Children's Products Containing Lead; Notice of Proposed Procedures and Requirements for a Commission Determination or Exclusion, 2428-2433 [E9-715]
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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules
established body of technical
regulations for which frequent and
routine amendments are necessary to
keep them operationally current.
Therefore, this proposed regulation: (1)
Is not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under Department of
Transportation (DOT) Regulatory
Policies and Procedures (44 FR 11034;
February 26, 1979); and (3) does not
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that will only affect air traffic
procedures and air navigation, it is
certified that this proposed rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States Code.
Subtitle I, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority.
This rulemaking is promulgated
under the authority described in
Subtitle VII, Part A, Subpart I, Section
40103. Under that section, the FAA is
charged with prescribing regulations to
assign the use of the airspace necessary
to ensure the safety of aircraft and the
efficient use of airspace. This regulation
is within the scope of that authority as
it modifies the High and Low offshore
airspace areas located off the east coast
of the United States.
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ICAO Considerations
As part of this proposal relates to
navigable airspace outside the United
States, this proposal is submitted in
accordance with the International Civil
Aviation Organization (ICAO)
International Standards and
Recommended Practices.
The application of International
Standards and Recommended Practices
by the FAA, Office of System
Operations Airspace and AIM, Airspace
& Rules Group, in areas outside the
United States domestic airspace, is
governed by the Convention on
International Civil Aviation.
Specifically, the FAA is governed by
Article 12 and Annex 11, which pertain
to the establishment of necessary air
navigational facilities and services to
promote the safe, orderly, and
expeditious flow of civil air traffic. The
purpose of Article 12 and Annex 11 is
to ensure that civil aircraft operations
on international air routes are
performed under uniform conditions.
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The International Standards and
Recommended Practices in Annex 11
apply to airspace under the jurisdiction
of a contracting state, derived from
ICAO. Annex 11 provisions apply when
air traffic services are provided and a
contracting state accepts the
responsibility of providing air traffic
services over high seas or in airspace of
undetermined sovereignty. A
contracting state accepting this
responsibility may apply the
International Standards and
Recommended Practices that are
consistent with standards and practices
utilized in its domestic jurisdiction.
In accordance with Article 3 of the
Convention, state-owned aircraft are
exempt from the Standards and
Recommended Practices of Annex 11.
The United States is a contracting state
to the Convention. Article 3(d) of the
Convention provides that participating
state aircraft will be operated in
international airspace with due regard
for the safety of civil aircraft. Since this
action involves, in part, the designation
of navigable airspace outside the United
States, the Administrator is consulting
with the Secretary of State and the
Secretary of Defense in accordance with
the provisions of Executive Order
10854.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
In consideration of the foregoing, the
Federal Aviation Administration
proposes to amend 14 CFR part 71 as
follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9S,
Airspace Designations and Reporting
Points, signed October 3, 2008 and
effective October 31, 2008, is amended
as follows:
Paragraph 2003—Offshore Airspace Areas.
*
*
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*
*
Atlantic High [Amended]
That airspace extending upward from
18,000 feet MSL to and including FL 600
within the area bounded on the east from
north to south by the Moncton FIR, New
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York Oceanic CTA/FIR, and the San Juan
Oceanic CTA/FIR; to the point where the San
Juan Oceanic CTA/FIR boundary turns
southwest at lat. 21°14′21″ N., long. 67°39′02″
W., thence from that point southeast via a
straight line to intersect a 100-mile radius of
the Fernando Luis Ribas Dominicci Airport at
lat. 19°47′28″ N., long. 67°09′37″ W., thence
counter-clockwise via a 100-mile radius of
the Fernando Luis Ribas Dominicci Airport
to lat. 18°53′05″ N., long. 67°47′43″ W.,
thence from that point northwest via a
straight line to intersect the point where the
Santo Domingo FIR turns northwest at lat.
19°39′00″ N., long. 69°09′00″ W., thence from
that point the area is bounded on the south
from east to west by the Santo Domingo FIR,
Port-Au-Prince CTA/FIR, and the Havana
CTA/FIR; bounded on the west from south to
north by the Houston Oceanic CTA/FIR,
southern boundary of the Jacksonville Air
Route Traffic Control Center and a line 12
miles offshore and parallel to the U.S.
shoreline.
*
*
*
*
*
Paragraph 6007—Offshore Airspace Areas.
*
*
*
*
*
San Juan Low, PR [Amended]
That airspace extending upward from
5,500 feet MSL from the point of intersection
of the San Juan Oceanic CTA/FIR and Miami
Oceanic CTA/FIR boundary at lat. 21°14′21″
N., long. 67°39′02″ W., thence from that point
southeast via a straight line to intersect a 100mile radius of the Fernando Luis Ribas
Dominicci Airport at lat. 19°47′28″ N., long.
67°09′37″ W., thence clockwise via a 100mile radius of the Fernando Luis Ribas
Dominicci Airport to lat. 18°53′05″ N., long.
67°47′43″ W., thence from that point
northwest via a straight line to intersect the
point where the Santo Domingo FIR turns
northwest at lat. 19°39′00″ N., long. 69°09′00″
W., thence from that point northeast along
the San Juan CTA/FIR and Miami CTA/FIR
boundary to the point of beginning.
*
*
*
*
*
Issued in Washington, DC, on January 5,
2009.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. E9–501 Filed 1–14–09; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1500
Children’s Products Containing Lead;
Notice of Proposed Procedures and
Requirements for a Commission
Determination or Exclusion
AGENCY: Consumer Product Safety
Commission.
ACTION: Notice of proposed procedures
and requirements.
SUMMARY: On August 14, 2008, Congress
enacted the Consumer Product Safety
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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules
Improvement Act of 2008 (CPSIA),
Public Law 110–314. The Commission
proposes to establish procedures and
requirements for: A Commission
determination that a commodity or class
of materials or a specific material or
product does not exceed the lead
content limits specified under section
101(a) of the CPSIA; or an exclusion of
a commodity or class of materials or a
specific material or product under
section 101(b), that exceeds the lead
content limits under section 101(a), but
which will not result in the absorption
of any lead into the human body nor
have any other adverse impact on public
health or safety. This notice sets out and
solicits comments on proposed
procedures and requirements and
information to be supplied with such
requests.
DATES: Written comments and
submissions in response to this notice
must be received by February 17, 2009.
ADDRESSES: Comments on the proposed
procedures and requirements for
Commission determinations that
specific materials or products do not
exceed the lead content limits should be
e-mailed to
Sec101Determinations@cpsc.gov.
Comments should be captioned
‘‘Section 101(a) Determinations.’’
Comments on the proposed procedures
and requirements for Commission
decisions on requests for exclusions
under section 101(b) should be e-mailed
to Sec101Exclusions@cpsc.gov.
Comments should be captioned
‘‘Section 101(b) Exclusions.’’ Comments
may also be mailed, preferably in five
copies, to the Office of the Secretary,
Consumer Product Safety Commission,
Room 502, 4330 East West Highway,
Bethesda, Maryland 20814, or delivered
to the same address (telephone (301)
504–7923). Comments also may be filed
by facsimile to (301) 504–0127.
Comments on the Paperwork
Reduction Act burdens posed by these
proposals should be directed to the Desk
Officer for the Consumer Product Safety
Commission, Office of Information and
Regulatory Affairs, OMB, Washington,
DC 20503. The Commission asks
commenters to provide copies of such
comments to the Commission’s Office of
the Secretary, with a caption or cover
letter identifying the materials as
comments submitted to OMB on the
proposed collection of information
requirements in the proposed
procedures and requirements under
sections 101(a) and (b) of the CPSIA.
