[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Rules and Regulations]
[Pages 72205-72219]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29204]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1107

[CPSC Docket No. CPSC-2011-0082]


Testing and Labeling Pertaining to Product Certification 
Regarding Representative Samples for Periodic Testing of Children's 
Products

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 to amend its regulations on testing and 
labeling pertaining to product certification. Pursuant to section 
14(i)(2)(B)(ii) of the Consumer Product Safety Act (CPSA), the final 
rule requires the testing of representative samples to ensure continued 
compliance of children's products with all applicable children's 
product safety rules. The final rule also establishes a recordkeeping 
requirement associated with the testing of representative samples.

DATES: To coincide with the effective date of 16 CFR part 1107, the 
final rule is effective on February 8, 2013, and it applies to products 
manufactured after that date.\1\
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    \1\ The Commission voted 2-1 to publish this final rule in the 
Federal Register. Chairman Inez M. Tenenbaum and Commissioner Robert 
S. Adler voted to publish the final rule. Commissioner Nancy A. Nord 
voted against publication of the final rule.

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?

    The final rule amends 16 CFR 1107.21 and 1107.26 of the 
Commission's regulation on testing and labeling pertaining to product 
certification in order to implement the statutory requirement in 
section 14(i)(2)(B) of the CPSA for the periodic testing of 
representative samples of children's products, as well as associated 
recordkeeping.

B. What does the law require?

    Section 14(a)(2) of the CPSA, 15 U.S.C. 2063(a)(2), requires 
manufacturers, including importers, and private labelers of any 
children's product that is subject to a children's product safety rule, 
to submit sufficient samples of the product, or samples that are 
identical in all material respects to the product, to a third party 
conformity assessment body whose 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, which certifies that such children's product 
complies with the children's product safety rule. 15 U.S.C. 
2063(a)(2)(B). A children's product certifier must issue 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 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)(2)(B), as 
originally provided in section 102 of the Consumer Product Safety 
Improvement Act of 2008 (CPSIA) prior to amendment, requires, in 
relevant part, that we 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,'' and the ``testing 
of random samples to ensure continued compliance.''
    In the Federal Register of May 20, 2010 (75 FR 28336), we published 
a proposed rule on ``Testing and Labeling Pertaining to Product 
Certification.'' The proposed rule was intended to implement parts of 
what was then known as section 14(d)(2)(B) of the CPSA (now renumbered 
section 14(i)(2)(B)) and to implement parts of section 14(a) of the 
CPSA. Proposed Sec.  1107.22, ``Random Samples,'' would have 
implemented the testing of random samples' requirement in the CPSA, by 
requiring each manufacturer of a children's product to select samples 
for periodic testing by using a process that assigns each sample in the 
production population an equal probability of being selected (75 FR at 
28349 through 28350, 28365).
    On August 12, 2011, the President signed into law Public Law 112-
28. Among other things, Public Law 112-28 changed the obligation for 
the testing of ``random samples'' to the testing of ``representative 
samples.'' Additionally, Public Law 112-28 corrected an editorial error 
in section 14 of the CPSA, by renumbering section 14(d) of the CPSA, 
``Additional Regulations for Third Party Testing,'' as section 14(i) of 
the CPSA.
    On November 8, 2011, we published a final rule in the Federal 
Register (76 FR 69482) for the testing and labeling rule, 16 CFR part 
1107, on those aspects of the rule left unchanged by Public Law 112-28. 
However, because Public Law 112-28 amended section 14(i)(2)(B)(ii) of 
the CPSA to require the testing of ``representative samples,'' the 
Commission deleted Sec.  1107.22 from the final rule on testing and 
labeling, and it issued a proposed rule (76 FR 69586), also on November 
8, to implement the new statutory requirement for the testing of 
representative samples.
    The Commission is now issuing a final rule amending 16 CFR 
1107.21(f) and 1107.26(a)(4) to implement the requirement to test 
``representative samples,'' pursuant to section 14(i)(2)(B)(ii) of the 
CPSA, as well as our implementing authority under section 3 of the 
CPSIA.

[[Page 72206]]

C. How does the final rule implement the law?

    The final rule amends Sec.  1107.21(f) to require a manufacturer to 
select representative product samples to be submitted to a third party 
conformity assessment body for periodic testing. The procedure used to 
select representative product samples for periodic testing must provide 
a basis for inferring compliance about the population of untested 
products produced during the applicable periodic testing interval. The 
number of samples selected for the sampling procedure must be 
sufficient to ensure continuing compliance with all applicable 
children's product safety rules. Moreover, a manufacturer must document 
the procedure used to select representative product samples for 
periodic testing and the basis for inferring the compliance of the 
product manufactured during the periodic testing interval from the 
results of the tested samples.
    The final rule also amends Sec.  1107.26(a)(4) to require a 
manufacturer of a children's product subject to an applicable 
children's product safety rule to maintain records documenting the 
testing of representative samples, including the number of 
representative samples selected and the procedure used to select 
representative samples. Records also must include the basis for 
inferring compliance of the product manufactured during the periodic 
testing interval from the results of the tested samples. Existing Sec.  
1107.26(b) requires that records be maintained for five years.

D. How do I comply with the requirement to periodically test 
representative samples?

1. Selecting Representative Samples
    Under the final rule, various methods can be used to determine that 
the selected samples are representative, depending upon on the rule, 
ban, standard, or regulation being evaluated. For example, for the 
chemical tests, a sample selected from a homogeneous material, such as 
a well-mixed container of paint, could be considered representative of 
the entire container. For discretely produced products, information 
indicating uniform materials and dimensional control could be used to 
indicate that a sample is representative of the product for mechanical 
tests. For example, if a bicycle handlebar sample is manufactured from 
the same grade of steel and with the same dimensions (e.g., wall 
thickness, length, shape, placement of holes for attaching brake 
levers) as other handlebars produced, then that handlebar sample can be 
considered representative of the population of handlebars for the 
purpose of complying with the handlebar stem test in 16 CFR 1512.18(g).
    Other methods may be used to establish that samples selected for 
periodic testing are representative--with respect to compliance--of the 
population of products manufactured since the last periodic test. 
Examples of such methods include: Inspecting incoming raw materials or 
component parts; generating process control data during product 
manufacture; and using manufacturing techniques with intrinsic 
manufacturing uniformity, such as die casting.
    Random sampling is another way of selecting representative samples 
that provides a basis for inferring the compliance of untested product 
units from the tested product units. The conditions that allow for the 
inference of compliance concerning untested units versus tested units 
may be met by a range of probability-based sampling designs, including, 
but not limited to, simple random sampling, cluster sampling, 
systematic sampling, stratified sampling, and multistage sampling. 
These methods allow the manufacturer the flexibility to select a random 
sampling procedure that is most appropriate for the manufacturer's 
product production setting but still allow for the inference about the 
compliance of the population of product units. For example, alternative 
sampling procedures--like systematic sampling (where a starting unit is 
randomly selected and then every kth unit after that is 
selected) or multistage sampling (where units are grouped in clusters, 
such as pallets, the clusters are randomly selected, and then units 
within the selected clusters are randomly drawn)--can be employed for 
products for which such sampling procedures would be beneficial. Even 
though every unit produced does not have the same probability of 
selection for testing in these examples, these techniques can be used 
to infer the compliance of the untested units. It should be noted, 
however, that just because random sampling can be used as one method of 
conducting representative testing, it is by no means the only method to 
meet the new broader ``representative'' sampling requirement in Public 
Law 112-28.
    With evidence that the samples submitted to a third party 
conformity assessment body are representative of the children's product 
produced since the last periodic test (or since product certification 
for the first periodic test interval), the manufacturer can infer the 
compliance of the untested units.
2. Determining Continued Compliance
    For the purposes of periodic testing, passing test results means 
the samples tested are in compliance with the applicable children's 
product safety rule. Most children's product safety rules require each 
product sample submitted to pass the prescribed tests. For example, 
each pacifier subjected to the guard and shield testing specified in 16 
CFR 1511.3 must pass the test. In a similar manner, each infant walker 
submitted for testing must pass the tests prescribed in 16 CFR part 
1216.
    However, for some children's product standards, compliance with the 
standard can include individual test results that exceed a specified 
maximum. For example, for children's products tested for compliance to 
16 CFR part 1611, Standard for the flammability of vinyl plastic film, 
the burn rate of 10 samples is averaged to determine if the average 
exceeds the maximum burn rate of 1.2 inches per second, as specified in 
16 CFR 1611.3. Because the maximum burn rate requirement in part 1611 
applies to the average burn rate of the 10 samples tested, it is 
possible for one or more of the tested samples to exceed the maxiumum 
burn rate when tested. In this example, if the average burn rate does 
not exceed 1.2 inches per second, the samples are considered to be in 
conformance with the standard and have passed the test.
    As another example, small carpets and rugs that are children's 
products are subject to the requirements for periodic testing. For 
small carpets and rugs, at least seven of the eight samples tested for 
compliance to 16 CFR part 1631, Standard for the surface flammability 
of small carpets and rugs (FF 2-70), must meet the test criterion 
specified in Sec.  1631.3(b). Alternatively, a small carpet or rug that 
does not meet the test criterion must be permanently labeled prior to 
its introduction into commerce. Small carpets and rugs that meet either 
condition would be considered to be in compliance with 16 CFR part 1631 
and deemed to have passed the periodic tests.
3. Creating and Maintaining Required Records
    Manufacturers must document periodic testing of representative 
samples. Documentation must include the number of representative 
samples selected, how the samples were selected, and the manufacturer's 
basis for inferring compliance of the untested

[[Page 72207]]

units during the testing interval, based on testing of the sampled 
units. Such documentation must be maintained for five years.

