69586 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 

1The Commission voted 5–0 to publish this 

notice of proposed rulemaking, with changes, in the 

Federal Register. Chairman Inez M. Tenenbaum, 

Commissioner Robert S. Adler, and Commissioner 

Thomas H. Moore issued a joint statement. 

Commissioner Nancy A. Nord issued a statement. 

The statements can be found at http:// 

www.cpsc.gov/pr/statements.html. 

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: Notice of proposed rulemaking. 

SUMMARY: The Consumer Product Safety 

Commission (‘‘CPSC,’’ ‘‘Commission,’’ 

or ‘‘we’’) is proposing to amend its 

regulations on testing and labeling 

pertaining to product certification. The 

proposed rule would address the testing 

of representative samples to ensure 

continued compliance of children’s 

products with all applicable rules, bans, 

standards, and regulations. The 

proposed rule also would establish a 

recordkeeping requirement associated 

with the testing of representative 

samples. We are taking this action to 

implement part of H.R. 2715 (Pub. L. 

112–28).1

DATES: Written comments must be 

received by January 23, 2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. CPSC–2011– 

0082, by any of the following methods: 

Electronic Submissions: Submit 

electronic comments in the following 

way: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

To ensure timely processing of 

comments, the Commission is no longer 

accepting comments submitted by 

electronic mail (email), except through: 

http://www.regulations.gov. 

Written Submissions: Submit written 

submissions in the following way: 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions), 

preferably in five copies, to: Office of the 

Secretary, Consumer Product Safety 

Commission, Room 820, 4330 East West 

Highway, Bethesda, MD 20814; 

telephone (301) 504–7923. 

Instructions: All submissions received 

must include the agency name and 

docket number for this proposed 

collection of information. All comments 

received may be posted without change, 

including any personal identifiers, 

contact information, or other personal 

information provided to: http:// 

www.regulations.gov. Do not submit 

confidential business information, trade 

secret information, or other sensitive or 

protected information electronically. 

Such information should be submitted 

in writing, with the sensitive portions 

clearly identified. 

Docket: For access to the docket to 

read background documents or 

comments received, go to: http:// 

www.regulations.gov. 

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 and Statutory Authority 

Section 14(a)(2) of the Consumer 

Product Safety Act (CPSA), 15 U.S.C. 

2063(a)(2), requires manufacturers and 

private labelers of any children’s 

product that is subject to a children’s 

product safety rule to submit samples of 

the product, or samples that are 

identical in all material respects to the 

product, to a third party conformity 

assessment body whose accreditation 

has been accepted by the CPSC to be 

tested for compliance with such 

children’s product safety rule. Based on 

that testing, the manufacturer or private 

labeler must issue a certificate that 

certifies that such children’s product 

complies with the children’s product 

safety rule. 15 U.S.C. 2063(a)(2)(B). 

CPSC regulations, at 16 CFR part 1110, 

limit the certificate requirement to 

importers and domestic manufacturers. 

The manufacturer or importer of the 

children’s product 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 such rule. This 

certificate is called a Children’s Product 

Certificate (‘‘CPC’’). 

Further, former section 14(d)(2)(B) of 

the CPSA, 15 U.S.C. 2063(d)(2)(B), as 

originally provided in section 102 of the 

Consumer Product Safety Improvement 

Act of 2008 (‘‘CPSIA’’), requires 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; 

• Testing of random samples to 

ensure continued compliance; 

• Verifying that a children’s product 

tested by a conformity assessment body 

complies with applicable children’s 

product safety rules; and 

• Safeguarding against the exercise of 

undue influence on a third party 

conformity assessment body by a 

manufacturer or private labeler. 

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 what was then known as 

section 14(d)(2)(B) of the CPSA and to 

implement parts of section 14(a) of the 

CPSA. Proposed § 1107.22, ‘‘Random 

Samples,’’ would implement 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 H.R. 2715 into law. Among other 

things, H.R. 2715 replaced the CPSA’s 

requirement for the testing of ‘‘random 

samples’’ with a requirement for the 

testing of ‘‘representative samples.’’ 

Additionally, H.R. 2715 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. 

Elsewhere in this Federal Register, 

we are publishing a final rule for part 

1107 on those aspects of the rule left 

unchanged by H.R. 2715. However, 

because H.R. 2715 amended the CPSA 

to require the testing of ‘‘representative 

samples,’’ we deleted § 1107.22 from the 

final rule, and we are issuing this 

proposed rule to implement the new 

statutory requirement for the testing of 

representative samples. Additionally, 

§ 1107.26 of the final rule establishes 

requirements pertaining to 

recordkeeping. We have reserved 

§ 1107.26(a)(4) in anticipation of a 

recordkeeping requirement related to 

representative samples. This proposed 

rule, therefore, would establish a new 

recordkeeping requirement for 

representative samples. 