FOR FURTHER INFORMATION CONTACT:
Kristina Hatlelid, PhD, M.P.H.,
Directorate for Health Sciences,
Consumer Product Safety Commission,
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4330 East West Highway, Bethesda,
Maryland 20814; telephone (301) 504–
7254; e-mail khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA establishes specific limits
on lead in children’s products. Section
101(a) of the CPSIA provides that by
February 10, 2009, products designed or
intended primarily for children 12 and
younger may not contain more than 600
ppm of lead. After August 14, 2009,
products designed or intended primarily
for children 12 and younger cannot
contain more than 300 ppm of lead. On
August 14, 2011, the limit may be
further reduced to 100 ppm unless the
Commission determines that it is not
technologically feasible to have this
lower limit. Paint, coatings or
electroplating may not be considered a
barrier that would make the lead
content of a product inaccessible to a
child.
B. Legal Considerations
1. Materials or Products That Do Not
Exceed the Lead Limits
Under section 101(a) of CPSIA,
consumer products designed or
intended primarily for children 12 years
old and younger that do not contain
more than 600 ppm of lead (as of
February 10, 2009), 300 ppm of lead (as
of August 14, 2009); 100 ppm after three
years (as of August 14, 2011), unless the
Commission determines that it is not
technologically feasible to have this
lower limit, are not considered to be
banned hazardous substances under the
Federal Hazardous Substances Act
(FHSA). However, in the absence of
Commission action, children’s products
remain subject to the testing
requirements of section 102 of the
CPSIA (codified at § 14 of the Consumer
Product Safety Act (CPSA)).
Under these provisions, for children’s
products manufactured on and after
February 10, 2009, general conformity
certificates certifying that they comply
with the applicable lead content limit
are required. The certification must be
based on tests of each product or a
reasonable testing program. On and after
August 14, 2009, absent Commission
action to the contrary, the certificates
must be based on testing performed by
a third-party laboratory whose
accreditation to perform the testing has
been accepted by the Commission.
Comments submitted to the Commission
suggest that these testing and
certification requirements will result in
significant expense for products that
may be inherently free of lead or
dangerous lead levels.
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Section 3 of the CPSIA grants the
Commission general rulemaking
authority to issue regulations, as
necessary, to implement the CPSIA.
There may be certain commodities or
classes of products or materials that
inherently do not contain lead or
contain lead at levels that would not
exceed the lead content limits under
section 101(a) of the CPSIA. To the
extent that such materials or products
exist, the Commission, either of its own
initiative or upon the request of an
interested person, is proposing to
exercise its CPSIA section 3 authority to
make determinations that certain
commodities or classes of material or
products do not exceed the lead limits
of section 101(a). This rule proposes a
procedure by which the Commission
will address requests for determinations
that these types of materials or products
do not and would not exceed the lead
limits. The effect of such a Commission
finding would be to relieve that material
or product from the testing requirement
of section 102 for purposes of
supporting the required certification.
If this proposal is issued in final form,
the Commission would concentrate its
efforts on evaluating those materials that
are commodity-like, are used across
industry in a number of applications,
and are subject to detailed consensus
standards related to lead content and
other pertinent properties. Given the
Commission’s resources, requests to
evaluate individual products of a single
manufacturer would be assigned a very
low priority.
Of course even where a material or
product has been so relieved of the
testing requirement, it must still meet
the statutory lead level requirements in
actual fact. The Commission will obtain
and test products in the marketplace to
assure that this remains the case and
will take appropriate enforcement
action in situations where that is not the
case.
2. Materials or Products That Exceed the
Lead Limits
The Commission is also proposing
procedures to address requests for
exclusions for certain products or
materials that exceed the lead content
limits in section 101(a). Section
101(b)(1) of the CPSIA provides that the
Commission may, by regulation,
exclude a specific product or material
that exceeds the lead limits established
for children’s products under section
101(a) if the Commission, after notice
and a hearing, determines on the basis
of the best-available, objective, peerreviewed, scientific evidence that lead
in such product or material will neither
(a) result in the absorption of any lead
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into the human body, taking into
account normal and reasonably
foreseeable use and abuse of such
product by a child, including
swallowing, mouthing, breaking, or
other children’s activities, and the aging
of the product; nor (b) have any other
adverse impact on public health or
safety.
Under section 101(b) of the CPSIA,
the Commission is required to provide
notice and a hearing to consider and
evaluate the best-available, objective,
peer-reviewed, scientific data before
promulgating a rule on exclusions.
Section 553 of the Administrative
Procedure Act (APA), provides that after
notice, the agency must give interested
persons an opportunity to participate in
the rule making through submission of
written data, views, or arguments with
or without opportunity for oral
presentation. 5 U.S.C. 553(c). Section
101(b) does not require a ‘‘hearing on
the record,’’ which would trigger more
extensive procedural requirements
under the APA. Accordingly, for this
matter the Commission has determined
that an oral hearing is not necessary to
satisfy the requirements of due process.1
Given the highly technical nature of the
information sought—peer-reviewed,
scientific data—the Commission
believes that the APA notice and
comment procedures based on written
submissions would provide the most
efficient process for obtaining the
required information as well as provide
adequate opportunity for all interested
parties to participate in the proceedings.
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C. Procedures and Requirements
1. Inherent Lead Content Level
Determination
Any request for a Commission
determination that a specific material or
product contains no lead or a lead level
below the applicable statutory limit
must be supported by objectively
reasonable and representative test
results or other scientific evidence
showing that the product or material
does not, and would not, exceed the
lead limit specified in the request.
A justification submitted by an
interested party for a determination
must include a detailed description of
the product or material; data on the lead
content of parts of the product or the
materials used in the production of a
product; data or information on
manufacturing processes through which
1 The Supreme Court has held that paper hearing
procedures are adequate where, in the total context
of the process, they are deemed to ensure adequate
notice and a genuine opportunity to explain one’s
case. Mathews v. Eldridge, 424 U.S. 319, 334–35
(1976). See also United States v. Florida East Coast
Railway Co., 410 U.S. 224, 238–41(1973).
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lead may be introduced into the product
or material; any other information
relevant to the potential for the lead
content of the product or material to
exceed the statutory lead limit specified
in the request, that is 600 ppm, 300
ppm, or 100 ppm, as applicable; and
detailed information on the test
methods used to support such data,
including the type of equipment used
and any other techniques employed, as
well as a statement as to why the data
is representative of the lead content of
such products or materials generally
and why the assessment of the
manufacturing processes strongly
supports a conclusion that they would
not be a source of lead contamination of
the product or material, if relevant.
MSDS sheets will not be sufficient to
satisfy the representative testing criteria
because they do not show sufficient
information regarding lead content.
Rather, the showing necessary to obtain
an exclusion must be based on
objectively reasonable and
representative testing of the material or
product.
As noted above, given the potential
number of requests for determinations
that might be submitted to the
Commission, the Commission would
evaluate industry-wide applications for
commodities or classes of materials or
products based on technical
specifications or other data suggesting
that the generic commodity or class of
materials is representative of that used
by a number of manufacturers before it
will review any brand specific products
or proprietary formulas from individual
manufacturers. The type of materials or
product classes that the Commission
considers may fall within the class for
priority evaluation might include, but
not be limited to, materials such as
paper, vegetable dyes, inks, adhesives,
fabrics, and the like, provided that
adequate documentation of the
technical specifications of the materials
or products such that they are
representative of a broad class and
testing data is provided as to those
generic products. In time, the
Commission would apply the same
criteria on a product by product or
material by material basis, if necessary,
and provided it has the resources to do
so.
