Testing and Labeling Pertaining to Product Certification, 69482-69544 [2011-27678]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Rules and Regulations]
[Pages 69482-69544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27678]



[[Page 69481]]

Vol. 76

Tuesday,

No. 216

November 8, 2011

Part III





Consumer Product Safety Commission





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16 CFR Part 1107





Testing and Labeling Pertaining to Product Certification; Final Rule

Federal Register / Vol. 76 , No. 216 / Tuesday, November 8, 2011 / 
Rules and Regulations

[[Page 69482]]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1107

[CPSC Docket No. CPSC-2010-0038]


Testing and Labeling Pertaining to Product Certification

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 that establishes 
protocols and standards with respect to certification and continued 
testing for children's products. The final rule also establishes 
requirements for labeling of consumer products to show that the product 
complies with the certification requirements under section 14(a) of the 
Consumer Product Safety Act (``CPSA''). The final rule implements 
section 14(a)(2) and (i) of the CPSA, as amended by section 102(b) of 
the Consumer Product Safety Improvement Act of 2008 (``CPSIA'').

DATES: The rule will become effective on February 8, 2013 and applies 
to products manufactured after that date. The incorporation by 
reference of the publications listed in this rule is approved by the 
Director of the Federal Register as of February 8, 2013.\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 https://www.cpsc.gov/pr/statements.html.

FOR FURTHER INFORMATION CONTACT: Randy Butturini, Project Manager, 
Office of Hazard Identification and Reduction, U.S. Consumer Product 
Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; 
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(301) 504-7562; email: RButturini@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

I. Purpose of the Final Rule

    The purpose of this final rule is to reduce the incidents of deaths 
and injuries associated with children's products. This will be 
accomplished by increasing the safety of children's products. The 
likelihood of a noncompliant product being detected before it is 
introduced to the public will be increased. Consequently, consumer 
confidence in children's products certified to comply with the 
applicable product safety rules may be increased. Potentially, the 
number of recalls for children's products could be reduced, and, with 
continued assessment of compliance, the scope of necessary recalls 
could be reduced. Further, third party testing during continuing 
production or importation can serve as an objective assessment of the 
effectiveness of a manufacturer's or importer's internal processes to 
ensure compliance, which would also serve to enhance the safety of 
children's products in the market.

II. Statutory Authority

A. The Consumer Product Safety Act, as Amended by the Consumer Product 
Safety Improvement Act of 2008

    Section 14(a)(1) of the CPSA, (15 U.S.C. 2063(a)(1)), as amended by 
section 102 of the CPSIA, establishes requirements for the testing and 
certification of products subject to a consumer product safety rule 
under the CPSA or similar rule, ban, standard, or regulation under any 
other act enforced by the Commission and which are imported for 
consumption or warehousing or distributed in commerce. Under section 
14(a)(1)(A) of the CPSA, manufacturers and private labelers must issue 
a certificate, which ``shall certify, based on a test of each product 
or upon a reasonable testing program, that such product complies with 
all rules, bans, standards, or regulations applicable to the product 
under the CPSA or any other Act enforced by the Commission.'' CPSC 
regulations, at 16 CFR part 1110, limit the certificate requirement to 
importers and domestic manufacturers. Section 14(a)(1)(B) of the CPSA 
further requires that the certificate provided by the importer or 
domestic manufacturer ``specify each such rule, ban, standard, or 
regulation applicable to the product.'' The certificate described in 
section 14(a)(1) of the CPSA is known as a General Conformity 
Certification (GCC).
    Section 14(a)(2) of the CPSA (15 U.S.C. 2063(a)(2)) establishes 
testing requirements for children's products that are subject to a 
children's product safety rule. (Section 3(a)(2) of the CPSA (15 U.S.C. 
2052(a)(2)) defines a children's product, in part, as a consumer 
product designed or intended primarily for children 12 years of age or 
younger.) Section 14(a)(2)(A) of the CPSA also states that, before a 
children's product subject to a children's product safety rule is 
imported for consumption or warehousing or distributed in commerce, the 
manufacturer or private labeler of such children's product must submit 
sufficient samples of the children's product ``or samples that are 
identical in all material respects to the product'' to an accredited 
``third party conformity assessment body'' to be tested for compliance 
with the children's product safety rule. Based on such testing, the 
manufacturer or private labeler, under section 14(a)(2)(B) of the CPSA, 
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 
perform such tests.
    Section 14(i)(2)(A) of the CPSA requires the Commission to initiate 
a program by which a manufacturer or private labeler may label a 
consumer product as complying with the certification requirements. This 
provision applies to all consumer products that are subject to a 
product safety rule administered by the Commission. (On August 12, 
2011, the President signed into law H.R. 2715, which amended both the 
CPSA and the CPSIA. Section 10(a) of H.R. 2715 redesignates what was 
identified as section 14(d) of the CPSA in the preamble of the proposed 
rule as section 14(i) of the CPSA; consequently, except where we are 
citing language from the proposed rule, the remainder of this document 
will refer to section 14(i) of the CPSA.)
    Section 14(i)(2)(B) of the CPSA requires the Commission to 
establish protocols and standards for:
     Ensuring that a children's product tested for compliance 
with a children's product safety rule is subject to testing 
periodically and when there has been a material change in the product's 
design or manufacturing process, including the sourcing of component 
parts;
     Testing of representative samples;
     Verifying that a children's product tested by a conformity 
assessment body complies with applicable children's product safety 
rules; and
     Safeguarding against the exercise of undue influence on a 
third party conformity assessment body by a manufacturer or private 
labeler.
    Section 14(i)(2)(B)(iii) of the CPSA provides for verification that 
a children's product tested by a conformity assessment body complies 
with applicable children's product safety rules. At this time, we are 
not imposing any verification obligations on manufacturers because we 
intend to conduct the verification ourselves under our inherent 
authorities while we gain more experience with the testing and 
certification requirements. When we find that a children's product

[[Page 69483]]

accompanied by a certificate of conformity does not pass the tests upon 
which the certification was based, we may initiate an investigation of 
the manufacturer, third party conformity assessment body, and any other 
relevant party in the supply chain, to determine the cause of the 
discrepancy.
    To implement sections 14(a) and (d) (now renumbered by H.R. 2715 as 
section 14(i)) of the CPSA, as amended by section 102 of the CPSIA, we 
published a proposed rule in the Federal Register on May 20, 2010 (75 
FR 28336). The proposed rule would:
     Define the elements of a ``reasonable testing program'' 
for purposes of section 14(a)(1)(A) of the CPSA;
     Establish the protocols and standards for continuing 
testing of children's products under section 14(d)(2)(B)(i), (ii), and 
(iv) (renumbered as sections 14(i)(2)(B)(i), (ii), and (iv)) of the 
CPSA; and
     Describe the label that manufacturers may place on a 
consumer product to show that the product complies with the 
certification requirements for purposes of what was numbered previously 
as section 14(d)(2)(A) of the CPSA (now renumbered by H.R. 2715 as 
section 14(i)(2)(A) of the CPSA).

