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[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Proposed Rules]
[Pages 2433-2435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-714]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500

Children's Products Containing Lead; Proposed Determinations 
Regarding Lead Content Limits on Certain Materials or Products; 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. This notice of proposed rulemaking (NPR) initiates a proceeding 
under section 3 of the CPSIA authorizing the Commission to issue 
regulations, as necessary, to implement the CPSIA. In this document, 
the Commission solicits written comments concerning preliminary 
determinations on certain natural, untreated and unadulterated 
materials and metals that have not been found to exceed the lead 
content limits prescribed under section 101(a) of the CPSIA.

DATES: Written comments and submissions in response to this notice must 
be received by February 17, 2009.

ADDRESSES: Comments should be e-mailed to 
[email protected]. Comments should be captioned ``Section 
101 Determinations of Certain Materials or Products 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.

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 [email protected].

SUPPLEMENTARY INFORMATION:

A. Background

    Under section 101(a) of CPSIA, consumer products designed or 
intended primarily for children 12 years old and younger that do not 
contain more than 600 ppm of lead (as of February 10, 2009), 300 ppm of 
lead (as of August 14, 2009); 100 ppm after three years (as of August 
14, 2011), unless the Commission determines that it is not 
technologically feasible to have this lower limit, are not considered 
to be banned hazardous substances under the Federal Hazardous 
Substances Act (FHSA). However, in the absence of Commission action, 
these products and materials remain subject to the testing requirements 
of section 102 of the CPSIA (codified at Sec.  14 of the Consumer 
Product Safety Act (CPSA)).
    Under these provisions, on and after February 10, 2009, general 
conformity certificates certifying that they comply with the applicable 
lead content limit are required for children's products. The 
certification must be based on tests of each product or a reasonable 
testing program. On and after August 14, 2009, absent Commission action 
to the contrary, the certificates must be based on testing performed by 
a laboratory whose accreditation to perform the testing has been 
accepted by the Commission.
    Section 3 of the CPSIA grants the Commission general rulemaking 
authority to issue regulations, as necessary, to implement the CPSIA. 
There may be certain products or materials that inherently do not 
contain lead or contain lead at levels that do not exceed the lead 
content limits under section 101(a) of the CPSIA. To the extent that 
such materials or products exist, the Commission, of its own 
initiative, is proposing to exercise its section 3 authority to make 
preliminary determinations that certain commodities or classes of 
materials or products do not exceed the lead limits prescribed in 
section 101(a) of the CPSIA. The effect of such a Commission finding 
would be to relieve the material or product from the testing 
requirement of section 102 of the CPSIA for purposes of supporting the 
required certification. Of course even where a material or product has 
been so relieved of the testing requirement, it must still meet the 
statutory lead level requirements in actual fact. 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.

B. Proposed Determinations on Certain Products and Materials

    The Commission staff identified a number of commodities or classes 
of materials that do not inherently contain lead or contain lead that 
does not exceed the CPSIA lead limits of 600 ppm or 300 ppm.

Certain Natural Materials

    Based on the staff's review, the Commission preliminarily 
determines that the following natural materials do not exceed the 600 
ppm or 300 ppm lead content limits under section 101(a) of the CPSIA. 
These preliminary determinations are based on materials that are 
untreated and unadulterated with respect to the addition of materials 
or chemicals, including pigments, dyes, coatings, finishes or any other 
substance, and that do not undergo any processing that could result in 
the addition of lead into the product or material:
    1. Precious gemstones: Diamond, ruby, sapphire, emerald
    2. Certain semiprecious gemstones provided that the mineral or 
material is not based on lead or lead compounds and is not associated 
in nature with any mineral that is based on lead or lead compounds 
(minerals that contain lead or are associated in nature with minerals 
that contain lead include, but are not limited to, the following: 
Aragonite, bayldonite, boleite, cerussite, crocoite, linarite, 
mimetite, phosgenite, vanadinite, and wulfenite)
    3. Natural or cultured pearls
    4. Wood

[[Page 2434]]

    5. Natural fibers such as cotton, silk, wool, hemp, flax, linen
    6. Other natural materials including coral, amber, feathers, fur, 
untreated leather

Certain Metals and Alloys

    Based on the staff's review, the Commission preliminarily 
determines that the following metals and alloys do not exceed the 600 
ppm or 300 ppm lead content limits under section 101(a) of the CPSIA 
provided that no lead or lead-containing metal is intentionally added:
    1. Surgical steel
    2. Precious metals: Gold (at least 10 karat); sterling silver (at 
least 925/1000); platinum; palladium; rhodium; osmium; iridium; 
ruthenium
    The preliminary determinations do not extend to the non-steel or 
non-precious metal components of a product, such as solder or base 
metals in electroplate, clad, or fill applications.

