11 March 2009
[Federal Register: March 11, 2009 (Volume 74, Number 46)]
[Rules and Regulations]
[Page 10475-10482]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr09-7]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Children's Products Containing Lead; Final Rule; Procedures and
Requirements for a Commission Determination or Exclusion
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is
issuing a final rule on procedures and requirements on requests 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 Consumer Product Safety
Improvement Act of 2008 (CPSIA), Public Law 110-314; or an exclusion of
a commodity or class of materials or a specific material or product
under section 101(b)(1) of the CPSIA, that exceeds the lead content
limits under section 101(a) of the CPSIA, 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.
DATES: Effective Date: This regulation becomes effective on March 11,
2009.
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; e-mail
khatlelid@cpsc.gov; telephone 301-504-7254.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA establishes specific limits on lead in children's
products. Section 101(a) of the CPSIA provides that after February 10,
2009, products designed or intended primarily for children 12 years of
age or younger may not contain more than 600 ppm of lead by weight for
any part of the product. After August 14, 2009, products designed or
intended primarily for children 12 years of age or younger cannot
contain more than 300 ppm of lead by weight for any part of the
product. On August 14, 2011, the limit will 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 or prevent the absorption of any lead
in the human body through normal and reasonably foreseeable use and
abuse of the product.
Consumer products designed or intended primarily for children 12
years of age or younger that do not contain more than 600 ppm or 300
ppm total lead by weight (as of August 14, 2009), are not considered to
be banned hazardous substances under the Federal Hazardous Substances
Act (FHSA). Children's products that meet the lead limits however, are
still subject to the testing requirements of section 102 of the CPSIA
(codified at section 14 of the Consumer Product Safety Act (CPSA)),
unless specifically relieved of those requirements through Commission
lead content determinations.\1\
---------------------------------------------------------------------------
\1\ On February 9, 2009, the Commission published a stay of
enforcement of testing and certification requirements of certain
provisions of subsection 14(a) of the CPSA as amended by section
102(a) of the CPSIA until February 10, 2010. 74 FR 6396. However,
absent 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 CPSIA, such
products will be subject to the testing requirements under section
102 of the CPSIA after February 10, 2010.
---------------------------------------------------------------------------
Children's products that contain more than 600 ppm or 300 ppm lead
in any component part (as of August 14, 2009) are considered to be
banned hazardous substances under the FHSA. However, 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) of 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: (a) 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 (b) have any other
adverse impact on public health or safety.'' Children's products that
have lead containing accessible parts that are specifically excluded
under this section would generally not be subject to the testing and
certification requirements of section 102 of the CPSIA for lead
content.
B. Statutory Authority
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. Accordingly, the Commission will exercise its authority under
section 3 of the CPSIA to make determinations regarding such
commodities or classes of material or products that do not and would
not exceed the lead limits of section 101(a) of the CPSIA.
In addition, the Commission may exercise its authority under
section 101(b)(1) of the CPSIA to issue any regulations on a specific
product or material that exceeds the lead limits established for
children's products under section 101(a) of 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: (a) 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 (b) have any other
adverse impact on public health or safety.
C. Notice of Proposed Rulemaking
On January 15, 2009, the Commission published a notice of proposed
rulemaking on procedures and requirements in the Federal Register (74
FR 2428) for future Commission determinations regarding certain
materials or products that do not and would not exceed the lead limits.
In the
[[Page 10476]]
same issue of the Federal Register (74 FR 2433), the Commission
published another notice of proposed rulemaking describing preliminary
determinations that specific materials including certain natural
materials and certain metal and alloys do not and would not exceed the
lead limits.
For materials or products 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, the Commission proposed procedures
and requirements by which requests for determinations on materials or
products will be reviewed. The Commission emphasized that it 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 and that review of individual products
of a single manufacturer would be assigned a low priority.
For materials or products that exceed the lead content limits in
section 101(a) of the CPSIA, section 101(b) of the CPSIA requires the
Commission to provide notice and a hearing to consider and evaluate the
best-available, objective, peer-reviewed, scientific data before
promulgating a rule on exclusions. Given the highly technical nature of
the information sought--peer-reviewed, scientific data--the Commission
stated its intention to provide notice and comment procedures based on
written submissions, rather than an oral hearing. 74 FR 2430.