Upon receipt of a complete request for
a determination, the Commission
proposes to direct the Office of Hazard
Identification and Reduction to assess
the request and make an initial
determination. If the recommendation is
to grant the exclusion, the Commission
will publish a notice of proposed
rulemaking inviting public comment on
whether the determination should be
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granted in final form, and the Office of
Hazard Identification and Reduction
will review and evaluate the comments
and supporting documentation before
making its recommendation to the
Commission for final agency action.
2. Exclusion of a Material or Product
Exceeding Lead Content Limit
For products that exceed the lead
content limits prescribed in section
101(a) of the CPSIA, the Commission
proposes procedures that will allow the
Commission to evaluate products or
materials for possible exclusions under
section 101(b)(1) of the CPSIA. Under
this section, such evaluations must be
based on the best-available, objective,
peer-reviewed, scientific evidence
showing that lead in such product or
material will not result in the absorption
of any lead into the body, taking into
account normal and reasonable
foreseeable use and abuse by a child,
nor have any other adverse impact on
health or safety. Therefore, a request for
an exclusion must be supported by the
best-available, objective, peer-reviewed,
scientific evidence that address these
issues, such as test results indicating
how much lead is present in the
product, how much lead comes out of
the product and the conditions under
which that may happen, and
information relating to a child’s
interaction, if any, with the product.2
Upon receipt of a complete exclusion
request, the Commission proposes to
direct the Office of Hazard Identification
and Reduction to assess the request and
make an initial determination. If the
recommendation is to grant the
exclusion, the Commission will publish
a notice of proposed rulemaking
inviting public comment on whether the
exclusion should be issued in final
form, and the Office of Hazard
Identification and Reduction will
review and evaluate the comments and
supporting documentation before
making its recommendation to the
Commission for final agency action.
D. Effect of Filing a Lead Content
Determination or Exclusion Request
The filing of a request for a lead
content determination or for an
exclusion would not have the effect of
automatically staying the effect of any
provision or limit under the statutes and
regulations enforced by the
Commission. Unless issued in final form
by the Commission after notice and
comment, all CPSC requirements related
to the lead content in the material or
2 The Commission notes that the statutory
language of section 101(b)(1) makes it difficult to
make a showing that would be adequate to exclude
any material or product on that basis.
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G. Executive Orders
According to Executive Order 12988
(February 5, 1996), agencies must state
in clear language the preemptive effect,
if any, of new regulations. The
preemptive effect of regulations such as
this proposal is stated in section 18 of
the FHSA. 15 U.S.C. 1261n.
exclusion, the proposed rule contains
‘‘collection of information
requirements’’ as that term is used in
the Paperwork Reduction Act, 44 U.S.C.
3501–3520. Therefore, the proposed rule
is being submitted to the Office of
Management and Budget (OMB) in
accordance with 44 U.S.C. 3507(d) and
implementing regulations codified at 5
CFR 1320.11. The estimated costs of
these requirements will depend on the
number of requests that are received by
the Commission.
The number of manufacturers or
importers that might seek a
determination that their products or
materials do not contain lead or exceed
the lead content limits or that might
seek an exclusion from the lead-content
requirements for their product is not
currently known. The requirements for
obtaining a determination or exclusion
are extensive, which may be a deterrent
to some firms; however, because a very
broad range of products, materials and
components are affected by the lead
content limits, the number of firms
seeking such determinations or
exclusions could be higher than
expected. It would be expected that the
firms making such requests would be
familiar with the product or material for
which the determination or exemption
is sought and the required information
may already be in the firm’s possession
or easily obtainable.
Based on comments received on the
CPSIA lead content provisions thus far,
staff estimates that a minimum of
approximately 250 firms may submit
requests. The burden to assemble the
information and prepare the
submission, if performed by a senior
level management employee, may take
approximately 40 hours. The
compensation would be approximately
$60 an hour (U.S. Department of Labor,
Bureau of Labor Statistics), and the
average cost of preparing a submission
would be about $2,400 ($60 × 40). An
estimate of the annual burden for the
information collection could reach
$600,000.
An estimate of the burden on the
federal government to review each
submission could be as much as 24
hours at an average hourly wage of $56,
the equivalent of a GS–14 employee, or
$1,344 for each submission ($56 × 24).
If approximately 250 submissions are
received, the cost of the annual burden
to the federal government will be
approximately $336,000.
H. Paperwork Reduction Act
Since the proposed rule would
require manufacturers to provide certain
information along with any request for
a Commission determination or
I. Effective Date
The APA generally requires that a
substantive rule be published not less
than 30 days before its effective date,
unless the agency finds for good cause
product and all applicable testing and
certification requirements would remain
in full force and effect. CPSIA § 101(e).
However, the Commission’s ability to
exercise its enforcement discretion is
not eliminated nor diminished.
E. Impact on Small Businesses
Under the Regulatory Flexibility Act
(RFA), when an agency issues a
proposed rule, it generally must prepare
an initial regulatory flexibility analysis
describing the impact the proposed rule
is expected to have on small entities. 5
U.S.C. 603. The RFA does not require a
regulatory flexibility analysis if the head
of the agency certifies that the rule will
not have a significant effect on a
substantial number of small entities.
The Commission’s Directorate for
Economic Analysis prepared a
preliminary assessment of the impact of
relieving certain materials or products
from the testing requirements of section
102 of the CPSIA. That assessment
found that the procedures and
requirements would only impact those
firms that wish to seek a formal
Commission determination or exclusion
from the requirements. Its only potential
effect on businesses, including small
businesses, will be to reduce the costs
that would have been associated with
testing the materials under section 102
of the CPSIA, if the request is granted.
Based on the foregoing assessment, the
Commission preliminarily finds that the
proposed rule would not have a
significant impact on a substantial
number of small entities.
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F. Environmental Considerations
Generally, CPSC rules are considered
to ‘‘have little or no potential for
affecting the human environment,’’ and
environmental assessments are not
usually prepared for these rules (see 16
CFR 1021.5(c)(1)). The proposed rule
will not result in any additional use of
lead over what is occurring at the
present time. Therefore, the
Commission does not expect the
proposal to have any negative
environmental impact.
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shown, that a lesser time period is
required. 5 U.S.C. 553(d)(3). Because the
Commission recognizes the need for
providing procedures for Commission
determinations and exclusions
expeditiously, for good cause shown,
the proposed effective date is the date
of publication of a final rule in the
Federal Register.
J. List of Relevant Documents
(1) Memorandum from Kristina M.
Hatlelid, PhD, M.P.H., Toxicologist,
Directorate for Health Sciences
‘‘Consumer Product Safety Improvement
Act of 2008 (CPSIA): Exclusions from
Compliance with Limits for Lead,
Certain Materials of Products: Required
Technical Information.’’ December
2008.
(2) Memorandum from Robert
Franklin, Economist, Directorate for
Economic Analysis, ‘‘Procedures for
Determinations Regarding Lead Limits
and Procedures for Exclusions from
Lead Limits Under Section 101 of the
Consumer Product Safety Improvement:
Small Business and Environmental
Impacts.’’ December 2008.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous
materials, Hazardous substances,
Imports, Infants and children, Labeling,
Law enforcement, and Toys.