B. H.R. 2715 and Its Impact on This Rulemaking

    On August 12, 2011, the President signed into law H.R. 2715. H.R. 
2715 amended the CPSA and the CPSIA in several ways. For example, 
section 2, ``Application of Third Party Testing Requirements,'' of H.R. 
2715, revised section 14(d) of the CPSA, in part, by:
     Renumbering the second paragraph of section 14(d) of the 
CPSA as section 14(i) of the CPSA. (When the CPSIA was enacted, it 
created, mistakenly, two paragraph (d)s in section 14 of the CPSA. The 
paragraph at issue in the proposed rule was the second of the two 
paragraphs numbered (d); H.R. 2715 contained a technical amendment to 
renumber the second paragraph (d) as a new paragraph (i) of section 14 
of the CPSA);
     Revising section 14(i)(2)(B)(ii) of the CPSA to require 
the testing of ``representative samples,'' rather than the testing of 
``random samples'';
     Creating a new section 14(i)(3)(A) of the CPSA requiring, 
no later than 60 days after the date of enactment, that we ``seek 
public comment on opportunities to reduce the cost of third party 
testing requirements consistent with assuring compliance with any 
applicable consumer product safety rule, ban, standard, or 
regulation.'' H.R. 2715 lists seven topics for public comment:
    [cir] The extent to which the use of materials subject to 
regulations of another government agency that requires third party 
testing of those materials may provide sufficient assurance of 
conformity with an applicable consumer product safety rule, ban, 
standard, or regulation without further third party testing;
    [cir] The extent to which modification of the certification 
requirements may have the effect of reducing redundant third party 
testing by or on behalf of 2 or more importers of a product that is 
substantially similar or identical in all material respects;
    [cir] The extent to which products 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;
    [cir] The extent to which manufacturers with a substantial number 
of substantially similar products subject to third party testing may 
reasonably make use of sampling procedures that reduce the overall test 
burden without compromising the benefits of third party testing;
    [cir] 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 CPSA;
    [cir] The extent to which technology, other than the technology 
already approved by the Commission, exists for third party conformity 
assessment bodies to test or to screen for testing consumer products 
subject to a third party testing requirement; and
    [cir] Other techniques for lowering the cost of third party testing 
consistent with assuring compliance with the applicable consumer 
product safety rules, bans, standards, and regulations.
     Creating a new section 14(i)(3)(B) of the CPSA, requiring 
us to review the public comments and stating that we ``may prescribe 
new or revised third party testing regulations if [we determine] that 
such regulations will reduce third party testing costs consistent with 
assuring compliance with the applicable consumer product safety rules, 
bans, standards, and regulations; and
     Creating a new section 14(i)(4) of the CPSA, titled, 
``Special rules for small batch manufacturers,'' to provide 
``alternative testing requirements'' for ``covered products'' 
manufactured by small batch manufacturers or to exempt small batch 
manufacturers from third party testing requirements. H.R. 2715 defines 
a ``covered product'' as ``a consumer product manufactured by a small 
batch manufacturer where no more than 7,500 units of the same product 
were manufactured in the previous calendar year.'' It defines a ``small 
batch manufacturer,'' in part, as ``a manufacturer that had no more 
than $1,000,000 in total gross revenue from sales of all consumer 
products in the previous calendar year.''
    H.R. 2715 also contains (among other things) provisions on 
registration of small batch manufacturers and exclusions of certain 
materials from third party testing. For example, H.R. 2715 created a 
new section 14(i)(5)(A)(i) of the CPSA, which states that the third 
party testing requirements do not apply to ``ordinary books or ordinary 
paper-based printed materials.''
    The Commission has chosen to finalize those parts of the proposed 
rule that were not affected directly or significantly by H.R. 2715, and 
we will reserve other subparts or provisions in the final rule, pending 
our consideration and implementation of H.R. 2715. For example, because 
section 14(i)(2)(B)(ii) of the CPSA, as amended by H.R. 2715, now 
refers to the testing of ``representative samples,'' we have decided to 
remove Sec.  1107.22 from subpart C of the final rule, which would have 
pertained to ``Random Samples.''

III. Comments on the Proposed Rule and Our Responses

    Below, we describe and explain each subpart and section of the 
final rule, as well as describe and respond to the comments on the 
proposed rule. A summary of each of the commenters' topics is 
presented, and each topic is followed by our response. For ease of 
reading, each comment will be prefaced by 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 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.

A. General Comments

    Several commenters addressed issues regarding testing and costs, 
generally.
    (Comment 1)--One commenter warned that because the overwhelming 
majority of consumer products sold in the United States are produced 
overseas,