II. Comments on the Proposed Rule and CPSC's Responses

A. How many comments were received about the proposed rule?

    The comment period for the proposed rule closed on January 23, 
2012. Eight commenters responded. A summary of these comments and the 
Commission's responses are set forth below in section II.B of this 
preamble. Additionally, on November 8, 2011, a request for comments 
titled, Application of Third Party Testing Requirements; Reducing Third 
Party Testing Burdens, Docket CPSC-2011-0081, was published in the 
Federal Register (76 FR 69596). Some of the comments received in that 
docket also address the testing of representative samples. We summarize 
and respond to those comments in section II.B, as well, to ensure that 
all comments on representative samples were considered as part of this 
rulemaking, in addition to any suggestions for amending the final rule. 
After consideration of all the comments, however, no changes were made 
to the final rule.

B. What comments did the Commission receive?

    A summary of the commenters' topics is presented below, followed by 
staff's responses. For ease of reading, each comment will be prefaced 
with a numbered ``Comment''; and each response will be prefaced by a 
numbered ``Response.'' The numbering is for identification purposes 
only and does not imply the importance of the comment or the order in 
which it was received.
1. General Comments and Comments on Definitions
    (Comment 1)--A commenter welcomes the change from random sampling 
(in the 16 CFR part 1107 NPR) to representative sampling in the 
proposed rule because the proposed rule includes a variety of methods 
to assure compliance.
    (Response 1)--As long as the test results from the representative 
samples can infer compliance of the untested units of the children's 
product, a variety of means can be employed, at the manufacturer's 
discretion, to select samples for testing under the final rule.
    (Comment 2)--A commenter asserts that:

    There is no definition of ``representative''' in 16 CFR Part 
1107.26 (sic) of the notified draft Regulation, so it would likely 
lead to a misunderstanding in the implementation of the regulation. 
It is suggested that a clear definition of ``representative 
samples'' should be given so that the representative samples can be 
selected in a convenient and applicable way. Only in this way can 
the implementation of the regulation be more effective.

    (Response 2)--We agree with the commenter that a clear 
understanding of ``representative samples'' will help to implement the 
required periodic testing of such samples effectively. For this reason, 
we define a ``representative sample'' in proposed Sec.  1107.21(f) as 
one that provides the manufacturer with a basis for inferring the 
compliance of the untested units of the product population from the 
tested units. In other words, the manufacturer must have a basis for 
thinking that the units making up the sample to be tested (or the 
representative sample) are like the untested units of the children's 
product with respect to compliance to the applicable children's product 
safety rule. The final rule maintains this definition, which places 
responsibility on the manufacturer to choose representative samples in 
a manner that provides a basis for inferring the compliance of the 
untested product units.
    (Comment 3)--A commenter opines that the proposed rule defines 
``representative'' in a rigid way, and thereby re-creates the effect of 
``random'' as in the original wording of the CPSIA. The commenter 
asserts that the word ``representative'' does not require any 
clarification. The commenter suggests that the common meaning of the 
word ``representative'' is that the sample stands for the body of 
product being tested, and further suggests the following as an 
alternate definition of ``representative'':

a sample is ``representative'' when it is
    (a) produced in a manufacturing lot not known to be produced in 
a materially different manner than other production lots of the same 
item,
    (b) produced according to the usual, typical manufacturing 
procedures,
    (c) selected without attempting to ``game'' the testing 
protocol, and
    (d) is not otherwise known by the manufacturer to be 
unrepresentative in any material way which might result in 
misleading testing results.

    (Response 3)--No change to the final rule was made based on this 
comment. The commenter's proposed definition characterizes 
``representative'' samples as those units that are ``not known to be 
different'' from the untested units, as opposed to the Commission's 
characterization, which is that ``representative'' samples are those 
units that are ``known to be like'' the untested samples on the basis 
provided by the manufacturer. The Commission considered the commenter's 
alternative definition but regards this definition of ``representative 
sampling'' as an attempt to prove a negative, which cannot be done. A 
``not known to be different'' form of representative sampling does not 
provide a basis for knowing that the samples tested are similar to the 
untested units of the product. Without that basis, the testing results 
can indicate only the compliance of the samples actually tested and not 
the compliance of the untested product units. Without a means to infer 
compliance of the untested product units, the testing of ``not known to 
be different'' representative samples cannot ensure continued 
compliance, as required by section 14(i)(2)(B)(ii) of the CPSA.
    To ensure continued compliance, the Commission's approach is to 
require a manufacturer to have knowledge of the similarity of the 
tested samples to the untested units because the absence of knowledge 
of their differences is not sufficient to ensure continued compliance. 
Knowledge of the similarity of tested samples may come from prior 
testing, the manufacturer's knowledge of its product, production 
processes, quality control procedures, a production testing program, 
the materials used in the product, and/or the design of the product. So 
long as the manufacturer has a rational basis for inferring the 
similarity of the untested product to the tested samples, and documents 
this rationale, the manufacturer has met the requirements in the final 
rule.
    (Comment 4)--A commenter suggests that the CPSC define 
``representative samples'' based on what they are not. The commenter 
states that as long as a sample is not a ``golden sample,'' meaning 
that it was not manufactured to be different in any way from the rest 
of the produced samples, then it should be considered to be 
representative.
    The commenter reasons that noncompliant outliers may exist even in 
the most homogenous of manufacturing practices, and manufacturers may 
not be able to prove why a single test result was an outlier. However, 
the commenter adds that it is much easier to prove that the 
manufacturer performed the due diligence necessary to ensure they did 
everything possible to prevent the outlier from being created.
    The commenter opines that this clarification would in no way change 
the CPSC's definition of a ``representative sample.'' According to the 
commenter, all manufacturers would still have to be able to prove that 
a test result is representative of their

[[Page 72208]]

entire product line. Moreover, adds the commenter, such a clarification 
will give manufacturers the assurance needed to rely on their 
individual remedial action plans if a failure occurs due to an outlier 
that does not represent the entire product line. The commenter predicts 
that this interpretation will protect manufacturers from having to 
destroy many more products that may still be compliant, should testing 
reveal a noncompliance.
    (Response 4)--The Commission considered this alternative definition 
but regards this definition of ``representative sampling'' as an 
attempt to prove a negative, which cannot be done. A ``not a golden 
sample'' form of representative sampling does not provide a basis for 
knowing that the samples tested are similar to the untested units of 
the product. Without that basis, the testing results can indicate the 
compliance only of the samples actually tested and not the compliance 
of the untested product units. Without a means to infer compliance of 
the untested product units, the testing of ``not a golden sample'' 
representative samples cannot ensure continued compliance, as required 
by section 14(i)(2)(B)(ii) of the CPSA.
    The term ``golden sample'' would seem to suggest a sample that is: 
(1) Not known to be similar to the population of units produced, and 
(2) would have a greater likelihood of passing the required tests. 
However, the absence of those two traits does not make a sample 
representative based on the definition in the final rule. For example, 
if a sample was taken of the first 400 items from a production run of 
100,000, the sample selector may have no greater confidence before the 
test that these items would pass the test than items selected from 
later in the run or throughout the run. The first 400 items may be 
representative samples, however, if the manufacturer has a basis for 
inferring that the units are representative of the remaining 99,600 
units. Absent some independent basis for knowing that the remaining 
99,600 units are similar to the first 400 units of product from the 
run, this could be a sampling approach that could fail to be 
representative.
    A single test failure in a number of samples tested does not 
automatically mean that the production lot from which the samples were 
selected is not compliant, and therefore, must be reworked or 
destroyed. A failing test result means that the manufacturer does not 
have a high degree of assurance that all of the units from the 
production lot from which the sample was taken are compliant with the 
applicable children's product safety rule. Further investigation is 
needed for the manufacturer to determine whether the manufacturer can 
still have a high degree of assurance that the untested units are 
compliant. This investigation might include examining the testing 
procedures, calibrating the test instrumentation, testing additional 
samples, or other actions.
    (Comment 5)--A commenter states that the CPSC interprets the need 
to ``ensure'' compliance to mean that no exercise of judgment or good 
faith is allowed and that regulated companies must always be able to 
prove compliance. The commenter adds that the proposed rule rules out 
reliance on ``process,'' or even the absence of contrary indicators, to 
support a conclusion that samples are ``representative.''
    (Response 5)--No changes to the final rule were made based on this 
comment because the final rule does indeed allow and require 
manufacturers to exercise judgment and good faith in selecting 
representative samples. In fact, the entire third party testing regime 
set forth in 16 CFR parts 1107 and 1109 depends upon the exercise of 
``due care'' by all certifiers. ``Due care'' is a flexible concept, 
defined as ``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.'' 16 
CFR 1107.2 & 1109.4(g).
    Because of the multitude of different industries and children's 
products, the Commission adopted a flexible performance standard in 
implementing third party testing requirements. Determining what 
constitutes ``a high degree of assurance,'' and ``the exercise of due 
care,'' requires the exercise of business judgment in all aspects of 
testing. The Commission stated numerous times throughout the final 
testing rule that manufacturers are required to know about their 
products and they must implement a testing program accordingly. 
Sections 1107.20(b) and (d), 1107.21(b)(2), 1107.21(c)(1), and 
1107.23(a) of 16 CFR part 1107, all refer to the manufacturer's 
knowledge of the product and its fabrication in implementing sampling 
and testing plans, as well as other manufacturer actions intended to 
provide a high degree of assurance of compliance to the applicable 
children's product safety rules.
    The final rule requires regulated companies to be able to provide a 
basis for inferring the compliance of the untested production units 
from the tested samples. Without such a basis, the testing would serve 
no purpose other than to demonstrate the compliance of the tested 
units. However, the final rule does not rule out the use of 
``process.'' In fact, ``process'' can show that the samples selected 
for testing are like the untested units. For example, a process that 
manages the lots or batches of constituent materials of a children's 
product can be used as a basis for inferring homogeneity of the 
products with respect to the chemical tests for lead and phthalates. As 
another example, a process that creates uniformly spaced holes in the 
crib rails for the uniformly constructed crib slats can be used as a 
basis for inferring the homogeneity of that portion of the product when 
conducting the component spacing test of ASTM F1169-10.
    Standing alone, the absence of contrary indicators is not 
sufficient to infer compliance of the untested production units from 
the tested samples because this could include willful ignorance of the 
potential differences between the untested units and the tested 
samples. Such an approach would not likely meet minimum due care 
requirements.
2. Selecting Representative Samples
    (Comment 6)--A commenter desires that the CPSC continue to consider 
random sampling to be a subset of representative sampling. The 
commenter asserts that including random sampling methods allows the 
manufacturer the flexibility to select a random sampling procedure that 
is most appropriate for the manufacturer's product production setting 
but still allows for the inference about the compliance of the 
population of product units. The commenter further states that many 
companies proactively implemented random testing programs when the CPSC 
first proposed and supported such programs in December 2008, and the 
commenter wants the CPSC to continue to recognize this as an acceptable 
means of representative sampling.
    (Response 6)--No change to the final rule arises out of this 
comment because the final rule allows random sampling as a means to 
ensure representative sampling. The Commission agrees that random 
samples are a form of representative sampling because the test results 
of the tested units can be used to infer the compliance of the untested 
units of the children's product. The preamble to the proposed rule 
specifically states:

