[Federal Register: July 21, 2010 (Volume 75, Number 139)]
[Rules and Regulations]
[Page 42311-42314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy10-6]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1611
[CPSC Docket No. CPSC-2010-0079]
Third Party Testing for Certain Children's Products; Vinyl
Plastic Film: 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 the CPSC regulations under
the Flammable Fabrics Act relating to vinyl plastic film. The
Commission is issuing this notice of requirements pursuant to the
Consumer Product Safety Act (CPSA).
DATES: Effective Date: The requirements for accreditation of third
party conformity assessment bodies to assess conformity with 16 CFR
part 1611 are effective upon publication of this document in the
Federal Register.\1\
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\1\ The Commission voted 3-2 to publish this notice of
requirements. Chairman Inez M. Tenenbaum, Commissioner Nancy A.
Nord, and Commissioner Anne Meagher Northup each issued a statement,
and the statements can be found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cpsc.gov/pr/statements.html.
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Comments in response to this notice of requirements should be
submitted by August 20, 2010. Comments should be captioned ``Third
Party Testing for Certain Children's Products; Vinyl Plastic Film:
Requirements for Accreditation of Third Party Conformity Assessment
Bodies.''
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2010-
0079, by any of the following methods:
Electronic Submissions: Submit electronic comments in the
following way:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Follow the instructions for submitting comments.
[[Page 42312]]
To ensure timely processing of comments, the Commission is no longer
accepting comments submitted by electronic mail (e-mail) except through
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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,
Maryland 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
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).
The Commission also is recognizing limited circumstances in which
it will accept certifications based on product testing conducted before
the third party conformity assessment body is accepted as accredited by
the CPSC. The details regarding those limited circumstances can be
found in part IV of this document below.
This notice provides the criteria and process for Commission
acceptance of accreditation of third party conformity assessment bodies
for testing pursuant to 16 CFR part 1611, Standard for the Flammability
of Vinyl Plastic Film, which sets a minimum standard for flammability
of vinyl plastic film which are subject to the requirements of the
Flammable Fabrics Act (15 U.S.C. 1191 et seq.) (FFA).
Section 3(a)(2) of the CPSA defines a children's product as ``a
consumer product designed or intended primarily for children 12 years
of age or younger.'' Although vinyl plastic film used in wearing
apparel or fabric is often for general use (that is, it is produced for
general consumption rather than being produced specifically for use by
children), some vinyl plastic film wearing apparel or fabric is
``designed or intended primarily for children 12 years of age or
younger.'' (For convenience, we will refer to vinyl plastic film
products designed or intended primarily for use in wearing apparel or
fabric for children 12 years of age or younger as ``youth vinyl plastic
film products.'') Youth vinyl plastic film products are subject to the
third party testing and certification requirements in section 14(a)(2)
of the CPSA. Accordingly, this notice of requirements addresses the
accreditation of conformity assessment bodies to test youth vinyl
plastic film for conformity with 16 CFR part 1611.
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 regulations identified immediately above.
The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA
is captioned as ``All Other Children's Product Safety Rules,'' but the
body of the statutory 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 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 in accordance with the regulations identified earlier in part I
of this document for which the third party
[[Page 42313]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cpsc.gov/ABOUT/Cpsia/labaccred.html.
The Commission stayed the enforcement of certain provisions of
section 14(a) of the CPSA in a notice published in the Federal Register
on February 9, 2009 (74 FR 6396); the stay applied to testing and
certification of various products, including vinyl plastic film. On
December 28, 2009, the Commission published a notice in the Federal
Register (74 FR 68588) revising the terms of the stay. One section of
the December 28, 2009, notice addressed ``Consumer Products or
Children's Products Where the Commission Is Continuing the Stay of
Enforcement Until Further Notice,'' due to factors such as pending
rulemaking proceedings affecting the product or the absence of a notice
of requirements. The vinyl plastic film testing and certification
requirements were included in that section of the December 28, 2009,
notice. As the factor preventing the stay from being lifted in the
December 28, 2009, notice with regard to testing and certifications of
vinyl plastic film was the absence of a notice of requirements,
publication of this notice has the effect of lifting the stay with
regard to 16 CFR part 1611.
