Children's Products Containing Lead; Exemptions for Certain Electronic Devices; Interim Final Rule, 6990-6993 [E9-3025]

Download as PDF mstockstill on PROD1PC66 with RULES 6990 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 foreign air carriers or trade associations 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 diverse and include representatives that 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 VerDate Nov<24>2008 16:07 Feb 11, 2009 Jkt 217001 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 Chair. g. The Chair shall arrange notification to all members of the time, place and agenda for any meeting through the secretariat and shall ensure that, to the extent practicable, any materials to be considered at the meeting are distributed to Committee members in advance. The Committee is not required to keep minutes, but the Chair may elect to do so. Committee recommendations to the Administrator must be approved by at least a two-thirds vote of the members. The Chair shall have the right to submit a separate report or recommendation to the Administrator. 7. Compensation. All non-government Committee members shall serve without compensation from the U.S. government, and shall bear all costs related to their participation on the Committee. 8. Public Participation. Unless otherwise decided by the Chair, all meetings of the Committee shall be closed. Interested persons wishing to attend a meeting who are not members of the Committee (or employees or consultants invited by a member) must request and receive approval in advance of the meeting from the Chair. 9. Availability of Records. Subject to the provisions of the Freedom of Information Act, Title 5 U.S.C. 522, records, reports, agendas, working papers, and other documents that are made available to, prepared by, or prepared for the Committee shall be 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. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 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 E:\FR\FM\12FER1.SGM 12FER1 mstockstill on PROD1PC66 with RULES Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Rules and Regulations 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 VerDate Nov<24>2008 16:07 Feb 11, 2009 Jkt 217001 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 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 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 E:\FR\FM\12FER1.SGM 12FER1 6992 Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Rules and Regulations mstockstill on PROD1PC66 with RULES 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. VerDate Nov<24>2008 16:07 Feb 11, 2009 Jkt 217001 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. PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 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 E:\FR\FM\12FER1.SGM 12FER1 Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Rules and Regulations 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. mstockstill on PROD1PC66 with RULES 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: VerDate Nov<24>2008 16:07 Feb 11, 2009 Jkt 217001 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. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 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. E:\FR\FM\12FER1.SGM 12FER1

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.

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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.
---------------------------------------------------------------------------

    \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
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