[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Proposed Rules]
[Page 2435-2439]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja09-57]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Children's Products Containing Lead; Exemptions for Certain
Electronic Devices; Notice of Proposed Rulemaking
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: On August 14, 2008, Congress enacted the Consumer Product
Safety Improvement Act of 2008 (CPSIA), Public Law 110-314, 122 Stat.
3016. Section 101 of the CPSIA provides for specific lead limits in
children's products. Section 101(b)(2) of the CPSIA provides that the
lead limits will not apply to any component part of a children's
product that is not accessible to a child through normal and reasonably
foreseeable use and abuse. In addition, 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. For certain electronic
devices for which it is not technologically feasible to meet the lead
limits, the Commission is proposing requirements to eliminate or
minimize the potential for exposure and accessibility of lead.
DATES: Written comments and submissions in response to this notice must
be received by February 17, 2009.
FOR FURTHER INFORMATION CONTACT: Comments should be e-mailed to
Sec101ElectronicDevices@cpsc.gov. Comments should be captioned
``Section 101 Electronic Devices NPR.'' Comments may also be mailed,
preferably in five copies, to the Office of the Secretary, Consumer
Product Safety Commission, Room 502, 4330 East West Highway, Bethesda,
Maryland 20814, or delivered to the same address (telephone (301) 504-
7923). Comments also may be filed by facsimile to (301) 504-0127.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA provides for specific lead limits in children's products.
Section 101(a) of the CPSIA provides that by February 10, 2009,
products designed or intended primarily for children 12 and younger may
not contain more than 600 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 as a consumer product designed
or intended primarily for children 12 years of age or younger under
section 235(a) of the CPSIA (to be codified at section 3(a)(2) of the
Consumer Product Safety Act). In determining whether a consumer product
is primarily intended for a child 12 years of age or younger, the
following factors will be considered:
A statement by the manufacturer about the intended use of
such product, including a label on such product if such statement is
reasonable.
Whether the product is represented in its packaging,
display, promotion or advertising as appropriate for use by children 12
years of age or younger.
Whether the product is commonly recognized by consumers as
being intended for use by a child 12 years of age or younger.
The Age Determination Guidelines issued by the Commission
in September 2002, and any successor to such guidelines.
Section 101(b)(2) of the CPSIA provides that the lead limits do not
apply to component parts of a product that are not accessible to a
child. This section specifies that a component part is not accessible
if it is not physically exposed by reason of a sealed covering or
casing and does not become physically exposed through reasonably
foreseeable use and abuse of the product including swallowing,
mouthing, breaking, or other children's activities, and the aging of
the product, as determined by the Commission. Paint, coatings, or
electroplating may not be considered to be a barrier that would render
lead in the substrate to be inaccessible to a child. Section 101
(b)(2)(B) further provides that the Commission must promulgate a rule
providing guidance with respect to what product components or classes
of components will be considered to be inaccessible. A proposed
interpretative rule providing guidance on inaccessibility is published
elsewhere in this Federal Register.
In addition, if the Commission determines that it is not now
technologically feasible for certain electronic devices to comply with
the lead limits, section 101(b)(4) of the
[[Page 2436]]
CPSIA provides that the Commission 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 September 26, 2008, the Commission staff requested comments on
the CPSC Web site on section 101(b)(2), Exception for Inaccessible
Component Parts, and section 101(b)(4), Certain Electronic Devices.
Staff specifically requested comments and information regarding:
The identification of children's electronic devices for
which lead is currently used in any concentration in any part or
component of the product.
Whether it is technologically feasible to achieve in all
parts of children's electronic devices the 600 ppm lead limit; the 300
ppm limit; the 100 ppm limit.
Whether any children's electronic product currently on the
market contains lead-containing component parts that are inaccessible,
and the reasons why such component parts are considered inaccessible.
Current compliance with or possibility of compliance with
regulations, such as the European Union directive on the restriction of
use of hazardous substances (EU RoHS Directive 2002/95/EC), or other
standards including information on: The lead limit in the standard
being met (e.g., EU RoHS lead limit is 1000 ppm); whether compliance
with such a standard was being met because of the existence of an
exemption that specifically allows the use of lead in some parts of a
product, and identification of such lead-containing parts.
