shall
promulgate a rule providing guidance with respect to what product
components or classes of components will be considered to be
inaccessible. An interpretative rule providing guidance on
inaccessibility (inaccessibility rule) was published in the Federal
Register on August 7, 2009 (74 FR 39535).
In addition, if the Commission determines that it is not
technologically feasible for certain electronic devices to comply with
the lead limits, section 101(b)(4) of the CPSIA provides that the
Commission shall issue requirements by regulation to eliminate or
minimize the potential for exposure to and accessibility of lead in
such electronic devices, and establish a schedule for achieving full
compliance unless the Commission determines that full compliance with
the lead limits is not technologically feasible within such a schedule.
Under section 101(d) of the CPSIA, technological feasibility is based
on the commercial availability of products, technology, or other
practices that will allow compliance with the lead limits.
On January 15, 2009, the Commission issued a notice of proposed
rulemaking on requirements for certain electronic devices that could
not comply with the lead limits due to technological infeasibility (74
FR 2435). The notice of proposed rulemaking was withdrawn on February
12, 2009 (74 FR 7021). On that date, the Commission issued an interim
final rule (74 FR 6991) to provide certain exemptions for children's
electronic devices including:
Inaccessible lead-containing component parts;
Accessible lead-containing components parts that cannot be
produced without lead due to the lack of technologically feasible
substitutions and which require lead for the proper functioning of the
component part; and
Lead-containing spare parts or other removable components
which are inaccessible when the product is assembled in functional form
or is otherwise granted an exemption.
The interim final rule also directed Commission staff to reevaluate
and report to the Commission on the technical feasibility of compliance
with the lead limits, including the technological feasibility of making
accessible component parts inaccessible, and the status of the
exemptions no less than every five years after publication of a final
rule in the Federal Register. Comments on the interim final rule were
due on March 16, 2009.
C. Discussion of Comments to the Interim Final Rule
The Commission received seven comments from consumer groups,
electronics associations, companies, and individuals. In general, most
comments sought to narrow or expand the scope of the exemptions.
1. Summary of the Law--Section 1500.88(a)
Section 1500.88(a), in essence, summarized the lead content limits
in children's products under 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. Section 1500.88(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, we have,
on our own initiative, revised the last sentence by adding, ``Section
101(b)(2) of the CPSIA further 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.''
2. Technological Feasibility--Section 1500.88(b)
Section 1500.88(b) explained that if the Commission determines that
it is not technologically feasible for certain electronic devices, the
Commission must issue requirements by regulation to eliminate or
minimize the potential for exposure to and accessibility of lead in
such electronic devices and establish a schedule by which such
electronic devices shall be in full compliance unless the Commission
determines that full compliance is not technologically feasible for
such devices within a schedule set by the Commission.
We have, on our own initiative, modified this section to add
``within a schedule set by the Commission'' after ``such devices.''
This modification reflects the statutory language at section
101(b)(4)(B) of the CPSIA.
One commenter requested guidance regarding the definition of
``electronic devices.''
The CPSIA does not provide a definition for electronic devices.
However, we believe a reasonable definition of an electronic device is
``a device that generates, stores, distributes, or converts electrical
energy into another energy form.'' Examples of children's electronic
devices include, but are not limited to, products with batteries or
power cords (or that use solar power or other power sources), such as
music players, headphones, some toys and games, some calculators, and
certain computers or similar electronic learning products.
3. Certain Lead-Containing Component Parts--Section 1500.88(c)
Section 1500.88(c) provided that certain lead-containing component
parts in electronic devices that are unable to meet the lead limits
would be granted exemptions provided that the use of lead is necessary
for the proper functioning of the component part and it is not
technologically feasible for the component part to meet the lead
content limits.
On our own initiative, we have modified this section to add the
word ``accessible'' in between ``certain'' and ``lead-containing
component parts,'' to make clear that the exemptions in the rule are
applicable only to accessible component parts. Inaccessible component
parts are already excluded from the lead limits under section 101(b)(2)
of the CPSIA.
[[Page 3156]]
One commenter stated that the exemptions should be narrowed to
cover only components of electrical goods. This commenter asserted that
the language in the interim final rule could be read to exclude general
materials that contain metal alloys and enable manufacturers to add
lead although it may not be technologically necessary to do so.
