[Federal Register Volume 72, Number 5 (Tuesday, January 9, 2007)]
[Proposed Rules]
[Pages 920-922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-109]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500


Children's Jewelry Containing Lead; Advance Notice of Proposed 
Rulemaking; Request for Comments and Information

AGENCY: Consumer Product Safety Commission.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is 
considering whether there may be a need to ban children's metal jewelry 
containing more than 0.06% lead by weight in metal components. This 
advance notice of proposed rulemaking (ANPR) initiates a rulemaking 
proceeding under the Federal Hazardous Substances Act (FHSA). The 
Commission is soliciting written comments concerning the risks of 
injury associated with children's jewelry containing lead, the 
regulatory options discussed in this notice, other possible ways to 
address these risks, and the economic impacts of the various regulatory 
alternatives. The Commission also invites interested persons to submit 
an existing standard, or a statement of intent to modify or develop a 
voluntary standard, to address the risk of injury described in this 
notice.

DATES: Written comments and submissions in response to this document 
must be received by March 12, 2007.

ADDRESSES: Comments should be e-mailed to [email protected]. Comments 
should be captioned ``Children's Jewelry Containing Lead ANPR.'' 
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

    On May 16, 2006, the CPSC docketed Sierra Club's request for a ban 
on children's jewelry containing more than 0.06% lead by weight as a 
petition under the Federal Hazardous Substances Act (FHSA) (Petition 
No. HP 06-1). 71 FR 35416. Information obtained from the petition and 
CPSC staff investigations indicate that excess lead exposure may result 
when children ingest metal jewelry containing more than 0.06% lead by 
weight in metal components. On December 11, 2006, the Commission voted 
to grant the petition and begin a rulemaking proceeding to address the 
risk of injury described in this notice.\1\
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    \1\ Acting Chairman Nancy A. Nord filed a statement which is 
available from the Office of the Secretary or on the Commission's 
Web site at http://www.cpsc.gov.
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B. The Risk of Injury

    The scientific community generally recognizes a level of 10 
micrograms of lead per deciliter of blood ([mu]g/dL) as a level of 
concern with respect to lead poisoning in children. Continuing 
national, state and local efforts to remove lead hazards from 
children's environments (e.g., eliminating lead from household paint, 
gasoline, and food cans) have resulted in reductions in mean blood lead 
levels (BLLs) and in the number of children with BLLs exceeding 10 
[mu]g/dL. Data from a recent national survey indicated that an 
estimated 310,000 U.S. children aged one to five years have BLLs 
exceeding this level (about 1.6 percent of children aged one to five 
years). Currently, lead-based paint in older housing remains the most 
common source for excess lead exposure for children, but exposures from 
other sources of lead, such as certain ethnic medicines, imported candy 
and spices, ceramicware, and other types of consumer products, 
including jewelry, have been documented.
    Investigations by the CPSC Laboratory staff indicated that the 
extractability of lead from children's metal jewelry is strongly 
associated with the lead content of these items. Staff investigations 
also indicated that when metal jewelry is ingested by children, excess 
lead exposure is likely for items that contain more than 0.06% lead, 
and that the amount of exposure likely increases with increasing lead 
content in the item.

C. Statutory Authority

    This proceeding is conducted pursuant to the Federal Hazardous 
Substances Act (FHSA), 15 U.S.C. 1261 et seq. Section 2(f)(1)(A) of the 
FHSA defines ``hazardous substance'' to include any substance or 
mixture of substances which is toxic and may cause substantial illness 
as a proximate result of any customary or reasonably foreseeable 
handling or use, including reasonably foreseeable ingestion by 
children. 15 U.S.C. 1261(f)(1)(A).
    Under section 2(q)(1)(B) of the FHSA, a substance is a ``banned 
hazardous substance'' if the Commission determines that, 
``notwithstanding such cautionary labeling as is or may be required 
under this Act for that substance, the degree or nature of the hazard 
involved in the presence or use

