Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 72205 

1The 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. 

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2012. 

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Issued in Burlington, Massachusetts, on 

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Colleen M. D’Alessandro, 

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[FR Doc. 2012–29472 Filed 12–4–12; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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

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) 

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 

§ 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 § 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. 


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72206 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

C. How does the final rule implement 

the law? 

The final rule amends § 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 

§ 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 § 1107.26(b) 

requires that records be maintained for 

five years. 

D. How do I comply with the 

requirement to periodically test 

representative samples? 

1. Selecting Representative Samples 

Under the final rule, various methods 

can be used to determine that the 

selected samples are representative, 

depending upon on the rule, ban, 

standard, or regulation being evaluated. 

For example, for the chemical tests, a 

sample selected from a homogeneous 

material, such as a well-mixed container 

of paint, could be considered 

representative of the entire container. 

For discretely produced products, 

information indicating uniform 

materials and dimensional control could 

be used to indicate that a sample is 

representative of the product for 

mechanical tests. For example, if a 

bicycle handlebar sample is 

manufactured from the same grade of 

steel and with the same dimensions 

(e.g., wall thickness, length, shape, 

placement of holes for attaching brake 

levers) as other handlebars produced, 

then that handlebar sample can be 

considered representative of the 

population of handlebars for the 

purpose of complying with the 

handlebar stem test in 16 CFR 

1512.18(g). 

Other methods may be used to 

establish that samples selected for 

periodic testing are representative— 

with respect to compliance—of the 

population of products manufactured 

since the last periodic test. Examples of 

such methods include: Inspecting 

incoming raw materials or component 

parts; generating process control data 

during product manufacture; and using 

manufacturing techniques with intrinsic 

manufacturing uniformity, such as die 

casting. 

Random sampling is another way of 

selecting representative samples that 

provides a basis for inferring the 

compliance of untested product units 

from the tested product units. The 

conditions that allow for the inference 

of compliance concerning untested 

units versus tested units may be met by 

a range of probability-based sampling 

designs, including, but not limited to, 

simple random sampling, cluster 

sampling, systematic sampling, 

stratified sampling, and multistage 

sampling. These methods allow the 

manufacturer the flexibility to select a 

random sampling procedure that is most 

appropriate for the manufacturer’s 

product production setting but still 

allow for the inference about the 

compliance of the population of product 

units. For example, alternative sampling 

procedures—like systematic sampling 

(where a starting unit is randomly 

selected and then every kth unit after 

that is selected) or multistage sampling 

(where units are grouped in clusters, 

such as pallets, the clusters are 

randomly selected, and then units 

within the selected clusters are 

randomly drawn)—can be employed for 

products for which such sampling 

procedures would be beneficial. Even 

though every unit produced does not 

have the same probability of selection 

for testing in these examples, these 

techniques can be used to infer the 

compliance of the untested units. It 

should be noted, however, that just 

because random sampling can be used 

as one method of conducting 

representative testing, it is by no means 

the only method to meet the new 

broader ‘‘representative’’ sampling 

requirement in Public Law 112–28. 

With evidence that the samples 

submitted to a third party conformity 

assessment body are representative of 

the children’s product produced since 

the last periodic test (or since product 

certification for the first periodic test 

interval), the manufacturer can infer the 

compliance of the untested units. 

2. Determining Continued Compliance 

For the purposes of periodic testing, 

passing test results means the samples 

tested are in compliance with the 

applicable children’s product safety 

rule. Most children’s product safety 

rules require each product sample 

submitted to pass the prescribed tests. 

For example, each pacifier subjected to 

the guard and shield testing specified in 

16 CFR 1511.3 must pass the test. In a 

similar manner, each infant walker 

submitted for testing must pass the tests 

prescribed in 16 CFR part 1216. 

However, for some children’s product 

standards, compliance with the 

standard can include individual test 

results that exceed a specified 

maximum. For example, for children’s 

products tested for compliance to 16 

CFR part 1611, Standard for the 

flammability of vinyl plastic film, the 

burn rate of 10 samples is averaged to 

determine if the average exceeds the 

maximum burn rate of 1.2 inches per 

second, as specified in 16 CFR 1611.3. 

