Children's Products Containing Lead; Exemptions for Certain Electronic Devices; Interim Final Rule, 6990-6993 [E9-3025]
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Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Rules and Regulations
‘‘shall ensure that each of the fees * * *
is reasonably related to the
Administration’s costs, as determined
by the Administrator, of providing the
service rendered * * *.’’ Section 119(d)
of the Aviation and Transportation
Security Act of 2001, Public Law 107–
71.
4. Objective. The Administrator
deems it appropriate to create the
Overflight Fees Aviation Rulemaking
Committee to obtain advice and
recommendations on the appropriate
amounts for future Overflight Fees.
5. Duties. The Committee is to
evaluate information regarding the
services rendered to overflights by the
FAA and the costs of providing those
services to overflights, and, based on
that evaluation, to make
recommendations regarding future
overflight fee increases. The Committee
shall provide its recommendations to
the Administrator by a deadline to be
determined by the Chair, which may be
modified by the Administrator.
6. Organization and Administration.
a. The Committee shall be led by the
Chair, who shall be a full-time employee
of the FAA appointed by the Assistant
Administrator for Financial Services.
The Chair may designate a Vice Chair,
who shall not be employed by the FAA
and who shall be a representative of
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of those carriers, or other system users
who are subject to Overflight Fees.
b. In addition to the Chair and Vice
Chair, the Committee shall be
comprised of not more than 15
members, who shall be employees or
other representatives of the foreign air
carriers (or trade associations of those
carriers) or other system users that are
subject to the FAA’s Overflight Fees.
The members shall be selected by the
Associate Administrator for Financial
Services and, to the extent possible, the
membership also shall be geographically
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conduct primarily enroute overflights
and primarily oceanic overflights. Each
member may designate one
representative and one alternate to serve
on the Committee. Each member of the
Committee shall have one vote.
c. Members may permit their
employees and consultants (including
financial, technical and legal
professionals) to attend any Committee
meeting and review Committee
documents.
d. Additional FAA personnel may
participate, as directed by the Chair, as
adjunct non-members of the Committee.
e. The Assistant Administrator for
Financial Services is the sponsor of the
Committee. The Associate
Administrator for Financial Services
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shall receive all Committee
recommendations and reports. The
Associate Administrator shall also be
responsible for providing administrative
support for the Committee and shall
provide a secretariat. The Chair shall be
responsible for establishment of the
procedures, consistent with this charter,
under which the Committee shall
operate.
f. Meetings shall be held as frequently
as needed, as determined solely by the
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to do so. Committee recommendations
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members. The Chair shall have the right
to submit a separate report or
recommendation to the Administrator.
7. Compensation. All non-government
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government, and shall bear all costs
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consultants invited by a member) must
request and receive approval in advance
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9. Availability of Records. Subject to
the provisions of the Freedom of
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records, reports, agendas, working
papers, and other documents that are
made available to, prepared by, or
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available for public inspection and
copying at the FAA Office of
Rulemaking, 800 Independence Avenue,
SW., Washington, DC 20591. Fees shall
be charged for the information furnished
to the public in accordance with the fee
schedule published in part 7 of title 49,
Code of Federal Regulations.
10. Public Interest. The formation of
the Committee is determined to be in
the public interest in connection with
the performance of duties imposed on
the FAA by law.
11. Effective Date and Duration. This
order is effective immediately. The
Committee shall remain in existence for
two years after the effective date of this
Order unless sooner terminated or
extended by the Administrator.
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Dated: December 17, 2008.
Robert A. Sturgell,
Acting Administrator.
[FR Doc. E9–2985 Filed 2–11–09; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1500
Children’s Products Containing Lead;
Exemptions for Certain Electronic
Devices; Interim Final Rule
AGENCY: Consumer Product Safety
Commission.
ACTION: Interim final rule.
SUMMARY: The Consumer Product Safety
Commission (CPSC or Commission) is
issuing an interim 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),
Public Law 110–314, 122 Stat. 3016. By
notice published elsewhere in today’s
Federal Register, the Commission is
withdrawing the proposed rule on
exemptions for certain electronic
devices published in the Federal
Register on January 15, 2009, 74 FR
2435.
DATES: This interim final rule is
effective February 10, 2009. Comments
must be in writing and should be
submitted by March 16, 2009.
