[Federal Register: December 28, 2010 (Volume 75, Number 248)]
[Rules and Regulations]
[Page 81789-81792]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de10-47]
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CONSUMER PRODUCT SAFETY COMMISSION
[CPSC Docket No. CPSC-2009-0064]
16 CFR Parts 1219 and 1220
Third Party Testing for Certain Children's Products; Full-Size
Baby Cribs and Non-Full-Size Baby Cribs: Requirements for Accreditation
of Third Party Conformity Assessment Bodies
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of requirements.
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SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is
issuing a notice of requirements that provides the criteria and process
for Commission acceptance of accreditation of third party conformity
assessment bodies for testing pursuant to specific CPSC regulations
relating to full-size and non-full-size baby cribs. The Commission is
issuing this notice of requirements pursuant to section 14(a)(3)(B)(vi)
of the Consumer Product Safety Act (CPSA) (15 U.S.C.
2063(a)(3)(B)(vi)).
DATES: Effective Date: The requirements for accreditation of third
party conformity assessment bodies to assess conformity with 16 CFR
parts 1219 and/or 1220 are effective December 28, 2010.
FOR FURTHER INFORMATION CONTACT: Robert ``Jay'' Howell, Assistant
Executive Director for Hazard Identification and Reduction, U.S.
Consumer Product Safety Commission, 4330 East West Highway, Bethesda,
Maryland 20814; e-mail rhowell@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2)
of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Public
Law 110-314, directs the CPSC to publish a notice of requirements for
accreditation of third party conformity assessment bodies to assess
children's products for conformity with ``other children's product
safety rules.'' Section 14(f)(1) of the CPSA defines ``children's
product safety rule'' as ``a consumer product safety rule under [the
CPSA] or similar rule, regulation, standard, or ban under any other Act
enforced by the Commission, including a rule declaring a consumer
product to be a banned hazardous product or substance.'' Under section
14(a)(3)(A) of the CPSA, each manufacturer (including the importer) or
private labeler of products subject to those regulations must have
products that are manufactured more than 90 days after the Federal
Register publication date of a notice of the requirements for
accreditation, tested by a third party conformity assessment body
accredited to do so, and must issue a certificate of compliance with
the applicable regulations based on that testing. Section 14(a)(2) of
the CPSA, as added by section 102(a)(2) of the CPSIA, requires that
certification be based on testing of sufficient samples of the product,
or samples that are identical in all material respects to the product.
The Commission also emphasizes that, irrespective of certification, the
product in question must comply with applicable CPSC requirements (see,
e.g., section 14(h) of the CPSA, as added by section 102(b) of the
CPSIA).
This notice provides the criteria and process for Commission
acceptance of accreditation of third party conformity assessment bodies
for testing pursuant to safety standards for full-size and non-full-
size baby cribs, which appears elsewhere in this issue of the Federal
Register. The standards for full-size and non-full-size baby cribs will
be codified at 16 CFR parts 1219 and 1220 respectively. The standards
contain the test methods that conformity assessment bodies will use to
assess full-size and non-full-size baby cribs. The Commission is
recognizing limited circumstances in which it will accept
certifications based on product testing conducted before the full-size
and non-full-size baby crib standards become effective in six months.
The details regarding those limited circumstances can be found in part
IV of this document below.
Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to
publish a notice of requirements for accreditation of third party
conformity assessment bodies to assess conformity with ``all other
children's product safety rules,'' this notice of requirements is
limited to the test methods identified immediately above.
The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA
is captioned: ``All Other Children's Product Safety Rules,'' but the
body of the statutory
[[Page 81790]]
requirement refers only to ``other children's product safety rules.''
Nevertheless, section 14(a)(3)(B)(vi) of the CPSA could be construed as
requiring a notice of requirements for ``all'' other children's product
safety rules, rather than as a notice of requirements for ``some'' or
``certain'' children's product safety rules. However, whether a
particular rule represents a ``children's product safety rule'' may be
subject to interpretation, and the Commission staff is continuing to
evaluate which rules, regulations, standards, or bans are ``children's
product safety rules.'' The CPSC intends to issue additional notices of
requirements for other rules which the Commission determines to be
``children's product safety rules.''