K. Conclusion
For the reasons stated above, the
Commission proposes to amend title 16
of the Code of Federal Regulations as
follows:
PART 1500—HAZARDOUS
SUBSTANCES AND ARTICLES:
ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority for part 1500 is
amended to read as follows:
Authority: 15 U.S.C. 1261–1278, 122 Stat.
3016.
2. Add new §§ 1500.89 and 1500.90 to
read as follows:
§ 1500.89 Procedures for Determinations
Regarding Lead Content of Materials or
Products under Section 101(a) of the
Consumer Product Safety Improvement Act.
(a) The Consumer Product Safety
Improvement Act provides for specific
lead limits in children’s products.
Section 101(a) of the CPSIA provides
that by February 10, 2009, products
designed or intended primarily for
children 12 and younger may not
contain more than 600 ppm of lead.
After August 14, 2009, products
designed or intended primarily for
children 12 and younger cannot contain
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more than 300 ppm of lead. On August
14, 2011, the limit may be further
reduced to 100 ppm, unless the
Commission determines that it is not
technologically feasible to meet this
lower limit. Paint, coatings or
electroplating may not be considered a
barrier that would make the lead
content of a product inaccessible to a
child.
(b) The Commission may, either on its
own initiative or upon the request of
any interested person, make a
determination that a material or product
does not contain lead levels that exceed
600 ppm, 300 ppm or 100 ppm.
(c) To request a determination under
paragraph (b) of this section, the request
must:
(1) Be e-mailed to cpsc-os@cpsc.gov
and titled ‘‘Section 101 Request for Lead
Content Determination.’’ Requests may
also be mailed, preferably in five copies,
to the Office of the Secretary, Consumer
Product Safety Commission, Room 502,
4330 East-West Highway, Bethesda,
Maryland 20814, or delivered to the
same address.
(2) Be written in the English language.
(3) Contain the name and address, and
e-mail address or telephone number, of
the requestor.
(4) Provide Documentation including:
(i) A detailed description of the
product or material;
(ii) Data on the lead content of parts
of the product or materials used in the
production of a product;
(iii) Data or information on
manufacturing processes through which
lead may be introduced into the product
or material;
(iv) Any other information relevant to
the potential for lead content of the
product or material to exceed the CPSIA
lead limits that is reasonably available
to the requestor;
(v) Detailed information on the relied
upon test methods for measuring lead
content of products or materials
including the type of equipment used or
any other techniques employed and a
statement as to why the data is
representative of the lead content of
such products or materials generally;
and
(vi) An assessment of the
manufacturing processes which strongly
supports a conclusion that they would
not be a source of lead contamination of
the product or material, if relevant.
(d) Where a submission fails to meet
all of the requirements of paragraph (c)
of this section, the Office of the
Secretary shall notify the person
submitting it, describe the deficiency,
and explain that the request may be
resubmitted when the deficiency is
corrected.
VerDate Nov<24>2008
17:02 Jan 14, 2009
Jkt 217001
(e) Each complete request for a
Commission determination will be
reviewed by the Office of Hazard
Identification and Reduction who will
preliminarily recommend granting or
denying the request. Where the
preliminary determination is to grant,
the Commission will publish a notice of
proposed rulemaking inviting public
comment on whether the preliminary
determination should be granted in final
form, and the Office of Hazard
Identification and Reduction will
review and evaluate the comments and
supporting documentation before
making its recommendation to the
Commission for final agency action.
(f) The filing of a request for a
determination does not have the effect
of automatically staying the effect of any
provision or limit under the statutes and
regulations enforced by the
Commission. Even though a request for
a determination has been filed, unless a
Commission determination is issued in
final form after notice and comment,
materials or products subject to the lead
limits under section 101 of the CPSIA
must be tested in accordance with
section 102 of the CPSIA.
§ 1500.90 Procedures for Exclusions from
Lead Limits under Section 101(b) of the
Consumer Product Safety Improvement Act.
(a) The Consumer Product Safety
Improvement Act provides for specific
lead limits in children’s products.
Section 101(a) of the CPSIA provides
that by February 10, 2009, products
designed or intended primarily for
children 12 and younger may not
contain more than 600 ppm of lead.
After August 14, 2009, products
designed or intended primarily for
children 12 and younger cannot contain
more than 300 ppm of lead. On August
14, 2011, the limit may be further
reduced to 100 ppm, unless the
Commission determines that it is not
technologically feasible to have this
lower limit. Paint, coatings or
electroplating may not be considered a
barrier that would make the lead
content of a product inaccessible to a
child.
(b) Section 101(b)(1) of the CPSIA
provides that the Commission may
exclude a specific product or material
from the lead limits established for
children’s products under the CPSIA if
the Commission, after notice and a
hearing, determines on the basis of the
best-available, objective, peer-reviewed,
scientific evidence that lead in such
product or material will neither:
(1) Result in the absorption of any
lead into the human body, taking into
account normal and reasonably
foreseeable use and abuse of such
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
product by a child, including
swallowing, mouthing, breaking, or
other children’s activities, and the aging
of the product; nor
(2) Have any other adverse impact on
public health or safety.
(c) To request an exclusion from the
lead limits as provided under paragraph
(a) of this section, the request must:
(1) Be e-mailed to cpsc-os@cpsc.gov.
and titled ‘‘Section 101 Request for
Exclusion of a Material or Product.’’
Requests may also be mailed, preferably
in five copies, to the Office of the
Secretary, Consumer Product Safety
Commission, Room 502, 4330 East West
Highway, Bethesda, Maryland 20814, or
delivered to the same address.
(2) Be written in the English language.
(3) Contain the name and address, and
e-mail address or telephone number, of
the requester.
(4) Provide Documentation including:
(i) A detailed description of the
product or material;
(ii) Data on the lead content of parts
of the product or materials used in the
production of a product;
(iii) Data or information on
manufacturing processes through which
lead may be introduced into the product
or material;
(iv) Any other information relevant to
the potential for lead content of the
product or material to exceed the CPSIA
lead limits that is reasonably available
to the requestor;
(v) Detailed information on the relied
upon test methods for measuring lead
content of products or materials
including the type of equipment used or
any other techniques employed and a
statement as to why the data is
representative of the lead content of
such products or materials generally;
and
(vi) An assessment of the
manufacturing processes which strongly
supports a conclusion that they would
not be a source of lead contamination of
the product or material, if relevant.
(5) Provide best-available, objective,
peer-reviewed, scientific evidence to
support a request for an exclusion that
addresses how much lead is present in
the product, how much lead comes out
of the product, and the conditions under
which that may happen, and
information relating to a child’s
interaction, if any, with the product.
(6) Provide best-available, objective,
peer-reviewed, scientific evidence that
is unfavorable to the request that is
reasonably available to the requestor.
(d) Where a submission fails to meet
all of the requirements of paragraph (c)
of this section, the Office of the
Secretary shall notify the person
submitting it, describe the deficiency,
E:\FR\FM\15JAP1.SGM
15JAP1
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules
and explain that the request may be
resubmitted when the deficiency is
corrected.
(e) Each complete request for
exclusion will be reviewed by the Office
of Hazard Identification and Reduction,
who will preliminarily recommend
granting or denying the request. Where
the preliminary determination is to
grant, the Commission will publish a
notice of proposed rulemaking inviting
public comment on whether the
proposed exclusion should be issued in
final form, and the Office of Hazard
Identification and Reduction will
review and evaluate the comments and
supporting documentation before
making its recommendation to the
Commission for final agency action.