ADDRESSES: Comments should be emailed to
Sec101ElectronicDevices@cpsc.gov.
Comments should be captioned
‘‘Section 101 Electronic Devices Interim
Rule.’’ Comments may also be mailed,
preferably in five copies, to the Office of
the Secretary, Consumer Product Safety
Commission, Room 502, 4330 East West
Highway, Bethesda, Maryland 20814, or
delivered to the same address
(telephone (301) 504–7923). Comments
also may be filed by facsimile to (301)
504–0127.
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; telephone (301) 504–
7254, e-mail khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA Lead Content Limits
The CPSIA provides for specific lead
limits in children’s products. Section
101(a) of the CPSIA provides that, by
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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 may be further reduced to 100
ppm after three years, or August 14,
2011, unless the Commission
determines that it is not technologically
feasible to have this lower limit. A
children’s product is defined in section
235(a) of the CPSIA as a consumer
product designed or intended primarily
for children 12 years of age or younger.
Section 101(b)(2) of the CPSIA
provides that the lead limits do not
apply to component parts of a product
that are not accessible to a child. This
section specifies that a component part
is not accessible if it is not physically
exposed by reason of a sealed covering
or casing and does not become
physically exposed through reasonably
foreseeable use and abuse of the product
including swallowing, mouthing,
breaking, or other children’s activities,
and the aging of the product, as
determined by the Commission. Paint,
coatings, or electroplating may not be
considered to be a barrier that would
render lead in the substrate to be
inaccessible to a child. Section 101
(b)(2)(B) further provides that the
Commission must promulgate a rule
providing guidance with respect to what
product components or classes of
components will be considered to be
inaccessible. A proposed interpretative
rule providing guidance on
inaccessibility was published in the
Federal Register on January 15, 2009, 74
FR 2439.
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 may 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. 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 technologically
infeasibility. 74 FR 2435. The comment
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period ends on February 17, 2009. As
discussed below, and by notice
published elsewhere in today’s Federal
Register, the Commission is
withdrawing that notice of proposed
rulemaking.
Stay of Enforcement
Due to substantial confusion by the
public and affected businesses regarding
implementation of the CPSIA, and as to
which testing and certification
requirements of the CPSIA apply to
which products under the Commission’s
jurisdiction, and what sort of testing is
required where the provisions do apply,
on February 2, 2009, the Commission
announced a stay of enforcement of
testing and certification requirements of
certain provisions of subsection 14(a) of
the Consumer Product Safety Act
(CPSA) as amended by section 102(a) of
the CPSIA until February 10, 2010.
Although the testing and certification
requirements are stayed for
manufacturers or importers of children’s
products, including electronic devices
until February 10, 2010, the stay of
enforcement did not provide any
meaningful relief to manufacturers or
importers of children’s electronic
devices that contain component parts
that exceed the lead contents limits due
to technological infeasibility. Absent
issuance of an immediate interim final
rule, such manufacturers and importers
would not be able to sell children’s
electronic devices containing
component parts that exceed lead
content limits due to technological
infeasibility until the issuance of a final
rule granting exemptions, and yet such
a final rule would necessarily issue after
the comment period closes for the
notice of proposed rulemaking on
February 17, 2009. Because the first lead
content limit will go into effect on
February 10, 2009, manufacturers,
importers, retailers and distributors
would not know how to address these
electronic products between the
February 10, 2009 date and the date of
any final rule based on the proposed
rule. Therefore, by notice published
elsewhere in today’s Federal Register,
the Commission is withdrawing the
proposed rulemaking and is issuing this
interim final rule to provide certainty
regarding exemptions for certain
children’s electronic devices that are in
the stream of commerce and fall within
the scope of the exemptions provided in
this interim final rule.
B. Discussion
The Interim Final Rule
The CPSIA provides authority for the
Commission under section 101(b)(4), to
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6991
issue regulations concerning certain
electronic devices to eliminate or
minimize the potential for exposure to
and accessibility of lead in such
electronic devices if it is not
technologically feasible to comply with
the lead limits set by the CPSIA. The
Commission recognizes that it is
currently not technologically feasible for
certain parts of electronic devices to
comply with the CPSIA lead limits.