Because the maximum burn rate 

requirement in part 1611 applies to the 

average burn rate of the 10 samples 

tested, it is possible for one or more of 

the tested samples to exceed the 

maxiumum burn rate when tested. In 

this example, if the average burn rate 

does not exceed 1.2 inches per second, 

the samples are considered to be in 

conformance with the standard and 

have passed the test. 

As another example, small carpets 

and rugs that are children’s products are 

subject to the requirements for periodic 

testing. For small carpets and rugs, at 

least seven of the eight samples tested 

for compliance to 16 CFR part 1631, 

Standard for the surface flammability of 

small carpets and rugs (FF 2–70), must 

meet the test criterion specified in 

§ 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 


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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 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 § 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 


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72208 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

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 


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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 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 § 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 


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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 §§ 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 


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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 

§ 1107.21(a), repetition of this in 

§ 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 §§ 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 


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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 


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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–E1001–08, CPSC–CH– 

E1001–08.1 or 2005 CPSC Laboratory SOP).

Lead Content in Children’s Metal Jewelry. 

Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08 or CPSC–CH– 

E1001–08.1).

Lead Content in Children’s Metal Products. 

Sec. 101 of CPSIA (Test Method CPSC–CH–E1002–08 and/or CPSC– 

CH–E1002–08.1).

Lead Content in Children’s Non-Metal Products. 

1303 .......................................................................................................... Lead Paint. 


tkelley on DSK3SPTVN1PROD with 
72214 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

2U.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). 

TABLE 1—PRODUCT SAFETY RULES APPLICABLE TO CHILDREN’S PRODUCTS—Continued 

16 CFR Part No. (or test method or standard) Description 

1220 .......................................................................................................... Non-Full-Size Cribs. 

1511 .......................................................................................................... Pacifiers. 

Sec. 108 of CPSIA (Test Method CPSC–CH–C1001–09.3 ) .................. Phthalate Content of Children’s 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 Manufacturing ............................................................................................................... 7,508 7,565 

316211 ............ Rubber and Plastic Footwear Manufacturing ............................................................................. 38 40 

316212 ............ House Slipper Manufacturing ..................................................................................................... 2 2 

316219 ............ Other Footwear Manufacturing ................................................................................................... 45 46 

323113 ............ Commercial Screen Printing ....................................................................................................... 4,464 4,488 

323115 ............ Digital Printing ............................................................................................................................ 2,326 2,357 

326299 ............ All Other Rubber Product Manufacturing ................................................................................... 583 626 

336991 ............ Motorcycle, Bicycle, and Parts Manufacturing ........................................................................... 417 422 

33712 .............. Household and Institutional Furniture Manufacturing ................................................................ 5,145 5,227 

33791 .............. Mattress Manufacturing .............................................................................................................. 398 410 

339113 ............ Surgical Appliance and Supplies Manufacturing ........................................................................ 1,772 1,866 

33991 .............. Jewelry and Silverware Manufacturing ...................................................................................... 2,369 2,382 

33992 .............. Sporting and Athletic Goods Manufacturing .............................................................................. 1,619 1,652 

33993 .............. Doll, Toy and Game Manufacturing ........................................................................................... 649 660 

339942 ............ Lead Pencil and Art Good Manufacturing .................................................................................. 123 129 

339999 ............ All Other Miscellaneous Manufacturing ...................................................................................... 3,798 3,841 

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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 72215 

3U.S. Department of Commerce, Bureau of the 

Census, ‘‘Revised 2008 Nonemployer Statistics 

Table.’’ Available at http://www.census.gov/econ/ 

nonemployer/Revised%202008%20Data%20

With%202009%20Methodology%20Applied.xls 

(last accessed 16 August 2011). 

businesses that actually manufacture 

children’s products. 

