28336 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

1The Commission voted 5–0 to approve 

publication of this proposed rule. Chairman Inez 

Tenenbaum and Commissioners Nancy Nord and 

Anne Northup filed statements concerning this 

action. These statements may be viewed on the 

Commission’s Web site at http://www.cpsc.gov/pr/ 

statements.html or obtained from the Commission’s 

Office of the Secretary. 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1107 

[CPSC Docket No. CPSC–2010–0038] 

RIN 3041–AC71 

Testing and Labeling Pertaining to 

Product Certification 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Consumer Product Safety 

Commission (‘‘CPSC’’ or ‘‘Commission’’) 

is issuing a proposed rule that would 

establish requirements for a reasonable 

testing program and for compliance and 

continuing testing for children’s 

products.1 The proposal would also 

address labeling of consumer products 

to show that the product complies with 

certification requirements under a 

reasonable testing program for 

nonchildren’s products or under 

compliance and continuing testing for 

children’s products. The proposed rule 

would implement section 14(a) and (d) 

of the Consumer Product Safety Act 

(‘‘CPSA’’), as amended by section 102(b) 

of the Consumer Product Safety 

Improvement Act of 2008 (‘‘CPSIA’’). 

DATES: Written comments and 

submissions in response to this notice 

must be received by August 3, 2010. 

ADDRESSES: You may submit comments, 

identified by Docket No. CPSC–2010– 

0038, 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 (e-mail) 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 502, 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 

rulemaking. 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. 

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, U.S. Consumer Product 

Safety Commission, 4330 East West 

Highway, Bethesda, Maryland 20814; 

301–504–7562; e-mail: 

RButturini@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Statutory Authority 

Section 14(a)(1) of the CPSA, (15 

U.S.C. 2063(a)(1)), as amended by 

section 102 of the CPSIA, establishes 

requirements for the testing and 

certification of products subject to a 

consumer product safety rule under the 

CPSA or similar rule, ban, standard, or 

regulation under any other act enforced 

by the Commission and which are 

imported for consumption or 

warehousing or distributed in 

commerce. Under section 14(a)(1)(A) of 

the CPSA, manufacturers and private 

labelers must issue a certificate which 

‘‘shall certify, based on a test of each 

product or upon a reasonable testing 

program, that such product complies 

with all rules, bans, standards, or 

regulations applicable to the product 

under the CPSA or any other Act 

enforced by the Commission.’’ CPSC 

regulations, at 16 CFR part 1110, limit 

the certificate requirement to importers 

and domestic manufacturers. Section 

14(a)(1)(B) of the CPSA further requires 

that the certificate provided by the 

importer or domestic manufacturer 

‘‘specify each such rule, ban, standard, 

or regulation applicable to the product.’’ 

The certificate described in section 

14(a)(1) of the CPSA is known as a 

General Conformity Certification (GCC). 

Section 14(a)(2) of the CPSA (15 

U.S.C. 2063(a)(2)) establishes testing 

requirements for children’s products 

that are subject to a children’s product 

safety rule. (Section 3(a)(2) of the CPSA 

(15 U.S.C. 2052(a)(2)) defines a 

children’s product, in part, as a 

consumer product designed or intended 

primarily for children 12 and younger.) 

Section 14(a)(2)(A) of the CPSA also 

states that, before a children’s product 

subject to a children’s product safety 

rule is imported for consumption or 

warehousing or distributed in 

commerce, the manufacturer or private 

labeler of such children’s product must 

submit sufficient samples of the 

children’s product ‘‘or samples that are 

identical in all material respects to the 

product’’ to an accredited ‘‘third party 

conformity assessment body’’ to be 

tested for compliance with the 

children’s product safety rule. Based on 

such testing, the manufacturer or private 

labeler, under section 14(a)(2)(B) of the 

CPSA, must issue a certificate that 

certifies that such children’s product 

complies with the children’s product 

safety rule based on the assessment of 

a third party conformity assessment 

body accredited to perform such tests. 

Section 14(d)(2)(A) of the CPSA 

requires the Commission to initiate a 

program by which a manufacturer or 

private labeler may label a consumer 

product as complying with the 

certification requirements. This 

provision applies to all consumer 

products that are subject to a product 

safety rule administered by the 

Commission. 

Section 14(d)(2)(B) of the CPSA 

requires the Commission to establish 

protocols and standards for: 

• Ensuring that a children’s product 

tested for compliance with a children’s 

product safety rule is subject to testing 

periodically and when there has been a 

material change in the product’s design 

or manufacturing process, including the 

sourcing of component parts; 

• Testing of random samples; 

• Verifying that a children’s product 

tested by a conformity assessment body 

complies with applicable children’s 

product safety rules; and 

• Safeguarding against the exercise of 

undue influence on a third party 

conformity assessment body by a 

manufacturer or private labeler. 

Section 14(d)(2)(B)(iii) of the CPSA 

provides for verification that a 

children’s product tested by a 

conformity assessment body complies 

with applicable children’s product 

safety rules. At this time, the 

Commission is not imposing any 

verification obligations on 

manufacturers because the Commission 

intends to conduct the verification itself 

under its inherent authorities while it 

gains more experience with the testing 

and certification requirements. When 

the Commission finds that a children’s 


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Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 28337 

product accompanied by a certificate of 

conformity does not pass the tests upon 

which the certification was based, it 

may initiate an investigation of the 

manufacturer, third party conformity 

assessment body, and any other relevant 

party in the supply chain, to determine 

the cause of the discrepancy. 

The proposed rule would implement 

sections 14(a) and (d) of the CPSA, as 

amended by section 102(b) of the 

CPSIA, by: 

• Defining the elements of a 

‘‘reasonable testing program’’ for 

purposes of section 14(a)(1)(A) of the 

CPSA; 

• Establishing the protocols and 

standards for continuing testing of 

children’s products under section 

14(d)(2)(B)(i), (ii), and (iv) of the CPSA; 

and 

• Describing the label that 

manufacturers may place on a consumer 

product to show that the product 

complies with the certification 

requirements for purposes of section 

14(d)(2)(A) of the CPSA. 

The proposed rule also builds upon 

previous documents and activities by 

the Commission. For example, on 

November 3, 2009, Commission staff 

made available a draft guidance 

document titled, ‘‘Guidance Document: 

Testing and Certification Requirements 

Under the Consumer Product Safety 

Improvement Act of 2008.’’ The draft 

guidance document, which is available 

at http://www.cpsc.gov/library/foia/

foia10/brief/102testing.pdf, was 

intended to provide the Commission’s 

interpretation of the requirements of 

section 102 of the CPSIA. Specifically, 

it sought to describe the Commission’s 

position on a reasonable testing program 

and how to certify that a product 

complies with all rules, bans, standards, 

or other regulations applicable to the 

product under the laws enforced by the 

Commission. The guidance document 

also sought to explain when and how 

component testing to certain specific 

requirements would be allowed. 

Although the Commission never voted 

on whether to approve or to not approve 

the issuance of the draft guidance 

document, the draft did represent the 

Commission staff’s thinking on the 

subject. Shortly thereafter, in the 

Federal Register of November 13, 2009 

(74 FR 58611), the Commission 

announced that it would hold a two-day 

public workshop to discuss issues 

relating to the testing, certification, and 

labeling of consumer products pursuant 

to section 14 of the CPSA. The 

workshop was held on December 10 

through 11, 2009, in Bethesda, 

Maryland, and the Commission invited 

interested parties to attend and 

participate in the meeting. Commission 

staff made presentations on specific 

topics and held breakout sessions on: 

• Sampling and statistical 

considerations; 

• Verification of third party test 

results; 

• Reasonable test programs and third 

party testing; 

• Challenges for small manufacturer/ 

low-volume production; 

• Component testing and material 

changes; and 

• Protection against undue influence. 

The notice also stated that the 

Commission wanted to use the 

workshop to discuss possible options 

for implementing section 14 of the 

CPSA. Several hundred individuals 

attended the workshop. 

The Commission understands the 

economic ramifications that small 

businesses (and even large businesses) 

face regarding the testing costs required 

by section 102 of the CPSIA. Moreover, 

retailers and importers may be imposing 

significant additional testing cost on 

manufacturers by requiring that 

products that have already been tested 

by a third party conformity assessment 

body be tested again by a specific third 

party conformity assessment body 

selected by the retailer or importer. The 

Commission wants to emphasize to 

retailers and sellers of children’s 

products that they can rely on 

certificates provided by product 

suppliers if those certificates are based 

on testing conducted by a third party 

conformity assessment body. Section 

19(b) of the CPSA provides that a 

retailer or seller of a children’s product 

shall not be subject to civil or criminal 

penalties for selling products that do not 

comply with applicable safety standards 

if it holds a certificate issued in 

accordance with section 14(a) of the 

CPSA to the effect that such consumer 

product conforms to all applicable 

consumer product safety rules, unless 

such person knows that such consumer 

product does not conform. The 

Commission notes that section 19(b) of 

the CPSA does not relieve any person of 

the obligation to conduct a corrective 

action should any product violate an 

applicable safety standard and need to 

be recalled. 

In order to provide some relief from 

testing costs, elsewhere in this issue of 

the Federal Register, the Commission 

has issued a separate proposed rule 

which would allow for testing of 

component parts as a basis for 

certification of finished products in 

certain circumstances. The Commission 

intends to make clear in the two 

proposed rules that, in some cases, the 

required certificate for children’s 

products can be based on component 

part testing as described in proposed 16 

CFR part 1109, rather than testing of the 

finished product, if components are 

tested by a third party testing 

conformity assessment body. 

Furthermore, these proposed rules 

would allow importers to base their 

product certification for a children’s 

product on a certificate provided by a 

foreign manufacturer as long as that 

manufacturer has based its certificate on 

third party testing conducted by a third 

party conformity assessment body. 

B. Responses to Comments on the 

Notice of Availability and the Public 

Workshop 

In connection with the public 

workshop, the Commission invited 

public comment on its implementation 

of various aspects of section 14 of the 

CPSA. 

The Federal Register notice 

announcing the meeting identified 

specific issues for public comment; for 

example, in the section titled, ‘‘What are 

the issues regarding additional third 

party testing of children’s products?’’ the 

Commission asked: 

• Should the potential hazard (either 

the severity or the probability of 

occurrence) be considered in 

determining how frequently the 

periodic testing is conducted? For 

example, should a product subject to a 

consumer product safety rule, where the 

potential hazard is death, be tested more 

frequently than a product where the 

potential hazard is some lesser degree of 

harm? If so, how might a rule 

incorporate potential hazard into testing 

frequency? 

• What changes should constitute a 

‘‘material change’’ in a product’s design 

or manufacturing process? Are there 

criteria by which one might determine 

whether a change is a ‘‘material’’ change? 

For example, a material change in a 

product’s design or manufacturing 

process could be described as a change 

that affects the product’s ability to 

comply with a consumer product safety 

rule. However, as a practical matter, it 

may be difficult to determine what 

consumer product safety rules apply to 

the product and the extent to which 

compliance with those rules is affected 

by a change. 

See 74 FR at 58614. 

The Commission received 38 

comments, and we discuss those 

comments, and our responses, in parts 

B.1 through B.12 of this document. To 

make it easier to identify comments and 

our responses, the word ‘‘Comment’’ or 

‘‘Comments’’ will appear before the 


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28338 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

comment’s description, and the word 

‘‘Response’’ will appear before our 

response. 

1. The Reasonable Testing Program 

In the Federal Register notice 

announcing the public workshop, the 

Commission had described a 

‘‘reasonable testing program’’ as 

consisting of: 

• Product specifications that describe 

the consumer product and list the safety 

rules, standards, etc., with which the 

product must comply. The product 

specification should include a complete 

description of the product and any other 

information, including, but not limited 

to, a bill of materials, parts listing, raw 

material selection and sourcing, and/or 

model names or numbers of items 

necessary to describe the product and 

differentiate it from other products; 

• Certification tests which are 

performed on samples of the 

manufacturer’s consumer product to 

demonstrate that the product is capable 

of passing the tests prescribed by the 

standard; 

• A production testing plan which 

describes the tests that must be 

performed and the testing intervals to 

provide reasonable assurance that the 

products as produced meet all 

applicable safety rules; 

• A remedial action plan which must 

be employed whenever samples of the 

consumer product or results from any 

other tests used to assess compliance 

yield unacceptable or failing test results; 

and 

• Documentation of the reasonable 

testing program and how it was 

implemented. 

See 74 FR at 58613. 

Comments: Most comments addressed 

the five elements of the reasonable 

testing program, either by suggesting 

that the Commission allow for some 

flexibility as to what constitutes a 

reasonable testing program or by 

suggesting specific exceptions or tests as 

part of a reasonable testing program. 

Several comments expressed concern 

that many manufacturers may not be 

able to specify their products down to 

the component or raw material level 

because proprietary information from 

offshore manufacturers may prevent 

importers from knowing every 

component of the products they 

purchase. One comment noted that 

importers typically do not control the 

production process of the products they 

import, so the Commission should 

define a reasonable testing program 

differently to address an importer’s 

special circumstances. 

Another comment suggested that 

‘‘reasonable’’ for some products would 

involve less than the five elements 

outlined by CPSC in the notice for a 

reasonable testing program. For 

example, because some regulations 

require placement of a label, the 

comment said that ‘‘testing’’ in that 

circumstance would consist of 

observing that the label was placed 

properly. 

One comment stated that any testing 

program that results in an acceptable 

confidence level that a product 

complies with the applicable standards 

should be considered an acceptable 

reasonable testing program. The 

comment also suggested that other 

items, such as factory certification (to 

recognized standards), audits, risk 

assessment plans, certification of a 

manufacturer’s quality system, etc., 

should be allowed as elements of a 

reasonable testing plan. 

One comment suggested allowing 

process capability testing, where, for a 

continuous-flow process, first-run 

samples are tested, as a form of 

certification testing. The comment urged 

the Commission to allow a manufacturer 

to search ‘‘backwards’’ and ‘‘forwards’’ in 

continuous-flow process for good 

product in the event that a test during 

manufacturing shows noncompliance. 

Several comments noted that, for 

seasonal or short-run products, only 

prototype samples may exist before 

production begins. Some comments 

stated that neither the same materials 

nor the same manufacturing processes 

were used to manufacture the prototype 

samples as would be used to 

manufacture the consumer product. 

Multiple comments stated that the 

relative hazard should be a factor in 

determining the test frequency. Some 

stated that higher risks should 

necessitate a higher test frequency, and 

where the perceived risk is low, third 

party testing should not be mandatory 

for some products. 

One comment suggested that a 

manufacturer’s record of manufacturing 

products with low-lead levels should 

result in relaxed testing requirements. 

One comment remarked on the 

differences between conformity 

assessment and certification. The 

comment suggested that CPSC 

regulations should clarify that a 

‘‘reasonable testing program’’ means a 

conformity assessment process such as 

that in Annex A of ISO/IEC 17000 and 

describe the five elements in generic 

terms that avoid the implication that 

‘‘testing’’ will always be the evaluation 

activity. This comment noted that the 

phrase ‘‘production testing plan’’ is 

misleading in that only testing is 

anticipated, and would expand the 

interpretation to include activities 

certification bodies use to assess 

continuing compliance. 

One comment said that the 

Commission must issue regulations 

clarifying what will constitute 

‘‘unacceptable or failing’’ test results for 

product testing. Additionally, the 

comment stated that the Commission’s 

regulations should explicitly allow for 

retesting prior to remanufacturing or 

redesigning. One comment specifically 

stated that the reasonable testing 

program should be implemented for 

children’s products. 

Response: The Commission believes 

that the five elements of a reasonable 

testing program are adaptable to 

manufacturers’ and importers’ 

circumstances, are present in most 

testing programs (even if some of the 

elements might seem trivial), and can be 

accomplished with seemingly little 

effort. However, the five elements are 

essential and should be included to 

ensure a high degree of assurance of 

compliance to the applicable rules, 

bans, standards, or regulations. 

For the product specification 

component of a reasonable testing 

program, a manufacturer is not required 

to specify every component or raw 

material of a product. The manufacturer 

is free to describe its product by model 

number, general description, 

photograph, etc., as long as the product 

is identifiable and differentiable from 

other products. 

The Commission agrees that other 

elements such as risk assessment plans, 

quality system certification, and factory 

certifications could be added to provide 

a manufacturer with a high degree of 

assurance that the product produced 

complies with all applicable 

requirements. However, many methods 

suggested in the comments would 

require CPSC to assess and recognize or 

certify the certification services 

providers and require the manufacturer 

and importer to purchase these 

certification services. The approach in 

the proposed rule seeks to identify a 

method whereby a manufacturer or 

importer can independently establish a 

reasonable testing program and establish 

a set of minimum requirements for these 

reasonable testing programs that reflect 

commonly used elements of a quality 

assurance/quality control system. If 

process capability testing can ensure 

with a high degree of assurance that the 

product is capable of meeting the 

applicable rules, bans, standards, or 

regulations, that form of testing can be 

used for certification testing. Similarly, 

techniques used during production to 

ensure, with a high degree of assurance, 

that the continuing production is 


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compliant can be considered as 

acceptable production testing plans. 

For children’s products, section 

14(a)(2) of the CPSA requires 

manufacturers to submit ‘‘sufficient 

samples of the children’s product, or 

samples that are identical in all material 

respects to the product,’’ to a third party 

conformity assessment bodies for 

testing. A prototype manufactured with 

different materials or manufacturing 

processes than the finished product 

cannot be considered the same in all 

material respects as the finished product 

with respect to compliance. Therefore, 

section 14(a)(2) of the CPSA does not 

allow for testing of prototype samples 

unless they are identical in all material 

respects to the finished product. The 

proposed rule would extend the 

requirement to test only prototype 

samples that are identical in all material 

respects to the finished product that 

will be imported for consumption, 

warehoused, or distributed in commerce 

to manufacturers of nonchildren’s 

products under section 14(a)(1) of the 

CPSA. 

While the Commission agrees that a 

higher risk level should necessitate a 

greater testing frequency, it should be 

noted that risk and potential severity are 

not indicators of the level of compliance 

to the legal standards, regulations, rules, 

and bans. Section 14 of the CPSA does 

not allow for the exclusion of any 

children’s product from third party 

testing based on a perceived low level 

of risk. Thus, regardless of other existing 

means of determining compliance, 

products must be tested for compliance 

to the applicable rules, bans, standards, 

or regulations. 

As for the conformity assessment 

process in ISO/IEC 17000, the 

Commission does not consider it to be 

equivalent to a reasonable testing 

program. In sections 14(a) and 

14(d)(2)(B) of the CPSA, testing is 

specifically mentioned as the evaluation 

activity. Thus, regardless of other means 

of determining compliance, products 

must be tested for compliance to the 

applicable rules. The conformity 

assessment process mentioned in Annex 

A of ISO/IEC 17000 includes 

attestations in its principles of 

conformity assessment. However, the 

CPSA requires the manufacturer to 

perform the attestation that its products 

comply with the applicable rules. If the 

manufacturer uses a third party 

conformity assessment body to conduct 

the testing of its products, then the 

determination and attestation functions 

would be performed by two separate 

parties. Thus, the conformity 

assessment process in ISO/IEC 17000 is 

not equivalent to the reasonable testing 

program mentioned in section 14(a) of 

the CPSA. However, the certification 

testing and the production testing plan 

in the reasonable testing program do 

allow a wide latitude of actions in 

determining initial and continuing 

compliance to the applicable rules for a 

product. 

Test results that indicate 

noncompliance to the applicable rules 

are unacceptable or failing test results. 

Retesting, as a general matter, should 

not be allowed because doing so may 

tempt unscrupulous parties to attempt 

to ‘‘test the product into compliance,’’ 

(i.e., to repeat testing a product until a 

sample passes the test and then reject 

the earlier unacceptable or failing test 

results). The intent of section 14 of the 

CPSA is to conduct tests to provide 

assurance that all the products being 

imported, warehoused, or distributed in 

interstate commerce comply with all 

applicable rules. 

2. Flexibility in Testing 

Comments: Many comments stressed 

the need for flexibility in test protocols. 

Some comments stated that the types of 

products are so varied that no one 

prescribed system could be devised to 

effectively and efficiently apply to all of 

them. Other comments noted that 

determining the number of samples to 

be tested should be left to the 

manufacturer, who has intimate 

knowledge of the product’s 

manufacturing process, to decide. 

Response: The Commission agrees 

that it is difficult to develop rigid 

protocols for testing across all categories 

of products, manufacturers, and 

importers. A manufacturer may tailor 

the tests to the needs of the individual 

product, and the tests do not need to be 

the same tests that are specified in the 

applicable rules, provided that they are 

at least as effective in assessing 

compliance. The proposed rule would 

leave decisions on procedures, such as 

the number of samples to test, up to the 

manufacturer provided that the testing 

plan provides a high degree of assurance 

that noncompliant products are not 

introduced into the stream of commerce. 