Accordingly, the Commission is issuing
an interim final rule providing
exemptions for certain electronic
devices.
1. Inaccessible Electronic Devices
Some lead-containing component
parts of electronic devices are, by
design, not accessible to children
because the lead is fully enclosed
within a component that is itself within
the electronic device. Accessibility of
the lead-containing component part may
be evaluated through application of the
accessibility probes described in 16 CFR
1500.48 and 1500.49, before and after
use and abuse tests at 16 CFR 1500.50
through 1500.53 (excluding the bite
tests of 1500.51(c) and 1500.52(c)). If a
lead-containing component part is not
accessible to a child, it is not subject to
the lead limits under the CPSIA.
2. Accessible Electronic Devices That
Are Exempt
Certain component parts in children’s
electronic devices cannot be produced
without lead due to the lack of
technologically feasible substitutions or
may require lead for the proper
functioning of the component part.
However, these component parts may
not be able to be made physically
inaccessible. An example is a cathode
ray tube, in which the lead in the glass
protects users from the x-ray radiation
generated by the device during normal
operation. However, other components
could be made to be inaccessible, taking
account of normal and reasonably
foreseeable use and abuse by children.
The Commission expects that
manufacturers will continue to assess
the technological feasibility of making
electronic devices that have accessible
component parts which contain lead
above the lead content limits
inaccessible, and make such component
parts inaccessible whenever possible.
To the extent that certain electronic
component parts cannot be made
inaccessible, the staff has reviewed the
exemptions granted under other
directives including European Union
Directive 2002/95/EC (EU RoHS), and
Korea Act for Resource Recycling of
Electrical and Electronic Equipment and
Vehicles (Korea RoHS), to evaluate
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possible exemptions when substitution
for lead was not possible due to
scientific and technical considerations.1
These measures are broader, containing
limits on allowable lead concentrations,
generally 1,000 ppm for lead content, in
electronic components and products,
without regard to the intended age range
of the users. However, the measures also
provide for certain exemptions to the
allowable lead concentrations for some
components.
Staff’s review of the use of lead in
children’s electronic devices showed
that in general, lead is added to
components in electronic products to
take advantage of the unique material
properties that lead and lead
compounds exhibit including improved
ability of the material to be machined
and improved corrosion resistance of an
alloy. For example, lead is added to
copper alloys to adjust its mechanical
strength and modulus of elasticity. Lead
is added to glass to adjust its index of
refraction. Lead also serves to
mechanically strengthen glass and in
the case of cathode-ray tubes, improve
its ability to absorb x-rays. Lead added
to bushing and bearing materials acts as
a dry lubricant to lower friction in the
components during use. Lead is also
used to adjust the mechanical properties
of electronic connectors.
As a result of these unique properties
for lead, the staff determined that it is
not technologically feasible for certain
components in electronic devices to
meet the lead content limits under the
CPSIA because the presence of the lead
is necessary for proper functioning of
certain component parts in electronic
devices and substitution of the lead is
not yet technologically feasible. Based
on staff’s review, the Commission has
determined that the following
exemptions for lead as used in certain
components parts in children’s
electronic devices that do not meet the
lead content limits under the CPSIA are
currently necessary:
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
(3500 ppm).
3. Lead used in the manufacture of
aluminum. The maximum amount of
1 European
Union Directive 2002/95/EC and
amendments to the directive are available at
https://eur-lex.europa.eu/en/index.htm. The Korea
RoHS is available at https://www.kece.eu/rohs/
kr.htm. The consideration and application of these
limited exemptions from such directives in this
interim final rule do not imply that the Commission
endorses or supports those directives in any way.
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lead shall be less than 0.4% by weight
(4000 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.
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.
3. Removable or Replaceable
Component Parts
Some components of children’s
electronic devices may be removable or
replaceable. For example, battery packs
and light bulbs may be provided as
spare or replacement parts. Until such
components are installed in the product,
lead-containing parts may be accessible
to a child. However, the Commission
finds that spare parts or other removable
components shall be considered
inaccessible under the provisions of the
CPSIA, provided that the leadcontaining component is inaccessible
when the product is assembled in
functional form or if the component
itself meets the criteria for exemption,
such as under the exemptions provided
herein.