(f) The filing of a request for exclusion
does not have the effect of automatically
staying the effect of any provision or
limit under the statutes and regulations
enforced by the Commission. Even
though a request for an exclusion has
been filed, unless an exclusion is issued
in final form by the Commission after
notice and comment, materials or
products subject to the lead limits under
section 101 of the CPSIA are considered
to be banned hazardous substances if
they do not meet the lead limits.
Dated: January 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. E9–715 Filed 1–14–09; 8:45 am]
BILLING CODE 6335–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1500
Children’s Products Containing Lead;
Proposed Determinations Regarding
Lead Content Limits on Certain
Materials or Products; Notice of
Proposed Rulemaking
mstockstill on PROD1PC66 with PROPOSALS
AGENCY: Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
SUMMARY: On August 14, 2008, Congress
enacted the Consumer Product Safety
Improvement Act of 2008 (CPSIA),
Public Law 110–314, 122 Stat. 3016.
This notice of proposed rulemaking
(NPR) initiates a proceeding under
section 3 of the CPSIA authorizing the
Commission to issue regulations, as
necessary, to implement the CPSIA. In
this document, the Commission solicits
written comments concerning
preliminary determinations on certain
natural, untreated and unadulterated
materials and metals that have not been
VerDate Nov<24>2008
17:02 Jan 14, 2009
Jkt 217001
found to exceed the lead content limits
prescribed under section 101(a) of the
CPSIA.
DATES: Written comments and
submissions in response to this notice
must be received by February 17, 2009.
ADDRESSES: Comments should be
e-mailed to
Sec101Determinations@cpsc.gov.
Comments should be captioned
‘‘Section 101 Determinations of Certain
Materials or Products NPR.’’ Comments
may also be mailed, preferably in five
copies, to the Office of the Secretary,
Consumer Product Safety Commission,
Room 502, 4330 East West Highway,
Bethesda, Maryland 20814, or delivered
to the same address (telephone (301)
504–7923). Comments also may be filed
by facsimile to (301) 504–0127.
FOR FURTHER INFORMATION CONTACT:
Kristina Hatlelid, PhD, M.P.H.,
Directorate for Health Sciences,
Consumer Product Safety Commission,
4330 East West Highway, Bethesda,
Maryland 20814; telephone (301) 504–
7254, e-mail khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
Under section 101(a) of CPSIA,
consumer products designed or
intended primarily for children 12 years
old and younger that do not contain
more than 600 ppm of lead (as of
February 10, 2009), 300 ppm of lead (as
of August 14, 2009); 100 ppm after three
years (as of August 14, 2011), unless the
Commission determines that it is not
technologically feasible to have this
lower limit, are not considered to be
banned hazardous substances under the
Federal Hazardous Substances Act
(FHSA). However, in the absence of
Commission action, these products and
materials remain subject to the testing
requirements of section 102 of the
CPSIA (codified at § 14 of the Consumer
Product Safety Act (CPSA)).
Under these provisions, on and after
February 10, 2009, general conformity
certificates certifying that they comply
with the applicable lead content limit
are required for children’s products. The
certification must be based on tests of
each product or a reasonable testing
program. On and after August 14, 2009,
absent Commission action to the
contrary, the certificates must be based
on testing performed by a laboratory
whose accreditation to perform the
testing has been accepted by the
Commission.
Section 3 of the CPSIA grants the
Commission general rulemaking
authority to issue regulations, as
necessary, to implement the CPSIA.
There may be certain products or
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
2433
materials that inherently do not contain
lead or contain lead at levels that do not
exceed the lead content limits under
section 101(a) of the CPSIA. To the
extent that such materials or products
exist, the Commission, of its own
initiative, is proposing to exercise its
section 3 authority to make preliminary
determinations that certain commodities
or classes of materials or products do
not exceed the lead limits prescribed in
section 101(a) of the CPSIA. The effect
of such a Commission finding would be
to relieve the material or product from
the testing requirement of section 102 of
the CPSIA for purposes of supporting
the required certification. Of course
even where a material or product has
been so relieved of the testing
requirement, it must still meet the
statutory lead level requirements in
actual fact. The Commission will obtain
and test products in the marketplace to
assure that this remains the case and
will take appropriate enforcement
action in situations where that is not the
case.
B. Proposed Determinations on Certain
Products and Materials
The Commission staff identified a
number of commodities or classes of
materials that do not inherently contain
lead or contain lead that does not
exceed the CPSIA lead limits of 600
ppm or 300 ppm.
Certain Natural Materials
Based on the staff’s review, the
Commission preliminarily determines
that the following natural materials do
not exceed the 600 ppm or 300 ppm
lead content limits under section 101(a)
of the CPSIA. These preliminary
determinations are based on materials
that are untreated and unadulterated
with respect to the addition of materials
or chemicals, including pigments, dyes,
coatings, finishes or any other
substance, and that do not undergo any
processing that could result in the
addition of lead into the product or
material:
1. Precious gemstones: Diamond,
ruby, sapphire, emerald
2. Certain semiprecious gemstones
provided that the mineral or material is
not based on lead or lead compounds
and is not associated in nature with any
mineral that is based on lead or lead
compounds (minerals that contain lead
or are associated in nature with
minerals that contain lead include, but
are not limited to, the following:
Aragonite, bayldonite, boleite, cerussite,
crocoite, linarite, mimetite, phosgenite,
vanadinite, and wulfenite)
3. Natural or cultured pearls
4. Wood
E:\FR\FM\15JAP1.SGM
15JAP1
]]>Agencies
[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Proposed Rules]
[Pages 2428-2433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-715]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Children's Products Containing Lead; Notice of Proposed
Procedures and Requirements for a Commission Determination or Exclusion
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed procedures and requirements.
-----------------------------------------------------------------------
SUMMARY: On August 14, 2008, Congress enacted the Consumer Product
Safety
[[Page 2429]]
Improvement Act of 2008 (CPSIA), Public Law 110-314. The Commission
proposes to establish procedures and requirements for: A Commission
determination that a commodity or class of materials or a specific
material or product does not exceed the lead content limits specified
under section 101(a) of the CPSIA; or an exclusion of a commodity or
class of materials or a specific material or product under section
101(b), that exceeds the lead content limits under section 101(a), but
which will not result in the absorption of any lead into the human body
nor have any other adverse impact on public health or safety. This
notice sets out and solicits comments on proposed procedures and
requirements and information to be supplied with such requests.
DATES: Written comments and submissions in response to this notice must
be received by February 17, 2009.
ADDRESSES: Comments on the proposed procedures and requirements for
Commission determinations that specific materials or products do not
exceed the lead content limits should be e-mailed to
Sec101Determinations@cpsc.gov. Comments should be captioned ``Section
101(a) Determinations.'' Comments on the proposed procedures and
requirements for Commission decisions on requests for exclusions under
section 101(b) should be e-mailed to Sec101Exclusions@cpsc.gov.
Comments should be captioned ``Section 101(b) Exclusions.'' Comments
may also be mailed, preferably in five copies, to the Office of the
Secretary, Consumer Product Safety Commission, Room 502, 4330 East West
Highway, Bethesda, Maryland 20814, or delivered to the same address
(telephone (301) 504-7923). Comments also may be filed by facsimile to
(301) 504-0127.