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 Motor Vehicle Parts and Suppliers .............................................................. 16,815 17,776 

4232 ................ Furniture and Home Furnishing Merchant Wholesalers ............................................................ 10,574 10,974 

42362 .............. Electrical and Electronic Appliance, Television, and Radio Set Merchant Wholesalers ........... 2,368 2,512 

42391 .............. Sporting and Recreational Goods and Supplies Merchant Wholesalers ................................... 4,693 4,845 

42392 .............. Toy and Hobby Goods and Supplies Merchant Wholesalers .................................................... 2,068 2,138 

42394 .............. Jewelry, Watch, Precious Stone, and Precious Metal Merchant Wholesalers .......................... 7,162 7,234

42399 .............. Other Miscellaneous Durable Goods Merchant Wholesalers .................................................... 8,816 9,054 

42432 .............. Men’s and Boy’s Clothing and Furnishings Merchant Wholesalers .......................................... 3,375 3,515 

42433 .............. Women’s, Children’s, and Infant’s Clothing, and Accessories Merchant Wholesalers ............. 6,655 6,859 

42434 .............. Footwear Merchant Wholesalers ................................................................................................ 1,435 1,498 

42499 .............. Other Miscellaneous Nondurable Goods Merchant Wholesalers .............................................. 10,812 11,058 

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. 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

NAICS Code Description 

SBA size 

standard 

(millions of 

dollars of 

annual sales) 

Criteria used 

for estimate of 

small firms 

(millions of 

dollars of 

annual sales) 

Small firms Total firms 

441221 ............ Motorcycle, ATV, and Personal Watercraft Dealers ........ <30 <25 4,794 4,879 

4421 ................ Furniture Stores ................................................................ <19 <10 16,033 16,611 

44813 .............. Children’s and Infant’s Clothing Stores ............................ <30 <25 2,057 2,074 

44814 .............. Family Clothing Stores ..................................................... <25 .5 <25 6,588 6,684 

44815 .............. Clothing Accessories Stores ............................................ <14 <10 2,757 2,774 

44819 .............. Other Clothing Stores ....................................................... <19 <10 6,331 6,393 


tkelley on DSK3SPTVN1PROD with 
72216 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

4U.S. Department of Commerce, Bureau of the 

Census, ‘‘Revised 2008 Nonemployer Statistics 

Table.’’ Available at http://www.census.gov/econ/ 

nonemployer/Revised%202008%20Data%20

With%202009%20Methodology%20Applied.xls 

(last accessed 16 August 2011). 

TABLE 4—NUMBER OF RETAILERS FOR SELECTED PRODUCT CATEGORIES—Continued 

NAICS Code Description 

SBA size 

standard (millions of dollars 

of 

annual sales) 

Criteria used 

for estimate of 

small firms 

(millions of 

dollars of 

annual sales) 

Small firms Total firms 

4482103 .......... Children’s & Juveniles’ Shoe Stores ................................ <25 .5 <25 227 230 

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 Stores ............................................ <25 .5 <25 4,612 4,629 

452 .................. General Merchandise Stores ............................................ <30 <25 6,873 6,971 

45322 .............. Gift, Novelty, and Souvenir Stores ................................... <30 <25 19,297 19,339 

454111 ............ Electronic Shopping .......................................................... <30 <25 11,374 11,646 

454113 ............ Mail Order Houses ........................................................... <35 .5 <25 5,281 5,645 

4542 ................ Vending Machine Operators ............................................. <10 <10 3,796 3,887 

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. 

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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 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 


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72218 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

5Bureau of Labor Statistics, Employer Costs for 

Employee Compensation, Table 9 (September 2011). 

Available at: http://www.bls.gov/news.release/ 

archives/ecec_12072011.htm. 

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 × 4 hours).5

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 diecast 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 × 4 hours per plan) at a 

total cost of approximately $6.5 million 

(128,000 hours × $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 × 4 hours per plan), at a 

total cost of approximately $32.3 

million (640,000 hours × $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 × 0.2) to 128,000 hours 

(640,000 hours × 0.2) annually or 

approximately $1.3 million (25,600 

hours × $50.41 per hour) to 

approximately $6.5 million (128,000 

hours × $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 §§ 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. 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 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 

■ 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 

■ 2. Add paragraph (f) to § 1107.21 to 

read as follows: 

§ 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. 