We are issuing this proposed rule 

pursuant to section 14(i)(2)(B) of the 

CPSA, as well as its implementing 

authority pursuant to section 3 of the 

CPSIA. 

II. Description of the Proposed Rule 

The proposal would amend Title 16 of 

the Code of Federal Regulations: Part 

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Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 69587 

1107, titled ‘‘Testing and Labeling 

Pertaining to Product Certification.’’ The 

amendment would implement section 

14(i)(2)(B)(ii) of the CPSA, by amending 

§ 1107.21, ‘‘Periodic Testing.’’ The 

proposal would require that periodic 

testing be conducted using 

representative samples. Additionally, 

the proposal would amend § 1107.26 to 

include a recordkeeping provision 

related to testing representative 

samples. 

A. Proposed § 1107.21(f)—Testing 

Representative Samples 

The proposal would create a new 

§ 1107.21(f), which would state that a 

manufacturer must select representative 

product samples to be submitted to the 

third party conformity assessment body 

for periodic testing. We recognize that 

the proposed rule on ‘‘Testing and 

Labeling Pertaining to Product 

Certification’’ (75 FR 28336 (May 20, 

2010)) would have treated ‘‘Random 

Samples’’ as a distinct section, rather 

than as a subparagraph within 

§ 1107.21, ‘‘Periodic Testing.’’ However, 

because we have treated the 

requirement in section 14(i)(2)(B)(ii) of 

the CPSA as part of the periodic testing 

process, the proposed rule would place 

a requirement for the testing of 

representative samples in § 1107.21, 

rather than create a separate section. 

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 of the applicable 

children’s product safety rules. 

Manufacturers must document the 

procedure used to select the product 

samples for periodic testing and 

document the basis for inferring the 

compliance of the product 

manufactured during the periodic 

testing interval from the results of the 

tested samples. 

Proposed § 1107.21(f) would 

implement the requirement to test 

representative samples, by requiring 

each manufacturer of a children’s 

product to select samples for periodic 

testing known to be representative of the 

population of products manufactured 

since the last periodic test occurred (or 

since certification for the first periodic 

tests). In order for the test results of the 

samples submitted to a third party 

conformity assessment body to infer 

compliance of the untested units of the 

children’s product, the manufacturer 

must have knowledge that the tested 

samples are, indeed, representative of 

the product produced. Haphazard 

methods of sample selection cannot 

provide a basis for inferring the 

compliance of the untested units 

without additional information 

indicating that the samples are 

representative. 

1. Representative Samples 

Representative samples of a children’s 

product selected for testing are 

comparable to the unselected portion of 

the children’s product population with 

respect to compliance to the applicable 

children’s product safety rule(s). To be 

representative, the manufacturer must 

have a basis for inferring that, had other 

samples been chosen for testing, test 

results from those samples would have 

indicated the same compliance or 

noncompliance to the applicable 

children’s product safety rule as the 

representative samples. 

Determining that the selected samples 

are representative may be achieved in 

many ways, 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 wellmixed 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, 

that handlebar sample can be 

considered representative of the 

population of handlebars for the 

purpose of the complying with the 

handlebar stem test in 16 CFR 

1512.18(g). 

Other methods that 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: Incoming 

inspection of raw materials or 

component parts; process control data 

generated during product manufacture; 

and use of manufacturing techniques 

with intrinsic manufacturing 

uniformity, such as die casting. 

Random sampling is another means of 

selecting representative samples that 

provide 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 in 

H.R. 2715. 

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. Testing To Ensure 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 

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69588 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 

CFR part 1611, Standard for the 

flammability of vinyl plastic film, 10 

samples are averaged to determine if the 

maximum burn rate exceeds 1.2 inches 

per second, as specified in 16 CFR 

1611.3. Because the maximum burn rate 

applies to the average, it is possible for 

one or more of the tested samples to 

exceed that burn rate when tested. In 

this circumstance, 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. 

B. Proposed § 1107.26(a)(4)— 

Recordkeeping 

Proposed § 1107.26(a)(4) would 

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, as set 

forth in proposed § 1107.21(f) on 

periodic testing, 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. 

The recordkeeping requirement for 

the testing of representative samples is 

intended to allow manufacturers to 

demonstrate continued compliance by 

establishing how the samples selected 

are representative of the population of 

products manufactured during the 

periodic testing interval and how the 

manufacturer can infer compliance of 

all products produced during this 

interval based on such testing. 