[[Page 921]]

of such [hazardous] substance in households is such that the objective 
of the protection of the public health and safety can be adequately 
served only by keeping such substance, when so intended or packaged, 
out of the channels of interstate commerce'' 15 U.S.C. 1261(q)(1)(B).
    A ban under section 2(q)(1)(B) of the FHSA may be used to reach 
articles intended for use in the household that are determined to be 
hazardous substances under section 3(a)(1). Section 3(a)(1) of the FHSA 
provides that the Commission may, by regulation, declare to be a 
``hazardous substance'' any substance or mixture of substances which 
meets the requirements of section 2(f)(1)(A). 15 U.S.C. 1262(a)(1). If 
the section 3(a)(1) proceeding resulted in a determination that jewelry 
containing more that 0.06% lead was a hazardous substance, then, if the 
article is ``intended for use by children,'' the jewelry would be 
banned automatically under section 2(q)(1)(A) of the FHSA. 15 U.S.C. 
1261(q)(1)(A). Section 3(a)(2) specifies the procedures for issuance of 
a regulation declaring a substance or mixture of substances to be a 
``hazardous substance.'' 15 U.S.C. 1262(a)(2).
    Sections 2(q)(2) and 3(f) through 3(i) specify the procedures for 
issuing a rule classifying a substance as a banned hazardous substance 
under section 2(q)(1)(B) of the Act. 15 U.S.C. 1261(q)(2), 1262(f)-(i). 
In accordance with section 3(f), this proceeding is commenced by 
issuance of this ANPR. 15 U.S.C. 1262(f). After considering any 
comments submitted in response to this ANPR, the Commission will decide 
whether to issue a proposed rule and a preliminary regulatory analysis 
in accordance with section 3(h) of the FHSA. 15 U.S.C. 1262(h). If a 
proposed rule is issued, the Commission would then consider the 
comments received in response to the proposed rule in deciding whether 
to issue a final rule and a final regulatory analysis. 15 U.S.C. 
1262(i).

D. Regulatory Alternatives

    One or more of the following alternatives could be used to reduce 
the identified risks associated with children's metal jewelry 
containing lead.
    1. Mandatory rule. The Commission could issue a rule declaring 
children's metal jewelry containing lead to be a banned hazardous 
substance.
    2. Labeling rule. The Commission could issue a rule requiring 
specified warnings and instructions for children's metal jewelry 
containing lead.
    3. Existing standard. The Commission could adopt an existing 
standard, in whole or in part, as a proposed regulation.
    4. Voluntary standard. If the industry developed, adopted, and 
substantially conformed to an adequate voluntary standard, the 
Commission could defer to the voluntary standard in lieu of issuing a 
mandatory rule.
    5. Corrective Actions under Section 15 of the FHSA. The Commission 
has authority under section 15 of the FHSA, 15 U.S.C. 1274, to pursue 
corrective actions on a case-by-case basis if the Commission determines 
that a product constitutes a banned hazardous substance.