The rule was intended to be limited to the materials and components
necessary for the electronic functioning of children's electronic
devices. In response to the comments, we have revised Sec. 1500.88(c)
by adding the word ``electronic'' before the word ``functioning.'' In
addition, we have further clarified Sec. 1500.88(d) to add the word
``electronic'' before ``component parts'' in the first sentence. Non-
functional uses of lead in children's electronic devices remain subject
to the lead content limits under section 101(a) of the CPSIA. For
example, if the metal component part was purely decorative, such as a
cell phone charm or wrist accessory sold with, or attached to, a
child's phone, that charm or accessory is not necessary to the proper
electronic functioning of the component part and is subject to the lead
content limits.
Another commenter requested that the exemptions for the metal alloy
components in children's electronic devices be extended to products
whose mechanical functions require the use of material containing lead,
such as a brass collar on the wheel of a toy. The commenter also
asserted that the electronic exemption for ``lead-bronze bearing shells
and bushings'' are not primarily used for the transmission of
electrical current, but are mechanical devices.
Section 101(b)(4) of the CPSIA allows exemptions to the lead
content limits if the Commission finds that it is not technologically
feasible to remove the lead from the electronic devices. This section
does not provide for exemptions for other types of products that are
unrelated to electronic devices. The exemptions under this rule include
bearing shells and bushings only when those bearing shells and bushings
are integral to the operation of certain electronic devices, such as
electric motors. For this reason, lead-bronze bearing shells and
bushings are allowed in children's electronic devices. However, the
exemption does not extend to bearing shells and bushings in children's
products that are unrelated to electronic operations because they do
not fall within the scope of these exemptions. Such components must
comply with the CPSIA's lead content limits. We note that if such
components are inaccessible to a child, they would not be subject to
the CPSIA lead content limits under 16 CFR 1500.87.
One commenter stated that the health implications of lead exposure
from the electronic products have not been considered and that the
interim final rule does not provide an incentive to improve technology
to reduce lead content. The commenter also stated that exempted
products should be labeled as to lead content. Another commenter stated
that no exemptions should be granted given the dangerous effects of
lead in children.
As discussed in the preamble to the interim final rule (74 FR at
6992), the complete elimination of lead, or the reduction in lead
content to the lead content limits specified in the CPSIA, is currently
not technologically feasible for certain components of children's
electronic products. Accordingly, the final rule provides for
exemptions from the lead limits for a limited number of components of
electronic devices that must be manufactured using lead, including in
certain metal alloys. Such component parts could include power cord
pins, cathode-ray tubes, and electrical connectors. Children are not
expected to experience significant exposures to lead from these few
applications. The lead containing components that are being exempted
are components that one would not expect children to mouth, swallow, or
handle for significant periods under normal and reasonably foreseeable
conditions. Moreover, with few exceptions, many electronic devices will
be in compliance with the lead limits under the CPSIA either because
they already meet the lead content limits or because the lead-
containing component part is inaccessible (74 FR at 6992).
Furthermore, we do not believe that labeling electronic devices for
their lead content would add to the safety of these products. In the
absence of the exemptions provided for in the CPSIA and this rule,
certain electronics devices would be banned if they were intended
primarily for children. The likely substitute for some of these
products would be similar products that are intended for general
consumer use. Thus, not providing these exemptions could result in
increases in the children's lead exposure from products intended for
general consumer use that are not subject either to the lead
limitations in the CPSIA or the alternate lead limits provided for in
the exemptions under this rule.
We also disagree with the commenter's assertion that the rule does
not provide incentives for technological improvements. Congress
recognized that certain electronic devices currently may not be able to
meet the lead content limits. However, under section 101(b)(5) of the
CPSIA, the Commission specifically was directed to periodically review
and revise the regulations, as necessary, no less than every five
years. The Commission intends to continue to evaluate the technological
feasibility of making accessible component parts inaccessible, and to
reevaluate the exemptions within that time frame as provided under
Sec. 1500.88(f) of this rule.
4. Exemptions for Lead--Section 1500.88(d)
This section set forth the specific exemptions for lead as used in
certain component parts in children's products. As discussed in part
C.3 of this preamble, we have added the word ``electronic'' before
``component parts'' in the first sentence of Sec. 1500.88(d) to make
clear that this rule applies to materials and components necessary for
the electronic functioning of children's electronic devices.