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nearly all of the work necessary to ensure compliance with the 
regulations will be performed overseas. The commenter stated that 
because the cost of compliance for foreign manufacturers can be 
relatively high--while the risks associated with noncompliance can be 
relatively low--it is important that our regulation balance the need 
for a high degree of assurance of compliance against the need to 
develop a practical regulatory structure that foreign manufacturers can 
and will implement.
    (Response 1)--The final rule is designed not to be overly 
prescriptive, thereby giving manufacturers some flexibility in 
designing their testing and certification programs to be consistent 
with the statutory requirements. For example, the final rule allows the 
manufacturer to determine the number of samples that are tested, as 
long as the manufacturer has a high degree of assurance that the 
products represented by the samples are in compliance with all 
applicable children's product safety rules. Further, while the final 
rule requires that manufacturers document their compliance, it gives 
manufacturers the flexibility to determine how to maintain this 
information. In addition, the final rule does not require any 
documentation to be maintained in English or kept in the United States, 
except the certificate.
    We also note that, on August 12, 2011, the President signed into 
law H.R. 2715, which amended the CPSIA in several respects. One 
provision in H.R. 2715 requires us to seek public comment on 
opportunities to reduce the cost of third party testing requirements 
consistent with assuring compliance with any applicable consumer 
product safety rule, ban, standard, or regulation. H.R. 2715 directs us 
to seek public comment on seven specific issues, including the extent 
to which modification of the certification requirements may have the 
effect of reducing redundant third party testing by or on behalf of two 
or more importers of a product that is substantially similar or 
identical in all material respects, and other techniques for lowering 
the cost of third party testing consistent with assuring compliance 
with the applicable consumer product safety rules, bans, standards, and 
regulations. Elsewhere in this issue of the Federal Register, we have 
published a notice seeking public comment on the issues in H.R. 2715. 
H.R. 2715 further requires us to review the public comments and states 
that we may prescribe new or revised third party testing regulations if 
we determine that such regulations will reduce third party testing 
costs consistent with assuring compliance with the applicable consumer 
product safety rules, bans, standards, and regulations.
    (Comment 2)--Two commenters stated that we should conduct a full 
cost-benefit analysis of the rule. One commenter added that costs of 
complying with the testing and certification rule, in combination with 
other requirements under the CPSIA and other rules administered by the 
CPSC, will result in a major rule with major implications to consumer 
product manufacturers, particularly children's product manufacturers, 
as well as to the entire supply chain. The commenter urged us to 
examine in greater detail, and to quantify, the full cost and burden of 
these rules. A third commenter implored us to consider the reduction in 
risk, if any, associated with each regulatory requirement and impose 
only those requirements that meaningfully enhance consumer safety in a 
way that makes increased costs and use of resources worthwhile.
    (Response 2)--This rule is being promulgated under the 
Administrative Procedure Act and also section 3 of the CPSIA; neither 
authority requires us to conduct a cost-benefit analysis. Moreover, by 
allowing in CPSIA expedited rulemaking, Congress made it clear that it 
did not want the Commission engaging in any unnecessary delay in 
promulgating this rule. However, we agree that the final rule 
constitutes a major rule, as defined by the Congressional Review Act of 
1996. While, in recognition of Congress's view as reflected in CPSIA, 
we decline to conduct a cost-benefit analysis for the final rule, we 
have changed the final rule to address some of the economic burden on 
manufacturers. Among the changes made to the final rule to reduce the 
burden are: (1) Reserving the subpart B requirements regarding a 
reasonable testing program; \2\ (2) eliminating certain requirements of 
the proposed rule for children's products such as the remedial action 
plan; (3) reducing the recordkeeping requirements in several respects; 
and (4) allowing the use of in-house ISO/IEC 17025:2005 laboratories to 
reduce the frequency of third party periodic testing. By way of further 
example, with regard to the reduction in the recordkeeping 
requirements, the final rule does not require records to be kept in the 
United States, nor does it require records to be translated into 
English, unless requested.
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    \2\ It should be noted, however, that although we are not 
finalizing subpart B at this time, 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 rule[s] based on a test of each product or a reasonable 
testing program.
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    Additionally, we note that a cost-benefit analysis would not 
necessarily be confined to manufacturers or those in a supply chain (as 
implied by one commenter). We expect, for instance, that consumers will 
benefit from the testing and certification of consumer products, 
particularly if such testing revealed potential problems associated 
with a product or its components, or if such testing prompted a 
manufacturer to redesign or remanufacture the product to make it safer.
    (Comment 3)--One commenter stated that some retailers are requiring 
many manufacturers to submit their products to as many as four 
different laboratories because the retailers want to see test results 
from specific laboratories. The commenter stated that we should clarify 
to retailers that this redundant testing is not necessary.
    (Response 3)--The preamble to the proposed rule stated that 
retailers and sellers of children's products can rely on certificates 
provided by finished product certifiers--without conducting additional 
testing themselves--if those certificates are based on testing 
conducted by a CPSC-accepted third party conformity assessment body (75 
FR at 28337).

B. Proposed Subpart A--General Provisions

1. Proposed Sec.  1107.1--Purpose
    Proposed Sec.  1107.1 would state that part 1107 establishes the 
requirements for a reasonable testing program for non-children's 
products; third party conformity assessment body testing to support 
certification and continuing testing of children's products; and 
labeling of consumer products to indicate that the certification 
requirements have been met pursuant to sections 14(a)(1), and (a)(2), 
(d)(2)(B) of the CPSA (15 U.S.C. 2063(a)(1), (a)(2), (d)(2)(B)).
    We did not receive any comments on this section. However, because 
we have decided to reserve subpart B, which would pertain to the 
reasonable testing program for non-children's products, we have removed 
the reference to the ``reasonable testing program for non-children's 
products.'' (We explain our decision to reserve subpart B of the 
proposed rule in part B.2 of this preamble below.)
    Additionally, because H.R. 2715 revised section 14(i)(2)(B)(ii) of 
the CPSA to refer to testing of ``representative'' rather than 
``random'' samples, we have, on our own initiative,

