[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Rules and Regulations]
[Pages 69546-69583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27677]
[[Page 69545]]
Vol. 76
Tuesday,
No. 216
November 8, 2011
Part IV
Consumer Product Safety Commission
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16 CFR Parts 1109
Conditions and Requirements for Relying on Component Part Testing or
Certification, or Another Party's Finished Product Testing or
Certification, To Meet Testing and Certification Requirements; Final
Rule
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 /
Rules and Regulations
[[Page 69546]]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1109
[CPSC Docket No. CPSC-2010-0037]
Conditions and Requirements for Relying on Component Part Testing
or Certification, or Another Party's Finished Product Testing or
Certification, to Meet Testing and Certification Requirements
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: The Consumer Product Safety Commission (``CPSC,''
``Commission,'' or ``we'') is issuing a final rule regarding the
conditions and requirements for relying on testing or certification of
either component parts of consumer products, or another party's
finished product, or both, to demonstrate, in whole or in part,
compliance of a consumer product with all applicable rules, bans,
standards, and regulations to support a children's product certificate
(``CPC''); as part of the standards and protocols for continued testing
of children's products; or to meet the requirements of any other rule,
ban, standard, guidance, policy, or protocol regarding consumer product
testing that does not already directly address component part testing.
DATES: The final rule is effective on December 8, 2011.\1\
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\1\ The Commission voted 3-2 to publish this final rule, with
changes, in the Federal Register. Chairman Inez M. Tenenbaum,
Commissioners Robert S. Adler and Thomas H. Moore voted to publish
the final rule with changes. Commissioners Nancy A. Nord and Anne M.
Northup voted against publication of the final rule. Chairman
Tenenbaum, Commissioner Adler, and Commissioner Moore issued a joint
statement. Commissioner Nord and Commissioner Northrup issued
statements. The statements can be found at http://www.cpsc.gov/pr/statements.html.
FOR FURTHER INFORMATION CONTACT: Randy Butturini, Project Manager,
Office of Hazard Identification and Reduction, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301)
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504-7562; email rbutturini@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. What is the purpose of the final rule?
Elsewhere in this issue of the Federal Register, we are issuing a
final rule titled, ``Testing and Labeling Pertaining to Product
Certification.'' That rule addresses testing, continuing testing, and
labeling requirements for children's products, and creates a new 16 CFR
part 1107. It is the hope of the Commission that component part testing
will help manufacturers meet their testing, continuing testing, and
certification obligations under section 14 of the Consumer Product
Safety Act (``CPSA'').
This final rule on component part testing is intended to give all
parties involved in testing and certifying consumer products pursuant
to sections 14(a) and 14(i) of the CPSA the flexibility to conduct or
rely on required certification testing where such testing is the
easiest and least expensive. For example, it may be more efficient to
test component parts of consumer products before final assembly. Such
testing may be done by component part suppliers so that test reports
can be provided to multiple manufacturers using such component parts.
Alternatively, manufacturers who assemble finished products can test
component parts as they are received to reduce costs where, for
example, the same component part is used in multiple product lines. The
final rule allows for maximum flexibility because a domestic
manufacturer or importer who is required to certify consumer products
pursuant to 16 CFR part 1110 (``finished product certifier'') can base
such certificate upon one or more of the following: (a) Component part
testing; (b) component part certification; (c) another party's finished
product testing; or (d) another party's finished product certification.
Component part testing as described in this rule is voluntary.
While some regulations may require testing a component part of a
product to meet a standard, such as the lead content limit in
children's products, which must be measured in parts per million per
component part, component part testing is never required to be
conducted before assembly of a final product. A finished product
certifier has the option to contract with its component part suppliers
to conduct testing on component parts before assembly; it could procure
testing of component parts after receiving them from suppliers but
before assembly; or it could provide a sufficient number of finished
products to a third party conformity assessment body to test for lead
content on a per component part basis.
Although relying on another party's finished product testing or
certification, or on component part testing before final assembly of a
consumer product, is voluntary, once a party decides to conduct or rely
upon either, the requirements in this rule apply. To the extent
component part testing is not addressed by another CPSC-enforced rule,
regulation, standard, or protocol, the final rule will apply. In
general, certifiers should test and certify consumer products,
including children's products, based on the most specific regulation
that applies to such consumer product.
Except for component part testing for phthalate content, discussed
in section II.D.3 of this preamble, this final rule is intended to
supersede all policy statements and guidelines as they apply to testing
of component parts.
B. What does the law require?
Except as provided in section 14(a)(2) of the CPSA, section
14(a)(1) of the CPSA, 15 U.S.C. 2063(a)(1), requires manufacturers and
private labelers of a product that is subject to a consumer product
safety rule (defined in section 3(a)(6) of the CPSA), or to any similar
rule, ban, standard, or regulation under any other act enforced by the
Commission, to issue a certificate of conformity. The certificate: (1)
Must certify, based on a test of each product or upon a reasonable
testing program, that the product complies with all CPSC requirements;
and (2) must specify each rule, ban, standard, or regulation applicable
to the product. This certificate is called a General Conformity
Certificate (``GCC'') for non-children's products. Although discussed
in the proposed rule, the final rule on ``Testing and Labeling
Pertaining to Certification'' does not implement requirements for a
reasonable testing program for non-children's products. Accordingly, we
have not adopted any provisions in this final rule directly related to
a reasonable testing program or a GCC. It should be noted, however,
that although we are not implementing requirements for a reasonable
testing program for non-children's products, manufacturers of non-
children's products that are subject to a product safety rule, ban,
standard, or regulation are still obligated by the CPSA, as amended by
the CPSIA, to certify that their products comply with all applicable
safety rules based on a test of each product or a reasonable testing
program. Nothing in this rule is intended to preclude a certifier from
using component part testing as part of a reasonable testing program to
certify non-children's products.
Section 14(a)(2) of the CPSA, 15 U.S.C. 2063(a)(2), requires
manufacturers and private labelers of any children's product that is
subject to a children's product safety rule to submit samples of the
product, or samples that are identical in all material respects to the
product, to a third party conformity assessment body whose
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accreditation has been accepted by the CPSC to be tested for compliance
with such children's product safety rule. Based on that testing, the
manufacturer or private labeler must issue a certificate that certifies
that such children's product complies with the children's product
safety rule based on the assessment of a third party conformity
assessment body accredited to conduct such tests. 15 U.S.C.
2063(a)(2)(B). The manufacturer or private labeler of the children's
product must issue either a separate certificate for each applicable
children's product safety rule or a combined certificate that certifies
compliance with all applicable children's product safety rules and
specifies each such rule. This certificate is called a Children's
Product Certificate (``CPC'').
Section 14(i)(2)(B) of the CPSA, 15 U.S.C. 2063(i), requires the
Commission, by regulation, to establish protocols and standards for
ensuring that a certified children's product that has been tested for
compliance with all applicable children's product safety rules is
subjected to additional testing periodically and when there has been a
material change in the product's design or manufacturing process,
including the sourcing of component parts. The final rule on ``Testing
and Labeling Pertaining to Product Certification,'' 16 CFR part 1107,
implements sections 14(a) and (i) of the CPSA. (On August 12, 2011, the
President signed H.R. 2715 into law. Among other things, H.R. 2715
corrected an editorial error in section 14 of the CPSA, by renumbering
a second section 14(d) of the CPSA on ``Additional Regulations for
Third Party Testing'' to section 14(i) of the CPSA. Accordingly,
throughout this preamble, including comment summaries and responses, we
have replaced references to section 14(d) of the CPSA with section
14(i) of the CPSA to be consistent with this renumbering.)
Section 14(g) of the CPSA contains additional requirements for
certificates. 15 U.S.C. 2063(g). Each certificate must identify the
manufacturer or private labeler issuing the certificate and any third
party conformity assessment body on whose testing the certificate
depends. The certificate must include, at a minimum, the date and place
of manufacture, the date and place where the product was tested, each
party's name, full mailing address, telephone number, and contact
information for the individual responsible for maintaining records of
test results. Every certificate must be legible, and all required
content must be in the English language. A certificate also may contain
the same content in any other language.
Section 14(g) of the CPSA also states that every certificate must
accompany the applicable product or shipment of products covered by the
same certificate, and a copy of the certificate must be furnished to
each distributor or retailer of the product. Upon request, the
manufacturer or private labeler issuing the certificate must furnish a
copy of the certificate to the Commission. CPSC regulations, at 16 CFR
part 1110, limit the parties responsible for issuing certificates to
domestic manufacturers and importers. Part 1110 also specifies the form
and content of certificates, and other requirements, including that
certificates can be provided in electronic form.
Finally, we note that H.R. 2715 requires us to seek public comment
on the extent to which manufacturers with a substantial number of
different components subject to third party testing may be evaluated to
show compliance with an applicable rule, ban, standard, or regulation
by third party testing of a subset of such components selected by a
third party conformity assessment body. This final rule allows finished
product certifiers to use component part testing to meet certification
requirements under certain circumstances. Elsewhere in this issue of
the Federal Register, we have published a notice seeking comment on the
issues specified in H.R. 2715, including the testing of a subset of
components.
C. What comments did we receive about the proposed rule?
In the Federal Register of May 20, 2010 (75 FR 28208), we published
a proposed rule that would establish a new part 1109, titled,
``Conditions and Requirements for Testing Component Parts of Consumer
Products.'' Proposed part 1109 would consist of two subparts: Subpart
A--General Conditions and Requirements, and Subpart B--Conditions and
Requirements for Specific Consumer Products, Component Parts, and
Chemicals. The proposed rule was intended to set out the conditions
under which a party certifying a product under section 14 of the CPSA
would be able to rely on tests of component parts of the product,
including materials used to produce it, as all or part of the basis for
a valid certificate verifying that the product complies with all
applicable requirements enforced by the Commission.
We received 26 comments on the proposed rule, discussing 58
different issues. Most commenters supported the proposed rule. For
example, one commenter suggested that the testing and certification of
component parts can be cost effective. Other commenters stated that the
proposed rule, along with the proposed rule on testing and labeling,
which appeared in the same issue of the Federal Register, were well
thought out and wholly appropriate. Another commenter said that
component part testing was more practical and protective of consumers
than requiring all tests to be performed on the finished product.
Another commenter stated that the rule appropriately placed the final
responsibility for ensuring that only certified component parts are
used in the finished product on the finished product certifier. Another
commenter liked the strong chain of custody and expressed the belief it
would encourage manufacturers to use suppliers who have good practices.
Other commenters expressed general concerns about the proposed
rule. For example, one commenter thought that the rule's complexity
would limit the willingness of some suppliers to certify their
component parts voluntarily and therefore, limit the relief that the
rule would provide to small businesses.
We discuss these comments, and our responses, in part II of this
preamble.
II. Comments on the Proposed Rule, CPSC's Responses, and Explanation of
the Final Rule
A. Introduction
The final rule establishes a new 16 CFR part 1109, setting forth
the conditions and requirements for relying on component part testing
or certification, or another party's finished product testing or
certification, to meet testing and certification requirements. The new
part 1109 consists of three subparts: Subpart A--General Conditions and
Requirements; Subpart B--Conditions and Requirements for Specific
Consumer Products, Component Parts, and Chemicals; and Subpart C--
Conditions and Requirements for Composite Testing.
In this section, we describe each section of the proposed rule,
summarize the comments we received for each section, and respond to the
comments. We also discuss what changes we made to the final rule. A
summary of each of the commenters' topics is presented, and each topic
is followed by the Commission's response. For ease of reading, each
topic will be prefaced with a numbered ``Comment''; and each response
will be prefaced by a corresponding numbered ``Response.'' Each
``Comment'' is numbered to help distinguish between different topics.
The number assigned to each comment
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is for organizational purposes only and does not signify the comment's
value or importance or the order in which it was received. Comments on
similar topics are grouped together.
B. General Comments
1. Should the final rule include finished products?
In the preamble to the proposed rule, we invited comment on whether
the final rule should allow finished product certifiers to rely on
tests or certifications on finished products as well as on component
parts:
The Commission invites comment on whether finished product
certifiers should be permitted to rely on other types of
certifications from other persons (in addition to component part
certifications). The proposed rule only would allow a finished
product certifier to rely on certificates relating to the
performance of individual component parts; it would not authorize a
finished product certifier to rely on a certificate from another
party certifying that the finished product itself complies with an
applicable rule. For example, it would not allow certification by
others in the case of standards, such as the small parts ban at 16
CFR 1500.19, which require testing of the entire product as opposed
to an individual component. Should this limitation be modified so
that the importer of a product would be able to base its own
certification on what might be termed a ``subordinate'' certificate
from a foreign manufacturer or other interested party to the effect
that the product complies with one or more of these standards? What
are the risks and benefits of allowing such an arrangement?
75 FR at 28209.
(Comment 1)--Some commenters asked whether an importer can accept a
finished product certificate from a foreign manufacturer to certify the
product. Some commenters stated that, occasionally, two certified
products are bundled together for retail sale as a single unit. The
commenters stated that the retailer or importer should be able to rely
upon the certificates for each of the two bundled products, rather than
have to follow the process of certifying the bundled product.
(Response 1)--The preamble to the proposed rule invited comment on
whether we should allow finished product suppliers to issue finished
product certificates upon which importers or other certifiers receiving
such products from the suppliers could use as the basis for issuing
their finished product certificates (75 FR 28209). The final rule
allows this practice because no practical difference exists between
relying on another party's component part testing or certification and
relying on another party's finished product testing or certification,
provided the same due care and documentation requirements are followed
for both types of testing and certification. Just as with component
part testing and certification, certifiers may be able to achieve
efficiencies by using this approach and still ensure compliance to
applicable safety standards.
For example, under the final rule, an importer can rely on finished
product testing or certification provided by a foreign supplier, as
suggested by the commenter. Where multiple parties import the same
product, a foreign supplier could provide finished product testing
reports or certifications to all importers, removing the necessity for
each importer to conduct certification testing. Likewise, a party who
``bundles'' one or more finished products can rely on finished product
testing or certifications from another party to issue a finished
product certificate for the bundled product. In cases where a finished
product certifier combines more than one certified finished product, it
has several options in certifying such bundled product. Based on the
certificates received for each product in the bundle, the finished
product certifier can: (a) Issue a new certificate for each product in
the bundle; (b) issue a new certificate for the bundled product; or (c)
pass along the finished product certificates provided by another party.
If the certifier chooses option (b), the certificate should indicate
what information required by section 14(g)(1) of the CPSA and 16 CFR
part 1110 is applicable to each product.
Our intent is that children's products introduced into commerce in
the United States are certified as compliant with all applicable
children's product safety rules by a party required to issue such
certificate pursuant to 16 CFR part 1110, a domestic manufacturer or an
importer. There are multiple ways that this can be achieved by a party
required to certify a children's product. The party required to certify
a children's product may use one or more of the following:
Procure component part testing (for those tests for which
component part testing is allowed) or finished product testing from a
CPSC-accepted third party conformity assessment body and issue a
finished product certificate based on those passing test results;
Rely upon component part testing or finished product
testing, procured by another party using a CPSC-accepted third party
conformity assessment body, as a basis for issuing a finished product
certificate; or
Rely upon component part certification or finished product
certification from another party as a basis for issuing a finished
product certificate. If the supplier providing a certificate is also a
required certifier (a domestic manufacturer or importer), then the
party receiving a certificate does not need to reissue a certificate.
If the supplier providing a certificate is doing so voluntarily, and is
not required to provide a certificate, then the domestic manufacturer
or importer must issue the finished product certificate. It may do so
based on the certificates provided.
We also have revised the title for part 1109 from, ``Conditions and
Requirements for Testing Component Parts of Consumer Products,'' to
``Conditions and Requirements for Relying on Component Part Testing or
Certification, or Another Party's Finished Product Testing or
Certification, to Meet Testing and Certification Requirements.'' The
revised title reflects more accurately the fact that the rule sets
forth conditions and requirements for relying on testing and
certification of component parts, as well as for relying on another
party's testing and certification of finished products, to meet the
testing and certification requirements in section 14 of the CPSA. We
also revised the following sections to reflect that a finished product
certifier may rely on finished product testing or certification, in
addition to component part testing or certification, from another party
who is not required to conduct testing or issue certifications: Sec.
1109.1; Sec. 1109.2; Sec. 1109.3; Sec. Sec. 1109.4(c), (i), and (m);
Sec. Sec. 1109.5(b), (d), (f), (g), (h), and (i).
2. Can there be a ``master certificate'' relied upon by multiple
manufacturers?
(Comment 2)--One commenter encouraged us to allow importers to
reference a ``master certificate'' issued by another interested party,
such as the manufacturer. The commenter stated that in many cases,
multiple importers will import identical finished products. Often,
these are nationally branded products that simply are imported
separately by multiple retailers for convenience. Without the ability
to reference another ``master'' certificate, each importer/retailer
would have to generate its own certificate independently, the commenter
asserted.
(Response 2)--As set forth in response to Comment 1 in section II.B
of this preamble, if a foreign manufacturer certifies its product and
sells that product to many importers, each importer may use the
manufacturer's certificate (and other required records) to issue its
own certificate. Importers may rely on a ``master certificate'' issued
by another interested party, such
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as a foreign manufacturer, to eliminate redundant testing, but only if
the importer issues its own certificate. Requiring the importer to
generate its own certificate means that the importer must exercise due
care to make certain that the foreign manufacturer's testing and
certification procedures are sufficient to ensure compliance with CPSC
regulations, as well as aid the CPSC's enforcement of certification
requirements.
If the importer makes a material change in the product, the
importer may be able to use the manufacturer's certificate, plus tests
pertaining only to the material change, as a basis for issuing its own
certificate. Importers remain responsible for the recordkeeping
requirements of products they certify.
3. Must component part manufacturers test their components?
(Comment 3)--One commenter stated that we should clarify that
component part testing is entirely voluntary for parties supplying
component parts or finished products to a finished product certifier
(``upstream suppliers''). The commenter further stated that raw
material or component part producers, who voluntarily certify their
components parts, should be able to include relevant limitations on the
certification form to avoid any confusion about the scope of the
certification and should not have to furnish certificates in connection
with the finished consumer product.
(Response 3)--We agree that component part testing by component
part suppliers is voluntary. To reduce any possible confusion about
whether the CPSA requires component part manufacturers or suppliers to
provide component part certificates, we have added clarifying language
regarding the voluntary nature of providing component part test reports
or component part certifications by parties other than those who are
required to certify pursuant to 16 CFR part 1110. The clarifying
language appears in the following sections: (1) Scope--Sec. 1109.1;
(2) Applicability--Sec. 1109.3; (3) definition of ``component part
certifier''--Sec. 1109.4(c); and (4) the definition of ``finished
product certifier''--Sec. 1109.4(h). For example, Sec. 1109.1 now
states: ``Component part manufacturers and suppliers may certify or
test their component parts, but are not required to do so.'' As another
example, the definition of ``component part certifier'' in Sec.
1109.4(c) now states that a component part certifier is a party who
voluntarily issues a certificate, even though they are not required to
do so. Further, in the first sentence of Sec. 1109.5(a) of the final
rule, we have clarified that ``[a]ny party, including a component part
manufacturer, a component part supplier, a component part certifier, or
a finished product certifier, may procure component part testing as
long as it complies with the requirements in this section and subparts
B and C of this part.''
With regard to limiting the scope of a certificate, the scope of a
certificate is dictated by statute and regulation. Sections 14(a)(1)(B)
(for non-children's products) and 14(a)(2)(B) (for children's products)
of the CPSA state that a certificate must list each safety rule
applicable to the product. This requirement is mirrored in 16 CFR
1110.11(b). Pursuant to proposed Sec. 1109.5(g) (renumbered to Sec.
1109.5(h) in the final rule), component part certificates also must
meet the content requirements in 16 CFR 1110.11. Thus, a component part
supplier who voluntarily certifies component parts must list all safety
standards and regulations to which the certificate applies. Unlike a
finished product certificate, however, a component part certifier may
not know all of the rules and regulations that a component part
ultimately may be subject to, or may not choose to certify a component
part to every applicable rule and regulation, depending upon what type
of finished product incorporates the component part. The requirement to
list the safety standards and regulations being certified should allow
component part certifiers to state unambiguously the scope of the
certification.
Finished product manufacturers should be mindful of the scope of
component part certifications and of how such component parts are
integrated into finished products to ensure that any additional testing
required to certify the finished product is met. For example, a
component part supplier of colored bolts may certify to the lead paint
and lead in substrate standards. A finished product certifier using
such bolts in a children's product would not need to retest for these
standards. However, a finished product certifier likely still would
need to conduct additional small parts testing on the finished product
because small parts testing is something that only can be conducted on
finished products.
Finally, under Sec. 1109.5(g), component part certifiers must
provide certificates to the finished product certifier who is relying
on such certification. A component part certifier, however, does not
have to furnish certificates to accompany a finished product; only the
finished product certifier must do this, pursuant to 16 CFR part 1110.
C. Subpart A--General Conditions and Requirements
1. Proposed Sec. 1109.1--Scope
Proposed Sec. 1109.1 would describe the scope of part 1109 as:
``applying to all tests of component parts of consumer products where
the test results are used to support a certificate of compliance issued
pursuant to section 14(a) of the CPSA or where the tests are otherwise
required or permitted by section 14 of the CPSA.''
As stated earlier in our response to Comment 3 in section II.B of
this preamble, we have revised Sec. 1109.1 to clarify that component
part manufacturers and suppliers may certify or test their component
parts, but they are not required to do so. Parties who are not required
to test finished products or to issue finished product certificates
pursuant to 16 CFR part 1110 may also voluntarily test such finished
products or issue finished product certificates.
Additionally, because the final rule extends to finished products,
we have reorganized Sec. 1109.1 to include finished products. As
revised, Sec. 1109.1(a) describes the overall scope of part 1109.
Section 1109.1(b) clarifies that component part testing and
certification and finished product testing and certification under part
1109 are voluntary. We also have added, on our own initiative, a new
Sec. 1109.1(c) to summarize the three subparts in part 1109, and we
have revised the reference to section 14(d) of the CPSA to section
14(i) of the CPSA due to renumbering arising out of H.R. 2715.
2. Proposed Sec. 1109.2--Purpose
Proposed Sec. 1109.2 would discuss the rule's purpose, which is to
set forth the conditions and requirements under which the Commission
will require or accept the results of testing of component parts of
consumer products, instead of the entire consumer product, to meet, in
whole or in part, the testing and certification requirements of
sections 14(a), 14(b), and 14(d) of the CPSA.
We received no comments related directly to the purpose of the
proposed rule. As stated earlier in our response to Comment 1 in
section II.B of this preamble, we revised the purpose in the final rule
to incorporate the concept that a finished product certifier may rely
upon finished product testing or certification from another party, in
addition to component part testing or certification, to meet the
testing and
[[Page 69550]]
certification requirements in sections 14(a) and 14(i) of the CPSA.
Likewise, we removed the concept that a component part could be tested
``instead of the entire consumer product,'' as stated in the proposed
rule because the final rule also allows a finished product certifier to
rely on testing or certification of a finished product conducted by
another party. On our own initiative, we removed the reference to
section 14(b) of the CPSA in the last sentence, which now states that
component part testing or finished product testing can be used to meet
the testing and certification requirements of sections 14(a) and 14(i)
of the CPSA. While nothing prohibits certifiers from using component
part testing as part of a reasonable testing program, section 14(b) of
the CPSA does not itself contain a certification or testing
requirement. Section 14(b) of the CPSA allows the Commission to
prescribe a reasonable testing program by rule. Elsewhere in this issue
of the Federal Register, we have issued a final rule on ``Testing and
Labeling Pertaining to Product Certification.'' The final rule on
``Testing and Labeling Pertaining to Product Certification'' reserves,
rather than finalizes, provisions pertaining to a ``reasonable testing
program.'' Thus, we removed the reference to section 14(b) of the CPSA.
We also revised the reference to section 14(d) of the CPSA to cite
section 14(i) of the CPSA throughout the rule as a result of
renumbering arising out of H.R. 2715.
3. Proposed Sec. 1109.3--Applicability
Proposed Sec. 1109.3 would specify that the rule applies to all
manufacturers, importers, or private labelers and to the manufacturers
or suppliers of component parts that are responsible for: (1)
Certifying products under section 14(a) of the CPSA or for continued
compliance testing under section 14(d) of the CPSA; or (2) testing
component parts of consumer products to support a certification of
compliance under section 14(a) of the CPSA, or to comply with
continuing testing requirements under section 14(d) of the CPSA.
We received no comments related directly to the applicability of
the proposed rule. As stated earlier in our response to Comment 1 and
Comment 3 in section II.B of this preamble, we revised, on our own
initiative, the final rule to incorporate the concept that a finished
product certifier may rely upon finished product testing or
certification from another party and to clarify, as well, that
component part testing is voluntary. We also simplified the final
rule's language to establish more clearly that the rule applies to
manufacturers and importers who are required to issue finished product
certificates pursuant to 16 CFR part 1110, as well as to manufacturers
and suppliers of component parts or finished products who are not
required to certify products, but who choose voluntarily to undertake
certification testing or issuing certificates. We revised the reference
to section 14(d) of the CPSA to cite section 14(i) of the CPSA, as a
result of renumbering arising out of H.R. 2715.
4. Proposed Sec. 1109.4--Definitions
Proposed Sec. 1109.4 would define various terms used in the rule.
a. Proposed Sec. 1109.4(a)--Certifier
Proposed Sec. 1109.4(a) would define a ``certifier'' as a firm
that is either a finished product certifier or a component part
certifier, as defined in the final rule.
We received no comments on the proposed definition. However, on our
own initiative, we have made a nonsubstantive editorial change to
replace the word ``firm'' with the word ``party.'' We made this change
in several places in the rule to be consistent internally and to
clarify that the term includes organizations and individuals.
b. Proposed Sec. 1109.4(b)--Component Part
Proposed Sec. 1109.4(b) would define a ``component part,'' in
part, as ``any part of a consumer product, including a children's
product, that either must or may be tested separately from a finished
consumer product, to assess the consumer product's ability to comply
with a specific rule, ban, standard, or regulation enforced by the
CPSC.''
(Comment 4)--Some commenters suggested that the definition of
``component part'' should include raw materials. The commenters said
that, in many cases, a supplier might use the same raw materials in
different combinations to make various component parts. For example, a
button manufacturer may use various combinations of five different
colored dyes and one type of plastic to manufacture a hundred different
colored buttons. If each raw material met the requirements of a
chemical content rule, then any component manufactured from the
materials also would comply.