This notice of requirements applies to all third party conformity
assessment bodies as described in section 14(f)(2) of the CPSA.
Generally speaking, such third party conformity assessment bodies are:
(1) Third party conformity assessment bodies that are not owned,
managed, or controlled by a manufacturer or private labeler of a
children's product to be tested by the third party conformity
assessment body for certification purposes; (2) ``firewalled''
conformity assessment bodies (those that are owned, managed, or
controlled by a manufacturer or private labeler of a children's product
to be tested by the third party conformity assessment body for
certification purposes and that seek accreditation under the additional
statutory criteria for ``firewalled'' conformity assessment bodies);
and (3) third party conformity assessment bodies owned or controlled,
in whole or in part, by a government.
The Commission requires baseline accreditation of each category of
third party conformity assessment body to the International
Organization for Standardization (ISO)/International Electrotechnical
Commission (IEC) Standard 17025:2005, ``General Requirements for the
Competence of Testing and Calibration Laboratories.'' The accreditation
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
testing for any of the test methods identified earlier in part I of
this document for which the third party conformity assessment body
seeks to be accredited.
(A description of the history and content of the ILAC-MRA approach
and of the requirements of the ISO/IEC 17025:2005 laboratory
accreditation standard is provided in the CPSC staff briefing
memorandum ``Third Party Conformity Assessment Body Accreditation
Requirements for Testing Compliance With 16 CFR Part 1501 (Small Parts
Regulations),'' dated November 2008 and available on the CPSC's Web
site at http://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf.)
The Commission has established an electronic accreditation
registration and listing system that can be accessed via its Web site
at http://www.cpsc.gov/about/cpsia/labaccred.html.
In the Federal Register of October 22, 2008 (73 FR 62965), the
Commission published a notice of requirements for the accreditation of
third party conformity assessment bodies to test children's products
for conformity with the then-existing CPSC regulations for full-size
baby cribs at 16 CFR part 1508 and for non-full-size baby cribs at 16
CFR part 1509. Elsewhere in this issue of the Federal Register, the
Commission is revoking 16 CFR parts 1508 and 1509, so testing to those
regulations will no longer be required. The revocation of those
regulations will become effective on June 28, 2011, and so, on that
date, we will no longer accept applications from third party conformity
assessment bodies for CPSC acceptance to test for conformity with 16
CFR parts 1508 and/or 1509.
As stated in part I of this document, the Commission, elsewhere in
this issue of the Federal Register, is issuing new standards for full-
size and non-full-size baby cribs that will be codified at 16 CFR parts
1219 and 1220, respectively. This notice of requirements is effective
on December 28, 2010. The final rule announcing the Safety Standards
for Full-Size Baby Cribs and Non-Full-Size Baby Cribs is effective on
June 28, 2011. The effect of these twin publications is that each
manufacturer (including the importer) or private labeler of a product
subject to 16 CFR parts 1219 or 1220 must have any such product
manufactured on or after June 28, 2011, tested by a third party
conformity assessment body accredited to do so and must issue a
certificate of compliance with 16 CFR parts 1219 or 1220 based on that
testing.
This notice of requirements is exempt from the notice and comment
rulemaking requirements of the Administrative Procedure Act, 5 U.S.C.
553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2)
of the CPSIA (15 U.S.C. 2063(a)(3)(G))).
II. Accreditation Requirements
A. Baseline Third Party Conformity Assessment Body Accreditation
Requirements
For a third party conformity assessment body to be accredited to
test children's products for conformity with the test methods
identified earlier in part I of this document, it must be accredited by
an ILAC-MRA signatory accrediting body, and the accreditation must be
registered with, and accepted by, the Commission. A listing of ILAC-MRA
signatory accrediting bodies is available on the Internet at http://
ilac.org/membersbycategory.html. The accreditation must be to ISO
Standard ISO/IEC 17025:2005, ``General Requirements for the Competence
of Testing and Calibration Laboratories,'' and the scope of the
accreditation must expressly include testing to the test method for
full-size and/or non-full-size baby cribs included in 16 CFR parts 1219
and/or 1220, Safety Standards for Full-Size Baby Cribs and Non-Full-
Size Baby Cribs. A true copy, in English, of the accreditation and
scope documents demonstrating compliance with these requirements must
be registered with the Commission electronically. The additional
requirements for accreditation of firewalled and governmental
conformity assessment bodies are described in parts II.B and II.C of
this document below.
