[Federal Register Volume 76, Number 65 (Tuesday, April 5, 2011)]
[Rules and Regulations]
[Pages 18645-18648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7905]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1303
[CPSC Docket No. CPSC-2008-0033]
Third Party Testing for Certain Children's Products; Notice of
Requirements for Accreditation of Third Party Conformity Assessment
Bodies--Lead Paint
AGENCY: U.S. Consumer Product Safety Commission.
ACTION: Notice of requirements; revision of testing terms.
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SUMMARY: The U.S. Consumer Product Safety Commission (``CPSC,''
``Commission,'' or ``we'') is amending the criteria and process for
Commission acceptance of accreditation of third party conformity
assessment bodies for testing to the lead paint ban regulations. We are
taking this action to require CPSC and/or ASTM published test methods
to be referenced by a third party conformity assessment body in the
scope of its accreditation.
DATES: Effective date: The revised requirements are effective April 5,
2011.
Comment date: Comments in response to this notice of requirements
should be submitted by May 5, 2011. Comments on this notice should be
captioned, ``Third Party Testing for Certain Children's Products;
Requirements for Accreditation of Third Party Conformity Assessment
Bodies--Lead Paint.''
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2008-
0033, by any of the following methods:
Electronic Submissions: Submit electronic comments in the following
way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments. To ensure timely processing of
comments, the Commission is no longer accepting comments submitted by
electronic mail (e-mail) except through http://www.regulations.gov.
Written Submissions: Submit written submissions in the following
way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions)
preferably in five copies, to: Office of the Secretary, U.S. Consumer
Product Safety Commission, Room 820, 4330 East West Highway, Bethesda,
MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this notice. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
(such as a Social Security Number) electronically; if furnished at all,
such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Robert ``Jay'' Howell, Assistant
Executive Director for he Office of Hazard Identification and
Reduction, U.S. Consumer Product Safety Commission, 4330 East West
Highway, Bethesda, MD 20814; e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 14(a)(3)(B)(i) of the Consumer Product Safety Act (CPSA),
as added by section 102(a)(2) of the Consumer Product Safety
Improvement Act of 2008 (CPSIA), Public Law 110-314, directed the CPSC
to publish a notice of requirements for accreditation of third party
conformity assessment bodies to test children's products for conformity
with the Commission's regulations at 16 CFR part 1303, Ban of Lead-
Containing Paint and Certain Consumer Products Bearing Lead-Containing
Paint (the lead paint ban). In the Federal Register of September 22,
2008, the Commission published a notice of requirements for
accreditation of third party conformity assessment bodies to test
children's products for conformity with the lead paint ban under 16 CFR
part 1303 (73 FR 54564).
In response to the September 22, 2008 notice of requirements, the
International Laboratory Accreditation Cooperation (ILAC) and the
American Association for Laboratory Accreditation (A2LA) submitted
letters asking us to specify test methods to ensure that accreditation
bodies are able to determine the acceptable technologies and methods
for lead analyses. The September 22, 2008 notice of requirements stated
that the accreditation must be to the International Standards
Organization (ISO)/International Electrotechnical Commission (IEC)
Standard ISO/IEC 17025:2005, ``General Requirements for the Competence
of Testing and Calibration Laboratories,'' and that the scope of the
accreditation must include testing to the requirements of 16 CFR part
1303. However, these requirements for accreditation did not reference a
specific test method, although the CPSC staff's test method (CPSC-CH-
E1003-09) was made available on the CPSC Web site at: http://www.cpsc.gov/about/cpsia/CPSC-CH-E1003-09.pdf. Therefore, to require
certain test methods that are acceptable to the CPSC for testing for
lead in paint, we are amending the notice of requirements to state that
the scope of the third party conformity assessment body's accreditation
shall specify certain test methodologies.
The Commission is revising the September 22, 2008 notice of
requirements to require reference of specific test methods for CPSC
acceptance of accreditation of third party conformity assessment bodies
to assess conformity with 16 CFR part
[[Page 18646]]
1303. One or more of the following test methods must be referenced: The
existing CPSC Standard Operating Procedure for Determining Lead (Pb) in
Paint and Other Similar Surface Coatings, CPSC-CH-E1003-09 and/or CPSC-
CH-E1003-09.1 and/or, ASTM F2853-10, ``Standard Test Method for
Determination of Lead in Paint Layers and Similar Coatings or in
Substrates and Homogenous Materials by Energy Dispersive X-Ray
Fluorescence Spectrometry Using Multiple Monochromatic Excitation
Beams.''