(Response 4)--Raw materials, such as the colored dyes mentioned by
the commenter, could be component parts if they meet the conditions in
Sec. 1109.5(a). However, if the compliance characteristics of raw
materials could be affected adversely by subsequent processing or
contamination, tests of the raw materials would not be suitable to show
compliance of component parts made out of such raw materials. The
language in the definition is broad enough to encompass raw materials
as ``any part of a consumer product.'' Thus, we decline to amend the
rule as suggested by the commenters.
However, on our own initiative, we have revised the definition of
``component part'' to clarify that the type of test performed on each
part may vary, depending upon the applicable regulation. For example,
each painted plasticized component part of a children's toy must be
tested to the lead paint limit and the phthalate content limit, while
painted wooden component parts of a children's toy would need to be
tested to the lead paint limit only. The proposed definition would
state, in part, that ``[w]ithin the same consumer product, which
component parts will have to be tested may vary, depending on the test
being conducted.'' We revised the sentence to state: ``[w]ithin the
same consumer product, the component parts to be tested and the tests
to be conducted may vary, depending on the applicable regulations and
required test methods, if any.''
c. Proposed Sec. 1109.4(c)--Component Part Certifier
Proposed Sec. 1109.4(c) would define a ``component part
certifier'' as: ``a firm that certifies component parts to be used in
consumer products as complying with one or more rules, bans, standards,
or regulations enforced by the CPSC pursuant to part 1109.''
We did not receive any comments about the definition. However,
because the final rule allows a finished product certifier to rely on
finished product testing or certification from another party, and it
reemphasizes that testing and certification of component parts is
voluntary, we revised the definition of ``component part certifier'' on
our own initiative. The final rule clarifies that a ``component part
certifier'' is a ``party who, although not required to do so pursuant
to part 1110 of this chapter, voluntarily certifies the following as
complying with one or more rules, bans, standards, or regulations
enforced by the CPSC, consistent with the content requirements for
certification in part 1110 of this chapter: (1) Component parts to be
used in consumer products; or (2) finished products.''
d. Proposed Sec. 1109.4(d)--CPSA
Proposed Sec. 1109.4(d) would define ``CPSA'' to mean the Consumer
Product Safety Act.
[[Page 69551]]
We received no comments on the definition, and we have finalized it
without change.
e. Proposed Sec. 1109.4(e)--CPSC
Proposed Sec. 1109.4(e) would define ``CPSC'' to mean the Consumer
Product Safety Commission.
We received no comments on the definition, and we have finalized it
without change.
f. Proposed Sec. 1109.4(f)--CPSIA
Proposed Sec. 1109.4(f) would define ``CPSIA'' to mean the
Consumer Product Safety Improvement Act of 2008.
We received no comments on the definition, and we have finalized it
without change.
g. Proposed Sec. 1109.4(g)--Due Care
Proposed Sec. 1109.4(g) would define ``due care'' to mean ``the
degree of care that a prudent and competent person engaged in the same
line of business or endeavor would exercise under similar
circumstances.''
We did not receive any comments about the definition of ``due
care.'' On our own initiative, we have clarified the definition by
adding one sentence. The new sentence states: ``[d]ue care does not
permit willful ignorance.'' This is not intended to be a substantive
change because any party who is willfully ignorant of material facts,
by definition, would not be exercising due care. However, we wanted the
final rule to emphasize that a party cannot, and should not, purposely
avoid knowing a business partner's testing and certification practices
to benefit from an exception contained in section 19(b) of the CPSA.
Section 19(b) of the CPSA provides that a person who holds a
certificate issued in accordance with section 14(a) of the CPSA is not
subject to the prohibitions in section 19(a)(1) of the CPSA (regarding
distributing noncomplying products) and section 19(a)(2) of the CPSA
(regarding distributing products subject to certain voluntary
corrective actions, mandatory recall orders, or that are banned
hazardous substances) unless such person knows that such consumer
product does not conform. Even those who can take advantage of the
exception in section 19(b) of the CPSA may still violate section
19(a)(6) of the CPSA if the products that are the subject of any
certificate issued by that person, in fact, do not comply with the
applicable standard(s) and such person, in the exercise of due care,
would have reason to know that their certificate is false or misleading
in any material respect. Certifiers and testing parties have an
obligation to resolve known or knowable (in the exercise of due care)
problems with testing or certification by another party before relying
upon or passing on test reports or certifications.
h. Proposed Sec. 1109.4(h)--Finished Product Certifier
Proposed Sec. 1109.4(h) would define a ``finished product
certifier'' as ``a firm responsible for certifying compliance of a
consumer product with all applicable rules, bans, standards, and
regulations pursuant to part 1110 of this chapter.''
We received no comments on this definition. However, on our own
initiative, we made several minor changes. We replaced the word
``firm'' with ``party'' to be consistent internally within the rule and
to clarify that the term includes organizations and individuals. We
also added the word ``finished'' before ``consumer product'' to
distinguish between voluntary component part certifiers and the
requirement in 16 CFR part 1110 to certify finished products. This
change arises out of the response to Comment 1 in section II.B of this
preamble. Finally, we moved the phrase ``pursuant to part 1110 of this
chapter'' from the end of the sentence and placed it after ``consumer
product'' to clarify that the requirement to certify finished consumer
products is contained in part 1110.
i. Proposed Sec. 1109.4(i)--Identical in All Material Respects
Proposed Sec. 1109.4(i) would define ``identical in all material
respects'' to mean that ``there is no difference with respect to
compliance to the applicable rules between the samples and the finished
product.''
We received no comments on this definition. However, on our own
initiative, we revised the definition to make several changes that
correspond to the change in the final rule that allows a finished
product certifier to rely on finished product testing or certification
from another party, as discussed in response to Comment 1 in section
II.B above. As revised, the definition states: ``identical in all
material respects'' requires that there be no difference with respect
to compliance to the applicable rules between the ``samples to be
tested for compliance and the component part or finished product
distributed in commerce.''
We also revised the phrase ``to the applicable rules'' with the
phrase ``to the applicable rules, bans, standards, or regulations.''
The inclusion of ``bans, standards, or regulations'' reflects more
accurately the language in section 14(a) of the CPSA. This is intended
to be a nonsubstantive editorial change.
j. Proposed Sec. 1109.4(j)--Paint
Proposed Sec. 1109.4(j) would define ``paint'' to mean ``any type
of surface coating that is subject to part 1303 of this chapter or
section 4.3.5.2 of ASTM F 963.''
We received no comments on this definition. However, on our own
initiative, we revised the reference to ASTM F 963 to read: ``ASTM F
963-08 (or any successor standard of section 4.3.5.2 of ASTM F 963-08
accepted by the Commission).'' This change clarifies that successor
standards for ASTM F 963 will apply if the Commission accepts them, so
that we will not need to update the rule upon adoption of successor
standards to ASTM F 963.
k. Proposed Sec. 1109.4(k)--Testing Party
Proposed Sec. 1109.4(k) would define ``testing party'' to mean:
``the firm (including, but not limited to, domestic manufacturers,
foreign manufacturers, importers, private labelers, third party
conformity assessment bodies, or component part suppliers) who tests a
consumer product, or any component part thereof, for compliance, in
whole or in part, with any applicable rule, ban, standard, or
regulation enforced by the CPSC.''
(Comment 5)--Some commenters noted that the definition of a
``testing party'' includes third party conformity assessment bodies.
The commenters also noted that proposed Sec. 1109.5(f)(4) (renumbered
Sec. 1109.5(g)(4) in the final rule) specifies that testing parties
must provide documentation of the sampling protocols used to the
finished product certifier. The commenters stated that third party
conformity assessment bodies are responsible only for the samples
submitted to them by suppliers or manufacturers and generally are not
responsible for the sampling process. Therefore, the commenters stated
that they cannot always provide sampling protocols to the certifier.
The commenters suggested that we delete or modify the requirement that
third party conformity assessment bodies provide documentation of the
sampling protocols.
(Response 5)--The commenters are correct that the proposed
definition of ``testing party'' would include a third party conformity
assessment body who may not be involved in sample selection or the
batch/lot identification of the product and may not be able to provide
documentation of these steps. Therefore, we have revised the definition
of ``testing party'' to encompass parties who procure testing, and we
exclude
[[Page 69552]]
specifically from the definition testing laboratories and third party
conformity assessment bodies. The definition also explains that
``procure'' means a party who either conducts testing themselves, when
such testing is allowed, or arranges for another party to conduct
testing. While they are not required to select samples, third party
conformity assessment bodies and testing laboratories still must
provide an attestation to a testing party or certifier who procures a
test from them, which states that all testing was performed in
compliance with applicable provisions of section 14 of the CPSA, and 16
CFR part 1107, or any more specific rules, bans, standards, or
regulations. This requirement is in Sec. 1109.5(g)(7).
l. Proposed Sec. 1109.4(l)--Third Party Conformity Assessment Body
Proposed Sec. 1109.4(l) would define ``third party conformity
assessment body'' as: ``a third party conformity assessment body
recognized by the CPSC to conduct certification testing on children's
products.''
We received no comments on this definition. However, on our own
initiative, we made several changes to the definition. First, we
removed ``third party conformity assessment body'' in the definition's
text because the phrase was not helpful. The revised definition states
that a ``third party conformity assessment body'' means ``a testing
laboratory whose accreditation has been accepted by the CPSC to conduct
certification testing on children's products.'' This is a
nonsubstantive change that is meant to clarify the definition.
We also added a new sentence to clarify that when the term ``third
party conformity assessment body'' is used throughout the rule, we mean
only those laboratories whose scope of accreditation includes the
applicable required tests. Only such laboratories can be used to
support certification of children's products pursuant to section 14(a)
of the CPSA and to ensure continued compliance pursuant to section
14(i) of the CPSA. This change also is nonsubstantive and is meant to
clarify the definition.
m. Proposed Sec. 1109.4(m)--Traceable
Proposed Sec. 1109.4(m) would define ``traceable'' to mean: ``the
ability of a certifier to identify the source of a component part of a
consumer product, including the name and address of the supplier of a
component part and, if different, the manufacturer or the component
part.''
(Comment 6)--Some commenters asked for clarification of component
part traceability. Several commenters suggested that traceable means
traceability to the part that was tested and not to the constituent
components of that part. One commenter stated that it would be
extremely difficult to track resin used in plastic parts and suggested
deleting the traceability requirements. Another commenter stated that
many component manufacturers are, in fact, assemblers of components
received from other suppliers. The commenter recommended that the
requirements for traceability extend through the supply chain to
include the manufacturers of the subcomponents used in component parts.
(Response 6)--After consideration of all of the comments received
on traceability, including Comments 12 through 14, discussed in section
II.C.5.e of this preamble and in this comment, we amended the
definition of ``traceability'' in the final rule to mean: ``the ability
of a certifier to identify all testing parties of a component part of a
consumer product or a finished product, including the name and address
of each testing party and any party that conducted testing on the
component part or finished product. Parties who conduct testing may
include a manufacturer, a supplier, a testing laboratory, or a third
party conformity assessment body.''
Traceability extends to the level at which a component part or
finished product is tested for compliance to the applicable rule(s).
For example, some component part suppliers make parts that may be used
eventually in both children's and non-children's products, and a
supplier does not necessarily know what the final use may be. This
supplier may decide against conducting certification testing on its
products. A distributor or subassembly fabricator who purchases such
products, however, may procure third party testing to be able to sell
the products to a children's product manufacturer. A finished product
certifier who relies on test reports provided by such distributor or
subassembly fabricator must be able to trace the component parts back
to the party who had the parts tested for compliance.
If a subassembly was tested for compliance to a chemical standard
(e.g., lead or phthalates), the testing would have to show that each
subcomponent of the subassembly met the required concentration limits.
The traceability requirement would extend to the subassembly and not to
the supplier of each subcomponent. If the certificate for a subassembly
is based on test reports or certificates of subcomponents (such as
resin and other constituents), the traceability extends to the
subcomponents. We decline to delete traceability requirements from the
final rule because the concept of traceability arises out of section
14(g)(1) of the CPSA and because traceability provides the ability to
determine where in the testing and certification process, errors
occurred that allowed the certification of noncomplying products.
On our own initiative, we also revised the definition to include
the concept that a certifier can rely on both component part testing
and finished product testing conducted by another party. This change
arises out of the response to Comment 1 in section II.B.1 of this
preamble.
n. Additional Definitions Suggested by Commenters
(Comment 7)--One commenter suggested that we add several
definitions to Sec. 1109.4 to clarify which inks are subject to 16 CFR
1303.2 (b)(2) and, therefore, could be subject to Sec. 1109.11
(component part testing for paint). The commenter suggested the
following definitions:
Ink: a pigmented, liquid or paste used for printing on
children's products.
Base Colors: A range of stock colors with which, by intermixing
in prescribed combination and amounts, an ink mixer can obtain a
wide range of tints, tones, shadings, and intermediate hues.
Scrapeable: Ink products that do not bond with the substrate and
can be removed from the substrate without causing undue harm or
damage to the underlying substrate. These inks are subject to the
provisions of part 1303 of this chapter.
Unscrapeable: Ink products that bond with the substrate and
cannot be removed from the underlying substrate. Unscrapeable inks
are not subject to the provisions of part 1303 of this chapter.
(Response 7)--Pursuant to section 14(i)(5)(A)(i) of the CPSA, as
amended by H.R. 2715, third party certification testing no longer
applies to ordinary books or to ordinary paper-based printed materials.
The exception does not apply to books or other printed materials that
contain components that are printed on material other than paper or
cardboard, non-paper components like metal or plastic parts, or to
accessories that are not part of the binding and finishing materials.
The exception also does not apply to books with inherent play value,
books designed or intended for a child 3 years of age or younger, and
does not include any toy or other article that is not a book that is
sold or packaged with an ordinary book.
Given the exception created by H.R. 2715, we do not have to
consider the commenter's suggestion regarding inks
[[Page 69553]]
used in ordinary books. With regard to the non-excepted products and
inks applied to other substrates, we decline to revise the rule as
suggested by the commenter. Our existing regulation defines paint and
other similar surface-coating materials to be:
A fluid, semi-fluid, or other material, with or without a suspension
of finely divided coloring matter, which changes to a solid film
when a thin layer is applied to metal, wood, stone, paper, leather,
cloth, plastic, or other surface. This term does not include
printing inks or those materials which actually becomes part of the
substrate, such as the pigment in a plastic article, or those
materials which are actually bonded to the substrate, such as by
electroplating or ceramic glazing.
16 CFR 1303.2(b)(1). Therefore, inks that are not printing inks or that
do not actually become part of the substrate would be considered to be
paints or other similar surface coatings. These inks could be tested or
certified according to Sec. 1109.11. Although not covered by Sec.
1109.11, component part testing or certification can be used with
printing inks and inks that actually become part of the substrate if
Sec. 1109.5 is met. For example, if an ink is manufactured wholly from
a combination of different base colors, and each base color is tested
and found to be compliant with the lead content requirements, then the
finished ink can be certified based on the testing of the base colors.
In conducting component part testing on printing inks or inks that
do become part of the substrate, testing parties and certifiers should
ensure that the tests are applicable to the form in which the ink will
be in the finished product. For example, if there are volatile
components in the ink that will evaporate during the manufacturing
process, the volatile components should not be considered in
calculating the lead concentration.
We also note that we have made a determination that CMYK process
printing inks (excluding spot colors, other inks that are not used in
CMYK process, inks that do not become part of the substrate under 16
CFR part 1303, and inks used in after-treatment applications, including
screen prints, transfers, decals, or other prints) inherently do not
contain lead in excess of the allowed limits and are excluded from the
testing requirements of the CPSIA (16 CFR Sec. 1500.91(d)(6)).
5. Proposed Sec. 1109.5--Conditions and Requirements Generally
Proposed Sec. 1109.5 would set out conditions and requirements
that apply generally to all types of component part testing and
certification, as well as to finished product testing and certification
by another party.
a. Proposed Sec. 1109.5(a)--Component Part Testing Allowed
Proposed Sec. 1109.5(a) would allow certification of a consumer
product with all applicable rules, bans, standards, and regulations as
required by section 14(a) of the CPSA, and may be used to ensure
continued compliance of children's products pursuant to section 14(d)
of the CPSA, based, in whole or in part, on testing of a component part
of the consumer product conducted by the certifier or a testing party
if several requirements are met.
We received no comments specifically on proposed Sec. 1109.5(a).
However, we have finalized this section with several changes arising
out of the response to Comment 3 in section II.B above. Comment 3
requested that we clarify that component part testing by suppliers is
voluntary. We agree. Consistent with this fact, on our own initiative,
we added a new opening sentence to Sec. 1109.5(a), clarifying that
component part testing is not only voluntary, any party can conduct
such testing: ``[A]ny party, including a component part manufacturer, a
component part supplier, a component part certifier, or a finished
product certifier, may procure component part testing, as long as it
complies with the requirements in this section and subparts B and C of
this part.'' The list of parties in this sentence is intended to be
illustrative and not exhaustive. On our own initiative, we also
clarified that a finished product certifier can rely on either passing
component part test reports or certification of one or more component
parts of a consumer product, to serve as the basis for issuing a
finished product certificate, if the requirements in section (a) are
met. Finally, we revised the reference to section 14(d) of the CPSA to
cite section 14(i) of the CPSA as a result of renumbering arising out
of H.R. 2715.
(1) Proposed Sec. 1109.5(a)(1)
Proposed Sec. 1105.5(a)(1) would state that finished product
certifiers may rely on testing of a component part of a consumer
product only where testing of the component part is required or
sufficient to assess the consumer product's compliance, in whole or in
part, with an applicable rule, ban, standard, or regulation. For
example, section 101 of the CPSIA requires testing an accessible
component part of a children's product for lead content because the
lead content requirement is measured per part. On the other hand,
testing a component part of a consumer product for compliance with the
small parts requirements of 16 CFR part 1501 will rarely, if ever, be
appropriate, because the test procedure described at 16 CFR 1501.4
generally requires that the finished product be tested to determine
whether small parts can be detached during the use or abuse test of the
finished product. Proposed Sec. 1109.5(a)(1) also would specify that
any doubts about whether testing one or more component parts of a
consumer product can help to assess whether the finished product
complies with applicable rules, bans, standards, and regulations should
be resolved in favor of testing the finished product.
We received no comments on this provision. However, on our own
initiative, we have revised Sec. 1109.5(a)(1) by making several minor
changes. We replaced the phrase ``can help'' in the second sentence
with the phrase ``is sufficient,'' to be consistent with the first
sentence that establishes when component part testing can be used; this
change also reflects more accurately our expectation of when component
part testing is appropriate. Throughout the final rule, we also changed
any references to the ``entire product'' to refer instead to the
``finished product'' to be consistent with the wording used to describe
a product ready for distribution to consumers.
(2) Proposed Sec. 1109.5(a)(2)
Proposed Sec. 1109.5(a)(2) would require that the component part
that is tested be identical in all material respects to the component
used in the finished consumer product. Under this section, to be
identical in all material respects to a component part for purposes of
supporting certification of a children's product, means a sample need
not necessarily be of the same size, shape, or finish condition (such
as polished, deburred, etc.) as the component part of the finished
product; rather, the sample may consist of any quantity that is
sufficient for testing purposes and may be in any form that has the
same content as the component part of the finished product. Proposed
Sec. 1109.5(a)(2) also would state that manufacturers must exercise
due care in the proper management and control of all raw materials,
component parts, subassemblies, and finished goods for any factor that
could affect the finished product's compliance with all applicable
rules. The manufacturer must exercise due care that the manufacturing
process does not add a prohibited chemical from an untested source,
such as the material hopper, regrind equipment, or other equipment used
in
[[Page 69554]]
the assembly of the finished product. Proposed Sec. 1109.4(g) would
define ``due care'' to mean the degree of care that a prudent and
competent person engaged in the same line of business or endeavor would
exercise under similar circumstances.
(Comment 8)--Multiple commenters expressed concern that a finished
product certifier would not be able to ensure that a tested component
part was not changed or degraded after testing in a way that could
affect compliance. One commenter wrote: ``[i]t is beyond the importer's
ability to reach back into the supplier's and sub-supplier's
manufacturing and transport processes to detect whether there was a
substitution or a material change in a component.'' Another commenter
wrote: ``[t]o take advantage of this rule, a manufacturer must take
responsibility at the sub-micro-level for manufacturing quality.''
Several commenters requested that the final rule state that the
finished product certifier must ``attest that due care was taken'' to
ensure that no action subsequent to component part testing changed or
degraded the product, rather than require the finished product
certifier to ``certify'' that no action was taken subsequent to
component part testing that changed or degraded the product. The
commenter asserted that this change should be made because a finished
product certifier does not have control over the actions of other
parties after testing occurs. One commenter noted that the due care
requirement applies only to a few specific provisions of the proposed
rule, such as proposed Sec. 1109.5(h)(1) (renumbered to Sec.
1109.5(i)(1) in the final rule), which pertains to reliance by finished
product certifiers on a component part certificate or a component part
test result. The commenter suggested that the due care standard
generally should be applicable to all elements of the proposed rule so
that manufacturers will not be left to wonder whether more than their
exercise of reasonable judgment and practice, based upon their
manufacturing experience and sound knowledge of the product, is
required for those aspects of the rule that do not reference explicitly
the due care standard.
One commenter quoted the following statement from the proposal:
``[t]he manufacturer must exercise due care that the manufacturing
process does not add a prohibited chemical from an untested source,
such as the material hopper, regrind equipment, or other equipment used
in the assembly of the finished product.'' The commenter went on to
state: ``[o]ur company has several hundred vendors producing thousands
of SKUs--do you honestly believe we could possibly manage how all these
independent companies wash out their molding machines or manage their
regrinding operations?''
(Response 8)--We agree that finished product certifiers cannot
always attest that no action was taken subsequent to component part
testing that could affect compliance adversely. In a practical sense,
all the finished product certifier can do to ensure the continued
compliance of the component part is to exercise due care toward that
end. Accordingly, we revised the rule to ensure that after a product is
tested, certifiers and testing parties who are in custody of the
product or component part, exercise due care to prevent contamination
or degradation of the component parts or finished products to which the
testing applies.
First, we moved the last three sentences of proposed Sec.
1109.5(a)(2) into a new Sec. 1109.5(b), now called Test result
integrity. Sections 1109.5(b)(1) through (b)(3) of the final rule track
the last three sentences in proposed Sec. 1109.5(a)(2), with some
modifications. In the proposed rule, each of the last three sentences
in Sec. 1109.5(a)(2) would refer to different entities, i.e., ``[a]
certifier,'' ``[m]anufacturers of finished consumer products,'' and
``[t]he manufacturer.'' Use of these varying terms may be confusing to
stakeholders, and they do not convey accurately that we intend all of
these provisions to apply to both testing parties and certifiers. Thus,
on our own initiative, we added an opening sentence to Sec. 1109.5(b)
to clarify that the provisions in (b)(1) through (b)(3) apply to both
certifiers and testing parties. Moreover, to address the commenters'
concern that certifiers will not always have knowledge or control over
the actions of other parties, we added that the requirements apply only
while a component part or finished product is in each party's custody.
Finally, the opening sentence in Sec. 1109.5(b) provides that it
applies to both component parts and finished products, to incorporate
the concept that a finished product certifier also can rely on finished
product testing or certification from another party, as set forth in
section II.B.1, above.
Second, to maintain test result integrity in the supply stream, we
added a new attestation to Sec. 1109.5(g)(10), as suggested by the
commenters. This section requires certifiers and testing parties to
attest to the exercise of due care to ensure compliance with the
requirements set forth in the revised Sec. 1109.5(b) on Test result
integrity.
With respect to the commenter's suggestion that the due care
standard be applied to all elements of the proposed rule, we assume
that prudence and competence will be exercised by all parties involved
in component part testing and certification. Due care in the context of
this rule, as explained in Sec. 1109.4(g) of the final rule, ``means
the degree of care that a prudent and competent person engaged in the
same line of business or endeavor would exercise under similar
circumstances. Due care does not permit willful ignorance.'' Due care
is stressed in sections where a certifier relies on component part or
finished product test reports or certificates supplied by another
party, and in sections that ensure that a product is not altered in a
manner that could affect compliance, such as contamination or
degradation, after certification testing.
With respect to the commenter with several hundred vendors
producing thousands of SKUs, it would not be necessary for the finished
product certifier to know ``how all these independent companies wash
out their molding machines or manage their regrinding operations.'' If
these vendor companies are providing component part or finished product
testing reports or certificates, they will have attested that due care
has been taken to ensure that actions subsequent to component part
testing have not adversely affected the part. A finished product
certifier should receive and review such attestations. Moreover, a
finished product certifier may rely upon test reports or component part
certificates from another party, provided that such certifier exercises
the degree of care that a prudent and competent person in the same line
of business would exercise in accepting their validity and is not being
willfully ignorant of information suggesting that a supplier is
providing noncompliant products, invalid test reports, or falsified
certifications. If the importer is unwilling to assume this burden of
exercising due care, it can always decide to procure third party
testing of children's products from a third party conformity assessment
body whose accreditation has been accepted by the CPSC, as set forth in
16 CFR part 1107, because this is a voluntary rule.
We did not receive any comments related to the first two sentences
in proposed Sec. 1109.5(a)(2) on samples for component part testing.
Section 1109.5(a)(2) has been finalized with these first two sentences
only, in order to focus on the sample selection requirements for
component part testing. We made several minor editorial changes. We
moved the phrase ``in all
[[Page 69555]]
material respects'' from the end of the first sentence and placed it in
the middle of the sentence, to clarify that the sample must be
``identical in all material respects,'' as defined in Sec. 1109.4(i).
We also removed the phrase ``to the applicable content limit'' from the
second sentence because it was unnecessary and because testing
component parts, depending on the product, may involve testing
something other than a content limit.
As set forth in response to Comment 8 immediately above, the
remaining requirements in proposed Sec. 1109.5(a)(2), regarding
ensuring that a component part is not contaminated or degraded after
testing but prior to distribution, have been renumbered to Sec.
1109.5(b) in the final rule. Aside from the changes outlined in
response to Comment 8, sections 1109.5(b)(1) and (b)(2) of the final
rule have been finalized from the last two sentences in proposed Sec.
1109.5(a)(2) with minor editorial changes. For example, on our own
initiative, we revised the phrase ``finished goods'' in Sec.
1109.5(b)(1) to ``finished products'' to avoid introducing a new term
and to use consistent language throughout the final rule.
Similarly, on our own initiative, we revised the language in Sec.