* * * * * 

■ 3. Add paragraph (a)(4) to § 1107.26 to 

read as follows: 

§ 1107.26 Recordkeeping. 

(a) * * * 

(4) Records documenting the testing 

of representative samples, as set forth in 

§ 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 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Part 203 

[Docket No. FR–5679–N–01] 

Federal Housing Administration: 

Prohibited Sources of Minimum Cash 

Investment Under the National 

Housing Act—Interpretive Rule 

AGENCY: Office of the General Counsel, 

HUD. 

ACTION: Interpretive rule. 

SUMMARY: HUD is issuing this 

interpretive rule to clarify the scope of 

the provision in the National Housing 

Act that prohibits certain sources of a 

homebuyer’s funds for the required 

minimum cash investment for single 

family mortgages to be insured by the 

Federal Housing Administration (FHA). 

Uncertainty has arisen as to the effect of 

this provision on State and local 

governments and their agencies’ and 

instrumentalities’ homeownership 

programs that provide funds for the 

minimum cash investment. This rule 

provides HUD’s interpretation that this 

statutory provision does not remove the 

availability of FHA insurance for use in 

conjunction with State and local 

government programs that provide 

funds toward the required minimum 

cash investment. Although interpretive 

rules are exempt from public comment 

under the Administrative Procedure 

Act, HUD nevertheless invites public 

comment on the interpretation provided 

in this rule. 

DATES: Effective Date: November 29, 

2012. Comment Due Date: January 4, 

2013. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this rule to the Regulations Division, 

Office of General Counsel, Department 

of Housing and Urban Development, 

451 7th Street SW., Room 10276, 

Washington, DC 20410–0500. 

Communications must refer to the above 

docket number and title. There are two 

methods for submitting public 

comments. All submissions must refer 

to the above docket number and title. 

1. Submission of Comments by Mail. 

Comments may be submitted by mail to 

the Regulations Division, Office of 

General Counsel, Department of 

Housing and Urban Development, 451 

7th Street SW., Room 10276, 

Washington, DC 20410–0500. 

2. Electronic Submission of 

Comments. Interested persons may 

submit comments electronically through 

the Federal eRulemaking Portal at 

www.regulations.gov. HUD strongly 

encourages commenters to submit 

comments electronically. Electronic 

submission of comments allows the 

commenter maximum time to prepare 

and submit a comment, ensures timely 

receipt by HUD, and enables HUD to 

make them immediately available to the 

public. Comments submitted 

electronically through the 

www.regulations.gov Web site can be 

viewed by other commenters and 

interested members of the public. 

Commenters should follow the 

instructions provided on that site to 

submit comments electronically. 

Note: To receive consideration as public 

comments, comments must be submitted 

through one of the two methods specified 

above. Again, all submissions must refer to 

the docket number and title of the rule. 

No Facsimile Comments. Facsimile 

(FAX) comments are not acceptable. 

Public Inspection of Public 

Comments. All properly submitted 

comments and communications 

submitted to HUD will be available for 

public inspection and copying between 

8 a.m. and 5 p.m. weekdays at the above 

address. Due to security measures at the 

HUD Headquarters building, an 

appointment to review the public 

comments must be scheduled in 

advance by calling the Regulations 

Division at 202–708–3055 (this is not a 

toll-free number). Individuals with 

speech or hearing impairments may 

access this number via TTY by calling 

the Federal Relay Service at 800–877– 

8339. Copies of all comments submitted 

are available for inspection and 

downloading at www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Millicent Potts, Associate General 

Counsel for Insured Housing, Office of 

General Counsel, U.S. Department of 

Housing and Urban Development Room 

9226, 202–708–2212. Hearing or speech 

impaired individuals may access these 

numbers via TTY by calling the toll free 

Federal Relay Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The National Housing Act 

Prohibition on Certain Sources of Cash 

Investment 

To qualify a mortgage for FHA 

mortgage insurance, section 203(b)(9)(A) 

of the National Housing Act (12 U.S.C. 

1709(b)(9)) requires the homebuyer to 


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