Accordingly, the Commission proposed procedures and requirements which
required that a request for exclusion must be supported by the best-
available, objective, peer-reviewed, scientific evidence, 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.
D. Discussion of Comments to the Proposed Rule
Several comments were received in response to the proposed rule.\2\
All of the commenters generally express support for the proposed
procedures and requirements. Additional comments are addressed below.
---------------------------------------------------------------------------
\2\ There were other comments that were submitted but that did
not address any issues related to this rule. Accordingly, they will
not be addressed here.
---------------------------------------------------------------------------
Standard for Exclusions
The ATV Companies \3\ question the Commission's statement regarding
the difficult standard that needs to be met for exclusions under
section 101(b)(1) of the CPSIA, suggesting that possibly no petition
might qualify for an exclusion and citing recent statements from a
Senate conferee suggesting that the exclusion is appropriate for use in
this context. They assert that exclusions provided for by Congress
should not be rendered meaningless and that Congress must have intended
to provide relief for some accessible components when evaluated in the
context of a child's reasonably foreseeable use and abuse of a product,
and that certain ATV components fall within the scope of such an
exclusion.
---------------------------------------------------------------------------
\3\ The ATV Companies are American Honda Motor Co., American
Suzuki Motor Corp., Arctic Cat Inc., Bombardier Recreational
Products Inc., Kawasaki Motors Corp., U.S.A., Polaris Industries
Inc., and Yamaha Motor Corp., U.S.A.
---------------------------------------------------------------------------
The Commission believes that the clear language of the statute
which provides that it must determine, on the basis of the best-
available, objective, peer-reviewed, scientific evidence that lead in
such product or material will not ``result in the absorption of any
lead into the human body * * *'' (emphasis added) does not allow the
Commission any discretion to consider materials or products whereby
exposure to the lead-containing elements under reasonably foreseeable
use and abuse conditions would result in any absorption of lead,
including through swallowing, mouthing, breaking, and the aging of the
product. While Congress focused on ingestion by using the words
``swallowing, mouthing, and breaking,'' the use or abuse of a
children's product containing lead in excess of the lead limits could
lead to the absorption of lead from hand to mouth contact, as the
Commission has recognized for many years. Had Congress not included the
use of the word ``any'', the Commission, relying, inter alia, on the
advice of its toxicologists, engineers and human factors experts, would
have had the authority to have considered whether the requirement could
be met if there were some low amount of absorption of lead, resulting
in ``no meaningful increase'' in children's blood lead levels, thereby
constituting a negligible risk. While there is no established threshold
for adverse effects of lead, peer-reviewed scientific literature
suggests ways of assessing the risk to children given child-specific
exposure routes, and taking into account the current knowledge of lead
toxicology. Models for such assessments have been advanced recently by
other federal and state agencies. See e.g., Development of Health
Criteria for School Site Risk Assessment Pursuant To Health and Safety
Code Section 901(G): Child-Specific Benchmark Change in Blood Lead
Concentration for School Site Risk Assessment, Final Report April 2007,
Integrated Risk Assessment Branch, Office of Environmental Health
Hazard Assessment, California Environmental Protection Agency.
Physiologically, if there is absorption of lead into the human body,
blood lead levels will increase, but whether that has significance from
a health standpoint remains a question. However, the addition of the
word ``any'' made it explicit that Congress had already made this risk
assessment and legislated that any absorption of lead from products or
materials containing lead above the content limits established by
Congress, no matter how insignificant, would be deemed unacceptable.
The exclusion is not rendered meaningless, as conceivably some product
could be over the lead limit but designed in a way to avoid hand to
mouth exposure or some other absorption pathway in children of a
certain age. Accordingly, the Commission must follow the clear language
of the statute and cannot grant any exclusion that does not meet this
requirement.
Other Considerations for Exclusion Requests
The United States Association of Importers of Textiles and Apparel
(USA-ITA) supports the proposed procedures for requesting exclusions or
determinations for other materials that may be included in apparel,
such as rhinestone beads. The Fashion Jewelry Trade Association (FJTA)
agrees that an oral hearing is not required for the Commission to act
on exclusions and requests expedited action on crystals. For proposed
exclusions, it states that only relevant exposure conditions should be
considered, including consideration of the child's age. The American
Apparel & Footwear Association (AAFA) et al. assert that the Commission
should rely on an extractable lead test rather than the total lead
content in its evaluations for proposed exclusions and requirements.