1109.5(b)(2) of the final rule. We replaced proposed language requiring
the exercise of due care to ensure that ``the manufacturing process
does not add a prohibited chemical from an untested source * * *'' with
language in the final rule stating that ``the manufacturing process
does not add or result in a prohibited level of a chemical from any
source * * *.'' This revision clarifies that the rule covers actively
adding a chemical to a product to create a noncompliance, as well as
passive addition of a prohibited chemical arising out of the
manufacturing process, regardless of whether the source is tested or
untested. For example, passive contamination could occur if a product
is manufactured in close proximity to another product or component,
where lead paint that exceeds the allowed lead content limit is being
sprayed. This circumstance may allow a children's product to become
contaminated with the lead paint. Another scenario may arise where the
ink or paint being applied to children's clothing meets the lead paint
standard, but the stamps or screens used to apply the paint result in
an unallowable amount of lead being transferred to the children's
product.
Finally, we renumbered the third sentence in proposed Sec.
1109.5(a)(2) to Sec. 1109.5(b)(3) in the final rule and made one
modification. On our own initiative, we revised the phrase: ``no change
* * * after testing'' and replaced it with the phrase: ``[n]o action or
inaction subsequent to testing,'' to clarify that the regulation covers
circumstances that involve passive actions, such as storage of consumer
products or components, as well as affirmative actions taken by a
testing party or certifier.
b. Proposed Sec. 1109.5(b)--Limitation
Under proposed Sec. 1109.5(b) (renumbered to Sec. 1109.5(c) in
the final rule), a finished product certifier would not be able to rely
on testing of a component part of a consumer product for any rule, ban,
standard, or regulation that requires testing the entire consumer
product to assess compliance.
We received no comments on this provision, but have renumbered it
as Sec. 1109.5(c) in the final rule. On our own initiative, we have
rephrased this limitation to state that a certifier ``must not use
tests of a component part of a consumer product for any rule, ban,
standard, or regulation that requires testing the finished product to
assess compliance with that rule, ban, standard, or regulation.'' This
change is intended to clarify the limitation.
c. Proposed Sec. 1109.5(c)--Test Method and Sampling Protocol
Proposed Sec. 1109.5(c) (renumbered to Sec. 1109.5(d) in the
final rule) would require that regardless of which entity performs
component part testing or selects samples for component part testing,
both certifiers and testing parties must ensure that the required test
methods and sampling protocols, as set forth in part 1107, as well as
any more specific applicable rules, bans, standards, regulations, or
testing protocols, are used to assess the compliance of the component
part.
(Comment 9)--Several commenters requested clarification of proposed
Sec. 1109.5(c) (renumbered to Sec. 1109.5(d) in the final rule). One
commenter stated that the provision that ``certifiers and testing
parties must ensure that the required test methods and sampling
protocols, as set forth in part 1107, * * * are used to assess
compliance of the component part,'' could be read as charging testing
parties with ensuring that certifiers comply with the provisions * *
*.'' This commenter stated that it assumes this is not the Commission's
intention. It requested clarification and suggested replacing ``both
certifiers and testing parties'' with ``certifiers.''
One commenter suggested adding: ``(and, as to test methods for
tests they conduct, testing parties).'' One commenter observed that the
proposed rule ``appears to clearly provide that the certifying party,
including a finished product certifier, must fulfill all the
requirements of Section 1107 in sampling and testing of the certified
component.'' The commenter requested that the rule address more
specifically issues particular to component parts, such as how
requirements for periodic testing and random sampling are to be applied
in the context of components or raw material inputs.
(Response 9)--We did not intend that testing parties ensure that
finished product certifiers comply with proposed Sec. 1109.5(c).
Accordingly, we have clarified the final rule to reflect that when
either party, a certifier or a testing party, procures a test, each is
responsible for exercising due care to ensure that any required
sampling protocols are followed, that the test is conducted using the
required test method, if any, and that all other applicable
requirements in section 1107, or any other more specific rule, ban,
standard, or regulation, are met. We also incorporated the concept that
a testing party or certifier may be testing or certifying either a
finished product or a component part. Further, the concept of ``due
care'' is incorporated into this provision, in recognition of the fact
that, for children's products, certification testing must be performed
by a third party conformity assessment body. Testing parties and
certifiers should use due care to ensure that the third party
conformity assessment body follows all applicable test methods.
A component part supplier who manufactures and certifies a
component part for a children's product is subject to periodic testing
and any sampling protocols that may be defined in 16 CFR part 1107, or
any more specific rule, standard, ban, or regulation. Finished product
certifiers who purchase the component part from a supplier who does not
certify or test the component part, must sample and test the batch or
lot of the supplied component, or submit samples of the finished
products in which the components are used, for testing for compliance
with all applicable safety rules, in accordance with 16 CFR part 1107.
(Comment 10)--One commenter stated that the definitions and the
requirements imposed on a component part certifier and a testing party
regarding their testing and reporting duties appear to be the same. The
commenter concluded that the only significant difference between a
component part certifier and a testing party appears to be that a
certifier assumes legal liability under the law, and a testing party
does not. The
[[Page 69556]]
commenter asked: (1) What additional benefits would component part
certifiers expect to receive for taking on the additional liabilities;
and (2) what kinds of enforcement actions, if any, would a testing
party be subject to if it failed to comply with the reporting and
recordkeeping requirements described in the proposed rules? The
commenter suggested that the rule define more specifically and
differentiate clearly the roles and duties of these two parties.
(Response 10)--The commenter is correct that the testing and
reporting duties of component part certifiers and testing parties in
the proposal were similar. This is because either a component part
certificate or a test report from a testing party can serve as the
basis for a finished product certificate. As the commenter noted,
however, a person who elects to be a component part certifier, thereby
assumes the responsibilities of a manufacturer under 16 CFR part 1107.
These responsibilities include: Third party certification testing,
third party periodic testing, and recordkeeping. A party may choose to
assume these responsibilities in the hope of increasing sales to
customers who desire to have their component parts certified. Also,
some customers may insist on certification of such parts, as a
condition of buying the party's products.
As to the commenter's second question, component part testing and
certification are voluntary. However, any party who undertakes such
testing or certification, and who fails to comply with an obligation
imposed by part 1109, has committed a prohibited act under section
19(a)(6) of the CPSA and may be subject to civil or criminal penalties,
pursuant to sections 20 and 21 of the CPSA.
(Comment 11)--One commenter stated that it would be useful for the
CPSC to specify what aspects of the reasonable testing program under 16
CFR part 1107 are required of a component part testing party. The
commenter stated that proposed Sec. 1109.5(c) (renumbered to Sec.
1109.5(d) in the final rule) seems to require a testing party to
maintain all aspects of a reasonable testing program, including the
recordkeeping and reporting requirements. Part 1109, however, has its
own recordkeeping requirements for testing parties, as well as its own
disclosure/reporting requirements.
(Response 11)--The final rule on ``Testing and Labeling Pertaining
to Product Certification,'' published elsewhere in this Federal
Register, reserves, rather than finalizes, the section on a reasonable
testing program \2\. Regardless, even under the proposed rule,
component part suppliers would not be required to test their products,
and therefore would not need a reasonable testing program. With regard
to children's products, component part suppliers who choose to become
component part testing parties or component part certifiers, must
follow testing standards and protocols under part 1107, as well as any
more specific rules that apply to the products manufactured. For
example, under part 1107, a component part testing party who procures
periodic testing may rely on a production testing plan to increase the
maximum amount of time between required third party tests to meet the
continued compliance provision of section 14(i) of the CPSA. Moreover,
testing parties must provide the documentation listed in Sec.
1109.5(g) of the final rule to a certifier relying on such
documentation as the basis for issuing a certificate.
---------------------------------------------------------------------------
\2\ It should be noted that although we are not implementing
requirements for a reasonable testing program for non-children's
products, manufacturers of non-children's products that are subject
to a product safety rule, ban, standard, or regulation are still
obligated by the CPSA, as amended by the CPSIA, to certify that
their products comply with all applicable safety rules based on a
test of each product or a reasonable testing program.
---------------------------------------------------------------------------
In addition to the changes discussed in response to comment 9, on
our own initiative we made several formatting and editorial changes to
Sec. 1109.5(d) intended to clarify the rule. We altered the format to
separate out the requirements related to test methods and sampling
protocols into three numbered paragraphs. The proposed rule had
contained the concepts in the three paragraphs, but had organized them
differently. In Sec. 1109.5(d)(3), we added language to include the
concept that testing and certification of both component parts and
finished products under this part 1109 rule must follow all applicable
requirements in part 1107 of this chapter, as well as section 14 of the
CPSA, and any more specific rule, ban, standard, or regulation.
Finally, we removed the phrase ``testing protocols'' from Sec.
1109.5(d)(3) because it is duplicative of the requirement to use
applicable test methods, if any, presented in Sec. 1109.5(d)(1).
d. Proposed Sec. 1109.5(d)--Timing
Proposed Sec. 1109.5(d) (renumbered to Sec. 1109.5(e) in the
final rule) would state that, subject to any more specific rule, ban,
standard, or regulation, component part testing may occur before final
assembly of a consumer product provided that nothing in the final
assembly of the consumer product can cause the component part or the
consumer product to become noncompliant.
We received no comments about this section of the proposed rule,
and have finalized with it with one editorial change, the addition of a
comma after the word ``product.'' Also, we renumbered this section in
the final rule to Sec. 1109.5(e).
e. Proposed Sec. 1109.5(e)--Traceability
Proposed Sec. 1109.5(e) (renumbered to Sec. 1109.5(f) in the
final rule) would specify that finished product certifiers may not rely
on component part testing conducted by another testing party unless
such component parts are traceable.
(Comment 12)--One commenter noted that finished product
manufacturers may receive discrete component part shipments that may be
commingled with similar components from other sources ordered at
different times. Since component parts generally do not carry
identifying manufacturing data, the commenter said the traceability
requirement will be understood better if they specifically include
instructions to maintain inventories to avoid commingling component
parts from different sources or even commingled component parts ordered
from the same source at different times. The commenter stated that
commingling can threaten the integrity of component testing as a viable
alternative testing procedure and that mixing a batch of noncompliant
component parts with a batch of compliant component parts contaminates
the entire lot without any way to sort them out again. The commenter
stated that we could discourage this by requiring finished product
manufacturers to manage their component part inventories in ways that
will avoid the use of commingled lots in a single finished production
lot.
(Response 12)--Section 1109.5(f) of the final rule (renumbered from
proposed Sec. 1109.5(e)) states: ``[a] certifier must not rely on
component part and/or finished product testing procured by a testing
party or another certifier unless such component parts or finished
products are traceable.'' This provision addresses the commenter's
concerns. The final rule defines traceability as: ``the ability of a
certifier to identify all testing parties of a component part of a
consumer product or a finished product, including the name and address
of each testing party and any party that conducted testing on the
component part or finished product. Parties who conduct testing may
include a manufacturer, a supplier, a
[[Page 69557]]
testing laboratory, or a third party conformity assessment body.''
Accordingly, finished product certifiers who rely on certified
component parts from another party must ensure that the component parts
are traceable to the party who had the component parts tested for
compliance. This requirement means that indistinguishable tested or
certified component parts covered by different test reports or
certificates should not be comingled. Further, Sec. 1109.5(b)(1)
requires that all testing parties and certifiers exercise due care to
ensure ``[p]roper management and control of all raw materials,
component parts, subassemblies, and finished products is established
and maintained for any factor that could affect the finished product's
compliance with all applicable rules.'' Although Sec. 1109.5 does not
address expressly comingling, comingling component parts can adversely
affect the traceability of the component parts of the finished product.
Comingling is not allowed if traceability is lost. The final rule gives
manufacturers the flexibility to manage inventories in a manner that
suits them, as long as compliance is established and maintained.
With respect to the commenter's concern about comingling lots from
the same manufacturer that might have been received at different times,
if the component part supplier has not identified a shipment as
belonging to a previously tested or certified lot or batch, then the
finished product manufacturer should not comingle the lots. This is
because the finished product manufacturer does not know if the
component part supplier has made a material change in the component
part after the previous lot was received, and so the finished product
manufacturer should conduct certification tests on the new lot (or
submit samples of all finished products in which the component part is
used for testing for compliance with all applicable safety rules).
Alternatively, if the component part supplier has certified or provided
testing data on the component part, the component parts could be
comingled, as long as the same certificate or testing data covered both
batches.
(Comment 13)--One commenter said that the rule should allow a
finished product certifier to issue a single certificate covering a set
of related products that may be composed of various combinations of a
set of component parts. The commenter said that each of the various
products covered by the certificate may not necessarily include every
component part. The commenter suggested that the rule allow flexibility
for a certificate to be over inclusive of the component parts (and
component part certifications) that may be used on that actual product,
as long as all component parts in a product are covered by at least one
of the certifications, and all other conditions of the rule are met.
(Response 13)--If traceability is not maintained between the final
products and their constituent component parts, this practice would not
be allowed under the rule. For example, if multiple suppliers provide
identical component parts, only one of which is included in the final
product, traceability is not maintained to a testing party of a
component part found to be noncompliant. However, if multiple suppliers
provide distinct component parts, and not every component part is
included in the final product, traceability to a component part's
testing party can be maintained, and that circumstance is allowed. The
traceability requirements in the final rule allow manufacturers and the
CPSC to trace testing and certification problems back to the party that
had the product tested for compliance. Also, such requirements may help
manufacturers identify products that are noncompliant, should a recall
become necessary.
The final rule does not contain any requirements regarding the
content of certificates. Certificate content requirements are set forth
in 16 CFR part 1110, which currently does not require a finished
product certificate to list component parts.
(Comment 14)--One commenter suggested that the traceability
provisions allow for flexibility, where there may be multiple sources
for a single component, but each source is certified independently and
listed separately on the certificate. Thus, for a particular product
covered by the certificate, a single component may be from Source A,
Source B, or Source C, but the components from all three sources have
been certified and all are listed on the finished product certificate.
(Response 14)--The final rule does not contain a requirement to
list component parts on a certificate. The regulation on certificate
contents, 16 CFR part 1110, also does not require a certificate to list
component parts. The final rule requires that each component part
ultimately can be traced to the party who had the component part
tested. Thus, documentation that merely contains the names of various
suppliers, without sufficient information to determine which testing
party or certifier procured certification testing on each component
part, would not comply with the traceability requirement in the final
rule.
However, on our own initiative, we finalized Sec. 1109.5(f) with
several changes. The final requirement states: ``[a] certifier must not
rely on component part and/or finished product testing procured by a
testing party or another certifier unless such component parts or
finished products are traceable.'' We added the phrase ``finished
product'' in two places to incorporate fully the concept that a
finished product certifier may rely on finished product testing or
certification from another party, as long as the finished product is
traceable. This change arises out of our response to Comment 1 in
section II.B.1 of this preamble. Additionally, we clarified that
certifiers can rely on testing or certification from both testing
parties and certifiers. The proposed rule would have used only the term
``testing party.'' Because certifiers can also be testing parties, we
included both terms in the final rule to prevent any confusion.
Finally, we made one editorial change, replacing the word ``conducted''
with the word ``procured'' to be consistent with use of these terms in
the definition of ``testing party'' in Sec. 1109.4(k).
f. Proposed Sec. 1109.5(f)--Documentation by Testing Party
Proposed Sec. 1109.5(f) (renumbered to Sec. 1109.5(g) in the
final rule) would require testing parties who are not certifying a
component part themselves to provide the following documentation to the
component part certifier, either in hard copy or electronically:
(1) Identification or a description of the component part tested;
(2) Identification of a lot or batch number for which the testing
applies;
(3) Identification of the applicable rules, bans, standards, and
regulations for which each component part was tested;
(4) Identification or a description of the testing methods and
sampling protocols used;
(5) The date or date range when the component part was tested;
(6) The results of each test on a component part; and
(7) If the product was tested by a third party conformity
assessment body, regardless of whether such third party testing was
required because the product is a children's product or whether the
testing party chose to use such third party conformity assessment body,
identification of such conformity assessment body, a copy of the
original test results, and a certification that all testing was
performed in compliance
[[Page 69558]]
with section 14 of the CPSA and proposed part 1107 of this title.
The preamble to the proposed rule explained that the information
listed is needed so that, if noncomplying products are found, we can
use this information to determine whether a finished product certifier,
component part certifier, or third party conformity assessment body is
not complying with the appropriate requirements. (75 FR 28210)
(1) Proposed Sec. 1109.5(f)(1)
On our own initiative, we finalized proposed Sec. 1109.5(f)(1)
(renumbered to Sec. 1109.5(g)(1) in the final rule) with one change to
include the concept that a testing party or certifier may test or
certify both component parts and finished products, as explained in
response to Comment 1 in section II.B.1 of this preamble.
(2) Proposed Sec. 1109.5(f)(2)
(Comment 15)--Some commenters took exception to proposed Sec.
1109.5(f)(2) (renumbered to Sec. 1109.5(g)(2) in the final rule),
which would require identification by lot or batch numbers. One
commenter noted that, for ink systems, lot and batch numbers are
assigned each time a color is mixed, which could amount to a large
number of tests per year, depending upon production schedules. The
commenter recommended that for printing ink systems, ink manufacturers
should be allowed to group-test, and certify ``product families'' for
component testing because product families represent the same ``core
formula.'' The commenter added that certification of any given
component should be allowed, as long as the formula, composition, and
manufacturing process does not change. The commenter remarked that the
date or date range of when a component part is tested serves the same
purpose as a batch or lot number, and thus, suggested that
identification by lot or batch numbers be deleted from the final rule.
Another commenter suggested that identification of a lot or batch
number should be understood to allow a component part certificate to
apply to all of the same materials (rather than a lot or batch) from a
supplier, unless and until a material change in the tested materials
requires further testing. The commenter noted that the certification
would represent the product line as produced by the manufacturer,
rather than just the units produced for a particular lot or batch.
(Response 15)--The intent of the proposed requirement to identify
the lot or batch number for which the testing applies was to allow for
the identification of the particular set of component parts to which
the testing applies. The commenters pointed out correctly that this may
be done in ways other than by lot or batch numbers. Accordingly, we
changed Sec. 1109.5(g)(2) of the final rule to require documentation
of ``a lot or batch number, or other sufficient information to enable
the identification of the component parts or finished products to which
the testing applies.'' This information could include, but would not be
limited to, lot or batch numbers, a production date range, or a
particular shipment or purchase.
Pursuant to section 14(i)(5)(A)(i) of the CPSA, as amended by H.R.
2715, third party certification testing no longer applies to ordinary
books or to ordinary paper-based printed materials. The exception does
not apply to non-paper components like metal or plastic parts, or to
accessories that are not part of the binding and finishing materials.
The exception also does not apply to books with inherent play value,
books designed or intended for a child 3 years of age or younger, and
does not include any toy or other article that is not a book that is
sold or packaged with an ordinary book. Thus, it is unnecessary for us
to address this comment as it relates to inks used in ordinary books
because, as a result of H.R. 2715, ordinary books do not need to be
component part tested for certification purposes. With regard to the
non-excepted products and inks applied to other substrates, inks may be
certified based upon tests of their component parts that show that any
combination of the component parts will meet all applicable
requirements, provided that no material change has occurred in the
component parts since they were tested. This aspect of component part
testing should allow the commenter to certify ``product families'' or
``core formulas.''
We disagree that the date of testing, or the date range over which
testing is conducted, always will have a logical relationship to
identification of the products to which the testing applies, as
required by Sec. 1109.5(g)(2). For example, a manufacturer could have
many different types of component parts tested on the same date. A date
or date range may be insufficient to identify each component part
tested. However, for those products where the date of testing or the
date range over which testing was conducted is the same as ``other
sufficient information to enable the identification of the component
parts or finished products to which the testing applies,'' such date
information can be used to meet the requirement of Sec. 1109.5(g)(2).
(3) Proposed Sec. 1109.5(f)(3)
On our own initiative, we finalized proposed Sec. 1109.5(f)(3)
(renumbered to Sec. 1109.5(g)(3) in the final rule) with a revision
incorporating the concept that a testing party or certifier may test
both component parts and finished products, as explained in response to
Comment 1 in section II.B.1 of this preamble.
(4) Proposed Sec. 1109.5(f)(4)
We finalized proposed Sec. 1109.5(f)(4) (renumbered to Sec.
1109.5(g)(4) in the final rule) with a minor editorial revision. On our
own initiative, we changed the words ``method'' and ``protocol'' to be
plural because products and parts may be tested for more than one
standard.
(5) Proposed Sec. 1109.5(f)(5)
On our own initiative, we finalized proposed Sec. 1109.5(f)(5)
(renumbered to Sec. 1109.5(g)(5) in the final rule) with a revision
incorporating the concept that both component parts and finished
products may be tested, as explained in response to Comment 1 in
section II.B.1 of this preamble.
(6) Proposed Sec. 1109.5(f)(6)
We finalized proposed Sec. 1109.5(f)(6) (renumbered to Sec.
1109.5(g)(6) in the final rule) with several changes. We broadened the
rule to include finished products, as discussed in response to Comment
1 in section II.B.1 of this preamble. On our own initiative, we
clarified that the Commission expects certifiers and testing parties to
provide both the test results and the test values, if any, to a
certifier who intends to rely upon such tests to certify a component
part or finished product.
(7) Proposed Sec. 1109.5(f)(7)
(Comment 16)--One commenter suggested that the terminology in
proposed Sec. 1109.5(f)(7) refer to ``all testing of component parts
by that body,'' instead of ``all testing,'' to emphasize that the
manufacturer, and not the testing laboratory, is responsible for
obtaining samples that are identical in all material respects to the
components used in the finished product.
(Response 16)--The issue raised by this commenter affects proposed
Sec. 1109.5(c), and 1109.5(f)(7) (renumbered to Sec. Sec. 1109.5(d)
and 1109.5(g)(7), respectively, in the final rule). The commenter is
correct that, unless parties contract otherwise, a third party
conformity assessment body is not responsible for the selection of
[[Page 69559]]
samples. Accordingly, we have revised the final rule to relieve testing
laboratories of any responsibility under either of these sections, by
redefining a testing party to exclude testing laboratories and third
party conformity assessment bodies in Sec. 1109.4(k). See section
II.C.4.k in this preamble. In addition, we have revised Sec.
1109.5(g)(7) to incorporate the commenter's suggestion to clarify who
has the responsibility to attest to compliance with 16 CFR part 1107.
The final rule states that the attestation is by ``the party conducting
the testing,'' meaning the third party conformity assessment body, in
the case of a children's product.
Furthermore, on our own initiative, we streamlined the requirement
by deleting the following text: ``regardless of whether it was required
because the product is a children's product or whether the testing
party chose to use such third party conformity assessment body,
identification of such third party conformity assessment body. * * *
Removal of this text is editorial, and it is not intended to be a
substantive amendment. It remains true that identification of the party
conducting the testing is required, regardless of the reason for using
a particular type of testing laboratory, including a third party
conformity assessment body. We also removed the requirement for
original test results in this section on our own initiative because
test results are already discussed in Sec. 1109.5(g)(6). Finally, we
broadened the rule to include finished products, as discussed in
response to Comment 1 in section II.B.1 of this preamble.
(Comment 17)--Another commenter stated that proposed Sec.
1109.5(f)(7) seems to require a testing party to ``certify'' that third
party testing results meet the requirements of section 14 of the CPSA.
The commenter said that the provision appears to conflict with other
provisions in the proposed rule that establish testing parties as
entities that conduct proper testing, but who do not have to
``certify'' under the CPSA.
(Response 17)--We agree that use of the word ``certify'' in
proposed Sec. 1109.5(f)(7) (renumbered to Sec. 1109.5(g)(7) in the
final rule) may be confused with a product certification requirement.
Accordingly, we changed the word ``certify'' to ``attest'' in Sec.
1109.5(g)(7). Pursuant to Sec. 1109.5(g)(7), the party who conducts
testing, including a manufacturer or supplier who conducts testing, a
testing laboratory, or a third party conformity assessment body, must
attest (state in writing) that such testing was performed in compliance
with section 14 of the CPSA and 16 CFR part 1107, or any more specific
applicable rule, ban, standard, or regulation. Moreover, the party
signing the attestation is only responsible for attesting to following
the requirements that are applicable to them. Thus, a third party
conformity assessment body that merely conducts testing will attest to
the testing protocol that was followed. Such a third party conformity
assessment body would not need to attest to following applicable
sampling protocols, if they were not the party responsible for sample
selection.
We finalized proposed Sec. 1109.5(f) (renumbered to Sec.
1109.5(g) in the final rule) with several changes. On our own
initiative, we changed the title of this section from ``Documentation
by testing party'' to ``Documentation by certifiers and testing
parties,'' to reflect more accurately that both certifiers and testing
parties are required to provide the documentation listed in this
section. We also clarified that each certifier and testing party is
responsible for providing the documentation to a certifier who is
relying on such documentation to issue a certificate: ``[e]ach
certifier and testing party must provide the following documentation,
either in hard copy or electronically, to a certifier relying on such
documentation as a basis for issuing a certificate.'' For example, a
component part testing party or certifier must provide the
documentation to a finished product certifier who is relying on such
documentation to issue a finished product certificate. A testing party
must provide this documentation to a component part supplier relying on
such documentation to certify a component part.
(8) New Sec. Sec. 1109.5(g)(8) Through (g)(10)
On our own initiative, we added three documentation requirements in
the final rule in Sec. Sec. 1109.5(g)(8), (g)(9), and (g)(10). We
based two requirements on other sections in the proposed rule, and the
third results from comments we received on the proposed rule.
New Sec. 1109.5(g)(8) requires that a testing party or certifier
provide: ``[c]omponent part certificate(s) and/or finished product
certificate(s), if any * * *'' to a certifier relying upon such
documentation as the basis for a certificate. The proposed rule
contemplated that finished product certifiers could rely upon component
part certificates, but the requirement that a component part certifier
provide access to the actual certificate was not listed in the
documentation section in proposed the proposed rule. For example,
proposed Sec. 1109.5(h)(1) would state: ``[a] finished product
certifier must exercise due care in order to rely, in whole or in part,
on a component part certificate issued by a component part certifier *
* *.'' We corrected the omission of component part certificates in the
final rule by adding Sec. 1109.5(g)(8). Moreover, we included both
component part certificates and finished product certificates, if any,
because a finished product certifier could rely upon either component
part certificates or finished product certificates from another party.
New Sec. 1109.5(g)(9) requires that a testing party or certifier
provide: ``[r]ecords to support traceability as defined in Sec.