    Random sampling is another means of selecting representative 
samples that provide a basis for inferring the compliance of

[[Page 72209]]

untested product units from the tested product units. The conditions 
that allow for the inference of compliance concerning untested units 
versus tested units may be met by a range of probability-based 
sampling designs, including, but not limited to, simple random 
sampling, cluster sampling, systematic sampling, stratified 
sampling, and multistage sampling. These methods allow the 
manufacturer the flexibility to select a random sampling procedure 
that is most appropriate for the manufacturer's product production 
setting but still allow for the inference about the compliance of 
the population of product units.

76 FR 69586, 69587 (Nov. 8, 2011).

    (Comment 7)--One commenter is having difficulty understanding how 
to select a representative sample for periodic testing. The commenter's 
products consist of sets of component parts, each produced on a 
different date. Some of the finished products contain component parts 
that were manufactured more than a year ago. The commenter adds that 
their finished products consist of multiple variations of component 
parts from many production lots, resulting in no more than a few with 
the same set of component parts.
    (Response 7)--The purpose of periodic testing is to ensure 
compliance with all the applicable children's product safety rules for 
continued production of a children's product. Previously tested lots or 
batches of component parts do not require periodic testing. If a lot or 
batch of component parts was sampled and tested for certification 
purposes, those test reports remain valid for the remainder of the 
particular lot or batch. Continued production or importation of newly 
produced component parts (assuming no material changes) are subject to 
periodic testing. If a manufacturer or importer conducted certification 
testing on each new lot or batch of component parts, that testing would 
constitute, in essence, recertification of the finished product, based 
on tests of each batch or lot of the components, and therefore, 
periodic testing requirements might not apply.
    Continuing production of the component parts can have 
representative samples selected for periodic testing purposes. For 
example, if a component part continues to be produced or imported, and 
it is included in a children's product, representative samples of the 
component part could be tested to comply with the periodic testing 
requirements. Alternatively, representative samples of continued 
production of the finished product could be selected for periodic 
testing purposes.
    If the source of component parts changes (either a new supplier of 
a currently used component part or a component part that had not been 
used before), that would be a material change, necessitating 
certification testing to the children's product safety rules that could 
be affected by the material change.
    Another method of conducting periodic testing could involve random 
sampling and testing of the continued production of component parts or 
of the finished product. Random sampling is an acceptable means of 
selecting a representative sample.
    If varying combinations of component parts can affect the 
compliance of the finished product, then those combinations of 
component parts represent a material change that requires certification 
testing for each combination that is materially different.
    (Comment 8)--This comment was received in Docket CPSC-2011-0081. A 
commenter believes that knowledge from first party testing and/or 
second party testing can be used to develop sampling plans for third 
party testing that reduce the overall test burden, while still allowing 
the compliance of untested products to be inferred from the products 
tested by the third party conformity assessment body.
    (Response 8)--We interpret ``first party testing'' as testing 
conducted by the manufacturer and ``second party testing'' as testing 
conducted by a retailer to whom a manufacturer sells children's 
products. We agree with the commenter that the manufacturer's knowledge 
of a product, the applicable children's product safety rules, and the 
manufacturing process, combined with first or second party testing, can 
be used to determine the procedure for selecting representative 
samples. The combination of the factors listed above can be used to 
infer the compliance of the untested production units from the samples 
tested by a third party conformity assessment body.
3. Imported Products
    (Comment 9)--A commenter states that if the manufacturing process 
of a children's product is ``managed properly,'' then the first customs 
clearance article should be regarded as a representative sample.
    (Response 9)--We are not sure what the commenter means by ``first 
customs clearance article,'' but we will assume, for the purposes of 
this answer, that it means the first article manufactured outside of 
the United States that is cleared for entry and consumption by U.S. 
Customs and Border Patrol. If the article is a finished children's 
product subject to a children's product safety rule, it must be 
accompanied by a Children's Product Certificate based on testing by a 
CPSC-accepted third party conformity assessment body.
    If, by ``managed properly,'' the commenter means that the imported 
products are homogeneous with respect to compliance, then the first 
customs clearance article, assuming that it was tested by a CPSC-
accepted third party conformity assessment body, can be regarded as a 
representative sample. Under the final rule, the manufacturer or 
importer must be able to provide a basis for why it believes its 
products are homogeneous. A demonstration of homogeneity with respect 
to compliance would serve as a basis to show that the representative 
samples chosen for testing are like the untested production units.
    For example, if a manufacturer injection molded an item using 
plastic pellets from the same lot or batch, the manufacturer would be 
assured that, with respect to the chemical tests, the plastic items 
were homogeneous. As another example, if a manufacturer produced small 
balls, and the production process included an automatic test to reject 
balls small enough to pose a small parts hazard (perhaps by falling 
through a hole into a reject bin), then the manufacturer would have 
demonstrated homogeneity with respect to the small balls requirement. 
Because an imported children's product must comply with all of the 
applicable children's product safety rules, an importer, wishing to use 
the first customs clearance article as a representative sample, must 
also show how that sample is representative for all of the applicable 
tests, including those for which the finished product is required to 
assess compliance.
    (Comment 10)--This comment was received in Docket CPSC-2011-0081. 
Two commenters state that the CPSC should clarify that importers are 
not required to determine ``representative sampling'' procedures. One 
commenter recommends that the CPSC look at the definition of 
``manufacturer'' used in the Testing and Labeling Pertaining to Product 
Certification rulemaking. The commenter notes that 16 CFR 1107.2 
defines ``manufacturer'' as ``the parties responsible for certification 
of a consumer product pursuant to 16 CFR 1110.'' According to Sec.  
1110.7(a), when products are manufactured outside of the United States, 
the importer must issue a certificate of conformity. The commenters 
believe that some could read this to mean that a ``representative 
sampling'' procedure must be determined by the importer, even if

[[Page 72210]]