3. Existing Testing Programs 

Comments: One comment asked if the 

Toy Safety Certification Program 

initiated by the Toy Institute of America 

(TIA) could be accepted as a reasonable 

testing program under section 14(a)(1) of 

the CPSA. Two other comments 

recommended that CPSC recognize the 

value of industry-specific certification 

programs prescribing testing methods 

for a product category and verifying 

conformance. Another two comments 

suggested that CPSC should consider 

the testing requirements in existing 

product safety standards to be 

acceptable in meeting the requirements 

of section 14 the CPSA, including 

existing regulations with their own 

reasonable testing program 

requirements. One comment noted that, 

unless the Commission can show that 

current industry testing programs are 

insufficient, no prescribed reasonable 

testing program should be implemented. 

One comment stated that CPSC should 

establish a safe harbor enforcement 

policy regarding recognized programs. 

The comment noted that an enforcement 

policy that accepts participation in such 

programs as demonstrable good faith, 

without imposition of civil or criminal 

liability under CPSIA’s expanded 

penalty limits, could act to promote 

participation in effective certification 

programs. 

Response: Manufacturers will need to 

ensure that any reasonable testing 

programs, whether they are industryspecific programs or not, also conform 

to the requirements of the CPSA and 

any implementing regulations 

promulgated by the Commission. If, in 

a manufacturer’s determination, a 

prescribed testing program ensures with 

a high degree of assurance that the 

products distributed in commerce will 

comply with the applicable rules, then 

the manufacturer is free to choose that 

program for its product. CPSC cannot 

generally consider all preexisting testing 

regulations to be acceptable for 

purposes of complying with section 14 

of the CPSA. For example, preexisting 

CPSC regulations may not mandate 

third party conformity assessment body 

testing for children’s products because 

those preexisting CPSC regulations were 

promulgated before the CPSIA’s 

enactment. Further, nothing in section 

14(a)(1) or 14(b) of the CPSA, nor 

section 3 of the CPSIA, which gives the 

Commission the authority to issue 

regulations to implement the CPSIA, 

requires the Commission to find 

industry testing programs to be 

insufficient before implementing a 

reasonable testing program. 

The proposed rule would not include 

any provision for a ‘‘safe harbor’’ 

enforcement policy based on a 

manufacturer’s participation in a 

voluntary or industry-sponsored 

program, nor has the Commission 

recognized any such program as 

indicating compliance within the 

requirements of the proposed rule. 

Section 14 of the CPSA does not contain 

a ‘‘safe harbor’’ exception nor does it 

establish any criteria by which the 

Commission could ‘‘recognize’’ testing 

programs for purposes of a ‘‘safe harbor.’’ 


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4. Random Samples 

In the Federal Register notice 

announcing the public workshop, the 

Commission explained that section 

14(d)(2)(B)(ii) of the CPSA refers to the 

‘‘testing of random samples to ensure 

continued compliance’’ and asked 

(among other things), ‘‘What constitutes 

a ‘random’ sample?’’ See 74 FR at 58614. 

At the workshop itself, CPSC staff 

presented a statistically-based rationale 

for selecting random samples. 

Comments: Many comments 

suggested that the word ‘‘random’’ 

should not be interpreted by its strict 

statistical definition, but should be 

adapted to the product type, how it is 

manufactured, and its intended use. 

One comment stated that random 

should be interpreted to mean free from 

overt selection bias and that it is more 

important that a sample be reasonably 

representative of the population from 

which it is selected. One comment 

suggested that, with the assistance of 

industry, the CPSC should develop 

guidelines regarding the circumstances 

and elements to consider when 

determining what constitutes a 

reasonable random sample. One 

comment mentioned the problems 

associated with random sampling of 

single-unit production and with very 

small production volumes (less than 10, 

for example). One comment noted that 

some manufacturing processes are of a 

continuous-flow type, and randomly 

selecting a sample would be disruptive 

to the production system. Another 

comment stated that products that are 

subjected to continuous testing with a 

specified frequency should be exempt 

from any additional random testing. 

Response: The Random House 

Dictionary of the English Language 

defines ‘‘random sampling’’ as ‘‘a method 

of selecting a sample from a statistical 

population in such a way that every 

possible sample that could be selected 

has the same probability of being 

selected.’’ The Commission believes that 

this is the most appropriate technical 

definition. It also seems more 

appropriate to use a definition where 

both terms (random and sampling) are 

defined together rather than two 

separate definitions, one of random and 

the second of sampling. More generally, 

terms such as a ‘‘representative’’ sample, 

a ‘‘non-fraudulent’’ sample, or a ‘‘nongolden’’ sample, do not have the 

underlying statistical attributes 

necessary to generalize about 

compliance of the untested portion of 

the product population from the tested 

samples. 

With regard to low-volume 

production, the proposed rule would 

not require random sampling unless a 

manufacturer produces 10,000 units of a 

product at which time the product 

would be subject to the proposed 

periodic testing requirements. 

Regardless of how random sampling is 

defined, section 14(d)(2)(B) of the CPSA 

requires samples to be tested. The 

samples must be selected from products 

in production or supply and must be 

tested by a third party conformity 

assessment body. 

Products manufactured in a 

continuous-flow process ultimately 

create individual products. If those 

products are subject to periodic testing, 

the requirement for random samples 

may constrain where in the 

manufacturing process periodic testing 

samples are selected. In general, product 

tests at a specific frequency are 

susceptible to transient events that 

could affect compliance and would be 

undetected. Random sampling has the 

capability of detecting such transient 

events and is thus required to ensure 

continued compliance of the product. 

5. Challenges for Small Manufacturers/ 

Low-Volume Production 

In the Federal Register notice 

announcing the public workshop, the 

Commission asked, ‘‘What provisions (if 

any) should be made for small 

manufacturers and manufacturers with 

low production volumes and why?’’ See 

74 FR at 58614. The Commission 

explained that specifying the frequency 

of periodic testing or the number of 

random samples to be tested may be 

inappropriate where the volume of 

children’s products being manufactured 

is low or where the children’s product 

is one-of-a-kind. 

Comments: Several comments were 

received specific to small manufacturers 

who may not have the technical, legal, 

or financial resources of large-volume 

manufacturers. One comment stressed 

the need for step-by-step guidance from 

the CPSC on how to follow the rules. 

Another comment noted that, for very 

small production volumes (often one or 

two custom items), testing of a 

representative sample should be 

allowed to suffice for all items. Two 

comments concurred with the draft 

Guidance Policy document text that did 

not require periodic testing for 

production volumes less than 10,000 

units or once a year, whichever is less. 

One comment suggested that, due to the 

economic ramifications associated with 

the development of a reasonable testing 

program, the CPSC should convene a 

Small Business Regulatory Enforcement 

Fairness Act (SBREFA) panel for this 

rulemaking. 

Response: While the Commission will 

provide general guidance on how to 

comply with the requirements of the 

CPSIA, manufacturers are responsible 

for fully understanding their 

manufacturing process and knowing 

how the regulations would apply to 

their products. Because there may be a 

disproportionate effect on small-volume 

manufacturers relative to large volume 

manufacturers, the proposed rule would 

not require periodic testing for 

production volumes of less than 10,000 

units because certification and periodic 

testing costs are largely independent of 

manufacturing volume. Certification 

testing and testing after a material 

change are still required and may be 

performed on portions of the finished 

product or representative samples that 

are the same with respect to compliance 

as the finished product. 

As for the comment regarding a 

SBREFA panel, the requirements for a 

SBREFA panel only apply to the 

Environmental Protection Agency and 

the Occupational Safety and Health 

Administration (OSHA). 

6. Verification of Third Party 

Conformity Assessment Bodies 

Comments: Several comments 

suggested that the CPSC, rather than 

manufacturers, should perform any 

verification of third party conformity 

assessment bodies. Another comment 

proposed that, upon demand by the 

CPSC, the conformity assessment body 

be required to produce a copy of the 

mandatory or voluntary standard against 

which the children’s product is being 

tested, a copy of the test protocol used 

for the test procedure, and a copy of the 

test results that can be traced back to the 

specific sample tested. Another 

comment noted that variations in 

sample preparation by conformity 

assessment bodies can and do lead to 

differing test results. One comment, 

noting lab-to-lab variations in test 

results for the same product, suggested 

that CPSC should require third party 

conformity assessment bodies to 

conduct blind correlation studies and 

lab audits. Another comment asserted 

that proficiency testing is the only true 

outside independent verification option 

for laboratories and should be limited to 

chemical tests only. 

Response: The Commission’s limited 

resources preclude CPSC from directly 

conducting verification of the numerous 

conformity assessment bodies. As stated 

earlier in part A of this document, at 

this time, the Commission is not 

proposing any verification obligations 

on manufacturers because the 

Commission intends to conduct the 

verification itself under its inherent 


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authorities while it gains more 

experience with the testing and 

certification requirements. Additionally, 

the activities and requirements for 

accrediting conformity assessment 

bodies are outside the scope of this 

rulemaking. 

The Commission acknowledges that 

variations in sample preparation can 

lead to some differences in test results. 

However, these variations should not be 

significant enough to alter the general 

determination of whether a product 

complies with the applicable children’s 

product safety rule. 

As for proficiency testing (by which 

the Commission means testing 

conducted by an independent evaluator 

of the competence of a ‘‘body’’ 

(organization, person, etc.) to perform 

specific tasks), the Commission 

considers proficiency testing to be one 

option for domestic manufacturers and 

importers to use for verification 

purposes. However, the requirements 

for verifying that a children’s product 

complies with the applicable children’s 

product safety rules are not limited to 

only chemical tests. 

7. Protection of Conformity Assessment 

Bodies Against Undue Influence 

Comments: One comment suggested 

that provisions of ISO/IEC Guide 65 be 

used to prevent undue influence from 

being exerted over third party testing 

body by a manufacturer or private 

labeler. Other comments suggested that 

laboratory certification beyond ISO/IEC 

17025 is neither productive nor 

necessary. Another comment suggested 

that the Commission should look to 

OSHA’s Nationally Recognized Testing 

Laboratory (NRTL) program to ensure 

impartiality and prevent conflict of 

interest. One comment stated that CPSC 

should extend existing CPSC fines and 

penalties that the CPSC can currently 

impose on manufacturers and retailers 

to apply to exerting or attempting to 

exert undue influence on third party 

conformity bodies. 

Response: ISO/IEC Guide 65 and 

OSHA’s NRTL program both deal with 

certifying bodies that perform many 

functions in addition to the testing 

functions performed by third party 

conformity assessment bodies. The ISO/ 

IEC 17025 certification system appears 

to be working as intended. There is no 

need to implement duplicative or 

additional requirements by requiring 

them in this proposed rule. 

With regard to extending fines, 

section 19 the CPSA already addresses 

fines and penalties. Section 19(a)(4) of 

the CPSA prohibits any attempt to 

exercise undue influence on a third 

party conformity assessment body. 

Sections 20 and 21 of the CPSA 

establish monetary and criminal 

penalties for violations of section 19 of 

the CPSA. 

8. Certificates 

Comments: One comment urged the 

Commission to recognize the registered 

certification marks of recognized 

product certification bodies, like those 

accredited under the OSHA NRTL 

program for applicable product scopes, 

in lieu of paper certificates of 

conformity. Another comment asserted 

that the CPSC has no jurisdiction to 

issue certification regulations except as 

part of a reasonable labeling rule 

adopted under section 14 of the CPSA. 

The comment argued that section 14(a) 

of the CPSA gives the manufacturer the 

option to select its own form and 

medium to convey certification of 

compliance with a CPSC standard. 

Finally, the comment contended that 

section 14 of the CPSA does not 

authorize the Commission to adopt any 

rule prescribing the content of the 

certificate or method of its distribution. 

Another comment stated that the CPSC 

has no jurisdiction to require that a 

certificate be on a separate piece of 

paper that accompanies the product. 

The comment also suggested that at 

least 180 days would be needed to 

comply with any new requirements. 

Response: The Commission does not 

believe that registered certification 

marks, by themselves, would provide 

the information required for certificates 

under section 14 of the CPSA. With 

respect to children’s products, third 

party conformity assessment bodies 

only test children’s products for 

compliance with the applicable 

children’s product safety rules. Third 

party conformity assessment bodies are 

not responsible for issuing certificates 

under section 14(a)(2) of the CPSA; to 

the contrary, under existing CPSC 

regulations, only domestic 

manufacturers and importers are 

required to issue certificates (see 16 CFR 

part 1110; see also 73 FR 68328 

(November 18, 2008)). 

Regarding the Commission’s 

jurisdiction to issue certification 

regulations, the Commission has the 

authority to issue implementing 

regulations under section 3 of the 

CPSIA, which provides that ‘‘[t]he 

Commission may issue regulations, as 

necessary, to implement this Act and 

the amendments made by this Act.’’ The 

Commission has not required 

certificates to be only in the form of a 

separate piece of paper. Certificates can 

be in electronic form. 

As for the effective date of any final 

rule, the Commission intends that any 

final rule resulting from this rulemaking 

become effective 180 days after its date 

of publication in the Federal Register. 

Interested parties who believe that the 

effective date should be longer or 

shorter should submit a comment to the 

proposed rule. The comment should 

include the specific facts on which they 

base their conclusion. 

9. Reliance on Test Results of Others for 

Certification Purposes 

Comments: Two comments noted that 

a foreign manufacturer may supply the 

same product to several importers, who 

would then be required to test the same 

product. The comments considered 

such testing of the same product by 

multiple importers to be wasteful and 

inefficient. Another comment stated that 

importers of many products will be 

overburdened with testing costs, 

whereas manufacturers making one 

product can efficiently test their 

products. The comment added that the 

importer would still be responsible for 

the product’s certificate, but would use 

test data furnished by the manufacturer. 

Finally, the comment noted that 

importers have little control over the 

design, manufacturing process, or 

sourcing of component parts, but 

manufacturers control all those aspects 

of production. Two other comments 

asserted that importers should be 

allowed to base their certificates on test 

reports and results of other entities. 

Another comment proposed that CPSC 

should recognize the vendor’s 

assumption of liability in making such 

certification and deem that retailers, 

importers and distributors of product 

subject to such certification may rely 

upon it without facing civil or criminal 

liability. 

One comment asked for clarification 

for importers who rely on foreign 

manufacturers’ certificates of conformity 

regarding what level of diligence can 

reasonably and effectively be exercised 

by the importers. 

One comment recommended that ink 

manufacturers be allowed to group, test 

and certify product families for 

component testing because product 

families represent the same core 

formula. The comment asserted that 

product family certification provides a 

reasonable, economically viable, testing 

model for these ink manufacturers. 

Response: While an importer is not 

required to commission testing itself 

and may, in certain cases, use 

component part test reports from the 

manufacturer, the importer is 

responsible for issuing the certificate for 

a children’s product (see 16 CFR 

1110.7(a)). The importer also must 

ensure that the proper testing was 


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conducted (i.e., a third party conformity 

assessment body accredited for the 

correct test conducted the testing). The 

importer is ultimately responsible for 

ensuring that its product meets CPSC 

requirements. In those cases in which 

the importer has little or no control over 

the manufacturing process and is 

relying on the manufacturer’s test data, 

the importer should take measures to 

understand the manufacturing and 

testing process. An importer needs to 

ensure that all necessary tests are 

conducted in an appropriate manner to 

ensure, with a high degree of assurance, 

that no noncompliant product is placed 

into commerce. In the Commission’s 

proposed rule on ‘‘Conditions and 

Requirements for Testing of Component 

Parts of Consumer Products’’ (which 

appears elsewhere in this issue of the 

Federal Register), the Commission is 

considering additional issues related to 

the reliance of a manufacturer on the 

test results of others for certification 

purposes. 

As for the comment regarding ink, an 

ink that has a similar base formula and 

varies only in color could contain some 

pigments that contain lead while the 

same base with different pigments did 

not. Thus, families of inks cannot be 

grouped for compliance testing. 

However, the Commission has 

previously made a determination that 

CYMK inks do not need to be tested 

since they do not contain lead. See 16 

CFR 1500.91. 

10. Additional Third Party Testing 

Requirements for Children’s Products 

Comments: One comment remarked 

that the Commission should offer 

guidance on the adequacy of specific 

programs to firms who request it. The 

comment also sought clarification on 

whether a test could be any reasonable, 

objective method for evaluating 

compliance with a standard. The 

comment suggested that any attempt to 

specify protocols and standards for 

testing children’s products, such as 

sample size and frequency, should be 

tied to specific standards. The comment 

also expressed interest in having the 

Commission provide a clearer definition 

of reasonable certainty, especially in the 

context of specific standards. Finally, 

the comment advised against attempting 

to establish any numerical standard, 

such as a specified confidence level 

with a specific number of samples to 

test. 

Another comment requested that the 

Commission should provide reasonably 

specific guidelines with regard to both 

periodic testing frequency and sample 

size to be used in such testing. The 

comment suggested a period of at least 

twice per year or once every 50,000 

units in any event, whichever occurs 

first. With regard to the sample size for 

periodic testing, the comment suggested 

(at least for toys) using the 12-unit 

sample size which has been the 

requirement of the CPSC Engineering 

Test Manual for many years as a starting 

point. A sample size of 18 pieces could 

be required for higher-risk products 

such as infant and toddler toys, and a 

lesser sample could be allowed for large, 

bulky, or expensive products to 

minimize cost. 

Many comments asserted that risk 

should be factored into any testing 

program. A product that poses a higher 

level of risk should undergo closer 

scrutiny. 

One comment provided a list of 

activities that would more precisely 

define a material change. The list 

included changes in tooling, product 

materials, assembly method, or the 

manufacturing facility. 

Another comment contended that 

once the children’s product has passed 

its certification testing, periodic testing 

is not required, and that only a material 

change would require retesting. 

One comment noted that first-party 

production testing is used extensively to 

control manufacturing and is effective 

in detecting problems that could lead to 

nonconforming products. The comment 

noted that the information can be used 

to reduce the number of samples 

required for periodic testing to one. 

One comment suggested that, in 

establishing procedures and standards 

for periodic testing of children’s 

products, CPSC should consider the 

potential for lead exposure in order to 

distinguish between products that pose 

a reasonable risk of noncompliance with 

the lead content limits and products 

that pose only a theoretical risk of 

noncompliance. 

Response: Several existing CPSC 

regulations are product-specific, 

allowing the Commission to develop 

guidance for those particular 

manufactured goods. However, section 

14(a) of the CPSA covers all products 

subject to a consumer product safety 

standard enforced by the Commission. 

In light of that fact, the CPSC cannot 

provide guidance for every product and 

every manufacturing process. For 

children’s products, only a third party 

conformity assessment body accredited 

to perform the required tests is allowed 

to test for compliance to the applicable 

children’s product safety rules. 

The proposed rule would consider 

non-conformity assessment body tests, 

such as production tests, process control 

measurements, or other means of 

assessing compliance, to be acceptable if 

they are as effective in discriminating 

compliance and noncompliance as the 

tests specified in the standards as part 

of a reasonable testing program. Neither 

the reasonable testing program for 

nonchildren’s products nor the 

certification and periodic tests for 

children’s products specify values for 

sample size or test frequency. 

The Commission recognizes that no 

one-size-fits-all testing program will be 

sufficient for all manufacturers. The 

proposed rule would state that a 

reasonable testing program is a program 

that, when structured with appropriate 

specifications, measurements, controls, 

and test intervals, will provide a high 

degree of assurance that the consumer 

products manufactured under the 

reasonable testing program will comply 

with all the requirements of the 

applicable rules. If a high degree of 

assurance is interpreted to be a 

statistical likelihood of not producing 

noncompliant products, the sample size 

for periodic testing will depend upon 

the number of samples that need to be 

tested to provide that statistical 

assurance. The number of samples 

could be fewer than 12 or more than 18. 

The Commission agrees that products 

with a higher potential for injury or 

death should undergo greater scrutiny. 

Because of the many types of 

children’s products and manufacturing 

processes that will be covered by the 

rule, the description of the activities 

that would trigger additional third party 

testing due to material changes needs to 

be described in general terms. A more 

general description gives manufacturers, 

who are experts in their product areas 

and are better suited to understand 

when a change in their product could 

affect the product’s ability to comply 

with applicable rules, the flexibility to 

develop testing programs to suit their 

products and manufacturing operations. 

For children’s products, section 

14(d)(2)(B)(i) of the CPSA says explicitly 

that the rule is intended to establish 

protocols and standards to ensure that 

children’s products are tested 

‘‘periodically,’’ as well as when there has 

been a material change to the product. 

Thus, even if no changes are made to a 

children’s product, it must be tested 

periodically. 

For children’s products with a 

reasonable testing program, it may be 

possible to show that one periodic test 

sample verifies and validates the 

program. However, for children’s 

products without a reasonable testing 

program, in order for third party testing 

to provide a high degree of assurance 

that the products produced comply with 

the rule, the Commission believes that 

testing only a single sample would not 


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be acceptable. Other than the exceptions 

for lead that are specified in section 101 

of the CPSIA and the lead 

determinations regarding certain 

materials or products in 16 CFR 

1500.91, all children’s products are 

required to be tested for lead content. 