C. Requests for Comments

    All interested persons are invited to submit to the Commission 
their comments and data concerning the Commission's preliminary 
determinations on the listed natural materials and metals and alloys. 
In particular, the Commission invites interested persons to submit any 
test results showing that substances covered by the proposed rule had 
lead exceeding the lead limits in section 101(a) of the CPSIA. In 
addition, the Commission seeks comments on:
     Other natural fibers that would not exceed the lead 
content limits
     Other natural materials that would not exceed the lead 
content limits
     Other metals or alloys that would not exceed the lead 
content limits
     Other materials, which by their nature, would not exceed 
the lead content limits.

Comments should be e-mailed to [email protected]. Comments 
should be captioned ``Section 101 Determinations of Certain Materials 
or Products 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. All comments and 
submissions should be received no later than February 17, 2009.

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 relieving certain materials or 
products from the testing requirements of section 102 of the CPSIA if 
they were found to be inherently under the lead content limits 
prescribed. The number of small businesses that will be directly 
affected by the rule is unknown but could be considerable. However, 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 
materials under section 102 of the CPSIA. 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 lead 
in the environment since such materials do not contain lead or contain 
lead at levels that do not exceed the CPSIA limits. Therefore, the 
Commission does not expect the proposed rule 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 FHSA. 15 U.S.C. 1261n.

G. Effective Date

    The Administrative Procedure Act requires that a substantive rule 
must be published not less than 30 days before its effective date, 
unless the rule relieves a restriction. 5 U.S.C. 553(d)(1). Because the 
proposed rule would provide relief from existing testing requirements 
under the CPSIA, the proposed effective date is the date of publication 
of a final rule in the Federal Register.

H. 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): Certain Materials or Products that Do 
Not Exceed the Limits for Lead Content.'' December 2008.
    (2) Memorandum from Robert Franklin, Economist, Directorate for 
Economic Analysis, ``Preliminary regulatory analysis of a rule making 
determinations that certain materials or products do not have lead 
contents that exceed the limits established in section 101(a) of the 
CPSIA.'' 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.

I. Conclusion

    For the reasons stated above, the Commission proposes to amend 
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.  1500.91 to read as follows:

Sec.  1500.91  Determinations Regarding Lead Content for Certain 
Materials or Products under Section 101 of the Consumer Product Safety 
Improvement Act.

    (a) The Consumer Product Safety Improvement Act 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 3 of the CPSIA grants the Commission general rulemaking

[[Page 2435]]

authority to issue regulations, as necessary, either on its own 
initiative or upon the request of any interested person, to make a 
determination that a material or product does not exceed the lead 
limits as provided under paragraph (a) of this section.
    (c) The following natural materials do not exceed the 600 ppm or 
300 ppm lead content limits under section 101(a) of the CPSIA provided 
that these materials have neither been treated or adulterated with the 
addition of materials or chemicals such as pigments, dyes, coatings, 
finishes or any other substance, nor undergone any processing that 
could result in the addition of lead into the product or material:
    (1) Precious gemstones: Diamond, ruby, sapphire, emerald.
    (2) Semiprecious gemstones provided that the mineral or material is 
not based on lead or lead compounds and is not associated in nature 
with any mineral that is based on lead or lead compounds (minerals that 
contain lead or are associated in nature with minerals that contain 
lead include, but are not limited to, the following: Aragonite, 
bayldonite, boleite, cerussite, crocoite, linarite, mimetite, 
phosgenite, vanadinite, and wulfenite).
    (3) Natural or cultured pearls.
    (4) Wood.
    (5) Natural fibers such as cotton, silk, wool, hemp, flax, linen.
    (6) Other natural materials including coral, amber, feathers, fur, 
untreated leather.
    (d) The following metals and alloys do not exceed the 600 ppm or 
300 ppm lead content limits under section 101(a) of the CPSIA provided 
that no lead or lead-containing metal is intentionally added but does 
not include the non-steel or non-precious metal components of a 
product, such as solder or base metals in electroplate, clad, or fill 
applications:
    (1) Surgical steel.
    (2) Precious metals: Gold (at least 10 karat); sterling silver (at 
least 925/1000); platinum; palladium; rhodium; osmium; iridium; 
ruthenium.

    Dated: January 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-714 Filed 1-14-09; 8:45 am]
BILLING CODE 6335-01-P
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