1109.4(m) * * *'' to a certifier relying upon such documentation as the
basis for a certificate. This requirement was moved from proposed Sec.
1109.5(i) on recordkeeping, which would require that ``all certifiers
must maintain records to support the traceability of component part
suppliers * * *.'' On our own initiative, we decided to move this
requirement to maintain traceability records to the documentation
section in the final rule, so that all documentation requirements are
in one section. Also, the slightly rephrased requirement to maintain
traceability records is more accurate, in that it recognizes that such
records can originate from both testing parties and certifiers, and it
informs that the details of what is meant by ``traceability records''
can be found in Sec. 1109.4(m). Section 1109.4(m) clarifies that
traceability records include: ``the name and address of each testing
party and any party that conducted testing on the component part or
finished product. * * * Traceability extends to the component part of
the product that was tested for compliance, such that if a subassembly
is tested, that subassembly must be traceable, not each component part
of the subassembly, if those parts were not individually tested for
other rules, bans, standards, or regulations.''
New Sec. 1109.5(g)(10) requires that a testing party or certifier
provide: ``[a]n attestation by each certifier and testing party that
while the component part or finished product was in its custody, it
exercised due care to ensure compliance with the requirements set forth
in subparagraph (b) of this section.'' Subparagraph (b) refers to Sec.
1109.5(b) on Test result integrity. The rationale for this addition is
set forth in response to Comment 9, discussed above in section
II.B.5.a.2 of this preamble.
g. Proposed Sec. 1109.5(g)--Effect of Voluntary Certification by
Component Part Certifiers
On our own initiative, we shortened the section titled, ``Effect of
voluntary certification'' in the final rule. We
[[Page 69560]]
removed the phrase ``by component part certifiers'' from the title to
reflect the fact that a testing party or certifier may test voluntarily
or certify finished products as well, as set forth in response to
Comment 1 in section II.B.1 of this preamble.
(1) Proposed Sec. 1109.5(g)(1)
Proposed Sec. 1109.5(g)(1) (renumbered to Sec. 1109.5(h)(1) in
the final rule) would consider any certificate issued by a component
part certifier in accordance with this part to be a certificate issued
in accordance with section 14(a) of the CPSA, and would further require
component part certificates to contain all of the information required
by part 1110 of this chapter. The preamble to the proposed rule (75 FR
at 28210) stated that this provision would allow finished product
certifiers to rely on section 19(b) of the CPSA, which provides that a
person who holds a certificate issued in accordance with section 14(a)
of the CPSA (to the effect that a consumer product conforms to all
applicable consumer product safety rules) is not subject to the
prohibitions in section 19(a)(1) of the CPSA (regarding distributing
noncomplying products) and section 19(a)(2) of the CPSA (regarding
distributing products subject to certain voluntary corrective actions,
mandatory recall orders, or that are banned hazardous substances),
unless such person knows that such consumer product does not conform.
The preamble to the proposed rule (75 FR at 28210 through 28211)
further stated that certifiers may violate section 19(a)(6) of the CPSA
if the products that are the subject of any certificate issued by that
person, in fact, do not comply with the applicable standard(s) and such
person, in the exercise of due care, would have reason to know that
their certificate is false or misleading in any material respect.
Proposed Sec. 1109.5(h)(1) (renumbered to Sec. 1109.5(i)(2) in the
final rule) would address how this duty of due care applies to finished
product certifiers.
Section 1109.5(h)(1) of the final rule has been finalized with one
revision. On our own initiative, we modified the second sentence in
Sec. 1109.5(h)(1) to remove: ``[a] component part certificate,'' and
replace it with: ``[a]ll certificates,'' to reflect the fact that this
section can relate to both a component part certificate and a finished
product certificate, as explained in response to Comment 1 in section
II.B.1 of this preamble. All certificates should meet the content
requirements set forth in sections 14(g) of the CPSA, as well as the
content requirements in our regulation set forth in part 1110. We note,
however, that the only certificate required to accompany a finished
product is the finished product certificate issued by an importer or
domestic manufacturer, as set forth in part 1110. Otherwise,
certificates must be provided to a certifier relying on such
documentation to certify a product, and certificates must be provided
to the Commission, upon request, pursuant to Sec. Sec. 1109.5(g) and
1109.5(j) of the final rule.
(2) Proposed Sec. 1109.5(g)(2)
Proposed Sec. 1109.5(g)(2) (renumbered to Sec. 1109.5(h)(2) in
the final rule) would provide that any person who elects to certify
compliance of a component part with an applicable rule must assume all
responsibilities of a manufacturer under part 1107 of this chapter with
respect to that component part's compliance with the applicable rule.
(Comment 18)--A commenter stated that because the word ``certify''
or ``certification'' is so prevalent in business communications in a
variety of different contexts, it would be quite simple for a component
part supplier to be deemed a component part certifier when it did not
intend to become one. To avoid this, the commenter would modify the
rule to require any party seeking to be a component part certifier
under proposed Sec. 1109.5(g) (renumbered to Sec. 1109.5(h) in the
final rule), or a testing party under proposed Sec. 1109.4(k), to
state specifically, in writing, that it is providing a certification or
supplying testing data as a certifier or testing party (as the case may
be) under those regulations.
(Response 18)--We do not believe that the prevalence of the terms
``certify'' and ``certification'' in business forms and communications
will cause the confusion feared by the commenter. As noted in proposed
Sec. 1109.5(g) (now renumbered as Sec. 1109.5(h) in the final rule),
component part certificates must contain all of the information
required by part 1110 of this chapter. That unique combination of
information, together with the required express certification that the
part or product complies with the identified requirements, should make
it clear when a party is issuing a certificate pursuant to section
14(a) of the CPSA.
However, we have changed the word ``certify,'' used in proposed
Sec. 1109.5(f)(7) (now renumbered to Sec. 1109.5(g)(7) in the final
rule) to ``attestation.'' We made this change to clarify and
distinguish that the ``attestations'' required in Sec. Sec.
1109.5(g)(7) and (10) of the final rule are not the same as product
certifications. The words ``certify'' and ``certification,'' as used in
this rule, refer to the product certifications required by section
14(a) of the CPSA.
(Comment 19)--One commenter stated that any obligation to provide a
component part or raw material certificate of conformity to the CPSC
should rest with the consumer product manufacturer and not with the
component part or raw material supplier.
(Response 19)--The CPSIA does not require component part suppliers
or raw material suppliers to certify their products. Testing or
certification of component parts are entirely voluntary activities for
component part manufacturers or component part suppliers. Parties that
have no requirement to test or certify their products, and who have not
undertaken such tasks, are not expected to provide the CPSC with a
certificate. However, we have clarified in Sec. 1109.5(h)(2) that any
party who elects to certify compliance of a component part or a
finished product with an applicable rule, standard, ban, or regulation,
must assume all responsibilities of a manufacturer under sections 14(a)
(requiring issuance of a General Conformity Certificate and/or a
Children's Product Certificate) and 14(i) (requiring continuing third
party testing of children's products) of the CPSA and 16 CFR part 1107
with respect to that component part or finished product's compliance to
the applicable rules, standards, bans, or regulations. Moreover, Sec.
1109.5(j) of the final rule requires certifiers and testing parties to
make documentation required by Sec. 1109.5(g) available to the CPSC
for inspection, upon request. Such documentation includes
certifications, if any. Once a party undertakes testing or
certification of a component part or finished product, they are
expected to adhere to the requirements of this rule.
Finally, with respect to providing certificates to the CPSC, we
also note that section 14(g)(3) of the CPSA states that, upon request,
a manufacturer or private labeler must provide a copy of a certificate
to the CPSC.
Section 1109.5(h)(2) has been finalized with several changes. On
our own initiative, we changed the word ``person'' to ``party'' to make
it clear that a certifier can be either a person or an entity, and to
be consistent with similar language throughout the final rule. We also
replaced the phrase ``applicable rule'' in both places it is used with
``applicable rules, standards, bans, or regulations,'' to track the
statutory language of section 14(a) of the CPSA and to be consistent
with similar language throughout the final rule.
[[Page 69561]]
Finally, we added a reference to sections 14(a) and 14(i) of the CPSA
for the reasons set forth in response to Comment 19 immediately above.
h. Proposed Sec. 1109.5(h)--Certification by Finished Product
Certifiers
(1) Proposed Sec. 1109.h(1)
Proposed Sec. 1109.5(h)(1) (part of which has been renumbered to
Sec. 1109.5(i)(2) in the final rule) would require a finished product
certifier to exercise due care in order to rely, in whole or in part,
on a component part certificate issued by a component part certifier or
on component part testing by a testing party as the basis for a
finished product certificate. The proposal also would require that, if
a finished product certifier fails to exercise due care in its reliance
on a certificate for a component part, we would not consider the
finished product certifier to hold a component part certificate issued
in accordance with section 14(a) of the CPSA. Proposed Sec.
1109.5(h)(1) would add that exercising due care means taking the steps
a prudent and competent person would take to conduct a reasonable
review of a component part certificate and to address any concern over
its validity.
We did not receive any comments on this section of the proposed
rule. On our own initiative, we revised Sec. 1109.5(i)(1) to clarify
the four different types of documentation that a finished product
certifier can rely upon to certify a finished product. We revised the
first sentence in proposed Sec. 1109.5(h)(1) to state: ``[a] finished
product certifier must exercise due care in order to rely, in whole or
in part, on one or more of the following as a basis for issuing a
finished product certificate: (i) Finished product certificate(s)
issued by another party; (ii) finished product test report(s) provided
by another party; (iii) component part certificate(s); or (iv)
component part test report(s).'' The phrase ``by another party'' is
associated only with finished product testing and certification in this
section because component part testing can be done by the finished
product certifier or another party. While finished product
certification also can be done by the finished product certifier, part
1109 would not come into play in that circumstance. Part 1109 is
relevant only when: (a) Any certifier relies on component part testing
or certification, regardless of who conducts the testing or provides
certification; and (b) a finished product certifier is relying on
finished product testing or certification provided by another party. We
moved the remaining text in proposed Sec. 1109.5(h)(1) to Sec.
1109.5(i)(2). This revision to clarify the four types of documentation
that a finished product certifier can rely on to certify a finished
product arises out of the changes made throughout the final rule to
incorporate the concept that a finished product certifier can rely upon
a finished product certificate provided by another party, as discussed
in response to Comment 1 in section II.B.1 of this preamble.
Because the concept that was included in the first sentence of
proposed Sec. 1109.5(h)(1), now comprises Sec. 1109.5(i)(1), Sec.
1109.5(i)(2) begins with the second sentence from what was proposed
Sec. 1109.5(h)(1). On our own initiative, we removed the phrase
regarding the requirement to exercise due care in reliance on ``a
certificate for a component part'' and replaced it with ``another
party's certifications or test reports.'' This phrase broadens Sec.
1109.5(i)(2) so that it incorporates all four of the options for
certifying a finished product under part 1109, now described in Sec.
1109.5(i)(1), including finished product testing and certification. We
also revised the phrase ``a component part certificate'' in the first
sentence to ``a certificate'' because the finished product certifier
may be relying on component part or finished product certificates. We
made a similar change in the second sentence to broaden ``a component
part certificate'' to ``another party's certification and/or test
reports'' to reflect the range of documentation that a finished product
certifier may rely on to certify a product. These changes arise out of
the concept that a testing party or certifier may test or certify both
component parts and finished products in the final rule, as explained
in response to Comment 1 in section II.B.1 of this preamble. Further,
on our own initiative, we inserted the phrase: ``Before relying on such
documents to issue a finished product certificate,'' to set forth our
expectation that a finished product certifier should exercise due care
in relying upon another party's documentation before issuing its own
certificate. Finally, we updated the definition of ``due care'' to
track the revised definition in Sec. 1109.4(g).
Section 1109.5(i)(2) in the final rule is intended to limit a
finished product certifier from relying on section 19(b) of the CPSA
when they know or should know that a certificate is invalid, or based
on faulty data or test procedures. Section 19(b) of the CPSA provides
that a person who holds a certificate issued in accordance with section
14(a) of the CPSA (to the effect that a consumer product conforms to
all applicable consumer product safety rules) is not liable for a
violation under section 19(a)(1) of the CPSA (regarding distributing
noncomplying products) and section 19(a)(2) of the CPSA (regarding
distributing products subject to certain voluntary corrective actions,
mandatory recall orders, or that are banned hazardous substances),
unless such person knows that such consumer product does not conform.
Willful ignorance of testing or certification violations committed by
suppliers will not shield finished product certifiers. Parties may also
violate section 19(a)(6) of the CPSA if the products that are the
subject of any certificate issued by that person, in fact, do not
comply with the applicable standard(s) and such person, in the exercise
of due care, would have reason to know that their certificate is false
or misleading in any material respect.
(2) Proposed Sec. 1109.5(h)(2)
Proposed Sec. 1109.5(h)(2) (renumbered to Sec. 1109.5(i)(3) in
the final rule) would state that a finished product certifier must not
rely on component part testing by a testing party or component part
certifier, unless it receives the documentation under proposed Sec.
1109.5(f) from the component part certifier or testing party. The
provision also would state that we may consider a finished product
certifier who does not obtain such documentation before certifying a
consumer product to have failed to exercise due care.
(Comment 20)--A commenter stated we should clarify that it is
sufficient if the finished product certifier ``identifies'' (instead of
``receives'') the testing party's compliance with proposed Sec.
1109.5(f) by reference to the testing party's having provided the
required documentation to the finished product manufacturer issuing a
certificate for the finished product.
(Response 20)--We interpret the commenter's suggestion as allowing
a certifier to provide access (such as through an Internet Web site) to
the records, rather than by requiring physical possession of those
records. We agree with the commenter and have revised the rule to
state: ``The finished product certifier may receive such documentation
either in hard copy or electronically, or access the documentation
through an Internet Web site.'' Electronic access to records can take
other forms as well, such as via flash drive, as an email attachment,
or by display on a monitor. The final rule does not require any
particular format for the transmission or receipt of electronic
records.
[[Page 69562]]
In addition, we have, on our own initiative, made two changes to
the first sentence in Sec. 1109.5(i)(3). We revised the first sentence
to state: ``[a] Finished product certifier must not rely on another
party's certificates or test reports unless the finished product
certifier receives the documentation under paragraph (g) of this
section from the certifier or testing party.'' We also replaced the
proposed rule's phrase: ``Must not rely on component part testing by a
testing party or component part certifier,'' to state: ``Must not rely
on another party's certificates or test reports'' in the final rule.
The revised language broadens the section to incorporate the concept
that a finished product certifier can rely on another party's finished
product test reports or certification, as well as rely on their
component part test reports or certificates, as discussed in response
to Comment 1, in section II.B.1 of this preamble. We also revised the
reference to Sec. 1109.5(f) to Sec. 1109.5(g) in the final rule,
where the documentation requirements are now stated.
(3) Proposed Sec. 1109.5(h)(3)
Under proposed Sec. 1109.5(h)(3), any certification of a consumer
product based, in whole or in part, on component part testing performed
by a component part certifier or a testing party must:
Identify both the corresponding documentation required in
proposed Sec. 1109.5(f) and any report provided by a third party
conformity assessment body on which the consumer product's
certification is based; and
Certify that nothing subsequent to component part testing,
for example, in the process of final assembly of the consumer product,
changed or degraded the consumer product such that it affected the
product's ability to meet all applicable rules, bans, standards, and
regulations.
(Comment 21)--Multiple commenters stated that adding detailed
component part information on the certificate would inject enormous
complexity to the certification process; they further asserted that we
should not require component part test results to be listed on the
certificate. One commenter added that, as long as the testing and
traceability requirements are met, the method of such documentation
should be determined by the certifier. One commenter would revise
proposed Sec. 1109.5(h)(3)(i) to state expressly that only component
parts (not subcomponents of components or raw materials of components)
need to be listed on the final product certification. For example, a
zipper is composed of several subcomponents; each of these
subcomponents would be required to be listed on the conformity
certificate of the zipper. However, the commenter said that it would be
burdensome to require that each zipper subcomponent be listed again on
the finished product certificate. The commenters said that traceability
of the subcomponents would be preserved because the finished product
certificate could refer to the certificate for the zipper, which would
list the subcomponents. Another commenter argued that if all of the
component part certification information is required on a finished
product certificate, the certificate would be long and complex. The
commenter asked for clarification on the requirements for certificates
and suggested a change in the rule as follows:
* * * Thus, the Commission should clarify that it is sufficient
for the finished-product certification to ``identify'' the testing
party's compliance with Sec. 1109.5(f) by generally referring to
the testing party's having provided the required documentation to
the finished-product certifier * * *
(Response 21)--The information required on certificates is
specified in section 14(g)(1) of the CPSA and 16 CFR part 1110. Section
14(g)(1) of the CPSA requires the certificates to include the date and
place where the product was tested. We interpret this to require
references to every test performed to support the certificate of the
product being certified, including tests of component parts. However,
references can be indirect, such as by referring readers of the
certificate to a source for the underlying certificates or test
reports. In addition, to avoid duplication or inconsistency in
requirements for certificates between this rule and 16 CFR part 1110,
we have deleted sections containing requirements for certificates from
the final rule. Thus, we have deleted proposed Sec. 1109.5(h)(3),
which would require certificates to identify documentation in proposed
Sec. 1109.5(f) and certify that no change occurred after testing that
could affect adversely a product's ability to comply with all
applicable rules, and proposed Sec. Sec. 1109.12(d) and 1109.13(d),
which would concern certificates for products tested for the lead in
paint limit and the phthalate content limit.
(Comment 22)--A commenter stated that, in proposed Sec.
1109.5(h)(3)(i), the word ``identify'' is ambiguous when it is applied
to requiring supporting documentation for a certificate. The commenter
suggested that it should be sufficient ``for the finished product
certification to `identify' the testing party's compliance with Sec.
1109.5(f) of the proposed rule by generally referring to the testing
party's having provided the required documentation to the finished
product certifier.''
(Response 22)--As noted immediately above in our response to
Comment 21, we deleted Sec. 1109.5(h)(3)(i) in the final rule, as well
as all other requirements for finished product certificates.
Accordingly, it is unnecessary for us to act on the commenter's
suggestion.
Proposed Sec. 1109.5(h)(3) has been deleted in the final rule for
the reason set forth in response to Comment 21 and because proposed
Sec. 1109.5(h)(3)(ii) is redundant to Sec. 1109.5(b) in the final
rule. Section 1109.5(b) requires certifiers, including finished product
certifiers, among other things, to exercise due care to ensure that
while a component part or finished product is in its custody, no action
or inaction subsequent to testing and before distribution in commerce
occurs that would affect compliance, including contamination or
degradation.
i. Proposed Sec. 1109.5(i)--Recordkeeping Requirements
Proposed Sec. 1109.5(i) (renumbered to Sec. 1109.5(j) in the
final rule) would require testing parties to maintain the documentation
that would be required in proposed Sec. 1109.5(f) for five years.
Additionally, the proposal would require all certifiers to maintain
records to support the traceability of component part suppliers for as
long as the product is produced or imported by the certifier, plus five
years. The proposal also would require test records to be kept for five
years and that all records are available in the English language. The
preamble to the proposed rule explained that the record retention
period would be set at five years because the statute of limitations
under 28 U.S.C. 2462 allows the Commission to bring an action within
that time. The proposal also would require certifiers to maintain the
records at the location within the United States specified in 16 CFR
1110.11(d), or, if the records are not maintained at the custodian's
address, at a location specified by the custodian. The proposal also
would require manufacturers to make these records available, either in
hard copy or electronically, for inspection by the CPSC, upon request.
(Comment 23)--Several commenters declared that maintaining records
for the ``life of the product, plus five years'' is excessive. One
commenter stated that they have been selling a product for more than 30
years and that keeping
[[Page 69563]]
records for that period of time would be very expensive.
(Response 23)--We have revised the final rule to state that a
maximum records retention period of five years will be sufficient for
all records required in Sec. 1109.5(g) of the final rule. If a product
has a significant noncompliance, it seems likely that the noncompliant
aspect of the product would become apparent within that period. Thus,
Sec. 1109.5(j) (renumbered from proposed Sec. 1109.5(i)), now
requires that records be kept for a period of five years. Certifiers
and testing parties may wish to consider maintaining records for
durable products, such as furniture or some infant products, for more
than five years. In the event of a recall, such records may be useful
in determining the number of affected products and limiting the
recall's scope.
(Comment 24)--Some commenters stated that the recordkeeping
requirements of proposed Sec. 1109.5(i) (renumbered to Sec. 1109.5(j)
in the final rule) seem burdensome in requiring that records be in
English and kept in a location in the United States. With much
manufacturing occurring outside of the United States and in non-English
speaking countries, the commenters said that allowing offshore storage
in the local language would make the records most usable to local
compliance (e.g., quality assurance) staff. One commenter suggested
allowing production of those records in English to CPSC staff, upon
request. A commenter suggested that instead of requiring that finished
product certifiers maintain the records at a location within the United
States, as proposed Sec. 1109.5(i) would require, we should allow the
records to be maintained outside the United States, as long as the
records can be accessed from the location in the United States that is
specified on the certificate.
(Response 24)--We agree that it could be burdensome to maintain all
records in the United States. To reduce this burden and still maintain
prompt access to records, when needed, Sec. 1109.5(j) (renumbered from
proposed Sec. 1109.5(i)) allows required records to be maintained
outside the United States, as long as the records can be provided to us
upon request, either in hard copy or electronically, such as through an
Internet Web site.
We also agree that, in many cases, it could be burdensome for the
records to be maintained in English. Therefore, Sec. 1109.5(j) allows
records to be maintained in languages other than English, if the
records can be provided immediately by the certifier or testing party
to the CPSC, and if an accurate English translation can be provided by
the certifier or testing party within 48 hours of our request, or
within such longer period as may be negotiated with CPSC staff. Note,
however, that section 14(g) of the CPSA and our regulation at 16 CFR
part 1110 require that certificates be in the English language.
Accordingly, all certificates, including component part certificates,
must be in English.
(Comment 25)--One commenter said that in the preamble to the
proposed rule (75 FR 28361), the CPSC states that it will: ``* * *
likely request access to these records only when it is investigating
potentially defective or noncomplying products.'' (Emphasis added). The
commenter expressed the belief that this indicates that collection of
this information on every item is not necessary for the proper
performance of the CPSC's functions.
Some commenters asked for more flexibility in developing the
recordkeeping requirements so that different industries and companies
can tailor recordkeeping to their products, processes, and materials
used. The commenters added that we should avoid provisions in the final
rule that would require companies to integrate multiple systems in
order to compile data points across hundreds of thousands to millions
of product component parts in order to meet the recordkeeping
requirements of the rule, as long as companies, upon request, can
provide reasonable data customary in a particular industry to verify
that certified components were used in the finished product.
(Response 25)--The commenter's citation to 75 FR at 28361 is
contained in the proposed rule, ``Testing and Labeling Pertaining to
Product Certification,'' and we have addressed it in the response to
comments memorandum and preamble for the final rule on part 1107. Thus,
this portion of the comment is out of scope for the proposed rule on
``Conditions and Requirements for Testing Component Parts of Consumer
Products.''
The remainder of the comment discusses the proposed rule on
component part testing. The commenters did not elaborate on what type
of flexibility is desired in the recordkeeping provisions. However, the
requirements listed in Sec. 1109.5(g) and (j) (formerly proposed Sec.
1109.5(f) and (i)) indicate only what information is expected to be
collected, not the format for collection. Therefore, it should be
necessary for the manufacturer or importer to identify and store only
the required elements that are not already part of their current
recordkeeping system and be certain that the remaining documentation
can be produced, upon request, in a manner that clearly identifies the
requisite parts. Section 1109.5(j) requires the records to be made
available to us, upon request, either in hard copy or electronically,
such as through an Internet Web site. This requirement does not oblige
the certifier to implement any specific records management system, and
so a certifier is free to structure its recordkeeping systems to meet
its needs and to capture the information required by the rule. No
change to the final rule was made based on this comment.
(Comment 26)--One commenter stated that the traceability
recordkeeping requirements are unnecessary, given the minimal risk to
the public's health from the health hazards being addressed, as
demonstrated by the CPSC's injury data regarding lead exposure.
(Response 26)--Congress has determined the allowable lead levels
and requires that products subject to such requirements be tested and
certified. The traceability recordkeeping requirements are intended to
make it possible to identify the parties who procured and conducted
testing on products that are not in compliance with the applicable
rules, bans, standards, and regulations, and to determine why the
testing and certification system did not prevent such noncompliance.
(Comment 27)--One commenter asserted that the proposed rule ``makes
it abundantly clear that the CPSC is perfecting a myriad of claims to
be made against any and all manufacturers when it suits the purpose of
the agency.'' The commenter expressed its fear that the agency could
make charges based on missing records or paperwork.
(Response 27)--Component part testing before final assembly of a
finished product is voluntary. A finished product certifier is not
required to rely on component part certificates or test reports. Even
when a test method requires testing of component parts, a finished
product certifier can test finished products by disassembling for
testing. In some cases, it may be more economical for the finished
product to be certified based on tests of the finished product itself,
instead of relying on component part certificates or test reports. The
main purposes of the documentation requirements in part 1109 are to
maintain the integrity of the testing and certification process and to
provide traceability to the testing of component parts and finished
products on which certification is based.
(Comment 28)--One commenter stated that the Commission needs to
[[Page 69564]]
provide more guidance to finished product or component part certifiers
on how to trace the component parts or how to manage the lot/batch
details in their recordkeeping systems. The commenter stated that while
some certifiers have sophisticated tracking systems, many certifiers do
not and will require a template to guide them.
(Response 28)--Given the range of consumer products, certifiers,
and testing parties affected by this rule, we decided to give parties
the flexibility to devise recordkeeping systems that are appropriate to
their operations. In particular, the breadth of component part types,
their manufacturing methods, and their uses make it impractical to
attempt to design a universal recordkeeping template. The final rule
specifies the documentation to be provided and its retention period.
Certifiers and testing parties should use their knowledge of
manufacturing specific products and component parts and tailor their
recordkeeping systems to the products, processes, and materials they
use.
(Comment 29)--Some commenters expressed concern that the
recordkeeping, documentation, and traceability requirements are too
complex and are likely to undercut any benefits from component part
testing. One commenter stated that using component part testing for
some rules, while finished product testing is required for other rules,
would be overly complex. One commenter stated that the complex
procedures might be appropriate for materials or products that pose a
risk of acute toxicity or a serious risk of injury but asserted that
they are ``overkill'' with regard to lead content, lead in paint
concentration, and phthalate concentration rules, which the commenter
apparently perceives as addressing lesser risks.