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elected to simplify Sec.  1107.1 to reflect the final rule's narrower 
purpose and have made minor, non-substantive changes to follow the 
language of the statute. This helps clarify which requirements in the 
statute this final rule is intended to address and which have been 
reserved for a later date. Additionally, proposed Sec.  1107.1 was 
silent regarding procedures to safeguard against the exercise of undue 
influence by a manufacturer on a third party conformity assessment 
body, even though proposed Sec.  1107.24, ``Undue influence,'' would 
contain such safeguards. Consequently, the final rule now mentions the 
establishment of procedures to safeguard against the exercise of undue 
influence by a manufacturer on a third party conformity assessment 
body. Thus, Sec.  1107.1 now states that the part establishes the 
protocols and standards for ensuring continued testing of children's 
products periodically and when there has been a material change in the 
product's design or manufacturing process and safeguarding against the 
exercise of undue influence by a manufacturer on a third party 
conformity assessment body. It also establishes a program for labeling 
of consumer products to indicate that the certification requirements 
have been met pursuant to sections 14(a)(2) and (i)(2)(B) of the 
Consumer Product Safety Act (CPSA) (15 U.S.C. 2063(a)(2) and 
(i)(2)(B)).
2. Proposed Sec.  1107.2--Definitions
    Proposed Sec.  1107.2 would define various terms used in the rule.
a. CPSA
    Proposed Sec.  1107.2 would define ``CPSA'' to mean the Consumer 
Product Safety Act.
    We received no comments on this definition and have finalized it 
without change.
b. CPSC
    Proposed Sec.  1107.2 would define ``CPSC'' to mean the Consumer 
Product Safety Commission.
    We received no comments on this definition and have finalized it 
without change.
c. CPSIA
    Proposed Sec.  1107.2 would define ``CPSIA'' to mean the Consumer 
Product Safety Improvement Act of 2008.
    We received no comments on this definition and have finalized it 
without change.
d. Detailed Bill of Materials
    Proposed Sec.  1107.2 would define ``detailed bill of materials'' 
to mean a list of the raw materials, subassemblies, intermediate 
assemblies, subcomponent parts, component parts, and the quantities of 
each needed to manufacture a finished product.
    We received no comments on this definition. However, because the 
term ``detailed bill of materials'' appeared only in proposed Sec.  
1107.10(b)(1) (which would require a product specification as part of 
the reasonable testing program), and because the final rule now 
reserves subpart B, we have removed the definition of ``detailed bill 
of materials'' from the final rule.
e. Due Care
    Proposed Sec.  1107.2 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 4)--One commenter noted that the due care requirement only 
applies to a few specific provisions of the proposed rule, such as 
proposed Sec.  1107.23(a) regarding ``material change'' in the 
product's design, manufacturing process, or sourcing of component 
parts. In some instances, this defined duty of ``due care'' would be 
coupled with a CPSC-created standard of ``high degree of assurance.'' 
The commenter appreciated our recognition that both the ``due care'' 
standard of conduct and the ``high degree of assurance'' standard for 
compliance are anchored in the judgment and knowledge of the 
manufacturer. For that reason, the commenter felt that the due care 
requirement should have general applicability to all elements of 
compliance for implementation of the CPSIA's testing and certification 
requirements. The commenter stated that manufacturers should not have 
to wonder whether more than their exercise of reasonable judgment and 
practice, based on their manufacturing experience and sound knowledge 
of the product, is required for aspects of the rules that do not 
explicitly reference these standards.
    (Response 4)--The definition of ``due care'' in Sec.  1107.2 refers 
to the actions of a prudent and competent person. We expect that all 
parties will exercise prudence and competence in the testing and 
certification of products. The final rule emphasizes due care in 
particular sections, as noted by the commenter, because these are areas 
that require additional care in order to prevent noncompliant products 
from being produced and certified.
    We recognize that manufacturers' knowledge of their products and 
their manufacture can serve as a basis for determining what steps are 
necessary to achieve a high degree of assurance that their products 
comply with the applicable product safety rules. Based on that 
knowledge, manufacturers are uniquely situated to know what actions are 
necessary to exercise due care and demonstrate a high degree of 
assurance regarding their specific circumstances.
    On our own initiative, we have revised the definition of ``due 
care'' in the final rule. The final rule's definition of ``due care'' 
includes a sentence stating that ``Due 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, the Commission wants to 
emphasize in the final rule that a party cannot purposely avoid knowing 
their business partner's testing and certification practices to avoid 
violating section 19 of the CPSA. A party will not be shielded from 
violating section 19 of the CPSA when that party knows or should know 
about testing and/or certification problems which may affect the 
ability of a consumer product to be compliant with all rules, bans, 
standards, or regulations. Certifiers and testing parties have an 
obligation to resolve known or knowable problems with testing and/or 
certification before relying upon or passing on test reports or 
certifications.
f. High Degree of Assurance
    Proposed Sec.  1107.2 would define ``high degree of assurance'' as 
``an evidence-based demonstration of consistent performance of a 
product regarding compliance based on knowledge of a product and its 
manufacture.''
    (Comment 5)--Multiple commenters questioned the definition of a 
``high degree of assurance.'' One commenter would like the rule to 
define the term ``high degree of assurance'' in a more understandable 
or quantitative way. The commenter considered the term to be confusing 
and misleading and believed this could lead to unnecessary conflicts 
between manufacturers and conformity assessment bodies when a judgment 
has to be made in certain cases. The commenter wondered if this 
requirement is targeting the design area, manufacturing process 
control, quality control, or testing procedures.
    Another commenter said that manufacturers would benefit from 
additional guidance on how to achieve a ``high degree of assurance'' 
through their testing programs. The preamble to the proposed rule 
referred to a 95 percent statistical significance level as constituting 
a ``high degree'' of

[[Page 69486]]