4. Accessible Electronic Devices Which
Are Not Exempt
All component parts of children’s
electronic devices that exceed the
CPSIA’s specified lead limits which
cannot be made inaccessible and that
are not exempted on the basis of
exemptions adopted by the Commission
must comply with the lead limits
specified in the CPSIA. The
Commission’s expectation is that, with
the exception of a few particular
applications such as cathode ray tubes,
many electronic devices will be in
compliance with the CPSIA lead
provisions either because they already
meet the lead content limits or through
the exception for inaccessibility of leadcontaining component parts. However,
to the extent that an accessible
component part does not qualify for an
exemption, it must continue to meet the
CPSIA lead limits.
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5. Periodic Review
The Commission will consider all
comments received during the comment
period as discussed below. In addition,
because of the changing state of
technology and continuing progress in
replacing lead with other substances,
and consistent with the mandate to
conduct periodic reviews under section
101(b)(5) of the CPSIA, staff will
reevaluate the technological feasibility
of compliance with the lead limits 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 as required by the CPSIA.
C. 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.
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
that would have been associated with
testing the exempted materials.
Accordingly, the Commission finds that
the proposed rule would not have a
significant impact on a substantial
number of small entities.
D. 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 interim final rule
will not result in any additional use of
lead over what is occurring at the
present time. Accordingly, the
Commission does not expect the
proposal to have any negative
environmental impact.
E. 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 proposal is stated in section 18 of
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the Federal Hazardous Substances Act.
15 U.S.C. 1261n.
F. Effective Date
The Administrative Procedure Act
(APA) requires that a substantive rule
must be published not less than 30 days
before its effective date, unless it grants
an exemption. 5 U.S.C. 553(d)(1).
Because this interim final rule grants
exemptions from the existing
requirements, the effective date is
February 10, 2009.
G. Request for Comments
The interim final rule will become
effective without prior notice and
comment. Notice and comment
procedures are not required under the
APA when the agency for good cause
finds that notice and comment is
impracticable, unnecessary or contrary
to the public interest. 5 U.S.C. 553(b)(B).
The Commission finds that the public
notice and comment before the issuance
of this interim final rule would have
been impracticable given the statutory
requirement imposed in the CPSIA that
the lead limits go into effect on February
10, 2009, six months after the enactment
of the CPSIA, and the inapplicability of
the Commission’s stay of certain testing
certification requirements to lead
content limits imposed on these
products.
Interested persons are invited to
submit comment on the interim final
rule. The Commission will consider
these comments before issuing final
regulations. In addition, comments
previously submitted in response to the
notice of proposed rulemaking will be
considered along with the comments to
the interim final rule in this proceeding.
Comments should be submitted by
March 16, 2009. Comments should be emailed to
Sec101ElectronicDevices@cpsc.gov.
Comments should be captioned
‘‘Section 101 Electronic Devices Interim
Rule.’’ Comments may also be mailed,
preferably in five copies, to the Office of
the Secretary, Consumer Product Safety
Commission, Room 502, 4330 East West
Highway, Bethesda, Maryland 20814, or
delivered to the same address
(telephone (301) 504–7923). Comments
also may be filed by facsimile to (301)
504–0127.
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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 16 CFR part 1500
as follows:
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16:07 Feb 11, 2009
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PART 1500—HAZARDOUS
SUBSTANCES AND ARTICLES:
ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority citation for part 1500
is revised to read as follows:
■
Authority: 15 U.S.C. 1261–1278, 122 Stat.
3016.
2. Add a new § 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 may be further
reduced to 100 ppm, unless the
Commission determines that it is not
technologically feasible to have this
lower limit. Paint, coatings or
electroplating may not be considered a
barrier that would make the lead
content of a product inaccessible to a
child.
(b) Section 101(b)(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.
(c) Certain 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, provided that 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 set forth in paragraph (a) of this
section.
(d) Exemptions for lead as used in
certain component parts in children’s
electronic devices include:
(1) Lead blended into the glass of
cathode ray tubes, electronic
components and fluorescent tubes.
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6993
(2) Lead used as an alloying element
in steel. The maximum amount of lead
shall be less than 0.35% by weight
(3500 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.
(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: February 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. E9–3025 Filed 2–11–09; 8:45 am]
BILLING CODE 6335–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2008–N–0039]
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Food and Drug Administration,
HHS.