component part testing is conducted by suppliers. These commenters 
explain that many testing decisions are made upstream in the supply 
chain. Now that the CPSC accepts component part testing, these 
commenters contend that decisions related to testing intervals and 
sample size are appropriately made by the manufacturer ultimately 
responsible for production samples to be tested, regardless of the 
importation method. The commenters argue that while it is important 
that the finished product certifier exercises due care in their 
reliance on supplier certifications, this should not mean that the 
finished product certifier should necessarily dictate its suppliers' 
sampling procedures or that the importer of record should require 
duplicative testing.
    (Response 10)--If the importer is the party that issues the 
Children's Product Certificate for a product, it is that importer's 
responsibility to ensure that periodic testing is performed on the 
children's products they import that are subject to an applicable 
children's product safety rule. Under the component part testing rule, 
16 CFR part 1109, an importer can rely on test reports or certificates 
from another party as long as they (the importer) exercise due care.
    If an importer relies on certificates for component parts or 
finished products that are supplied by another party, such as a foreign 
manufacturer or a supplier, then it is the voluntary certifier of the 
component part or finished product who is responsible for periodic 
testing of representative samples for the component parts or finished 
products they certify, and not the importer. The importer must exercise 
due care to ensure that applicable testing is completed in an 
appropriate manner. However, if the importer arranges for periodic 
testing itself, the importer retains the responsibility for selecting 
and testing representative samples periodically to ensure continued 
compliance. Periodic testing, including representative sample 
selection, may be contracted to another party. If so contracted, the 
other party, called the ``testing party'' in the component part testing 
rule, 16 CFR part 1109 (e.g., a foreign manufacturer or distributor) 
must provide the basis that the samples selected for testing are 
representative.
    A manufacturer or importer issuing the Children's Product 
Certificate must still exercise due care in relying on another party's 
test reports or certifications.
    The Commission reminds the commenter that representative samples 
are selected for periodic testing, which is testing conducted on 
continuing production of a previously certified children's product. If 
each imported lot or batch of a children's product is third party 
tested and certified, then the periodic testing requirements might not 
apply. Lots or batches that are tested and certified would not 
represent continued production, even if the name or model number of the 
children's product did not change.
4. Periodic Testing of Component Parts
    (Comment 11)--A commenter suggests that the frequency of testing 
component parts needs to be considered with respect to the level of 
control exerted over product safety from other regulations with 
stricter limits on lead and heavy metals, and with respect to the 
business relationships they have with their suppliers. For example, the 
commenter considers it sufficient to test for conformity to ASTM F963, 
``Standard Consumer Safety Specification for Toy Safety,'' and total 
lead once every 2 years as a consequence of the strict specification on 
the raw materials used in their component parts.
    (Response 11)--If the commenter's phrase ``strict specification on 
the raw materials used in their component parts'' means a production 
testing plan as described in 16 CFR 1107.21(c)(2), then submitting 
representative samples to a third party conformity assessment body for 
periodic testing every 2 years is allowable, as long as it provides a 
high degree of assurance of compliance with all applicable children's 
product safety rules. Unless the manufacturer implements and documents 
a production testing plan (or uses an ISO/IEC 17025:2005-accredited 
first party testing laboratory for testing to ensure continued 
compliance), the maximum testing interval for periodic tests is one 
year. These periods are the maximum allowed interval. Periodic testing 
should be conducted at a frequency which, when combined with the 
manufacturer's other efforts at assuring continued compliance, gives 
the manufacturer a high degree of assurance of continued compliance.
    (Comment 12)--This comment was received in Docket CPSC-2011-0081. A 
commenter states that the manufacturer, working together with the 
factory, should determine representative sampling of products with a 
substantial number of different components, based on knowledge of the 
products, the applicable product safety standard, and the manufacturing 
processes that go into making the products.
    (Response 12)--We agree that the above-mentioned factors should be 
taken into account when selecting a representative sample for periodic 
testing purposes. The method used for selecting representative samples 
must be one that provides a basis for inferring the compliance of the 
untested production units from the test results of the tested samples. 
The manufacturer or importer of a children's product subject to a 
children's product safety rule retains the responsibility to ensure 
that periodic tests are conducted on representative samples. 
Representative sample selection and testing may be contracted to 
another party. If so contracted, the other party (e.g., a foreign 
manufacturer or distributor) must provide the basis for inferring the 
compliance of the untested production units based on testing of the 
selected representative samples. The manufacturer or importer issuing 
the Children's Product Certificate must still exercise due care in 
relying on another party's test reports or certifications.
    (Comment 13)--A commenter who manufactures multiple products from a 
set of common component parts states that the proposal for testing 
representative samples has an advantage for this product type. The 
representative sample can be assembled from common components across 
the product lines and each component tested according to the relevant 
safety concerns under the CPSIA.
    (Response 13)--This practice is acceptable under the final rule for 
tests that do not require the finished product for testing. For 
example, determining compliance to the use and abuse testing of toys 
described in Sec. Sec.  1500.50, 1500.51, 1500.52, and 1500.53 on 
representative samples of common component parts is likely to be 
unacceptable to determine compliance of a finished product to that 
standard. For the use and abuse tests, a finished product is necessary 
to conduct the tests.
    However, component part testing of representative samples for 
compliance to all children's product safety rules that do not require 
the finished product to assess compliance (such as the chemical tests) 
can be conducted. The passing test results for those component parts 
may be used to support children's product certification for finished 
products employing those component parts.
    (Comment 14)--A commenter recommends that 16 CFR 1107.21(c)(1) be 
amended to include explicit language allowing the use of component part 
testing for periodic testing purposes. The commenter states that 
specific regulatory language needs to be inserted into the text, or the 
commenter's customers may not include component

[[Page 72211]]

part testing in their contractual relationships with the commenter.
    (Response 14)--Section 16 CFR 1107.21(a) states: ``Component part 
testing pursuant to 16 CFR part 1109 may be used to support the 
periodic testing requirements of this section.'' Because the use of 
component part testing is allowed explicitly in Sec.  1107.21(a), 
repetition of this in Sec.  1107.21(c)(1) is unnecessary.
    (Comment 15)--The following comments on using component parts as 
representative samples were received in Docket CPSC-2011-0081. One 
commenter suggests that if a product can be proven to be composed of 
the same material throughout the end product, then a component could be 
submitted as a representative sample. The commenter adds that 
traceability would be important as there are ways that raw materials 
could be contaminated in the assembly.
    A second commenter provides an example of a representative sample 
with sampling from a construction set of 50 different physical 
component configurations injection molded with four different colors of 
polyvinyl chloride resin. The commenter states that a sample could be 
considered representative as long as all four colors of material were 
sampled and compliance with the lead substrate or phthalate limits 
could be established.
    A third commenter opines that as long as representative materials 
or components used in finished production can be sampled, such a 
process should be maintained as suitable for determining compliance 
with the lead-in-paint, lead substrate, and phthalate limits for toys 
and other child care articles. The commenter asserts that Congress 
clearly recognized the advantage of permissive use of ``representative 
sampling'' for the purpose of certifying compliance for like materials 
and components to these requirements.
    (Response 15)--The commenters are describing forms of component 
part testing used to meet the requirements of periodic testing. These 
practices are allowed by 16 CFR part 1109. For the chemical content 
tests, component part testing can be used for periodic test purposes. 
If the raw materials are tested for lead (and phthalates, if 
appropriate), then any products made from those raw materials can use 
the raw material test reports to support the products' Children's 
Product Certificates. Component part testing is not allowed for tests 
that require a finished product, such as use and abuse testing of toys 
described in Sec. Sec.  1500.50, 1500.51, 1500.52, and 1500.53.
5. Testing Costs
    (Comment 16)--This comment was received in Docket CPSC-2011-0081. 
One commenter states that changing the ``random'' sampling requirement 
to ``representative'' sampling will reduce the testing burden because, 
for some manufacturers, particularly suppliers of raw materials or 
components, or manufacturers of simple products, substantially similar 
products may be representative of the whole body of product to be 
certified.
    (Response 16)--The Commission agrees that changing ``random'' 
sampling to ``representative'' sampling has the potential to reduce the 
testing burden for manufacturers because more techniques for sample 
selection are available that can leverage the manufacturer's knowledge 
of the product and its production processes. Component part testing of 
raw materials for periodic testing purposes is one means by which a 
representative sample can be selected. For example, if the same lots or 
batches of raw materials were used to create several children's 
products, the results of the chemical tests for one of the products 
could be used to support the certification requirements of the other 
products.
    (Comment 17)--A commenter states that implementation of the new 
rules will impose a significant compliance cost on his company. The 
commenter asserts that the additional costs will not result in 
increased safety of his company's products and states that ``they were 
already safe.'' The commenter's additional compliance cost concerns 
pertain to rules promulgated since the CPSIA, in particular, 16 CFR 
part 1107, on testing and labeling pertaining to children's product 
certification, and not specifically to the proposed rule regarding the 
use of representative samples for periodic testing.
    (Response 17)--No change to the final rule was made based on this 
comment. Congress provided the CPSC with a third party testing regime 
to improve the safety of children's products. The final rule implements 
part of this testing regime. The Commission acknowledges that the cost 
of the testing required by 16 CFR part 1107 can be significant for some 
companies. The Commission also is considering other means to reduce 
third party testing burdens pursuant to section 14(i)(3) of the CPSA, 
which requires the Commission to seek and consider comments on 
opportunities to reduce third party testing burdens consistent with 
assuring compliance.
    (Comment 18)--A commenter states that the CPSC's rules for testing 
children's products are too complicated and costly, and that compliance 
with the rules is practically impossible. The commenter fears that 
``[t]he power of the agency to use violations of its rules to levy 
excessive fines and even attack via injunction ensures that it can 
dictate any outcome it wants.''
    (Response 18)--This rulemaking is limited to the use of 
representative samples for periodic testing of children's products 
covered by an applicable children's product safety rule. The final rule 
is intended to aid industry and the regulated community in 
understanding what is expected for the periodic testing of children's 
products.
6. Recordkeeping Requirements
    (Comment 19)--A commenter opines that the recordkeeping 
requirements of the proposed rule are excessive, uneconomical, and 
unreasonable. The commenter asserts: ``There is absolutely no safety 
benefit to this recordkeeping, nor will the records maintain (sic) help 
the agency figure out if there is a safety issue with the affected 
product.''
    (Response 19)--The Commission disagrees with the assertion that no 
safety benefit comes from recordkeeping. Because failure in the 
certification system of children's products could occur in many ways, 
recordkeeping can provide data to help identify the source of the 
failure. A safety benefit of the recordkeeping requirement is that, if 
noncompliant products are found in the marketplace, information is 
readily available that might help the manufacturer and the CPSC 
determine how such noncompliance occurred and its extent. Requiring 
manufacturers to provide a rationale for why their samples were chosen 
for periodic testing may help determine whether that rationale could 
have been a contributing factor in the incidence of noncompliant 
children's products being introduced into commerce.
    (Comment 20)--A commenter suggests that the Commission prove that:

    (a) Congress wanted all manufacturers to ESTABLISH that each and 
every sample was `representative,'
    (b) the required recordkeeping for proof that each testing 
sample is ``representative'' bears a rational relationship to the 
agency's mandate to keep the citizenry safe,
    (c) the devotion of resources to the activities described in the 
rule actually makes anyone safer, and
    (d) the benefits of the new rule outweigh its costs.