assurance, but the proposed rule would not mandate a 95 percent 
confidence threshold. The commenter asked what factors would permit a 
manufacturer to satisfy the ``high degree of assurance'' requirement 
with a statistical significance level below 95 percent and asked us to 
provide an example of a situation where a manufacturer could still 
achieve a high degree of assurance with less than 95 percent assurance.
    Another commenter argued that the term ``high degree of assurance'' 
is subjective and subject to varied interpretations. The commenter 
suggested that a statistical confidence limit would help remove the 
subjectivity and set a specific threshold by which we can enforce our 
rules better. The commenter also was concerned that the wording may 
lead some manufacturers to believe that they do not have to test to the 
standard in all cases, as long as they foresee little risk of 
noncompliance, or assume that the risk is low of being discovered 
having noncompliant products in the marketplace. The commenter said the 
final rule should clarify that testing to applicable standards is 
required.
    (Response 5)--The determination of a ``high degree of assurance'' 
for a given product will vary by industry, product, component part, and 
by manufacturer. Therefore, selecting an example using a hypothetical 
certifier would be of little value to manufacturers. We have 
intentionally defined the term in a manner that allows the manufacturer 
the flexibility to develop a testing program to ensure their product 
complies with all applicable children's product safety rules. This rule 
provides broad protocols and standards for regulated firms to follow 
and adapt to their particularized needs given their products and 
processes. The use of quantitative values for the definition of ``high 
degree of assurance'' could lead to difficulties for some 
manufacturers. The preamble to the proposed rule stated: ``We decided 
against defining `high degree of assurance' with respect to a 95 
percent probability or confidence level because there may be difficulty 
in applying the statistical methods to all manufacturing processes'' 
(75 FR 28344). The intent of the definition is to enable a manufacturer 
to have a degree of confidence, based on evidence (rather than only on 
a belief) that all of the products manufactured are compliant with the 
applicable product safety rules. Knowledge of a product's design and 
how it is manufactured, control over component parts, and measurements 
showing consistent performance, are some elements that can be used to 
demonstrate a ``high degree of assurance.''
    As for the commenter asking us to clarify that testing to 
applicable standards is required, Sec.  1107.20 (a) of the final rule 
states that manufacturers must submit samples of a children's product 
to a third party conformity assessment body for testing. We believe 
these statements are clear enough to convey that certification testing 
involves tests.
    (Comment 6)--Two commenters agreed that a numerical target for 
defining what constitutes a high degree of assurance--in the context of 
programs based on good manufacturing practices (GMP)--is misplaced. One 
commenter noted that the explanation of the definition of ``high degree 
of assurance'' provided in the preamble to the proposed rule (75 FR at 
28344) implies that we prefer the 95 percent statistical level of 
confidence for a high-degree-of-assurance approach and consider it the 
default. The commenter is concerned that the 95-percent-confidence-
level language may prompt third party conformity assessment bodies and 
retailers to adopt standardized testing protocols that demand large 
sample sizes, which will be a particular burden for the initial 
certification and may not be warranted in many cases. The commenter 
expressed the belief that the goal, across a broad range of different 
products that are subject to different manufacturing requirements and 
material sourcing, must be a standard that correlates ``a high degree 
of assurance'' with an ``evidence-based demonstration of consistent 
performance'' that relies more appropriately upon process controls to 
assure conformance. The commenter indicated that, while generally 
accepted process controls may include statistical sampling as part of 
process control programs, in and of themselves, they are not preferable 
to good manufacturing practices. The commenter said that the final rule 
must be clear in this regard.
    (Response 6)--Standards for GMPs are generally industry-specific in 
areas such as: Cosmetics, pharmaceutical operations, food handling, and 
medical devices. It is unlikely that any GMP-based program would be 
deemed workable or acceptable for all children's product manufacturing 
methods.
    A certifier's determination that a product complies--with a high 
degree of assurance--with the applicable children's product safety 
rules, may derive from statistically based testing, the application of 
good manufacturing practices, or other knowledge of the product and its 
manufacture. Because GMP-based programs are industry-specific, we 
disagree with the commenter's assertion that the programs are 
preferable to other accepted process controls in all manufacturing 
situations.
    The final rule defines a ``high degree of assurance'' in general 
terms because the definition is intended to be applied to a wide 
variety of products that use many different manufacturing processes. 
Customizing the definition of ``high degree of assurance'' to fit one 
type of product or GMP-based program will necessarily increase the 
difficulty of manufacturers applying the definition to dissimilar 
products or manufacturing processes. Further, because GMP-based 
programs vary across industries--and the comments were not specific 
about which aspect(s) of a GMP program we should adopt, or which GMPs 
we should adopt--we cannot revise the definition, as requested by the 
commenter.
    As for the commenter who interpreted the preamble to the proposed 
rule as expressing a preference for a 95 percent confidence level, we 
do not consider a numerically based definition of a ``high degree of 
assurance'' to be the default position. Defining a ``high degree of 
assurance'' with respect to a 95 percent probability or confidence 
level would be difficult to apply to all manufacturing processes for 
children's products. Defining a ``high degree of assurance'' as a 95 
percent, or higher, probability or confidence level could result in 
greater testing demands on small manufacturers. As discussed in the 
preamble of the proposed rule (75 FR at 28344), a statistical 
definition is not needed in order to provide an evidence-based high 
degree of assurance.
    Regarding the concern that conformity assessment bodies and 
retailers may require large numbers of samples for certification 
testing, the children's product certifier (not the conformity 
assessment body or retailer) specifies the number of samples to be 
tested. The final rule requires the number of samples to be sufficient 
to give the certifier a high degree of assurance that the tests 
conducted demonstrate accurately the ability of the product to comply 
with the applicable children's product safety rules. As we previously 
stated in the preamble to the proposed rule:

    The Commission wants to emphasize to retailers and sellers of 
children's products that they can rely on certificates provided by 
product suppliers if those certificates are based on testing 
conducted by a third party conformity assessment body.

75 FR at 28337.


[[Page 69487]]


