[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Proposed Rules]
[Page 2428-2433]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja09-55]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Children's Products Containing Lead; Notice of Proposed
Procedures and Requirements for a Commission Determination or Exclusion
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed procedures and requirements.
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SUMMARY: On August 14, 2008, Congress enacted the Consumer Product
Safety
[[Page 2429]]
Improvement Act of 2008 (CPSIA), Public Law 110-314. The Commission
proposes to establish procedures and requirements for: A Commission
determination that a commodity or class of materials or a specific
material or product does not exceed the lead content limits specified
under section 101(a) of the CPSIA; or an exclusion of a commodity or
class of materials or a specific material or product under section
101(b), that exceeds the lead content limits under section 101(a), but
which will not result in the absorption of any lead into the human body
nor have any other adverse impact on public health or safety. This
notice sets out and solicits comments on proposed procedures and
requirements and information to be supplied with such requests.
DATES: Written comments and submissions in response to this notice must
be received by February 17, 2009.
ADDRESSES: Comments on the proposed procedures and requirements for
Commission determinations that specific materials or products do not
exceed the lead content limits should be e-mailed to
Sec101Determinations@cpsc.gov. Comments should be captioned ``Section
101(a) Determinations.'' Comments on the proposed procedures and
requirements for Commission decisions on requests for exclusions under
section 101(b) should be e-mailed to Sec101Exclusions@cpsc.gov.
Comments should be captioned ``Section 101(b) Exclusions.'' 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.
Comments on the Paperwork Reduction Act burdens posed by these
proposals should be directed to the Desk Officer for the Consumer
Product Safety Commission, Office of Information and Regulatory
Affairs, OMB, Washington, DC 20503. The Commission asks commenters to
provide copies of such comments to the Commission's Office of the
Secretary, with a caption or cover letter identifying the materials as
comments submitted to OMB on the proposed collection of information
requirements in the proposed procedures and requirements under sections
101(a) and (b) of the CPSIA.
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 establishes specific limits on lead 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. Legal Considerations
1. Materials or Products That Do Not Exceed the Lead Limits
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,
children's products 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, for children's products manufactured on and
after February 10, 2009, general conformity certificates certifying
that they comply with the applicable lead content limit are required.
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 third-party laboratory whose accreditation to
perform the testing has been accepted by the Commission. Comments
submitted to the Commission suggest that these testing and
certification requirements will result in significant expense for
products that may be inherently free of lead or dangerous lead levels.
Section 3 of the CPSIA grants the Commission general rulemaking
authority to issue regulations, as necessary, to implement the CPSIA.
There may be certain commodities or classes of products or materials
that inherently do not contain lead or contain lead at levels that
would not exceed the lead content limits under section 101(a) of the
CPSIA. To the extent that such materials or products exist, the
Commission, either of its own initiative or upon the request of an
interested person, is proposing to exercise its CPSIA section 3
authority to make determinations that certain commodities or classes of
material or products do not exceed the lead limits of section 101(a).
This rule proposes a procedure by which the Commission will address
requests for determinations that these types of materials or products
do not and would not exceed the lead limits. The effect of such a
Commission finding would be to relieve that material or product from
the testing requirement of section 102 for purposes of supporting the
required certification.
If this proposal is issued in final form, the Commission would
concentrate its efforts on evaluating those materials that are
commodity-like, are used across industry in a number of applications,
and are subject to detailed consensus standards related to lead content
and other pertinent properties. Given the Commission's resources,
requests to evaluate individual products of a single manufacturer would
be assigned a very low priority.
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.
2. Materials or Products That Exceed the Lead Limits
The Commission is also proposing procedures to address requests for
exclusions for certain products or materials that exceed the lead
content limits in section 101(a). Section 101(b)(1) of the CPSIA
provides that the Commission may, by regulation, exclude a specific
product or material that exceeds the lead limits established for
children's products under section 101(a) if the Commission, after
notice and a hearing, determines on the basis of the best-available,
objective, peer-reviewed, scientific evidence that lead in such product
or material will neither (a) result in the absorption of any lead
[[Page 2430]]
into the human body, taking into account normal and reasonably
foreseeable use and abuse of such product by a child, including
swallowing, mouthing, breaking, or other children's activities, and the
aging of the product; nor (b) have any other adverse impact on public
health or safety.