    (Response 20)--Section 2(a)(1) of Public Law 112-28 amended section

[[Page 72212]]

14(i)(2)(B)(ii) of the CPSA to state that the Commission shall, by 
regulation, establish protocols and standards ``for the testing of 
representative samples to ensure continued compliance.'' Because the 
text of the CPSA in this section explicitly calls for regulations to 
establish standards, we interpret that phrase to include establishing 
standards for representative samples.
    With regard to the commenter's suggestion regarding the 
relationship between recordkeeping and ``keeping the citizenry safe,'' 
the safety benefits of the recordkeeping requirement are described in 
the response to Comment 19 above. The recordkeeping requirements are 
intended to help prevent children's products from creating an 
unreasonable risk of death or injury for consumers.
    By enacting section 14(i)(2)(B)(ii) of the CPSA, Congress 
determined that establishing protocols and standards for periodic 
testing of representative samples of children's products are worthy of 
resources and they strengthen the safety of children's products.
    The Commission has provided an assessment of the impact of the rule 
on small businesses under the Regulatory Flexibility Act, but it is not 
required to conduct a cost-benefit analysis.
7. Comments Considered Outside the Scope of the Rulemaking
    (Comment 21)--A commenter proposes that they provide a Certificate 
of Conformity to the CPSC for each finished product distributed to the 
U.S. market that requires certification under the CPSIA. The commenter 
wants the CPSC to determine whether the commenter acted with due 
diligence with respect to product safety. The certificate would include 
references to component part tests.
    (Response 21)--The final rule is limited to the testing of 
representative samples for periodic testing of children's products. A 
request for the CPSC to evaluate certificates of conformity regarding 
due diligence is beyond the scope of this proposal.
    (Comment 22)--A commenter recommends that the Commission have a 
series of public meetings to review the concept of representative 
samples because of the enormous range of children's products subject to 
the rule. The commenter predicts that Commission guidance on an 
industry basis, over the range of products, would materially assist its 
member companies to comply.
    (Response 22)--This rulemaking is limited to the use of 
representative samples for periodic testing of children's products 
covered by an applicable children's product safety rule. However, the 
Commission will consider the request for public meetings or other 
guidance regarding the implementation of 16 CFR part 1107, as 
necessary, beyond the efforts taken, to date.

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 sets forth the 
Commission's regulation for meeting the requirement in section 
14(i)(2)(B)(ii) of the CPSA to test ``representative samples.'' 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(c)(2). 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 the Commission's final regulatory flexibility analysis for 
the final rule on representative samples for periodic testing of 
children's products.

A. Objective of the Final Rule

    The objective of the final rule is to reduce the risk of injury 
from consumer products, especially from products intended for children 
age 12 years and younger. The final rule will accomplish this objective 
by requiring manufacturers (including private labelers and importers of 
products manufactured by foreign manufacturers) to select the samples 
of children's products for periodic testing (which is be required by 16 
CFR 1107.21), using a procedure that provides a basis for inferring 
that if the selected samples comply with the applicable children's 
product safety rules, then the units not selected will also comply. In 
order to ensure compliance of all units produced, one must be able to 
infer the compliance of the untested units of a product from tests 
performed on the sampled units.

B. Comments on the Initial Regulatory Flexibility Act

    We received several comments regarding the initial regulatory 
flexibility analysis (IRFA), which we respond to below.
    (Comment 23)--One commenter states that the initial regulatory 
flexibility analysis was a ``[s]ham.'' The commenter argues that the 
``regulatory cost analysis is a whitewash, not a true arm's length 
analysis'' and that ``no company will be able to keep up with these 
rules, big or small.'' The commenter further states: ``[t]he new rules 
cannot be afforded by any but the biggest companies--and yet, it's the 
big companies that have caused the most notorious and dangerous recalls 
of Children's Products.'' The commenter opines that it is the small 
companies that will be impacted most adversely by the new rule. The 
commenter finally argues: ``[h]aving devoted pages to toting up how 
many companies would be affected by the rule and meaningless and 
inaccurate data on revenues of those companies, the authors then punt 
on the impact of the law.''
    (Response 23)--The Commission disagrees with the assertion that the 
IRFA for the proposed rule, which would establish requirements for the 
selection of representative samples, is a sham. As the commenter noted, 
the IRFA described the number and types of small entities that could be 
impacted by the proposed rule, the requirements that the rule would 
impose on small entities, and the types of costs small businesses might 
incur in meeting the requirements. However, the proposed rule did not 
specify the procedure that firms must use for selecting representative 
samples: It only required firms to use a procedure that would provide a 
basis for inferring compliance about the population of products 
manufactured during that period. Because the Commission did not know 
what procedures firms would use to meet the requirements of the 
proposed rule, or know to what extent the procedures used would differ 
from the procedures that firms would have used to select samples for 
periodic testing in the absence of the proposed rule, we were not able 
to quantify further the costs that the rule would have on small

[[Page 72213]]

businesses. The IRFA specifically requested comments on this issue.
    The only revenue data that was included in the IRFA was the average 
revenue reported by the U.S. Bureau of the Census for the very small, 
nonemployer businesses that could be impacted by the proposed rule. It 
is not known to what the commenter is referring when the commenter 
states that the IRFA contained meaningless and inaccurate data on the 
revenues of the affected companies. We agree that the proposed rule 
could have a disproportionate impact on small businesses. However, the 
commenter seems to be discussing the impacts of the general rule on 
testing and labeling pertaining to product certification, which was 
published in the Federal Register on November 8, 2011. The current 
rulemaking pertains only to the selection of samples for periodic 
testing and not to the requirements for testing and certification, in 
general.
    (Comment 24)--One commenter notes that two industries were omitted 
from the list of industries that could be impacted by the proposed rule 
in the IRFA. The two omitted industries were ``screen printing'' (NAICS 
code 323113) and ``digital printing'' (NAICS code 323115).
    (Response 24)--We agree that some manufacturers in the two 
industries referred to by the commenter could be impacted by the final 
rule. These industries have been added to the relevant table in the 
final regulatory flexibility analysis. Additionally, the tables have 
been updated to reflect the most current available data.
    (Comment 25)--One commenter states that the rule will have a 
tremendous negative economic impact on a substantial number of small 
entities, and that generally, when agencies request information 
regarding economic impact on small entities, cost and time estimates 
are provided. The commenter ``believe[s] that these costs will outweigh 
the paperwork and necessity of testing products that are well within 
the limits based on component part testing.'' The commenter further 
provides: ``The Commission needs to consider alternative testing 
strategies that allow the small business to incorporate and use current 
testing protocols that meet the same end goal: Ensuring that all 
products meet both the lead and phthalate content limits, as 
applicable.''
    (Response 25)--We agree that the final rule could have a negative 
economic impact on some small entities. The IRFA described the 
requirements of the proposed rule and the types of costs that firms 
subject to the rule might incur. However, because the proposed rule did 
not specify the procedure that firms must use for selecting 
representative samples, and because we did not know what procedures 
firms would use to meet the requirements of the proposed rule or to 
what extent the procedures used would differ from the procedures that 
firms would have used to select samples for periodic testing in the 
absence of the proposed rule, we were not able to quantify further the 
costs that the rule would have on small businesses. The notice of 
proposed rulemaking also contained an additional discussion of the 
potential costs associated with the recordkeeping requirements of the 
proposed rule.
    Although alternatives for reducing the costs associated with third 
party testing are not being addressed in this rulemaking, the 
Commission is examining alternatives for further reducing the costs 
associated with third party testing. Any alternatives that are 
identified may be addressed in future rulemakings, as needed.

C. Description of the Number of Small Entities to Which the Final Rule 
Will Apply

    By regulation (16 CFR part 1110), the Commission has determined 
that the domestic manufacturer or importer is responsible for ensuring 
that a consumer product is properly tested, and, based on the testing 
results, certifying that it conforms to all applicable consumer product 
safety rules. Therefore, it is the domestic manufacturer or importer 
who will be responsible for ensuring that representative samples of 
children's products that are subject to one or more children's product 
safety rules are tested to ensure continued compliance. The definition 
of a children's product is broad and includes bicycles, furniture, 
apparel, jewelry, televisions, electronic games, toys, and so on, if 
designed or intended primarily for a child 12 years of age or younger. 
Virtually all children's products are subject to one or more children's 
product safety rules. A full list of the children's product safety 
rules for which third party testing and certification will be required 
is provided in Table 1.

     Table 1--Product Safety Rules Applicable to Children's Products
------------------------------------------------------------------------
   16 CFR Part No. (or test method or
               standard)                           Description
------------------------------------------------------------------------
1420...................................  All-Terrain Vehicles.
1203...................................  Bicycle Helmets.
1512...................................  Bicycles.
1513...................................  Bunk Beds.
1500.86(a)(5)..........................  Clacker Balls.
1500.86(a)(7) and (8)..................  Dive Sticks and Other Similar
                                          Articles.
1505...................................  Electrically Operated Toys or
                                          Articles.
1615...................................  Flammability of Children's
                                          Sleepwear, Sizes 0 through 6X.
1616...................................  Flammability of Children's
                                          Sleepwear, Sizes 7 through 14.
1610...................................  Flammability of Clothing
                                          Textiles.
1632...................................  Flammability of Mattresses and
                                          Mattress Pads.
1633...................................  Flammability (Open-Flame) of
                                          Mattress Sets.
1611...................................  Flammability of Vinyl Plastic
                                          Film.
1219...................................  Full-Size Cribs.
1215...................................  Infant Bath Seats.
1216...................................  Infant Walkers.
Sec. 101 of CPSIA (Test Method CPSC-CH-  Lead Content in Children's
 E1001-08, CPSC-CH-E1001-08.1 or 2005     Metal Jewelry.
 CPSC Laboratory SOP).
Sec. 101 of CPSIA (Test Method CPSC-CH-  Lead Content in Children's
 E1001-08 or CPSC-CH-E1001-08.1).         Metal Products.
Sec. 101 of CPSIA (Test Method CPSC-CH-  Lead Content in Children's Non-
 E1002-08 and/or CPSC-CH-E1002-08.1).     Metal Products.
1303...................................  Lead Paint.