III. Environmental Considerations 

This proposed rule falls within the 

scope of the Commission’s 

environmental review regulations at 16 

CFR 1021.5(c)(2), which provide a 

categorical exclusion from any 

requirement for the agency to prepare an 

environmental assessment or 

environmental impact statement for 

product certification rules. 

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 Commission is proposing this 

rule in order to implement Section 

14(i)(2)(B)(ii) of the CPSA. As originally 

enacted in 2008, this provision required 

the Commission to promulgate a 

regulation to establish protocols and 

standards for the testing of ‘‘random 

samples’’ to ensure that children’s 

products continue to comply with all 

applicable children’s product safety 

rules. H.R. 2715, which was enacted on 

August 12, 2011, amended the provision 

by substituting the term 

‘‘representative’’ for the term ‘‘random,’’ 

in describing the samples that must be 

tested. 

A. Objectives of the Rule 

The objective of the rule is to reduce 

the risk of death and injury from 

consumer products, especially from 

products intended for children aged 12 

years and younger. The proposed rule 

would accomplish this objective by 

requiring that manufacturers select the 

samples of children’s products for 

periodic testing (which will be required 

by 16 CFR 1107.21), using a procedure 

that results in the selection of samples 

from a population that is representative 

of the unselected products and 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. 

(The term ‘‘manufacturer,’’ for purposes 

of this proposed rule, includes private 

labelers and importers of products 

manufacturer by foreign manufacturers.) 

Being able to infer the compliance of the 

untested units is how the continued 

compliance of the product is ensured. 

B. Small Entities to Which the Rule Will 

Apply 

By regulation (16 CFR part 1110), the 

domestic manufacturer or importer is 

responsible for ensuring that a 

consumer product is properly tested, 

and, based upon the testing results, 

certifying that the product conforms to 

all applicable consumer product safety 

rules. Therefore, the domestic 

manufacturer or importer 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 given 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. 

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Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 69589 

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

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

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. 

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. 

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 whose 

firms 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. 

C. 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 that are subject to a 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 that 

are 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 Surgical Appliance and Supplies 

Manufacturing category includes crash 

helmets, but most of the other products 

in this category are not under the 

CPSC’s jurisdiction. 

TABLE 2—MANUFACTURERS

NAICS Code Description Small firms Total firms 

31411 ........................ Carpet and Rug Mills ........................................................................................................ 244 262 

315 ............................ Apparel Manufacturing ...................................................................................................... 7,126 7,195 

316211 ...................... Rubber and Plastic Footwear Manufacturing ................................................................... 43 45 

316212 ...................... House Slipper Manufacturing ........................................................................................... 1 1 

316219 ...................... Other Footwear Manufacturing ......................................................................................... 53 54 

326299 ...................... All Other Rubber Product Manufacturing ......................................................................... 622 666 

336991 ...................... Motorcycle, Bicycle, and Parts Manufacturing ................................................................. 447 452 

33712 ........................ Household and Institutional Furniture Manufacturing ....................................................... 6,058 6,154 

33791 ........................ Mattress Manufacturing .................................................................................................... 427 441 

339113 ...................... Surgical Appliance and Supplies Manufacturing .............................................................. 1,817 1,916 

33991 ........................ Jewelry and Silverware Manufacturing ............................................................................. 2,470 2,484 

33992 ........................ Sporting and Athletic Goods Manufacturing ..................................................................... 1,707 1,748 

33993 ........................ Doll, Toy and Game Manufacturing ................................................................................. 694 705 

339942 ...................... Lead Pencil and Art Good Manufacturing ........................................................................ 124 129 

339999 ...................... All Other Miscellaneous Manufacturing ............................................................................ 4,646 4,695 

Total Manufacturers ................................................................................................... 26,479 26,947 

Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, 

Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. Available at: http:// 

www2.census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011. 

In addition to the manufacturers in 

Table 3, there were 25,184 nonemployer 

businesses classified in NAICS 315 

(Apparel Manufacturing) and 61,180 

classified in NAICS 3399 (Other 

Miscellaneous Manufacturers) in 2008. 

Nonemployer businesses are generally 

very small businesses with no 

employees. They are typically sole 

proprietorships, and they may or may 

not constitute the owner’s principal 

source of income. The average receipts 

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2U.S. Department of Commerce, Bureau of the 

Census, ‘‘Revised 2008 Nonemployer Statistics 

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

nonemployer/Revised%202008%20

Data%20With%202009%20Methodology

%20Applied.xls (last accessed 16 August 2011). 