FJTA requests that, in the absence of published best-available,
objective, peer-reviewed scientific evidence, test data using accepted
published test methods should be considered reliable information. It
also opposes the requirement that a request for exclusion should
include evidence that may be unfavorable to the requestor, because it
claimed that the purpose of the public
[[Page 10477]]
comment process is to elicit countervailing information.
The standard for lead established by the CPSIA is based on total
lead content of component parts of children's products. However,
section 101(b)(1) of the CPSIA provides that the Commission may exclude
a specific product or material from the lead content limits if the
Commission determines lead in such product or material will not result
in the absorption of any lead into the body, taking into account normal
and reasonably foreseeable use and abuse by a child based on factors
specific to the product or material and to the children using the
product. Therefore, under this section, exclusion of a product or
material from the lead content limits would necessarily be based on
factors other than the total lead content. A request should contain as
much credible scientific evidence as is available, including any test
data using established test methods particularly if the requestor is
asking the Commission to consider estimates of extractable lead in
reaching conclusions about the absorption of lead in the child's body.
However, such a submission will be reviewed by staff to determine the
veracity and applicability of the studies to the product or material in
question and whether, in consideration with other available evidence,
it supports a showing that lead in such product or material would not
result in the absorption of any lead into the body.
The Commission will continue to require that a request for
exclusion be accompanied by information unfavorable to the request, if
reasonably available. In addition, the Commission will require that a
request for a determination be accompanied by information unfavorable
to the request, if reasonably available and if it accurately reflects
the product's lead content. Therefore, this final rule requires the
production of ``representative'' data to ensure that the Commission has
relevant data reflecting the actual likely lead content of the product
or class of products. To the extent that such information is reasonably
available to the requestor, particularly if the information was
produced by or presented to the requestor, it must be provided to the
Commission to ensure that all available information and data is
reviewed in determining whether an exclusion or determination is
appropriate based on the totality of the evidence.
Process Timeline and Treatment of Confidential Information
AAFA requests that the Commission articulate a timeline for the
process, indicate how requests for exclusion will be disclosed, and
provide guidelines on how business-confidential information will be
protected. The Office of the California Attorney General (CA AG) also
requests that the Commission continue to post applications and
supporting documents and, where materials are withheld from the public,
provide the reasons for withholding the information.
As part of this rulemaking, the Commission has specified a timeline
for processing requests for determinations and exclusions. The
Commission will continue its practice of providing public access to
requests and supporting materials received from the requestors as well
as comments from the public. With respect to confidential materials,
the Commission will note in the public docket where such materials are
withheld from the public docket. Section 6(a)(2) of the CPSA, 15 U.S.C.
2055(a)(2), and the regulations promulgated under 16 CFR 1015.18 and
1015.19 govern requests for confidential treatment of information and
requests for disclosure of such information. These procedures are
applicable to any such requests received in these proceedings.
Additional Requirements for Determinations
The CA AG states that the Commission should be explicit in the
regulation, not just the preamble, that a determination that the lead
content of a material or product is below the lead limits does not
relieve the material or product from complying with the applicable lead
limits. In addition, the CA AG suggests additional information to be
obtained from applicants including: (1) Data or information on the
facilities and manufacturing processes used to manufacture the material
or product, and any materials used in the product; and (2) an
assessment of the likelihood or lack thereof that the use of leaded
materials in a facility will result in lead contamination of a material
or product that ordinarily does not contain lead. Consumers Union, et
al.\4\ state that products from the market should be tested with
reasonable frequency to act as an effective deterrent.
---------------------------------------------------------------------------
\4\ Consumers Union, Consumer Federation of America, Kids in
Danger, Public Citizen, and the U.S. Public Interest Research Group
filed joint comments. In their comments, they expressed satisfaction
with the Commission's process for determining exclusions based on
best available, objective, peer reviewed, scientific evidence that
the product or material cannot result in the absorption of any lead
in the human body as discussed above.
