[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Rules and Regulations]
[Pages 49286-49291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19678]
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CONSUMER PRODUCT SAFETY COMMISSION
16 Chapter II
[CPSC Docket No. CPSC-2011-0052]
Third Party Testing for Certain Children's Products; Notice of
Requirements for Accreditation of Third Party Conformity Assessment
Bodies To Assess Conformity With the Limits on Phthalates in Children's
Toys and Child Care Articles
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of Requirements.
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SUMMARY: The Consumer Product Safety Commission (CPSC, Commission, or
we) 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 phthalates
limits in section 108 of the Consumer Product Safety Improvement Act of
2008 (CPSIA). The Commission is issuing this notice of requirements
pursuant to section 14(a)(3)(B)(vi) of the Consumer Product Safety Act
(CPSA).
DATES: Effective Date: The requirements for accreditation of third
party conformity assessment bodies to assess conformity with phthalates
limits when tested in accordance with CPSC-CH-C1001-09.3, Standard
Operating Procedure for Determination of Phthalates, and GB/T 22048-
2008, Toys and Children's Products--Determination of Phthalate
Plasticizers in Polyvinyl Chloride Plastic are effective August 10,
2011.
Submit comment by September 9, 2011. Comments on this notice should
be captioned ``Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity with the Limits on Phthalates in
Children's Toys and Child Care Articles.''
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2011-
0052, 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
ways: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions) preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, Room 502, 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: Carol Afflerbach, Compliance Officer,
Office of Compliance and Field Investigations, U.S. Consumer Product
Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; e-
mail cafflerbach@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 (also known
as ``testing laboratories'' or ``laboratories'') to assess children's
products for conformity with ``other children's product safety rules.''
\1\ 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
[[Page 49287]]
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 the applicable CPSC requirements
(see, e.g., section 14(h) of the CPSA, as added by section 102(b) of
the CPSIA).
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\1\ The Commission voted 5-0 to publish this notice of
requirements, with amendments, in the Federal Register. Chairman
Inez M. Tenenbaum and Commissioners Thomas H. Moore and Robert S.
Adler filed a joint statement regarding the vote. Commissioners
Nancy A. Nord and Anne M. Northup filed individual statements. The
statements may be viewed at http://www.cpsc.gov/pr/statements/html.
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This notice provides the criteria and process for Commission
acceptance of accreditation of third party conformity assessment bodies
for testing pursuant to the following test methods:
CPSC-CH-C1001-09.3, Standard Operating Procedure for
Determination of Phthalates, issued on April 1, 2010 (``CPSC Test
Method''). This is the most recent version of the test method, and it
can be downloaded from the CPSC Web site at http://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.3.pdf; and/or
GB/T 22048-2008, Toys and Children's Products--
Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic,
issued on June 16, 2008 (``Chinese Test Method'').
The Commission is recognizing limited circumstances in which it
will accept certifications based on product testing conducted before
the publication of this notice of requirements. The details regarding
those limited circumstances can be found in part VI 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 test methods CPSC-CH-C1001-09.3, Standard Operating
Procedure for Determination of Phthalates, and GB/T 22048-2008, Toys
and Children's Products--Determination of Phthalate Plasticizers in
Polyvinyl Chloride Plastic. The CPSC acknowledges that the test methods
for determining phthalates content are not, by themselves, rules that
are codified in the Code of Federal Regulations. However, section
108(d) of the CPSIA considers the phthalates content limits to be
``consumer product safety standards'' under the Consumer Product Safety
Act. Section 14(a)(3)(B)(vi) of the CPSA directs the Commission to
publish notices of requirements for the accreditation of third party
conformity assessment bodies to assess conformity with ``other
children's product safety rules,'' and section 14(f)(1) of the CPSA
defines a ``children's product safety rule,'' in part, as ``a consumer
product safety rule under [the CPSA].'' Section 3(a)(6) of the CPSA, in
turn, defines a ``consumer product safety rule'' as ``a consumer
products safety standard described in section 7(a) [of the CPSA] * * *
or a rule under this Chapter declaring a consumer product a banned
hazardous product.'' Accordingly, because the phthalates content limits
are ``consumer product safety standards'' under the CPSA, it follows
that they are also ``consumer product safety rules'' under section
3(a)(6) of the CPSA and, in turn, ``children's product safety rules''
under section 14(f)(1) of the CPSA. Thus, the phthalates content limits
are ``children's product safety rules'' for which a notice of
requirements for accreditation of third party conformity assessment
bodies must be published. In addition, because the test methods would
be used to assess conformity with the phthalates limits, it is
appropriate for the notice of requirements to apply to the CPSC Test
Method and the Chinese Test Method.
