[Federal Register Volume 63, Number 245 (Tuesday, December 22, 1998)]
[Rules and Regulations]
[Pages 70648-70649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33866]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500


Codification of Guidance Policy on Lead in Consumer Products

AGENCY: Consumer Product Safety Commission.

ACTION: Final policy statement.

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SUMMARY: The Commission codifies a policy statement, previously 
approved by the Commission and published in the Federal Register, that 
provides guidance for manufacturers, importers, distributors, and 
retailers of consumer products that may contain harmful amounts of the 
element lead. To protect children and other persons from the toxic 
effects of exposure to lead, the Commission recommends that such 
persons obtain sufficient tests and analyses to ensure that their 
products do not contain harmful levels of lead.

DATES: This codification is effective December 22, 1998. This policy 
has been applicable since December 24, 1997.

FOR FURTHER INFORMATION CONTACT: Mary Toro, Office of Compliance, 
Consumer Product Safety Commission, Washington, D.C. 20207; telephone 
(301) 504-0608, ext. 1378.

SUPPLEMENTARY INFORMATION: On January 22, 1998, the Commission 
published in the Federal Register the text of a document that provides 
guidance for manufacturers, importers, distributors, and retailers of 
consumer products that may contain harmful amounts of the element lead. 
63 FR 3310. To protect children and other persons from the toxic 
effects of exposure to lead, the Commission recommends that such 
persons obtain sufficient tests and analyses to ensure that their 
products do not contain harmful levels of lead.
    In order to make this policy more accessible to interested parties, 
the Commission is codifying the policy as 16 CFR 1500.230.
    Since this is a statement of policy and interpretative rule, 
neither a general notice of proposed rulemaking or a delayed effective 
date is required. 5 U.S.C. 553(d)(2). A delayed effective date is not 
required for the additional reason that this policy is not a

[[Page 70649]]

substantive rule. 5 U.S.C. 553(d)(3). Accordingly, this codification 
will become effective immediately upon its publication in the Federal 
Register.

List of Subjects in 16 CFR Part 1500

    Consumer protection, Hazardous substances, Imports, Infants and 
children, Labeling, Law enforcement, Reporting and recordkeeping 
requirements, and Toys.
    For the reasons given above, the Commission amends 16 CFR part 1500 
as follows:

PART 1500--[AMENDED]

    1. The authority citation for part 1500 continues to read as 
follows:

    Authority: 15 U.S.C. 1261-1278.

    2. A new Sec. 1500.230 is added, to read as follows:


Sec. 1500.230  Guidance for lead (Pb) in consumer products.