---------------------------------------------------------------------------
The Commission has already indicated that all children's products
subject to a determination must comply with the lead limit in its
Statement of Commission Enforcement Policy on Section 101 Lead Limits,
dated February 6, 2009, and includes in the regulation the requirement
for compliance with the CPSIA lead limits. The Commission had also
indicated that a request for a determination would need to include
information on ``manufacturing processes through which lead may be
introduced in to the product * * * and why the assessment of the
manufacturing processes strongly supports a conclusion that they would
not be a source of lead contamination.'' However, in response to these
comments, the Commission will also clarify that the procedures and
requirements for determinations will include a request for an
evaluation of facilities and manufacturing processes as well as a
request for an assessment of whether lead uses in manufacturing
facilities could possibly result in lead contamination of a material or
product. With respect to market testing, compliance and enforcement
activities, including market testing, have always been and continue to
be essential to the Commission's mission. Moreover, even when a
particular product or material has been relieved of the requirement to
undergo testing and certification under section 102 of the CPSIA,
manufacturers and importers continue to be responsible for verifying
that the material or product has not been altered or modified, or
experienced any change in the processing, facility or supplier
conditions that could impart lead into the material or product to
ensure that it meets the statutory lead levels at all times.
E. Procedures and Requirements
1. Sec. 1500.89--Lead Content Level Determinations
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 and how
it is used by the child;
[[Page 10478]]
Representative data on the lead content of parts of the
product or the materials used in the production of a product;
All relevant data or information on manufacturing
processes through which lead may be introduced into the product or
material;
An assessment of the likelihood or lack thereof that the
manufacturing processes will result in lead contamination of a material
or product that ordinarily does not contain lead;
All relevant data or information on the facilities used to
manufacture the material or product, and any other materials used in
the product;
An assessment of the likelihood or lack thereof that the
use of leaded materials in a facility will result in lead contamination
of a material or product that ordinarily does not contain lead;
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;
Detailed information on the relied upon test methods for
measuring lead content of products or materials, including the type of
equipment used and 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
Any data or information that is unfavorable to the request
that is reasonably available to the requestor.
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 a
determination must be based on objectively reasonable and
representative testing of the material or product.
Upon receipt of a complete request for a determination, the Office
of Hazard Identification and Reduction (EXHR) will assess the request
to determine whether the product or material is one that does not
contain lead in excess of the limits of section 101 of the CPSIA. EXHR
will make an initial recommendation within thirty (30) calendar days to
the extent practicable; EXHR may request an extension from the
Executive Director of the CPSC, if necessary, to make its initial
determination. A complete request is one that does not require
additional information from the requestor for EXHR to make an initial
recommendation to the Commission. If a request is submitted that is not
complete, 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. If EXHR's initial
recommendation is to deny the request for a lead content determination,
it will provide, in a staff memorandum to the Commission for ballot
vote, the basis for the denial with sufficient detail for the
Commission to make an informed decision that reasonable grounds for a
determination are not presented. The Commission, by ballot vote, will
render a decision on the staff's recommendation. The ballot vote and
the staff memorandum will be posted on the CPSC Web site. Any
determination by the Commission to grant a request will be published in
the Federal Register for comment. If the Commission concludes that the
request shall be denied, the requestor shall be notified in writing of
the denial from the Office of the Secretary along with the official
ballot results and the EXHR staff's memorandum of recommendations.
If the staff's initial recommendation is to grant the lead content
determination, it will submit the basis for that recommendation to the
Commission in a memorandum to be voted on by ballot, with sufficient
detail for the Commission to make an informed decision that reasonable
grounds for a determination are presented. If the notice of proposed
rulemaking (NPR) is published, it will invite public comment in the
Federal Register. EXHR will review and evaluate any comments and
supporting documentation before making its final recommendation to the
Commission for final agency action, by staff memorandum submitted to
the Commission. If the Commission, after review of the staff's final
recommendation, determines that a material or product does not and
would not exceed the lead content limits, it will decide by ballot vote
on whether to publish a final rule in the Federal Register. Although
such materials or products would be relieved of the testing and
certification requirements in section 102 of the CPSIA, manufacturers
and importers would continue to be responsible for verifying that the
material or product has not been altered or modified, or experienced
any change in the processing, facility or supplier conditions that
could impart lead into the material or product. These materials or
products must still meet the statutory lead level requirements at all
times. 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 and could
take additional regulatory action if repeated enforcement actions call
into question the original determination. In addition, all materials or
products must still meet any other applicable consumer product safety
rules as defined in the CPSA or similar rules, bans standards, or
regulations under any other Act enforced by the Commission.