B. Comments
Fourteen comments addressed the use of lead in children's
electronic devices. Eight comments addressed the issue of the
technological feasibility of certain electronic devices meeting the
CPSIA lead limits, indicating that for certain materials or parts, it
would be difficult to achieve the specified maximum lead limits. One
commenter interpreted technological feasibility as referring to cost-
benefit analysis.
The Commission's proposed exemptions are based in part on the
information provided by these commenters, along with other information
provided by the Commission staff, regarding the difficulty in attaining
compliance with the CPSIA for certain materials or products.
Technological feasibility as defined in the CPSIA means commercial
availability of materials or parts, or the possible future availability
of materials or parts. It does not refer to economic considerations,
such as cost-benefit analysis.
Six comments addressed electronic components that are generally
enclosed within the product, asserting that only ingestible parts
should be considered accessible, based on small parts testing. The
CPSIA defines accessibility as physical exposure to lead-containing
component parts. Based on staff's review, the Commission preliminarily
determines that an accessible component part of a children's product is
one that a child may touch or place in the mouth, not just a part that
a child might ingest. Physical inaccessibility refers generally to a
component part that is located inside a product that a child cannot
touch. Accordingly, the Commission is recommending in a proposed
interpretative rule published elsewhere in this Federal Register, the
use of accessibility probes, as well as appropriate use and abuse
testing, to evaluate access to lead-containing component parts.
Several comments were received on other standards that address the
use of lead in electronic devices, specifically the European Union
Directive 2002/95/EC on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (often abbreviated as
EU RoHS). Most comments stated that EU RoHS requirements would be
appropriate for regulating children's electronic products. One comment
cautioned that the EU RoHS directive does not allow an exemption for
inaccessible parts and should not be adopted for use in the United
States.
Because the Commission recognizes that it is currently not
technologically feasible for certain parts of electronic devices to
comply with the CPSIA lead limits, and because the exemptions published
in the Annex to EU Directive 2002/95/EC are based, in part, on
scientific technological feasibility, the Commission proposes to adopt,
as exemptions to the CPSIA lead limits for electronic devices, those
exemptions, provided that the exemption is based on a functional
requirement both for the use of a lead-containing component and for the
use of lead in such component. However, the Commission does not propose
to adopt the EU RoHS exemption for crystal glass or any other exemption
for uses of lead that are solely decorative or otherwise non-functional
since those articles would customarily be subject to the CPSIA lead
limits. The current EU RoHS exemptions are available at http://eur-
lex.europa.eu/en/index/htm, and an annotated version is attached to the
staff briefing memorandum referenced in the list of relevant documents.
Since the EU RoHS process for reviewing exemptions is ongoing, the
Commission proposes to adopt future exemptions promulgated under EU
Directive 2002/95/EC, if consistent with the Commission's
determinations that are issued in a final rule on exemptions for
certain electronic devices. The general lead limit in the EU RoHS
directive is 0.1 percent (equivalent to 1000 parts per million (ppm)),
while the CPSIA limits are 600 ppm as of February 10, 2009, 300 ppm as
of August 14, 2009, and as of August 14, 2011, 100 ppm, if
technologically feasible. Under the Commission's proposed approach,
exemption is necessary for any accessible component exceeding the
pertinent CPSIA lead limit.
C. Exemptions for Certain Electronic Devices
Electronic devices are included in certain children's products
regulated under the provisions of the CPSIA. 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 Act.
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. Other
components could be made to be inaccessible, taking account of normal
and reasonably foreseeable use and abuse by children. Accessibility of
the lead-containing component 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
component, whether an electronic device or not, is not accessible to a
child, it is not subject to the lead limits under the CPSIA. A proposed
guidance rule on
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inaccessibility is published elsewhere in this Federal Register.
2. Accessible Electronic Devices That Are Exempt
Certain components cannot be produced without lead for safety
reasons and cannot 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.
The European Union and other countries and authorities have adopted
restrictions on the use of lead and other chemicals in electronic
devices. The purpose of the restrictions is to address concerns related
to human health and environmental impacts of waste electrical and
electronic equipment. EU Directive 2002/95/EC \1\ on the restriction of
the use of certain hazardous substances in electrical and electronic
equipment, implemented July 1, 2006, specifies that substances such as
lead be substituted with safer materials. The directive specifies a
maximum concentration for lead of 0.1 percent (equivalent to 1000 parts
per million (ppm)) in each homogeneous material in an electronic
device.