Test Method CPSC-CH-E1003-09 was revised in Test Method CPSC-CH-
E1003-09.1 to reflect ministerial edits and remove the statement that
the rules for accreditation for lead in paint testing do not explicitly
require the use of a particular standard operating procedure.
Additionally, the following statement was added. ``Adjustments may be
necessary to achieve total digestion for certain paints and should be
based on sound chemistry knowledge and appropriate acids for the sample
material being analyzed.'' It is still based on standard test
procedures, such as ASTM International (formerly the American Society
for Testing and Materials) ASTM E1645, ASTM E1613-04, and Association
of Official Analytical Chemists (AOAC) standard AOAC 974.02. This test
method will be made available on the CPSC Web site at: http://www.cpsc.gov/about/cpsia/CPSC-CH-E1003-09_1.pdf.
In addition to the CPCS's test methods, CPSC staff finds that ASTM
F2853-10, ``Standard Test Method for Determination of Lead in Paint
Layers and Similar Coatings or in Substrates and Homogenous Materials
by Energy Dispersive X-Ray Fluorescence Spectrometry Using Multiple
Monochromatic Excitation Beams.'' which uses a specific type of X-Ray
Fluorescence (XRF) technology, may be used as a test method and is as
effective, precise, and reliable as method CPSC-CH-E1003-09 posted on
the CPSC Web site. The standard is available on the ASTM Web site at:
http://www.astm.org/Standards/F2853.htm. Supporting data about the
associated interlaboratory research report has been filed with ASTM and
can be obtained by contacting ASTM and requesting Research Report
RR:F40-1001. Our findings are based on a study conducted in August
2009, as updated in December 2010, which evaluates the effectiveness,
precision, and reliability of XRF methods and other alternative methods
for measuring lead in paint or other surface coatings when used in
children's products. The studies on XRF are published on the CPSC's Web
site at: http://www.cpsc.gov/ABOUT/Cpsia/leadinpaintmeasure.pdf and
http://www.cpsc.gov/ABOUT/Cpsia/leadinpaintmeasure_update.pdf. XFR
methods and equipment other than those specified in ASTM F2853-10 are
not considered effective for testing in paint and surface coatings for
the purpose of determining conformity with 16 CFR part 1303 at this
time. We are working with the National Institute of Standards and
Technology (NIST) to develop and release a lead in paint standard
reference material (SRM) 2569, consisting of a thin, uniform film with
thickness and lead concentrations appropriate to testing of painted
surfaces, and which would be suitable for validating ASTM F2853-10.
This SRM may become available in 2011. We also are aware that other
commercial reference materials are now available that may be suitable
for validating ASTM F2853-10.
Many third party conformity assessment bodies operate on a two year
cycle for review and renewal of accreditation. Accordingly, in order to
give third party conformity assessment bodies sufficient time to amend
their scope documents to reflect the specific test methods accepted by
the Commission, CPSC-CH-E1003-09 and/or CPSC-CH-E1003-09.1 and/or ASTM
F2853-10, CPSC-accepted third party conformity assessment bodies that
are listed on the CPSC Web site as approved to 16 CFR part 1303
(without reference to a test method) will have two years from the date
of publication of this notice in the Federal Register to reapply and be
accepted by the CPSC for CPSC-CH-E1003-09 and/or CPSC-CH-E1003-09.1
and/or ASTM F2853-10 for testing to the lead in paint regulation at 16
CFR part 1303. After that date, previously accepted third party
conformity assessment bodies that test for 16 CFR part 1303 must have
been accepted by the CPSC for one or more of the required test methods
to maintain CPSC-accepted status. All accreditations must be by an
accreditation body that is a signatory to the International Laboratory
Accreditation Cooperation--Mutual Recognition Arrangement (ILAC-MRA)
and the scope of the accreditation must include:
16 CFR part 1303 (CPSC-CH-E1003-09 and/or CPSC-CH-E1003-
09.1), and/or
16 CFR part 1303 (ASTM F2853-10).
New applicants seeking CPSC acceptance of accreditation to test to
16 CFR part 1303 will have the option to apply without reference to a
specific test method under 16 CFR part 1303 or to apply to the CPSC for
acceptance to test to 16 CFR part 1303 according to one or more test
methods for up to one year after publication of this notice in the
Federal Register. After one year from the publication of this notice in
the Federal Register, the option for third party conformity assessment
bodies to apply for CPSC-acceptance of accreditation to 16 CFR part
1303 without reference to a CPSC required test method will not be
permitted.
To make it easier for interested parties to understand the nature
of the revisions, we are republishing the notice of requirements in its
entirety for readability. The republished notice incorporates several
nonsubstantive changes or grammatical changes, such as replacing the
term ``laboratory'' with ``third party conformity assessment body.''