2. Sec. 1500.90--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, any requests seeking an exclusion must
submit documentation 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 reasonably foreseeable use and abuse by
a child, including swallowing, mouthing, breaking, or other children's
activities, and the aging of the product, nor have any other adverse
impact on health or safety. This is the standard by which the
Commission will review such requests for exclusions. A justification
submitted by an interested party for an exclusion should provide:
A detailed description of the product or material and how
it is used by a child;
Representative data on the lead content of parts of the
product or materials used in the production of a product;
All relevant 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 lead
content of the product or material to exceed the CPSIA lead limits that
is reasonably available to the requestor;
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;
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;
Best-available, objective, peer-reviewed, scientific
evidence to support a request for an exclusion that demonstrates that
the normal and reasonably foreseeable use and abuse activity by a child
(including
[[Page 10479]]
swallowing, mouthing, breaking, or other children's activities) and the
aging of the material or product for which exclusion is sought, will
not result in the absorption of any lead into the body, nor have any
other adverse impact on health or safety. This literature should
support a request for 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; and
Best-available, objective, peer-reviewed, scientific
evidence that is unfavorable to the request that is reasonably
available to the requestor.
Upon receipt of a complete request for an exclusion, the Office of
Hazard Identification and Reduction (EXHR) will assess the request on
the basis of its review of the submitted materials, that the normal and
reasonably foreseeable use and abuse activity by a child (including
swallowing, mouthing, breaking, or other children's activities) and the
aging of the material or product for which exclusion is sought, will
not result in the absorption of any lead into the human body, nor have
any other adverse impact on public health or safety, and make an
initial recommendation within thirty (30) calendar days to the extent
practicable. EXHR may request an extension from the Executive Director
of the CPSC, if necessary, to make its initial recommendation. A
complete request is one that does not require additional information
from the requestor for EXHR to make an initial recommendation to the
Commission. If a request is submitted that is not complete, 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.
If EXHR's initial recommendation is to deny the request for an
exclusion, it will provide, in a staff memorandum to the Commission,
submitted to the Commission for ballot vote, the basis for denial with
sufficient detail for the Commission to make an informed decision that
reasonable grounds for an exclusion are not presented. The Commission,
by ballot vote, will render a decision on the staff's recommendation.
The ballot vote and the staff memorandum will be posted on the CPSC Web
site. Any determination by the Commission to grant a request will be
published in the Federal Register for comment. If the Commission
concludes that the request shall be denied, the requestor shall be
notified in writing of the denial, from the Office of the Secretary
along with the official ballot results and the EXHR staff's memorandum
of recommendation.
If the staff's initial recommendation is to grant the exclusion, it
will submit the basis for that recommendation to the Commission in a
memorandum to be voted on by ballot, with sufficient detail for the
Commission to make an informed decision that reasonable grounds for a
determination are presented. If the notice of proposed rulemaking (NPR)
is published, it will invite public comment in the Federal Register.
EXHR will review and evaluate any comments and supporting documentation
before making its final recommendation to the Commission, by staff
memorandum submitted to the Commission for final agency action. If the
Commission, after review of the staff's final recommendation,
determines that an exclusion is supported by the evidence, it will by
ballot vote decide on whether to publish a final rule in the Federal
Register.
F. Effect of Filing a Lead Content Determination or Exclusion Request
Under section 101(e) of the CPSIA, 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
product would remain in full force and effect. However, the
Commission's ability to exercise its enforcement discretion is not
eliminated nor diminished.
G. 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. The
Commission preliminarily found that the proposed rule would not have a
significant impact on a substantial number of small entities. The
procedures and requirements would allow certain businesses, including
small businesses, the ability to seek determinations and exclusions
which would allow these entities to continue to manufacture their
products without the continuing cost of testing the materials for the
presence of lead. Based on the foregoing assessment, the Commission
certifies that the rule issued today on procedures and requirements
would not have a significant impact on a substantial number of small
entities.
H. 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(a)). The rule on procedures and requirements is not expected to
have an adverse impact on the environment, thus, the Commission
concludes that no environment assessment or environmental impact
statement is required in this proceeding.