11. Labeling Program 

As stated earlier in part A of this 

document, section 14(d)(2)(A) of the 

CPSA requires the Commission to 

initiate a program by which a 

manufacturer or private labeler may 

label a consumer product as complying 

with the certification requirements. This 

provision applies to all consumer 

products that are subject to a product 

safety rule administered by the 

Commission. 

Comments: One comment 

recommended that the Commission not 

initiate a labeling program because it 

will contribute to confusion within the 

small business community about the 

tracking label. Another comment 

suggested that the Commission should 

provide examples of allowable text for 

such labels, but should not have specific 

requirements for things such as size, 

color, font or location as these will 

depend on the product. The comment 

further noted that it would be a huge 

burden to impose specifications such as 

‘‘label’’ text or size. 

One comment noted that some 

children’s products currently must 

contain a label and that label should be 

considered sufficient. Two comments 

stated that, if a consumer compares a 

children’s product with a label stating 

compliance to all applicable rules to a 

comparable product with no applicable 

rules (and thus no label), the absence of 

the label will be misperceived as 

noncompliance by the consumer and 

will thus disadvantage the second 

product. One comment suggested that 

the label requirement be harmonized as 

best as possible with existing Federal 

regulations such as U.S. Customs and 

Border Production country of origin 

labeling (19 U.S.C. 1304 and 19 CFR 

134.33) and the Federal Trade 

Commission’s Textile and Wool 

Products Identification Act’s fiber 

content labeling requirements (15 U.S.C. 

70 and 16 CFR part 303). Another 

comment said that the use of the label 

should be restricted to identifying the 

manufacturer/importer and the batch to 

help facilitate and narrow the scope of 

recalls. One comment suggested that 

there needs to be accommodations or 

exclusions for products that are 

impossible to mark that are similar to 

exclusions provided in the J list of the 

U.S. Customs and Border Protection 

regulations for country of origin 

markings or products that would be 

destroyed by marking. One comment 

urged CPSC to include the certification 

requirements of section 14(a) of the 

CPSA on a label on the product. 

Response: Section 14(d)(2)(A) of the 

CPSA requires the Commission to 

initiate a program by which a 

manufacturer or private labeler may 

label their products as complying with 

the certification requirements. The 

Commission staff’s suggested text and 

format for the label will make it easier 

for consumers, small businesses, and 

any other interested party to notice it, 

understand its meaning, and distinguish 

it from tracking labels. Varying the text 

and the font size and style on the label 

could lead to greater confusion in 

understanding than a consistent label. 

Because the use of the label is optional 

for manufacturers, similar-looking 

products, or even units of the same 

product, may or may not contain the 

label. The label is intended to show 

compliance with CPSC certification 

requirements. It is not intended to be a 

tracking label or demonstrate 

compliance with laws or regulations 

administered by other federal agencies. 

The comment suggesting the 

Commission should include the 

certification requirements of section 

14(a) of the CPSA on a label on the 

product is outside the scope of the 

labeling program in the proposed rule 

which is being promulgated pursuant to 

section 14(d)(2)(A) of the CPSA. 

Additionally, on November 18, 2008, 

the Commission issued a rule (see 16 

CFR part 1110; see also 73 FR 68328) 

addressing the requirements for 

certificates under section 14(a) of the 

CPSA. 

12. Comments Outside the Scope of the 

Rule 

Comments: Several comments 

addressed issues pertaining to specific 

tests or other provisions in the CPSIA, 

such as tracking labels and the 

interpretation of statutory definitions. 

Several comments suggested that xray fluorescence (XRF) technology 

should be an acceptable method to test 

for the presence of lead. 

Two comments suggested that CPSC 

require a hazard analysis of children’s 

products if manufacturers are permitted 

to perform the analysis themselves 

without a third party check of the 

results. 

One comment would interpret the 

CPSIA’s definition of ‘‘children’s 

product’’ as a product with which a 

child plays. 

One comment suggested that the 

CPSC tracking label require the name of 

the manufacturer or importer, the 

production date, the compliance 

identifier, and the model number. 

One comment said that the electronic 

availability of certificates should satisfy 

the ‘‘accompany’’ and ‘‘furnish’’ 

requirements as opposed to requiring a 

paper certificate. One comment stated 

that the CPSC cannot require the 

certificate to contain the specific week 

of manufacture or the particular unit of 

equipment used to manufacture the 

product. 

One comment argued that the 

Commission has no jurisdiction over 

architectural glass (e.g., glass used in 

windows and doors). 

Response: Because these comments 

address issues that are unrelated to 

reasonable testing programs, continued 

testing of children’s products, and labels 

to show that a product complies with 

the certification requirements in section 

14(a) of the CPSA, they are outside the 

scope of this rule. Consequently, we 

decline to address them here. 

C. Description of the Proposed Rule 

The proposal would create a new part 

in Title 16 of the Code of Federal 

Regulations: Part 1107, titled ‘‘Testing 

and Labeling Pertaining to Product 

Certification.’’ The new part 1107 would 

consist of four subparts: Subpart A 

would be ‘‘General Provisions’’; Subpart 

B would be the requirements for a 

‘‘Reasonable Testing Program for 

Nonchildren’s Products’’; Subpart C 

would be the requirements for 

‘‘Certification of Children’s Products’’; 

and Subpart D would be the 

requirements for a ‘‘Consumer Product 

Labeling Program.’’ 

1. Proposed Subpart A General 

Provisions 

a. Proposed § 1107.1—Purpose 

Proposed § 1107.1 would state that 

part 1107 establishes the requirements 

for: a reasonable testing program for 

nonchildren’s products; third party 

conformity assessment body testing to 

support certification and continuing 

testing of children’s products; and 

labeling of consumer products to 

indicate that the certification 

requirements have been met pursuant to 

sections 14(a)(1), and (a)(2), (d)(2)(B) of 

the CPSA (15 U.S.C. 2063(a)(1), (a)(2), 

(d)(2)(B)). 

b. Proposed § 1107.2—Definitions 

Proposed § 1107.2 would state that, 

unless otherwise stated, the definitions 

of the Consumer Product Safety Act and 

the Consumer Product Safety 

Improvement Act of 2008 apply to this 

part. Proposed § 1107.2 also would 

define certain terms or abbreviations for 


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purposes of part 1107. For example, 

with respect to abbreviations, proposed 

§ 1107.2 would define ‘‘CPSA’’ to mean 

the Consumer Product Safety Act. 

Proposed § 1107.2 would define ‘‘CPSC’’ 

to mean the Consumer Product Safety 

Commission. 

Proposed § 1107.2 would define 

‘‘detailed bill of materials’’ to mean a list 

of the raw materials, sub-assemblies, 

intermediate assemblies, subcomponent parts, component parts, and 

the quantities of each needed to 

manufacture a finished product. 

Proposed § 1107.2 would define ‘‘due 

care’’ to mean the degree of care that a 

prudent and competent person engaged 

in the same line of business or endeavor 

would exercise under similar 

circumstances. 

Proposed § 1107.2 would define ‘‘high 

degree of assurance’’ to mean an 

evidence-based demonstration of 

consistent performance of a product 

regarding compliance based on 

knowledge of a product and its 

manufacture. The term ‘‘high degree of 

assurance’’ appears in several proposed 

provisions, and so the concept of what 

constitutes a ‘‘high degree of assurance’’ 

would be important for purposes of 

interpreting and complying with certain 

proposed sections. We considered 

several alternative definitions for a high 

degree of assurance. One alternative 

definition would be, for quantitative 

tests, where a high degree of assurance 

would be at least a 95 percent 

probability that all the product 

produced meets the requirements of the 

applicable rules; for non-quantitative 

(pass/fail) tests, a high degree of 

assurance could mean a 95 percent 

confidence that at least 95 percent of the 

product produced meets the 

requirements of the applicable rules. 

The 95 percent level is widely used in 

the natural and social sciences as the 

minimum acceptable probability for 

determining statistical significance and 

has been found to be effective. However, 

we recognize that defining a ‘‘high 

degree of assurance’’ as a 95 percent or 

greater probability could result in 

greater testing demands on small 

manufacturers. For example, for a nonquantitative test, a method such as the 

‘‘rule of three’’ could be used to 

determine the number of samples 

needed for testing. For a 95 percent 

confidence that no more than five 

percent of the production fails to 

comply, 3/0.05 = 60 units will be 

needed for testing. For small production 

volumes where 60 samples would be 

considered excessive, alternative 

methods would be needed. Thus, we 

decided against defining ‘‘high degree of 

assurance’’ with respect to a 95 percent 

probability or confidence level because 

there may be difficulty in applying the 

statistical methods to all manufacturing 

processes. We invite comment on 

possible amendments or revisions to the 

proposed definition of ‘‘high degree of 

assurance.’’ 

Proposed § 1107.2 would define 

‘‘identical in all material respects’’ to 

mean there is no difference with respect 

to compliance to the applicable rules 

between the samples and the finished 

product. 

Proposed § 1107.2 would define 

‘‘manufacturer’’ to mean the parties 

responsible for certification of a 

consumer product pursuant to 16 CFR 

part 1110. Currently, 16 CFR part 1110 

limits the certification requirement to 

domestic manufacturers and importers. 

Proposed § 1107.2 would define 

‘‘manufacturing process’’ to mean the 

techniques, fixtures, tools, materials, 

and personnel used to create the 

component parts and assemble a 

finished product. 

Proposed § 1107.2 would define 

‘‘production testing plan’’ to mean a 

document that shows what tests must be 

performed and the frequency at which 

those tests must be performed to 

provide a high degree of assurance that 

the products manufactured after 

certification continue to meet all the 

applicable safety rules. 

Proposed § 1107.2 would define ‘‘third 

party conformity assessment body’’ to 

mean a third party conformity 

assessment body recognized by the 

CPSC to conduct certification testing on 

children’s products. 

2. Proposed Subpart B—Reasonable 

Testing Program for Nonchildren’s 

Products 

Proposed subpart B would consist of 

one provision and would describe the 

‘‘reasonable testing program’’ for 

nonchildren’s products. 

a. Proposed § 1107.10—Reasonable 

Testing Program for Nonchildren’s 

Products 

Proposed § 1107.10(a) would state 

that, except as otherwise provided in a 

specific regulation under this title or a 

specific standard prescribed by law, a 

manufacturer certifying a product 

pursuant to a reasonable testing program 

must ensure that the reasonable testing 

program provides a high degree of 

assurance that the consumer products 

covered by the program will comply 

with all applicable rules, bans, 

standards or regulations. The proposed 

exception for specific regulations or 

standards prescribed by law is meant to 

recognize that certain preexisting CPSC 

regulations or standards that were 

previously voluntary standards which, 

by statute, are now considered to be 

mandatory consumer product safety 

standards or are to be adopted as 

mandatory standards may have specific 

testing requirements or protocols. The 

reasonable testing programs 

requirements under proposed § 1107.10 

are not intended to supersede those 

preexisting testing requirements listed 

in Table 1. Table 1 only lists testing 

requirements as they pertain to 

nonchildren’s products because 

proposed § 1107.10 would not apply to 

children’s products. 

TABLE 1—EXISTING TESTING PROGRAMS THAT WOULD NOT BE SUPERSEDED BY PROPOSED § 1107.10 REGARDING A

REASONABLE TESTING PROGRAM

16 CFR part Subject 

1201 ..................................... Safety Standard for Architectural Glazing Materials. 

1202 ..................................... Safety Standard for Matchbooks. 

1203 ..................................... Safety Standard for Bicycle Helmets. 

1204 ..................................... Safety Standard for Omnidirectional Citizen Band Base Station Antennas. 

1205 ..................................... Safety Standard for Walk-Behind Power Lawn Mowers. 

1207 ..................................... Safety Standard for Swimming Pool Slides. 

1209 ..................................... Interim Safety Standard for Cellulose Insulation. 

1210 ..................................... Safety Standard for Cigarette Lighters. 

1211 ..................................... Safety Standard for Automatic Residential Garage Door Operators. 

1212 ..................................... Safety Standard for Multi-Purpose Lighters. 

1610 ..................................... Standard for the Flammability of Clothing Textiles. 

1611 ..................................... Standard for the Flammability of Vinyl Plastic Film. 


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TABLE 1—EXISTING TESTING PROGRAMS THAT WOULD NOT BE SUPERSEDED BY PROPOSED § 1107.10 REGARDING A

REASONABLE TESTING PROGRAM—Continued 

16 CFR part Subject 

1630, 1631 ........................... Standards for the Surface Flammability of Carpets and Rugs. 

A reasonable testing program serves 

as the basis for issuance of the general 

conformity certification for 

nonchildren’s products unless the 

manufacturer conducts a test of each 

product. A reasonable testing program is 

a program that, when structured with 

appropriate specifications, 

measurements, controls, and test 

intervals, will provide a high degree of 

assurance that the consumer products 

manufactured under the reasonable 

testing program will comply with all the 

requirements of the applicable rules. 

The manufacturer is responsible for 

establishing a reasonable testing 

program because it is necessary to 

support the issuance of a general 

conformity certificate where a test of 

each product is not undertaken. All the 

elements of the reasonable testing 

program should be in place, and 

certification tests completed with 

passing results before a general 

conformity certificate can be issued for 

a product. 

Several existing nonchildren’s 

product standards issued by the 

Commission already contain productspecific testing programs that were 

developed by the Commission at the 

time the standard was issued and for 

which certification was required before 

the CPSIA’s enactment. For existing 

rules that contain testing requirements, 

and do not contain specific testing 

programs, the reasonable testing 

program establishes the minimum set of 

requirements to be met for certification. 

For the remaining applicable rules, the 

implementation of reasonable testing 

programs will vary depending on the 

product under consideration and the 

compliance characteristics being tested. 

Persons issuing general conformity 

certificates should exercise due care in 

developing and implementing a 

reasonable testing program that 

demonstrates that their products comply 

with the applicable rules. 

Commission staff examined existing 

CPSC regulations, such as the 

regulations pertaining to 

omnidirectional citizens band base 

station antennas, walk-behind lawn 

mowers, and automatic residential 

garage door openers, and selected 

common features of existing reasonable 

testing programs that CPSC has found to 

be effective. The proposed elements of 

a reasonable testing program would be 

necessary to demonstrate a product’s 

compliance at the time of certification 

and as production of the product 

continues after certification. Because the 

requirement for a reasonable testing 

program would apply to a wide variety 

of product types and manufacturing 

processes, it is designed to be scalable 

to production volumes and adaptable to 

the specifics of the product. A 

manufacturer may develop the scope 

and details of each element of a 

reasonable testing program based on the 

manufacturer’s knowledge and expertise 

regarding the product and its 

manufacturing processes. 

The Commission’s primary concern is 

ensuring that manufacturers produce 

safe and compliant products. Testing is 

not an end in itself, but rather one part 

of a process to ensure the safety of 

consumer products. For this reason, the 

Commission believes the primary 

objective in a reasonable testing 

program is determining whether or not 

a manufacturer produces safe and 

compliant products. When CPSC staff 

discovers unsafe or noncompliant 

products, CPSC may have reason to 

examine a manufacturer’s programs and 

processes. Because the Commission 

recognizes that even the best processes 

can occasionally yield noncompliant 

products, the Commission is especially 

concerned about unsafe or 

noncompliant products emerging from 

defective processes. 

Proposed § 1107.10(b) would describe 

the five elements that a reasonable 

testing program must contain. The 

Commission invites comments on these 

five elements of a reasonable testing 

program. How well do these elements 

fall within the elements of existing 

quality assurance/quality control 

programs? In cases where no quality 

assurance/quality control programs 

exist, what activities will have to occur 

to implement the proposed reasonable 

testing program? Please explain. 

Proposed § 1107.10(b)(1) would state 

that a reasonable testing program must 

have a product specification. The 

product specification would contain a 

description of the consumer product 

and lists the applicable rules, bans, 

standards or regulations to which the 

product is subject. A product 

specification should describe the 

product listed on a general conformity 

certification in sufficient detail to 

identify the product and distinguish it 

from other products made by the 

manufacturer. Proposed § 1107.10(b)(1) 

would state that the product 

specification may include items such as 

a color photograph or illustration, 

model names or numbers, a detailed bill 

of materials, a parts listing, raw material 

selection and sourcing requirements. 

Proposed § 1107.10(b)(1)(i) would state 

that a product specification must 

include any component parts that are 

certified pursuant to 16 CFR part 1109. 

(Elsewhere in this issue of the Federal 

Register, the Commission is issuing a 

proposed rule regarding component part 

testing.) 

Proposed § 1107.10(b)(1)(ii) would 

state that product specifications that 

identify individual features of a product 

that would not be considered a material 

change may use the same product 

specification for all products 

manufactured with those specific 

features. Features that would not be 

considered a material change include 

different product sizes or other features 

that cover variations of the product 

where those variations do not affect the 

product’s ability to comply with 

applicable rules. For example, several 

sizes of the same article of clothing 

made with the same materials would 

not be considered a material change. 

Another example would be if a product 

specification lists a number of 

complying component parts that are 

grouped in a number of different 

combinations for separate products, the 

differences in the number of component 

parts between the products would not 

be considered a material change. 

Additionally, a product with different 

versions of software downloaded into 

various units that would not affect 

compliance, such as various language 

packages downloaded into various 

educational toys, would not be 

considered a material change. 

Proposed § 1107.10(b)(1)(iii) would 

state that each manufacturing site must 

have a separate product specification. 

This would be required because a 

manufacturer cannot assume that units 

of the same product manufactured in 

more than one location are identical in 

all material respects. 


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Proposed § 1107.10(b)(2) would state 

that a manufacturer must conduct 

certification tests on a product before 

issuing a general conformity certificate 

for that product. Certification tests 

provide evidence that a product 

identified in a product specification 

complies with the applicable rules, 

bans, standards, or regulations. 

Certification tests are required as part of 

a reasonable testing program in lieu of 

a test of each product. Proposed 

§ 1107.10(b)(2) would state that a 

certification test would be a test 

performed on samples of the product 

that are identical to the finished product 

in all material respects to demonstrate 

that the product complies with the 

applicable safety rules. Proposed 

§ 1107.10(b)(2) would require 

certification tests to contain certain 

elements. 

Proposed § 1107.10(b)(2)(i) would 

state that, for purposes of proposed 

§ 1107.10, a sample means a component 

part of the product or the finished 

product which is subjected to testing. 

Samples submitted for certification 

testing would be required to be identical 

in all material respects to the product to 

be distributed in commerce. The 

manufacturer would be required to 

submit a sufficient number of samples 

for certification testing so as to provide 

a high degree of assurance that the 

certification tests accurately represent 

the product’s compliance with all 

applicable rules. 

Proposed § 1107.10(b)(2)(i)(A) would 

only allow finished products or 

component parts listed on the product 

specification to be submitted for 

certification testing. Proposed 

§ 1107.10(b)(2)(i)(B) would allow a 

manufacturer to substitute component 

part testing for finished product testing 

pursuant to 16 CFR part 1109 unless the 

rule, ban, standard or regulation 

applicable to the product requires 

testing of the finished product. If a 

manufacturer relies upon certification 

testing of component part(s) (rather than 

tests of the finished product), the 

manufacturer would be required to 

demonstrate how the combination of 

testing of component part(s), portions of 

the finished product, and finished 

product samples demonstrate, with a 

high degree of assurance, compliance 

with all applicable rules, bans, 

standards, or regulations. 

Proposed § 1107.10(b)(2)(ii) would 

state that a material change is any 

change in the product’s design, 

manufacturing process, or sourcing of 

component parts that a manufacturer 

exercising due care knows, or should 

know, could affect the product’s ability 

to comply with the applicable rules, 

bans, standards, or regulations. 

Proposed § 1107.10(b)(2)(ii)(A) would 

state that when a previously-certified 

product undergoes a material change 

that only affects the product’s ability to 

comply with certain applicable rules, 

bans, standards, or regulations, 

certification for the new product 

specification may be based on 

certification testing of the materially 

changed component part, material, or 

process, and the passing certification 

tests of the portion of the previouslycertified product that were not 

materially changed. For example, if a 

material change is limited to using a 

different paint on the product, new 

certification testing of that product may 

be limited to evaluating the paint to the 

applicable safety rules. 

Proposed § 1107.10(b)(2)(ii)(B) would 

require a manufacturer to conduct a 

certification test of the finished product 

if a material change affects the finished 

product’s ability to comply with an 

applicable rule, ban, standard, or 

regulation. Proposed 

§ 1107.10(b)(2)(ii)(C) would require a 

manufacturer to exercise due care to 

ensure that reliance on anything other 

than retesting of the finished product 

after a material change occurs does not 

allow a noncompliant product to be 

distributed in commerce. A 

manufacturer should resolve any doubts 

in favor of retesting the finished product 

for certification. 

Proposed § 1107.10(b)(3) would 

explain that a production testing plan 

describes what tests must be performed 

and the frequency at which those tests 

must be performed to provide a high 

degree of assurance that the products 

manufactured after certification 

continue to meet all the applicable 

safety rules, bans, standards, or 

regulations. A production testing plan 

may include recurring testing or the use 

of process management techniques, 

such as control charts, statistical process 

control programs, or failure modes and 

effects analyses (FMEAs), designed to 

control potential variations in product 

manufacturing that could affect the 

product’s ability to comply with the 

applicable rules, bans, standards, or 

regulations. 