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 requirement refers only to ``other children's
product safety rules.'' Nevertheless, section 14(a)(3)(B)(vi) of the
CPSA could be construed to require 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. 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 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.
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 the phthalates limits of
section 108 of the CPSIA. 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
[[Page 49288]]
absence of a notice of requirements. The phthalates content testing and
certification requirements for children's toys and child care articles
were included in that section of the December 28, 2009 notice. The
absence of a notice of requirements prevented the lifting of the stay
in the December 28, 2009 notice with regard to testing and
certifications of children's toys and child care articles for
phthalates content. On February 8, 2011, the Commission published a
notice in the Federal Register (76 FR 6765), continuing the stay of
enforcement for testing and certification of children's products for
which a notice of requirements for accreditation of laboratories had
not yet been published.
The phthalates content testing and certification requirements for
children's toys and child care articles were mentioned specifically as
an example of a provision for which the stay would continue, pending
publication of the notice of requirements. Thus, publication of this
notice of requirements would have had the effect of lifting the stay on
testing and certification requirements for phthalates content in
children's toys and child care articles; however, on July 27, 2011, the
Commission voted to stay enforcement of the testing and certification
requirements of section 14 of the CPSA with respect to toys and child
care articles subject to the phthalates content limits until December
31, 2011.
Accordingly, the Commission will enforce third party testing and
certification requirements for products subject to the phthalates
content limits if such products are manufactured on or after January 1,
2012. (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. Testing & Certification to Phthalates Limits--Prior Guidance
Remains in Effect
The Commission approved a ``Statement of Policy: Testing of
Component Parts with Respect to Section 108 of the Consumer Product
Safety Improvement Act'' on August 7, 2009. On August 17, 2009, a
Notice of Availability regarding the Statement of Policy was published
in the Federal Register (74 FR 41400). The Statement of Policy can be
viewed and downloaded from the CPSC Web site at: http://www.cpsc.gov/about/cpsia/componenttestingpolicy.pdf. In brief, we believe that only
those plastic parts or other product parts which could conceivably
contain phthalates (``plasticized component parts'') should be tested
for phthalates. We consider it to be unnecessary to test and certify
materials that are known not to contain phthalates or to certify that
phthalates are absent from materials that are known not to contain
phthalates.\2\ In addition, we believe that when testing covered
products, the assessment of the concentration of phthalates is to be
based on testing of the plasticized component parts, rather than
testing of the entire product, to avoid dilution of the concentrations
of phthalates that can occur when the entire product is considered. The
Statement of Policy remains in effect until further notice (except that
the CPSC Test Method referenced in the Statement of Policy, CPSC-CH-
C1001-09.2, has been superseded by CPSC-CH-C1001-09.3 as outlined in
part VI of this document below).
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\2\ Untreated/unfinished wood, metal, natural fibers, natural
latex and mineral products are not expected to inherently contain
phthalates and need not be tested or certified provided that these
materials have neither been treated or adulterated with the addition
of materials that could result in the addition of phthalates into
the product or material.
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The Commission voted to publish a ``Draft Guidance Regarding Which
Children's Products are Subject to the Requirements of CPSIA Section
108'' on February 13, 2009. On February 23, 2009, the staff guidance
was published in the Federal Register (74 FR 8058). This staff guidance
can be viewed and downloaded from the CPSC Web site at: http://www.cpsc.gov/businfo/frnotices/fr09/draftphthalatesguidance.pdf. The
Commission may choose to update this staff guidance or initiate a
formal rulemaking concerning the topics addressed by the guidance after
receipt of the Chronic Hazard Advisory Panel report required by section
108(b)(2)(C) of the CPSIA. Until such time, this staff guidance remains
in effect (except that the CPSC Test Method referenced in the guidance,
CPSC-CH-C1001-09.1, has been superseded by CPSC-CH-C1001-09.3 as
outlined in part VI of this document below).
Answers to frequently asked questions that provide guidance
concerning the requirements of section 108 of the CPSIA can be viewed
on the CPSC Web site at: http://www.cpsc.gov/about/cpsia/sect108.html#faqs. The Commission intends for this guidance to be
useful and therefore the materials on this Web page may be modified
periodically in the future. In order to receive automatic notification
of any such updates, interested parties may sign up for the CPSIA email
subscription list at: https://www.cpsc.gov/about/cpsia/cpsialist.aspx.
The Commission notes that the phthalate content limits in section 108
of the CPSIA are statutory requirements and we may always take action
with regard to products defined in this section of the statute that
exceed those limits.
III. Responses to Comments Received on the CPSC Testing Method
The Commission requested comments regarding the Statement in the
Notice of Availability published in the Federal Register (74 FR 41400).