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\1\ European Union Directive 2002/95/EC and amendments to the
directive are available at http://eur-lex.europa.eu/en/index.htm.
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The 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,'' but 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. Most exemptions refer to specific
types of products or components or other applications without providing
restrictions on lead concentration. Other exemptions allow applications
that exceed the generally applicable 1000 ppm limit for lead content,
but specify alternate maximum lead concentrations for the indicated
materials. There is no exemption in the directive based on
inaccessibility, since the goal is to restrict the overall use of lead
in products.
Some of the EU RoHS exemptions involve lead-containing components
that would likely be inaccessible to children using electronic devices.
Under the CPSIA, if the component is not accessible to a child, it
would not be subject to the lead limits. A proposed guidance rule on
inaccessibility is published elsewhere in this Federal Register.
However, the Commission believes that some exempted uses of lead, such
as the cathode ray tubes discussed above, and certain other components
that create electrical connections or that are required for product
functions, cannot be made inaccessible. With respect to children's
electronic devices, the Commission seeks comments on what components
listed in the EU Directive 2002/95/EC, other than cathode ray tubes,
cannot currently be made inaccessible to a child and why.
Because the EU RoHS exemptions were established in part to consider
the technological feasibility of limiting the use of lead, the
Commission proposes to adopt, as exemptions to the CPSIA lead limits
for electronic devices, the exemptions published in the Annex to the EU
Directive 2002/95/EC, provided that the exemption is based on a
functional requirement both for the use of a lead-containing component
and for the use of lead in such component. The existing EU RoHS
exemptions for cathode ray tubes and certain components or the metal
alloys used to make certain components allow the use of lead in
applications for which substitution of the lead is not yet feasible. On
the other hand, the directive provides an exemption for crystal glass
used solely for decorative purposes. Since such use is not required for
the function of the electronic device, the Commission proposes to
disallow the crystal glass exemption and any other exemption for
decorative or non-functional uses of lead for children's electronic
devices subject to the CPSIA lead limits.
Except for crystal glass and other non-functional uses of lead for
children's electronic devices, to the extent that a lead-containing
component part is used in an electronic device and is within the
exemptions published in the Annex to the EU Directive 2002/95/EC, or is
otherwise inaccessible to a child, that component part would be
relieved from the testing requirement of section 102 for purposes of
supporting the required certification. The current EU RoHS exemptions
are available at http://eur-lex.europa.eu/en/index/htm, and an
annotated list of the exemptions are attached to the staff briefing
memorandum referenced in the list of relevant documents. Since the EU
RoHS process for reviewing exemptions is ongoing, the Commission
proposes to adopt future exemptions promulgated under EU Directive
2002/95/EC, if consistent with the Commission's determinations that are
issued in a final rule on exemptions for certain electronic devices.
Of course even where a component part has been relieved of the
testing requirement, other component parts that are accessible or that
do not fall within the scope of the EU RoHS exemptions must still meet
the statutory lead level requirements, and would be subject to the
testing requirement of section 102 of the CPSIA. The Commission will
obtain and test products in the marketplace to assure that this remains
the case and will take appropriate enforcement action in situations
where that is not the case.
3. Removable or Replaceable Component Parts
Some components of 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 proposes that spare parts or other removable
components 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 possible exemptions
with respect to EU RoHS.
4. Accessible Electronic Devices Which Are Not Exempt
All component parts of 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 from
EU RoHS must comply with the lead limits specified in the CPSIA. The
Commission notes that the implementation of EU RoHS and similar
regulations has resulted in enormous advances in electronics
technologies. On the basis of the preliminary information obtained by
the staff, the Commission believes that in many, if not most, cases,
materials and components used in electronic devices that meet the EU
RoHS directive's general lead limit at 1000 ppm will also meet the
CPSIA's 600 ppm limit, and possibly the 300 ppm limit. Therefore, 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-
[[Page 2438]]
containing component parts. However, to the extent that an accessible
component part does not qualify for EU RoHS exemption, it must continue
to meet the CPSIA lower lead limits, not the EU RoHS lead limit of 1000
ppm.