Proposed § 1107.10(b)(3)(i) through 

(iii) would require a production test 

plan to contain the following elements: 

• A description of the production 

testing plan, including, but not limited 

to, a description of the tests to be 

conducted or the measurements to be 

taken, the intervals at which the tests or 

measurements will be made, the number 

of samples tested, and the basis for 

determining that such tests provide a 

high degree of assurance of compliance 

if they are not the tests prescribed in the 

applicable rule, ban, standard, or 

regulation. 

• A separate production testing plan 

for each manufacturing site; and 

• Production testing intervals 

selected to be short enough to ensure 

that, if the samples selected for 

production testing comply with an 

applicable rule, ban, standard, or 

regulation, there is a high degree of 

assurance that the untested products 

manufactured during that interval also 

will comply with the applicable rule, 

ban standard, or regulation. Production 

test intervals should be appropriate for 

the specific testing or alternative 

measurements being conducted. 

Proposed § 1107.10(b)(3)(iii)(A) would 

allow a manufacturer to use 

measurement techniques that are 

nondestructive and tailored to the needs 

of an individual product instead of 

conducting product performance tests to 

assure a product complies with all 

applicable rules, bans, standards, or 

regulations. For example, a 

manufacturer may have determined 

that, by controlling the particle size and 

water content of cellulose insulation, it 

is possible to determine compliance to 

the cellulose insulation critical radiant 

flux test (16 CFR part 1209.6) by 

examination of a sample of a fixed 

volume under a graduated microscope 

and measuring its weight. Sizes and 

weights within certain limits mean that 

the insulation will pass the critical 

radiant flux test. As another example, a 

manufacturer may choose to determine 

compliance to the requirements for 

garage door opener photoelectric 

sensors (16 CFR 1211.11) by placing the 

sensor in a fixture with a calibrated light 

flux, then measuring the response 

voltage of the light-sensitive element 

directly. An element output voltage 

above a threshold would indicate 

passing performance for the tests 

described in the safety standard. 

Proposed § 1107.10(b)(3)(iii)(B) would 

require any production test method 

used to conduct production testing to be 

as effective in detecting noncompliant 

products as the tests used for 

certification. Proposed 

§ 1107.10(b)(3)(iii)(C) would state that if 

a manufacturer is uncertain whether a 

production test is as effective as the 

certification test, the manufacturer must 

use the certification test. For example, if 

the probability that all production 

products are compliant using the tests 

methods used for certification is 95 

percent, the probability that all 

production products are compliant 

using alternative testing methods should 

be at least 95 percent. If there is 

uncertainty whether the test method 


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will achieve the same level of detection 

of compliance, then the specific tests 

required by the applicable rules should 

be used. 

Proposed § 1107.10(b)(4) would 

describe the remedial action plan. 

Proposed § 1107.10(b)(4)(i) would state 

that a remedial action plan describes the 

steps to be taken whenever samples of 

a product or a component part of a 

product fails a test or fails to comply 

with an applicable rule, ban, standard, 

or regulation. A remedial action plan 

would be required to contain 

procedures the manufacturer must 

follow to investigate and address failing 

test results in addition to any reporting 

obligation it may have. Manufacturers 

would be required to take remedial 

action after any failing test result to 

ensure with a high degree of assurance 

that the products manufactured after the 

remedial action has been taken comply 

with the applicable rules, bans, 

standards, or regulations. The type of 

remedial action may differ depending 

upon the applicable rule, ban, standard, 

or regulation. Proposed 

§ 1107.10(b)(4)(i) also would state that a 

remedial action can include, but is not 

limited to, the following: 

• Changes to the manufacturing 

process, the equipment used to 

manufacture the product, the product’s 

materials, or design; 

• Reworking the product produced; 

or 

• Other actions deemed appropriate 

by the manufacturer, in the exercise of 

due care, to assure compliant products. 

Proposed § 1107.10(b)(4)(ii) would 

state that any remedial action that 

results in a material change to a 

product’s design, parts, suppliers of 

parts, or manufacturing process that 

could affect the product’s ability to 

comply with any applicable rules would 

require a new product specification for 

that product. Before a product covered 

by the new product specification can be 

certified as compliant with the 

applicable rules, bans, standards, or 

regulations, a manufacturer would be 

required to have passing certification 

test results for the applicable rules, 

bans, standards, or regulations. 

Proposed § 1107.10(b)(5) would 

impose recordkeeping requirements to 

document the reasonable testing 

program. Documentation is necessary to 

establish the identity of the product, 

and to demonstrate that the product 

complies with the applicable rules, 

when it is certified and on a continuing 

basis as production progresses. 

Documentation supports the validity of 

a general conformity certificate and 

provides validation that a test of each 

product produced is not necessary. 

Proposed § 1107.10(b)(5)(i)(A) through 

(b)(5)(i)(E) would identify the records 

that a manufacturer of a nonchildren’s 

product would be required to maintain. 

In brief, these records would be: 

• Records of the general conformity 

certificate for each product; 

• Records of each product 

specification; 

• Records of each certification test 

and, if the manufacturer elected to have 

a third party conformity assessment 

body test the product, identification of 

any third party conformity assessment 

body on whose testing the certificate 

depends. Records of certification tests 

would be required to describe how the 

product was certified as meeting the 

requirements, including how each 

applicable rule was evaluated, the test 

results, and the actual values of the 

tests; 

• Records to demonstrate compliance 

with the production testing plan 

requirement, including a list of the 

applicable rules, bans, standards, or 

regulations, a description of the types of 

production tests conducted, the number 

of samples tested, the production 

interval selected for performance of 

each test, and the test results. Records 

of a production test program would be 

required to describe how the production 

tests demonstrate that the continuing 

production complies with the 

applicable rules. References to 

techniques in relevant quality 

management and control standards, 

such as ANSI/ISO/ASQ Q9001–2008: 

Quality management systems— 

Requirements, ANSI/ASQ Z1.4–2008: 

Sampling Procedures and Tables for 

Inspection by Attributes, and/or ANSI/ 

ASQ Z1.9–2008: Sampling Procedures 

and Tables for Inspection by Variables 

for Percent Nonconforming, would be 

allowed to demonstrate that the 

production tests have the necessary 

accuracy, precision sensitivity, 

repeatability, and confidence to 

distinguish between compliant and 

noncompliant products. These 

standards are widely recognized in 

industry and were developed by 

organizations with international 

exposure and millions of members. 

Retaining test results can help identify 

the events that led to the creation of 

noncompliant products, the number of 

products affected, and their disposition; 

and 

• Records of all remedial actions 

taken, including the specific action 

taken, the date the action was taken, the 

person who authorized the actions, and 

any test failure which necessitated the 

action. Records of remedial action 

would be required to relate the action 

taken to the product specification of the 

product that was the subject of that 

remedial action and the product 

specification of any new product 

resulting from any remedial action. 

Proposed § 1107.10(b)(5)(ii) would 

require a manufacturer to create a new 

set of records for a product if a remedial 

action results in a new product 

specification. 

Proposed § 1107.10(b)(5)(iii) would 

require a manufacturer to maintain the 

records specified in subpart B at the 

location within the United States 

specified in 16 CFR 1110.11(d) or, if the 

records are not maintained at the 

custodian’s address, at a location within 

the United States specified by the 

custodian. The manufacturer would be 

required to make these records 

available, either in hard copy or 

electronically, for inspection by the 

CPSC upon request. 

Proposed § 1107.10(b)(5)(iv) would 

require a manufacturer to maintain 

records (except for test records) for as 

long as the product is being produced or 

imported by the manufacturer plus five 

years. The proposal also would require 

test records to be maintained for five 

years and all records to be available in 

the English language. Records would be 

required to be maintained for five years 

because the statute of limitations under 

28 U.S.C. 2462 allows the Commission 

to bring an action within that time. It 

would be unnecessarily burdensome to 

require a manufacturer to maintain 

records beyond the time the 

Commission could pursue an action. 

Proposed § 1107.10(c) would state 

that, if any certification test results in a 

failure, a manufacturer cannot certify a 

product until the manufacturer has 

taken remedial action, and the product 

manufactured after the remedial action 

passes certification testing. 

Proposed § 1107.10(d) would state 

that a manufacturer of a nonchildren’s 

product may, but is not required to, use 

a third party conformity assessment 

body to conduct certification testing. 

The third party conformity assessment 

body would not have to be a third party 

conformity assessment body recognized 

by the CPSC to conduct certification 

testing on children’s products. 

Proposed § 1107.10(e) would state 

that manufacturers of children’s 

products may voluntarily establish a 

reasonable testing program consistent 

with this subpart. 

3. Proposed Subpart C—Certification of 

Children’s Products 

Proposed subpart C would contain the 

requirements pertaining to the 

certification of children’s products. The 

subpart would consist of seven sections, 

and most sections would implement the 


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requirements in section 14(d)(2)(B) of 

the CPSA. 

Some industries have developed and 

implemented testing and certification 

programs that are intended to determine 

compliance with specific standards. The 

Commission invites comments about 

such programs. 

a. Proposed § 1107.20—General 

Requirements 

Proposed § 1107.20(a) would require 

manufacturers to submit a sufficient 

number of samples of a children’s 

product, or samples that are identical in 

all material respects to the children’s 

product, to a third party conformity 

assessment body for testing to support 

certification. The proposal would not 

specify the exact number of samples to 

be tested; instead, the proposal would 

require that the number of samples 

selected provide a high degree of 

assurance that the tests conducted for 

certification purposes accurately 

demonstrate the ability of the children’s 

product to meet all applicable children’s 

product safety rules. 

Proposed § 1107.20(b) would state 

that, if the manufacturing process for a 

children’s product consistently creates 

parts that are uniform in composition 

and quality, a manufacturer may submit 

fewer samples to provide a high degree 

of assurance that the finished product 

complies with the applicable children’s 

product safety rules. If the 

manufacturing process for a children’s 

product results in variability in the 

composition or quality of children’s 

products, a manufacturer may need to 

submit more samples to provide a high 

degree of assurance that the finished 

product complies with the applicable 

children’s product safety rules. An 

example of a manufacturing process that 

consistently creates highly similar parts 

would be die casting. Manufacturing 

processes with greater inherent 

variability may necessitate testing of 

more samples to provide a high degree 

of assurance that the finished product 

complies with the applicable children’s 

product safety rules. An example of a 

manufacturing process with greater 

inherent variability would be hand 

assembly of the product. 

Proposed § 1107.20(c) would state 

that, except where otherwise specified 

by a children’s product safety rule, a 

manufacturer may substitute component 

part testing for finished product testing 

pursuant to 16 CFR part 1109 if the 

component part, without the remainder 

of the finished product, is sufficient to 

determine compliance for the finished 

product. For example, assume that a 

children’s product is a cotton sweater 

with a metal zipper and that the 

manufacturer wishes to test the sweater 

for compliance to the lead limits in 

section 101 of the CPSIA. Because the 

Commission has determined that 

textiles, such as cotton, do not exceed 

the statutory lead limits, the 

manufacturer would test the metal 

zipper only for lead rather than the 

cotton in the sweater. In this example, 

therefore, testing the component part 

(the metal zipper) is sufficient to 

determine the finished product’s 

compliance with the lead limit. 

Proposed § 1107.20(d) would state 

that, if a product sample fails 

certification testing, even if other 

samples have passed the same 

certification test, the manufacturer must 

investigate the reasons for the failure 

and take remedial action. A 

manufacturer would not be allowed to 

certify the children’s product until the 

manufacturer establishes, with a high 

degree of assurance, that the finished 

product does comply with all applicable 

children’s product safety rules. 

b. Proposed § 1107.21 Periodic Testing 

Section 14(d)(2)(B)(i) of the CPSA 

requires children’s products to be tested 

periodically for compliance with all 

applicable children’s product safety 

rules. Although the statute does not 

require all periodic testing to be 

conducted by a third party conformity 

assessment body, the Commission 

proposes to require that manufacturers 

submit samples of their products to a 

third party conformity assessment body 

for testing to the applicable children’s 

product safety rules at least once every 

two years if they have a reasonable 

testing program. As proposed by the 

Commission, not every periodic test has 

to be done by a third party conformity 

assessment body if the manufacturer has 

implemented four elements of a 

reasonable testing program as described 

in subpart B of this part (certification for 

children’s products is covered by 

proposed § 1107.20 of this part). 

Depending upon the type and rigor of 

the production testing done by a 

manufacturer, and the manufacturer’s 

ability to do in-house compliance 

testing of the product or component part 

to the applicable children’s product 

safety rule(s), production testing may 

serve as the non-third party periodic 

compliance testing. The Commission 

recognizes that some compliance testing 

may be too complex for a manufacturer 

to undertake in-house. In that case, the 

manufacturer may elect to have the 

product or a component part tested by 

a third party which may or may not be 

a third party conformity assessment 

body, depending upon whether the test 

satisfies the schedule for periodic 

testing described above. Other 

circumstances may arise during 

production of the product that may 

require consideration of additional 

testing by a third party conformity 

assessment body. The factors described 

in proposed § 1107.21(c)(2) may provide 

some guidance in those circumstances. 

Proposed § 1107.21(a) would 

implement the periodic testing 

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

the CPSA by requiring each 

manufacturer to conduct periodic 

testing at least annually, except as 

otherwise provided in paragraphs (b) 

and (d) of this section (which we 

discuss later in this part of the 

preamble) or as provided in regulations 

under this title. Manufacturers may 

need to conduct periodic tests more 

frequently than on an annual basis to 

ensure a high degree of assurance that 

the product being tested complies with 

all applicable children’s product safety 

rules. More frequent periodic testing 

may help a manufacturer identify 

noncompliant products more quickly 

and, as a result, may limit the scope of 

any potential product recall. In 

addition, more frequent testing may 

reduce the manufacturer’s liability for 

civil penalties resulting from a 

noncompliant product, reduce potential 

damage to a manufacturer’s reputation, 

and increase the manufacturer’s 

confidence in the effectiveness of the 

periodic testing. 

Proposed § 1107.21(b) would state 

that, if a manufacturer has implemented 

a reasonable testing program as 

described in subpart B of this part (with 

the exception of the certification 

element which, for children’s products, 

would be required to comply with the 

requirements in proposed § 1107.20), it 

would be required to submit samples of 

its product to a third party conformity 

assessment body for periodic testing to 

all applicable children’s product safety 

rules at least once every two years. If a 

manufacturer’s reasonable testing 

program fails to provide a high degree 

of assurance of compliance with all 

applicable children’s product safety 

rules, the Commission may require the 

manufacturer to meet the requirements 

of proposed § 1107.21(c) or modify its 

reasonable testing program to ensure a 

high degree of assurance. Currently, the 

rule on children’s bicycle helmets is the 

only children’s product safety rule that 

contains requirements for a reasonable 

testing program. The reasonable testing 

program requirements in this rule are 

not intended to replace that preexisting 

testing requirement. For existing rules 

that contain testing requirements and do 

not contain specific testing programs, 

the reasonable testing program and the 


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two year minimum third party 

conformity assessment testing 

requirement establishes the minimum 

set of requirements for periodic testing. 

As the Commission promulgates new or 

revised children’s product safety rules, 

it may establish different testing 

requirements for those children’s 

products than the requirements 

described in this proposed rule. 

Proposed § 1107.21(c) would state 

that, if a manufacturer has not 

implemented a reasonable testing 

program as described in subpart B of 

this part, then all periodic testing would 

be required to be conducted by a third 

party conformity assessment body, and 

the manufacturer would be required to 

conduct periodic testing described in 

proposed § 1107.21(c)(1) and (c)(2). In 

brief, proposed § 1107.21(c)(1) would 

require the manufacturer to develop a 

periodic test plan to assure that 

children’s products manufactured after 

the issuance of a children’s product 

certification, or when the previous 

periodic testing was conducted, 

continue to comply with all applicable 

children’s product safety rules. The 

periodic test plan would have to include 

the tests to be conducted, the intervals 

at which the tests will be conducted, the 

number of samples tested, and the basis 

for determining that the periodic testing 

plan provides a high degree of assurance 

that the product being tested continues 

to comply with all applicable children’s 

product safety rules. The proposal 

would require the manufacturer to have 

a separate periodic testing plan for each 

manufacturing site producing a 

children’s product. 

Proposed § 1107.21(c)(2) would 

require the periodic testing interval 

selected to be short enough to ensure 

that, if the samples selected for periodic 

testing pass the test, there is a high 

degree of assurance that the other 

untested children’s products 

manufactured during the interval 

comply with the applicable children’s 

product safety rules. The interval for 

periodic testing may vary depending 

upon the specific children’s product 

safety rules that apply to the children’s 

product. For example, the intervals 

selected to test for small parts where 

there is variability in the factors 

assuring that no small parts are created, 

and for lead in paint, where one tested 

container is used for a large production 

volume, may not be the same. Assuring 

that products do not generate small 

parts may require more frequent testing 

than that required to assure that the 

paint used does not contain lead in 

excess of the acceptable limits. The 

appropriate periodic testing interval 

may vary for a manufacturer depending 

on the manufacturer’s knowledge of the 

product and its manufacturing 

processes. Under proposed 

§ 1107.21(c)(2)(i) through (c)(2)(ix), 

factors to be considered when 

determining the periodic testing interval 

would include, but not be limited to: 

• High variability in test results, as 

indicated by a relatively large sample 

standard deviation in quantitative tests; 

• Measurements that are close to the 

allowable numerical limit for 

quantitative tests; 

• Known manufacturing process 

factors which could affect compliance 

with a rule. For example, if the 

manufacturer knows that a casting die 

wears down as the die nears the end of 

its useful life, the manufacturer may 

wish to test more often as the casting die 

wears down; 

• Consumer complaints or warranty 

claims; 

• Nonmaterial changes such as 

introduction of a new set of component 

parts into the assembly process, or the 

manufacture of a fixed number of 

products; 

• Potential for serious injury or death 

resulting from a noncompliant 

children’s product; 

• The number of children’s products 

produced annually, such that a 

manufacturer should consider testing a 

children’s product more frequently if 

the product is produced in very large 

numbers or distributed widely 

throughout the United States; 

• The children’s product’s similarity 

to other children’s products with which 

the manufacturer is familiar and/or 

whether the children’s product has 

many different component parts 

compared to other children’s products 

of a similar type; and 

• The inability to determine the 

children’s product’s noncompliance 

easily through means such as visual 

inspection. 

Proposed § 1107.21(d) would pertain 

to the periodic testing frequency for 

low-volume manufacturers. In brief, the 

proposal would not require a 

manufacturer to conduct periodic 

testing unless it has produced or 

imported more than 10,000 units of a 

particular product. (See Appendix A of 

the Memorandum Requirements for 

Certification and Continued Testing of 

Children’s Products, Established by the 

Consumer Product Safety Improvement 

Act of 2008 from Randy Butturini, 

Office of Hazard Identification and 

Reduction, for Commission staff’s 

rationale for selecting the 10,000 

number). The proposed rule would not 

require periodic testing at every 10,000 

units manufactured; instead, once that 

threshold has been reached, the 

manufacturer would be subject to the 

periodic testing requirements of 

proposed § 1107.21(a), and (b) or (c). 

The manufacturer is responsible for 

deciding how often such periodic 

testing will occur. In other words, 

assume that a manufacturer produces 

9,000 units of product X. Under the 

proposal, the manufacturer would not 

have to engage in periodic testing unless 

it produces 10,000 units of product X; 

at that time, the manufacturer would be 

required to conduct periodic testing on 

an annual basis (under proposed 

§ 1107.21(a)) and it would be required to 

comply with the requirements of 

proposed § 1107.21(b) or § 1107.21 (c) 

(depending on whether the 

manufacturer has implemented a 

reasonable testing program under 

subpart B). The proposal would not 

require the manufacturer to engage in 

periodic testing every time it produces 

10,000 units of product X. 

The low-volume exception would 

apply both to manufacturers and 

importers who produce or import a 

specific product at a low volume 

(10,000 units under the proposed rule). 

