Federal Register, Volume 77 Issue 234 (Wednesday, December 5, 2012)

[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 k^th 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