Children's Products Containing Lead; Final Rule; Procedures and Requirements for a Commission Determination or Exclusion, 10475-10482 [E9-5075]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Rules and Regulations]
[Pages 10475-10482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5075]


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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.

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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\
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    \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.
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    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.
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    \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.
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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.
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    \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.
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    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.
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    \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.
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    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