In other words, proposed § 1107.21(d) 

would focus on the volume of a specific 

product rather than attempt to 

distinguish between ‘‘large’’ and ‘‘small’’ 

manufacturers. Thus, an individual who 

hand carves 30 products would fall 

within proposed § 1107.21(d), as would 

a multinational corporation who makes 

9,000 units of a particular product. 

c. Proposed § 1107.22—Random 

Samples 

Proposed § 1107.22 would implement 

the testing of random samples 

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

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. We 

recognize that there are alternative 

approaches for deciding whether 

something represents a ‘‘random’’ 

sample. One alternative approach would 

be to say that a random sample is a 

sample not intentionally identified 

beforehand for testing. Another possible 

approach would be to require only that 

a random sample adequately represent 

the production sample pool from which 

it was chosen. The Commission chose 

neither alternative because the purpose 

of random sampling is to establish a 

basis for inferring compliance about a 

population of untested products from a 

set of tested products. If the products 

selected for testing are not randomly 

selected, there is no statistical basis for 

inferring the compliance of the untested 


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28350 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

products. Manufacturers may select 

additional samples based on the 

manufacturer’s knowledge of the 

product and its production to provide 

greater assurance of compliance. For 

example, if a manufacturer knows its 

control over compliance degrades with 

continuing production, the 

manufacturer may always test the last 

unit produced. Proposed § 1107.22 

would state that the production 

population is the number of products 

manufactured or imported after the 

initial certification or last periodic 

testing of a children’s product. Proposed 

§ 1107.22 would allow a manufacturer 

to use a procedure that randomly selects 

items from a list to determine which 

samples are the random samples for 

testing before production begins. For 

example, if the planned production 

quantity in a period is 50,000, and 12 

random samples are to be selected for 

periodic testing, before the products are 

manufactured, a random process would 

have to identify which 12 of the 50,000 

will be selected for periodic testing. 

Manufacturers that produce products 

that continue to be distributed in 

commerce as they are manufactured 

may wish to test the random samples as 

they are selected to minimize the 

potential quantity of noncompliant 

products if a test has failing test results. 

Proposed § 1107.22 would allow 

manufacturers to select samples for 

testing as they are manufactured. 

Proposed § 1107.22 would allow 

manufacturers who produce children’s 

products that continue to be distributed 

in commerce as they are manufactured 

to test the samples as they become 

available instead of waiting until all the 

random samples have been selected 

before conducting testing. 

d. Proposed § 1107.23—Material Change 

Proposed § 1107.23 would implement 

the requirement in section 14(d)(2)(B)(i) 

of the CPSA to test a children’s product 

when a material change has occurred. 

Proposed § 1107.23(a) would state that if 

a children’s product undergoes a 

material change in product design or 

manufacturing process, including the 

sourcing of component parts, that a 

manufacturer exercising due care knows 

or should know that such material 

change could affect the product’s ability 

to comply with the applicable children’s 

product safety rules, the manufacturer 

must submit a sufficient number of 

samples of the materially changed 

product for testing by a third party 

conformity assessment body. Such 

testing would be required before a 

manufacturer could certify the 

children’s product. The extent of such 

testing would depend on the nature of 

the material change. Proposed 

§ 1107.23(a) would state that, when a 

material change is limited to a 

component part of the finished 

children’s product and does not affect 

the ability of the children’s product to 

meet other applicable children’s 

product safety rules, a manufacturer 

may issue a children’s product 

certificate based on the earlier third 

party certification tests and on test 

results of the changed component part 

conducted by a third party conformity 

assessment body. For example, if the 

paint is changed on a children’s 

product, issuance of a children’s 

product certificate may be based on 

previous product testing and on tests of 

the new paint for compliance to lead, 

heavy metal, and phthalate 

concentrations. 

Proposed § 1107.23(a) also would 

state that changes that cause a children’s 

product safety rule to no longer apply to 

a children’s product are not considered 

to be material changes. For example, 

assume that a children’s product 

consists of a cotton sweater with metal 

buttons and that the children’s product 

would be subject to the lead limits in 

section 101 of the CPSIA. If the 

manufacturer decided to use wooden 

buttons instead of metal buttons, the use 

of wooden buttons would eliminate the 

need to test the product for lead, and the 

change to wooden buttons, while 

arguably a change in the product’s 

component parts, would not be a 

‘‘material change’’ under proposed 

§ 1107.23(a) for the purposes of 

complying with the lead content limits. 

However, for other children’s product 

safety rules, such as small parts, the 

change may be a material change. 

Proposed § 1107.23(a) also would 

require a manufacturer to exercise due 

care to ensure that reliance on anything 

other than retesting of the finished 

product after a material change would 

not allow a noncompliant children’s 

product to be distributed in commerce. 

A manufacturer should resolve any 

doubts in favor of retesting the finished 

product for certification. Additionally, a 

manufacturer would be required to 

exercise due care to ensure that any 

component part undergoing componentpart-level testing is the same as the 

component part on the finished 

children’s product in all material 

respects. 

Proposed § 1107.23(b) would state 

that, for purposes of proposed subpart 

B, the term ‘‘product design’’ includes all 

component parts, their composition, 

and their interaction and functionality 

when assembled. To determine which 

children’s product safety rules apply to 

a children’s product, a manufacturer 

should examine the product design for 

the children’s product as received by 

the consumer. For example, if a 

children’s product has a component part 

that contains lead or has a sharp edge, 

but is inaccessible when the product is 

assembled, then the lead and sharp edge 

requirements would not be applicable to 

the finished product. Changes to a 

product’s design may result in a product 

being subject to additional children’s 

product safety rules. For example, if a 

wooden button on a children’s product 

is replaced with a plastic button, the 

wooden button previously excluded 

from testing for lead content has been 

replaced with a component part that 

would be subject to testing for 

compliance with the lead content 

requirements. 

Proposed § 1107.23(c) would state 

that a material change in the 

manufacturing process is a change in 

how the children’s product is made that 

could affect the finished children’s 

product’s ability to comply with the 

applicable children’s product safety 

rules. For each change in the 

manufacturing process, a manufacturer 

should exercise due care to determine if 

compliance to an existing applicable 

children’s product safety rule could be 

affected or if the change results in a 

newly-applicable children’s product 

safety rule. The following are some 

examples of a material change to the 

manufacturing process of a children’s 

product: 

• A new technique is used to fasten 

buttons to a doll’s dress which could 

affect the children’s products ability to 

comply with the small parts rule; 

• New solvents are used to clean 

equipment employed in the 

manufacture of children’s products; the 

new solvents could affect the children’s 

products ability to comply with the lead 

content and phthalates requirements; 

and 

• A new mold for an accessible metal 

component part of a children’s product 

is introduced into the assembly line 

which could affect the children’s 

products ability to comply with 

requirements for sharp edges. 

Proposed § 1107.23(d) would state 

that a material change in the sourcing of 

component parts results when the 

replacement of one component part of a 

children’s product with another 

component part could affect compliance 

with the applicable children’s product 

safety rules. This would include, but is 

not limited to, changes in component 

part composition, component part 

supplier, or the use of a different 

component part from the same supplier 

who provided the initial component 

part. 


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e. Proposed § 1107.24—Undue Influence 

Proposed § 1107.24(a) would 

implement the requirement to safeguard 

against undue influence, pursuant to 

section 14(d)(2)(B)(iv) of the CPSA, by 

requiring each manufacturer to establish 

procedures to safeguard against the 

exercise of undue influence by a 

manufacturer on a third party 

conformity assessment body. 

Proposed § 1107.24(b)(1) would 

require the procedures established 

under proposed § 1107.24(a) to include, 

at a minimum: 

• Safeguards to prevent attempts by 

the manufacturer to exercise undue 

influence on a third party conformity 

assessment body, including a written 

policy statement from company officials 

that the exercise of undue influence is 

not acceptable, and directing that 

appropriate staff receive annual training 

on avoiding undue influence, and sign 

a statement attesting to participation in 

such training; 

• A requirement to notify the 

Commission immediately of any attempt 

by the manufacturer to hide or exert 

undue influence over test results; and 

• A requirement to inform employees 

that allegations of undue influence may 

be reported confidentially to the 

Commission and to describe the manner 

in which such a report can be made. 

f. Proposed § 1107.25—Remedial Action 

Proposed § 1107.25(a) would require 

each manufacturer of a children’s 

product to have a remedial action plan 

that contains procedures the 

manufacturer must follow to investigate 

and address failing test results. A 

manufacturer would be required to take 

remedial action after any failing test 

result to ensure, with a high degree of 

assurance, that the children’s products 

manufactured after the remedial action 

has been taken comply with all 

applicable children’s product safety 

rules. 

Proposed § 1107.25(b) would not 

permit a manufacturer to certify a 

product if any certification test by a 

third party conformity assessment body 

results in a failure, until the 

manufacturer has taken remedial action 

and the product manufactured after the 

remedial action passes certification 

testing. 

Proposed § 1107.25(c) would require a 

manufacturer whose children’s product 

has received a failing test result to take 

remedial action to ensure, with a high 

degree of assurance, that the children’s 

product complies with all applicable 

children’s product safety rules. The 

proposal would state that remedial 

action can include, but is not limited to, 

redesign, changes in the manufacturing 

process, or changes in component part 

sourcing. For existing production, 

remedial action may include rework, 

repair, or scrap of the children’s 

product. If a remedial action results in 

a material change, the proposed rule 

would require a manufacturer to have a 

third party conformity assessment body 

retest the redesigned or remanufactured 

product before the manufacturer can 

certify the product. 

g. Proposed § 1107.26—Recordkeeping 

Proposed § 1107.26(a) would require a 

children’s product manufacturer subject 

to an applicable children’s product 

safety rule to maintain the following 

records: 

• Records of the children’s product 

certificate for each product. The 

children’s product covered by the 

certificate must be clearly identifiable 

and distinguishable from other 

products; 

• Records of each third party 

certification test. The manufacturer 

must have separate certification tests 

records for each manufacturing site; 

• Records of the periodic test plan 

and periodic test results for a children’s 

product; 

• Records of descriptions of all 

material changes in product design, 

manufacturing process, and sourcing of 

component parts, and the certification 

tests run and the test values; 

• Records of the undue influence 

procedures, including training materials 

and training records of all employees 

trained on these procedures; and 

• Records of all remedial actions 

taken following a failing test result, 

including the rule that was tested, the 

specific remedial action taken, the date 

the action was taken, the person who 

authorized the action, any test failure 

which necessitated the action, and the 

results from certification tests showing 

compliance after the remedial action 

was taken. 

Proposed § 1107.26(b) would require a 

manufacturer to maintain the records 

specified in subpart C at the location 

within the United States specified in 16 

CFR 1110.11(d) or, if the records are not 

maintained at the custodian’s address, 

at a location within the United States 

specified by the custodian. The 

manufacturer would be required to 

make these records available, either in 

hard copy or electronically, for 

inspection by the CPSC upon request. 

Proposed § 1107.26(c) would require a 

manufacturer to maintain records 

(except for test records) for as long as 

the product is in production or 

imported by the manufacturer plus 5 

years. Test records would be required to 

be maintained for 5 years. All records 

would be required to be available in the 

English language. 

4. Proposed Subpart D—Consumer 

Product Labeling Program 

a. Introduction 

Proposed subpart D, consisting of one 

section, would implement the label 

provision at section 14(d)(2)(A) of the 

CPSA. Section 14(d)(2)(A) of the CPSA 

requires the Commission to initiate a 

program by which a manufacturer or 

private labeler may label a consumer 

product as complying with the 

certification requirements in section 

14(a) of the CPSA. 

b. Proposed § 1107.40 Labeling 

Consumer Products To Indicate That the 

Certification Requirements of Section 14 

of the CPSA Have Been Met 

Proposed § 1107.40(a) would allow 

manufacturers and private labelers of a 

consumer product to indicate, by a 

uniform label on or provided with the 

product, that the product complies with 

any consumer product safety rule under 

the CPSA, or with any similar rule, ban, 

standard or regulation under any other 

act enforced by the CPSC. 

Proposed § 1107.40(b) would require 

the label to be printed in bold typeface, 

using an Arial font of not less than 12 

points, be visible and legible, and state 

‘‘Meets CPSC Safety Requirements’’. 

The Commission considered whether 

a shorter label statement would 

adequately convey the intended 

message and concluded that it would 

not. Acronyms such as ‘‘CPSIA’’ or 

‘‘CPSA’’ were considered. However, the 

Commission concluded that the 

meaning of the acronym might not be 

known to a sufficient number of people. 

Further, even those persons who might 

know what the acronyms stood for 

would not necessarily know why it was 

marked on the label or product. The 

acronym ‘‘CPSC’’ might be more widely 

recognized, but viewers still may not 

know why it is present. Further, the 

Commission does not want the presence 

of a ‘‘CPSC’’ marking on a label, package, 

or product to give the impression that 

the CPSC has tested, approved, or 

endorsed the product. 

The Commission also considered the 

statement ‘‘Meets CPSC Requirements,’’ 

but this statement did not seem very 

informative for persons who did not 

recognize the term ‘‘CPSC.’’ Inserting the 

word ‘‘safety’’ to form the statement 

‘‘Meets CPSC Safety Requirements’’ 

would convey the message that the 

product met some safety requirements, 

even to those persons who are not 

familiar with CPSC. Giving the full 


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28352 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

name of the CPSC would make the 

statement too long to be practical in 

some cases, and the length could 

discourage viewers from reading the 

message. Therefore, the proposal would 

have the statement say ‘‘Meets CPSC 

Safety Requirements’’ to indicate that 

the product has been certified by the 

manufacturer or private labeler as 

complying with all applicable safety 

requirements enforced by CPSC. 

Proposed § 1107.40(c) would allow a 

consumer product to bear the label if the 

manufacturer or private labeler has 

certified, pursuant to section 14 of the 

CPSA, that the consumer product 

complies with all applicable consumer 

product safety rules under the CPSA 

and with all rules, bans, standards, or 

regulations applicable to the product 

under any other act enforced by the 

Consumer Product Safety Commission. 

Proposed § 1107.40(d) would allow a 

manufacturer or private labeler to use 

another label on the consumer product 

as long as such label does not alter or 

mislead consumers as to the meaning of 

the label described in proposed 

§ 1107.40(b). A manufacturer or private 

labeler would not be allowed to imply 

that the CPSC has tested, approved, or 

endorsed the product. 

D. Regulatory Flexibility Act 

1. Introduction 

The Commission has examined the 

impact of the proposed rule under the 

Regulatory Flexibility Act (5 U.S.C. 601 

through 612). The Regulatory Flexibility 

Act requires agencies to analyze 

regulatory options that would minimize 

any significant impact of a rule on small 

entities. The Commission has conducted 

an initial regulatory flexibility analysis 

of the proposed rule regarding the 

potential impact on small entities. 

2. Objectives and Legal Basis for 

Proposed Rule 

The Commission is proposing this 

rule to implement sections 14(a) and 

14(d)(2)(A) and (B) of the CPSA, as 

amended by the CPSIA. The objective of 

the rule is to reduce the risk of injury 

from consumer products, especially 

from products intended for children 

aged 12 years and younger. The rule 

will accomplish this objective by 

requiring that manufacturers of 

nonchildren’s products that are subject 

to consumer product safety rules 

develop and maintain a reasonable 

testing program that provides a high 

degree of assurance that their products 

conform to all the applicable safety 

standards. For children’s products, an 

additional layer of protection is 

provided by requiring that certain 

testing be performed by a third party 

conformity assessment body. The 

proposed testing programs should allow 

manufacturers to discover noncompliant 

products and take the necessary 

corrective actions to keep noncompliant 

products from entering commerce or to 

remove them expeditiously if they have 

been introduced into commerce. 

3. Number of Small Firms Impacted 

The number of firms that could be 

impacted was estimated by reviewing 

every category in the North American 

Industrial Classification System 

(NAICS) and selecting those firms that 

manufacture or sell any consumer 

product that could be covered by a 

consumer product safety rule. These 

firms include any establishment that 

could manufacture or sell a 

nonchildren’s product or children’s 

products. Firms are classified by an 

NAICS code that describes their primary 

activity. Therefore, firms that might 

manufacture or import consumer 

products covered by a consumer 

product safety rule as a secondary or 

tertiary activity might not have been 

counted. There is no separate NAICS 

category for importers. Firms that 

import product might be classified as 

manufacturers, wholesalers, or retailers. 

a. Manufacturers 

According to the criteria established 

by the 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 manufacturers that 

are classified by the NAICS categories 

that cover most children’s and general 

use products that are subject to a 

consumer product safety rule. Although 

there are more than 36,000 

manufacturers that would be considered 

small in these categories, not all of these 

firms are engaged in manufacturing 

children’s products or general use 

products that are subject to a consumer 

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, All Other 

Miscellaneous Chemical Product and 

Preparation Manufacturing includes 

some products such as matchbooks and 

fireworks, subject to consumer product 

safety rules but also includes products, 

such as distilled water and hydraulic 

fluids, that are not subject to consumer 

product safety rules. All Other 

Miscellaneous Electrical Equipment and 

Component Manufacturing includes 

consumer products such as garage door 

openers as well as non consumer 

products such as particle accelerators. 

The Surgical Appliance and Supplies 

Manufacturing category includes 

bicycle helmets, but most of the other 

products in this category are not under 

CPSC jurisdiction. 

TABLE 2—MANUFACTURERS

NAICS code Description Small firms Total firms 

31411 .......... Carpet and Rug Mills ..................................................................................................................... 261 284 

31519 .......... Other Apparel Knitting Mills (Outerwear, Underwear, and Sleepwear) ......................................... 235 246 

3152 ............ Cut and Sew Apparel Manufacturing ............................................................................................. 9,313 9,388 

3159 ............ Apparel Accessories and Other Apparel Manufacturing ............................................................... 907 920 

316211 ........ Rubber and Plastic Footwear Manufacturing ................................................................................ 52 56 

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

316219 ........ Other Footwear Manufacturing ...................................................................................................... 68 69 

321911 ........ Wood Window and Door Manufacturing ........................................................................................ 1,241 1,297 

32551 .......... Paint and Coating Manufacturing .................................................................................................. 1,042 1,093 

325998 ........ All Other Misc. Chemical Product and Preparation Manufacturing ............................................... 957 1,045 

326191 ........ Plastics Plumbing Fixture Manufacturing ....................................................................................... 465 488 

326299 ........ All Other Rubber Product Manufacturing ....................................................................................... 633 681 

332321 ........ Metal Window and Door Manufacturing ........................................................................................ 1,071 1,138 

332998 ........ Enameled Iron and Metal Sanitary Ware Manufacturing .............................................................. 60 72 

333112 ........ Lawn and Garden Tractor and Home Lawn and Garden Equip. Mfg. .......................................... 117 134 

33422 .......... Radio, Television Broadcasting and Wireless Comm. Equip. Mfg. ............................................... 811 894 

335222 ........ Household Refrigerator and Home Freezer Manufacturing .......................................................... 12 18 


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TABLE 2—MANUFACTURERS—Continued 

NAICS code Description Small firms Total firms 

335999 ........ All Other Misc. Electrical Equipment and Component Mfg. .......................................................... 737 791 

336991 ........ Motorcycle, Bicycle, and Parts Manufacturing ............................................................................... 456 466 

33712 .......... Household and Institutional Furniture Manufacturing .................................................................... 6,052 6,179 

33791 .......... Mattress Manufacturing .................................................................................................................. 448 462 

339113 ........ Surgical Appliance and Supplies Manufacturing ........................................................................... 1,601 1,691 

33991 .......... Jewelry and Silverware Manufacturing .......................................................................................... 2,737 2,752 

33992 .......... Sporting and Athletic Goods Manufacturing .................................................................................. 1,886 1,930 

33993 .......... Doll, Toy and Game Manufacturing ............................................................................................... 763 776 

339999 ........ All Other Miscellaneous Manufacturing ......................................................................................... 4,440 4,499 

Total Manufacturers .......................................................................................................................................... 36,367 37,371 

Source: U.S. Census Bureau, 2006 County Business Patterns. 

b. Wholesalers 

Wholesalers would be impacted by 

the proposed rule if they import any 

children’s products or general use 

products that are subject to a consumer 

product safety rule. Wholesalers that 

obtain their products strictly from 

domestic manufacturers or from other 

wholesalers would not be impacted by 

the proposed rule since the 

manufacturer would be responsible for 

testing and certifying the product. Table 

3 shows the number of wholesalers by 

NAICS code that would cover most 

children’s products and general use 

products that are subject to a consumer 

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 77,000 

wholesalers that would be considered 

small in these categories, not all of these 

firms are engaged in importing 

children’s or general use products that 

are subject to a consumer 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 

would be those that import all terrain 

vehicles or other off-road vehicles, 

especially those intended for children 

age 12 years and younger. 