Under section 101(b) of the CPSIA, the Commission is required to
provide notice and a hearing to consider and evaluate the best-
available, objective, peer-reviewed, scientific data before
promulgating a rule on exclusions. Section 553 of the Administrative
Procedure Act (APA), provides that after notice, the agency must give
interested persons an opportunity to participate in the rule making
through submission of written data, views, or arguments with or without
opportunity for oral presentation. 5 U.S.C. 553(c). Section 101(b) does
not require a ``hearing on the record,'' which would trigger more
extensive procedural requirements under the APA. Accordingly, for this
matter the Commission has determined that an oral hearing is not
necessary to satisfy the requirements of due process.\1\ Given the
highly technical nature of the information sought--peer-reviewed,
scientific data--the Commission believes that the APA notice and
comment procedures based on written submissions would provide the most
efficient process for obtaining the required information as well as
provide adequate opportunity for all interested parties to participate
in the proceedings.
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\1\ The Supreme Court has held that paper hearing procedures are
adequate where, in the total context of the process, they are deemed
to ensure adequate notice and a genuine opportunity to explain one's
case. Mathews v. Eldridge, 424 U.S. 319, 334-35 (1976). See also
United States v. Florida East Coast Railway Co., 410 U.S. 224, 238-
41(1973).
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C. Procedures and Requirements
1. Inherent Lead Content Level Determination
Any request for a Commission determination that a specific material
or product contains no lead or a lead level below the applicable
statutory limit must be supported by objectively reasonable and
representative test results or other scientific evidence showing that
the product or material does not, and would not, exceed the lead limit
specified in the request.
A justification submitted by an interested party for a
determination must include a detailed description of the product or
material; data on the lead content of parts of the product or the
materials used in the production of a product; data or information on
manufacturing processes through which lead may be introduced into the
product or material; any other information relevant to the potential
for the lead content of the product or material to exceed the statutory
lead limit specified in the request, that is 600 ppm, 300 ppm, or 100
ppm, as applicable; and detailed information on the test methods used
to support such data, including the type of equipment used and any
other techniques employed, as well as a statement as to why the data is
representative of the lead content of such products or materials
generally and why the assessment of the manufacturing processes
strongly supports a conclusion that they would not be a source of lead
contamination of the product or material, if relevant. MSDS sheets will
not be sufficient to satisfy the representative testing criteria
because they do not show sufficient information regarding lead content.
Rather, the showing necessary to obtain an exclusion must be based on
objectively reasonable and representative testing of the material or
product.
As noted above, given the potential number of requests for
determinations that might be submitted to the Commission, the
Commission would evaluate industry-wide applications for commodities or
classes of materials or products based on technical specifications or
other data suggesting that the generic commodity or class of materials
is representative of that used by a number of manufacturers before it
will review any brand specific products or proprietary formulas from
individual manufacturers. The type of materials or product classes that
the Commission considers may fall within the class for priority
evaluation might include, but not be limited to, materials such as
paper, vegetable dyes, inks, adhesives, fabrics, and the like, provided
that adequate documentation of the technical specifications of the
materials or products such that they are representative of a broad
class and testing data is provided as to those generic products. In
time, the Commission would apply the same criteria on a product by
product or material by material basis, if necessary, and provided it
has the resources to do so.
Upon receipt of a complete request for a determination, the
Commission proposes to direct the Office of Hazard Identification and
Reduction to assess the request and make an initial determination. If
the recommendation is to grant the exclusion, the Commission will
publish a notice of proposed rulemaking inviting public comment on
whether the determination should be granted in final form, and the
Office of Hazard Identification and Reduction will review and evaluate
the comments and supporting documentation before making its
recommendation to the Commission for final agency action.
2. Exclusion of a Material or Product Exceeding Lead Content Limit
For products that exceed the lead content limits prescribed in
section 101(a) of the CPSIA, the Commission proposes procedures that
will allow the Commission to evaluate products or materials for
possible exclusions under section 101(b)(1) of the CPSIA. Under this
section, such evaluations must be based on the best-available,
objective, peer-reviewed, scientific evidence showing that lead in such
product or material will not result in the absorption of any lead into
the body, taking into account normal and reasonable foreseeable use and
abuse by a child, nor have any other adverse impact on health or
safety. Therefore, a request for an exclusion must be supported by the
best-available, objective, peer-reviewed, scientific evidence that
address these issues, such as test results indicating how much lead is
present in the product, how much lead comes out of the product and the
conditions under which that may happen, and information relating to a
child's interaction, if any, with the product.\2\
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\2\ The Commission notes that the statutory language of section
101(b)(1) makes it difficult to make a showing that would be
adequate to exclude any material or product on that basis.
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Upon receipt of a complete exclusion request, the Commission
proposes to direct the Office of Hazard Identification and Reduction to
assess the request and make an initial determination. If the
recommendation is to grant the exclusion, the Commission will publish a
notice of proposed rulemaking inviting public comment on whether the
exclusion should be issued in final form, and the Office of Hazard
Identification and Reduction will review and evaluate the comments and
supporting documentation before making its recommendation to the
Commission for final agency action.
