[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