(Response 29)--The requirement in the final rule that the component
parts tested be traceable, arises out of the requirement in section
14(g)(1) of the CPSA, which requires the finished product certificate
to contain some specific information, including the date and place of
manufacture, the name and address of any third party laboratory on
whose testing the certification depends, the date of the testing, and
contact information for the individual responsible for maintaining
records of test results. Thus, if we allow parties other than the
finished product certifier, such as component part suppliers, to test
and certify products, the regime must have elements of traceability, as
well as ensure the integrity of the testing and certification process.
For example, specific information about testing and certification of
component parts will not necessarily appear on the face of a
certificate if such testing and certification is done by component part
suppliers. However, we still need to be able to trace the product or
component parts back to the parties responsible for testing and
certification if a noncompliance is found.
The complexity of the testing and certification process to which
the commenter alluded, stems, in part, from the variety of methods
available to test or certify component parts and finished products.
This flexibility is built into the requirements to allow those who
voluntarily test or certify component parts or finished products, to
choose the methods that are best suited to their circumstances. How a
product is tested or certified, meaning whether the finished product
certifier relies on component part testing or certification, or
finished product testing or certification, depends upon the product and
the applicable safety standards being tested. For example, the same
product may involve testing of component parts, such as lead in
substrate; and it also might require that some tests, such as small
parts testing, be performed on the finished product.
The documentation requirements in proposed Sec. 1109.5(f)
(renumbered in the final rule to Sec. 1109.5(g)) and the traceability
requirements of proposed Sec. 1109.5(e) (renumbered to Sec. 1109.5(f)
of the final rule) are needed to ensure that the finished product
certifier has the required information to issue a finished product
certificate. These data must be available to the finished product
certifier for each component part used in the finished product that was
tested separately from the finished product. The statute applies
certification requirements to all consumer product safety rules under
the CPSA and to any similar rule, ban, standard, or regulation under
any other act enforced by the Commission; we do not have the discretion
to relax these requirements for products subject to any particular one
of these rules. Therefore, we will not relax the recordkeeping
requirements in the final rule, as suggested by these commenters.
D. Subpart B--Conditions and Requirements for Specific Consumer
Products, Component Parts, and Chemicals
Subpart B, Sec. 1109.11 through 1109.13 of the proposed rule,
would set forth conditions and requirements for specific chemical
content regulated by the CPSC. These would include the limits for lead
content of paint and similar surface-coating materials in 16 CFR part
1303; the limitation of the amounts of compounds of antimony, arsenic,
barium, cadmium, chromium, lead, mercury, or selenium in paints or
other surface coatings in toys in section 4.3.5.2 of ASTM F 963
(``Standard Consumer Safety Specification for Toy Safety''); the limits
for lead content in children's products in section 101(a) of the CPSIA;
and the prohibition against more than 0.1 percent of certain phthalates
in children's toys and child care articles in section 108 of the CPSIA.
(Section 106(a) of the CPSIA states that the requirements of ASTM F 963
must be considered consumer product safety standards issued by the
Commission under section 9 of the CPSA.)
1. Proposed Sec. 1109.11--Component Part Testing for Paint and Other
Surface Coatings
Proposed Sec. 1109.11 would address component part testing for the
levels of specified chemicals in paints or surface coatings. This
aspect of the proposed rule was based on the Commission's previously
published enforcement policy for testing products for compliance with
lead limits. 74 FR 68593 (December 28, 2009).
Section 101(f)(1) of the CPSIA required us to revise our
preexisting regulation (at 16 CFR 1303.1) so that paints and similar
surface coating materials having a lead content in excess of 0.009
percent of the weight of the total nonvolatile content of the paint or
the weight of the dried paint film are banned hazardous products. (To
simplify this discussion, we use the term ``paint'' broadly to include
any type of surface coating that is subject to 16 CFR part 1303 or
section 4.3.5.2 of ASTM F 963.) The new lower limit in 16 CFR part 1303
applies not only to paint sold to consumers, as such (for example, a
gallon of paint sold at a hardware store), but also to any paint on
toys or other articles for children and to any paint on certain
household furniture items (not limited to children's furniture). See 16
CFR part 1303. The principles for testing paint subject to 16 CFR part
1303 also apply to the testing of paint and surface coatings for toys
in section 4.3.5.2 of ASTM F 963.
We received several comments about component part testing of paint,
which were unrelated to any particular provision of the proposed rule.
(Comment 30)--A commenter stated that the presumption that only the
CPSC (or Congress) can make sound judgments when considering safety
issues is simply not supported by the data. The commenter added that
the concept of using component parts supported by General Conformity
[[Page 69565]]
Certificates (GCCs) is simple enough. The commenter asked that, given
that the restrictions on lead in paint and lead content of children's
products are clear under the CPSIA, why not let businesses exercise
their judgment on how to meet those requirements and then measure
businesses on their success in doing so?
(Response 30)--The proposed rule did not make any presumptions
regarding who can make sound judgments about safety issues. The
restrictions on lead mentioned by the commenter pertain to the lead in
paint requirements under 16 CFR part 1303 and lead content restrictions
on children's products in section 101 of the CPSIA. Section 14(a)(2) of
the CPSA requires that children's products be tested by a third party
conformity assessment body before a children's product can be
certified. Therefore, component part tests used as a basis for issuing
a children's product certificate must also be conducted by a third
party conformity assessment body.
GCCs, issued pursuant to section 14(a)(1) of the CPSA, do not
require third party conformity assessment body testing, and therefore,
reliance on such certificates is not permissible as the basis for
issuing a Children's Product Certificate. However, GCCs of component
parts can be used as a basis for issuing a finished product certificate
for a non-children's product.
Part 1109 is intended to give businesses the flexibility to use
component part tests in whole, or in part, as the basis for issuing a
finished product certificate. Businesses must determine whether
component part testing is allowed or required, based on any applicable
standard or test method, and they also must decide whether to use
component part testing when certifying finished products.
(Comment 31)--One commenter noted that the proposed rule seemed to
address paints as if they were components of finished products. The
commenter noted that components of finished products, such as
fasteners, are often painted, and it would be useful to clarify whether
the rule would apply to certifiers of components, as well as to
certifiers of finished products.
(Response 31)--By noting in Sec. 1109.4(b) of the final rule that
``* * * a component part means any part of a consumer product * * *,''
it is possible that a component part may be both a component part of a
finished product and a component part of another component part. Paints
are component parts, in addition to being subject to 16 CFR part 1303.
The rule applies to component part certifiers and finished product
certifiers.
(Comment 32)--A commenter requested that we specifically approve
testing and certification to the lead paint standard of finished
product components prior to their incorporation into the finished
product because specific allowance of this finished component testing
method for children's products would enhance the likelihood that such
testing would be embraced by importers, retailers, and private
labelers.
(Response 32)--The commenter correctly interpreted that the
proposed rule would allow paints used in products subject to a rule to
be tested as component parts without the need to be tested on the
finished product. Specifically, ``paint'' clearly fits into the
definition of ``component part'' in Sec. 1109.4(b) of the final rule.
On our own initiative, we shortened the name of Sec. 1109.11 to
``Component part testing for paint.'' The phrase ``and other surface
coatings'' was removed because the word ``paint'' is a defined term in
the rule, at Sec. 1109.4(j), which includes other surface coatings.
a. Proposed Sec. 1109.11(a)--Generally
Proposed Sec. 1109.11(a) would state that the Commission will
permit certification of a product as being in compliance with the lead
paint limit of part 1303 of this chapter or the content limits for
paint on toys of section 4.3.4.2 of ASTM F 963 if, for each paint used
on the product, the party that certifies the product either has
obtained a test report or holds a paint certificate, as described
below, and meets the requirements in Sec. Sec. 1109.11(a)(1) through
(a)(3).
We received no comments on proposed Sec. 1109.11(a). On our own
initiative, we finalized this section with several changes. First, we
revised the language to include both finished products and component
parts, consistent with changes throughout the rule to incorporate
finished product testing or certification, as discussed in response to
Comment 1 in section II.B.1 of this preamble. Second, we amended the
reference to section 4.3.5.2 of ASTM F 963 to include ``ASTM F 963-08
or any successor standard of this section accepted by the Commission *
* * .'' This revision is consistent with a change made to the
definition of ``paint'' in Sec. 1109.4(j) of the final rule, and
allows us to rely on revised versions of ASTM F 963 without revising
part 1109 whenever we accept a successor standard to any particular
version of ASTM F 963. Finally, we deleted the phrase which required
that for each paint used on the product, the ``party that certifies the
product either has obtained a test report or holds a paint certificate
as described below'' and replaced it with a statement that the
requirements ``in Sec. 1109.5 and paragraph (b) of this section are
met.'' Although the deleted language is an accurate statement of the
Commission's expectation, it is duplicative of the general requirements
already set forth in Sec. 1109.5. Throughout Subpart B we simplified
the rule by removing language that is duplicative of general
requirements for component part testing, and we replaced such language
with a requirement that the general requirements in Sec. 1109.5 be
met, in addition to any more specific requirements set forth in Subpart
B.
(1) Proposed Sec. 1109.11(a)(1)
Because compliance of a paint to its content limits is a function
of the paint and not the component part or substrate to which it is
applied, proposed Sec. 1109.11(a)(1) (renumbered to Sec.
1109.11(b)(1) in the final rule) would require that all testing be
performed on dry paint that is scraped off of a substrate for testing
(the substrate used need not be of the same material as the material
used in the finished product or have the same shape or other
characteristics as the part of the finished product to which the paint
will be applied).
(Comment 33)--One commenter urged us to make an explicit statement
allowing the use of spray sampling/multiple stamping (where one sample
of a product is painted or stamped with a surface coating over a larger
area than on the actual product in order to ensure enough paint or
other surface coating is available for testing) as an alternative to
requiring the destruction of many samples to obtain a sufficient
quantity of a paint or surface coating for testing when the paint
appears only on a small part of the product.
(Response 33)--As explained in proposed Sec. 1109.11(a)(1) and (2)
(renumbered to Sec. 1109.11(b)(1) and (2) in the final rule), paint to
be tested can be applied to any suitable substrate. The substrate need
not be of the same material as the material used in the finished
product. Further, a larger quantity of paint may be tested than the
quantity used on the finished product. The commenter seemed to believe
that the paint must be scraped off an example of the finished product;
however, this is not the case. The techniques described by the
commenter are acceptable under the rule, but other techniques also
could be used.
However, on our own initiative, we moved Sec. 1109.11(a)(1) to
Sec. 1109.11(b)(1) in the final rule, and added explanatory
[[Page 69566]]
language regarding the two requirements for component part testing of
paint in this new section (b) as follows: ``(b) Requirement. For each
paint used on the product: * * *'' We also removed the text in brackets
regarding the fact that ``the substrate used need not be of the same
material as the material used in the finished product * * *'' and made
this information a separate sentence. We made these changes simply for
formatting purposes, and we do not consider them to be substantive
changes. Finally, on our own initiative, we clarified in Sec.
1109.11(b)(1) that it is unnecessary to scrape dried paint off of a
substrate for testing when using Energy Dispersive X-Ray Fluorescence
Spectrometry as described in the ASTM F 2583-10 test method to test for
lead in paint. Although the paint must be dry, it does not need to be
scraped off of a substrate when using this technology. We made this
change to acknowledge that on April 5, 2011, we published in the
Federal Register, a Notice of Requirements for accreditation of third
party conformity assessment bodies for lead in paint (76 FR 18645). In
that Notice of Requirements, the use of ASTM F2583-10, ``Standard Test
Method for Determination of Lead in Paint Layers and Similar Coatings
or in Substrates and Homogeneous Materials by Energy Dispersive X-Ray
Fluorescence Spectrometry Using Multiple Monochromatic Excitation
Beams,'' is allowed for testing the lead content in paint.
(2) Proposed Sec. 1109.11(a)(2)
Proposed Sec. 1109.11(a)(2) (renumbered to Sec. 1109.11(b)(2) in
the final rule) would provide that the tested paint must be identical
in all material respects to that used in production of the consumer
product. The paint samples tested must have the same composition as the
paint used on the finished product. However, a larger quantity of the
paint may be tested than is used on the consumer product, in order to
generate a sufficient sample size. The paint may be supplied to the
testing laboratory either in liquid form or in the form of a dried film
of the paint on any suitable substrate.
We received one comment related to proposed Sec. 1109.11(a)(2),
which we have summarized above in Comment 33. Additionally, on our own
initiative, we renumbered proposed Sec. 1109.11(a)(2) to Sec.
1109.11(b)(2) in the final rule. We also revised the last sentence to
state that paint may be supplied to the testing laboratory ``for
testing'' either in liquid form or in the form of a dried film of the
paint on any suitable substrate. This revision is intended to clarify
the reason why such paint is supplied to a testing laboratory.
(3) Proposed Sec. 1109.11(a)(3)
Proposed Sec. 1109.11(a)(3) would require that the documentation
required by a testing party and the certificate required of finished
product certifiers under section 14(a) of the CPSA identify each paint
tested by color, location, specification number or other
characteristic, the manufacturer of the paint, and the supplier of the
paint (if different).
(Comment 34)--One commenter stated that proposed Sec.
1109.11(a)(3) would specify that the documentation required by a
testing party and the certificate required by certifiers shall identify
each paint tested by location and formulation. The commenter stated
that paint formulations involve commercial and technical secrets and
that the requirement to identify paint formulations is beyond the scope
of the CPSIA. The commenter suggested deleting the requirement to
identify paint formulations.
(Response 34)--The commenter has misinterpreted proposed Sec.
1109.11(a)(3), which would require that documentation identify each
paint tested ``by color, location, formulation, or other
characteristic'' (emphasis added). Nevertheless, we deleted this
section in the final rule because it is duplicative of the general
requirement for all products in Sec. 1109.5(g)(1). Section
1109.5(g)(1) of the final rule requires identification of the component
part to which the test report or certificate applies. Any
characteristic sufficient to identify the paint that was tested will
satisfy this requirement (e.g., ``red paint on coat of doll,'' or ``red
paint 1234''). The final rule does not require a certifier to
provide formulation data. No change has been made to the final rule in
response to this comment.
(Comment 35)--One commenter stated that the requirement in proposed
Sec. 1109.11(a)(3) for the documentation to identify the location on
the finished product where each paint is used would be too difficult to
identify each accurately before its use. The commenter suggested
deleting this requirement or making it voluntary.
(Response 35)--As noted above in the response to Comment 34, we
deleted proposed Sec. 1109.11(a)(3) from the final rule. Section
1109.5(g)(1) of the final rule requires that a certifier or testing
party identify the component part tested. This includes paint. This
identification may be, for example, by color, location, formulation, or
other characteristic. At least one characteristic is necessary to
identify which paint component part on the product is tested or
certified. The final rule does not require specifying more than one of
these characteristics, but certifiers and testing parties should do so
if it is necessary to identify the applicable paint. Therefore, the
documentation does not necessarily have to specify the location of the
paint on the part. Further, when the test report or certification is
solely for the paint, as opposed to a component part with paint applied
to it, the location where the paint ultimately might be used is
irrelevant to the paint's certification.
b. Proposed Sec. 1109.11(b)--Test Reports
Proposed Sec. 1109.11(b) would state that, as part of its basis
for certification of a children's product to the lead paint limit or
other paint limit, a certifier may rely on a test report showing
passing test results for one or more paints used on the product, based
on testing performed by a third party conformity assessment body. The
manufacturer of the children's product must ensure that each paint
sample sent to a third party conformity assessment body is identical in
all material respects to the paint used on the finished product. Test
reports must identify each paint tested, by color, formulation, or
other characteristic, and identify the manufacturer of the paint and
the supplier of the paint (if different).
We received no comments on proposed Sec. 1109.11(b). However, on
our own initiative we deleted this section from the final rule because
it is duplicative of other regulations regarding paint, as well as the
general requirements for component part testing or certification that
have already been set forth in Sec. 1109.5. For example, the fact that
paint on a children's product must meet the lead paint limit is already
set forth in 16 CFR part 1303. Additional limits on heavy metals in
paint for children's products are set forth in section 4.3.5.2 of ASTM
F 963. The fact that a children's product must be tested by a third
party conformity assessment body is required by section 14(a)(2) of the
CPSA and our regulation at 16 CFR part 1107, published elsewhere in
this Federal Register. The fact that component part samples tested must
be identical in all material respects to the component parts used in
the finished product is required by Sec. 1109.5(a)(2) of the final
rule, as well as Sec. 1109.11(b)(2). Finally, identification of the
paint tested is required by Sec. 1109.5(g)(1) of the final rule.
[[Page 69567]]
c. Proposed Sec. 1109.11(c)--Paint Certificates
(1) Proposed Sec. 1109.11(c)(1)--Children's Products
Proposed Sec. 1109.11(c)(1) would state that, as part of its basis
for certification of a children's product to the lead paint limit or
other paint limit, a component part certifier or finished product
certifier may rely on a certificate from another person certifying that
paint complies with the applicable limit. The paint certificate for a
children's product must be based on testing by a third party conformity
assessment body of samples of paints that are identical in all material
respects to the paints used on the finished product. The paint
certificate must identify all test reports underlying the
certification.
We received no comments on proposed Sec. 1109.11(c)(1). However,
on our own initiative, we deleted this section from the final rule
because the requirements are duplicative of other regulations and the
general requirements for component part testing or certification in
Sec. 1109.5 of the final rule. For example, the fact that a finished
product certifier can rely on component part testing or certification
is duplicative of Sec. 1109.5(a) and 1109.5(i)(1) of the final rule.
The fact that a Children's Product Certificate must be based on testing
by a third party conformity assessment body is duplicative of section
14(a)(2) of the CPSA and our regulation at 16 CFR part 1107, published
elsewhere in this Federal Register. The fact that component part
samples tested must be identical in all material respects to the
component parts used in the finished product is required by Sec.
1109.5(a)(2) of the final rule, as well as Sec. 1109.11(b)(2).
Finally, as described in response to Comment 21 in section II.C.5.h.(3)
of this preamble, content requirements for certificates have been
removed from the final rule. Certificate content requirements are set
forth in section 14(g) of the CPSA and our regulation at 16 CFR part
1110.
(2) Proposed Sec. 1109.11(c)(2)--Non-Children's products
Proposed Sec. 1109.11(c)(2) would provide that for non-children's
products that are subject to lead paint limits (such as certain
furniture items), a finished product certifier may base its
certification to the lead paint limit on its own testing of each paint
used on the product, on testing by any third party conformity
assessment body, on paint certification(s) from any person, or on a
combination of these methods.
We received no comments on proposed Sec. 1109.11(c)(2). On our own
initiative, however, we deleted this section from the final rule
because it is a restatement of the law on non-children's products and
the general requirements for component part testing or certification in
Sec. 1109.5 of the final rule. Moreover, pursuant to Sec. 1109.5(a)
of the final rule, a finished product certifier may rely on component
part testing to certify its product.
(3) Proposed Sec. 1109.11(c)(3)--Traceability
Proposed Sec. 1109.11(c)(3) would provide that any finished
product certifier who certifies a children's product as complying with
the lead paint limit or other paint limit should be able to trace each
batch of paint that is used on the product to the supplier and, if
different, the paint manufacturer.
(Comment 36)--A commenter stated that our position on the testing
of paint (Traceability, proposed Sec. 1109.11(c)(3)), should not be
interpreted literally, so long as the manufacturer can show the source
of that batch, consistent with the more general definition and
requirement of traceability.
(Response 36)--We agree with the commenter. Similar to other
component parts, the traceability of paint to the lead content
requirements or other rules should extend to the level at which the
paint was tested for compliance. We amended Sec. 1109.4(m) to define
traceability to extend to the component part of the product tested. In
the commenter's example, if the paint was tested at the batch level (as
opposed to the constituent components of the paint), the traceability
extends to the batch. We also deleted the traceability requirement
specifically for paint in proposed Sec. 1109.11(c)(3), because it was
duplicative of the traceability requirements in Sec. Sec. 1109.4(m)
and 1109.5(f) in the final rule, which applies to all products and
component parts, including paint.
(Comment 37)--One commenter sought clarification of the
traceability requirement for testing paint (proposed Sec.
1109.11(c)(3)). The commenter stated that requiring a finished product
manufacturer to trace a batch of paint to its source would be
reasonable. However, the commenter added, if the intent of the
provision is to require the manufacturer to be able to trace back from
a particular item of a finished product to the batch of paint used on
that product, then the requirement would be onerous and serve no clear
purpose.
(Response 37)--We deleted Sec. 1109.11(c)(3) from the final rule
because it is duplicative of the general traceability requirements that
apply to all component parts in Sec. Sec. 1109.4(m) and 1109.5(f) of
the final rule. One reason for the traceability requirement is to be
able to identify the testing party and the third party conformity
assessment body if a noncomplying paint is found on a children's
product distributed in commerce. Traceability from the finished product
to the party who tested the paint is required to help determine why the
testing and certification scheme embodied in parts 1107 and 1109 failed
to prevent the use of a noncomplying paint on a children's product.
Moreover, if a noncompliant paint is found, traceability information
can help us and a manufacturer to determine the scope of any resulting
recall.
(4) Proposed Sec. 1109.11(c)(4)--Prevention of Contamination
Subsequent to Testing
Proposed Sec. 1109.11(c)(4) would require that the finished
product manufacturer must ensure that paint meeting the applicable
limits when tested and certified is not contaminated later with lead
from other sources before or during application to the product.
We received no comments regarding this section. However, on our own
initiative, we deleted Sec. 1109.11(c)(4) from the final rule because
it is duplicative of Sec. 1109.5(b) on test result integrity that
applies to all certifiers and testing parties.
2. Proposed Sec. 1109.12--Component Part Testing for Lead Content of
Children's Products
On August 14, 2011, the general limit for lead in any accessible
part of a children's product was reduced from 300 parts per million
(``ppm'') to 100 ppm (see section 101(a)(2)(B) of the CPSIA). On August
12, 2011, the President signed H.R. 2715 into law. The new law revised
section 101 of the CPSIA to state that the lead content limits apply
only to children's products that are manufactured after the effective
date of each limit; thus, the 100 ppm lead content limit applies only
to children's products manufactured after August 14, 2011.
Currently, testing and certification is required for metal
component parts of children's metal jewelry. 73 FR 78331 (December 22,
2008); 74 FR 6396 (February 9, 2009). The certification must be based
on testing by a third party conformity assessment body whose
accreditation to test for lead in children's metal jewelry has been
accepted by the CPSC. Such entities are listed on the CPSC's Web site
(see http://www.cpsc.gov/cgi-bin/
[[Page 69568]]
labapplist.aspx). If the children's metal jewelry bears paint, it must
also be certified as in compliance with the 90 ppm lead paint limit in
16 CFR part 1303. The requirement for testing and certification of
other children's products for lead content (except paint) currently is
stayed until December 31, 2011.
Children's products, other than children's metal jewelry, or
products made of materials which, by their nature, will never exceed
the lead content limits, must be certified as being in compliance with
the 100 ppm lead content limit, only if they are manufactured after
December 30, 2011, and only as to accessible parts that are not subject
to a Commission determination, as described in 16 CFR 1500.91. Pursuant
to section 14(a)(2) of the CPSA, the certification must be based on
testing by a third party conformity assessment body whose accreditation
to test for lead in children's products has been accepted by the CPSC.
This section of the final rule is based on our previously published
enforcement policy for testing products for compliance with lead
limits. 74 FR 68593, 68595 (December 28, 2009). Section 1109.12 on
component part testing for lead content of children's products is
intended to supersede the enforcement policy with regard to component
part testing of lead content in children's products contained in
section V of the enforcement policy.
We received several general comments, summarized below, about
component part testing for lead content in children's products that do
not relate directly to a proposed section of the rule.
(Comment 38)--One commenter requested that we make an explicit
statement about component part testing, given that certain types of
component part materials are exempt from testing and certification
requirements. The commenter is concerned that, without specific
language, the final customer will not accept component testing if
exempt parts are not tested. The commenter placed the comment on the
docket for the proposed 16 CFR part 1107 rule, and recommended revising
proposed Sec. 1107.20(c) as follows:
(c) Except where otherwise specified by a children's product
safety rule, a manufacturer may substitute component part testing
for complete product testing pursuant to 16 CFR [part] 1109 if the
component part, without the remainder of the finished product, is
sufficient to determine compliance for the entire product. Component
part testing can be used to substantiate compliance for those
children's products where part of the product has been exempted from
testing pursuant to Section 1500.91. (Italics indicate proposed
language.)
(Response 38)--This comment concerns the component part testing
rule; accordingly, we are responding to this comment here. If the
suggested change were to be made, the appropriate place to make the
change would be to the component part testing for lead content section,
proposed 16 CFR 1109.12. We agree that component part testing is
appropriate to substantiate compliance for children's products in which
part of the product has been exempted for testing. However, we do not
believe that it is necessary to revise the final rule to add the
language suggested by the commenter. The commenter's suggested language
would be duplicative of what already is stated in other rules on
exceptions from testing. Lead content, in particular, must be tested
part-by-part under section 101 of the CPSIA. Because the statute and
the regulations already specify that exempted materials do not require
testing, we decline to repeat those exemptions in part 1109.
(Comment 39)--One commenter stated that the proposed rule on
component part testing was stricter than necessary and that Congress
did not require such a complicated regulatory scheme. The commenter
stated that the CPSC's recall data from 1999-2010, show only one death
and three purported injuries from lead. The commenter further states
that incidents of fraud in testing are infrequent and are already
addressed by other statutes. The commenter also mentioned its own
record of a single recall of a total of 130 pieces since 1985.
(Response 39)--Section 14(a)(2) of the CPSA requires manufactures
of children's product subject to an applicable children's product
safety rule to submit sufficient samples to a CPSC-accepted third party
conformity assessment body for testing. Based on such third party
testing, a children's product manufacturer must issue a certificate
that such product complies with the applicable children's product
safety rules. Section 14(d)(2)(B) of the CPSA requires the Commission,
by regulation, to establish protocols and standards for ensuring that a
children's product tested for compliance with an applicable children's
product safety rule is subject to test periodically and when there has
been a material change in the product's design or manufacturing
process, including the sourcing of component parts. Additionally,
section 101 of the CPSIA establishes new lead content limits for
children's products, and it lowers the lead paint requirement to 90
ppm.