I. 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.
J. Paperwork Reduction Act
The rule would require manufacturers to provide certain information
along with any request for a Commission determination or exclusion. For
this reason, the rule contains ``collection of information
requirements'' as that term is used in the Paperwork Reduction Act, 44
U.S.C. 3501-3520. Therefore, the preamble to the proposed rule
discussed the paperwork burden that may be incurred and specifically
requested comments on the paper burden of the proposal. The agency has
applied to OMB for a control number for this information collection,
and it will publish a notice in the Federal Register providing the
number when the agency receives approval from the Office of Management
and Budget (OMB).
K. Effective Date
The Administrative Procedure Act 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 and
requirements for Commission determinations and exclusions
expeditiously, for good cause
[[Page 10480]]
shown, the effective date is March 11, 2009.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
L. Conclusion
0
For the reasons stated above, the Commission amends chapter II of title
16 of the Code of Federal Regulations as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1500 is revised to read as follows:
Authority: 15 U.S.C. 1261-1278, 122 Stat. 3016
0
2. Add new Sec. Sec. 1500.89 and 1500.90 to read as follows:
Sec. 1500.89 Procedures and requirements 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 years of age or younger may not contain more
than 600 ppm of lead. After August 14, 2009, products designed or
intended primarily for children 12 years of age or younger cannot
contain more than 300 ppm of lead. On August 14, 2011, the limit will
be further reduced to 100 ppm, unless the Commission determines that
this lower limit is not technologically feasible. Paint, coatings or
electroplating may not be considered a barrier that would make the lead
content of a product inaccessible to a child or prevent the absorption
of any lead in the human body through normal and reasonably foreseeable
use and abuse of the product.
(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 leads levels that exceed 600 ppm, 300 ppm,
or 100 ppm, as applicable.
(c) A determination by the Commission under paragraph (b) of this
section that a material or product does not contain lead levels that
exceed 600 ppm, 300 ppm, or 100 ppm, as applicable does not relieve the
material or product from complying with the applicable lead limit as
provided under paragraph(a) of this section.
(d) 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 and how it
is used by a child;
(ii) Representative data on the lead content of parts of the
product or materials used in the production of a product;
(iii) All relevant data or information on manufacturing
processes through which lead may be introduced into the material or
product;
(iv) An assessment of the likelihood or lack thereof that the
manufacturing processes will result in lead contamination of a
material or product that ordinarily does not contain lead;
(v) All relevant data or information on the facilities used to
manufacture the material or product, and any other materials used in
the product;
(vi) An assessment of the likelihood or lack thereof that the
use of leaded materials in a facility will result in lead
contamination of a material or product that ordinarily does not
contain lead;
(vii) Any other information relevant to the potential for 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;
(viii) 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
(ix) Any data or information that is unfavorable to the request
that is reasonably available to the requestor.
(e) Where a submission fails to meet all of the requirements of
paragraph (d) 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.
(f) Upon receipt of a complete request for a determination, the
Office of Hazard Identification and Reduction (EXHR) will assess the
request to determine whether the product or material is one that does
not contain lead in excess of the limits as provided under paragraph
(a) of this section. EXHR will make an initial recommendation within
thirty (30) calendar days, to the extent practicable. EXHR may request
an extension from the Executive Director of the CPSC, if necessary, to
make its initial determination. A complete request is one that does not
require additional information from the requestor for EXHR to make an
initial recommendation to the Commission.
(g) Where the Office of Hazard Identification and Reduction's
(EXHR) initial recommendation is to deny the request for a lead content
determination, it will provide, in a staff memorandum to the
Commission, submitted to the Commission for ballot vote, the basis for
the denial with sufficient detail for the Commission to make an
informed decision that reasonable grounds for a determination are not
presented. The Commission, by ballot vote, will render a decision on
the staff's recommendation. The ballot vote and the staff memorandum
will be posted on the CPSC Web site. Any determination by the
Commission to grant a request will be published in the Federal Register
for comment. If the Commission concludes that the request shall be
denied, the requestor shall be notified in writing of the denial from
the Office of the Secretary along with the official ballot results and
the EXHR staff's memorandum of recommendation.