[[Page 72214]]

 
1220...................................  Non-Full-Size Cribs.
1511...................................  Pacifiers.
Sec. 108 of CPSIA (Test Method CPSC-CH-  Phthalate Content of Children's
 C1001-09.3 ).                            Toys and Child Care Articles.
1510...................................  Rattles.
1224...................................  Portable Bed Rails.
1501...................................  Small Parts Rule.
1630...................................  Surface Flammability of Carpets
                                          and Rugs.
1631...................................  Surface Flammability of Small
                                          Carpets and Rugs.
1217...................................  Toddler Beds.
(ASTM F963)............................  Toys.
------------------------------------------------------------------------

    The number of firms that could be impacted was estimated by 
reviewing every industry in the North American Industrial 
Classification System (NAICS) and selecting industries with firms that 
could manufacture or sell any children's product that could be covered 
by a consumer product safety rule. Firms are classified in the NAICS 
category that describes their primary activity. Therefore, firms that 
might manufacture or import consumer products covered by a safety rule 
as a secondary or tertiary activity may not have been counted. There is 
no separate NAICS category for importers. Firms that import products 
might be classified as manufacturers, wholesalers, or retailers.
1. Manufacturers
    According to the criteria established by the U.S. Small Business 
Administration (SBA), manufacturers are generally considered to be 
small entities if they have fewer than 500 employees. Table 2 shows the 
number of manufacturing firms by the NAICS categories that cover most 
children's products subject to a children's product safety rule. 
Although there are more than 26,000 manufacturers that would be 
considered small in these categories, not all of these firms are 
engaged in manufacturing children's products subject to a children's 
product safety rule. It would be expected that most of the firms 
engaged in Doll, Toy, and Game manufacturing produce some products that 
are intended for children age 12 and younger. On the other hand, the 
category Surgical Appliance and Supplies Manufacturing includes crash 
helmets, but most of the other products in this category are not under 
the CPSC's jurisdiction.

  Table 2--Number of Manufacturing Firms in Selected Product Categories
------------------------------------------------------------------------
    NAICS Code           Description        Small firms     Total firms
------------------------------------------------------------------------
31411.............  Carpet and Rug Mills             241             258
315...............  Apparel                        7,508           7,565
                     Manufacturing.
316211............  Rubber and Plastic                38              40
                     Footwear
                     Manufacturing.
316212............  House Slipper                      2               2
                     Manufacturing.
316219............  Other Footwear                    45              46
                     Manufacturing.
323113............  Commercial Screen              4,464           4,488
                     Printing.
323115............  Digital Printing....           2,326           2,357
326299............  All Other Rubber                 583             626
                     Product
                     Manufacturing.
336991............  Motorcycle, Bicycle,             417             422
                     and Parts
                     Manufacturing.
33712.............  Household and                  5,145           5,227
                     Institutional
                     Furniture
                     Manufacturing.
33791.............  Mattress                         398             410
                     Manufacturing.
339113............  Surgical Appliance             1,772           1,866
                     and Supplies
                     Manufacturing.
33991.............  Jewelry and                    2,369           2,382
                     Silverware
                     Manufacturing.
33992.............  Sporting and                   1,619           1,652
                     Athletic Goods
                     Manufacturing.
33993.............  Doll, Toy and Game               649             660
                     Manufacturing.
339942............  Lead Pencil and Art              123             129
                     Good Manufacturing.
339999............  All Other                      3,798           3,841
                     Miscellaneous
                     Manufacturing.
                   -----------------------------------------------------
                    Total Manufacturers.          31,497          31,971
------------------------------------------------------------------------
Source: U.S. Department of Commerce, Bureau of the Census, 2009 County
  Business Patterns, Number of Firms, Number of Establishments,
  Employment, and Annual Payroll by Enterprise Employment Size for the
  United States, All Industries: 2009. (available at http://www2.census.gov/econ/susb/data/2009/us_6digitnaics_2009.xls. Last
  accessed on 28 February 2012.)

    In addition to the manufacturers in Table 2, there were 25,184 
nonemployer businesses classified in NAICS 315 (Apparel Manufacturing), 
27,645 classified in NAICS 3231 (Printing and Related Support 
Activities), and 61,180 classified in NAICS 3399 (Other Miscellaneous 
Manufacturers) in 2008. Nonemployer businesses are generally very small 
businesses with no employees. They are generally sole proprietorships 
and may or may not be the owner's principal source of income. The 
average receipts for the nonemployer businesses classified in apparel 
manufacturing were about $31,000; for those classified in printing and 
related support activities, the average revenue was $49,424; and the 
average receipts for the nonemployer businesses classified other 
miscellaneous manufacturers were about $41,000.\2\ There is no 
information regarding the number of nonemployer

[[Page 72215]]

businesses that actually manufacture children's products.
---------------------------------------------------------------------------

    \2\ U.S. Department of Commerce, Bureau of the Census, ``Revised 
2008 Nonemployer Statistics Table.'' Available at http://www.census.gov/econ/nonemployer/Revised%202008%20Data%20With%202009%20Methodology%20Applied.xls 
(last accessed 16 August 2011).
---------------------------------------------------------------------------

2. Wholesalers
    Wholesalers would be impacted by the final rule if they import any 
children's product that is subject to a children's product safety rule. 
Wholesalers who obtain their products strictly from domestic 
manufacturers or from other wholesalers would not be impacted by the 
final rule because the manufacturer or importer would be responsible 
for certifying the products. Table 3 shows the number of wholesalers by 
NAICS code that would cover most children's products that are subject 
to a children's product safety rule. According to the SBA criteria, 
wholesalers are generally considered to be small entities if they have 
fewer than 100 employees. Although there are more than 78,000 
wholesalers that would be considered small in these categories, not all 
of these firms are engaged in importing children's products that are 
subject to a children's product safety rule. A significant proportion 
of the firms classified as Toy and Hobby Goods and Supplies Merchant 
Wholesalers probably import at least some children's products. However, 
the only firms classified as Motor Vehicle and Motor Vehicle Parts and 
Suppliers that would be impacted by the final rule are those that 
import all-terrain vehicles that are intended for children 12 year old 
or younger.

      Table 3--Number of Wholesalers in Selected Product Categories
------------------------------------------------------------------------
    NAICS Code           Description        Small firms     Total firms
------------------------------------------------------------------------
4231..............  Motor Vehicle and             16,815          17,776
                     Motor Vehicle Parts
                     and Suppliers.
4232..............  Furniture and Home            10,574          10,974
                     Furnishing Merchant
                     Wholesalers.
42362.............  Electrical and                 2,368           2,512
                     Electronic
                     Appliance,
                     Television, and
                     Radio Set Merchant
                     Wholesalers.
42391.............  Sporting and                   4,693           4,845
                     Recreational Goods
                     and Supplies
                     Merchant
                     Wholesalers.
42392.............  Toy and Hobby Goods            2,068           2,138
                     and Supplies
                     Merchant
                     Wholesalers.
42394.............  Jewelry, Watch,                7,162           7,234
                     Precious Stone, and
                     Precious Metal
                     Merchant
                     Wholesalers.
42399.............  Other Miscellaneous            8,816           9,054
                     Durable Goods
                     Merchant
                     Wholesalers.
42432.............  Men's and Boy's                3,375           3,515
                     Clothing and
                     Furnishings
                     Merchant
                     Wholesalers.
42433.............  Women's, Children's,           6,655           6,859
                     and Infant's
                     Clothing, and
                     Accessories
                     Merchant
                     Wholesalers.
42434.............  Footwear Merchant              1,435           1,498
                     Wholesalers.
42499.............  Other Miscellaneous           10,812          11,058
                     Nondurable Goods
                     Merchant
                     Wholesalers.
                   -----------------------------------------------------
                    Total Wholesalers...          74,773          77,463
------------------------------------------------------------------------
Source: U.S. Department of Commerce, Bureau of the Census, 2009 County
  Business Patterns, Number of Firms, Number of Establishments,
  Employment, and Annual Payroll by Enterprise Employment Size for the
  United States, All Industries: 2009. (available at http://www2.census.gov/econ/susb/data/2009/us_6digitnaics_2009.xls. Last
  accessed on 28 February 2012.)

    In addition to the wholesalers tabulated in Table 3, the U.S. 
Census Bureau estimated that there were 206,072 nonemployer businesses 
classified in NAICS categories that could include wholesalers of 
children's products. As noted above, nonemployer businesses are 
generally very small sole proprietorships. The average receipts for the 
nonemployer business wholesalers were about $86,000.\3\ An unknown 
number of nonemployer wholesalers could import children's products.
---------------------------------------------------------------------------

    \3\ U.S. Department of Commerce, Bureau of the Census, ``Revised 
2008 Nonemployer Statistics Table.'' Available at http://www.census.gov/econ/nonemployer/Revised%202008%20Data%20With%202009%20Methodology%20Applied.xls 
(last accessed 16 August 2011).
---------------------------------------------------------------------------

3. Retailers
    Retailers who obtain all of their products from domestic 
manufacturers or wholesalers will not be directly impacted by the final 
rule because the manufacturers or wholesalers would be responsible for 
the testing and certification of the children's products. However, 
there are some retailers who manufacture or directly import some 
products, and therefore, will be responsible for ensuring that these 
products are properly tested and certified. The number of such 
retailers is not known. Table 4 shows the number of retailers by NAICS 
code that would cover most children's products. According to SBA size 
standards, retailers are generally considered to be small entities if 
their annual sales are less than $7 million to $30 million, depending 
on the specific NAICS category. Because of the way in which the data 
were reported by the Bureau of the Census, the estimates of the number 
of small firms in each category in Table 4 are based on similar, but 
different criteria. Although there are more than 100,000 firms that 
would be considered to be small businesses in these categories, it is 
not known how many of these firms are engaged in importing or 
manufacturing children's products. Many of these firms probably obtain 
all of their products from domestic wholesalers or manufacturers and 
would not be directly impacted by the final rule.