Our implementation of the statute for component part testing is
intended to reduce the statutorily required testing burden, by allowing
considerable flexibility for component part suppliers and finished
product certifiers. Component part suppliers may choose voluntarily to
have their component parts tested or certified. Finished product
suppliers may use voluntarily a combination of component part
certificates, component part test reports, or test reports or
certificates of the finished product to show compliance with the
applicable product safety rules. Component part testing may be used
voluntarily to reduce the economic burden associated with testing and
certification, by taking advantage of component part tests that can be
used for multiple products. Because the CPSA requires third party
testing of children's products, and because the commenter did not
suggest ways in which the rule on component part testing could be made
less strict and still comply with the law, nor did the commenter
provide any explanation on how a regulation based on risk assessment
would comply with the CPSIA, we have no basis to revise the final rule
in response to this comment.
(Comment 40)--One commenter suggested that, because there have not
been recalls or reports of illness or injury due to the presence of
lead in ordinary books, they should be excluded from the requirements
of the CPSIA. The commenter added that there should be a much more
reduced testing regimen for books and other products that have a very
low potential for risk, followed by their removal from the testing
requirement altogether.
(Response 40)--Pursuant to section 14(i)(5)(A)(i) of the CPSA, as
amended by H.R. 2715, third party certification testing no longer
applies to ordinary books or to ordinary paper-based printed materials.
The exception does not apply to non-paper components like metal or
plastic parts, or to accessories that are not part of the binding and
finishing materials. The exception also does not apply to books with
inherent play value, books designed or intended for a child 3 years of
age or younger, and does not include any toy or other article that is
not a book that is sold or packaged with an ordinary book. Thus, given
how H.R. 2715 has amended section 14(i) of the CPSA, it is unnecessary
for us to address the commenter's issues and concerns.
(Comment 41)--One commenter stated that it cost $3,700 for the
third party testing required for one of his
[[Page 69569]]
products. The commenter also said the 90 ppm lead concentration limit
is not realistic. The standard aluminum die-cast alloy, A380, allows a
lead content of up to 500 parts per million, the commenter observed.
A380 is used for cooking and baking ware, and according to the
commenter, it does not make sense that a child cannot play with a die-
cast toy but can eat food baked in a die-cast cake pan. The commenter
asserted that because his facility is ISO 9001:2008 compliant, it
documents all receipts of raw materials, and conducts a metal analysis
for each production run with a spectrometer, there is no need for a
third party test.
(Response 41)--The CPSIA altered the lead concentration limit in
paint and other surface coatings to 90 ppm (16 CFR part 1303). Such
limit does not apply to lead content in children's products. As of
August 14, 2011, section 101 of the CPSIA specifies a maximum limit of
100 ppm lead content in children's products; it does not impose a
comparable limit on non-children's products (such as the cooking and
baking ware named by the commenter). The 100 ppm limit is set by
statute and is not based on a hazard analysis of the particular product
under consideration. Section 14(a) of the CPSA states that
manufacturers of children's products must have third party conformity
assessment body testing to provide a basis for issuing a Children's
Product Certificate. The CPSA contains no provision for excluding
products made by companies that are ISO 9001:2008 compliant, that
document their receipts, or that use first party testing techniques
during production. H.R. 2715 establishes a process by which a
functional purpose exception to the lead content limit may be granted
to a product, class of product, material, or component part if the
Commission makes certain determinations, after a notice and hearing. To
date, we have not granted any functional purpose exceptions. Because
the statute is clear on the lead limits and the requirement for third
party testing, and in the absence of functional exceptions, we decline
to revise the rule based on this comment.
a. Proposed Sec. 1109.12(a)--Generally
Proposed Sec. 1109.12(a) would explain that a certifier may rely
on component part testing of each accessible part of a children's
product for lead content, where such component part testing is
performed by a third party conformity assessment body, provided that:
(1) The determination of which, if any, parts are inaccessible
pursuant to section 101(b)(2) of the CPSIA is based on an evaluation of
the finished product; and
(2) For each accessible component part of the product, the
certifier either has a component part test report or a component part
certificate.
We received no comments on proposed Sec. 1109.12(a). On our own
initiative, however, we finalized this section with several revisions.
Section 1109.12 now states:
A certifier may rely on component part testing of each
accessible component part of a children's product for lead content,
where such component part testing is performed by a third party
conformity assessment body, provided that the requirements in Sec.
1109.5 are met, and the determination of which, if any, parts are
inaccessible pursuant to section 101(b)(2) of the Consumer Product
Safety Improvement Act of 2008 (CPSIA) and part 1500.87 of this
chapter is based on an evaluation of the finished product.
We do not consider the revisions to be substantive; they are instead
intended to remove statements that are unnecessary in this rule on
component part testing, and to add helpful citations to other relevant
statutes and regulations. We deleted proposed Sec. 1109.12(a)(2) from
the final rule because it is duplicative of the general requirements
for component part testing set forth in Sec. Sec. 1109.5(g)
(documentation requirements) and (i) (requirements for finished product
certifiers) of the final rule. We also added a citation to Sec. 1109.5
to clarify that all of the general requirements in that section for
component part testing must be met for lead content component part
testing. Proposed Sec. 1109.12(a) was renumbered to Sec. 1109.12, and
we moved the language that was in proposed Sec. 1109.12(a)(1) into
Sec. 1109.12. This formatting change was done to streamline the rule;
by deleting subparagraph (a)(2), it was no longer necessary to number
the remaining paragraphs as paragraph (a) or subparagraph (a)(1).
Finally, we incorporated citation references to both the CPSIA and our
regulation at 16 CFR 1500.87, which discuss the determination of
inaccessible parts of a children's product, to clarify how testing
parties and certifiers should determine what is an inaccessible part of
a finished product for lead content testing purposes.
b. Proposed Sec. 1109.12(b)--Component Part Test Reports
Proposed Sec. 1109.12(b) would state that, as part of its basis
for certification of a children's product to the lead content limit, a
finished product certifier could rely on a test report showing passing
test results for one or more component parts used on the product, based
on testing by a third party conformity assessment body. The proposal
would require the component part test reports to identify each
component part tested, by part number or other specification, as well
as the manufacturer of the component part and the supplier (if
different).
We received no comments on proposed Sec. 1109.12(b). However, on
our own initiative we deleted this section from the final rule because
it is duplicative of other regulations and the general requirements for
component part testing in Sec. 1109.5. For example, the fact that a
certification to the lead content limit for children's products must be
based on testing conducted by a third party conformity assessment body
is already a requirement pursuant to section 14(a)(2) of the CPSA and
part 1107 of this chapter, published elsewhere in this Federal
Register. The fact that a finished product certifier can rely on
passing test reports or a certification of one or more component parts
of a consumer product to certify a finished product is provided for in
Sec. 1109.5(a) and 1109.5(i) of the final rule. Finally, documentation
requirements for reliance on test reports or certifications, including
product identification, are set forth in Sec. 1109.5(g) of the final
rule.
c. Proposed Sec. 1109.12(c)--Component Part Certificates
Proposed Sec. 1109.12(c) would state that, as part of its basis
for certification of a children's product to the lead content limit, a
finished product certifier could rely on a certificate from another
person certifying that a component part complies with the lead limit.
The component part certificate would have to be based on testing by a
third party conformity assessment body of a sample identical in all
material respects to the component part(s) used in the finished
product. The certificate pertaining to the component part must identify
all test reports underlying the certification consistent with section
14 of the CPSA.
We received no comments on proposed Sec. 1109.12(c). However, on
our own initiative, we deleted this section from the final rule because
it is duplicative of other regulations and the general requirements for
component part testing in Sec. 1109.5. For example, the fact that a
finished product certifier can rely on a certification of one or more
component parts of a consumer product to certify a finished product is
provided for in Sec. 1109.5(a) and 1109.5(i) of the final rule. The
fact that a certification to the lead content limit for children's
products must be based on testing
[[Page 69570]]
conducted by a third party conformity assessment body is already a
requirement pursuant to section 14(a)(2) of the CPSA and part 1107,
published elsewhere in this Federal Register. The requirement that
sample component parts tested on which certification is based must be
identical in all material respects to the component part(s) used in the
finished product is required by section 14(a)(2) of the CPSA and Sec.
1109.5(a)(2) of the final rule. Finally, documentation requirements for
reliance on certifications are set forth in Sec. 1109.5(g) of the
final rule. As described in response to Comment 21 in section
II.C.5.h.(3) of this preamble, all requirements for the contents of
certificates have been deleted from the final rule. All certificate
content requirements are set forth in section 14(g) of the CPSA and our
regulation at 16 CFR part 1110.
d. Proposed Sec. 1109.12(d)--Certificates for the Finished Product
Proposed Sec. 1109.12(d) would require the certificate
accompanying the children's product to list each component part tested,
by part number or other specification, and for each such component
part, identify the corresponding test report, paint certificate, or
component part certificate on which certification for the finished
product is based.
We received several comments regarding certificate requirements for
component parts, which are summarized in Comment 21 in section
II.C.5.h.(3) of this preamble. As set forth in the response to Comment
21, we decided to delete all content requirements for certificates to
avoid duplication in or inconsistency with the requirements in 16 CFR
part 1110. Accordingly, we deleted proposed Sec. 1109.12(d) from the
final rule. All certificate content requirements are set forth in
section 14(g) of the CPSA and our regulation at 16 CFR part 1110.
3. Proposed Sec. 1109.13--Component Part Testing for Phthalates in
Children's Toys and Child Care Articles
Section 108 of the CPSIA permanently prohibits the sale of any
children's toy or child care article containing concentrations of more
than 0.1 percent of three specified phthalates (di-(2-ethylhexyl)
phthalate, dibutyl phthalate, or benzyl butyl phthalate). Section 108
of the CPSIA also prohibits, on an interim basis, the sale of any
children's toy that can be placed in a child's mouth or child care
article containing concentrations of more than 0.1 percent of three
additional phthalates (diisononyl phthalate, diisodecyl phthalate, or
di-n-octyl phthalate), pending the recommendation of a Chronic Hazard
Advisory Panel.
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.\3\ 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).
---------------------------------------------------------------------------
\3\ 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 nor adulterated with the
addition of materials that could result in the addition of
phthalates into the product or material.
---------------------------------------------------------------------------
On August 12, 2011, the President signed H.R. 2715 into law. Among
other things, H.R. 2715 amended section 108 of the CPSIA by adding a
new section 108(d)(1) of the CPSIA which states, in part, that the
phthalate content limits ``shall not apply to any component part of a
children's toy or child care article that is not accessible to a child
through normal and reasonably foreseeable use and abuse of such
product, as determined by the Commission.'' Pursuant to section
108(d)(3) of the CPSIA, we must promulgate a rule within one year of
enactment of this revision to provide guidance on inaccessibility.
Phthalate content limits outlined in section 108 of the CPSIA
became effective on February 10, 2009. However, the requirement for
testing and certification for the phthalate content requirements is
stayed until December 31, 2011 (76 FR 49288). Accordingly, third party
testing and certification requirements for products subject to the
phthalates content limits apply to products manufactured on or after
January 1, 2012.
a. Proposed Sec. 1109.13(a)--Generally
Proposed Sec. 1109.13(a) would state that a finished product
certifier may rely on component part testing of appropriate component
parts of a children's toy or child care article for phthalate content
if the certifier is provided with a copy of the original test results
obtained from the third party conformity assessment body or a component
part certificate.
We received no comments directly related to proposed Sec.
1109.13(a). On our own initiative, we have finalized this section with
two changes. We broadened the first sentence to clarify that any
certifier, not just a finished product certifier, can rely on component
part testing of children's toys or child care articles for phthalate
content. We also amended the end of the sentence that required a
finished product certifier to be provided a copy of the original test
results obtained from a third party conformity assessment body. This
statement is duplicative of the documentation requirements already set
forth in Sec. 1109.5(g) of the final rule. Accordingly, this section
now states that a certifier can rely on component part testing of
appropriate component parts of a children's toy or child care article
for phthalates provided that the requirements for component part
testing in Sec. 1109.5 are met.
b. Proposed Sec. 1109.13(b)--Component Part Test Reports
Proposed Sec. 1109.13(b) would state that, as part of its basis
for certification of a children's product to the phthalate content
limit, a finished product certifier may rely on a test report showing
passing test results for one or more component parts used on the
product, based on testing by a recognized third party conformity
assessment body. Component part test reports must identify each
component part tested, by part number or other specification, and the
component part's supplier, and if different, the component part's
manufacturer.
We received no comments on proposed Sec. 1109.13(b). However, on
our own initiative, we deleted this section from the final rule because
it is duplicative of other regulations and the general requirements for
component part testing in Sec. 1109.5 of the final rule.
[[Page 69571]]
For example, the fact that a certification to the phthalate limit for
children's toys and child care articles must be based on testing
conducted by a third party conformity assessment body is already a
requirement pursuant to section 14(a)(2) of the CPSA and part 1107,
published elsewhere in this Federal Register. The fact that a finished
product certifier can rely on passing test reports or a certification
of one or more component parts of a consumer product to certify a
finished product is provided for in Sec. 1109.5(a) and 1109.5(i) of
the final rule. Finally, documentation requirements for reliance on
test reports or certifications are already set forth in Sec. 1109.5(g)
of the final rule.
c. Proposed Sec. 1109.13(c)--Component Part Certificates
Proposed 1109.13(c) would state that, as part of its basis for
certification of a children's product to the phthalate content limit, a
finished product certifier may rely on a certificate from another
person certifying that a component part complies with the limit. The
component part report must be based on testing by a third party
conformity assessment body of a samples that are identical in all
material respects to the component parts used in the finished product.
The component part certificate must identify all test reports
underlying the certification required by section 14 of the CPSA. Any
person who certifies a children's product as complying with the
phthalate content limits must be able to trace each component part of
the product to the component part's supplier and, if different, the
component part's manufacturer.
We received no comments on proposed Sec. 1109.13(c). On our own
initiative, however, we deleted this section from the final rule
because it is duplicative of other regulations and the general
requirements for component part testing in Sec. 1109.5 of the final
rule. For example, the fact that a finished product certifier can rely
on a component part certificate for one or more component parts of a
consumer product to certify a finished product is provided for in Sec.
1109.5(a) and 1109.5(i) of the final rule. The fact that a
certification to the phthalate limit for children's toys and child care
articles must be based on testing conducted by a third party conformity
assessment body is already a requirement pursuant to section 14(a)(2)
of the CPSA and part 1107, published elsewhere in this Federal
Register. The requirement that the tested component part samples on
which certification is based must be identical in all material respects
to the component part(s) used in the finished product is required by
section 14(a)(2) of the CPSA and Sec. 1109.5(a)(2) of the final rule.
Documentation requirements for reliance on another party's test reports
or certificates are already set forth in Sec. 1109.5(g) of the final
rule. Further, as described in response to Comment 21 in section
II.C.5.h.(3) of this preamble, we deleted all requirements for the
contents of certificates from the final rule. All certificate content
requirements are set forth in section 14(g) of the CPSA and our
regulation at 16 CFR part 1110. Finally, traceability requirements for
all component parts are set forth in Sec. Sec. 1109.4(m) and 1109.5(f)
of the final rule.
d. Proposed Sec. 1109.13(d)--Certificates for the Finished Product
Proposed Sec. 1109.13(d) would require that the certificate
accompanying the children's product list each component part required
to be tested by part number or other specification and, for each such
part, identify the corresponding test report from a third party
conformity assessment body on which the product's certification is
based.
We received several comments regarding certificate requirements for
component parts, which are summarized in Comment 21 in section
II.C.5.h.(3) of this preamble. As set forth in response to Comment 21,
we decided to delete all content requirements for certificates, to
avoid duplication or inconsistency in content requirements that have
already been codified in 16 CFR part 1110. Accordingly, we deleted
proposed Sec. 1109.13(d) from the final rule. All certificate content
requirements are set forth in section 14(g) of the CPSA and our
regulation at 16 CFR part 1110.
4. Proposed Sec. 1109.14--Composite Part Testing
Composite part testing is where more than one paint or surface
coating, or more than one component part, are combined and the
combination is tested for the level of the target chemical. This can
reduce the number of tests required or the number of products needed to
obtain a sample large enough to test.
a. Proposed Sec. 1109.14(a)--Paint and Other Surface Coatings
Proposed Sec. 1109.14(a) (renumbered to Sec. 1109.21(a) in the
final rule) would state that, in testing paints for compliance with
chemical content limits, testing parties may test a combination of
different paint samples so long as they follow procedures ensuring that
no failure to comply with the lead limits will go undetected, as
described in proposed Sec. 1109.14(c). Testing and certification of
composite paints must comply with proposed Sec. 1109.11.
(Comment 42)--One commenter stated that many manufacturers have
multiple paint colors that are mixed from base colors and that testing
all marketed colors for lead, including custom colors, imposes a
hardship. The commenter said that if each of the base colors complied
with the 90 parts per million lead in paint standard, then all of the
resulting colors would also meet the standard. The commenter stated
that it would be useful if the final rule specifically allowed
manufacturers to certify all of their paint colors on the basis of
tests on the base colors only, provided that there is no contamination
in the manufacturing process that could cause the paint colors to
violate the standard.
(Response 42)--The commenter is correct that if each base paint
complies with the standard, then the final mixed paints will comply
with the standard, provided there is no contamination in the
manufacturing process. The constituent components of paint may be
considered component parts. If each constituent component complies with
the lead in paint standard, then any combination of those components
will also be compliant. In the commenter's example, if the constituent
components are tested or certified, those test results and certificates
can be used as the basis for issuing test reports or certificates for
any paint that is a combination of those constituent components.
To make this explicit, we added the following language to Sec.
1109.21 (a):
A certificate may be based on testing each component part of the
paint according to the requirements of Sec. 1109.11 and certifying
that each component part in the mixture individually complies with
the lead in paint limit or other paint limit.
(Comment 43)--Some commenters noted that the effect of composite
testing is to lower the acceptable lead-in-paint level in a component
to a very small parts per million value. In other words, because
composite testing considers all the lead in the composite to be in each
component part of the composite, composite testing may not be useful
where the component parts contain significant, but permissible, levels
of lead. One commenter considered this a ``gamble.'' The commenters
recommended that the 90 ppm limit be applied to composite samples. One
commenter based this recommendation on an argument that lead poses a
minimal risk.
[[Page 69572]]
(Response 43)--In composite testing, different paint samples are
tested together. The test result received represents the total chemical
content (lead in paint in this case) in the mixture. The total chemical
content is completely allocated to each paint in proportion to the
composite. If the computation of total lead divided by the weight of
each paint does not exceed the lead-in-paint limits, then no paint in
the mixture exceeds the lead content limits. If this computation
exceeds the lead limits, it still may be possible that no paint in the
composite individually exceeds the lead limit. This is especially
likely if the paint with the largest proportion in the composite has
some lead and there are only small amounts of other paints in the
composite.
For example, if different parts of a doll are painted with small
amounts of different paints, the paints could be mixed together and
tested for lead content. Assume the doll has three different paints, A,
B, and C. Composite testing of a mixture of 50% A, 30% B, and 20% C are
tested for lead content. The lead content of the composite is 40 ppm.
When the total lead content is applied to each paint, the potential
concentration of lead in each paint is the measured amount divided by
the percentage of the composite, or:
Potential lead content of paint A = 40 ppm/50% or 80 ppm.
Potential lead content of paint B = 40 ppm/30% or 133 ppm.
Potential lead content of paint C = 40 ppm/20% or 200 ppm.
In this example, because both paints B and C could potentially contain
more than 90 ppm lead, more testing is needed to determine if this is
actually the case.
We disagree with the commenter's characterization of composite
testing as a ``gamble.'' Composite testing is a way to screen several
paints quickly and less expensively than separate tests for each paint.
If the composite does not meet the lead limits, then according to the
rule, ``* * * additional testing would be required to determine which
of the paints, * * * if any, fail to meet the applicable limit.'' The
commenter's suggestion that 90 ppm be retained for the composite sample
would not comply with the law because the composite might have less
than 90 ppm lead, but some of the individual paints (that could be used
on products or component parts) in the composite might exceed 90 ppm.
We have finalized proposed Sec. 1109.14(a) with several changes.
On our own initiative, we created a new Subpart C for composite testing
so that Subpart B is for regulations about specific consumer products
or chemicals, and we renumbered this section to Sec. 1109.21(a). We
also shortened the title of this section to ``Paint'' and removed ``and
other surface coatings,'' because ``paint'' is a defined term in Sec.
1109.4(j) that includes other surface coatings. In the first sentence,
we broadened the reference to ``testing parties'' to include both
``certifiers and testing parties,'' to acknowledge and clarify that
certifiers can also be testing parties. Also in the first sentence, we
revised the phrase ``parties may test a combination of different paint
samples'' to ``parties may procure tests conducted on a combination of
different paint samples'' to clarify and emphasize that certifiers and
testing parties for children's products must procure tests from a third
party conformity assessment body. As set forth in the response to
Comment 42, we added a sentence to this section to clarify the use of
composite testing of paints to certify a product. Finally, we clarified
that the testing and certification of composite paints must meet the
general requirements for component part testing set forth in Sec.
1109.5 and the requirements for component part testing of paints set
forth in Sec. 1109.11.
b. Proposed Sec. 1109.14(b)--Component Parts
Proposed Sec. 1109.14(b) (renumbered to Sec. 1109.21(b) in the
final rule) would allow a third party conformity assessment body to
test a combination of component parts so long as the third party
conformity assessment body follows procedures ensuring that no failure
to comply with the content limits will go undetected, as described in
proposed Sec. 1109.14(c). Testing and certification of composite
component parts for lead content must comply with Sec. 1109.12.
Testing and certification of composite component parts for phthalate
content must comply with Sec. 1109.13.
We did not receive any comments on proposed Sec. 1109.14(b). On
our own initiative, however, we made several changes in finalizing this
section, in addition to renumbering. We revised the opening sentence to
clarify who is responsible for procuring third party testing to state
that ``[a] certifier or testing party may procure tests conducted on a
combination of component parts for compliance with chemical content
limits so long as test procedures are followed to ensure that no
failure to comply with the content limits will go undetected * * *.''
We removed ``third party conformity assessment bodies'' from the
opening sentence and replaced it with ``[a] certifier or testing
party,'' because this rule puts the responsibility for ensuring that a
certification is based on appropriate test methods and protocols on the
party procuring testing. Consistent with this fact, we emphasized that
certifiers and testing parties may ``procure tests,'' because they must
rely on a third party conformity assessment body to conduct
certification testing for children's products. We clarified that
composite part testing for lead content must comply with the general
rules for component part testing in Sec. 1109.5 as well as the
requirements for component part testing of lead content in Sec.
1109.12. We made this same clarification for phthalate testing, such
that composite part testing for phthalate content must comply with the
general rules for component part testing in Sec. 1109.5 as well as the
requirements for component part testing of phthalate content in Sec.
1109.13.
c. Proposed Sec. 1109.14(c)--How To Evaluate Composite Part Testing
Proposed Sec. 1109.14(c) (renumbered to Sec. 1109.21(c) in the
final rule) would state that when using composite testing, only the
total amount or percentage of the target chemical is determined instead
of the amount in each individual paint or component part. Therefore, to
determine that each paint or component part is within the applicable
limit, the entire amount of the target chemical in the composite is
attributed to each paint or component part. If this method yields an
amount of the target chemical that exceeds the limit applicable to any
paint or component part in the composite sample, additional testing
would be required to determine which of the paints or component parts,
if any, fail to meet the applicable limit.
We received no comments on this proposed definition. However,
because we have renumbered the provisions that were proposed as subpart
B into a new subpart C, we have renumbered it as Sec. 1109.21(c).
E. Miscellaneous Comments
(Comment 44)--One commenter urged us to conduct a full cost-benefit
analysis of both the component testing rule and the testing and
labeling rule.
(Response 44)--While we could have conducted a cost-benefit
analysis, in the case of the component part testing rule, such an
analysis would have little value. The component part testing rule gives
manufacturers with a lower cost alternative for meeting the testing and
certification requirements of section 14 of the CPSA. If manufacturers
do not
[[Page 69573]]
find that component part testing reduces their costs, they are free to
rely solely upon tests conducted on the finished product.
(Comment 45)--One commenter stated that implementation of the
proposed rule would end the use of recycled materials in children's
products. The commenter stated that it was unnecessary for safety
reasons and not environmentally ``friendly.''
(Response 45)--We acknowledge that the 100 ppm lead content limit
in section 101 of the CPSIA could result in reduced use of recycled
materials in children's products. This is because the lead content of
general use products can be higher than the amount allowed for
children's products. Therefore, manufacturers of children's products
may need to refrain from using recycled materials to avoid the
possibility that the lead content exceeds the limits established by
section 101 of the CPSIA. However, the lead limits were established by
the CPSIA and so any changes to those limits must occur by statute
rather than by regulation.
(Comment 46)--One commenter stated that the imposition of
regulating each part of a particular product at the level before the
final piece is completed made little sense and that safety issues
should be dealt with at the finished product level. The commenter felt
that because it is up to the manufacturer of a finished product to
ensure its safety, it would be unnecessary and cumbersome for a
government entity to micromanage each component part of that product.
The commenter felt that while component part regulation of simpler
products, such as children's toys, may be possible, component part
regulation of more complex products would be senseless and a very
difficult task. The commenter asserted that we should be concerned only
with the finished product's compliance with the applicable standard.
How the product was produced should be of lesser importance. The
commenter predicted that such a focus on finished product compliance
would force those who run businesses and commerce to compete and
innovate to achieve the mandatory result. The commenter concluded by
suggesting that the CPSC should not over regulate and thereby miss the
mark of ensuring a safe toy for children.
(Response 46)--Finished product certifiers are responsible for the
finished product's compliance with applicable product safety rules.
Finished product certifiers include domestic manufacturers and
importers.
In some cases, component part testing, while optional, may be more
economical than finished product testing. For example, assume that a
manufacturer makes 10 different toy cars, and the toy cars use the same
metal axles. Component part testing of the metal axles for their
compliance with the lead limit for children's product could result in
testing only the metal axles rather than testing the metal axles 10
times (once with each type of toy car). Therefore, the final rule gives
finished product certifiers the option to take advantage of component
part testing, provided that the testing follows 16 CFR parts 1107 and
1109. However, we do not require component part manufacturers to test
component parts as participation is voluntary. Finished product
certificates always may be based on testing the finished product. Even
when a regulation requires that tests be performed on a per part basis,
such as lead content in children's products, finished products can be
disassembled for testing purposes, if that is more efficient for a
particular product.