(h) Where the Office of Hazard Identification and Reduction's
(EXHR) initial recommendation is to grant the request for a lead
content determination, it will submit the basis for that recommendation
to the Commission in a memorandum to be voted on by ballot, with
sufficient detail for the Commission to make an informed decision that
reasonable grounds for a determination are presented. If the notice of
proposed rulemaking (NPR) is published, it will invite public comment
in the Federal Register. EXHR will review and evaluate any comments and
supporting documentation before making its final recommendation to the
Commission for final agency action, by staff memorandum submitted to
the Commission. If the Commission, after review of the staff's final
recommendation, determines that a material or product does not and
would not exceed the lead content limits, it will decide by ballot
vote, on whether to publish a final rule in the Federal Register.
(i) The filing of a request for a determination does not have the
effect of 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
[[Page 10481]]
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, unless the testing requirement is otherwise
stayed by the Commission.
Sec. 1500.90 Procedures and requirements 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 years of age or younger may not contain more
than 600 ppm of lead. After August 14, 2009, products designed or
intended primarily for children 12 years of age or younger cannot
contain more than 300 ppm of lead. On August 14, 2011, the limit will
be further reduced to 100 ppm, unless the Commission determines that
this lower limit is not technologically feasible. Paint, coatings or
electroplating may not be considered a barrier that would make the lead
content of a product inaccessible to a child or prevent the absorption
of any lead in the human body through normal and reasonably foreseeable
use and abuse of the product.
(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 requestor.
(4) Provide documentation including:
(i) A detailed description of the product or material and how it
is used by a child;
(ii) Representative data on the lead content of parts of the
product or materials used in the production of a product;
(iii) All relevant 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 demonstrating that
the normal and reasonably foreseeable use and abuse activity by a
child (including swallowing, mouthing, breaking, or other children's
activities) and the aging of the material or product for which
exclusion is sought, 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 literature should support a request for
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, and explain that the
request may be resubmitted when the deficiency is corrected.
(e) Upon receipt of a complete request for an exclusion, the Office
of Hazard Identification and Reduction (EXHR) will assess the request
to determine whether, on the basis of its review of the submitted
materials, that the normal and reasonably foreseeable use and abuse
activity by a child (including swallowing, mouthing, breaking, or other
children's activities) and the aging of the material or product for
which exclusion is sought, will not result in the absorption of any
lead into the human body nor have any other adverse impact on health or
safety. EXHR will make an initial recommendation within thirty (30)
calendar days to the extent practicable. EXHR may request an extension
from the Executive Director of the CPSC, if necessary, to make its
initial recommendation. A complete request is one that does not require
additional information from the requestor for EXHR to make an initial
recommendation to the Commission.
(f) Where the Office of Hazard Identification and Reduction's
(EXHR) initial recommendation is to deny the request for an exclusion,
it will provide in a staff memorandum to the Commission, submitted to
the Commission for ballot vote, the basis for denial with sufficient
detail for the Commission to make an informed decision that reasonable
grounds for an exclusion are not presented. The Commission, by ballot
vote, will render a decision on the staff's recommendation. The ballot
vote and the staff memorandum will be posted on the CPSC Web site. Any
determination by the Commission to grant a request will be published in
the Federal Register for comment. If the Commission concludes that the
request shall be denied, the requestor shall be notified in writing of
the denial from the Office of the Secretary along with the official
ballot results and the EXHR's staff's memorandum of recommendation.
(g) Where the Office of Hazard Identification and Reduction's
(EXHR) initial recommendation is to grant the exclusion, it will submit
the basis for that recommendation to the Commission in a memorandum to
be voted on by ballot, with sufficient detail for the Commission to
make an informed decision that reasonable grounds for a determination
are presented. If the notice of proposed rulemaking (NPR) is published,
it will invite public comment in the Federal Register. EXHR will review
and evaluate the comments and supporting documentation before making
its final recommendation to the Commission, by staff memorandum
submitted to the Commission, for final agency action. If the
Commission, after review of the staff's final recommendation,
determines that an exclusion is supported by the evidence, it will
decide by ballot vote, on whether to publish a final rule in the
Federal Register.
(h) The filing of a request for exclusion does not have the effect
of 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
[[Page 10482]]
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 as
provided under paragraph (a) of this section.
Dated: March 5, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-5075 Filed 3-10-09; 8:45 am]
BILLING CODE 6335-01-P
|