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%20With

%202009%20Methodology%20Applied.xls (last 

accessed 16 August 2011). 

for the nonemployer businesses 

classified in Apparel Manufacturing 

was about $31,000, and the average 

receipts for the nonemployer businesses 

classified as Other Miscellaneous 

Manufacturers was about $41,000.2

D. Wholesalers 

Wholesalers would be impacted by 

the rule if they import any children’s 

product that is subject to a product 

safety rule. Wholesalers who obtain 

their products strictly from domestic 

manufacturers or from other wholesalers 

would not be impacted by the 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 product safety rule. 

According to 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—WHOLESALERS

NAICS Code Description Small firms Total firms 

4231 .......................... Motor Vehicle and Motor Vehicle Parts and Suppliers .................................................... 17,734 18,769 

4232 .......................... Furniture and Home Furnishing Merchant Wholesalers .................................................. 11,353 11,844 

42362 ........................ Electrical and Electronic Appliance, Television, and Radio Set Merchant Wholesalers 2,444 2,591 

42391 ........................ Sporting and Recreational Goods and Supplies Merchant Wholesalers ......................... 5,019 5,196 

42392 ........................ Toy and Hobby Goods and Supplies Merchant Wholesalers .......................................... 2,227 2,302 

42394 ........................ Jewelry, Watch, Precious Stone, and Precious Metal Merchant Wholesalers ................ 7,363 7,447

42399 ........................ Other Miscellaneous Durable Goods Merchant Wholesalers .......................................... 9,040 9,302 

42432 ........................ Men’s and Boy’s Clothing and Furnishings Merchant Wholesalers ................................. 3,557 3,722 

42433 ........................ Women’s, Children’s, and Infant’s Clothing, and Accessories Merchant Wholesalers ... 6,797 7,029 

42434 ........................ Footwear Merchant Wholesalers ...................................................................................... 1,521 1,593 

42499 ........................ Other Miscellaneous Nondurable Goods Merchant Wholesalers .................................... 11,203 11,490 

Total Wholesalers ...................................................................................................... 78,258 81,285 

Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, 

Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. (Available at: http://www2.

census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011. 

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. 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. 

E. Retailers 

Retailers that obtain all of their 

products from domestic manufacturers 

or wholesalers will not be directly 

impacted by the rule because the 

manufacturers or wholesalers would be 

responsible for the testing and 

certification of the children’s products. 

However, there are some retailers that 

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 

rule. 

TABLE 4—RETAILERS

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 

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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%20With%

202009%20Methodology%20Applied.xls (last 

accessed 16 August 2011). 

TABLE 4—RETAILERS—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 

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 

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 Store ........................ < 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, 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. 

Nonemployer businesses are generally 

very small sole proprietorships. The 

average receipts for the nonemployer 

business wholesalers were about 

$40,000.4 An unknown number of 

nonemployer wholesalers could import 

children’s products. 

F. Compliance, Reporting, and 

Recordkeeping Requirements of 

Proposed Rule 

The proposed rule would require that 

children’s product manufacturers select 

representative samples required for the 

third party periodic testing (required by 

16 CFR 1107.21) to be selected using a 

procedure that provides a basis for 

inferring compliance about the 

population of untested products 

produced during the applicable periodic 

testing interval. The proposed rule 

would further require that the number 

of samples selected must be sufficient to 

ensure continuing compliance with all 

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. 

Haphazard or nonpurposive methods 

of sample selection cannot provide a 

basis for believing that the samples are 

representative without additional 

information. In many cases, a 

manufacturer’s knowledge of the 

manufacturing processes or materials 

used in the process 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 if the production processes 

are controlled such that the all 

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, as 

well as inspection, tests, and processcontrol 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 one to make 

statistical inferences about the 

population of the products, based upon 

results of tests on the selected samples. 

The proposed rule would require that 

manufacturers document the procedures 

used to select the product samples for 

periodic testing and document the basis 

for that 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 provided that the manufacturer can 

translate them accurately into English 

within 48 hours—or any longer period 

negotiated with CPSC staff, upon a 

request by the CPSC to translate the 

records. 

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 even though the Commission 

has not mandated the use of statistical 

sampling techniques. Some 

manufacturers may have these skills inhouse; others may need to hire outside 

consultants with these skills. There also 

may be some ongoing costs associated 

with selecting the representative 

samples once the procedures have been 

developed. There also would be some 

costs associated with documenting the 

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69592 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 

5Bureau of Labor Statistics, Employer Costs for 

Employee Compensation, Table 9 (March 2011). 