D. Effect of Filing a Lead Content Determination or Exclusion Request
The filing of a request for a lead content determination or for an
exclusion would not have the effect of automatically staying the effect
of any provision or limit under the statutes and regulations enforced
by the Commission. Unless issued in final form by the Commission after
notice and comment, all CPSC requirements related to the lead content
in the material or
[[Page 2431]]
product and all applicable testing and certification requirements would
remain in full force and effect. CPSIA Sec. 101(e). However, the
Commission's ability to exercise its enforcement discretion is not
eliminated nor diminished.
E. 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.
That assessment found that the procedures and requirements would only
impact those firms that wish to seek a formal Commission determination
or exclusion from the requirements. Its only potential 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, if the request is granted. 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.
F. 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 use
of lead over what is occurring at the present time. Therefore, the
Commission does not expect the proposal to have any negative
environmental impact.
G. 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.
H. Paperwork Reduction Act
Since the proposed rule would require manufacturers to provide
certain information along with any request for a Commission
determination or exclusion, the proposed rule contains ``collection of
information requirements'' as that term is used in the Paperwork
Reduction Act, 44 U.S.C. 3501-3520. Therefore, the proposed rule is
being submitted to the Office of Management and Budget (OMB) in
accordance with 44 U.S.C. 3507(d) and implementing regulations codified
at 5 CFR 1320.11. The estimated costs of these requirements will depend
on the number of requests that are received by the Commission.
The number of manufacturers or importers that might seek a
determination that their products or materials do not contain lead or
exceed the lead content limits or that might seek an exclusion from the
lead-content requirements for their product is not currently known. The
requirements for obtaining a determination or exclusion are extensive,
which may be a deterrent to some firms; however, because a very broad
range of products, materials and components are affected by the lead
content limits, the number of firms seeking such determinations or
exclusions could be higher than expected. It would be expected that the
firms making such requests would be familiar with the product or
material for which the determination or exemption is sought and the
required information may already be in the firm's possession or easily
obtainable.
Based on comments received on the CPSIA lead content provisions
thus far, staff estimates that a minimum of approximately 250 firms may
submit requests. The burden to assemble the information and prepare the
submission, if performed by a senior level management employee, may
take approximately 40 hours. The compensation would be approximately
$60 an hour (U.S. Department of Labor, Bureau of Labor Statistics), and
the average cost of preparing a submission would be about $2,400 ($60 x
40). An estimate of the annual burden for the information collection
could reach $600,000.
An estimate of the burden on the federal government to review each
submission could be as much as 24 hours at an average hourly wage of
$56, the equivalent of a GS-14 employee, or $1,344 for each submission
($56 x 24). If approximately 250 submissions are received, the cost of
the annual burden to the federal government will be approximately
$336,000.
I. Effective Date
The APA generally requires that a substantive rule be published not
less than 30 days before its effective date, unless the agency finds
for good cause shown, that a lesser time period is required. 5 U.S.C.
553(d)(3). Because the Commission recognizes the need for providing
procedures for Commission determinations and exclusions expeditiously,
for good cause shown, the proposed effective date is the date of
publication of a final rule in the Federal Register.
J. 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): Exclusions from Compliance with Limits
for Lead, Certain Materials of Products: Required Technical
Information.'' December 2008.
(2) Memorandum from Robert Franklin, Economist, Directorate for
Economic Analysis, ``Procedures for Determinations Regarding Lead
Limits and Procedures for Exclusions from Lead Limits Under Section 101
of the Consumer Product Safety Improvement: Small Business and
Environmental Impacts.'' 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.
K. 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 new Sec. Sec. 1500.89 and 1500.90 to read as follows:
Sec. 1500.89 Procedures for Determinations Regarding Lead Content of
Materials or Products under Section 101(a) 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
[[Page 2432]]
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 meet 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) The Commission may, either on its own initiative or upon the
request of any interested person, make a determination that a material
or product does not contain lead levels that exceed 600 ppm, 300 ppm or
100 ppm.
(c) To request a determination under paragraph (b) of this section,
the request must:
(1) Be e-mailed to cpsc-os@cpsc.gov and titled ``Section 101
Request for Lead Content Determination.'' Requests 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.
(2) Be written in the English language.
(3) Contain the name and address, and e-mail address or telephone
number, of the requestor.
