Children's Products Containing Lead; Exemptions for Certain Electronic Devices; Notice of Proposed Rulemaking, 2435-2439 [E9-716]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Proposed Rules]
[Pages 2435-2439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-716]


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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 https://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

[[Page 2437]]

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 https://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 https://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