E. Existing Standards

    CPSC staff reviewed existing State standards relevant to lead in 
children's metal jewelry promulgated in California and Illinois. On 
September 22, 2006, legislation was enacted in California on lead 
containing jewelry, A.B. No. 1681. This law provides, in part, for 
phased-in compliance of specified materials to be used in jewelry for 
retail sale in California. This law contains a number of provisions 
separated by type of material used in the product or components, and by 
whether the product is for children aged six years and younger. 
Children's products must contain less than 0.06 percent lead in certain 
metallic components, and certain other components are limited to less 
than 0.02 percent lead. Lead content in children's jewelry is limited 
to less than 0.06 percent by September 1, 2007, and plastic and rubber 
components to less than 0.02 percent by August 31, 2009. The use of 
glass or crystal is limited to a total of one gram in the product 
unless it contains less than 0.02 percent lead by weight and has no 
intentionally added lead.
    On June 20, 2006, the State of Illinois enacted Public Act 094-
0879, which amends the Illinois Lead Poisoning Prevention Act to define 
a ``lead bearing substance'' as, in part, ``any item containing or 
coated with lead such that the lead content is more than six-hundredths 
of one percent (0.06%) lead by total weight.'' This act restricts the 
use of lead bearing substances and bans their use ``in or upon any 
items, including, but not limited to, clothing, accessories, jewelry, 
decorative objects, edible items, candy, food, dietary supplements, 
toys, furniture, or other articles used by or intended to be and 
chewable by children.'' This act covers children aged six years and 
younger.
    Canada has also established regulations concerning lead in 
children's jewelry under ``The Children's Jewellery Regulations,'' 
effective May 10, 2005. The regulations provide limits both for lead 
content (600 mg/kg; equivalent to 0.06 percent) and ``migratable'' or 
accessible lead (90 mg/kg) for children's jewelry items imported, 
advertised, or sold in Canada. Children's jewelry is defined as 
``jewellery item(s) which is (are) designed, sized, decorated, 
packaged, and/or otherwise produced, advertised or sold in such a 
manner as to make it reasonably apparent that the item(s) is intended 
to attract, appeal to, or be worn primarily by a child under the age of 
15 years.''
    These standards offer vastly differing requirements for test 
methods, test materials, product categories, age categories, and so 
forth. Provisions in standards that do not address jewelry do not fall 
within the scope of this proceeding. At this time, CPSC staff is 
focusing on metal jewelry containing lead because the available data 
indicate that such products could be hazardous due to their lead 
content and potential for exposure. More information concerning 
potential lead exposure of other non-metal materials that may be used 
in jewelry is needed before staff can assess whether other non-metal 
materials used in jewelry present a hazard. Furthermore, additional 
information and data must be obtained before staff can properly assess 
the appropriate test or test methodology to be used, the appropriate 
product or products to be addressed, and the appropriate age group to 
be covered under any proposed regulation.

F. Economic Considerations

    CPSC staff gathered data on certain classifications of jewelry and 
toy manufacturers. The U.S. Census Bureau, using the North American 
Industry Classification System, provides data on three types of 
manufacturers: Jewelry (Except Costume); Jewelers' Material and 
Lapidary Work; and Costume Jewelry and Novelty Manufacturing. Of these, 
the Jewelry (Except Costume) manufacturers, which deal primarily with 
precious metals, constitute about 76 percent of the value of jewelry 
manufacturing shipments; the Costume category accounts for about ten 
percent of shipments. For 2004, the total value of shipments for all 
three classifications was more than $7.8 billion. The data indicated 
that nearly 3,000 establishments produce jewelry items in the U.S. Most 
of these are relatively small; almost 60 percent have one to four 
employees and 84 percent have fewer than 20 employees. All but 19 firms 
have fewer than 500 employees (the definition of small business used by

[[Page 922]]

the U.S. Small Business Administration). As of 2004, domestic 
production was about 24 percent of the total U.S. market, with products 
from Israel, India, Belgium, China, Thailand, and Italy making up about 
three-quarters of jewelry imports by value.
    Because children's jewelry may include toy jewelry, staff 
considered data for toy, doll, and stuffed animal accessories that may 
include jewelry items. The value of shipments of these products is 
approximately $30 million annually, although this figure includes many 
products that would not be considered jewelry. Finally, staff 
considered manufacturing of craft kits and supplies, which would 
include jewelry-making kits. The value of shipments for this category 
is about $180 million annually. This figure also includes many products 
that would not be considered jewelry.
    While this information provides an overview of U.S. manufacturing 
of jewelry and related toy products, the data do not allow staff to 
analyze the specific impact of any potential regulation of lead in 
children's jewelry. Further, while staff has information about the 
overall economic impact of excess lead exposure in children, there is 
no information available that addresses the effect of lead exposures 
specifically from children's jewelry. While reducing lead in children's 
jewelry could result in reduced lead exposure in children, the extent 
of the reduction and the resulting benefits may be difficult to 
quantify. Comments on these issues and on costs and benefits of a 
potential rule are specifically solicited.