    (a) Summary. (1) The U.S. Consumer Product Safety Commission issues 
this guidance to manufacturers, importers, distributors, and retailers 
to protect children from hazardous exposure to lead in consumer 
products.1 The Commission identifies the major factors that 
it considers when evaluating products that contain lead, and informs 
the public of its experience with products that have exposed children 
to potentially hazardous amounts of lead.
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    \1\ This guidance is not a rule. It is intended to highlight 
certain obligations under the Federal Hazardous Substances Act. 
Companies should read that Act and the accompanying regulations in 
this part for more detailed information.
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    (2) To reduce the risk of hazardous exposure to lead, the 
Commission requests manufacturers to eliminate the use of lead that may 
be accessible to children from products used in or around households, 
schools, or in recreation. The Commission also recommends that, before 
purchasing products for resale, importers, distributors, and retailers 
obtain assurances from manufacturers that those products do not contain 
lead that may be accessible to children.
    (b) Hazard. Young children are most commonly exposed to lead in 
consumer products from the direct mouthing of objects, or from handling 
such objects and subsequent hand-to-mouth activity. The specific type 
and frequency of behavior that a child exposed to a product will 
exhibit depends on the age of the child and the characteristics and 
pattern of use of the product. The adverse health effects of lead 
poisoning in children are well-documented and may have long-lasting or 
permanent consequences. These effects include neurological damage, 
delayed mental and physical development, attention and learning 
deficiencies, and hearing problems. Because lead accumulates in the 
body, even exposures to small amounts of lead can contribute to the 
overall level of lead in the blood and to the subsequent risk of 
adverse health effects. Therefore, any unnecessary exposure of children 
to lead should be avoided. The scientific community generally 
recognizes a level of 10 micrograms of lead per deciliter of blood as a 
threshold level of concern with respect to lead poisoning. To avoid 
exceeding that level, young children should not chronically ingest more 
than 15 micrograms of lead per day from consumer products.
    (c) Guidance. (1) Under the Federal Hazardous Substances Act 
(FHSA), 15 U.S.C. 1261(f)(1), household products that expose children 
to hazardous quantities of lead under reasonably foreseeable conditions 
of handling or use are ``hazardous substances.'' A household product 
that is not intended for children but which creates such a risk of 
injury because it contains lead requires precautionary labeling under 
the Act. 15 U.S.C. 1261(p). A toy or other article intended for use by 
children which contains a hazardous amount of lead that is accessible 
for children to ingest is a banned hazardous substance. 15 U.S.C. 
1261(q)(1)(B). In evaluating the potential hazard associated with 
products that contain lead, the Commission staff considers these major 
factors on a case-by-case basis: the total amount of lead contained in 
a product, the bioavailability of the lead, the accessibility of the 
lead to children, the age and foreseeable behavior of the children 
exposed to the product, the foreseeable duration of the exposure, and 
the marketing, patterns of use, and life cycle of the product.
    (2) Paint and similar surface coatings containing lead have 
historically been the most commonly-recognized sources of lead 
poisoning among the products within the Commission's jurisdiction. The 
Commission has, by regulation, banned paint and other similar surface 
coatings that contain more than 0.06% lead (``lead-containing paint''), 
toys and other articles intended for use by children that bear lead-
containing paint, and furniture articles for consumer use that bear 
lead-containing paint. 16 CFR Part 1303. In recent years, however, the 
Commission staff has identified a number of disparate products--some 
intended for use by children and others simply used in or around the 
household or in recreation--that presented a risk of lead poisoning 
from sources other than paint. These products included vinyl 
miniblinds, crayons, figurines used as game pieces, and children's 
jewelry.
    (3) In several of these cases, the staff's determination that the 
products presented a risk of lead poisoning resulted in recalls or in 
the replacement of those products with substitutes, in addition to an 
agreement to discontinue the use of lead in future production. The 
Commission believes that, had the manufacturers of these lead-
containing products acted with prudence and foresight before 
introducing the products into commerce, they would not have used lead 
at all. This in turn would have eliminated both the risk to young 
children and the costs and other consequences associated with the 
corrective actions.
    (4) The Commission urges manufacturers to eliminate lead in 
consumer products to avoid similar occurrences in the future. However, 
to avoid the possibility of a Commission enforcement action, a 
manufacturer who believes it necessary to use lead in a consumer 
product should perform the requisite analysis before distribution to 
determine whether the exposure to lead causes the product to be a 
``hazardous substance.'' If the product is a hazardous substance and is 
also a children's product, it is banned. If it is a hazardous household 
substance but is not intended for use by children, it requires 
precautionary labeling. This same type of analysis also should be 
performed on materials substituted for lead.
    (5) The Commission also notes that, under the FHSA, any firm that 
purchases a product for resale is responsible for determining whether 
that product contains lead and, if so, whether it is a ``hazardous 
substance.'' The Commission, therefore, recommends that, prior to the 
acquisition or distribution of such products, importers, distributors, 
and retailers obtain information and data, such as analyses of chemical 
composition or accessibility, relevant to this determination from 
manufacturers, or have such evaluations conducted themselves.

    Dated: December 17, 1998.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 98-33866 Filed 12-21-98; 8:45 am]
BILLING CODE 6355-01-U