                          Table 4--Number of Retailers for Selected Product Categories
----------------------------------------------------------------------------------------------------------------
                                                                   Criteria used
                                                     SBA size      for estimate
                                                     standard     of small firms
       NAICS Code              Description         (millions of    (millions of     Small firms     Total firms
                                                    dollars of      dollars of
                                                  annual sales)    annual sales)
----------------------------------------------------------------------------------------------------------------
441221..................  Motorcycle, ATV, and             <30               <25           4,794           4,879
                           Personal Watercraft
                           Dealers.
4421....................  Furniture Stores.....            <19               <10          16,033          16,611
44813...................  Children's and                   <30               <25           2,057           2,074
                           Infant's Clothing
                           Stores.
44814...................  Family Clothing                  <25.5             <25           6,588           6,684
                           Stores.
44815...................  Clothing Accessories             <14               <10           2,757           2,774
                           Stores.
44819...................  Other Clothing Stores            <19               <10           6,331           6,393

[[Page 72216]]

 
4482103.................  Children's &                     <25.5             <25             227             230
                           Juveniles' Shoe
                           Stores.
4482104.................  Family Shoe Stores...            <25.5             <25           2,905           2,941
45111...................  Sporting Goods Stores            <14               <10          14,388          14,545
45112...................  Hobby, Toy, & Game               <25.5             <25           4,612           4,629
                           Stores.
452.....................  General Merchandise              <30               <25           6,873           6,971
                           Stores.
45322...................  Gift, Novelty, and               <30               <25          19,297          19,339
                           Souvenir Stores.
454111..................  Electronic Shopping..            <30               <25          11,374          11,646
454113..................  Mail Order Houses....            <35.5             <25           5,281           5,645
4542....................  Vending Machine                  <10               <10           3,796           3,887
                           Operators.
                         ---------------------------------------------------------------------------------------
                          Total Retailers......  ...............  ..............         107.313         124,700
----------------------------------------------------------------------------------------------------------------
Source: U.S. Census Bureau, 2007 Economic Census, Retail Trade, Summary Statistics by Sales Size of Firms for
  the United States, Release date 11/02/2010.

    In addition to the retailers tabulated in Table 4, the U.S. Census 
Bureau estimated that there were 324,918 nonemployer businesses 
classified in NAICS categories that could include retailers of 
children's products. As noted above, nonemployer businesses are 
generally very small sole proprietorships. The average receipts for the 
nonemployer business retailers were about $40,000.\4\ An unknown number 
of nonemployer retailers could import children's products.
---------------------------------------------------------------------------

    \4\ U.S. Department of Commerce, Bureau of the Census, ``Revised 
2008 Nonemployer Statistics Table.'' Available at http://www.census.gov/econ/nonemployer/Revised%202008%20Data%20With%202009%20Methodology%20Applied.xls 
(last accessed 16 August 2011).
---------------------------------------------------------------------------

D. Compliance, Reporting, and Recordkeeping Requirements

    The final rule requires that children's product manufacturers 
select samples required for third party periodic testing (required by 
16 CFR 1107.21) using a procedure that provides a basis for inferring 
compliance about the population of untested products produced during 
the applicable periodic testing interval. The final rule requires 
further that the number of samples selected must be sufficient to 
ensure continuing compliance with all of the applicable children's 
product safety rules.
    In order to be able to infer the compliance of the untested 
products, the samples selected must be representative of the untested 
or unselected units in the population of products produced during the 
periodic testing interval. In other words, children's product 
manufacturers must have a basis for believing that if the samples 
selected for periodic testing show compliance with the applicable 
children's product safety rules, then one can infer the compliance of 
the untested units in the population. In many cases, a manufacturer's 
knowledge of the manufacturing processes or materials used may provide 
such information. For example, if the manufacturer knows that a product 
or component is manufactured using the same grade of material as all of 
the other units, and the production processes are controlled such that 
all of the dimensions are the same as all other units, then that 
product or component could be considered representative of all other 
units produced during the interval. Information that can be used to 
establish that a sample is representative can come from a variety of 
sources, including inspection of, or tests on, incoming materials or 
components and inspection, tests, and process-control data generated 
during production.
    Other methods of selecting representative samples include various 
probability-based sampling methods. These methods include simple random 
sampling, cluster sampling, systematic sampling, stratified sampling, 
and multistage sampling. Probability-based sampling methods allow 
statistical inferences to be made about the population of the products, 
based upon results of tests on the selected samples.
    The final rule requires that manufacturers document the procedures 
used to select the product samples for periodic testing and note the 
basis for their belief that the samples are representative of the 
untested product produced during the periodic testing interval. The 
records must be maintained for five years. The records can be 
maintained electronically or in hardcopy. The manufacturer must make 
the records available for inspection by the CPSC, upon request. The 
records may be maintained in languages other than English, if they can 
be provided immediately to the CPSC, upon request, and as long as the 
manufacturer can translate the records into English accurately within 
48 hours of a request to do so by the CPSC, or any longer period 
negotiated with CPSC staff.
    There will be some costs associated with developing and 
implementing sampling procedures that will result in the selection of 
representative samples. Some knowledge of subjects, such as statistics 
and quality control techniques, may be necessary to develop the 
procedure. Some manufacturers may have these skills in-house; others 
may need to hire consultants with these skills. There also may be some 
ongoing costs associated with selecting the representative samples once 
the procedures have been developed. There will also be some costs 
associated with documenting the procedure and maintaining the records 
that are required by the final rule. However, because there are 
potentially a wide range of methods for selecting representative 
samples, and we do not know which methods will be used by firms, the 
magnitude of the costs cannot be estimated.

E. Federal Rules That May Duplicate, Overlap, or Conflict With the 
Final Rule

    The final rule establishes requirements that must be met in 
selecting the samples of children's products for the periodic testing 
required by 16 CFR 1107.21. It does not duplicate, overlap, or conflict 
with other federal rules.

F. Steps Taken To Minimize the Adverse Economic Impact on Small 
Businesses

    The final rule establishes a performance standard rather than

[[Page 72217]]

mandates a specific procedure for selecting samples for periodic 
testing that all manufacturers must use. Manufacturers may use any 
procedure they choose for selecting samples for periodic testing as 
long as the procedure provides a basis for inferring compliance about 
the entire population of products manufactured during the applicable 
interval. Manufacturers are also free to change the procedures that 
they use to select samples, if they determine that a procedure 
different from the one they are using would be less costly, provided 
that the new procedure provides a basis for inferring compliance about 
the population of untested products produced during the applicable 
period.
    As discussed in the initial regulatory flexibility analysis, we 
considered less stringent alternatives for selecting representative 
samples, such as allowing manufacturers to select the samples using any 
procedure, provided that the procedure used would not purposively lead 
to the selection of samples that the manufacturer knows are more likely 
to comply with a standard or requirement than other samples (often 
referred to as ``golden samples''). We reexamined these alternatives 
during review of the public comments submitted in response to the 
notice of proposed rulemaking. Such alternatives were not adopted 
because we generally believe that it is necessary for manufacturers to 
have a positive basis for believing that the samples selected for 
periodic testing are, in fact, representative of the entire population 
of units produced during the applicable periodic testing interval. 
Using a ``not a golden sample'' form of representative sampling would 
require manufacturers to prove a negative, which cannot be implemented 
or enforced. The approach does not provide a basis for knowing that the 
samples tested are similar to the untested units of the product. 
Without that basis, the testing results can indicate the compliance 
only of the samples actually tested and not the compliance of the 
untested product units. Without a means to infer compliance of the 
untested product units, the testing of ``not a golden sample'' 
representative samples cannot ensure continued compliance, as required 
by section 14(i)(2)(B)(ii) of the CPSA.