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]]>Agencies
[Federal Register Volume 74, Number 28 (Thursday, February 12, 2009)]
[Rules and Regulations]
[Pages 6990-6993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3025]
=======================================================================
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Children's Products Containing Lead; Exemptions for Certain
Electronic Devices; Interim Final Rule
AGENCY: Consumer Product Safety Commission.
ACTION: Interim final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is
issuing an interim 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), Public Law 110-314, 122 Stat. 3016. By notice
published elsewhere in today's Federal Register, the Commission is
withdrawing the proposed rule on exemptions for certain electronic
devices published in the Federal Register on January 15, 2009, 74 FR
2435.
DATES: This interim final rule is effective February 10, 2009. Comments
must be in writing and should be submitted by March 16, 2009.
ADDRESSES: Comments should be e-mailed to
Sec101ElectronicDevices@cpsc.gov. Comments should be captioned
``Section 101 Electronic Devices Interim Rule.'' Comments may also be
mailed, preferably in five copies, to the Office of the Secretary,
Consumer Product Safety Commission, Room 502, 4330 East West Highway,
Bethesda, Maryland 20814, or delivered to the same address (telephone
(301) 504-7923). Comments also may be filed by facsimile to (301) 504-
0127.
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; telephone (301) 504-
7254, e-mail khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA Lead Content Limits
The CPSIA provides for specific lead limits in children's products.
Section 101(a) of the CPSIA provides that, by
[[Page 6991]]
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 may be
further reduced to 100 ppm after three years, or August 14, 2011,
unless the Commission determines that it is not technologically
feasible to have this lower limit. A children's product is defined in
section 235(a) of the CPSIA as a consumer product designed or intended
primarily for children 12 years of age or younger.
Section 101(b)(2) of the CPSIA provides that the lead limits do not
apply to component parts of a product that are not accessible to a
child. This section specifies that a component part is not accessible
if it is not physically exposed by reason of a sealed covering or
casing and does not become physically exposed through reasonably
foreseeable use and abuse of the product including swallowing,
mouthing, breaking, or other children's activities, and the aging of
the product, as determined by the Commission. Paint, coatings, or
electroplating may not be considered to be a barrier that would render
lead in the substrate to be inaccessible to a child. Section 101
(b)(2)(B) further provides that the Commission must promulgate a rule
providing guidance with respect to what product components or classes
of components will be considered to be inaccessible. A proposed
interpretative rule providing guidance on inaccessibility was published
in the Federal Register on January 15, 2009, 74 FR 2439.
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 may 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.
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 technologically infeasibility.
74 FR 2435. The comment period ends on February 17, 2009. As discussed
below, and by notice published elsewhere in today's Federal Register,
the Commission is withdrawing that notice of proposed rulemaking.
Stay of Enforcement
Due to substantial confusion by the public and affected businesses
regarding implementation of the CPSIA, and as to which testing and
certification requirements of the CPSIA apply to which products under
the Commission's jurisdiction, and what sort of testing is required
where the provisions do apply, on February 2, 2009, the Commission
announced a stay of enforcement of testing and certification
requirements of certain provisions of subsection 14(a) of the Consumer
Product Safety Act (CPSA) as amended by section 102(a) of the CPSIA
until February 10, 2010. Although the testing and certification
requirements are stayed for manufacturers or importers of children's
products, including electronic devices until February 10, 2010, the
stay of enforcement did not provide any meaningful relief to
manufacturers or importers of children's electronic devices that
contain component parts that exceed the lead contents limits due to
technological infeasibility. Absent issuance of an immediate interim
final rule, such manufacturers and importers would not be able to sell
children's electronic devices containing component parts that exceed
lead content limits due to technological infeasibility until the
issuance of a final rule granting exemptions, and yet such a final rule
would necessarily issue after the comment period closes for the notice
of proposed rulemaking on February 17, 2009. Because the first lead
content limit will go into effect on February 10, 2009, manufacturers,
importers, retailers and distributors would not know how to address
these electronic products between the February 10, 2009 date and the
date of any final rule based on the proposed rule. Therefore, by notice
published elsewhere in today's Federal Register, the Commission is
withdrawing the proposed rulemaking and is issuing this interim final
rule to provide certainty regarding exemptions for certain children's
electronic devices that are in the stream of commerce and fall within
the scope of the exemptions provided in this interim final rule.