Comments on the Paperwork Reduction Act burdens posed by these
proposals should be directed to the Desk Officer for the Consumer
Product Safety Commission, Office of Information and Regulatory
Affairs, OMB, Washington, DC 20503. The Commission asks commenters to
provide copies of such comments to the Commission's Office of the
Secretary, with a caption or cover letter identifying the materials as
comments submitted to OMB on the proposed collection of information
requirements in the proposed procedures and requirements under sections
101(a) and (b) of the CPSIA.
FOR FURTHER INFORMATION CONTACT: Kristina Hatlelid, PhD, M.P.H.,
Directorate for Health Sciences, Consumer Product Safety Commission,
4330 East West Highway, Bethesda, Maryland 20814; telephone (301) 504-
7254; e-mail khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
The CPSIA establishes specific limits on lead in children's
products. Section 101(a) of the CPSIA provides that by February 10,
2009, products designed or intended primarily for children 12 and
younger may not contain more than 600 ppm of lead. After August 14,
2009, products designed or intended primarily for children 12 and
younger cannot contain more than 300 ppm of lead. On August 14, 2011,
the limit may be further reduced to 100 ppm unless the Commission
determines that it is not technologically feasible to have this lower
limit. Paint, coatings or electroplating may not be considered a
barrier that would make the lead content of a product inaccessible to a
child.
B. Legal Considerations
1. Materials or Products That Do Not Exceed the Lead Limits
Under section 101(a) of CPSIA, consumer products designed or
intended primarily for children 12 years old and younger that do not
contain more than 600 ppm of lead (as of February 10, 2009), 300 ppm of
lead (as of August 14, 2009); 100 ppm after three years (as of August
14, 2011), unless the Commission determines that it is not
technologically feasible to have this lower limit, are not considered
to be banned hazardous substances under the Federal Hazardous
Substances Act (FHSA). However, in the absence of Commission action,
children's products remain subject to the testing requirements of
section 102 of the CPSIA (codified at Sec. 14 of the Consumer Product
Safety Act (CPSA)).
Under these provisions, for children's products manufactured on and
after February 10, 2009, general conformity certificates certifying
that they comply with the applicable lead content limit are required.
The certification must be based on tests of each product or a
reasonable testing program. On and after August 14, 2009, absent
Commission action to the contrary, the certificates must be based on
testing performed by a third-party laboratory whose accreditation to
perform the testing has been accepted by the Commission. Comments
submitted to the Commission suggest that these testing and
certification requirements will result in significant expense for
products that may be inherently free of lead or dangerous lead levels.
Section 3 of the CPSIA grants the Commission general rulemaking
authority to issue regulations, as necessary, to implement the CPSIA.
There may be certain commodities or classes of products or materials
that inherently do not contain lead or contain lead at levels that
would not exceed the lead content limits under section 101(a) of the
CPSIA. To the extent that such materials or products exist, the
Commission, either of its own initiative or upon the request of an
interested person, is proposing to exercise its CPSIA section 3
authority to make determinations that certain commodities or classes of
material or products do not exceed the lead limits of section 101(a).
This rule proposes a procedure by which the Commission will address
requests for determinations that these types of materials or products
do not and would not exceed the lead limits. The effect of such a
Commission finding would be to relieve that material or product from
the testing requirement of section 102 for purposes of supporting the
required certification.
If this proposal is issued in final form, the Commission would
concentrate its efforts on evaluating those materials that are
commodity-like, are used across industry in a number of applications,
and are subject to detailed consensus standards related to lead content
and other pertinent properties. Given the Commission's resources,
requests to evaluate individual products of a single manufacturer would
be assigned a very low priority.
Of course even where a material or product has been so relieved of
the testing requirement, it must still meet the statutory lead level
requirements in actual fact. The Commission will obtain and test
products in the marketplace to assure that this remains the case and
will take appropriate enforcement action in situations where that is
not the case.
2. Materials or Products That Exceed the Lead Limits
The Commission is also proposing procedures to address requests for
exclusions for certain products or materials that exceed the lead
content limits in section 101(a). Section 101(b)(1) of the CPSIA
provides that the Commission may, by regulation, exclude a specific
product or material that exceeds the lead limits established for
children's products under section 101(a) if the Commission, after
notice and a hearing, determines on the basis of the best-available,
objective, peer-reviewed, scientific evidence that lead in such product
or material will neither (a) result in the absorption of any lead
[[Page 2430]]
into the human body, taking into account normal and reasonably
foreseeable use and abuse of such product by a child, including
swallowing, mouthing, breaking, or other children's activities, and the
aging of the product; nor (b) have any other adverse impact on public
health or safety.
Under section 101(b) of the CPSIA, the Commission is required to
provide notice and a hearing to consider and evaluate the best-
available, objective, peer-reviewed, scientific data before
promulgating a rule on exclusions. Section 553 of the Administrative
Procedure Act (APA), provides that after notice, the agency must give
interested persons an opportunity to participate in the rule making
through submission of written data, views, or arguments with or without
opportunity for oral presentation. 5 U.S.C. 553(c). Section 101(b) does
not require a ``hearing on the record,'' which would trigger more
extensive procedural requirements under the APA. Accordingly, for this
matter the Commission has determined that an oral hearing is not
necessary to satisfy the requirements of due process.\1\ Given the
highly technical nature of the information sought--peer-reviewed,
scientific data--the Commission believes that the APA notice and
comment procedures based on written submissions would provide the most
efficient process for obtaining the required information as well as
provide adequate opportunity for all interested parties to participate
in the proceedings.
---------------------------------------------------------------------------
\1\ The Supreme Court has held that paper hearing procedures are
adequate where, in the total context of the process, they are deemed
to ensure adequate notice and a genuine opportunity to explain one's
case. Mathews v. Eldridge, 424 U.S. 319, 334-35 (1976). See also
United States v. Florida East Coast Railway Co., 410 U.S. 224, 238-
41(1973).
---------------------------------------------------------------------------
C. Procedures and Requirements
1. Inherent Lead Content Level Determination
Any request for a Commission determination that a specific material
or product contains no lead or a lead level below the applicable
statutory limit must be supported by objectively reasonable and
representative test results or other scientific evidence showing that
the product or material does not, and would not, exceed the lead limit
specified in the request.
A justification submitted by an interested party for a
determination must include a detailed description of the product or
material; data on the lead content of parts of the product or the
materials used in the production of a product; data or information on
manufacturing processes through which lead may be introduced into the
product or material; any other information relevant to the potential
for the lead content of the product or material to exceed the statutory
lead limit specified in the request, that is 600 ppm, 300 ppm, or 100
ppm, as applicable; and detailed information on the test methods used
to support such data, including the type of equipment used and any
other techniques employed, as well as a statement as to why the data is
representative of the lead content of such products or materials
generally and why the assessment of the manufacturing processes
strongly supports a conclusion that they would not be a source of lead
contamination of the product or material, if relevant. MSDS sheets will
not be sufficient to satisfy the representative testing criteria
because they do not show sufficient information regarding lead content.
Rather, the showing necessary to obtain an exclusion must be based on
objectively reasonable and representative testing of the material or
product.