(Comment 47)--One commenter noted that a publisher's ordinary books
may have varying titles and authorial content, but they are all made
with the same materials in the same manner. The commenter asserted that
the differences between ordinary books are not material to compliance
with the applicable rules. The commenter suggested relying on component
part certification for all children's paper-based printed products
manufactured using tested component materials. The commenter said a
publisher with a reasonable testing program that publishes products
without material changes could rely on the component certifications for
all materials published within a 2-year period.
(Response 47)--Pursuant to section 14(i)(5)(A)(i) of the CPSA, as
amended by H.R. 2715, third party certification testing no longer
applies to ordinary books or to ordinary paper-based printed materials.
The exception does not apply to non-paper components like metal or
plastic parts, or to accessories that are not part of the binding and
finishing materials. The exception also does not apply to books with
inherent play value, books designed or intended for a child 3 years of
age or younger, and does not include any toy or other article that is
not a book that is sold or packaged with an ordinary book. Thus, it is
unnecessary for us to address the commenter's concerns as they relate
to ordinary books and ordinary paper-based printed materials. With
regard to the non-excepted products, we agree that component part
testing of books for chemical content can be used in the manner
described by this commenter. As long as all of the inks and other
component parts of a book meet all applicable requirements, the printed
and assembled book will meet the requirements as well. As for the 2-
year testing interval for nonexcepted children's books, as suggested by
the commenter, the testing interval is subject to the children's
product periodic testing provisions of 16 CFR part 1107.
(Comment 48)--One commenter suggested that final testing and
certification should defer to the Occupational Safety and Health
Administration (OSHA)-designated Nationally Recognized Testing
Laboratory (NRTL) certification program. The commenter added that this
program determines products certified by the NRTL, because they are
manufactured and distributed for consumer use, and they are per se
compliant with the proposed testing and certification rules. The CPSC
would still maintain its authority to exercise recall, civil penalty,
and other authorities, if violations are found, the commenter asserted.
(Response 48)--Pursuant to section 14(a)(3)(C) of the CPSA, we have
chosen to designate accrediting bodies that are full-member signatories
to the International Laboratory Accreditation Cooperation--Mutual
Recognition Arrangement (ILAC-MRA) to conduct third party testing.
Given that children's products intended for the U.S. market are
manufactured in nations throughout the world, we decided to avoid
designating accreditation programs or entities that are recognized only
in a specific region, nation, or locality. The reasons for this are:
(1) To keep the program as simple as possible for use by manufacturers,
private labelers, importers, testing laboratories, and other interested
parties; (2) to establish uniform requirements, regardless of location;
(3) to establish a program that is manageable within agency resources;
and (4) to maintain a degree of consistency in the procedures used by
the designated accrediting bodies.
Moreover, the commenter appears to misstate testing requirements.
Consumer products are not tested for whether they are compliant with
the testing and certification rule (i.e., parts 1107 and 1109); rather,
consumer products are tested for compliance with applicable rules,
bans, standards, and regulations that the CPSC enforces. Moreover,
section 14(i)(2)(B)(i) of the CPSA requires such testing periodically
and when there has been a material change. Therefore, continued testing
is required by the statute and ``per se conformance'' with the
applicable product safety rules
[[Page 69574]]
is not allowed. Additionally, section 14(a) of the CPSA requires
manufacturers (including importers) to certify that their products
comply with the applicable product safety rules. This responsibility
cannot be delegated to another party, such as a certification body.
The qualifications of testing laboratories performing certification
tests are outside the scope of this final rule. Such qualifications are
addressed in the various notices of requirements that we have published
pursuant to section 14(a)(3) of the CPSA.
Finally, we acknowledge that recently enacted H.R. 2715 requires us
to seek public comment on ``opportunities to reduce the cost of third
part testing requirements consistent with assuring compliance with any
applicable consumer product safety rule, ban, standard, or
regulation.'' One topic that H.R. 2715 requires us to address pertains
to ``the extent to which evidence of conformity with other national or
international governmental standards may provide assurance of
conformity to consumer product safety rules, bans, standards, or
regulations applicable under [the Consumer Product Safety Act].''
Elsewhere in this issue of the Federal Register, we have published a
notice inviting public comment on the issues identified in H.R. 2715,
so the commenter's argument would be raised and addressed, more
appropriately, in that proceeding. We note, however, that very few
products covered under the OSHA-designated Nationally Recognized
Testing Laboratory certification program would be children's products
for which third party testing would be required. Moreover, products
that are subject to the OSHA certification program would likely be
covered by CPSC regulations, if at all, for which the only requirement
is a General Conformity Certificate based on a reasonable testing
program. OSHA certification testing may be a sufficient basis for such
certifications depending upon the product and the type of testing
involved. Given that the CPSC does not have jurisdiction over products
when the risks of injury associated with the consumer product could be
eliminated or reduced to a sufficient extent by the actions of OSHA,
there may be very little overlap between a particular product's results
under OSHA's testing program and any CPSC-required testing.
(Comment 49)--One commenter said that it should be unnecessary for
the manufacturer or private labeler of a finished children's product to
ensure that every certificate (notably component part or materials
testing certificates) required under section 102 of CPSIA accompanies
the product or shipment of products and is furnished to each
distributor or retailer of the product.
(Response 49)--Section 14(g)(3) of the CPSA requires that a GCC or
a CPC accompany the applicable product or shipment of products covered
by the same certificate, and it also requires that a copy of the
certificate be furnished to each distributor or retailer of the
product. We do not require component part certificates to accompany the
finished product, although testing parties and certifiers must provide
such documentation to a certifier relying on the documentation to issue
a certificate, and must provide such documentation to the CPSC, upon
request.
(Comment 50)--One commenter stated that the final rule should
require adequate product design hazard review, both before introduction
of products into commerce in the United States and, where appropriate,
as an element of remedial action plans.
(Response 50)--This comment is outside the scope of 16 CFR part
1109 because product design hazard review may not be appropriate for
all components, and neither the proposed, nor final rules on component
part testing addresses remedial action plans. Remedial action plans are
discussed in the rulemaking for 16 CFR part 1107, and so we address
this comment in that rulemaking.
(Comment 51)--One commenter said that testing requirements for lead
and the imposition of penalties on companies that violate the lead
standards would reduce the incidence of lead poisoning. The commenter,
however, did not provide any additional comment on the proposed rule.
(Response 51)--The requirements limiting lead content in children's
products (section 101 of the CPSIA) and the imposition of penalties for
violations of those requirements are beyond the scope of this rule.
(Comment 52)--A commenter disagreed with recent notices of
requirements that we issued regarding the flammability standards for
carpets and rugs (16 CFR parts 1630 and 1631) and vinyl plastic film
(16 CFR part 1611), which considered a standard of general application
to all consumer products in a category to be a ``children's product
safety rule'' for purposes of the CPSIA. See 75 FR 42315 (July 21,
2010) and 75 FR 42311 (July 21, 2010), respectively. The commenter
contended that a standard of general application to all consumer
products in a category should not be considered a ``children's product
safety rule'' for purposes of the CPSIA. The commenter expressed the
belief that such an interpretation will expand testing burdens in an
unwarranted way, posing difficulties for all participants in the supply
chain and potentially resulting in the elimination of some products
from the children's product category due to added test costs.
(Response 52)--The question of which rules constitute children's
product safety rules is beyond the scope of this rulemaking. This rule
addresses the requirements and conditions for component part testing,
and it does not address whether a particular safety standard
constitutes a children's product safety rule.
(Comment 53)--One commenter suggested that the testing costs could
be reduced by reducing the number of components that must be tested.
The commenter suggested that this could be done by expanding the number
of materials for which testing for phthalate content is not required.
Another commenter pointed out that inaccessible components are exempted
from the lead content requirements. The commenter stated that, using
the same logic, inaccessible components also should be exempted from
the phthalate requirements.
(Response 53)--The question of which materials require testing for
phthalate content is beyond the scope of this rulemaking. This rule
addresses the requirements and conditions for component part testing,
and it does not address section 108 of the CPSIA, which contains the
requirements for phthalate content.
We acknowledge, however, that recently enacted H.R. 2715 contains a
provision excluding inaccessible component parts from the phthalate
prohibitions. The legislation requires us to promulgate regulations
with respect to the inaccessible phthalates section or to adopt a
guidance document comparable to that for lead. We will address such
matters in a separate proceeding.
(Comment 54)--One commenter suggested that wet chemistry should not
be considered the only retest method if a composite sample fails a
test. X-Ray fluoroscopy could be a valid method for lead and heavy
metals, and Fourier transform infrared spectroscopy could be a valid
method for phthalates in determining which component or components
caused the failure, the commenter observed. The commenter urged us to
allow the use of XRF technology, following the method in ASTM F2853 for
testing small quantities of paints and coatings where there is an
insufficient amount of the paint or other
[[Page 69575]]
surface coatings to using the method that would normally be
recommended.
(Response 54)--Section 1109.21(c) of the final rule does not
specify what type of testing is required to determine which component
parts have not met the concentration limits of the applicable rules.
Specifying alternate test methods for determining the lead content in
paint and surface coatings and for phthalate concentrations is beyond
the scope of this rulemaking.
We do note, however, that on April 5, 2011, we published in the
Federal Register a notice of requirements for accreditation of third
party conformity assessment bodies for lead in paint (76 FR 18645). In
that notice of requirements, the use of ASTM F2583-10, ``Standard Test
Method for Determination of Lead in Paint Layers and Similar Coatings
or in Substrates and Homogeneous Materials by Energy Dispersive X-Ray
Fluorescence Spectrometry Using Multiple Monochromatic Excitation
Beams,'' is allowed for testing the lead content in paint.
III. Environmental Considerations
Generally, the Commission's regulations are considered to have
little or no potential for affecting the human environment, and
environmental assessments and impact statements are not usually
required. See 16 CFR 1021.5(a). The final rule contains the
Commission's conditions and requirements for relying on component part
testing or certification, or another party's finished product testing
or certification, to meet testing and certification requirements in
section 14 of the CPSA. As such, the final rule is not expected to have
an adverse impact on the environment. The rule falls within the
categorical exclusion in 16 CFR 1021.5(b)(2) for product certification
rules. Accordingly, no environmental assessment or environmental impact
statement is required.
IV. Regulatory Flexibility Analysis
The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612,
generally requires that agencies review proposed rules for their
potential economic impact on small entities, including small
businesses. The RFA calls for agencies to prepare and make available
for public comment an initial regulatory flexibility analysis
describing the impact of the proposed rule on small entities and
identifying impact-reducing alternatives. 5 U.S.C. 603. The RFA further
requires agencies to consider comments they receive on the initial
regulatory flexibility analysis and prepare a final regulatory
flexibility analysis describing the impact of the final rule on small
entities and identifying alternatives that could reduce that impact.
Id. 604. This section summarizes CPSC staff's final regulatory
flexibility analysis for the final rule on component part testing.
(CPSC staff's final regulatory flexibility analysis can be found at Tab
B of staff's briefing package.)
A. Reason for Agency Action and Objective of the Final Rule
Some testing can be done more efficiently on component parts of a
product rather than on the finished product itself. This is especially
true for tests for the chemical content (e.g., lead or phthalate
content) of a component part. The final rule establishes the conditions
and requirements that must be met for a finished product certifier (the
domestic manufacturer or importer) of a consumer product to rely upon
tests conducted on component parts of the finished product as a basis
for issuing a finished product certificate. It also describes the
conditions and requirements that must be met for a finished product
certifier to rely upon finished product testing conducted by or
certificates issued by other parties.
In the absence of a rule allowing for component part testing, each
component part of a children's product would have to be tested each
time the manufacturer had to certify or periodically test the product,
even if the same component part were used and tested in other products.
The final rule allows the finished product certifier to rely upon tests
conducted on component parts to certify that finished products in which
the component parts are used comply with the applicable safety rules.
Therefore, component part testing allows some testing costs to be
spread over more units of finished products. The final rule also
describes the conditions and requirements that must be met for a
finished product certifier to rely upon finished product testing
procured by or certificates issued by other parties that can reduce the
cost of testing a product that is imported by more than one importer.
This can reduce significantly the cost of testing consumer products for
compliance with applicable consumer product safety rules, bans,
standards, and regulations.
B. Comments on the Initial Regulatory Flexibility Act
We received three comments regarding the initial regulatory
flexibility analysis.
(Comment 55)--One commenter noted that, in estimating the number of
firms that could be impacted by the proposed rule, the book publishing
industry (NAICS code 511130) and printing industry (NAICS code 323117)
were not included; thus, the commenter recommended their inclusion for
the final Regulatory Flexibility Analysis.
(Response 55)--We acknowledge that the initial regulatory
flexibility analysis inadvertently omitted these industries. However,
the recently enacted H.R. 2715 exempts ordinary books and ordinary
printed materials from the third party testing requirements, so the
commenter's concern no longer applies.
(Comment 56)--One commenter stated that the initial regulatory
flexibility analysis was ``flawed and self-justifying.'' The commenter
asserted that a ``best case'' scenario was used to justify the rule.
The commenter claimed that the requirements that the rule imposes to
use component testing, including the recordkeeping burdens and legal
risks, could make the rule hard to use. Therefore, the commenter
asserted, the rule could end up providing little, if any, relief to
small businesses. Another commenter echoed these comments, stating that
some aspects of the proposed rule would reduce the costs of testing for
some products, but the proposed rule's restrictions and conditions
would prevent the rule from providing material relief to small and
medium-sized businesses that manufacture or import thousands of
different products using tens of thousands of components that are
consumed at very small volumes.
(Response 56)--The purpose of a regulatory flexibility analysis is
to describe the impact of a rule on small entities. The intent of the
component part testing rule is to provide manufacturers and private
labelers the option of certifying conformity with some safety rules
based upon certification or testing of component parts. In many cases,
this option has the potential for reducing testing costs, especially if
the same component part is used in more than one finished product.
However, to ensure that the testing and certification requirements of
the CPSIA are not undermined by allowing component part testing, there
are some conditions on the use of component testing, including the
traceability and recordkeeping requirements. We acknowledge that, in
some cases, these requirements may reduce or even eliminate the
advantages that the component part testing option offers. In these
cases, the manufacturer or private labeler always has the option to
certify their products based upon tests of the finished product.
[[Page 69576]]
(Comment 57)--One commenter stated that while some suppliers might
provide certificates or third party testing, several types of
components are not likely to be tested voluntarily by the suppliers.
These include:
Low-volume components;
Components made in small lots;
Components made by a small supplier (e.g., many fabrics);
and
Components that derive only a tiny percentage of revenue
from regulated products; or that cater principally to other industries.
The commenter asserted that the CPSC's logic appeared to be that if the
CPSC can be certain that some certificates will be widely available,
then all certificates will be widely available. Another commenter
stated that they had surveyed their suppliers and found little interest
in providing the testing required for children's products.
(Response 57)--The initial regulatory flexibility analysis did not
assume that suppliers would certify all component parts. Where
suppliers voluntarily certify their products or provide testing
reports, component part testing has the potential to reduce
significantly the testing costs for manufacturers of finished products.
However, the rule does not require suppliers to certify or provide
third party test results on their products. We agree that some
suppliers, such as the ones that supply the products in the above list,
might choose not to certify their products or provide the third party
testing results.
C. Description of the Number of Small Entities to Which the Final Rule
Will Apply
The final rule applies to any domestic manufacturer or importer of
consumer products who must issue a finished product certificate,
pursuant to 16 CFR part 1110, who uses component part testing or
finished product testing or certification by another party as the basis
for certification. The regulatory flexibility analysis for the final
rule on testing and labeling pertaining to certification indicates that
there were about 250,000 firms classified in industries, according to
the North American Industrial Classification System (NAICS), that could
manufacture or import children's products that could be subject to a
consumer product safety rule, ban, standard, or regulation. Of these,
more than 91 percent would be classified as a small business, according
to the classification standards established by the U.S. Small Business
Administration. Additionally, there are more than 4,700 small firms
classified in industries that are unlikely to include children's
products but could manufacture or import other consumer products
subject to a product safety rule, ban, standard, or regulation. These
include manufacturers of household appliances, lawn and garden
equipment makers, manufacturers of fireworks, and firms that could
manufacture or use architectural glazing materials. However, these are
over estimates of the number firms to which the rule would apply.
Many of the NAICS categories included in the analysis are broad and
include products that are not covered by any consumer product safety
rules. Most firms included in the estimates were retailers or
wholesalers and not manufacturers. Retailers or wholesalers that import
consumer products would be responsible for ensuring that the product
was tested properly and certified; but many retailers and wholesalers
likely obtain all of their products from domestic manufacturers or
wholesalers, and therefore, would not be impacted directly by the final
rule. Finally, not all of the manufacturers and importers of consumer
products that are subject to consumer product safety rules will use
component part testing in certifying the products.
In addition to the firms discussed above, the U.S. Census Bureau
estimates that there are more than 600,000 nonemployer businesses
classified in the same NAICS categories. Nonemployer businesses are
generally very small sole proprietorships with average receipts of
about $55,000. Very little is known about the nonemployer businesses,
but an unknown number could be manufacturers or importers of consumer
products subject to a consumer product safety rule, ban, standard, or
regulation.
The final rule also applies to manufacturers or wholesalers of
component parts that may be used in consumer products, who voluntarily
provide test reports or certify their products as complying with one or
more consumer product safety rules. Manufacturers of clothing textiles,
paints and coatings, buttons and other fasteners, and plastic materials
and resins could certify their products voluntarily or provide third
party test results to their customers. The 2007 Economic Census showed
that there were 5,220 establishments that were engaged in manufacturing
these materials or components.\4\ However, not all of these
establishments are expected to test or certify their products.
---------------------------------------------------------------------------
\4\ Based on the 2007 Economic Census establishment data for the
following NAICS codes: 313, 325211, 325510, and 339993. Obtained
from http://factfinder.census.gov/ on 30 March 2010.
---------------------------------------------------------------------------
D. Projected Recordkeeping and Compliance Requirements
Component part testing is voluntary \5\ for manufacturers
(including importers) of consumer products and for manufacturers and
suppliers of components that might be used in consumer products. The
only firms that are expected to use component part testing are firms
that determine that it would be advantageous for them to do so. This
could include manufacturers of consumer products who might be able to
reduce their testing costs by using component part testing and
manufacturers or suppliers of component parts who believe that it would
be to their advantage to do so, perhaps because it provides a marketing
advantage over competitors (or because competitors are doing so).
However, if a firm chooses to engage in component part testing, the
final rule describes the conditions and requirements that must be met.
---------------------------------------------------------------------------
\5\ While testing and certification of component parts is
voluntary, some statutes and/or regulations require that an
applicable chemical limit be measured by component part. For
example, the lead content requirement is now 100 ppm per component
part. Although the specific lead measurement is by component part,
component part testing under this rule is still voluntary. A
finished product certifier could supply samples of finished product
to a third party conformity assessment body, who would measure the
lead content in each applicable sample by component part.
---------------------------------------------------------------------------
A manufacturer or supplier who tests a component part must ensure
that the samples are collected and that the tests are performed
according to the requirements in sections 14(a) and 14(i) of the CPSA.
If the product is a children's product or a component to be used in a
children's product, the testing must meet the requirements of 16 CFR
part 1107, which includes requirements for the testing and
certification of children's products, including requirements for third
party testing. For both children's and non-children's products, any
testing or certification must also meet any more specific rules, bans,
standards, or regulations that are applicable to the product or
component. A finished product certifier cannot rely upon component part
product testing or finished product testing procured by another party
unless the component parts or finished products are traceable to the
parties who procured the tests. Firms using component part testing must
exercise due care to ensure that no action or inaction subsequent to
testing and before distribution in commerce has occurred that would
affect the compliance of the component part, such
[[Page 69577]]
as by contamination or degradation during the manufacturing process of
the finished product.
A subassembly or even a finished product can be considered to be a
component part for purposes of the final rule. Thus, the final rule
allows a foreign manufacturer of a children's product to procure the
required third party tests on the children's product and provide those
test results to the importers of the product. The importers could rely
upon the tests procured by the foreign manufacturer in issuing their
own certificate for the product, provided that all of the requirements
of the final rule have been met.
The final rule requires that the component part testing be
documented, and if the testing is done by a manufacturer or supplier of
a component part, this documentation must be provided to the finished
product certifier. The required documentation or records are:
(1) Identification of the component part or the finished product
tested;
(2) Identification of a lot or batch number, or other
information sufficient to identify the component parts or finished
products to which the testing applies;
(3) Identification of the applicable rules, bans, standards, and
regulations for which each component part or finished product was
tested;
(4) Identification of the testing method(s) and sampling
protocol(s) used;
(5) The date or date range when the component part or the
finished product was tested;
(6) Test reports that provide the results of each test on a
component part or finished products, and the test values, if any;
(7) Identification of the party that conducted each test
(including testing conducted by a manufacturer, testing laboratory,
or third party conformity assessment body and an attestation by the
party conducting the testing that all testing of a component part or
finished product by that party was performed in compliance with
applicable provisions of section 14 of the CPSA, 16 CFR part 1107,
or any more specific rules, bans, standards, or regulations;
(8) Component part certificate(s) or a finished product
certificate, if any;
(9) Records to support traceability as defined in the draft
final rule; and
(10) An attestation by each certifier and testing party that
while the component part or finished product was in its custody, it
exercised due care to ensure among other things, that the products,
components, and raw materials were not handled, stored, or processed
in a way that could affect the ability of the product to comply with
all applicable rules.
All records must be maintained for five years. The records must be
made available to the CPSC for inspection, upon request. The records do
not have to be maintained in English, as long as the records in the
original language can be provided to us immediately and can be
translated into English within 48 hours of a request by us, unless a
longer period is negotiated with CPSC staff.
The professional skills that would be required are the same that
would be required to meet the requirements of the testing and labeling
rule. Depending upon the specific product and the safety rules with
which the component part manufacturer or supplier intends to test for
compliance, people with special knowledge, such as engineers or
chemists, may be needed to design and develop a testing program and to
conduct the testing. Statistical skills or statistical consultants may
be required to determine the testing frequency, sample size, and
collection method for internal production testing and third party
testing if the product is a children's product or the component part is
for a children's product.
The final rule is not likely to have a significant adverse impact
on a substantial number of small entities. As noted, component part
testing is not mandatory. The only companies that are expected to
engage in component part testing are companies that believe it will be
advantageous to do so. Finished product manufacturers are expected to
use component part testing if it lowers their testing costs. Although
there will be some cost to manufacturers or suppliers of component
parts who elect to engage in the voluntary testing of component parts,
if the cost increase would have a significant adverse impact, it is
unlikely that such firms would engage in or continue to engage in
component part testing. Component part suppliers who engage in
component part testing would be able to spread the cost of the testing
over a higher production volume than finished product manufacturers.
This would lower the cost of the testing per unit. At least some costs
incurred by component part suppliers are likely to be passed on to the
finished product manufacturers because finished product manufacturers
are likely to be willing to pay more for a component part if it means
that they do not have to test the component part themselves.
E. Steps Taken To Minimize Impact on Small Entities
The intent of the final rule is to reduce the impact of the testing
and certification rule; thus, it is actually a step that the Commission
has taken to reduce the impact of the testing and certification rule on
manufacturers of finished products. It is not expected to have a
significant adverse impact on a substantial number of small entities.
Nevertheless, we made some changes to the rule that will reduce the
economic impact further.
One change from the proposed rule is that the final rule does not
require records to be kept in the English language. Instead, the final
rule requires that an English translation of the records be provided to
the CPSC upon request. Additionally, the records do not need to be
maintained in the United States, as long as the records can be provided
to us, either in hardcopy or electronically, upon request.
We also simplified the traceability requirements to require that
traceability only has to be maintained back to the party who procured
the testing results. For example, if a component part supplier, who is
not the manufacturer of a component part, obtains testing results, a
manufacturer of a finished product that uses that component part would
have to maintain traceability only to the party who procured the
testing, not to the manufacturer of the component part, as would have
been required by the rule as proposed.
F. Alternatives Considered to the Final Rule
We considered alternatives to the final rule. These included: Not
issuing a final rule allowing for component part testing (i.e., taking
no action); not imposing any recordkeeping requirements; and
eliminating the traceability requirements from the rule.
One alternative would be to end rulemaking concerning component
part testing and not finalize the proposed rule. If this alternative
were adopted, manufacturers potentially could use component part
testing for lead content testing following the interim enforcement
policy issued on December 28, 2009 (74 FR 68593-68596). However,
manufacturers could not rely upon testing procured by suppliers to
establish compliance with other consumer product safety rules, bans,
standards, or regulations (such as for compliance with limits on
phthalate content or the limits on the heavy metal content in paints
and surface coatings on toys). If the final rule were not finalized,
importers of consumer products would not be able to rely upon testing
procured by or certifications issued by the foreign manufacturers of
the products.
We decided not to end the rulemaking because the final rule offers
domestic manufacturers and importers options that have the potential to
reduce the cost of testing and certifying consumer products, by
spreading the cost of testing over more units of production and
allowing certifiers of finished
[[Page 69578]]
products to rely upon testing procured by or certificates issued by
their suppliers. Moreover, manufacturers retain the option of
submitting samples of finished products to testing laboratories to be
evaluated for compliance with all applicable rules, bans, standards,
and regulations. Therefore, the final rule allows manufacturers and
importers of consumer products to select the option that is most
advantageous to them.
We considered eliminating altogether--or reducing significantly--
the recordkeeping and traceability requirements in the final rule.
However, while eliminating these requirements could have reduced,
somewhat, the costs associated with component part testing, we
concluded that the recordkeeping and traceability requirements are
needed to provide the finished product certifier with the information
required by section 14(g) of the CPSA to certify the finished product,
which includes the test results, the date and place where the product
was tested, and the parties who conducted the testing. Moreover, many
of the records required normally would be generated in the course of
testing a product or component and reporting the results (e.g., the
test reports), which suggests that eliminating the requirements would
not necessarily eliminate all of the recordkeeping costs. Further, such
documentation is required for the CPSC to investigate testing and
certification failures when component part testing is used. Finally,
the final rule allows the firms that are impacted significant
flexibility in designing and maintaining the records. Generally, the
rule requires specific information, but it does not specify the format
in which the information must be maintained, as long as the information
is provided to parties who require it, such as finished product
certifiers and the CPSC, if it is requested.