G. Solicitation of Information and Comments

    This ANPR is an initial step in a proceeding that could result in a 
mandatory rule banning children's metal jewelry containing more than 
0.06% lead by weight in metal components. All interested persons are 
invited to submit to the Commission their comments on any aspect of the 
alternatives discussed above. In particular, CPSC solicits the 
following additional information:
    1. Information on any children believed to have been injured or 
killed as a result of ingesting metal jewelry containing lead, 
including the ages of such children, and their BLLs;
    2. The circumstances under which these injuries and deaths 
occurred, including information on the suspected metal jewelry product;
    3. The costs to manufacturers of redesigning children's metal 
jewelry to remove the risk from lead or the cost of removing children's 
metal jewelry containing lead from the market;
    4. A description of substitutes for children's metal jewelry 
containing lead that could reduce the described risk of injury;
    5. Comparisons of the costs and utility of using lead in children's 
metal jewelry versus any available substitute products;
    6. Other information on the potential costs and benefits of 
potential rules;
    7. Steps that have been taken by industry or others to reduce the 
risk of injury to children due to lead from metal jewelry products;
    8. The likelihood and nature of any significant economic impact of 
a rule on small entities;
    9. Alternatives the Commission should consider, as well as the 
costs and benefits of those alternatives to minimize the burdens or 
costs to small entities;
    10. The costs and benefits of mandating a testing requirement;
    11. The costs and benefits of mandating a quality control/quality 
assurance program requirement and/or recordkeeping requirement;
    12. The market share of children's jewelry relative to all jewelry 
for both precious and costume (non-precious) jewelry;
    13. The estimated average expected life of a piece of jewelry 
(precious and non-precious) and/or an estimated number of jewelry 
pieces in U.S. households;
    14. The distribution of jewelry sales by manufacturing and/or 
retail price for both precious and costume (non-precious) jewelry; and
    15. Information on the lead content and accessibility of lead in 
non-metallic materials and components used in children's jewelry 
containing lead including, but not limited to, plastics, rubber, 
crystals, glass and ceramics.
    Also, in accordance with section 3(f) of the FHSA, the Commission 
solicits:
    1. Written comments with respect to the risk of injury identified 
by the Commission, the regulatory alternatives being considered, and 
other possible alternatives for addressing the risk.
    2. Any existing standard or portion of a standard which could be 
issued as a proposed regulation.
    3. A statement of intention to modify or develop a voluntary 
standard to address the risk of injury discussed in this notice, along 
with a description of a plan (including a schedule) to do so.
    Comments should be e-mailed to [email protected]. Comments should be 
captioned ``Children's Jewelry Containing Lead ANPR.'' 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 March 12, 2007.

H. FHSA Enforcement During the Pendency of the Rulemaking

    Manufacturers, importers and retailers of children's jewelry are 
reminded that the Federal Hazardous Substances Act of its own force 
bans articles of children's jewelry that meet the statutory definition 
of a ``banned hazardous substance.'' 15 U.S.C. 1261(q)(1). The CPSC 
Compliance staff therefore intends to continue enforcing the statute as 
appropriate during the pendency of this rulemaking. To avoid problems, 
manufacturers, importers and retailers are advised to follow the 
guidance provided in the Interim Enforcement Policy for Children's 
Metal Jewelry Containing Lead (February 3, 2005) which is available on 
the CPSC Web site at http://www.cpsc.gov/BUSINFO/pbjewelgd.pdf.

    Dated: January 4, 2007.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
 [FR Doc. E7-109 Filed 1-8-07; 8:45 am]
BILLING CODE 6355-01-P