As noted above, given the potential number of requests for
determinations that might be submitted to the Commission, the
Commission would evaluate industry-wide applications for commodities or
classes of materials or products based on technical specifications or
other data suggesting that the generic commodity or class of materials
is representative of that used by a number of manufacturers before it
will review any brand specific products or proprietary formulas from
individual manufacturers. The type of materials or product classes that
the Commission considers may fall within the class for priority
evaluation might include, but not be limited to, materials such as
paper, vegetable dyes, inks, adhesives, fabrics, and the like, provided
that adequate documentation of the technical specifications of the
materials or products such that they are representative of a broad
class and testing data is provided as to those generic products. In
time, the Commission would apply the same criteria on a product by
product or material by material basis, if necessary, and provided it
has the resources to do so.
Upon receipt of a complete request for a determination, the
Commission proposes to direct the Office of Hazard Identification and
Reduction to assess the request and make an initial determination. If
the recommendation is to grant the exclusion, the Commission will
publish a notice of proposed rulemaking inviting public comment on
whether the determination should be granted in final form, and the
Office of Hazard Identification and Reduction will review and evaluate
the comments and supporting documentation before making its
recommendation to the Commission for final agency action.
2. Exclusion of a Material or Product Exceeding Lead Content Limit
For products that exceed the lead content limits prescribed in
section 101(a) of the CPSIA, the Commission proposes procedures that
will allow the Commission to evaluate products or materials for
possible exclusions under section 101(b)(1) of the CPSIA. Under this
section, such evaluations must be based on the best-available,
objective, peer-reviewed, scientific evidence showing that lead in such
product or material will not result in the absorption of any lead into
the body, taking into account normal and reasonable foreseeable use and
abuse by a child, nor have any other adverse impact on health or
safety. Therefore, a request for an exclusion must be supported by the
best-available, objective, peer-reviewed, scientific evidence that
address these issues, such as test results indicating how much lead is
present in the product, how much lead comes out of the product and the
conditions under which that may happen, and information relating to a
child's interaction, if any, with the product.\2\
---------------------------------------------------------------------------
\2\ The Commission notes that the statutory language of section
101(b)(1) makes it difficult to make a showing that would be
adequate to exclude any material or product on that basis.
---------------------------------------------------------------------------
Upon receipt of a complete exclusion request, the Commission
proposes to direct the Office of Hazard Identification and Reduction to
assess the request and make an initial determination. If the
recommendation is to grant the exclusion, the Commission will publish a
notice of proposed rulemaking inviting public comment on whether the
exclusion should be issued in final form, and the Office of Hazard
Identification and Reduction will review and evaluate the comments and
supporting documentation before making its recommendation to the
Commission for final agency action.
D. Effect of Filing a Lead Content Determination or Exclusion Request
The filing of a request for a lead content determination or for an
exclusion would not have the effect of automatically staying the effect
of any provision or limit under the statutes and regulations enforced
by the Commission. Unless issued in final form by the Commission after
notice and comment, all CPSC requirements related to the lead content
in the material or
[[Page 2431]]
product and all applicable testing and certification requirements would
remain in full force and effect. CPSIA Sec. 101(e). However, the
Commission's ability to exercise its enforcement discretion is not
eliminated nor diminished.
E. Impact on Small Businesses
Under the Regulatory Flexibility Act (RFA), when an agency issues a
proposed rule, it generally must prepare an initial regulatory
flexibility analysis describing the impact the proposed rule is
expected to have on small entities. 5 U.S.C. 603. The RFA does not
require a regulatory flexibility analysis if the head of the agency
certifies that the rule will not have a significant effect on a
substantial number of small entities.
The Commission's Directorate for Economic Analysis prepared a
preliminary assessment of the impact of relieving certain materials or
products from the testing requirements of section 102 of the CPSIA.
That assessment found that the procedures and requirements would only
impact those firms that wish to seek a formal Commission determination
or exclusion from the requirements. Its only potential effect on
businesses, including small businesses, will be to reduce the costs
that would have been associated with testing the materials under
section 102 of the CPSIA, if the request is granted. Based on the
foregoing assessment, the Commission preliminarily finds that the
proposed rule would not have a significant impact on a substantial
number of small entities.
F. Environmental Considerations
Generally, CPSC rules are considered to ``have little or no
potential for affecting the human environment,'' and environmental
assessments are not usually prepared for these rules (see 16 CFR
1021.5(c)(1)). The proposed rule will not result in any additional use
of lead over what is occurring at the present time. Therefore, the
Commission does not expect the proposal to have any negative
environmental impact.
G. Executive Orders
According to Executive Order 12988 (February 5, 1996), agencies
must state in clear language the preemptive effect, if any, of new
regulations. The preemptive effect of regulations such as this proposal
is stated in section 18 of the FHSA. 15 U.S.C. 1261n.
H. Paperwork Reduction Act
Since the proposed rule would require manufacturers to provide
certain information along with any request for a Commission
determination or exclusion, the proposed rule contains ``collection of
information requirements'' as that term is used in the Paperwork
Reduction Act, 44 U.S.C. 3501-3520. Therefore, the proposed rule is
being submitted to the Office of Management and Budget (OMB) in
accordance with 44 U.S.C. 3507(d) and implementing regulations codified
at 5 CFR 1320.11. The estimated costs of these requirements will depend
on the number of requests that are received by the Commission.
The number of manufacturers or importers that might seek a
determination that their products or materials do not contain lead or
exceed the lead content limits or that might seek an exclusion from the
lead-content requirements for their product is not currently known. The
requirements for obtaining a determination or exclusion are extensive,
which may be a deterrent to some firms; however, because a very broad
range of products, materials and components are affected by the lead
content limits, the number of firms seeking such determinations or
exclusions could be higher than expected. It would be expected that the
firms making such requests would be familiar with the product or
material for which the determination or exemption is sought and the
required information may already be in the firm's possession or easily
obtainable.
Based on comments received on the CPSIA lead content provisions
thus far, staff estimates that a minimum of approximately 250 firms may
submit requests. The burden to assemble the information and prepare the
submission, if performed by a senior level management employee, may
take approximately 40 hours. The compensation would be approximately
$60 an hour (U.S. Department of Labor, Bureau of Labor Statistics), and
the average cost of preparing a submission would be about $2,400 ($60 x
40). An estimate of the annual burden for the information collection
could reach $600,000.
An estimate of the burden on the federal government to review each
submission could be as much as 24 hours at an average hourly wage of
$56, the equivalent of a GS-14 employee, or $1,344 for each submission
($56 x 24). If approximately 250 submissions are received, the cost of
the annual burden to the federal government will be approximately
$336,000.
I. Effective Date
The APA generally requires that a substantive rule be published not
less than 30 days before its effective date, unless the agency finds
for good cause shown, that a lesser time period is required. 5 U.S.C.
553(d)(3). Because the Commission recognizes the need for providing
procedures for Commission determinations and exclusions expeditiously,
for good cause shown, the proposed effective date is the date of
publication of a final rule in the Federal Register.
J. List of Relevant Documents
(1) Memorandum from Kristina M. Hatlelid, PhD, M.P.H.,
Toxicologist, Directorate for Health Sciences ``Consumer Product Safety
Improvement Act of 2008 (CPSIA): Exclusions from Compliance with Limits
for Lead, Certain Materials of Products: Required Technical
Information.'' December 2008.
(2) Memorandum from Robert Franklin, Economist, Directorate for
Economic Analysis, ``Procedures for Determinations Regarding Lead
Limits and Procedures for Exclusions from Lead Limits Under Section 101
of the Consumer Product Safety Improvement: Small Business and
Environmental Impacts.'' December 2008.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
K. Conclusion
For the reasons stated above, the Commission proposes to amend
title 16 of the Code of Federal Regulations as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority for part 1500 is amended to read as follows:
Authority: 15 U.S.C. 1261-1278, 122 Stat. 3016.