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. Once the Commission adds
a third party conformity assessment body to that list, the third party
conformity assessment body may commence testing of full-size and/or
non-full-size baby cribs to support certification by the manufacturer
or private labeler of compliance with the test methods identified
earlier in part I of this document.
B. Additional Accreditation Requirements for Firewalled Conformity
Assessment Bodies
In addition to the baseline accreditation requirements in part II.A
of this document above, firewalled conformity assessment bodies seeking
accredited status 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
[[Page 81791]]
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 ten
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 if this
issue needs to be addressed in the future.
As required by section 14(f)(2)(D) of the CPSA, the Commission must
formally accept, by order, the accreditation application of a third
party conformity assessment body before the third party conformity
assessment body can become an accredited firewalled conformity
assessment body. The Commission's order must also find that accrediting
the firewalled conformity assessment body would provide equal or
greater consumer safety protection than the manufacturer's or private
labeler's use of an independent 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 relevant to the
accreditation request.
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 Web
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 ILAC-MRA accreditation certificate and scope statement,
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 satisfactorily completed, 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 staff's review is complete,
the 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 may initially 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
staff recommendation to accredit a firewalled conformity assessment
body, the firewalled conformity assessment body then 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 may then begin
testing of children's products to support certification of compliance
with the regulations identified earlier in part I of this document for
which it has been accredited.
IV. Acceptance of Children's Product Certifications Based on Third
Party Conformity Assessment Body Testing to the New Safety Standards
for Full-Size and Non-Full-Size Baby Cribs Prior to Their Effective
Date
Elsewhere in this issue of the Federal Register, the Commission is
publishing new safety standards for full-size and non-full-size baby
cribs, which will be codified at 16 CFR parts 1219 and 1220,
respectively. The effect of this notice of requirements and the final
rule is that each manufacturer (including the importer) or private
labeler of a product subject to 16 CFR parts 1219 or 1220 must have any
such product manufactured on or after June 28, 2011 tested by a third
party conformity assessment body accredited to do so and must issue a
certificate of compliance with 16 CFR parts 1219 or 1220 based on that
testing.
To ease the transition to the new standards and avoid a
``bottlenecking'' of products at conformity assessment bodies at or
near the effective date of 16 CFR parts 1219 and 1220, the Commission
will accept certifications based on testing that occurred prior to the
effective date of the new standards in certain prescribed
circumstances. However, any such testing must comport with all CPSC
requirements, including:
1. At the time of product testing, the product \1\ was tested by a
third party conformity assessment body that was ISO/IEC 17025
accredited by an ILAC-MRA accreditation body at the time of the test.
For firewalled conformity assessment bodies, the firewalled conformity
assessment body must be one that the Commission has accredited by order
at or before the time the product was tested, even if the order did not
include the test methods specified in this notice. If the third party
[[Page 81792]]
conformity assessment body has not been accredited as a firewalled
conformity assessment body by a Commission order, the Commission will
not accept a certificate of compliance based on testing performed by
the third party conformity assessment body before it is accredited, by
Commission order, as a firewalled conformity assessment body;
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\1\ The CPSIA requires that certification be based on testing of
sufficient samples of the product or samples that are identical in
all material respects to the product.
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2. The third party conformity assessment body's application is
accepted by the CPSC by June 28, 2011, as established by the
Commission;
3. The test results show compliance with 16 CFR part 1219 or 16 CFR
part 1220;
4. The product was tested on or after July 23, 2010 and before June
28, 2011; and
5. The third party conformity assessment body's accreditation
remains in effect through the effective date for mandatory third party
testing and manufacturer/private labeler certification for the subject
products' respective regulations.
Dated: December 17, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-32180 Filed 12-27-10; 8:45 am]
BILLING CODE 6355-01-P