(4) Provide Documentation including:
(i) A detailed description of the product or material;
(ii) Data on the lead content of parts of the product or materials
used in the production of a product;
(iii) Data or information on manufacturing processes through which
lead may be introduced into the product or material;
(iv) Any other information relevant to the potential for lead
content of the product or material to exceed the CPSIA lead limits that
is reasonably available to the requestor;
(v) Detailed information on the relied upon test methods for
measuring lead content of products or materials including the type of
equipment used or any other techniques employed and a statement as to
why the data is representative of the lead content of such products or
materials generally; and
(vi) An assessment of the manufacturing processes which strongly
supports a conclusion that they would not be a source of lead
contamination of the product or material, if relevant.
(d) Where a submission fails to meet all of the requirements of
paragraph (c) of this section, the Office of the Secretary shall notify
the person submitting it, describe the deficiency, and explain that the
request may be resubmitted when the deficiency is corrected.
(e) Each complete request for a Commission determination will be
reviewed by the Office of Hazard Identification and Reduction who will
preliminarily recommend granting or denying the request. Where the
preliminary determination is to grant, the Commission will publish a
notice of proposed rulemaking inviting public comment on whether the
preliminary determination should be granted in final form, and the
Office of Hazard Identification and Reduction will review and evaluate
the comments and supporting documentation before making its
recommendation to the Commission for final agency action.
(f) The filing of a request for a determination does not have the
effect of automatically staying the effect of any provision or limit
under the statutes and regulations enforced by the Commission. Even
though a request for a determination has been filed, unless a
Commission determination is issued in final form after notice and
comment, materials or products subject to the lead limits under section
101 of the CPSIA must be tested in accordance with section 102 of the
CPSIA.
Sec. 1500.90 Procedures for Exclusions from Lead Limits under Section
101(b) 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 101(b)(1) of the CPSIA provides that the Commission may
exclude a specific product or material from the lead limits established
for children's products under the CPSIA if the Commission, after notice
and a hearing, determines on the basis of the best-available,
objective, peer-reviewed, scientific evidence that lead in such product
or material will neither:
(1) Result in the absorption of any lead into the human body,
taking into account normal and reasonably foreseeable use and abuse of
such product by a child, including swallowing, mouthing, breaking, or
other children's activities, and the aging of the product; nor
(2) Have any other adverse impact on public health or safety.
(c) To request an exclusion from the lead limits as provided under
paragraph (a) of this section, the request must:
(1) Be e-mailed to cpsc-os@cpsc.gov. and titled ``Section 101
Request for Exclusion of a Material or Product.'' Requests 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.
(2) Be written in the English language.
(3) Contain the name and address, and e-mail address or telephone
number, of the requester.
(4) Provide Documentation including:
(i) A detailed description of the product or material;
(ii) Data on the lead content of parts of the product or materials
used in the production of a product;
(iii) Data or information on manufacturing processes through which
lead may be introduced into the product or material;
(iv) Any other information relevant to the potential for lead
content of the product or material to exceed the CPSIA lead limits that
is reasonably available to the requestor;
(v) Detailed information on the relied upon test methods for
measuring lead content of products or materials including the type of
equipment used or any other techniques employed and a statement as to
why the data is representative of the lead content of such products or
materials generally; and
(vi) An assessment of the manufacturing processes which strongly
supports a conclusion that they would not be a source of lead
contamination of the product or material, if relevant.
(5) Provide best-available, objective, peer-reviewed, scientific
evidence to support a request for an exclusion that addresses how much
lead is present in the product, how much lead comes out of the product,
and the conditions under which that may happen, and information
relating to a child's interaction, if any, with the product.
(6) Provide best-available, objective, peer-reviewed, scientific
evidence that is unfavorable to the request that is reasonably
available to the requestor.
(d) Where a submission fails to meet all of the requirements of
paragraph (c) of this section, the Office of the Secretary shall notify
the person submitting it, describe the deficiency,
[[Page 2433]]
and explain that the request may be resubmitted when the deficiency is
corrected.
(e) Each complete request for exclusion will be reviewed by the
Office of Hazard Identification and Reduction, who will preliminarily
recommend granting or denying the request. Where the preliminary
determination is to grant, the Commission will publish a notice of
proposed rulemaking inviting public comment on whether the proposed
exclusion should be issued in final form, and the Office of Hazard
Identification and Reduction will review and evaluate the comments and
supporting documentation before making its recommendation to the
Commission for final agency action.
(f) The filing of a request for exclusion does not have the effect
of automatically staying the effect of any provision or limit under the
statutes and regulations enforced by the Commission. Even though a
request for an exclusion has been filed, unless an exclusion is issued
in final form by the Commission after notice and comment, materials or
products subject to the lead limits under section 101 of the CPSIA are
considered to be banned hazardous substances if they do not meet the
lead limits.
Dated: January 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-715 Filed 1-14-09; 8:45 am]
BILLING CODE 6335-01-P