    (Comment 7)--Two commenters contended that the proposed definition 
of a ``high degree of assurance'' lacks clarity. Both commenters said 
that the rule should have additional examples of what constitutes ``a 
high degree of assurance.'' One commenter acknowledged that the 
discussion in the preamble to the proposed rule makes clear that the 
definition mandates no specific formula (75 FR at 28344). However, the 
commenter noted that the preamble to the proposed rule gave no specific 
examples, other than the use of statistical methods. The commenter 
argued that the final rule should recognize other means of achieving 
this confidence level, including ways that do not rely solely on 
product testing or statistical methods. These methods include 
appropriate quality assurance processes and risk management. Quality 
assurance processes can include: Factory/supplier evaluations, design 
reviews, manufacturing process controls, process auditing, or similar 
controls or reviews. Risk management includes: Analysis of a given 
possible failure, the likelihood of the failure, and the potential 
consequences associated with the failure. The commenter argued that 
importers can use these activities to boost desired outcomes and reduce 
unexpected outcomes; and the commenter further maintained that the 
activities can be performed in a feedback loop that facilitates true 
root-cause analysis and correction, if there is a failure.
    The commenters suggested substitute definitions for ``a high degree 
of assurance'' that are practically identical. One suggested definition 
reads: ``A high degree of assurance means an evidence-based 
determination of consistent performance of a product regarding 
compliance based on knowledge of a product and its manufacture.'' 
Acceptable evidence-based determinations may be based on evidence 
derived through any appropriate process or control or combination of 
processes and/or controls, such as (but not limited to):
     Design validation;
     Manufacturing process control audits;
     In-process manufacturing controls, measurements, and 
tests;
     Component and material testing, as defined in 16 CFR part 
1109;
     Finished product testing;
     Raw materials certification; and
     Other controls or processes that provide information about 
the safety or compliance of a product.
    The other commenter's suggested definition reads: ``High degree of 
assurance means an evidence-based determination of consistent 
performance of a product regarding compliance based on knowledge of a 
product and its manufacture. Acceptable determinations may be based on 
evidence derived through any appropriate tool or control methodology 
(or combination of tools and/or control methodologies), such as but not 
limited to:
     Design Validation
     Process Validation
     Manufacturing Process Control Audits
     Raw material validation and controls
     In-process manufacturing controls, measurements, and tests
     Component and material testing as defined at 16 CFR part 
1109
     Finished Product Testing''
    (Response 7)--The commenters are correct that certifiers can use 
process controls, mathematical techniques, simulations, and other 
aspects of a product and its manufacture, as part of the basis for 
determining whether a particular product complies with the applicable 
product safety rules with a high degree of assurance. The commenters 
also are correct that the preamble to the proposed rule (75 FR at 
28344) provided statistically based examples in the definition of a 
``high degree of assurance.'' However, a method on the commenters' list 
may be adequate for one rule, but inadequate for another. As an 
example, Design Validation may be a good technique to ensure that a toy 
does not have a hole large enough to allow access to a sharp edge or 
point. However, Design Validation may be inadequate for controlling 
lead content because its techniques are ill-suited for controlling 
continuing production of component parts. As another example, component 
part testing is a useful technique for determining the chemical content 
of lead and the prohibited phthalates, but it is inadequate for 
determining compliance to the pacifier pull tests because the entire 
product is required to conduct the test. ``A high degree of assurance'' 
is defined in general terms because it is intended to be applied to a 
wide variety of products that use many different manufacturing 
processes. Providing a list of the intended applications as part of the 
definition would introduce the risk of a manufacturer applying 
techniques that are inappropriate for evaluating the applicable 
children's product safety rule.
    Therefore, we decline to amend the definition of ``a high degree of 
assurance,'' as suggested by the commenters. Specific examples are not 
universally applicable; and therefore, they should not be included in 
the definition of ``a high degree of assurance.'' Any such list 
necessarily would be underinclusive or possibly confusing or 
misleading. Additionally, certification and periodic testing of 
children's products must be based on tests of the finished product, or 
its component parts, sufficient to show compliance (or continuing 
compliance, in the case of periodic testing) with all applicable 
children's product safety rules. A definition of a ``high degree of 
assurance,'' that includes methods other than testing, might lead some 
certifiers to conclude mistakenly that certification or periodic test 
requirements might be met by means other than testing.
    (Comment 8)--One commenter suggested that the final rule allow a 
company's prior safety record to replace product safety testing as 
evidence that a company has met the requirement for a high degree of 
assurance (``HDA''). The commenter wrote:

    The ``high degree of assurance'' should be based on an overall 
assessment of the safety record of the company. It should NOT be 
based on the results of an individual product, even if recalled or 
deemed dangerous.

    The commenter pointed out that its company had a very good safety 
record. The commenter added:

    With this record over so many years, our company should be 
deemed to have satisfied this HDA requirement and be endorsed as 
having a reasonable testing program without further inquiry.

    (Response 8)--Section 14(a)(2) of the CPSA makes clear that 
children's product certification is based upon third party testing of 
the product and not a company's safety record. For this reason, the 
final rule does not provide relief from the testing requirements in the 
statute. In addition, the commenter's suggestion that a manufacturer 
should be allowed to rely upon its prior safety record to demonstrate a 
high degree of assurance would be a difficult concept to apply in 
practice because of the likely changes in any given manufacturer's 
safety record over time and potential disagreements as to whether a 
product caused a safety problem, whether the safety problem resulted 
from product misuse, and whether safety issues had to occur at a 
particular rate of frequency before testing was warranted.
    (Comment 9)--One commenter stated that a ``high degree of 
assurance'' could be provided best by using an accredited product 
certification program that meets the requirements of the International 
Standards Organization/International Electrotechnical Commission (ISO/
IEC) Guide 65, General requirements for bodies operating product 
certification

[[Page 69488]]

systems, and the fundamentals of System 5 product certification 
requirements of ISO/IEC Guide 67, Conformity assessment--Fundamentals 
of product certification.
    (Response 9)--The various activities a certification body 
undertakes, such as testing, conformity assessment, and surveillance 
can be used to demonstrate a high degree of assurance that a product 
complies with the applicable product safety rules. However, the 
techniques used by certification bodies are not the only means a 
manufacturer could use. Process control techniques, failure modes and 
effects analyses, and other quality assurance methods, depending upon 
the product under consideration, could be as effective as certification 
body methods. Because we want to give certifiers the flexibility to 
decide which methods apply best to their particular products, we 
decline to define a ``high degree of assurance'' using ISO/IEC Guide 65 
and Guide 67 requirements. A manufacturer who wishes to use those 
requirements to ensure a high degree of assurance of compliance may do 
so. However, we reiterate that testing in support of certification of a 
children's product must be performed by a CPSC-accepted third party 
conformity assessment body whose scope of accreditation includes the 
tests required for certification, and certification of a product cannot 
be delegated to another party, such as a certification body.
    (Comment 10)--A commenter suggested that the language related to 
periodic testing intervals and sample sizes is inconsistent in the 
preamble to the proposed rule. The commenter conceded that it is 
difficult to specify the exact number of products that must be tested 
in order to reach a high degree of assurance that a product is 
compliant. The commenter noted that the response to comments section of 
the preamble to the proposed rule titled, Additional Third Party 
Testing Requirements for Children's Products, stated that ``the sample 
size for periodic testing will depend upon the number of samples that 
need to be tested to provide that statistical assurance'' (75 FR at 
28342). The commenter agreed with this statement but noted the 
inconsistency between the language used in that section and the 
language found in the response to comments section titled, The 
Reasonable Testing Program, which specifies that the testing intervals 
must provide ``reasonable assurance'' that the product meets the 
requirements of the applicable product safety rules (75 FR at 28338). 
The commenter noted that there is a difference between a ``high degree 
of assurance'' and ``reasonable assurance.'' The commenter expressed 
the belief that the testing program should be statistically based, such 
that a confidence level of 95 percent must be achieved to indicate 
compliance. This requirement would eliminate the possibility of testing 
only a single sample to indicate compliance, the commenter asserted.
    (Response 10)--In the preamble to the proposed rule, under the 
response to comments section, Additional Third Party Testing 
Requirements for Children's Products (75 FR at 28342), we stated the 
following:

    If a high degree of assurance is interpreted to be a statistical 
likelihood of not producing noncompliant products, the sample size 
for periodic testing will depend upon the number of samples that 
need to be tested to provide that statistical assurance (italics 
added) * * *

    The word ``that'' refers to ``a high degree of assurance,'' which 
appears at the beginning of the sentence. With respect to the other 
alleged inconsistencies mentioned in the comment, it is worth noting 
that the preamble to the proposed rule uses the phrase ``high degree of 
assurance'' 20 times; whereas, the codified text of the proposed rule 
does not use the term ``reasonable assurance'' at all. The term 
``reasonable assurance'' appears only once in the preamble to the 
proposed rule, in the introduction to the response to comments section 
titled, The Reasonable Testing Program, where it is listed as one of 
the previous questions that we asked in the Federal Register notice 
announcing the December 2009 public workshop.
    We also do not agree with the commenter that there should be a 
specific probability level (i.e., 95 percent) in the definition of ``a 
high degree of assurance.'' As previously noted in the preamble to the 
proposed rule (75 FR at 28344), ``we decided against defining `high 
degree of assurance' with respect to a 95 percent probability or 
confidence level because there may be difficulty in applying the 
statistical methods to all manufacturing processes.'' Many 
manufacturing processes, such as low-volume and continuous 
manufacturing, are ill-suited to use a sampling technique for quality 
control purposes. In addition, for small-volume manufacturers, the 
number of samples required to achieve 95 percent confidence could be 
excessive, even to the point of requiring all of the products 
manufactured to be tested. Because the final rule's testing 
requirements apply to a wide variety of products, manufacturers, and 
manufacturing processes, the rule must give manufacturers the 
flexibility to determine the best way to comply with the testing 
requirements.
    The intent of the definition is for a manufacturer to have a high 
degree of assurance based upon evidence (rather than only a belief) 
that all of the products manufactured are compliant with the applicable 
safety rules. Knowledge of the product's design and how the product is 
manufactured, control over component parts, measurements showing 
consistent or inconsistent performance, the associated hazard, and many 
other elements such as these, can be used to determine the number of 
samples required for certification and for the periodic testing 
intervals, as noted in the final rule.
g. Identical in All Material Respects
    Proposed Sec.  1107.2 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.
    (Comment 11)--Several commenters asked us to clarify the definition 
of ``identical in all material respects.'' One commenter said that the 
definition appears absolute in that it does not allow any ``difference 
with respect to compliance.'' The commenter indicated that such a 
definition would make testing requirements unnecessarily rigid and 
costly.
    Another commenter contended that the definition of ``identical in 
all material respects'' cannot be absolute. One commenter would revise 
the definition to read: `` `Identical in all material respects' means 
there is no difference between the sample and the finished product that 
could affect compliance to the applicable rules.'' Another commenter 
suggested revising the definition of ``identical in all material 
respects'' to mean ``to a high degree of assurance, there is no 
difference between the samples and the finished product that is 
material to compliance of the applicable rule.'' One commenter 
suggested that the definition of ``identical in all material respects'' 
should mean ``a manufacturer possess [sic] a reasonable belief that, 
there is no difference between the samples and the finished product is 
not materially compliant.''
    (Response 11)--We do not regard the definitions suggested by the 
commenters to be improvements of the existing definition of ``identical 
in all material respects.'' For example, defining ``identical in all 
material respects'' to mean ``there is no difference between the sample 
and the finished product that could affect compliance to the applicable 
rules''

[[Page 69489]]