TABLE 3—WHOLESALERS

NAICS Code Description Small firms Total firms 

4231 ............ Motor Vehicle and Motor Vehicle Parts and Suppliers .................................................................. 16,947 17,858 

4232 ............ Furniture and Home Furnishing Merchant Wholesalers ................................................................ 10,534 10,981 

42362 .......... Electrical and Electronic Appliance, Television, and Radio Set Merchant Wholesalers ............... 2,147 2,269 

42391 .......... Sporting and Recreational Goods and Supplies Merchant Wholesalers ...................................... 4,397 4,552 

42392 .......... Toy and Hobby Goods and Supplies Merchant Wholesalers ....................................................... 2,170 2,248 

42394 .......... Jewelry, Watch, Precious Stone, and Precious Metal Merchant Wholesalers ............................. 7,735 7,815 

42399 .......... Other Miscellaneous Durable Goods Merchant Wholesalers ........................................................ 10,146 10,367 

42432 .......... Men’s and Boy’s Clothing and Furnishings Merchant Wholesalers .............................................. 3,235 3,393 

42433 .......... Women’s, Children’s, and Infant’s Clothing, and Accessories Merchant Wholesalers ................. 5,965 6,186 

42434 .......... Footwear Merchant Wholesalers ................................................................................................... 1,434 1,493 

42499 .......... Other Miscellaneous Nondurable Goods Merchant Wholesalers .................................................. 12,497 12,753 

Total ..... ......................................................................................................................................................... 77,207 79,915 

Source: U.S. Census Bureau, 2006 County Business Patterns. 

c. Retailers 

Retailers that obtain all of their 

products from domestic manufacturers 

or wholesalers will not be directly 

impacted by the proposed rule, since 

the direct impact of the proposed rule 

would be experienced by the 

manufacturer. However, there are some 

retailers that manufacture or directly 

import some products and, therefore, 

would be responsible for ensuring that 

these products are subjected to testing 

by third party conformity assessment 

bodies. 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 the SBA criteria, retailers 

are generally considered to be small 

entities if their annual sales are less 

than $7 million ($27 million in the case 

of general merchandise stores). Because 

of the way in which the data were 

reported, Table 4 shows the total 

number of firms in each of the 

categories that operated all year and the 

number with sales of less than $5 

million ($25 million in the case of 

general merchandise stores). Although 

there are more than 125,000 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 

or general use products that are subject 

to a consumer product safety rule. Many 

of these firms probably obtain all of 

their products from domestic 

wholesalers or manufacturers and 

would not be directly impacted by the 

rule. 


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TABLE 4—RETAILERS

NAICS Code Description Small firms Total firms 

441221 ........ Motorcycle, ATV, and Personal Watercraft Dealers ...................................................................... 3,969 4,001 

4421 ............ Furniture Stores ............................................................................................................................. 16,282 17,542 

44813 .......... Children’s and Infant’s Clothing Stores ......................................................................................... 2,146 2,200 

44814 .......... Family Clothing Stores ................................................................................................................... 5,998 6,240 

4482103 ...... Children’s & juveniles’ shoe stores ................................................................................................ 300 305 

4483 ............ Jewelry, luggage, & leather goods stores ..................................................................................... 16,341 16,778 

45111 .......... Sporting goods stores .................................................................................................................... 14,451 14,831 

45112 .......... Hobby, toy, & game stores ............................................................................................................ 4,832 4,903 

452 .............. General Merchandise Stores ......................................................................................................... 7,387 7,494 

45322 .......... Gift, Novelty, and Souvenir Store .................................................................................................. 21,412 21,637 

453998 ........ All Other Misc. Store Retailers (except Tobacco Stores) .............................................................. 11,934 12,228 

4542 ............ Vending machine operators ........................................................................................................... 4,081 4,278 

45439 .......... Other direct selling establishments ................................................................................................ 15,938 16,431 

Total ..... ......................................................................................................................................................... 125,071 128,868 

Source: U.S. Census Bureau, 2002 Economic Census, Release date 11/25/2005. 

4. The Potential Effects of the Proposed 

Rule 

a. Reasonable Testing Program 

The proposed rule would require any 

manufacturer of a nonchildren’s product 

to establish a reasonable testing program 

for the product unless they test every 

product. Most manufacturers probably 

have some quality control programs in 

place that are intended to demonstrate 

that the products as manufactured meet 

the manufacturer’s specifications, 

including their specifications for 

complying with any safety regulations. 

In some cases, these programs would 

meet the requirements of the reasonable 

testing program as described in the 

proposed rule. Other manufacturers may 

have to modify their current programs to 

ensure that they meet the requirements 

of the proposed rule. For example, some 

manufacturers might have to modify 

their programs to ensure that the testing 

program adequately covers all consumer 

product safety rules that are applicable 

to their products. Some manufacturers 

might have to increase their testing 

frequency. Some manufacturers might 

have some informal testing programs 

that would have to be formalized and 

better documented. There may also be 

some manufacturers that do not have a 

program in place. These firms will have 

to develop reasonable testing programs. 

Compliance with the proposed rule 

would require a variety of professional 

skills on the part of manufacturers. 

Lawyers may be required to review 

CPSC regulations in order to determine 

which regulations are applicable to a 

product. Depending upon the specific 

product and the safety rules that are 

applicable to it, people with knowledge 

of subjects such as engineering and 

chemistry may be required to develop 

the product specifications, conduct the 

certification tests, and to design a 

program for production testing. 

Statistical skills or statistical 

consultants may be required to 

determine the frequency, sample size, 

and collection method for production 

testing. For some production tests, 

professionals such as engineers or 

chemists might be required, depending 

upon the consumer product safety rules 

applicable to the product. In some cases, 

the production tests could be carried out 

by the firm’s production workers or 

technicians, perhaps working under the 

supervision of an engineer, chemist, or 

similar professional. When the 

manufacturer does not have the internal 

capability to perform some of the 

required production testing, the testing 

may need to be performed by a third 

party testing assessment body. 

The cost to firms of complying with 

this provision of the proposed rule 

would depend upon the extent of the 

changes that firms will have to make to 

their existing testing programs. For 

firms that already have testing programs 

that would meet the requirements of the 

proposed rule, there could be no 

additional costs. For other firms, the 

cost of complying with the requirements 

of the proposed rule will depend upon 

several factors, including the 

characteristics of their products and the 

steps that the firm will have to take to 

comply with the requirements. Because 

of the wide variety of products and 

manufacturers that would be covered by 

the proposed rule and because the 

characteristics of each product and the 

circumstances of each firm are different, 

the Commission cannot reliably 

estimate the cost to manufacturers of the 

reasonable testing program requirement 

of the proposed rule. The Commission 

invites comments that provide more 

information on the cost and other 

impacts of this requirement on 

manufacturers. 

b. Third Party Testing of Children’s 

Products 

The proposed rule would establish 

requirements for the continued testing 

of children’s products by third party 

conformity assessment bodies for 

certification, periodically, and when 

there has been a material change in the 

products design or manufacturing 

process, including the sourcing of 

component parts. 

Manufacturers will have to develop 

and maintain records that demonstrate 

compliance with the third party testing 

requirements. The Commission 

welcomes comment on these 

requirements, including comments on 

the possible burden that these 

recordkeeping requirements might 

impose. 

It is expected that the cost of the third 

party testing requirements could have a 

significant impact on a substantial 

number of small entities. The cost of 

third party testing is influenced by 

many factors, including the amount and 

skill of the labor required to conduct the 

tests, the cost of the equipment 

involved, the cost of transporting the 

product samples to the test facility, and 

the geographic area where the tests are 

conducted. Some tests require a 

substantial amount of time to conduct 

including the preparation of the sample. 

It might take a couple of days, for 

example, to test a bicycle for 

compliance with the bicycle standard 

(16 CFR part 1512). Similarly, a chemist 

testing the lead content of a product 

might be able to test only a few 

component parts a day due to the 

amount of time required to prepare the 

samples and to clean and calibrate the 

equipment between tests. 

It should be noted that the price that 

a given manufacturer pays for testing is 

often the result of negotiations between 

the testing laboratory and the 


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manufacturer. Manufacturers that do a 

large volume of business with a testing 

laboratory can frequently obtain 

substantial discounts on the laboratory’s 

normal charges, whereas manufacturers 

that do only a small volume of business 

may not. 

Some information on the cost of third 

party testing for some of the applicable 

tests is provided below. The information 

was collected from a number of sources, 

including published price lists from 

some testing laboratories, conversations 

with representatives of testing 

laboratories, and actual invoices 

provided by consumer product 

manufacturers. The data are not based 

upon a statistically valid survey of 

testing laboratories. Additionally, the 

costs are only the costs that would be 

charged by the testing laboratory and do 

not include the costs of the products 

consumed in destructive tests or the 

cost of shipping the samples to the 

laboratories. 

i. Costs Associated With Various Third 

Party Tests 

Lead Content and Lead-in-Paint: The 

cost per component part for testing for 

lead content and lead-in-paint using 

inductively coupled plasma (ICP) 

analysis will range from a low of about 

$20 per test to more than $100 per test. 

The lowest per unit cost represents a 

substantially discounted price charged 

to a particular customer by a laboratory 

in China and might not be typical. 

Within the United States, typical prices 

range from around $50 to more than 

$100 per test. 

The cost of testing for lead content 

using XRF technology is significantly 

less expensive. Some firms have offered 

to screen products for lead content for 

as little as $2 per test. These offers were 

generally directed to stores or 

businesses that wanted to check their 

inventory for conformity with the 

retroactive lead content requirements 

that were contained in the CPSIA. Some 

testing laboratories will charge for XRF 

testing at an hourly rate, which can be 

around $100. Ten to 30 components 

parts can be tested in an hour. However, 

with the exception of some plastics, 

XRF is not acceptable for all 

certification purposes. 

Phthalates: The cost of testing for 

phthalate content will range from 

around $100 (a discounted price by a 

laboratory in China) to about $350. 

These are the costs per component part 

and include testing for all six of the 

prohibited phthalates specified in the 

CPSIA. 

Bicycle Standard: According to one 

testing laboratory, it takes 1 to 2 days to 

test a bicycle. The estimated price for 

testing one bicycle may range from 

around $700, if the testing is performed 

in China, to around $1,100 if the testing 

is performed in the United States. A 

manufacturer that needs several models 

of bicycle tested at the same time might 

be able to obtain discounts from these 

prices. However, this does not include 

the testing of component parts for lead 

and phthalates, which would add to the 

costs of bicycle testing. 

Bicycle Helmets: One laboratory 

quoted a price of $600 for testing one 

model of a bicycle helmet to the CPSC 

bicycle helmet standard. A price list 

from another laboratory stated that 

conducting the certification testing to 

the Snell Foundation’s bicycle helmet 

standard (which is similar to the CPSC 

standard, but considered by some to be 

more stringent) was $830. 

Full-Size Cribs: As with bicycles, 

testing cribs requires a substantial 

amount of labor time to assemble the 

crib, take the appropriate measurements 

and perform the required tests. The cost 

of testing a full-size crib will be around 

$1,200 in the United States. The cost 

can vary depending on the features of 

the individual cribs that require testing 

and between laboratories. Some 

manufacturers might receive discounted 

prices. This does not include testing the 

crib for lead and phthalates, which, to 

the extent necessary, would add to the 

cost of testing a crib to all applicable 

safety rules. 

Toys: The ASTM F963 toy standard 

was made a mandatory standard by the 

CPSIA. The standard includes a wide 

variety of tests, including tests for 

soluble heavy metals in surface coatings 

and for various physical and mechanical 

criteria. Based on the itemized prices on 

several invoices from testing 

laboratories that have been provided to 

CPSC staff or otherwise made public, 

the cost of the physical and mechanical 

tests range from about $50 to $245. The 

cost of the chemical test for the presence 

of heavy metals ranges from about $60 

to $190 per surface coating. Again, these 

costs do not include testing for lead and 

phthalates, which add to the total cost. 

The flammability requirements of 

ASTM F963 were not made mandatory 

by the CPSIA, but the Commission was 

directed to examine the flammability 

requirements and consider 

promulgating rules addressing the issue. 

If some flammability tests are eventually 

required, the cost per test could be in 

the range of $20 to $50 based on some 

observed costs for the ASTM F963 

flammability tests. 

ii. Cost of Third Party Testing by 

Product 

The cost to obtain the required third 

party testing for a product depends on 

the types and number of tests that must 

be performed on each product, the size 

of the sample that is required to provide 

a high degree of assurance that the 

products comply with the applicable 

safety rules, and the extent to which 

component part testing can be used. 

Because of the wide variety of 

manufacturers, and importers, and 

products that would be affected by the 

proposed rule, we cannot provide 

comprehensive estimates of the impact 

of the proposed rule on all products or 

firms. The discussion immediately 

below is intended to provide some 

perspective on the potential impact. The 

Commission invites additional public 

comments on the discussion and more 

specific information on the impact and 

cost of the third party testing 

requirements of the proposed rule. 

The third party testing costs discussed 

in this section apply to the costs 

associated with either the periodic 

testing requirement or the requirement 

that additional third party testing be 

conducted if there is a material change 

in the product’s design or 

manufacturing process. However, in the 

latter case, the testing might be limited 

to those rules where compliance might 

have been impacted by the change. 

Number of units for testing: The 

proposed rule would require the 

manufacturer to submit enough units to 

the conformity assessment body to 

provide a high degree of assurance that 

the products comply with the applicable 

consumer product safety rules. The 

exact number will depend upon the 

characteristics of the product, the lot 

size, whether the tests produce 

quantitative or qualitative data, whether 

the product has an established 

reasonable testing program, and the 

interpretation of a high degree of 

assurance. A discussion of the statistical 

aspects of designing a sampling plan 

was presented by Dr. Michael Greene of 

the CPSC staff at the Product Testing 

Workshop on December 10, 2009. 

Quantitative testing data is data where 

the relevant variable can be measured 

with some degree of precision. For 

example, the lead content of a substance 

can be measured in terms of parts per 

million (ppm). Qualitative data is where 

the outcome of a test is simply a ‘‘pass’’ 

or ‘‘fail.’’ For example, in a drop test the 

result might simply be whether a sharp 

edge was exposed (a ‘‘fail’’) or a sharp 

edge was not exposed (a ‘‘pass’’). When 

the data is qualitative, the sample size 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
28356 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

will usually have to be larger than when 

the data is quantitative. 

For example, as of August 14, 2011 

the lead content of children’s products 

must be no greater than 100 ppm unless 

the Commission determines that a limit 

of 100 ppm is not technologically 

feasible for a product or product 

category. If, for illustrative purposes, a 

high degree of assurance means at least 

a 95 percent probability that all 

products are in compliance and a 

manufacturer is testing a component 

part for lead content, then the 

manufacturer could determine the 

appropriate sample size if it knew the 

mean lead content of the component 

part, the standard deviation about the 

mean, and the size of the lot that was 

to be tested. Table 5 shows the sample 

sizes that would be required to provide 

a high degree of assurance for different 

lot sizes by mean and standard 

deviation (assuming a normal 

distribution). Larger sample sizes would 

be required for products with higher 

means, larger standard deviations, and 

larger lot sizes. Smaller sample sizes 

would be required for products with 

lower means, standard deviations and 

lot sizes. 

TABLE 5—SAMPLE SIZES REQUIRED TO PROVIDE AT LEAST 95 PERCENT PROBABILITY THAT THE LOT IS COMPLIANT

(GIVEN THE AVAILABILITY OF QUANTITATIVE TEST DATA) 

Mean (ppm) Standard deviation 

(ppm) Lot size (units) Sample size (units) 

Probability that the 

lot is compliant 

10 ............................................................................................. 1 1,000 4 .998 

10 ............................................................................................. 1 2,500 4 .995 

10 ............................................................................................. 1 10,000 4 .992 

10 ............................................................................................. 1 25,000 5 .978 

10 ............................................................................................. 1 50,000 5 .957 

15 ............................................................................................. 3 1,000 5 .993 

15 ............................................................................................. 3 2,500 5 .983 

15 ............................................................................................. 3 10,000 6 .992 

15 ............................................................................................. 3 25,000 6 .981 

15 ............................................................................................. 3 50,000 6 .962 

35 ............................................................................................. 5 1,000 6 .965 

35 ............................................................................................. 5 2,500 7 .976 

35 ............................................................................................. 5 10,000 8 .972 

35 ............................................................................................. 5 25,000 9 .978 

35 ............................................................................................. 5 50,000 9 .957 

Where only qualitative (e.g., pass/fail) 

testing data is available, the sample 

sizes needed to provide a high degree of 

assurance will be higher than those in 

Table 5. Such tests include some of the 

use and abuse tests for testing children’s 

products (e.g., the drop test). As 

discussed by Dr. Michael Greene at the 

CPSIA Product Testing Workshop, more 

samples may be necessary because there 

is more uncertainty in the test data. In 

other words, with only pass/fail data, it 

is not known if the result was close to 

the threshold or far from the threshold. 

In these cases, it might be necessary to 

define a high degree of assurance as a 

probability that no more than a given 

proportion of noncompliant products. 

For example, as discussed by Dr. Greene 

at the Product Testing Workshop, a 95 

percent probability that no more than a 

certain proportion ‘‘p’’ of the units in a 

lot do not comply is approximately 

given by the formula p ≈ 3/k, where ‘‘k’’ 

is the sample size. Thus, if 50 items 

were tested and no noncompliant items 

were found, there is a 95 percent 

probability that no more than 6 percent 

of the items in the lot do not comply. 

In other words, if the lot size were 1,000 

and 50 units were tested and no 

noncompliant product were found, 

there is a 95 percent probability that no 

more than 60 units in the entire lot are 

not in compliance. If the lot size were 

10,000 units, there would be a 95 

percent probability that no more than 

600 of the products would be 

noncompliant. If a higher level of 

assurance were required, the sample 

size would have to be larger. If a lower 

level of assurance were acceptable the 

sample size could be smaller. 

The examples in Table 5 illustrate the 

disproportionate impact that the 

proposed rule could have on small 

businesses or businesses with lowvolume products. In the first example in 

Table 5, the same number of units 

would have to be submitted to a third 

party testing conformity assessment 

body whether 1,000 units or 10,000 

units were in the lot. In other words, the 

total third party testing costs would be 

the same, but the cost per unit for a 

manufacturer producing only 1,000 

units would be 10 times the cost per 

unit for a manufacturer producing 

10,000 units. 

The examples in table 5 also illustrate 

the potential that component part 

testing could offer for reducing the cost 

of testing. For example, assume a 

manufacturer produces five products in 

lots of 10,000 units, but uses a common 

component part on each of the products 

that it purchases in lots of 50,000. The 

manufacturer could conduct the 

applicable chemical tests on the 

component part rather than on the 

finished product. If, following the 

sample sizes in Table 5, the mean of the 

component was 10 and the standard 

deviation was 1, this would reduce the 

cost of testing that component part by a 

factor of four over the cost that would 

apply if only tests on the finished 

product were acceptable. This is 

because without component part testing, 

the manufacturer would have to 

conduct tests on the component part as 

it was used in each of the five products. 

If each product were produced in lots of 

10,000 units, this would amount to four 

tests on the component for each product 

or 20 total tests on the same component 

part. With component part testing, the 

manufacturer could simply conduct the 

tests on the component part, which was 

assumed to be purchased in a lot of 

50,000 units, which would only require 

five tests of the component to provide 

a 95 percent probability that all of the 

units in the lot were in compliance. 

Random Samples: The proposed rule 

would require that samples for periodic 

testing for children’s products be 

selected randomly. A random sample is 

one in which each unit has an equal 

chance of being included in the sample. 

The proposed rule would specify that 

each unit produced or imported by the 

firm since the last random sample was 

drawn must have an equal chance of 

being selected. There will be some 


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Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 28357 

additional cost associated with selecting 

a random sample rather than a 

convenience sample. The Commission 

invites comments on this proposed 

provision and is especially interested in 

comments describing the cost or other 

burdens that this proposed provision 

would impose. 

iii. Hypothetical Product Testing 

Examples 

To provide some information on what 

the magnitude of the third party testing 

costs may be for some manufacturers of 

children’s products, this section 

discusses the potential cost of 

conducting third party testing for two 

product categories: Bicycles and toys. 

These examples are hypothetical and 

are intended to illustrate some potential 

cost implications of the proposed rule 

but might not be representative of every 

manufacturer in each category. The 

costs per test that are assumed in the 

examples can vary significantly. The 

Commission invites any comments that 

provide better information on the 

potential impacts on individual 

manufacturers. 

Bicycles: Children’s bicycles must be 

tested for compliance with the CPSC 

bicycle standard, which was estimated 

above to cost between $700 and $1,100. 

Additionally, the paint used on the 

bicycle must be tested for compliance 

with the lead-in-paint standard and the 

accessible component parts on the 

bicycle must be tested for lead content. 

The number of paints and component 

parts that require testing can vary 

among different models, but information 

provided by CPSC Compliance staff 

suggests that 75 components parts might 

be a reasonable estimate for the average. 

This example will use estimates in the 

middle of these ranges for the testing 

costs discussed above and assume that 

the cost of testing to the bicycle 

standard is $900 and the cost for testing 

a component part for lead content is 

$50. It is further assumed that 

quantitative data is available for all 

applicable tests and that the variation is 

low enough that testing four units will 

provide the high degree of assurance 

desired that products comply with the 

applicable safety rules. To the extent 

that some of the tests in the bicycle 

standard might be qualitative in nature, 

the sample size for testing would need 

to be larger. 

If component part testing is not 

available to this manufacturer, the cost 

of testing the bicycle to each applicable 

safety rule one time would be about 

$4,650 (testing to the bicycle standard 

itself at $900 and testing 75 components 

parts for lead content). If a sample of 

four units were required to be tested to 

provide the required high degree of 

assurance, then the cost of the third 

party testing to the manufacturer would 

be $18,600. 

The manufacturer in this example 

might be able to reduce the testing costs 

with component part testing if some of 

the components parts were used on 

more than one model. If component part 

testing reduced the cost of the lead 

content testing by this manufacturer by 

a factor of four, then the cost of testing 

to the bicycle standard itself would still 

be $900, but the average cost of testing 

the lead content of the component parts 

would be reduced to $12.50 per 

component part. Therefore the cost of 

testing the bicycle once would be 

$1,837.50. The cost to test four units to 

provide the required high degree of 

assurance would be $7,350. 