V. Paperwork Reduction Act
The final rule contains information collection requirements that
are subject to public comment and review by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520). In a May 20, 2010, Federal Register notice regarding the
proposed rule (75 FR 28208, 28217-18), we described the information
collection and the annual reporting burden. Our estimate included the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
We invited comment on: (1) Whether the collection of information is
necessary for the proper performance of the CPSC's functions, including
whether the information will have practical utility; (2) the accuracy
of the CPSC's estimate of the burden of the proposed collection of
information, including the validity of the method and assumptions used;
(3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
We received several comments about the burden estimates contained
in the proposed rule.
(Comment 58)--Several commenters stated that the estimates for
recordkeeping time and expense were greatly underestimated. One
commenter asserted that the proposed rule would impose more extensive
requirements than the requirements that are contained in the interim
enforcement policy, emphasizing that those requirements are extremely
burdensome. The commenter stated that the proposed rule would impose
specific and voluminous recordkeeping requirements. The commenter said
that we should not require this information on every item, nor should
we require companies to integrate multiple systems to compile the data,
as long as companies, upon request, can provide reasonable data that is
customary in a particular industry. Another commenter noted the burden
associated with extracting all of the data that would be required by
the proposed rule. The commenter pointed out that the data would come
from several different record systems, some of which would have to be
obtained manually. Moreover, the commenter remarked that the CPSC is
unlikely to review the data, making the task unnecessarily burdensome,
without any practical utility. The commenter, a large toy manufacturer,
stated that it has several full-time staff who operate globally to
manage their component testing process. Therefore, the commenter said
that the 20,000 to 30,000 hours, or approximately 20 full-time
employees, which we estimated would be needed to handle the paperwork
and recordkeeping requirements of the component testing rule, is
probably grossly underestimated. One commenter stated that it would be
costly to extract the data required from multiple recordkeeping systems
that have evolved over time. The commenter added that we envisioned
extraction of the data to be easier than it is. One commenter stated
that its company would probably have to open an office in Asia and
expand its staff in the United States to manage the paperwork and
recordkeeping required by the rule. The commenter expressed the belief
that complying with the component part testing rule at its company
alone could require 20,000 hours, per annum.
(Response 58)--We acknowledge that we significantly underestimated
the total cost burden of the recordkeeping requirements. We have
increased our estimate of the recordkeeping burden of meeting the
requirements in the final rule. To decrease the burden presented by the
recordkeeping requirements, the final rule provides that records do not
have to be kept in the United States--if they can be accessed by the
CPSC--upon request. Also, records do not have to be maintained in
English if they can be translated by the manufacturer in a timely
manner.
Nevertheless, we believe that some commenters might have
misunderstood aspects of the proposed recordkeeping requirements.
Neither the proposed rule, nor the final rule, require a firm to
develop a new system of records if: It has retained the information in
a different set of records; can provide the required information to
distributers and finished product certifiers; and is able to furnish it
to the CPSC, upon request, as required by the rule.
Title: Conditions and Requirements for Relying on Component Part
Testing or Certification, or Another Party's Finished Product Testing
or Certification, to Meet Testing and Certification Requirements
Description: The scope of the final rule includes component part
testing and certification, as well as testing and certification of a
finished product by a party who is not required to do so by 16 CFR part
1110, such as a foreign manufacturer (``finished product supplier'').
The final rule requires testing parties (parties that procure tests)
and certifiers (both component part and finished product certifiers) to
provide the following documentation to a certifier intending to rely
upon such information to issue a certificate:
Identification of the component part or the finished
product tested;
Identification of a lot or batch number, or other
information sufficient to identify the component parts or finished
products to which the testing applies;
Identification of the applicable rules, bans, standards,
and regulations for which each component part or finished product was
tested;
[[Page 69579]]
Identification of the testing method(s) and sampling
protocol(s) used;
Date or date range when the component part or finished
product was tested;
Test reports that provide the results of each test on a
component part or finished product, and the test values, if any;
Identification of the party that conducted each test
(including testing conducted by a manufacturer, testing laboratory, or
third party conformity assessment body), and an attestation by the
party conducting the testing that all testing of a component part or
finished product by that party was performed in compliance with
applicable provisions of section 14 of the CPSA, part 1107 of this
chapter, or any more specific rules, bans, standards, or regulations;
Component part certificate(s) or finished product
certificate(s), if any;
Records to support traceability as defined in Sec.
1109.4(m); and
An attestation by each certifier and testing party that
while the component part or finished product was in its custody, it
exercised due care to ensure compliance with the requirements set forth
in Sec. 1109.5(b).
Certifiers and testing parties must maintain this information for five
years from the date of creation.
Records required to be maintained are similar to the records that a
manufacturer would be required to develop and maintain under the final
rule on ``Testing and Labeling Pertaining to Product Certification''
(which appears elsewhere in this issue of the Federal Register). Most
of the records for children's products concern documentation of the
test plan and test results for the component part or finished product,
which would be required regardless of whether the component part was
tested as part of the finished product or apart from the finished
product. Even without component part testing, certifiers would be
expected to maintain records regarding the lot, batch, or other
information identifying the component parts used because changes in the
component part or the sourcing of the component part would constitute a
material change and trigger requirements for additional testing.
Based on the comments received, we revised the burden estimate that
was set forth in the proposed rule on ``Testing and Labeling Pertaining
to Product Certification'' and likewise, we revised the burden estimate
for the component testing rule. A full discussion of the revised
analysis appears in the final rule on ``Testing and Labeling Pertaining
to Certification,'' which is published elsewhere in this issue of the
Federal Register. The estimate of the total recordkeeping burden
consists of three components: (1) The number of products for which
recordkeeping will be required; (2) the average number of hours, per
product, that will be required to manage the recordkeeping; and (3) the
hourly compensation rate to be used to estimate the cost of the
recordkeeping. The final rule on ``Testing and Labeling Pertaining to
Certification'' contains the following revised estimates, concluding
that the total cost of recordkeeping associated with that rule is $197
million:
300,000 non-apparel children's products are covered by the
final rule;
[dec222] An average of 5 hours will be required for the
recordkeeping associated with these products;
Approximately 1.3 million children's apparel and footwear
products are covered by the final rule;
[dec222] An average of 3 hours will be required for the
recordkeeping associated with these products;
Total hour burden = 5.4 million hours (300,000 x 5 hours
plus 1,300,000 x 3 hours);
Total cost of recordkeeping burden = $197 million (5.4
million hours x $36.43 per hour).
The component part rule will shift some testing costs and some
recordkeeping costs to component part and finished product suppliers
because some testing will be performed by these parties rather than by
the finished product certifiers. However, a finished product certifier
will still be responsible for receiving records from component part and
finished product suppliers and recording information on the finished
product certificate. Thus, even if a finished product certifier could
rely entirely on component part and finished product suppliers for all
required testing, the finished product supplier would still have some
recordkeeping burden. Therefore, although the component part testing
rule is expected to reduce the total cost of the testing required by
the testing and certification rule, it will lead to an increase in the
recordkeeping burden for those who choose to use component part
testing.
No clear basis exists for estimating the amount of testing that
will be performed by component part and finished product suppliers; nor
is it known how many component part and finished product suppliers will
be willing to provide the required testing or conformity certificates.
Likewise, there is no clear method for estimating the number of
finished product certifiers who might conduct their own component part
testing. In the preamble to the proposed rule (75 FR at 28218), we
suggested that the recordkeeping burden for the component part testing
rule could amount to 10 percent of the burden estimated for the testing
and labeling rule. Although some comments suggested that the resulting
estimates were too low, no commenter provided a better estimate or
suggested a better method for estimating the burden. Moreover, because
the estimate of the recordkeeping burden for the testing and labeling
rule has been increased, using the same methodology used in the
proposed rule, the estimates for the component rule also would
increase. This may address the concern of the commenters who believed
the estimate used in the proposed rule was too low.
Therefore, if we continue use to use the estimate that component
part testing will amount to about 10 percent of the burden estimated
for the testing and labeling rule, then the hour burden of the
component part rule would be about 540,000 hours. At $36.43 per hour,
the total cost of the recordkeeping for the component part rule would
be about $19.7 million.
Estimate Limitations: There are some limitations to the above
estimates that warrant mentioning.
While the estimates of the number of products are more accurate
than the original estimates, they are not based on a well-designed
survey or comprehensive database. Additionally, the extent to which
some products might be certified by multiple importers or are
manufactured at different sites has not been established.
Recordkeeping for the flammability of children's sleepwear might be
captured in the OMB submission on another rule, but the recordkeeping
associated with the lead content rules should be captured here.
However, no adjustment for this has been made because we have not tried
to separate children's sleepwear from other apparel items.
The recordkeeping considered here is best thought of as the
recordkeeping required by the testing and certification requirements of
section 102 of the CPSIA. It would be impossible to separate the time
associated with the initial certification from the time associated with
periodic testing and documenting material changes, especially given
that it often involves issuing a new certificate.
For finished goods manufacturers who also perform their own
component testing, it is difficult to separate the recordkeeping burden
associated with component part testing from the recordkeeping burden
associated with
[[Page 69580]]
the testing and labeling rule. This could lead to overestimates of the
costs associated with the testing and labeling rule and possibly
underestimates associated with the component part testing rule. Better
estimates may be possible if the recordkeeping burden is reevaluated
after the rules are finalized.
VI. Executive Order 12988 (Preemption)
According to Executive Order 12988 (February 5, 1996), agencies
must state in clear language the preemptive effect, if any, of new
regulations. Section 26 of the CPSA only addresses the preemptive
effect of consumer product safety standards under the CPSA. The current
rule is not a consumer product safety standard under the CPSA.
Accordingly, this rule does not fall within the scope of any
provision of any act enforced by the Commission that grants preemptive
effect to rules.
VII. Effective Date
The Administrative Procedure Act (``APA'') generally requires that
the effective date of a rule be at least 30 days after publication of a
final rule. 5 U.S.C. 553(d). The preamble to the proposed rule
indicated that we would make any final rule based on this proposal
effective 180 days after the date of publication of a final rule in the
Federal Register. The preamble to the proposed rule explained that 180
days should allow time for any product changes needed for testing of
component parts and for implementation of the component part testing
requirements.
We did not receive any comments regarding the effective date.
However, we recognize that the stay of testing and certification
requirements for lead content and phthalates in certain children's
products expires on December 31, 2011. Accordingly, we want
stakeholders to be able to take advantage of the efficiencies of
component part testing or certification, as well as finished product
testing or certification, without undue delay. While this rule does
impose recordkeeping obligations, component part testing is voluntary.
Therefore, the final rule will become effective on December 8, 2011.
List of Subjects in 16 CFR Part 1109
Business and industry, Children, Consumer protection, Imports,
Product testing and certification, Records, Record retention, Toys.
Accordingly, 16 CFR part 1109 is added to read as follows:
PART 1109--CONDITIONS AND REQUIREMENTS FOR RELYING ON COMPONENT
PART TESTING OR CERTIFICATION, OR ANOTHER PARTY'S FINISHED PRODUCT
TESTING OR CERTIFICATION, TO MEET TESTING AND CERTIFICATION
REQUIREMENTS
Subpart A--General Conditions and Requirements
Sec.
1109.1 Scope.
1109.2 Purpose.
1109.3 Applicability.
1109.4 Definitions.
1109.5 Conditions, requirements, and effects generally.
Subpart B--Conditions and Requirements for Specific Consumer Products,
Component Parts, and Chemicals
1109.11 Component part testing for paint.
1109.12 Component part testing for lead content of children's
products.
1109.13 Component part testing for phthalates in children's toys and
child care articles.
Subpart C--Conditions and Requirements for Composite Testing
1109.21 Composite Testing.
Authority: Secs. 3 and 102, Pub. L. 110-314, 122 Stat. 3016; 15
U.S.C. 2063.
Subpart A--General Conditions and Requirements
Sec. 1109.1 Scope.
(a) This part applies to tests or certifications of the following
when such testing or certification is used to support a certificate of
compliance pursuant to section 14(a) of the Consumer Product Safety Act
(CPSA) or to meet continued testing requirements pursuant to section
14(i) of the CPSA:
(1) Component parts of consumer products; and
(2) Finished products when conducted by a party that is not
required to test or certify products pursuant to part 1110 of this
chapter.
(b) Component part manufacturers and suppliers may certify or test
their component parts, but are not required to do so. Also, parties
that are not required to test finished products, or to issue finished
product certificates pursuant to part 1110 of this chapter, may do so
voluntarily.
(c) Subpart A establishes general requirements for component part
testing and certification, and relying on component part testing or
certification, or another party's finished product certification or
testing, to support a certificate of compliance issued pursuant to
section 14(a) of the Consumer Product Safety Act (CPSA) or to meet
continued testing requirements pursuant to section 14(i) of the CPSA.
Subpart B sets forth additional requirements for component part testing
of chemical content. Subpart C describes the conditions and
requirements for composite testing.
Sec. 1109.2 Purpose.
The purpose of this part is to set forth the conditions and
requirements under which passing component part test reports,
certification of component parts of consumer products, or finished
product testing or certification procured or issued by another party,
can be used to meet, in whole or in part, the testing and certification
requirements of sections 14(a) and 14(i) of the CPSA.
Sec. 1109.3 Applicability.
The provisions of this part apply to all manufacturers and
importers who are required to issue finished product certifications
pursuant to section 14(a) of the CPSA and part 1110 of this chapter and
to procure tests to ensure continued compliance pursuant to section
14(i) of the CPSA. This part also applies to manufacturers and
suppliers of component parts or finished products who are not required
to test or certify consumer products pursuant to part 1110 of this
chapter, but who voluntarily choose to undertake testing or
certification.
Sec. 1109.4 Definitions.
The following definitions apply to this part:
(a) Certifier means a party that is either a finished product
certifier or a component part certifier as defined in this section.
(b) Component part means any part of a consumer product, including
a children's product that either must or may be tested separately from
a finished consumer product to assess the consumer product's ability to
comply with a specific rule, ban, standard, or regulation enforced by
the CPSC. Within the same consumer product, the component parts to be
tested and the tests to be conducted may vary, depending on the
applicable regulations and required test methods, if any.
(c) Component part certifier means a party who, although not
required to do so pursuant to part 1110 of this chapter, voluntarily
certifies the following as complying with one or more rules, bans,
standards, or regulations enforced by the CPSC, consistent with the
content requirements for certifications in part 1110 of this chapter:
(1) Component parts to be used in consumer products; or
(2) Finished products.
(d) CPSA means the Consumer Product Safety Act.
[[Page 69581]]
(e) CPSC means the Consumer Product Safety Commission.
(f) CPSIA means the Consumer Product Safety Improvement Act of
2008.
(g) Due care means the degree of care that a prudent and competent
person engaged in the same line of business or endeavor would exercise
under similar circumstances. Due care does not permit willful
ignorance.
(h) Finished product certifier means a party responsible for
certifying compliance of a finished consumer product pursuant to part
1110 of this chapter with all applicable rules, bans, standards, and
regulations enforced by the CPSC.
(i) Identical in all material respects means there is no difference
with respect to compliance to the applicable rules, bans, standards, or
regulations, between the samples to be tested for compliance and the
component part or finished product distributed in commerce.
(j) Paint means any type of surface coating that is subject to part
1303 of this chapter or section 4.3.5.2 of ASTM F 963-08 (or any
successor standard of section 4.3.5.2 of ASTM F 963-08 accepted by the
Commission).
(k) Testing party means a party (including, but not limited to,
domestic manufacturers, foreign manufacturers, importers, private
labelers, or component part suppliers) who procures tests (either by
conducting the tests themselves, when this is allowed, or by arranging
for another party to conduct the tests), of a consumer product, or any
component part thereof, for compliance, in whole or in part, with any
applicable rule, ban, standard, or regulation enforced by the CPSC.
Testing laboratories and third party conformity assessment bodies are
not testing parties under this definition.
(l) Third party conformity assessment body means a testing
laboratory whose accreditation has been accepted by the CPSC to conduct
certification testing on children's products. Only third party
conformity assessment bodies whose scope of accreditation includes the
applicable required tests can be used to test children's products for
purposes of supporting certification pursuant to section 14(a) of the
CPSA and testing to ensure continued compliance pursuant to section
14(i) of the CPSA.
(m) Traceable means the ability of a certifier to identify all
testing parties of a component part of a consumer product or a finished
product, including the name and address of each testing party and any
party that conducted testing on the component part or finished product.
Parties that conduct testing may include a manufacturer, a supplier, a
testing laboratory, or a third party conformity assessment body.
Traceability extends to the component part of the product that was
tested for compliance, such that if a subassembly is tested, that
subassembly must be traceable, not each component part of the
subassembly, if those parts were not individually tested for other
rules, bans, standards, or regulations.
Sec. 1109.5 Conditions, requirements, and effects generally.
(a) Component part testing allowed. Any party, including a
component part manufacturer, a component part supplier, a component
part certifier, or a finished product certifier, may procure component
part testing as long as it complies with the requirements in this
section and subparts B and C of this part. A finished product certifier
may certify compliance of a consumer product with all applicable rules,
bans, standards, and regulations as required by section 14(a) of the
CPSA, and may ensure continued compliance of children's products
pursuant to section 14(i) of the CPSA, based, in whole or in part, on
passing component part test reports or certification of one or more
component parts of a consumer product if the following requirements are
met:
(1) Testing of the component part is required or sufficient to
assess compliance, in whole or in part, of the consumer product with
the applicable rule, ban, standard, or regulation. Any doubts about
whether testing one or more component parts of a consumer product is
sufficient to assess whether the finished product complies with
applicable rules, bans, standards, and regulations should be resolved
in favor of testing the finished product; and
(2) The component part tested is identical in all material respects
to the component parts used in the finished consumer product. To be
identical in all material respects to a component part for purposes of
supporting a certification of a children's product, a sample need not
necessarily be of the same size, shape, or finish condition as the
component part of the finished product; rather, it may consist of any
quantity that is sufficient for testing purposes and be in any form
that has the same content as the component part of the finished
product.
(b) Test Result Integrity. A certifier or testing party must
exercise due care to ensure that while a component part or finished
product is in its custody:
(1) Proper management and control of all raw materials, component
parts, subassemblies, and finished products is established and
maintained for any factor that could affect the finished product's
compliance with all applicable rules;
(2) The manufacturing process does not add or result in a
prohibited level of a chemical from any source, such as the material
hopper, regrind equipment, or other equipment used in the assembly of
the finished product; and
(3) No action or inaction subsequent to testing and before
distribution in commerce has occurred that would affect compliance,
including contamination or degradation.
(c) Limitation. A certifier must not use tests of a component part
of a consumer product for any rule, ban, standard, or regulation that
requires testing the finished product to assess compliance with that
rule, ban, standard, or regulation.
(d) Test method and sampling protocol. Each certifier and testing
party must exercise due care to ensure that when it procures a test for
use in meeting the requirements of sections 14(a) or 14(i) of the CPSA:
(1) All testing is done using required test methods, if any;
(2) Required sampling protocols are followed, if any; and
(3) Testing and certification follows the applicable requirements
in sections 14(a) and 14(i) of the CPSA, and part 1107 of this chapter
or any more specific rules, bans, standards, or regulations, used to
assess compliance of the component part or finished product.
(e) Timing. Subject to any more specific rule, ban, standard, or
regulation, component part testing may occur before final assembly of a
consumer product, provided that nothing in the final assembly of the
consumer product can cause the component part or the final consumer
product to become noncompliant.
(f) Traceability. A certifier must not rely on component part or
finished product testing procured by a testing party or another
certifier unless such component parts or finished products are
traceable.
(g) Documentation by certifiers and testing parties. Each certifier
and testing party must provide the following documentation, either in
hard copy or electronically, to a certifier relying on such
documentation as a basis for issuing a certificate:
(1) Identification of the component part or the finished product
tested;
(2) Identification of a lot or batch number, or other information
sufficient to identify the component parts or finished products to
which the testing applies;
[[Page 69582]]
(3) Identification of the applicable rules, bans, standards, and
regulations for which each component part or finished product was
tested;
(4) Identification of the testing method(s) and sampling
protocol(s) used;
(5) The date or date range when the component part or finished
product was tested;
(6) Test reports that provide the results of each test on a
component part or finished product, and the test values, if any;
(7) Identification of the party that conducted each test (including
testing conducted by a manufacturer, testing laboratory, or third party
conformity assessment body), and an attestation by the party conducting
the testing that all testing of a component part or finished product by
that party was performed in compliance with applicable provisions of
section 14 of the CPSA, part 1107 of this chapter, or any more specific
rules, bans, standards, or regulations;
(8) Component part certificate(s) or finished product
certificate(s), if any;
(9) Records to support traceability as defined in Sec. 1109.4(m);
and
(10) An attestation by each certifier and testing party that while
the component part or finished product was in its custody, it exercised
due care to ensure compliance with the requirements set forth in
subparagraph (b) of this section.
(h) Effect of voluntary certification. (1) The Commission will
consider any certificate issued by a component part certifier in
accordance with this part to be a certificate issued in accordance with
section 14(a) of the CPSA. All certificates must contain all of the
information required by part 1110 of this chapter.
(2) Any party who elects to certify compliance of a component part
or a finished product with applicable rules, standards, bans, or
regulations, must assume all responsibilities of a manufacturer under
sections 14(a) and 14(i) of the CPSA and part 1107 of this chapter with
respect to that component part or finished product's compliance to the
applicable rules, standards, bans, or regulations.
(i) Certification by finished product certifiers. (1) A finished
product certifier must exercise due care in order to rely, in whole or
in part, on one or more of the following as a basis for issuing a
finished product certificate:
(i) Finished product certificate(s) issued by another party;
(ii) Finished product test report(s) provided by another party;
(iii) Component part certificate(s); or
(iv) Component part test report(s).
(2) If a finished product certifier fails to exercise due care in
its reliance on another party's certifications or test reports, then
the Commission will not consider the finished product certifier to hold
a certificate issued in accordance with section 14(a) of the CPSA.
Exercising due care in this context means taking the steps that a
prudent and competent person in the same line of business would take to
conduct a reasonable review of another party's certification or test
reports, and to address any concern over their validity, before relying
on such documents to issue a finished product certificate. Due care
does not permit willful ignorance. Such steps may vary according to the
circumstances.
(3) A finished product certifier must not rely on another party's
certifications or test reports unless the finished product certifier
receives the documentation under paragraph (g) of this section from the
certifier or testing party. The finished product certifier may receive
such documentation either in hard copy or electronically, or access the
documentation through an Internet Web site. The Commission may consider
a finished product certifier who does not obtain such documentation
before certifying a consumer product to have failed to exercise due
care.
(j) Recordkeeping requirements. Each certifier or testing party
must maintain the documentation required in paragraph (g) of this
section for five years, and must make such documentation available for
inspection by the CPSC upon request, either in hard copy or
electronically, such as through an Internet Web site. Records may be
maintained in languages other than English if they can be:
(1) Provided immediately by the certifier or testing party to the
CPSC; and
(2) Translated accurately into English by the certifier or testing
party within 48 hours of a request by the CPSC or any longer period
negotiated with CPSC staff.
Subpart B--Conditions and Requirements for Specific Consumer
Products, Component Parts, and Chemicals
Sec. 1109.11 Component part testing for paint.
(a) Generally. The Commission will permit certification of a
consumer product, or a component part of a consumer product, as being
in compliance with the lead paint limit of part 1303 of this chapter or
the content limits for paint on toys of section 4.3.5.2 of ASTM F 963-
08 or any successor standard of section 4.3.5.2 of ASTM F 963-08
accepted by the Commission if, for each paint used on the product, the
requirements in Sec. 1109.5 and paragraph (b) of this section are met.
(b) Requirement. For each paint used on the product:
(1) Unless using the test method ASTM F 2853-10 to test for lead in
paint, all testing must be performed on dry paint that is scraped off
of a substrate for testing. The substrate used need not be of the same
material as the material used in the finished product or have the same
shape or other characteristics as the part of the finished product to
which the paint will be applied; and
(2) The tested paint is identical in all material respects to that
used in production of the consumer product. The paint samples to be
tested must have the same composition as the paint used on the finished
product. However, a larger quantity of the paint may be tested than is
used on the consumer product in order to generate a sufficient sample
size. The paint may be supplied to the testing laboratory for testing
either in liquid form or in the form of a dried film of the paint on
any suitable substrate.
Sec. 1109.12 Component part testing for lead content of children's
products.
A certifier may rely on component part testing of each accessible
component part of a children's product for lead content, where such
component part testing is performed by a third party conformity
assessment body, provided that the requirements in Sec. 1109.5 are
met, and the determination of which, if any, parts are inaccessible
pursuant to section 101(b)(2) of the Consumer Product Safety
Improvement Act of 2008 (CPSIA) and part 1500.87 of this chapter is
based on an evaluation of the finished product.
Sec. 1109.13 Component part testing for phthalates in children's toys
and child care articles.
A certifier may rely on component part testing of appropriate
component parts of a children's toy or child care article for phthalate
content provided that the requirements in Sec. 1109.5 are met.
Subpart C--Conditions and Requirements for Composite Testing
Sec. 1109.21 Composite testing.
(a) Paint. In testing paint for compliance with chemical content
limits, certifiers and testing parties may procure tests conducted on a
combination of different paint samples
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so long as test procedures are followed to ensure that no failure to
comply with the lead limits will go undetected (see paragraph (c) of
this section). A certificate may be based on testing each component
part of the paint according to the requirements of Sec. 1109.11 and
certifying that each component part in the mixture individually
complies with the lead in paint limit or other paint limit. Testing and
certification of composite paints must also comply with Sec. Sec.
1109.5 and 1109.11.
(b) Component parts. A certifier or testing party may procure tests
conducted on a combination of component parts for compliance with
chemical content limits so long as test procedures are followed to
ensure that no failure to comply with the content limits will go
undetected (see paragraph (c) of this section). Testing and
certification of composite component parts for lead content must also
comply with Sec. Sec. 1109.5 and 1109.12. Testing and certification of
composite component parts for phthalate content must also comply with
Sec. Sec. 1109.5 and 1109.13.
(c) How to evaluate composite testing. When using composite
testing, only the total amount or percentage of the target chemical is
determined, not how much was in each individual paint or component
part. Therefore, to determine that each paint or component part is
within the applicable limit, the entire amount of the target chemical
in the composite is attributed to each paint or component part. If this
method yields an amount of the target chemical that exceeds the limit
applicable to any paint or component part in the composite sample,
additional testing would be required to determine which of the paints
or component parts, if any, fail to meet the applicable limit.
Dated: October 21, 2011.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2011-27677 Filed 11-7-11; 8:45 am]
BILLING CODE 6355-01-P