B. Discussion
The Interim Final Rule
The CPSIA provides authority for the Commission under section
101(b)(4), to issue regulations concerning certain electronic devices
to eliminate or minimize the potential for exposure to and
accessibility of lead in such electronic devices if it is not
technologically feasible to comply with the lead limits set by the
CPSIA. The Commission recognizes that it is currently not
technologically feasible for certain parts of electronic devices to
comply with the CPSIA lead limits. Accordingly, the Commission is
issuing an interim final rule providing exemptions for certain
electronic devices.
1. Inaccessible Electronic Devices
Some lead-containing component parts of electronic devices are, by
design, not accessible to children because the lead is fully enclosed
within a component that is itself within the electronic device.
Accessibility of the lead-containing component part may be evaluated
through application of the accessibility probes described in 16 CFR
1500.48 and 1500.49, before and after use and abuse tests at 16 CFR
1500.50 through 1500.53 (excluding the bite tests of 1500.51(c) and
1500.52(c)). If a lead-containing component part is not accessible to a
child, it is not subject to the lead limits under the CPSIA.
2. Accessible Electronic Devices That Are Exempt
Certain component parts in children's electronic devices cannot be
produced without lead due to the lack of technologically feasible
substitutions or may require lead for the proper functioning of the
component part. However, these component parts may not be able to be
made physically inaccessible. An example is a cathode ray tube, in
which the lead in the glass protects users from the x-ray radiation
generated by the device during normal operation. However, other
components could be made to be inaccessible, taking account of normal
and reasonably foreseeable use and abuse by children. The Commission
expects that manufacturers will continue to assess the technological
feasibility of making electronic devices that have accessible component
parts which contain lead above the lead content limits inaccessible,
and make such component parts inaccessible whenever possible.
To the extent that certain electronic component parts cannot be
made inaccessible, the staff has reviewed the exemptions granted under
other directives including European Union Directive 2002/95/EC (EU
RoHS), and Korea Act for Resource Recycling of Electrical and
Electronic Equipment and Vehicles (Korea RoHS), to evaluate
[[Page 6992]]
possible exemptions when substitution for lead was not possible due to
scientific and technical considerations.\1\ These measures are broader,
containing limits on allowable lead concentrations, generally 1,000 ppm
for lead content, in electronic components and products, without regard
to the intended age range of the users. However, the measures also
provide for certain exemptions to the allowable lead concentrations for
some components.
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\1\ European Union Directive 2002/95/EC and amendments to the
directive are available at https://eur-lex.europa.eu/en/index.htm.
The Korea RoHS is available at https://www.kece.eu/rohs/kr.htm. The
consideration and application of these limited exemptions from such
directives in this interim final rule do not imply that the
Commission endorses or supports those directives in any way.
---------------------------------------------------------------------------
Staff's review of the use of lead in children's electronic devices
showed that in general, lead is added to components in electronic
products to take advantage of the unique material properties that lead
and lead compounds exhibit including improved ability of the material
to be machined and improved corrosion resistance of an alloy. For
example, lead is added to copper alloys to adjust its mechanical
strength and modulus of elasticity. Lead is added to glass to adjust
its index of refraction. Lead also serves to mechanically strengthen
glass and in the case of cathode-ray tubes, improve its ability to
absorb x-rays. Lead added to bushing and bearing materials acts as a
dry lubricant to lower friction in the components during use. Lead is
also used to adjust the mechanical properties of electronic connectors.
As a result of these unique properties for lead, the staff
determined that it is not technologically feasible for certain
components in electronic devices to meet the lead content limits under
the CPSIA because the presence of the lead is necessary for proper
functioning of certain component parts in electronic devices and
substitution of the lead is not yet technologically feasible. Based on
staff's review, the Commission has determined that the following
exemptions for lead as used in certain components parts in children's
electronic devices that do not meet the lead content limits under the
CPSIA are currently necessary:
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 (3500 ppm).
3. Lead used in the manufacture of aluminum. The maximum amount of
lead shall be less than 0.4% by weight (4000 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.
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.