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 November 8, 2011, Federal Register notice regarding 
the proposed rule (76 FR 69586, 69592-93), we described the information 
collection and the annual reporting burden. Our estimate includes 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 one comment on the burden estimates contained in the 
proposed rule.
    (Comment 26)--One commenter agrees with our estimate that it might 
take 4 hours per product or group of products to prepare the records 
required by the rule to document the procedures used to select 
representative samples and the basis for inferring the compliance of 
the untested products manufactured during the period. However, the 
commenter states that the estimated hourly cost of $50.08 was probably 
low and that a more accurate estimate was $75 per hour, given the 
likely involvement of lawyers and other professionals. The commenter 
also questions the assumption that manufacturers would use the same 
sampling plan for similar or closely related products or product lines. 
The commenter states that they thought it would be much more likely 
that a plan would be developed and documented for each item. The 
commenter also states that another 4 hours would be required for each 
test sample selected.
    (Response 26)--The hourly cost estimate of $50.08 in the proposed 
rule was based upon the average hourly cost for total employee 
compensation for all management, professional, and related workers in 
private industry, as reported by the Bureau of Labor Statistics as part 
of the ``Employer Costs for Employee Compensation data series. 
Therefore, the cost estimate we used assumed appropriately that the 
work would be done by management and professional employees. Of course, 
the costs for any particular businesses may be higher or lower than the 
average. We do not believe that the commenter provided sufficient 
information to change our approach for estimating the hourly cost of 
producing the records for documenting the selection of representative 
samples. However, the hourly cost estimate is being updated to reflect 
the most recent estimate reported by the Bureau of Labor Statistics, 
which is $50.41, as of September 2011.
    We agree with the commenter that some manufacturers may determine 
that they need to develop a separate sampling procedure for each 
children's product that they manufacture. The discussion in the notice 
of proposed rulemaking allowed for this possibility when it stated that 
in some cases, ``a manufacturer might have only one product in a 
particular product line.'' 76 FR 69592. However, we believe that other 
manufacturers may have multiple products in their product lines and 
determine that the same sampling procedure may be used for groups of 
similar or closely related products or product lines. As stated in the 
notice of proposed rulemaking, we do ``not have information on the 
number of closely related products or product lines that manufacturers 
offer or the average number of individual models within each set of 
closely related products or product lines.'' Id. Therefore, a range of 
possible values was used in estimating the recordkeeping burden, and 
the notice of proposed rulemaking invited comments from manufacturers 
and others to gain better insight on the potential recordkeeping burden 
of the proposed rule. This comment was the only one that addressed this 
issue. However, it did not provide sufficient information to change the 
assumptions we used in the notice of proposed rulemaking for estimating 
the recordkeeping burden.
    The commenter's statement that an additional 4 hours would be 
required for each test sample selected appears to be a reference to the 
amount of time associated with the other recordkeeping requirements of 
the final rule on testing and labeling pertaining to product 
certification (16 CFR part 1107), which was published in the Federal 
Register on November 8, 2011. Those recordkeeping costs were discussed 
in the Federal Register notice associated with that rulemaking (76 FR 
69537-40) and are not related to the current final rule on selecting 
representative samples.
    The information collection requirement associated with the final 
rule is summarized below.
    Title: Amendment to Regulation on Testing and Labeling Pertaining 
to Product Certification Regarding

[[Page 72218]]

Representative Samples for Periodic Testing of Children's Products
    Description of Respondents: Manufacturers of children's products.
    Description: The final rule would require records that describe how 
the samples for periodic testing are selected, the number of samples 
that will be selected, and an explanation of why the procedure 
described will result in the selection of representative samples, such 
that one can infer that the untested units produced during the periodic 
testing interval comply with the applicable children's product safety 
rules if the samples selected comply.
    We estimate the burden of this collection of information as 
follows: Although it might take a manufacturer several hours, perhaps 
several days to analyze its products and manufacturing processes to 
determine its options for selecting representative samples (and some 
might need to hire consultants for this purpose), the actual 
documentation of the procedure and basis for inferring compliance will 
probably take less time.
    On the assumption that because this document is required by 
regulation, manufacturers will make sure that the document is reviewed 
and edited properly, it could take an average of 4 hours to prepare 
this document, once the procedure that will be used is decided and the 
number of samples has been determined. Developing the sampling 
procedure and documenting it are managerial or professional functions. 
According to the Bureau of Labor Statistics, as of September 2011, 
total compensation for management, professional, and related 
occupations for all workers in private industry was $50.41 an hour. 
Therefore, the cost of creating the record documenting a procedure for 
selecting representative samples could be estimated to be about $202 
($50.41 x 4 hours).\5\
---------------------------------------------------------------------------

    \5\ Bureau of Labor Statistics, Employer Costs for Employee 
Compensation, Table 9 (September 2011). Available at: http://www.bls.gov/news.release/archives/ecec_12072011.htm.
---------------------------------------------------------------------------

    In developing the estimates of the recordkeeping burden associated 
with the testing and labeling pertaining to the certification of a 
children's products rule, we estimated that there were about 1.6 
million children's products. However, manufacturers probably will not 
need to develop and document a separate sampling procedure for each 
product. It might be more reasonable to believe that manufacturers will 
be able to use the same sampling plan for similar or closely related 
products or product lines. Therefore, manufacturers may need to develop 
and document separate sampling procedures for each set of closely 
related children's products or children's product lines rather than 
each individual product. For example, a manufacturer of die-cast toy 
cars might offer 50 different models, but if each one is manufactured 
using the same manufacturing processes and the same materials, one 
sampling plan for all die-cast cars by this manufacturer might be 
sufficient. We do not have information on the number of closely related 
products or product lines that manufacturers offer or the average 
number of individual models within each set of closely related products 
or product lines. In some cases, a manufacturer might have only one 
product in a particular product line. Some large manufacturers may 
offer several hundred models or styles within some product lines.
    A starting point to estimate the recordkeeping burden of the final 
rule is to assume that each product line averages 10 to 50 individual 
product models or styles. If each product line averages 50 individual 
models or styles, then a total of 32,000 individual sampling plans (1.6 
million children's products / 50 models or styles) would need to be 
developed and documented. This would require 128,000 hours (32,000 
plans x 4 hours per plan) at a total cost of approximately $6.5 million 
(128,000 hours x $50.41 per hour). If each product line averages 10 
individual models or styles, then a total of 160,000 different sampling 
plans (1.6 million children's products / 10 models or styles) would 
need to be documented. This would require 640,000 hours (160,000 plans 
x 4 hours per plan), at a total cost of approximately $32.3 million 
(640,000 hours x $50.41 per hour).
    Once a sampling plan is developed and documented, manufacturers 
will probably not incur the full cost of documenting their sampling 
plans in subsequent years because the same plan and documentation 
should be valid. However, each year, it is expected that manufacturers 
will retire some product lines and introduce new ones. Moreover, some 
manufacturers will leave the market, and other manufacturers will enter 
the market. Therefore, there will be some ongoing costs associated with 
documenting sampling plans.
    We do not have data on the number of new product lines introduced 
annually, whether from existing manufacturers or from new manufacturers 
entering a market. For purposes of this analysis, we will assume that 
about 20 percent of the children's product lines are new each year, 
either because an existing manufacturer has changed an existing product 
line to the extent that a new sampling plan is required, introduced a 
new product line, or because a new manufacturer has entered the market. 
If this is the case, then the ongoing recordkeeping costs associated 
with the final rule would be 25,600 hours (128,000 hours x 0.2) to 
128,000 hours (640,000 hours x 0.2) annually or approximately $1.3 
million (25,600 hours x $50.41 per hour) to approximately $6.5 million 
(128,000 hours x $50.41 per hour) annually.
    Another potential ongoing recordkeeping cost might result if 
manufacturers make adjustments or revisions to their sampling plans or 
procedures for their existing product lines. This might occur if 
manufacturers find that their initial procedures are difficult to 
implement or if they come up with more efficient methods of selecting 
representative samples. We do not have any information that could be 
used to estimate how often manufacturers will revise these plans. For 
purposes of this analysis, we will assume that this, too, would amount 
to about 20 percent of the burden estimated for the initial year, or 
approximately $1.3 million to $6.5 million annually.

VI. Executive Order 12988 (Preemption)

    Executive Order 12988 (February 5, 1996), requires agencies to 
state in clear language the preemptive effect, if any, of new 
regulations. The final rule would be issued under the authority of the 
CPSA and the CPSIA. The CPSA provision on preemption appears at section 
26 of the CPSA. The CPSIA provision on preemption appears at section 
231 of the CPSIA. The preemptive effect of this rule would be 
determined in an appropriate proceeding by a court of competent 
jurisdiction.

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 Commission stated in the proposed 
rule, at 76 FR 69593, that a final rule would become effective on the 
same date as the rule on ``Testing and Labeling Pertaining to 
Certification'' because Sec. Sec.  1107.21(f) and 1107.26(a)(4) on 
representative sampling are an amendment to that rule. Accordingly, the 
effective date of the final rule is February 8, 2013, and it applies to 
products manufactured after this date, to coincide with the effective 
date of 16 CFR part 1107.

[[Page 72219]]

List of Subjects in 16 CFR Part 1107

    Business and industry, Children, Consumer protection, Imports, 
Product testing and certification, Records, Record retention, Toys.

    Accordingly, the Commission amends 16 CFR part 1107 as follows:

PART 1107--TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION

0
1. The authority citation for part 1107 continues to read as follows:

    Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. L. 110-314, 122 
Stat. 3016, 3017, 3022.

Subpart C--Certification of Children's Products

0
2. Add paragraph (f) to Sec.  1107.21 to read as follows:


Sec.  1107.21  Periodic testing.

* * * * *
    (f) A manufacturer must select representative product samples to be 
submitted to the third party conformity assessment body for periodic 
testing. The procedure used to select representative product samples 
for periodic testing must provide a basis for inferring compliance 
about the population of untested products produced during the 
applicable periodic testing interval. The number of samples selected 
for the sampling procedure must be sufficient to ensure continuing 
compliance with all applicable children's product safety rules. The 
manufacturer must document the procedure used to select the product 
samples for periodic testing and the basis for inferring the compliance 
of the product manufactured during the periodic testing interval from 
the results of the tested samples.
* * * * *

0
3. Add paragraph (a)(4) to Sec.  1107.26 to read as follows:


Sec.  1107.26  Recordkeeping.

    (a) * * *
    (4) Records documenting the testing of representative samples, as 
set forth in Sec.  1107.21(f), including the number of representative 
samples selected and the procedure used to select representative 
samples. Records also must include the basis for inferring compliance 
of the product manufactured during the periodic testing interval from 
the results of the tested samples;
* * * * *

    Dated November 29, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-29204 Filed 12-4-12; 8:45 am]
BILLING CODE 6355-01-P