Additionally, on our own initiative, we have revised Sec.
1500.88(d)(1) to insert a comma between ``electronic components'' and
``and fluorescent tubes'' to clarify that electronic components and
fluorescent tubes should be considered as separate items rather than as
one item or as synonyms. We also have revised Sec. 1500.88(d)(2) to
replace ``3,500 ppm'' with ``3,500 ppm,'' for purposes of consistency
with how the ppm levels are expressed elsewhere in the final rule. We
also have revised Sec. 1500.88(d)(8) to insert a comma between ``the
seal frit and frit ring'' and ``as well as in print pastes'' to clarify
that a seal frit and frit ring are distinct from print pastes.
Commenters representing the electronics industry manufacturers
asserted that the list of exempted materials and components in the
final rule is too limited. They requested that the rule incorporate all
of the current exemptions of the use of lead in the European Union's
Restriction on Hazardous Substances (EU RoHS) directive to avoid
inconsistencies and to harmonize with other standards. They claimed
that while ongoing research aims to find alternatives and eliminate the
use of lead, it is not yet technologically feasible to avoid all uses
of lead. The commenters also asserted that testing for lead in
electronic products is difficult and costly.
We do not believe that it is necessary to incorporate into the rule
all of the exemptions listed in the EU RoHS directive. (European Union
Directive 2002/95/EC and amendments to the directive are available at
https://eur-
[[Page 3157]]
lex.europa.eu/en/index.htm.) The European Union and other countries and
authorities have adopted restrictions on the use of lead and other
chemicals in electronic devices to address concerns related to human
health and environmental impacts of waste electrical and electronic
equipment. The EU RoHS directive allows certain exemptions if
substitution is not possible from the scientific and technical point of
view or if the negative environmental or health impacts caused by
substitution are likely to outweigh the human and environmental
benefits of the substitution. It also specifies that exemptions must be
reviewed at least every four years with the aim of removing such
exemptions if it becomes technologically or scientifically possible to
replace the lead in a particular application. The list of exemptions
covered under the EU RoHS directive is intended to cover all electric
and electronic equipment.
The list of exemptions provided under this rule is intended to
allow the use of lead-containing components used in children's products
that are necessary for the electronic functioning of the children's
electronic device. Accordingly, the list of exemptions does not include
exemptions for uses of lead in components that have no application to,
or would not otherwise be used in children's products. For example,
adopting the EU RoHS directive would result in the inclusion of EU RoHS
directive exemption 23, ``Lead alloys as solder for transducers used in
high-powered (designed to operate for several hours at acoustic power
levels of 125dB SPL and above) loudspeakers'' into the final rule. Such
high powered speakers may be appropriate for use in a stadium, but are
not a children's product. Because the commenters did not identify any
specific exemption under the EU RoHS directive or similar directives
that may, in fact, require the use of lead in a component of children's
electronic devices and that also is not listed as an exemption under
this rule, we decline to revise the list of exemptions at this time. We
note that this rule does not preclude the commenters from complying
with the EU RoHS directive if they choose to do so. However, if
commenters need additional exemptions for lead-containing component
parts in children's electronic devices, they can submit a petition
under the procedures set forth under 16 CFR part 1051 with the
supporting documentation. A general request for regulatory action which
does not reasonably specify the type of action requested is not
sufficient for purposes of a petition request. 16 CFR 1051.6(a)(5).
Commenters also requested that the rule explicitly state that
exempted or inaccessible parts are not subject to the testing
requirement of section 102 of the CPSIA.
With regard to inaccessible component parts, the preamble to the
inaccessibility rule stated that a manufacturer currently is not
required to provide third-party testing to demonstrate inaccessibility
(74 FR at 39537). In addition, many of the exemptions provided under
this rule do not require testing under section 102 of the CPSIA because
there are no lead limits associated with the exemptions. However, the
exemptions for the metal alloys are not blanket or absolute exemptions.
Instead, they are presented as alternate lead limits. As such, those
components, i.e., copper (less than 4 percent lead by weight), steel
(less than 0.35 percent lead by weight), and aluminum (less than 0.4
percent lead by weight), must still be tested by the manufacturer to
verify that these component parts comply with these higher lead limits
under section 102 of the CPSIA.