The total cost of the third party testing 

to the manufacturer would depend upon 

the number of youth model bicycles that 

the manufacturer offered. If the 

manufacturer had five different models, 

and if component part testing could 

reduce the costs of the lead-content 

testing by a factor of four, the total cost 

of the third party testing to the firm 

would be about $36,750. 

Toys: Toys are subject to the 

requirements for lead and phthalate 

content, and to several physical and 

mechanical requirements, including the 

requirements of ASTM F963, which was 

made a mandatory standard by the 

CPSIA. In this example, it is assumed 

that the testing costs are at the low to 

middle part of the ranges and that the 

hypothesized toy contains one metal 

component part that must be tested for 

lead content using ICP analysis (at $50) 

and two plastic component parts for 

which XRF analysis can be used for 

determining the lead content (two tests 

at $6 each). The plastic component parts 

also must be tested for phthalate content 

(two tests at $225 each). Additionally, it 

is assumed that the toy contains four 

different paints that must be tested for 

both lead content ($50/test) and soluble 

heavy metals ($125/test). Finally, it is 

assumed that the toy is subject to some 

mechanical requirements that include 

use and abuse testing for which only 

qualitative data is available at $50 per 

test. Thus, the cost of testing this toy for 

compliance to each applicable rule one 

time would be $1,262: $1,212 is 

associated with the chemical (lead, 

heavy metal, and phthalate) testing and 

$50 is associated with the mechanical 

testing (including use and abuse 

testing). 

If the means and standard deviations 

of the lead, heavy metal, and phthalate 

contents of all of the product 

components parts are sufficiently low 

that testing four units could statistically 

provide the required high degree of 

assurance, then the cost the chemical 

testing for this toy would be $4,848 

($1,212 × 4). If the means or standard 

deviations of the lead, heavy metal, or 

phthalate content were higher, which is 

likely the case for some materials, more 

units might have to be tested to provide 

the required high degree of assurance 

and the resulting cost would also be 

higher. 

Because the testing data for 

mechanical requirements are qualitative 

in nature, the number of units that 

might have to be tested to provide the 

required high degree of assurance would 

be more than required for the chemical 

tests. If a high degree of assurance were 

considered to be a 95 percent 

probability that no more than 6 percent 

of the units in the lot did not comply, 

then 50 units would have to be tested. 

In this case, the cost of mechanical 

testing would be $2,500 ($50 × 50). 

Combining the cost of the chemical 

tests and the cost of the tests for 

mechanical or physical requirements, 

the total cost to this hypothetical 

manufacturer to obtain the required 

high degree of assurance that the 

products complied with all applicable 

safety rules would be $7,348. If, as in 

the bicycle example, component part 

testing could be used to reduce the cost 

of the chemical testing by a factor of 

four, then the total cost of testing the toy 

could be reduced to $3,712 ($4,848/4 + 

$2,500). 

Again, the total cost to the 

manufacturer would depend upon 

factors such as the complexity of the 

products, the variation in the materials 

used, the opportunities to use 

component part testing, and the number 

of different toys that were offered. For 

example, if the manufacturer offered 

five similar toys and the third party 

testing costs were similar for each toy 

and component part testing allowed the 

manufacturer to reduce the costs of 

chemical testing by a factor of four, the 

total cost to the manufacturer for testing 

the toys would be $18,560. The annual 

cost would be higher if the testing had 

to be repeated more than once annually 

or there were material changes in the 

design of the products or production 

processes during the year. 

iv. Impact of Third Party Testing on 

Firms 

Whether such costs would have a 

substantial adverse impact on a firm 

depends upon the individual 

circumstances of the firm. One factor 

that can give an indication of whether 

something will have a significant impact 

is the magnitude of the impact in 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
28358 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

relation to the revenue of the firm. A 

typical profit rate is about 5 percent of 

revenue. In other words, for every $1 of 

revenue, only 5 cents might remain after 

paying all expenses. Therefore, a new 

cost that amounted to 1 percent of 

revenue could, all other things equal, 

reduce the profit by 20 percent and 

might be considered to be a significant 

impact by some firms. This would be 

consistent with what some other 

agencies consider to be significant. 

OSHA, for example, considers an 

impact to be significant if the costs 

exceed 1 percent of revenue or 5 percent 

of profit. 

Using the toy example above, with 

component part testing, if the third 

party testing costs were spread over 

10,000 units, the cost of the testing 

would be about $0.37 per unit ($3,712/ 

10,000). According to a toy industry 

representative, the average retail price of 

a toy is about $8. However, depending 

upon the channels of distribution and 

the practices in the particular market or 

industry, the price that a manufacturer 

receives for a product can be less than 

half of what the product eventually sells 

for at retail. Therefore, if the 

manufacturer received $4 for the toy 

that cost $0.37 per unit to test, the third 

party testing costs would be 9.2 percent 

of revenue ($0.37/$4) and could exceed 

the expected profit. Even if the 

manufacturer received $30 per unit for 

the toy (which might indicate a retail 

price of around $60 or more), the third 

party testing cost would still exceed 1 

percent of the revenue per unit and 

might be considered to be a significant 

impact. 

It is possible that the impact could be 

reduced if the manufacturer had an 

established reasonable testing program 

that met the requirements of the 

proposed rule. In such cases, 

manufacturers would be required to 

conduct periodic third party tests per 

rule at least once every two years rather 

than at least once a year. For example, 

if the hypothetical manufacturer of the 

toy used in the above example had a 

reasonable testing program and 

determined that obtaining one periodic 

third party test per applicable rule were 

sufficient, and the annual production 

volume were 10,000 units, then the per 

unit testing cost (without any 

component testing) would be about 

$0.06 ($1,262/20,000). (However, it 

should be noted that testing a product 

for compliance with each applicable 

rule one time is likely to require that the 

manufacturer submit more than one 

sample of the product to the testing 

laboratory. This is because some 

required tests cannot be performed on 

the same sample that has been used for 

another test. For some chemical tests, it 

may be necessary to use more than one 

sample of the product to obtain enough 

of a component to test.) If the 

manufacturer received $4 for each unit, 

then the periodic third party testing 

costs would amount to about 1.5 percent 

of revenue ($0.06/$4), which still could 

be considered to be a significant impact. 

If component part testing reduced the 

cost of the chemical tests by a factor of 

four, then the cost of the periodic third 

party testing could be reduced to $353 

($50 + $1,212/4) or about $0.02 per unit, 

if 10,000 units were produced annually 

and third party testing were conducted 

only once every two years. This would 

be about 0.5 percent of revenue if the 

manufacturer received $4 for each unit, 

which might not be considered 

significant. If the production volume 

were lower or the revenue per unit 

received by the manufacturer were 

lower, the impact would be greater. If 

the production volume were higher or 

the revenue per unit received by the 

manufacturer were higher, then the 

impact of the third party testing 

requirement would be lower. 

It should be noted that the only cost 

considered in this hypothetical example 

is the cost of the third party testing. Any 

additional costs associated with inhouse periodic testing or a reasonable 

testing program would be in addition to 

these costs and increase the impact, as 

would any additional third party testing 

costs associated with material changes 

in the product’s design, the 

manufacturing processes, or the 

sourcing of component parts. Other 

costs that were not considered were the 

cost of the samples consumed in the 

testing and the cost of shipping the 

samples to the third party conformity 

assessment body. 

v. Caveats and Possible Market 

Reactions to Third Party Testing 

Requirements 

Manufacturers can be expected to 

react to a significant increase in their 

costs due to testing requirements in 

several ways. Some manufacturers 

might attempt to redesign their products 

to reduce the number of tests required, 

by reducing the features or the number 

of components parts used in their 

products. Manufacturers could also be 

expected to reduce the number of 

children’s products that they offer or, in 

some cases, exit the market for 

children’s products entirely. Some may 

go out of business altogether. 

The requirement for third party 

certification testing could be a barrier to 

new firms entering the children’s 

product market, unless they expect to 

have relatively high volume products. 

This could be especially important for 

firms that expected to serve a niche 

market, including products intended for 

children with special needs. The 

requirement for third party testing when 

there is a material change in a product’s 

design or manufacturing process could 

cause some small or low-volume 

manufacturers to forgo or delay 

implementing some improvements to a 

product’s design or manufacturing 

process in order to avoid the cost of the 

third party testing. 

The cost of testing some toys and 

other children’s products could be 

higher than those in the above 

examples. The cost would be higher, for 

example, for products that had more 

components parts or where the 

variability in the test results was greater, 

which would require more samples to 

be tested. The cost of testing would also 

be higher if there was less opportunity 

for component part testing. The cost of 

testing could be lower for products that 

were subject to fewer safety rules or that 

contained fewer component parts. For 

some apparel articles, for example, the 

only tests required might be for lead 

content on some components parts for 

which component part testing might be 

permissible. 

Although the above examples 

illustrate the potential for component 

part testing to reduce the costs of 

testing, it might not be an option for all 

products or manufacturers. Component 

part testing is most likely to be an 

option for component parts that are 

common to multiple products (e.g., 

paints, bolts of a standard size). The 

potential for component part testing to 

reduce the cost of testing would be less 

for products that have component parts 

that are unique to that product. 

5. Protection Against Undue Influence 

The proposed rule would require all 

manufacturers of children’s products to 

establish procedures to prevent attempts 

to exercise undue influence on a third 

party conformity assessment body and 

to report to the Commission 

immediately of any attempt by any 

interested party to exert undue 

influence over test results, and that 

employees are aware that they may 

report any allegations of undue 

influence to the Commission 

confidentially. There would be some 

cost to firms to develop the materials or 

training programs to comply with these 

requirements. The Commission invites 

comments from the public providing 

information on the cost and other 

impacts of this provision. 


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6. Consumer Product Labeling Program 

The consumer product labeling 

program that would be established by 

the proposed rule would allow firms to 

label any product that complies with the 

certification requirements for the 

product with a label that states that the 

product ‘‘Meets CPSC Safety 

Requirements.’’ This provision is not 

expected to have a significant impact on 

firms because the program is voluntary 

and the costs of adding or modifying a 

label on a product are expected to be 

low. 

7. Summary of Impact on Small 

Businesses 

The proposed rule, if finalized, could 

have a significant adverse impact on a 

substantial number of small businesses. 

The provisions of the proposed rule that 

are expected to have the most 

significant impact are provisions related 

to requirements for the third party 

testing of children’s products with and 

without a reasonable testing program. 

The impact of the proposed rule would 

be expected to be disproportionate on 

small and low-volume manufacturers. 

This is because testing costs are 

relatively fixed. Therefore, the per unit 

impact of testing costs will be greater on 

low-volume producers than on highvolume producers. 

The provisions of the proposed rule 

that would require manufacturers of 

nonchildren’s products to establish and 

maintain a reasonable testing program 

also could have an adverse impact on 

some manufacturers. The impact of 

these provisions are expected to be less 

significant than the impact of the 

provisions related to children’s products 

because many manufacturers are 

believed to already have at least some 

quality assurance or testing programs in 

place. The provisions related to the 

proposed requirement for a reasonable 

testing program are intended to provide 

manufacturers with a high degree of 

flexibility in designing and 

implementing the programs, which 

would also serve to reduce the potential 

impact on a firm. 

The other requirements in the 

proposed rule for protection against 

undue influence over a conformity 

assessment body and the consumer 

product labeling program are less likely 

to have a significant adverse impact on 

a substantial number of small 

businesses. The Commission invites 

comments on these provisions. 

8. Federal Rules Which May Duplicate, 

Overlap, or Conflict With the Proposed 

Rule 

The proposed rule would establish 

the minimum requirements for testing 

and certification of consumer products. 

Some individual consumer product 

safety rules contain specific testing 

requirements. Manufacturers would be 

expected to meet the more stringent 

requirements whether they are the 

provisions of this proposed rule or the 

requirements in the specific safety rule. 

However, the rules would not require 

manufacturers to duplicate their efforts 

to comply with both sets of 

requirements. Testing and 

recordkeeping required to comply with 

the more stringent rule would also meet 

the requirements of the less stringent 

rule. Manufacturers will not be required 

to duplicate tests or recordkeeping to 

comply with both sets of rules. There 

are no known Federal rules that conflict 

with the proposed rule. 

9. Alternatives for Reducing the Adverse 

Impact on Small Businesses 

The Commission recognizes that the 

proposed rule could have a significant 

and disproportionate impact on small 

and low-volume manufacturers. The 

Commission has incorporated some 

provisions into the proposed rule that 

are intended to lessen the impact on 

small businesses. These include some 

relief from the periodic testing 

requirement for children’s products, the 

ability to use component part testing 

(which would be addressed by a 

separate Commission rule elsewhere in 

this issue of the Federal Register). The 

Commission invites comments on these 

provisions and other provisions or 

alternatives that could lessen the 

adverse impact on small or low-volume 

businesses. 

The Commission is proposing that 

manufactures that have implemented 

reasonable testing programs that meet 

the requirements contained in the 

proposed rule would be obligated to 

conduct third party periodic tests at 

least once every two years instead of at 

least once every year if they have not 

implemented reasonable testing 

programs. This provision could 

significantly reduce the third party 

periodic testing costs of manufacturers 

that have such programs. However, the 

reduction could be limited for firms that 

do not have the ability to conduct the 

tests in-house, for importers that do 

have significant control over the actual 

production of their products, and for 

manufacturers who might have more 

frequent material changes in their 

products’ designs, manufacturing 

processes, or sourcing of component 

parts. The Commission invites comment 

on this provision, including whether 

this provision would provide sufficient 

relief to enough firms to maintain this 

provision in the final rule. 

a. Partial Exemption From Periodic 

Testing 

The proposed rule would require that 

all children’s products be tested 

periodically by a third party conformity 

assessment body and establishes one 

year as the maximum interval between 

third party periodic tests if the 

manufacturer does not have a 

reasonable testing program and two 

years if the manufacturer does have a 

reasonable testing program. However, if 

fewer than 10,000 units of a product 

have been manufactured or imported 

since the last time the product was 

submitted to a third party conformity 

assessment body, the manufacturer 

would not be subject to the periodic 

testing requirements unless 10,000 units 

have been manufactured or imported. 

This provision would allow low-volume 

manufacturers to spread their periodic 

testing costs over more units. The 

exemption would not relieve the 

manufacturer from the obligation to 

have the product tested by a third party 

conformity assessment body before the 

product is introduced into commerce, or 

when there has been a material change 

in the product’s design or production 

processes, nor would the exemption 

extend beyond the initial exemption for 

the first 10,000 units. 

b. Component Testing 

The proposed rule would allow firms 

to submit component parts for third 

party testing when the required testing 

does not need to be performed on the 

finished product. This can reduce the 

cost to manufacturers particularly where 

one component part might be common 

to more than one product. Such 

component parts might include paints, 

polymers used in molding different 

parts, and standard-sized bolts. In these 

cases the component parts might be 

received in larger lots than the 

production lots of the products in which 

they are used. Therefore, the testing 

costs for those component parts will be 

spread over more units than if they were 

required to be tested on the finished 

products. 

10. Alternatives That May Further 

Reduce the Impact on Small Businesses 

The Commission also invites 

comments on other alternatives that 

could provide some relief to small 

businesses that would be adversely 

impacted by the proposed rule. 

Alternatives could include things such 

as: (1) The establishment of different 

compliance or reporting requirements 

that take into account the resources 

available to small businesses; (2) the 

clarification, consolidation, or 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
28360 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

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 to the extent statutorily 

permissible under section 14 of the 

CPSA. In providing such comments, the 

Commission requests that the comments 

provide specific suggestions and well 

developed justifications for the 

suggestions. Some possible alternatives 

that could be considered are discussed 

below. 

a. Less Stringent Requirements for Third 

Party Testing 

The proposed rule would require that 

enough third party tests be conducted to 

provide a high degree of assurance that 

the products comply with the applicable 

rules. This could require most 

manufacturers to submit multiple 

samples for third party testing each 

year, especially if they have not 

implemented a reasonable testing 

program. However, the Commission 

could adopt an alternative that would 

limit the number of samples required for 

third party testing. For example, the 

Commission could simply require that 

manufacturers submit sufficient samples 

to a third party conformity assessment 

body so that compliance with each rule 

could be assessed at least once annually. 

The proposed rule would require that 

periodic third party testing be 

conducted at least once a year or at least 

once every two years if the 

manufacturer has established a 

reasonable testing program. A year was 

chosen as the maximum interval 

between periodic testing because many 

children’s products are produced on an 

annual or seasonal cycle, but, in the 

case of manufacturers with reasonable 

testing programs, the Commission 

believed that the information about the 

products provided the manufacturer by 

the internal testing programs could 

substitute for some third party tests. The 

Commission could, however, consider a 

different maximum interval between the 

periodic tests. For example, the 

Commission could consider requiring 

that third party tests be conducted at 

less frequent or more frequent intervals. 

The advantage of less stringent 

requirements is that they could 

significantly reduce the cost of the third 

party testing requirement. The 

disadvantage is that the testing would 

provide less information about whether 

all of the products produced were in 

compliance with the applicable safety 

rules. Requiring third party tests more 

frequently would provide additional 

assurance that the products comply 

with the applicable safety rules. 

However, this would also increase the 

costs associated with third party testing. 

The Commission invites comments on 

these and similar alternatives. For 

example, should the Commission 

consider a less stringent requirement? If 

so, what should the alternative 

requirement be? Should the less 

stringent requirement apply to all 

manufacturers or only those that meet 

certain criteria, such as to small or lowvolume manufacturers? 

b. Limits on Third Party Testing for 

Small or Low-Volume Manufacturers 

The Commission could consider 

additional alternatives that would 

provide relief to small or low-volume 

manufacturers. Substantial relief could 

be provided to small or low-volume 

manufacturers. The Commission invites 

comments on third party testing limits 

for small or low-volume manufacturers 

that still meet statutory requirements of 

section 14(d) of the CPSA. In providing 

such comments, it is important to note 

that the Commission cannot exempt 

small or low-volume manufacturers of 

children’s products from initial third 

party certification testing to applicable 

standards, regulations, or bans or from 

third party testing when there is a 

material change to the product and has 

already specified limits on periodic 

testing where a manufacturer produces 

less than 10,000 units of a particular 

product. The Commission seeks 

comments on additional alternatives 

that may provide testing cost relief to 

small or low-volume manufacturers 

while still satisfying the testing and 

compliance requirements of section 

14(d) of the CPSA. 

c. Alternative Test Methods for Small or 

Low-Volume Manufacturers 

Some small manufacturers have 

encouraged the Commission to allow 

alternative test methods such as those 

relying on XRF technology. XRF testing 

methods are significantly less expensive 

than the ICP analysis that the 

Commission currently requires for most 

lead content testing (with the exception 

of homogenous polymer products). The 

Commission staff uses XRF for 

screening samples. 

The Commission invites comments on 

the possibility of using alternative 

testing technologies for reducing the 

burden on small and low-volume 

manufacturers. For example, could the 

Commission allow small or low-volume 

manufacturers to use less expensive, but 

potentially less accurate third party 

testing methods? If so, under what 

conditions? 

E. 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 

through 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, gathering and maintaining 

the data needed, and completing and 

reviewing each collection of 

information. 

We particularly 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 

methodology 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: Testing and Labeling Pertaining 

to Product Certification. 

Description: The proposed rule would 

implement section 102(b) of the CPSIA, 

which requires certifications of 

compliance with safety standards for 

each product subject to a consumer 

product safety rule, ban, standard, or 

regulation promulgated and/or enforced 

by the CPSC. A certification that a 

nonchildren’s product complies with 

applicable consumer products safety 

rules, bans, standards, and regulations 

must be supported by a reasonable 

testing program or a test of each 

product. A certification that a children’s 

product complies with the applicable 

children’s product safety rules must be 

supported by testing performed by an 

approved third party conformity 

assessment body. The proposed rule 

would impose recordkeeping 

requirements related to those testing 

and certification requirements. The 

recordkeeping requirements are 

intended to allow one to uniquely 

identify each product and establish that 

it was properly certified before it enters 

commerce and has been properly 

retested for conformity with all 

applicable rules on a continuing basis, 

including after a material change in the 

product’s design or manufacturing 


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Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 28361 

processes, including the sourcing of 

component parts. 

Each manufacturer or importer of a 

consumer product subject to an 

applicable safety rule would be required 

to establish and maintain the following 

records: 

• A copy of the certificate of 

compliance for each product. In the case 

of nonchildren’s products, the required 

certificate is a general conformity 

certificate. In the case of children’s 

products, the certificate must be based 

upon testing by a third party conformity 

assessment body. (Proposed 

§§ 1107.10(a)(5)(i)(A), 1107.26(a)(1)) 

• For nonchildren’s products, a 

record of each product specification, 

including any new product specification 

resulting from remedial action. 