appears to be so similar to the proposed definition that adopting the 
commenter's suggested definition would not alter the rule. Samples used 
for certification testing and the finished product may be different--
just not different in any way that would affect the sample's ability to 
demonstrate compliance of the finished product. The definition of 
``identical in all material respects'' is intended to emphasize that if 
anything other than the finished product is subjected to testing, then 
the characteristics of that sample must be identical to the testing of 
the finished product, insofar as complying with the applicable product 
safety rule. Otherwise, the test may not indicate that the finished 
product, in fact, complies with the applicable product safety rule.
    The second definition suggested for ``identical in all material 
respects'' (``To a high degree of assurance, there is no difference 
between the samples and the finished product that is material to 
compliance of the applicable rule'') also does not emphasize adequately 
that the finished product is what must comply with the applicable 
rules. In addition, using the phrase ``to a high degree of assurance'' 
in describing the similarity (with respect to conformance to the 
applicable rules), results in some doubt that the samples, in fact, are 
``identical in all material respects.'' Further, Sec.  1107.20(a) of 
the final rule states that manufacturers must submit a sufficient 
number of samples of a children's product, or samples that are 
identical in all material respects to the children's product, to a 
third party conformity assessment body for testing to support 
certification. The number of samples selected must provide a high 
degree of assurance that the tests conducted for certification purposes 
accurately demonstrate the ability of the children's product to meet 
all applicable children's product safety rules. Using a ``high degree 
of assurance'' in the definition of ``samples'' would involve a double 
use of the term with no corresponding increase in clarity.
    In a similar manner, the third definition suggested for ``identical 
in all material respects,'' which uses the phrase ``a reasonable 
belief,'' introduces doubt that the samples are identical to the 
finished product with respect to compliance. Additionally, ``a 
reasonable belief'' standard in the definition would result in an 
inquiry into the state of mind of a particular manufacturer and could 
lead to disagreements between the CPSC and manufacturers over whether a 
manufacturer's belief was ``reasonable'' in a specific instance. 
Further, the commenter did not explain or clarify their interpretation 
of the phrase ``materially compliant''; the absence of such an 
explanation or interpretation would result in additional uncertainty in 
the definition.
    Nevertheless, on our own initiative, we have revised the definition 
of ``identical in all material respects'' to make minor clarifications 
to improve the definition's accuracy and consistency with the statute. 
For example, the proposed definition would refer to ``compliance to the 
applicable rules;'' the final definition now adds: ``bans, standards, 
or regulations'' after ``rules,'' to be more consistent with section 
14(f)(1) of the CPSA. We also have revised the phrase ``between the 
samples and the finished product'' to read: ``between the samples to be 
tested for compliance and the finished product distributed in 
commerce,'' to reflect that, under the final rule, the items that must 
be ``identical in all material respects'' are the samples that are to 
be tested for compliance (as opposed to samples that are tested for any 
other purpose) and the product that is actually distributed in 
commerce.
    (Comment 12)--One commenter urged us to state that the phrase 
``identical in all material respects'' is intended to be consistent 
with the ``objectively reasonable basis'' standard from 16 CFR part 
1633, and that we would consider individual subordinate mattresses that 
meet the requirements of 16 CFR 1633 to be ``identical in all material 
respects'' to the qualified prototype to which a specific mattress is 
subordinate.
    (Response 12)--We agree with the commenter that ``identical in all 
material respects'' is consistent with a demonstration on an 
``objectively reasonable basis,'' as stated in 16 CFR 
Sec. thnsp;1633.4(b)(3). We consider individual subordinate mattresses 
that meet the requirements of 16 CFR part 1633 to be ``identical in all 
material respects'' to the qualified prototype to which a specific 
mattress is subordinate.
h. Manufacturer
    Proposed Sec.  1107.2 would define ``manufacturer'' as ``the 
parties responsible for certification of a consumer product pursuant to 
16 CFR part 1110.''
    We received no comments on this definition and have finalized it 
without change.
i. Manufacturing Process
    Proposed Sec.  1107.2 would define ``manufacturing process'' as 
``the techniques, fixtures, tools, materials, and personnel used to 
create the component parts and assemble a finished product.''
    (Comment 13)--Two commenters noted that the proposed definition 
includes ``personnel used to create the component parts and assemble a 
finished product.'' The commenters argued that this should not be 
construed to mean that any change in the employees who are involved in 
the production of a part or product is equivalent to a change in the 
manufacturing process.
    (Response 13)--Regarding the commenters' suggestion on the 
definition of ``manufacturing process,'' the commenters may be 
confusing a change in the manufacturing process with a material change 
that could affect compliance to an applicable product safety rule. The 
commenters are partly correct that any change in personnel involved 
with a manufacturing process does not necessarily constitute a material 
change with respect to the product's compliance. However, for 
manufacturing processes that rely on high levels of craftsmanship or 
technical expertise, such a personnel change could affect compliance 
and, therefore, might be considered a material change to the 
manufacturing process.
    Therefore, we have finalized the definition of ``manufacturing 
process'' without change.
j. Production Testing Plan
    Proposed Sec.  1107.2 would define ``production testing plan'' as 
``a document that shows what tests must be performed and the frequency 
at which those tests must be performed to provide a high degree of 
assurance that the products manufactured after certification continue 
to meet all the applicable safety rules.''
    We received no comments on this definition, but, on our own 
initiative, we have chosen to remove it from the final rule. We have 
removed the definition because it is duplicative of the description and 
requirements of ``a production testing plan'' in Sec.  1107.21(c)(2) of 
the final rule.
k. Third Party Conformity Assessment Body
    Proposed Sec.  1107.2 would define ``third party conformity 
assessment body'' to mean 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 have revised the definition by making editorial changes 
to describe more accurately our accreditation process and to indicate 
that the third party conformity assessment body's scope of 
accreditation must include the

[[Page 69490]]

applicable CPSC-required tests. Thus, the final rule now defines 
``third party conformity assessment body'' as ``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 for children's product 
certification or periodic testing purposes.''

C. Proposed Subpart B--Reasonable Testing Program for Non-Children's 
Products

    Proposed subpart B would consist of one provision and would 
describe the ``reasonable testing program'' for non-children's 
products. For example, proposed Sec.  1107.10(a) would explain that, 
except as otherwise provided by a specific CPSC regulation or a 
specific standard prescribed by law, a manufacturer certifying a 
product pursuant to a reasonable testing program must ensure that the 
program ``provides a high degree of assurance that the consumer 
products covered by the program will comply with all applicable rules, 
bans, standards, or regulations.'' Proposed Sec.  1107.10(b) would 
state that a reasonable testing program must consist of five elements: 
(1) Product specification; (2) certification tests; (3) a production 
testing plan; (4) a remedial action plan; and (5) recordkeeping. The 
proposal would describe, in greater detail, the requirements for each 
element of the reasonable testing program.
    We received many comments on proposed subpart B. The comments 
addressed issues regarding the proposed provisions of a reasonable 
testing program on topics such as: product specifications, 
certification tests, samples for certification testing, production 
testing, remedial action, and recordkeeping. The commenters raised many 
concerns about the cost and burden of the proposal as well as practical 
issues, which illustrates the difficulty of drafting a regulation that 
can apply to many different types of products and manufacturing 
processes, yet still provide sufficient guidance to enable 
manufacturers to implement the requirements of a reasonable testing 
program effectively. Consequently, we are deferring action with respect 
to finalizing subpart B. We will reserve subpart B in the final rule 
and, except as stated otherwise in this preamble, continue evaluating 
the issues raised in the comments regarding a reasonable testing 
program. We note, however, that our deferral of action does not remove 
the responsibility of manufacturers, under section 14(a)(1) of the CPSA 
to certify based on tests of their products or based on reasonable 
testing programs that their products comply with all rules, bans, 
standards, or regulations applicable to such products.

D. Proposed Subpart C--Certification of Children's Products

    Proposed subpart C would contain the requirements for the 
certification of children's products. The proposed subpart C would 
consist of seven sections and would implement most requirements in 
section 14(i)(2)(B) of the CPSA.
1. General Comments
    Several commenters raised issues with respect to proposed subpart C 
generally, or on general concepts, such as testing.
    (Comment 14)--One commenter argued that the terms ``reasonable 
assurance'' and ``sufficient number of samples'' are likely to result 
in widely disparate interpretations. The commenter urged that 
``reasonable assurance'' should be defined as a statistically 
significant number with a confidence level of 95 percent, based on 
testing enough samples to provide statistical validity. The commenter 
said that setting a specific confidence limit would enable us to 
enforce this section by avoiding subjectivity and by creating 
uniformity and consistency among manufacturers and conformity 
assessment bodies.
    The commenter noted that ``upstream'' controls (i.e., processes, 
inspections, and tests conducted prior