2. Add new Sec. Sec. 1500.89 and 1500.90 to read as follows:
Sec. 1500.89 Procedures for Determinations Regarding Lead Content of
Materials or Products under Section 101(a) of the Consumer Product
Safety Improvement Act.
(a) The Consumer Product Safety Improvement Act provides for
specific lead limits in children's products. Section 101(a) of the
CPSIA provides that by February 10, 2009, products designed or intended
primarily for children 12 and younger may not contain more than 600 ppm
of lead. After August 14, 2009, products designed or intended primarily
for children 12 and younger cannot contain
[[Page 2432]]
more than 300 ppm of lead. On August 14, 2011, the limit may be further
reduced to 100 ppm, unless the Commission determines that it is not
technologically feasible to meet this lower limit. Paint, coatings or
electroplating may not be considered a barrier that would make the lead
content of a product inaccessible to a child.
(b) The Commission may, either on its own initiative or upon the
request of any interested person, make a determination that a material
or product does not contain lead levels that exceed 600 ppm, 300 ppm or
100 ppm.
(c) To request a determination under paragraph (b) of this section,
the request must:
(1) Be e-mailed to cpsc-os@cpsc.gov and titled ``Section 101
Request for Lead Content Determination.'' Requests may also be mailed,
preferably in five copies, to the Office of the Secretary, Consumer
Product Safety Commission, Room 502, 4330 East-West Highway, Bethesda,
Maryland 20814, or delivered to the same address.
(2) Be written in the English language.
(3) Contain the name and address, and e-mail address or telephone
number, of the requestor.
(4) Provide Documentation including:
(i) A detailed description of the product or material;
(ii) Data on the lead content of parts of the product or materials
used in the production of a product;
(iii) Data or information on manufacturing processes through which
lead may be introduced into the product or material;
(iv) Any other information relevant to the potential for lead
content of the product or material to exceed the CPSIA lead limits that
is reasonably available to the requestor;
(v) Detailed information on the relied upon test methods for
measuring lead content of products or materials including the type of
equipment used or any other techniques employed and a statement as to
why the data is representative of the lead content of such products or
materials generally; and
(vi) An assessment of the manufacturing processes which strongly
supports a conclusion that they would not be a source of lead
contamination of the product or material, if relevant.
(d) Where a submission fails to meet all of the requirements of
paragraph (c) of this section, the Office of the Secretary shall notify
the person submitting it, describe the deficiency, and explain that the
request may be resubmitted when the deficiency is corrected.
(e) Each complete request for a Commission determination will be
reviewed by the Office of Hazard Identification and Reduction who will
preliminarily recommend granting or denying the request. Where the
preliminary determination is to grant, the Commission will publish a
notice of proposed rulemaking inviting public comment on whether the
preliminary determination should be granted in final form, and the
Office of Hazard Identification and Reduction will review and evaluate
the comments and supporting documentation before making its
recommendation to the Commission for final agency action.
(f) The filing of a request for a determination does not have the
effect of automatically staying the effect of any provision or limit
under the statutes and regulations enforced by the Commission. Even
though a request for a determination has been filed, unless a
Commission determination is issued in final form after notice and
comment, materials or products subject to the lead limits under section
101 of the CPSIA must be tested in accordance with section 102 of the
CPSIA.
Sec. 1500.90 Procedures for Exclusions from Lead Limits under Section
101(b) of the Consumer Product Safety Improvement Act.
(a) The Consumer Product Safety Improvement Act provides for
specific lead limits in children's products. Section 101(a) of the
CPSIA provides that by February 10, 2009, products designed or intended
primarily for children 12 and younger may not contain more than 600 ppm
of lead. After August 14, 2009, products designed or intended primarily
for children 12 and younger cannot contain more than 300 ppm of lead.
On August 14, 2011, the limit may be further reduced to 100 ppm, unless
the Commission determines that it is not technologically feasible to
have this lower limit. Paint, coatings or electroplating may not be
considered a barrier that would make the lead content of a product
inaccessible to a child.
(b) Section 101(b)(1) of the CPSIA provides that the Commission may
exclude a specific product or material from the lead limits established
for children's products under the CPSIA if the Commission, after notice
and a hearing, determines on the basis of the best-available,
objective, peer-reviewed, scientific evidence that lead in such product
or material will neither:
(1) Result in the absorption of any lead into the human body,
taking into account normal and reasonably foreseeable use and abuse of
such product by a child, including swallowing, mouthing, breaking, or
other children's activities, and the aging of the product; nor
(2) Have any other adverse impact on public health or safety.
(c) To request an exclusion from the lead limits as provided under
paragraph (a) of this section, the request must:
(1) Be e-mailed to cpsc-os@cpsc.gov. and titled ``Section 101
Request for Exclusion of a Material or Product.'' Requests may also be
mailed, preferably in five copies, to the Office of the Secretary,
Consumer Product Safety Commission, Room 502, 4330 East West Highway,
Bethesda, Maryland 20814, or delivered to the same address.
(2) Be written in the English language.
(3) Contain the name and address, and e-mail address or telephone
number, of the requester.
(4) Provide Documentation including:
(i) A detailed description of the product or material;
(ii) Data on the lead content of parts of the product or materials
used in the production of a product;
(iii) Data or information on manufacturing processes through which
lead may be introduced into the product or material;
(iv) Any other information relevant to the potential for lead
content of the product or material to exceed the CPSIA lead limits that
is reasonably available to the requestor;
(v) Detailed information on the relied upon test methods for
measuring lead content of products or materials including the type of
equipment used or any other techniques employed and a statement as to
why the data is representative of the lead content of such products or
materials generally; and
(vi) An assessment of the manufacturing processes which strongly
supports a conclusion that they would not be a source of lead
contamination of the product or material, if relevant.
(5) Provide best-available, objective, peer-reviewed, scientific
evidence to support a request for an exclusion that addresses how much
lead is present in the product, how much lead comes out of the product,
and the conditions under which that may happen, and information
relating to a child's interaction, if any, with the product.
(6) Provide best-available, objective, peer-reviewed, scientific
evidence that is unfavorable to the request that is reasonably
available to the requestor.
(d) Where a submission fails to meet all of the requirements of
paragraph (c) of this section, the Office of the Secretary shall notify
the person submitting it, describe the deficiency,
[[Page 2433]]
and explain that the request may be resubmitted when the deficiency is
corrected.
(e) Each complete request for exclusion will be reviewed by the
Office of Hazard Identification and Reduction, who will preliminarily
recommend granting or denying the request. Where the preliminary
determination is to grant, the Commission will publish a notice of
proposed rulemaking inviting public comment on whether the proposed
exclusion should be issued in final form, and the Office of Hazard
Identification and Reduction will review and evaluate the comments and
supporting documentation before making its recommendation to the
Commission for final agency action.
(f) The filing of a request for exclusion does not have the effect
of automatically staying the effect of any provision or limit under the
statutes and regulations enforced by the Commission. Even though a
request for an exclusion has been filed, unless an exclusion is issued
in final form by the Commission after notice and comment, materials or
products subject to the lead limits under section 101 of the CPSIA are
considered to be banned hazardous substances if they do not meet the
lead limits.
Dated: January 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-715 Filed 1-14-09; 8:45 am]
BILLING CODE 6335-01-P