We received several comments on the CPSC Test Method. We describe and
respond to the comments in this section of the document. To make it
easier to identify the comments and our responses, the word
``Comment,'' in parentheses, will appear before the comment's
description, and the word ``Response,'' in parentheses, will appear
before our response. We also have numbered each comment to help
distinguish between different topics. The number assigned to each
comment is for organizational purposes only and does not signify the
comment's value, or importance, or the order in which it was received.
(Comment 1)--Some commenters questioned the necessity to run the
test in triplicate. Other test multiples from two to five were
suggested. Some commenters asked whether the sample to be tested always
needed to be ground to a powder. A commenter asked about the proper
cleaning protocol of the cryogenic mill.
(Response 1)--We have examined all suggestions and comments
pertaining to the CPSC Test Method and have updated our test method to
address these issues (CPSC-CH-C1001-09.3). We adjusted the method to
allow the third party conformity assessment body to choose an
appropriate quality assurance program; thus, the third party conformity
assessment body will determine the number of replicates to be tested.
The CPSC Test Method allows, but does not require, third party
conformity assessment bodies to pulverize the sample. Cryogenic mill
equipment should be cleaned as thoroughly as any other laboratory
equipment that comes into contact with a sample.
(Comment 2)--One commenter suggested that the official Chinese test
method, GB/T 22048-2008, Toys and Children's Products--Determination of
Phthalate Plasticizers in Polyvinyl
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Chloride Plastic, should be added to the lists of acceptable extraction
and analysis methods. The commenter also suggested that each
plasticized component part should be cut into pieces no larger than 2
mm prior to the extraction step.
(Response 2)--We have reviewed the test method GB/T 22048-2008 and
determined that it is an acceptable test method for inclusion in this
notice of requirements. With regard to the 2 mm maximum size of pieces,
we agree with this comment and have incorporated the dimension into the
current edition of the CPSC Test Method (CPSC-CH-C1001-09.3).
(Comment 3)--Another commenter suggested that the CPSC Test Method
include a description of the limit of detection (LOD) and limit of
quantitation (LOQ). The commenter added that, on the last page of CPSC-
CH-C1001-09.2, there appears to be an error in the DEHP calculation.
Under column C, measured DEHP concentration by GC-MSW is 200 [micro]g/
ml. In the final calculation column, 200 [micro]g/ml is mistakenly
cited as 20 [micro]g/ml.
(Response 3)--Detection and quantitation limits have not been
outlined specifically at this point. Third party conformity assessment
bodies should follow their own internal quality assurance program.
These limits may be introduced in the future, following further
validation and round robin studies. The DEHP calculation included a
typographical error that was corrected for the current edition of the
test method (CPSC-CH-C1001-09.3).
(Comment 4)--One commenter stated that grinding the sample into a
powder is time-consuming, adds additional expense to the testing
methods, and could introduce the possibility of significant
interlaboratory variability.
(Response 4)--Grinding the sample into a powder is no longer
required in the CPSC Test Method; however, third party conformity
assessment bodies may continue to do so, if they wish.
(Comment 5)--One commenter asked how the CPSC Test Method prevents
interferences that can lead to a false positive for the phthalates of
interest. The commenter also asked if the detection method could be
revised.
(Response 5)--We have updated the CPSC Test Method (to CPSC-CH-
C1001-09.3) to include a vigorous qualitative assessment by trained
staff to avoid false positives. Such steps include: Retention time
matching with known standards and full-scan mass spectrum analysis. We
will continue to consider new methods that could simplify or improve
the analysis.
(Comment 6)--One commenter pointed out typographical
inconsistencies found within the text of the method. Additionally, the
commenter asked: What is the minimum signal-to-noise ratio required,
and what are the reproducibility and detection limits of the method?
(Response 6)--We have corrected the typographical errors that might
have caused confusion. Signal-to-noise, detection limits, and
reproducibility requirements have not been outlined specifically at
this point. Third party conformity assessment bodies should follow
their own internal quality assurance program. Testing requirements may
be adjusted following further validation and round robin studies.
(Comment 7)--One commenter asked if the chromatography was
optimized.
(Response 7)--The gas chromatography parameters outlined have been
successful at providing adequate separation while minimizing sampling
time. However, due to the nature of DINP and DIDP, they will not
completely separate chromatographically. DINP and DIDP are actually a
mixture of compounds; DINP and DIDP contain some of the same phthalate
species, leading to an overlap. We recommend following the selection
monitoring analysis scheme outlined in the CPSC Test Method to quantify
these compounds for instances when they are both present.