5. Periodic Review
Because of the changing state of technology and continuing progress
in replacing lead with other substances, and consistent with the CPSIA
mandate to conduct periodic reviews under section 101(b)(5), the
Commission will direct staff to reevaluate the technological
feasibility of compliance with the lead limits for electronic devices,
including the status of EU RoHS limits and exemptions, no less than
every five years.
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.
The Commission's Directorate for Economic Analysis prepared a
preliminary assessment of the impact of excluding certain electronic
devices from the requirements of Section 101(a) of the CPSIA. That
assessment found that the potential cost of the rule consists of the
continued risk associated with the absorption of lead from the
children's electronic products that, in the absence of the exemption,
would not have been available for use. The potential benefit, on the
other hand, consists of the value that consumers attach to having the
otherwise barred children's electronic devices available for use.
Because the rule would allow the continued use of some lead-containing
electronic devices intended for the use of children, when it is not
technologically feasible to produce the devices without lead, there
would be some amount of exposure of lead from these products. However,
the exemptions are not expected to increase the lead exposure to
children from electronic devices, relative to pre-CPSIA levels. In some
cases, limitations on the exemptions should help reduce lead exposure.
For example, under the exemptions proposed in the rule, the use of lead
crystal with children's electronic products for decorative purposes
would not be allowed. Additionally, the exemptions could, in some
cases, ultimately result in reduced lead exposure if, in the absence of
the exemptions, parents would have substituted for their children's use
electronic products intended for the general public--products not
subject to the lead limitations of the CPSIA.
The number of small businesses that will be directly affected by
the rule is unknown but could be considerable. However, because the
proposed rule is designed to exempt certain specified materials from
the requirements of section 101(a) of the CPSIA, it 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.
Based on the foregoing assessment, the Commission preliminarily
finds that the proposed 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 proposed rule will not result in any additional use
of lead over what is occurring at the present time. Therefore, the
Commission does not expect the proposal to have any negative
environmental impact.
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 proposal
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 it grants an exemption. 5 U.S.C. 553(d)(1). Because the proposed
rule would grant exemptions from the existing requirements, the
effective date will be the date of publication of a final rule in the
Federal Register.
H. Request for Comments
Interested persons are invited to submit comment on the proposed
rule. Comments should be e-mailed to Sec101ElectronicDevices@cpsc.gov.
Comments should be captioned ``Section 101 Electronic Devices NPR.''
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.
I. List of Relevant Documents
(1) Memorandum from Kristina M. Hatlelid, PhD, M.P.H.,
Toxicologist, Directorate for Health Sciences ``Consumer Product Safety
Improvement Act of 2008 (CPSIA) Exclusions and Exemptions from
Compliance with Limits for Lead: Inaccessibility and Certain Electronic
Devices.'' December 2008.
(2) Memorandum from Robert Franklin, Economist, Directorate for
Economic Analysis, ``Preliminary Regulatory Analysis of a Rule
Exempting Certain Electronic Devices from Section 101(a) of the
Consumer Product Safety Improvement Act.'' December 2008.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
J. Conclusion
For the reasons stated above, the Commission amends Title 16 of the
Code of Federal Regulations as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority for part 1500 is amended to read as follows:
Authority: 15 U.S.C. 1261-1278, 122 Stat. 3016.
2. Add a new Sec. 1500.88 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
[[Page 2439]]
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) Lead-containing component parts in electronic devices unable to
meet the lead limits set forth in section (a) due to technological
feasibility are granted exemptions published in the Annex to the
European Union Directive 2002/95/EC, as amended through European Union
Commission Decision of January 24, 2008, provided that the exemption is
based on a functional requirement both for the use of a lead-containing
component and for the use of lead in such component, and does not
include the crystal glass exemption and any other exemption for
decorative or non-functional uses of lead.
(d) 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 published in the Annex of European Union Directive
2002/95/EC are not subject to the lead limits in section (a).
(e) Commission staff is directed to reevaluate and report to the
Commission on the technological feasibility of compliance with the lead
limits in section (a) no less than five years after publication of a
final rule in the Federal Register on electronic devices.
Dated: January 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-716 Filed 1-14-09; 8:45 am]
BILLING CODE 6335-01-P