The Commission noted in the December 28, 2009, notice that the stay
of enforcement did not extend to guaranties under the FFA. The
manufacturer or supplier of vinyl plastic film may issue a guaranty,
based on reasonable and representative testing, that the vinyl plastic
film complies with FFA standards. The holder of a valid guaranty is not
subject to criminal prosecution under section 7 of the FFA (penalties)
for a violation of section 3 of the FFA (prohibited transactions).
The reasonable and representative tests sufficient for the issuance
of an FFA guaranty are generally performed by the manufacturer; those
tests are sufficient for the issuance of a general conformity
certification for nonchildren's products under section 14(a)(1) of the
CPSA. However, because section 14(a)(2) of the CPSA requires children's
products subject to a children's product safety rule to be tested by an
accredited third party conformity assessment body, reasonable and
representative tests sufficient for the issuance of an FFA guaranty
which are performed by a manufacturer are not sufficient for the
issuance of a certification of compliance with 16 CFR part 1611 for
youth vinyl plastic film products (unless the manufacturer's facility
is a CPSC-accredited firewalled conformity assessment body).
This notice of requirements is effective on July 21, 2010. Further,
as the publication of this notice of requirements effectively lifts the
stay of enforcement with regard to testing and certifications related
to 16 CFR part 1611, each manufacturer of a children's product subject
to 16 CFR part 1611 must have any such product manufactured after
October 19, 2010 tested by a third party conformity assessment body
accredited to do so and must issue a certificate of compliance with 16
CFR part 1611 based on that testing. (Under the CPSA, the term
``manufacturer'' includes anyone who manufactures or imports a
product.)
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 in the
regulations 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 regulations
in 16 CFR part 1611, Standard for the Flammability of Vinyl Plastic
Film. A true copy, in English, of the accreditation and scope documents
demonstrating compliance with the requirements of this notice 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. Subject to the limited
provisions for acceptance of ``retrospective'' testing noted in part IV
below, 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 the regulations 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 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.
[[Page 42314]]
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
Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 may ultimately seek acceptance as a firewalled third party
conformity assessment body also can 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 will then 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.
Subject to the limited provisions for acceptance of
``retrospective'' testing noted in part IV of this document below, 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. Limited Acceptance of Children's Product Certifications Based on
Third Party Conformity Assessment Body Testing Prior to the
Commission's Acceptance of Accreditation
The Commission will accept a certificate of compliance with the
standard for vinyl plastic film included in 16 CFR part 1611, Standard
for the Flammability of Vinyl Plastic Film, based on testing performed
by an accredited third party conformity assessment body (including a
government-owned or -controlled conformity assessment body, and a
firewalled conformity assessment body) prior to the Commission's
acceptance of its accreditation if:
At the time of product testing, the product was tested by
a third party conformity assessment body that was ISO/IEC 17025
accredited by an ILAC-MRA member at the time of the test. For
firewalled conformity assessment bodies, the firewalled conformity
assessment body must be one that the Commission accredited by order at
or before the time the product was tested, even though the order will
not have included the test methods in the regulations specified in this
notice. If the third party conformity assessment body has not been
accredited by a Commission order as a firewalled conformity assessment
body, 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;
The third party conformity assessment body's application
for testing using the test methods in the regulations identified in
this notice is accepted by the CPSC on or before September 20, 2010;
The product was tested on or after July 21, 2010 with
respect to the regulations identified in this notice;
The accreditation scope in effect for the third party
conformity assessment body at the time of testing expressly included
testing to the regulations identified earlier in part I of this
document;
The test results show compliance with the applicable
current standards and/or regulations; and
The third party conformity assessment body's
accreditation, including inclusion in its scope the standards described
in part I of this notice, remains in effect through the effective date
for mandatory third party testing and manufacturer certification for
conformity with 16 CFR part 1611.
Dated: July 15, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-17722 Filed 7-20-10; 8:45 am]
BILLING CODE 6355-01-P