The Commission intends to address component part testing 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 an upcoming rulemaking.
As for the other specific exemptions mentioned in Sec. 1500.88(d),
such as lead used in compliant pin connector systems (Sec.
1500.88(d)(6)), lead used in optical and filter glass (Sec.
1500.88(d)(7)), lead oxide in plasma display panels and surface
conduction electron emitter displays used in structural elements (Sec.
1500.88(d)(8)), and lead oxide in the glass envelope of Black Light
Blue lamps (Sec. 1500.88(d)(9)), we did not receive comments on those
provisions. Consequently, the final rule retains those provisions
without change.
5. Removable or Replaceable Parts--Section 1500.88(e)
This section provided that components of electronic devices that
are removable or replaceable, such as battery packs and light bulbs,
are not subject to the lead content limits if they were otherwise
granted an exemption, or are inaccessible when the product is assembled
in functional form.
On our own initiative, we have added commas after ``replaceable''
and ``exemption'' to clarify that section for readability.
Several commenters addressed removable and replaceable parts. Some
commenters supported the exemption from the lead content limits for
such parts on the basis that replacing or installing parts of a
children's electronic device is not a children's activity. Other
commenters opposed the exemption because children could access the
lead-containing parts when they are not installed.
We decline to revise the rule as suggested by some commenters. We
have determined that removable or replaceable parts, such as battery
packs and light bulbs, that are inaccessible when installed in the
product, are not subject to the lead content requirements. When
installed, such parts are inaccessible under 16 CFR 1500.87. In
addition, these types of spare parts or replacement parts, including
battery pack and light bulbs, are not intended primarily for children
since such parts are available for general use by the public. While
spare parts may sometimes be included with a children's product, in
many instances, the parts, necessary for the functioning of the
electronic device, are to be installed by adults, and are inaccessible
to children once installed.
One commenter requested guidance regarding whether a metal key sold
with electrical electronic equipment would be subject to the lead
content limits. According to the commenter, keys are made with copper
alloy and aluminum and contain lead of up to 0.4%. The commenter stated
that substitutes containing lead below 300 ppm are unavailable.
The definition of ``children's product'' means a consumer product
designed or intended primarily for children 12 years of age. A key used
in connection with a child's electronic device does not necessarily
make the key a children's product if the key is intended for an adult
to use in safeguarding or monitoring the use of the electronic
equipment. In such instances, the key would be in the possession of the
adult at all times, and would not be considered a children's product.
In other instances, if a key is to be used primarily by a child in
connection with an electronic device, an exemption from the lead
content limits under the CPSIA would apply only in instances where such
a key is necessary for the electronic functioning of the device.
6. Review Period--Section 1500.88(f)
This section provides that the Commission staff will reevaluate and
report to the Commission on the technological feasibility of compliance
with the lead content limits for
[[Page 3158]]
children's electronic devices, including the technological feasibility
of making accessible component part inaccessible, and the status of the
exemptions no less than every five years.
One commenter stated that the EU RoHS directive specifies that
exemptions must be reviewed every four years. The commenter requested
that the Commission adopt the same four year review cycle.
As discussed in part C.4 of this preamble, we are not adopting all
of the exemptions in the EU RoHS directive. Accordingly, the
Commission's review of the exemptions provided under this rule will be
based on the application of lead in children's electronic devices.
Section 101(b)(5) of the CPSIA provides that reviews and possible
revision must occur no less frequently than every five years. Thus, we
do not believe that the rule needs to be revised at this time. However,
to the extent technological advances are made in the next few years,
such that the existing exemptions warrant revision or rescission, we
will review such changes and consider revisions prior to the five year
review period.
D. Impact on Small Businesses
Under the Regulatory Flexibility Act (RFA), when an agency issues a
proposed rule, it generally must prepare an initial regulatory
flexibility analysis describing the impact the proposed rule is
expected to have on small entities. 5 U.S.C. 603. The RFA does not
require a regulatory flexibility analysis if the head of the agency
certifies that the rule will not have a significant effect on a
substantial number of small entities.
In the preamble to the interim final rule (74 FR at 6992), the
Commission's Directorate for Economic Analysis determined that the
exemption for certain specified materials from the requirements of
section 101(a) of the CPSIA will not result in any increase in the
costs of production for any firm. Its only effect on businesses,
including small businesses, will be to reduce the costs associated with
compliance with the lead content limits of the CPSIA. Based on the
foregoing assessment, the Commission certifies that the rule would not
have a significant impact on a substantial number of small entities.