3. Removable or Replaceable Component Parts
Some components of children's electronic devices may be removable
or replaceable. For example, battery packs and light bulbs may be
provided as spare or replacement parts. Until such components are
installed in the product, lead-containing parts may be accessible to a
child. However, the Commission finds that spare parts or other
removable components shall be considered inaccessible under the
provisions of the CPSIA, provided that the lead-containing component is
inaccessible when the product is assembled in functional form or if the
component itself meets the criteria for exemption, such as under the
exemptions provided herein.
4. Accessible Electronic Devices Which Are Not Exempt
All component parts of children's electronic devices that exceed
the CPSIA's specified lead limits which cannot be made inaccessible and
that are not exempted on the basis of exemptions adopted by the
Commission must comply with the lead limits specified in the CPSIA. The
Commission's expectation is that, with the exception of a few
particular applications such as cathode ray tubes, many electronic
devices will be in compliance with the CPSIA lead provisions either
because they already meet the lead content limits or through the
exception for inaccessibility of lead-containing component parts.
However, to the extent that an accessible component part does not
qualify for an exemption, it must continue to meet the CPSIA lead
limits.
5. Periodic Review
The Commission will consider all comments received during the
comment period as discussed below. In addition, because of the changing
state of technology and continuing progress in replacing lead with
other substances, and consistent with the mandate to conduct periodic
reviews under section 101(b)(5) of the CPSIA, staff will reevaluate the
technological feasibility of compliance with the lead limits 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 as required by the CPSIA.
C. 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.
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 that would have
been associated with testing the exempted materials. Accordingly, the
Commission finds that the proposed rule would not have a significant
impact on a substantial number of small entities.
D. 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 interim final rule will not result in any additional
use of lead over what is occurring at the present time. Accordingly,
the Commission does not expect the proposal to have any negative
environmental impact.
E. 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 proposal
is stated in section 18 of
[[Page 6993]]
the Federal Hazardous Substances Act. 15 U.S.C. 1261n.
F. Effective Date
The Administrative Procedure Act (APA) requires that a substantive
rule must be published not less than 30 days before its effective date,
unless it grants an exemption. 5 U.S.C. 553(d)(1). Because this interim
final rule grants exemptions from the existing requirements, the
effective date is February 10, 2009.
G. Request for Comments
The interim final rule will become effective without prior notice
and comment. Notice and comment procedures are not required under the
APA when the agency for good cause finds that notice and comment is
impracticable, unnecessary or contrary to the public interest. 5 U.S.C.
553(b)(B). The Commission finds that the public notice and comment
before the issuance of this interim final rule would have been
impracticable given the statutory requirement imposed in the CPSIA that
the lead limits go into effect on February 10, 2009, six months after
the enactment of the CPSIA, and the inapplicability of the Commission's
stay of certain testing certification requirements to lead content
limits imposed on these products.
Interested persons are invited to submit comment on the interim
final rule. The Commission will consider these comments before issuing
final regulations. In addition, comments previously submitted in
response to the notice of proposed rulemaking will be considered along
with the comments to the interim final rule in this proceeding.
Comments should be submitted by March 16, 2009. Comments should be e-
mailed to Sec101ElectronicDevices@cpsc.gov. Comments should be
captioned ``Section 101 Electronic Devices Interim Rule.'' Comments may
also be mailed, preferably in five copies, to the Office of the
Secretary, Consumer Product Safety Commission, Room 502, 4330 East West
Highway, Bethesda, Maryland 20814, or delivered to the same address
(telephone (301) 504-7923). Comments also may be filed by facsimile to
(301) 504-0127.
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 16 CFR part 1500 as
follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1500 is revised to read as follows:
Authority: 15 U.S.C. 1261-1278, 122 Stat. 3016.
0
2. Add a new 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 may be further reduced to 100 ppm, unless
the Commission determines that it is not technologically feasible to
have this lower limit. Paint, coatings or electroplating may not be
considered a barrier that would make the lead content of a product
inaccessible to a child.
(b) Section 101(b)(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.
(c) Certain 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,
provided that 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 set forth in paragraph
(a) of this section.
(d) Exemptions for lead as used in certain component 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 (3500 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.
(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: February 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-3025 Filed 2-11-09; 8:45 am]
BILLING CODE 6335-01-P