These changes were made to make the notice of requirements consistent
with other recent notices of requirements published in the Federal
Register. See, e.g., Third Party Testing for Certain Children's
Products; Children's Sleepwear, Sizes 0 Through 6X and 7 Through 14:
Requirements for Accreditation of Third Party Conformity Assessment
Bodies, (75 FR 70911 (November 19, 2010)); Third Party Testing for
Certain Children's Products; Youth All-Terrain Vehicles: Requirements
for Accreditation of Third Party Conformity Assessment Bodies, (75 FR
52616 (August 27, 2010)).
II. Accreditation Requirements
The notice of requirements that appeared in the Federal Register on
September 22, 2008 (73 FR 5456) is amended to read as follows:
A. Baseline Third Party Conformity Assessment Body Accreditation
Requirements
For a third party conformity assessment body to be CPSC-accepted as
accredited to test children's products for conformity with the lead
paint ban and 16 CFR part 1303, it must be accredited to ISO/IEC 17025-
2005 by an accreditation body that is a signatory to the ILAC-MRA, and
the accreditation must be registered with, and accepted by, the
Commission. A listing of ILAC-MRA signatory accreditation bodies is
available on the Internet at: http://ilac.org/membersbycategory.html.
The scope of the accreditation must include 16 CFR part 1303 (CPSC-CH-
E1003-09 and/or CPSC-CH-E1003-09.1) and/or 16 CFR part 1303 (ASTM
F2853-10).
The Commission will maintain on its Web site an up-to-date listing
of third party conformity assessment bodies whose accreditations it has
accepted and the scope of each accreditation.
[[Page 18647]]
Once the Commission adds a third party conformity assessment body to
that list, the third party conformity assessment body may commence
testing of children's products to support the manufacturer's
certification that the product complies with 16 CRF part 1303.
B. Additional Accreditation Requirements for Firewalled Conformity
Assessment Bodies
In addition to the baseline accreditation requirements in Section
II.A of this document above, firewalled conformity assessment bodies
seeking accredited status by the CPSC must submit to the Commission
copies, in English, of their training documents, showing how employees
are trained to notify the Commission immediately and confidentially of
any attempt by the manufacturer, private labeler, or other interested
party to hide or exert undue influence over the third party conformity
assessment body's test results. This additional requirement applies to
any third party conformity assessment body in which a manufacturer or
private labeler of a children's product to be tested by the third party
conformity assessment body owns an interest of 10 percent or more.
While the Commission is not addressing common parentage of a third
party conformity assessment body and a children's product manufacturer
at this time, it will be vigilant to see whether this issue needs to be
addressed in the future.
As required by section 14(f)(2)(D) of the CPSA, the Commission must
accept formally, by order, the application from a third party
conformity assessment body before the third party conformity assessment
body can become accredited by the CPSC as a firewalled conformity
assessment body.
C. Additional Accreditation Requirements for Governmental Conformity
Assessment Bodies
In addition to the baseline accreditation requirements of part II.A
of this document above, the CPSIA permits accreditation of a third
party conformity assessment body owned or controlled, in whole or in
part, by a government if:
To the extent practicable, manufacturers or private
labelers located in any nation are permitted to choose conformity
assessment bodies that are not owned or controlled by the government of
that nation;
The third party conformity assessment body's testing
results are not subject to undue influence by any other person,
including another governmental entity;
The third party conformity assessment body is not accorded
more favorable treatment than other third party conformity assessment
bodies in the same nation who have been accredited;
The third party conformity assessment body's testing
results are accorded no greater weight by other governmental
authorities than those of other accredited third party conformity
assessment bodies; and
The third party conformity assessment body does not
exercise undue influence over other governmental authorities on matters
affecting its operations or on decisions by other governmental
authorities controlling distribution of products based on outcomes of
the third party conformity assessment body's conformity assessments.
The Commission will accept the accreditation of a governmental
third party conformity assessment body if it meets the baseline
accreditation requirements of part II.A of this document above and
meets the additional conditions stated here. To obtain this assurance,
CPSC staff will engage the governmental entities seeking accreditation.
III. How does a third party conformity assessment body apply for
acceptance of its accreditation?
The Commission has established an electronic accreditation
acceptance and registration system accessed via the Commission's
Internet site at: http://www.cpsc.gov/about/cpsia/labaccred.html. The
applicant provides, in English, basic identifying information
concerning its location, the type of accreditation it is seeking, and
electronic copies of its accreditation certificate and scope statement
by its ILAC-MRA signatory accreditation body, and firewalled third
party conformity assessment body training document(s), if relevant.