E. Environmental Considerations
Generally, CPSC rules are considered to ``have little or no
potential for affecting the human environment,'' and environmental
assessments are not usually prepared for these rules (see 16 CFR
1021.5(c)(1)). The final rule is not expected to have an adverse impact
on the environment, thus, the Commission concludes that no environment
assessment or environmental impact statement is required in this
proceeding.
F. Executive Orders
According to Executive Order 12988 (February 5, 1996), agencies
must state in clear language the preemptive effect, if any, of new
regulations. The preemptive effect of regulations such as this final
rule is stated in section 18 of the Federal Hazardous Substances Act.
15 U.S.C. 1261n.
G. Effective Date
The Administrative Procedure Act requires that a substantive rule
must be published not less than 30 days before its effective date,
unless the rule relieves a restriction. 5 U.S.C. 553(d)(1). Because the
final rule provides relief from existing testing requirements under the
CPSIA and is virtually identical to an interim final rule that has been
in effect since February 10, 2009, the effective date for the final
rule is January 20, 2010.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
0
For the reasons stated above, the Commission amends chapter II of title
16 of the Code of Federal Regulations 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. Revise Sec. 1500.88 to read as follows:
Sec. 1500.88 Exemptions from lead limits under section 101 of the
Consumer Product Safety Improvement Act for Certain Electronic Devices.
(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 will be further reduced to 100 ppm,
unless the Commission determines that it is not technologically
feasible to meet this lower limit. Section 101(b)(2) of the CPSIA
further 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.
(b) Section 101(b)(4) of the CPSIA provides that if the Commission
determines that it is not technologically feasible for certain
electronic devices to comply with the lead limits, the Commission must
issue requirements by regulation to eliminate or minimize the potential
for exposure to and accessibility of lead in such electronic devices
and establish a compliance schedule unless the Commission determines
that full compliance is not technologically feasible within a schedule
set by the Commission.
(c) Certain accessible lead-containing component parts in
children's electronic devices unable to meet the lead limits set forth
in paragraph (a) of this section due to technological infeasibility are
granted the exemptions that follow in paragraph (d) of this section
below, provided that use of lead is necessary for the proper electronic
functioning of the component part and it is not technologically
feasible for the component part to meet the lead content limits set
forth in paragraph (a) of this section.
(d) Exemptions for lead as used in certain electronic components
parts in children's electronic devices include:
(1) Lead blended into the glass of cathode ray tubes, electronic
components, and fluorescent tubes.
(2) Lead used as an alloying element in steel. The maximum amount
of lead shall be less than 0.35% by weight (3,500 ppm).
(3) Lead used in the manufacture of aluminum. The maximum amount of
lead shall be less than 0.4% by weight (4,000 ppm).
(4) Lead used in copper-based alloys. The maximum amount of lead
shall be less than 4% by weight (40,000 ppm).
(5) Lead used in lead-bronze bearing shells and bushings.
(6) Lead used in compliant pin connector systems.
(7) Lead used in optical and filter glass.
[[Page 3159]]
(8) Lead oxide in plasma display panels (PDP) and surface
conduction electron emitter displays (SED) used in structural elements;
notably in the front and rear glass dielectric layer, the bus
electrode, the black stripe, the address electrode, the barrier ribs,
the seal frit and frit ring, as well as in print pastes.
(9) Lead oxide in the glass envelope of Black Light Blue (BLB)
lamps.
(e) Components of electronic devices that are removable or
replaceable, such as battery packs and light bulbs that are
inaccessible when the product is assembled in functional form or are
otherwise granted an exemption, are not subject to the lead limits in
paragraph (a) of this section.
(f) Commission staff is directed to reevaluate and report to the
Commission on the technological feasibility of compliance with the lead
limits in paragraph (a) of this section for children's electronic
devices, including the technological feasibility of making accessible
component parts inaccessible, and the status of the exemptions, no less
than every five years after publication of a final rule in the Federal
Register on children's electronic devices.
Dated: January 12, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-877 Filed 1-19-10; 8:45 am]
BILLING CODE 6355-01-P