Available at: http://www.bls.gov/ncs. 

procedure and maintaining the records 

that would be required by the proposed 

rule. We invite comment on these costs 

and other impacts that the proposed 

rule could have on manufacturers. 

G. Alternatives for Reducing the 

Adverse Impact on Small Businesses 

The Regulatory Flexibility Act 

requires agencies to consider 

alternatives to proposed rules that 

would accomplish the stated objectives 

of the applicable statutes and that 

would reduce the economic impact on 

small entities. At a minimum, agencies 

must consider: 

1. The establishment of differing 

compliance or reporting requirements 

that take into account the resources 

available to small businesses; 

2. The clarification, consolidation, or 

simplification of compliance and 

reporting requirements for small 

entities; 

3. The use of performance rather than 

design standards; and 

4. An exemption from coverage of the 

rule, or any part of the rule thereof, for 

small entities. 

One alternative we considered was to 

propose less stringent alternatives for 

selecting representative samples. One 

alternative would be to allow 

manufacturers to select the samples 

using any method, provided that the 

method used would not purposively 

lead to the selection of samples that the 

manufacturers knows are more likely to 

comply with a standard or requirement 

than other samples, or select samples 

that are manufactured and chosen 

specifically to comply with a standard 

or requirement (often referred to as 

‘‘golden samples’’). For example, 

manufacturers could pull randomly or 

nonpurposively the samples for periodic 

testing from their finished goods 

inventory or from the next lot or batch 

when the periodic testing needs to be 

completed. 

This alternative was not incorporated 

in the proposed rule because we think 

that it is necessary for the manufacturer 

to have a positive basis for their belief 

that the samples selected for periodic 

testing are, in fact, representative of the 

entire population of units produced 

during the periodic testing interval. If 

the manufacturer does not have a basis 

for believing that the samples selected 

are representative, then the ability to 

make inferences regarding the 

compliance of the untested units 

produced during the interval is limited, 

and the continued compliance, as stated 

in § 14(i)(2)(B)(ii) of the CPSA, cannot 

be ensured. 

We invite comments on these or any 

other alternatives to the proposed rule 

that could reduce the impact on small 

businesses. In providing such 

comments, we request that the 

comments provide specific suggestions 

and well-developed justifications for the 

suggestions. 

V. Paperwork Reduction Act 

This proposed 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). We describe the provisions in 

this section of the document with an 

estimate of 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 invite comments 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. 

Title: Amendment to Regulation on 

Testing and Labeling Pertaining to 

Product Certification Regarding 

Representative Samples for Periodic 

Testing of Children’s Products 

Description: The proposed 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. 

Description of Respondents: 

Manufacturers of children’s products. 

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 would be 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 March 2011, total 

compensation for management, 

professional, and related occupations 

for all workers in private industry was 

$50.08 an hour. Therefore, the cost of 

creating the record documenting a 

procedure for selecting representative 

samples could be estimated to be about 

$200 ($50.08 × 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 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 proposed 

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, 

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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 $6.4 million 

(128,000 hours × $50.08 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 million 

(640,000 hours × $50.08 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 

draft proposed 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 × $50.08 per hour) to 

approximately $6.4 million (128,000 

hours × $50.08 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 

$6.4 million annually. 

As noted above, we do not have 

empirical data for most of the numbers 

used in the examples above. We invite 

comments from manufacturers and 

others to gather better insight on the 

potential recordkeeping burden of the 

draft proposed rule. 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), we have submitted the 

information collection requirements of 

this rule to OMB for review. Interested 

persons are requested to fax comments 

regarding information collection by 

December 8, 2011, to the Office of 

Information and Regulatory Affairs, 

OMB (see ADDRESSES). 

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 proposed 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 intends 

that any final rule based on this 

proposal would become effective on the 

same date as the rule on ‘‘Testing and 

Labeling Pertaining to Certification,’’ 

published elsewhere in this Federal 

Register, which is February 8, 2013. 

VIII. Request for Comments 

The issuance of this proposed rule 

begins a rulemaking proceeding under 

sections 3 and 102 of the CPSIA that 

will establish performance and 

recordkeeping requirements for the 

testing of representative samples for 

periodic testing of children’s products. 

We invite interested persons to submit 

comments on any aspect of the 

proposed rule. Comments should be 

submitted in accordance with the 

instructions in the ADDRESSES section at 

the beginning of this notice. 

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 

proposes to amend 16 CFR part 1107, as 

proposed to be added elsewhere in this 

issue of the Federal Register, to read 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; 

* * * * * 

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69594 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 

Dated: October 21, 2011. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2011–27686 Filed 11–7–11; 8:45 am] 

BILLING CODE 6355–01–P 

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