(Comment 8)--One commenter suggested that we create a flexible
correlative policy that permits use of several methods suitable for the
routine identification and measurement of total phthalate
concentration, such as ASTM D7083-04, the Canada Product Safety Bureau
method, the European Toy Safety Directive method, and GB/T 22048-2008,
Toys and Children's Products--Determination of Phthalate Plasticizers
in Polyvinyl Chloride Plastic.
(Response 8)--The current edition of the CPSC Test Method (CPSC-CH-
C1001-09.3) allows alternative test methods. Additionally, any
combination of the approved extraction and analysis methods listed may
be used. We have included GB/T 22048-2008, Toys and Children's
Products--Determination of Phthalate Plasticizers in Polyvinyl Chloride
Plastic, as an additional test method in this notice of requirements.
We have not included ASTM D7083-04 as an alternative detection method
due to the lack of selectivity from using a flame ionization detector;
this method may lead to false positives. We will review other suggested
methods and may include them as alternatives in future revisions of the
test method.
IV. 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 CPSC-
CH-C1001-09.3, Standard Operating Procedure for Determination of
Phthalates, and/or to the test method GB/T 22048-2008, Toys and
Children's Products--Determination of Phthalate Plasticizers in
Polyvinyl Chloride Plastic. 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 IV.B
and IV.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 children's toys and
child care articles for phthalates content to support certification by
the manufacturer or private labeler of compliance with the test
method(s) 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 IV.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
[[Page 49290]]
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 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 IV.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 IV.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.
V. 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 ILAC-MRA accreditation certificate and scope
statement, and firewalled third party conformity assessment body
training document(s), if relevant.
CPSC 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 staff's review is complete, 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 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 begin
testing children's products to support certification of compliance with
the phthalates content limits for which it has been accredited.
VI. Acceptance of Children's Product Certifications Based on Third
Party Conformity Assessment Body Testing to CPSC-CH-C1001-09, Standard
Operating Procedure for Determination of Phthalates, and/or GB/T 22048-
2008, Toys and Children's Products--Determination of Phthalate
Plasticizers in Polyvinyl Chloride Plastic, Prior to the Effective Date
For certifications of children's toy or child care articles subject
to the phthalates content limits in section 108 of the CPSIA, the
Commission will allow certifications to be based on prior testing under
certain conditions. Firms that elect to voluntarily have the phthalates
content of children's toys and child care articles tested by a third
party conformity assessment body, using either the CPSC Test Method or
the Chinese Test Method, before January 1, 2012, will not need to have
those products retested. The Commission's acceptance of certifications
based on prior testing under certain conditions should prevent testing
backlogs at accredited third party conformity assessment bodies, making
it less likely that the Commission will have to postpone the effective
date for certification.
The Commission will accept a certificate of compliance to the
phthalates limits in section 108 of the CPSIA 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) 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
[[Page 49291]]
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 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;
For tests conducted using the CPSC Test Method, the test
was conducted on or after July 27, 2009. The Commission has chosen July
27, 2009, because it is the date the Commission posted a test method
for testing component parts for phthalates on the Commission Web site:
(http://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.2.pdf). The test
method was updated on April 1, 2010, to the current method (http://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.3.pdf.). The Commission will
accept phthalates content certifications for products tested before
January 1, 2012, if the product was tested using either CPSC-CH-C1001-
09.2 or CPSC-CH-C1001-09.3. The Commission acknowledges that, on March
3, 2009, it released a test method that involved testing the entire
product (http://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.1.pdf)
(``March 2009 test method''). The Commission will not accept phthalates
content certifications for products tested using the March 2009 test
method (CPSC-CH-C1001-09.1). The Commission considers testing the
entire product to be less protective of children because mouthable
component parts with high concentrations of phthalates in products with
large quantities of nonplasticized parts would be able to pass the test
because the total mass of the product would dilute the overall
phthalate measure.
For tests conducted using the Chinese Test Method, the
test was conducted on or after June 18, 2008. The Commission has chosen
June 18, 2008, because that is the date that the Chinese Test Method
was issued.
The third party conformity assessment body's application
for accreditation is accepted by CPSC by the mandatory effective date,
as established by the Commission;
The accreditation scope in the application for
accreditation expressly includes one or both of the acceptable test
methods identified earlier in part I of this document;
The test results show compliance with the applicable
current standards; and
The third party conformity assessment body's accreditation
and inclusion of one or both of the test methods (identified earlier in
part I of this document) in its scope remain in effect through the
effective date for mandatory third party testing and manufacturer
certification for the subject products' respective standards.
Dated: July 29, 2011.
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. 2011-19678 Filed 8-9-11; 8:45 am]
BILLING CODE 6355-01-P