Commission staff will review the submission for accuracy and
completeness. In the case of baseline third party conformity assessment
bodies and government-owned or government-operated conformity
assessment bodies, when that review and any necessary discussions with
the applicant are completed satisfactorily, the third party conformity
assessment body in question is added to the CPSC's list of accredited
third party conformity assessment bodies at: http://www.cpsc.gov/about/cpsia/labaccred.html. In the case of a firewalled conformity assessment
body seeking accredited status, when the CPSC staff's review is
complete, the CPSC staff transmits its recommendation on accreditation
to the Commission for consideration. (A third party conformity
assessment body that ultimately may seek acceptance as a firewalled
third party conformity assessment body also initially can request
acceptance as a third party conformity assessment body accredited for
testing of children's products other than those of its owners.) If the
Commission accepts a CPSC staff recommendation to accredit a firewalled
conformity assessment body, the firewalled conformity assessment body
will be added to the CPSC's list of accredited third party conformity
assessment bodies. In each case, the Commission will notify the third
party conformity assessment body electronically of acceptance of its
accreditation. All information to support an accreditation acceptance
request must be provided in the English language.
Once the Commission adds a third party conformity assessment body
to the list, the third party conformity assessment body then may begin
testing children's products to support certification of compliance with
16 CFR part 1303, for which it has been accredited.
New applicants for CPSC acceptance of accreditation to 16 CFR part
1303 will have the option to apply to the CPSC without reference to a
specific test method or to apply for CPSC acceptance to include a
specific reference to 16 CFR part 1303 (CPSC-CH-E1003-09 and/or CPSC-
CH-E1003-09.1) and/or 16 CFR part 1303 (ASTM F2853-10) for up to one
year after publication of this notice in the Federal Register. After
one year, the option to apply for accreditation to 16 CFR part 1303
without reference to a CPSC required test method will not be permitted.
CPSC-accepted third party conformity assessment bodies for 16 CFR
part 1303 without a reference to one of the specified test methods have
up to two years from the date of publication of this notice in the
Federal Register to reapply and become accepted by the CPSC for 16 CFR
part 1303 (CPSC-CH-E1003-09 and/or CPSC-CH-E1003-09.1) and/or 16 CFR
part 1303 (ASTM F2853-10). To maintain CPSC-accepted status, third
party conformity assessment bodies that are CPSC-accepted for 16 CFR
part 1303 without reference to one of the required test methods must
reapply with, and be accepted by, the CPSC within the two-year period,
irrespective of whether the scope document from their accreditation
body that was supplied with their
[[Page 18648]]
earlier CPSC application included a reference to one of the required
test methods. Previously CPSC-accepted third party conformity
assessment bodies for 16 CFR part 1303 (including those that had one of
the specified test methods in their accreditation scope document that
was supplied with their earlier CPSC application) must reapply to
maintain CPSC acceptance because the CPSC did not record references to
test methods. If accepted, the third party conformity assessment body
will remain on the list of accepted third party conformity bodies whose
accreditations the CPSC has accepted for 16 CFR part 1303.
IV. Acceptance of Children's Product Certifications Based on Third
Party Conformity Assessment Body Testing to 16 CFR Part 1303
The September 22, 2008 Federal Register Notice of Requirements for
Accreditation of Third Party Conformity Assessment Bodies to Assess
Conformity with Part 1303 of Title 16, Code of Federal Regulations
established that each manufacturer (including the importer) or private
labeler of children's products subject to the lead paint ban must have
products that are manufactured after December 21, 2008 tested by a
laboratory accredited (by the CPSC) and must issue a certificate of
compliance with the lead paint ban based upon that testing.
This amended notice of requirements published today addresses only
the CPSC acceptance criteria for a third party conformity assessment
body for testing to the lead paint ban at 16 CFR part 1303. This
amended notice does not affect the already-established criteria for
CPSC acceptance of certificates of compliance. A product manufacturer's
certificate of compliance to 16 CFR part 1303 must be based on testing
by a third party conformity assessment body that is posted on the CPSC
Web site as accepted for 16 CFR part 1303 at the time the product is
tested. The Commission will accept a certificate of compliance with 16
CFR part 1303, Ban of Lead-Containing Paint for a children's product
based on testing performed by an accredited (CPSC-accepted) third party
conformity assessment body (including a government-owned or government-
controlled conformity assessment body, or a firewalled conformity
assessment body) if the testing was conducted on a date for which the
third party conformity assessment body was listed as accepted by the
CPSC for testing to the lead paint ban at 16 CFR part 1303.
Dated: March 30, 2011.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2011-7905 Filed 4-4-11; 8:45 am]
BILLING CODE 6355-01-P