(Proposed § 1107.10(a)(5)(i)(B) and (E)) 

• Records of each certification test, 

including identification of the third 

party conformity assessment body, if 

any, that conducted the test. (Proposed 

§§ 1107.10(a)(5)(i)(C), 1107.26(a)(2)) 

• Records of the production testing 

and periodic test plans and results. 

(Proposed §§ 1107.10(a)(5)(i)(D), 

1107.26(a)(3)) 

• For children’s products, records 

relating to all material changes. 

(Proposed § 1107.26(a)(4)) 

• Records of all remedial actions 

taken. (Proposed §§ 1107.10(a)(5)(i)(E), 

1107.26(a)(6)) 

• For children’s products, records of 

undue influence procedures. (Proposed 

§ 1107.26(a)(5)) 

Description of Respondents: The 

recordkeeping requirements contained 

in this proposed rule would apply to all 

manufacturers or importers of consumer 

products that are covered by one or 

more consumer product safety rules 

promulgated and/or enforced by the 

CPSC. The CPSC reviewed every 

category in the NAICS and selected 

those that included firms that could 

manufacture or sell any consumer 

product that could be covered by a 

consumer product safety rule. Using 

data from the U.S. Census Bureau, we 

determined that there were over 37,000 

manufacturers, almost 80,000 

wholesalers, and about 128,000 retailers 

in these categories. However, not all of 

the firms in these categories 

manufacture or import products that are 

covered by consumer product safety 

rules. Therefore, these numbers would 

constitute a high estimate of the number 

of firms that are subject to the 

recordkeeping requirements. 

Estimate of the Burden: The hour 

burden of the recordkeeping 

requirements will likely vary greatly 

from product to product depending 

upon such factors as the complexity of 

the product and the amount of testing 

that must be documented. CPSC staff 

does not have comprehensive data on 

the universe of products that will be 

impacted. Therefore, estimates of the 

hour burden of the recordkeeping 

requirements are somewhat speculative. 

The CPSC invites comments that can 

provide more information about the 

number of hours required for the 

recordkeeping requirements of the 

proposed rule. 

Previously, the CPSC staff estimated 

that the recordkeeping burden of the 

mattress open flame flammability 

standard would be about one hour per 

model (prototype) per year. Many of the 

recordkeeping requirements in that 

standard are comparable to the 

requirements in this proposed rule. 

However, that rule concerned only the 

recordkeeping requirements for one rule 

(mattress flammability) while 

manufacturers of children’s products 

will frequently have to document their 

compliance with more than one product 

safety rule (e.g., lead-in-paint, lead 

content, phthalates, and some product 

specific rules, such as the ASTM F963 

toy standard). Therefore, one can 

assume the burden of the proposed rule 

could be twice the hour burden of the 

recordkeeping required for the mattress 

flammability rule. (Information on the 

product safety rules that apply to 

different consumer products can be 

found at http://www.cpsc.gov/businfo/ 

regsbyproduct.html.) 

According to a representative of a 

trade association, there are an estimated 

50,000 to 60,000 individual toys on the 

market. It is likely that there are at least 

that many other children’s products in 

product categories such as wearing 

apparel, accessories, jewelry, juvenile 

products, children’s furniture, etc. 

Additionally nonchildren’s products 

that are subject to product safety rules 

include paints, nonmetal furniture (for 

lead-in-paint), all-terrain vehicles, 

bicycles, and bunk beds. Therefore, we 

estimate that there are approximately 

100,000 to 150,000 individual products 

to which the recordkeeping 

requirements would apply. 

Assuming the annual recordkeeping 

burden per product will be two hours 

and that there are between 100,000 and 

150,000 products to which the 

recordkeeping requirements would 

apply, the total hour burden for the 

recordkeeping requirements is estimated 

to be between 200,000 and 300,000 

hours. 

The total cost burden of the 

recordkeeping requirements is expected 

to be between $9.8 and $14.7 million. 

This estimate is obtained by multiplying 

the total burden hours by $48.91, which 

is the total hourly compensation for 

private sector workers in management, 

professional, and related occupations. 

The recordkeeping requirements are not 

expected to result in any additional cost 

to the Federal government. The CPSC 

will likely request access to these 

records only when it is investigating 

potentially defective or noncomplying 

products. Investigating potentially 

defective or noncomplying product is a 

regular ongoing activity of the 

Commission. It is anticipated that access 

to the records required by this rule will 

make it easier for the investigators to 

narrow the scope of their investigations 

to particular production or import lots. 

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 June 

21, 2010, to the Office of Information 

and Regulatory Affairs, OMB (see 

ADDRESSES). 

F. Environmental Considerations 

This proposed rule falls within the 

scope of the Commission’s 

environmental review regulations at 16 

CFR 1021.5(c)(2) which provides a 

categorical exclusion from any 

requirement for the agency to prepare an 

environmental assessment or 

environmental impact statement for 

product certification rules. 

G. Executive Order 12988 

Executive Order 12988 (February 5, 

1996), requires agencies to state in clear 

language the preemptive effect, if any, of 

new regulations. The proposed 

regulation would be issued under 

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 in by a court of competent 

jurisdiction. 

H. Effective Date 

The Commission is proposing that 

any final rule based on this proposal 

become effective 180 days after its date 

of publication in the Federal Register. 

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 add 16 CFR part 1107 to 

read as follows: 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
28362 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

PART 1107—TESTING AND LABELING 

PERTAINING TO PRODUCT 

CERTIFICATION 

Subpart A—General Provisions 

Sec. 

1107.1 Purpose. 

1107.2 Definitions. 

Subpart B—Reasonable Testing Program 

for Nonchildren’s Products 

1107.10 Reasonable testing program for 

nonchildren’s products. 

Subpart C—Certification of Children’s 

Products 

1107.20 General requirements. 

1107.21 Periodic testing. 

1107.22 Random samples. 

1107.23 Material change. 

1107.24 Undue influence. 

1107.25 Remedial action. 

1107.26 Recordkeeping. 

Subpart D—Consumer Product Labeling 

Program 

1107.40 Labeling consumer products to 

indicate that the certification 

requirements of section 14 of the CPSA 

have been met. 

Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. 

L. 110–314, 122 Stat. 3016, 3017, 3022. 

Subpart A—General Provisions 

§ 1107.1 Purpose. 

This part establishes the requirements 

for: A reasonable testing program for 

nonchildren’s products; third party 

conformity assessment body testing to 

support certification and continuing 

testing of children’s products; and 

labeling of consumer products to 

indicate that the certification 

requirements have been met pursuant to 

sections 14(a)(1), and (a)(2), (d)(2)(B) of 

the Consumer Product Safety Act 

(CPSA) (15 U.S.C. 2063(a)(1), (a)(2), 

(d)(2)(B)). 

§ 1107.2 Definitions. 

Unless otherwise stated, the 

definitions of the Consumer Product 

Safety Act and the Consumer Product 

Safety Improvement Act of 2008 apply 

to this part. The following definitions 

apply for purposes of this part: 

CPSA means the Consumer Product 

Safety Act. 

CPSC means the Consumer Product 

Safety Commission. 

Detailed bill of materials means a list 

of the raw materials, sub-assemblies, 

intermediate assemblies, subcomponent parts, component parts, and 

the quantities of each needed to 

manufacture a finished product. 

Due care means the degree of care that 

a prudent and competent person 

engaged in the same line of business or 

endeavor would exercise under similar 

circumstances. 

High degree of assurance means an 

evidence-based demonstration of 

consistent performance of a product 

regarding compliance based on 

knowledge of a product and its 

manufacture. 

Identical in all material respects 

means there is no difference with 

respect to compliance to the applicable 

rules between the samples and the 

finished product. 

Manufacturer means the parties 

responsible for certification of a 

consumer product pursuant to 16 CFR 

part 1110. 

Manufacturing process means the 

techniques, fixtures, tools, materials, 

and personnel used to create the 

component parts and assemble a 

finished product. 

Production testing plan means a 

document that shows what tests must be 

performed and the frequency at which 

those tests must be performed to 

provide a high degree of assurance that 

the products manufactured after 

certification continue to meet all the 

applicable safety rules. 

Third party conformity assessment 

body means a third party conformity 

assessment body recognized by the 

CPSC to conduct certification testing on 

children’s products. 

Subpart B—Reasonable Testing 

Program for Nonchildren’s Products 

§ 1107.10 Reasonable testing program for 

nonchildren’s products. 

(a) Except as otherwise provided in a 

specific regulation under this title or a 

specific standard prescribed by law, a 

manufacturer certifying a product 

pursuant to a reasonable testing program 

must ensure that the reasonable testing 

program provides a high degree of 

assurance that the consumer products 

covered by the program will comply 

with all applicable rules, bans, 

standards, or regulations. 

(b) A reasonable testing program must 

consist of the following elements: 

(1) Product Specification. The product 

specification is a description of the 

consumer product and lists the 

applicable rules, bans, standards or 

regulations to which the product is 

subject. A product specification should 

describe the product listed on a general 

conformity certification in sufficient 

detail to identify the product and 

distinguish it from other products made 

by the manufacturer. The product 

specification may include, but is not 

limited to, a color photograph or 

illustration, model names or numbers, a 

detailed bill of materials, a parts listing, 

raw material selection and sourcing 

requirements. 

(i) A product specification must 

include any component parts that are 

certified pursuant to 16 CFR Part 1109. 

(ii) Product specifications that 

identify individual features of a product 

that would not be considered a material 

change may use the same product 

specification for all products 

manufactured with those specific 

features. Features that would not be 

considered a material change include 

different product sizes or other features 

that cover variations of the product 

where those variations do not affect the 

product’s ability to comply with 

applicable rules, bans, standards, or 

regulations. 

(iii) Each manufacturing site must 

have a separate product specification. 

(2) Certification Tests. A manufacturer 

must conduct certification tests on a 

product before issuing a general 

conformity certificate for that product. 

A certification test is a test performed 

on samples of the product that are 

identical to the finished product in all 

material respects to demonstrate that the 

product complies with the applicable 

safety rules, bans, standards, or 

regulations. Certification tests must 

contain the following elements: 

(i) Samples. For purposes of this 

section, a sample means a component 

part of the product or the finished 

product which is subject to testing. 

Samples submitted for certification 

testing must be identical in all material 

respects to the product to be distributed 

in commerce. The manufacturer must 

submit a sufficient number of samples 

for certification testing so as to provide 

a high degree of assurance that the 

certification tests accurately represent 

the product’s compliance with all 

applicable rules. 

(A) Only finished products or 

component parts listed on the product 

specification can be submitted for 

certification testing. 

(B) A manufacturer may substitute 

component part testing for finished 

product testing pursuant to 16 CFR part 

1109 unless the rule, ban, standard or 

regulation applicable to the product 

requires testing of the finished product. 

If a manufacturer relies upon 

certification testing of component 

part(s) (rather than tests of the finished 

product), the manufacturer must 

demonstrate how the combination of 

testing of component part(s), portions of 

the finished product, and finished 

product samples demonstrate, with a 

high degree of assurance, compliance 

with all applicable rules, bans, 

standards, or regulations. 

(ii) Material Change. A material 

change is any change in the product’s 

design, manufacturing process, or 


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sourcing of component parts that a 

manufacturer exercising due care 

knows, or should know, could affect the 

product’s ability to comply with the 

applicable rules, bans, standards, or 

regulations. 

(A) When a previously-certified 

product undergoes a material change 

that only affects the product’s ability to 

comply with certain applicable rules, 

bans, standards, or regulations, 

certification for the new product 

specification may be based on 

certification testing of the materially 

changed component part, material, or 

process, and the passing certification 

tests of the portions of the previouslycertified product that were not 

materially changed. 

(B) A manufacturer must conduct 

certification tests of the finished 

product if a material change affects the 

finished product’s ability to comply 

with an applicable rule, ban, standard, 

or regulation. 

(C) A manufacturer must exercise due 

care to ensure that reliance on anything 

other than retesting of the finished 

product after a material change occurs 

does not allow a noncompliant product 

to be distributed in commerce. A 

manufacturer should resolve any doubts 

in favor of retesting the finished product 

for certification. 

(3) Production Testing Plan. A 

production testing plan describes what 

tests must be performed and the 

frequency at which those tests must be 

performed to provide a high degree of 

assurance that the products 

manufactured after certification 

continue to meet all the applicable 

safety rules, bans, standards, or 

regulations. A production testing plan 

may include recurring testing or the use 

of process management techniques such 

as control charts, statistical process 

control programs, or failure modes and 

effects analyses (FMEAs) designed to 

control potential variations in product 

manufacturing that could affect the 

product’s ability to comply with the 

applicable rules, bans, standards, or 

regulations. A production testing plan 

must contain the following elements: 

(i) A description of the production 

testing plan, including, but not limited 

to, a description of the tests to be 

conducted or the measurements to be 

taken, the intervals at which the tests or 

measurements will be made, the number 

of samples tested, and the basis for 

determining that such tests provide a 

high degree of assurance of compliance 

if they are not the tests prescribed in the 

applicable rule, ban, standard, or 

regulation; 

(ii) Each manufacturing site must 

have a separate production testing plan; 

(iii) The production testing interval 

selected must be short enough to ensure 

that, if the samples selected for 

production testing comply with an 

applicable rule, ban, standard, or 

regulation, there is a high degree of 

assurance that the untested products 

manufactured during that interval also 

will comply with the applicable rule, 

ban, standard, or regulation. Production 

test intervals should be appropriate for 

the specific testing or alternative 

measurements being conducted. 

(A) A manufacturer may use 

measurement techniques that are 

nondestructive and tailored to the needs 

of an individual product instead of 

conducting product performance tests to 

assure a product complies with all 

applicable rules, bans, standards, or 

regulations. 

(B) Any production test method used 

to conduct production testing must be 

as effective in detecting noncompliant 

products as the tests used for 

certification. 

(C) If a manufacturer is uncertain 

whether a production test is as effective 

as the certification test, the 

manufacturer must use the certification 

test. 

(4) Remedial Action Plan. 

(i) A remedial action plan describes 

the steps to be taken whenever samples 

of a product or a component part of a 

product fails a test or fails to comply 

with an applicable rule, ban, standard, 

or regulation. A remedial action plan 

must contain procedures the 

manufacturer must follow to investigate 

and address failing test results. 

Manufacturers must take remedial 

action after any failing test result to 

ensure with a high degree of assurance 

that the products manufactured after the 

remedial action has been taken comply 

with the applicable rules, bans, 

standards, or regulations. The type of 

remedial action may be different 

depending upon the applicable rule, 

ban, standard, or regulation. Remedial 

action can include, but is not limited to: 

(A) Changes to the manufacturing 

process, the equipment used to 

manufacture the product, the product’s 

materials, or design; 

(B) reworking the product produced; 

or 

(C) other actions deemed appropriate 

by the manufacturer, in the exercise of 

due care, to assure compliant products. 

(ii) Any remedial action that results in 

a material change to a product’s design, 

parts, suppliers of parts, or 

manufacturing process that could affect 

the product’s ability to comply with any 

applicable rules requires a new product 

specification for that product. Before a 

product covered by the new product 

specification can be certified as 

compliant with the applicable rules, 

bans, standards, or regulations, a 

manufacturer must have passing 

certification test results for the 

applicable rules, bans, standards, or 

regulation. 

(5) Recordkeeping. 

(i) A manufacturer of a nonchildren’s 

product must maintain the following 

records: 

(A) Records of the general conformity 

certificate for each product; 

(B) Records of each product 

specification; 

(C) Records of each certification test 

and, if the manufacturer elected to have 

a third party conformity assessment 

body test the product, identification of 

any third party conformity assessment 

body on whose testing the certificate 

depends. Records of certification tests 

must describe how the product was 

certified as meeting the requirements, 

including how each applicable rule was 

evaluated, the test results, and the 

actual values of the tests; 

(D) Records to demonstrate 

compliance with the production testing 

plan requirement, including a list of the 

applicable rules, bans, standards, or 

regulations, a description of the types of 

production tests conducted, the number 

of samples tested, the production 

interval selected for performance of 

each test, and the test results. Records 

of a production test program must 

describe how the production tests 

demonstrate that the continuing 

production complies with the 

applicable rules. References to 

techniques in relevant quality 

management and control standards, 

such as ANSI/ISO/ASQ Q9001–2008: 

Quality management systems— 

Requirements, ANSI/ASQ Z1.4–2008: 

Sampling Procedures and Tables for 

Inspection by Attributes, and/or ANSI/ 

ASQ Z1.9–2008: Sampling Procedures 

and Tables for Inspection by Variables 

for Percent Nonconforming, may be 

used to demonstrate that the production 

tests have the necessary accuracy, 

precision sensitivity, repeatability, and 

confidence to distinguish between 

compliant and noncompliant products; 

(E) Records of all remedial actions 

taken, including the specific action 

taken, the date the action was taken, the 

person who authorized the actions, and 

any test failure which necessitated the 

action. Records of remedial action must 

relate the action taken to the product 

specification of the product that was the 

subject of that remedial action and the 

product specification of any new 

product resulting from any remedial 

action; 


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(ii) If a remedial action results in a 

new product specification, the 

manufacturer must create a new set of 

records for the product. 

(iii) A manufacturer must maintain 

the records specified in this subpart at 

the location within the United States 

specified in 16 CFR 1110.11(d) or, if the 

records are not maintained at the 

custodian’s address, at a location within 

the United States specified by the 

custodian. The manufacturer must make 

these records available, either in hard 

copy or electronically, for inspection by 

the CPSC upon request. 

(iv) A manufacturer must maintain 

records (except for test records) for as 

long as the product is in production or 

imported by the manufacturer plus five 

years. Test records must be maintained 

for five years. All records must be 

available in the English language. 

(c) If any certification test results in a 

failure, a manufacturer cannot certify a 

product until the manufacturer has 

taken remedial action, and the product 

manufactured after the remedial action 

passes certification testing. 

(d) Manufacturers of a nonchildren’s 

product may use a third party 

conformity assessment body to conduct 

certification testing but are not required 

to use a third party conformity 

assessment body recognized by the 

CPSC to conduct certification testing on 

children’s products. 

(e) Manufacturers of children’s 

products may voluntarily establish a 

reasonable testing program consistent 

with this subpart. 

Subpart C—Certification of Children’s 

Products 

§ 1107.20 General requirements. 

(a) Manufacturers must submit a 

sufficient number of samples of a 

children’s product, or samples that are 

identical in all material respects to the 

children’s product, to a third party 

conformity assessment body for testing 

to support certification. The number of 

samples selected must provide a high 

degree of assurance that the tests 

conducted for certification purposes 

accurately demonstrate the ability of the 

children’s product to meet all applicable 

children’s product safety rules. 

(b) If the manufacturing process for a 

children’s product consistently creates 

finished products that are uniform in 

composition and quality, a 

manufacturer may submit fewer samples 

to provide a high degree of assurance 

that the finished product complies with 

the applicable children’s product safety 

rules. If the manufacturing process for a 

children’s product results in variability 

in the composition or quality of 

children’s products, a manufacturer may 

need to submit more samples to provide 

a high degree of assurance that the 

finished product complies with the 

applicable children’s product safety 

rules. 

(c) Except where otherwise specified 

by a children’s product safety rule, a 

manufacturer may substitute component 

part testing for complete product testing 

pursuant to 16 CFR part 1109 if the 

component part, without the remainder 

of the finished product, is sufficient to 

determine compliance for the entire 

product. 

(d) If a product sample fails 

certification testing, even if other 

samples have passed the same 

certification test, the manufacturer must 

investigate the reasons for the failure 

and take remedial action. A 

manufacturer cannot certify the 

children’s product until the 

manufacturer establishes, with a high 

degree of assurance, that the finished 

product does comply with all applicable 

children’s product safety rules. 

§ 1107.21 Periodic testing. 

(a) Each manufacturer must conduct 

periodic testing at least annually, except 

as otherwise provided in paragraphs (b) 

and (d) of this section or as provided in 

regulations under this title. 

Manufacturers may need to conduct 

periodic tests more frequently than on 

an annual basis to ensure a high degree 

of assurance that the product being 

tested complies with all applicable 

children’s product safety rules. 

(b) If a manufacturer has implemented 

a reasonable testing program as 

described in subpart B of this part, it 

must submit samples of its product to a 

third party conformity assessment body 

for periodic testing to the applicable 

children’s product safety rules at least 

once every two years. If a 

manufacturer’s reasonable testing 

program fails to provide a high degree 

of assurance of compliance with all 

applicable children’s product safety 

rules, the Commission may require the 

manufacturer to meet the requirements 

of paragraph (c) of this section or 

modify its reasonable testing program to 

ensure a high degree of assurance. 

(c) If a manufacturer has not 

implemented a reasonable testing 

program as described in subpart B of 

this part, then all periodic testing must 

be conducted by a third party 

conformity assessment body, and the 

manufacturer must conduct periodic 

testing as follows: 

(1) Periodic Test Plan. Manufacturers 

must develop a periodic test plan to 

assure that children’s products 

manufactured after the issuance of a 

children’s product certification, or when 

the previous periodic testing was 

conducted, continue to comply with all 

applicable children’s product safety 

rules. The periodic test plan must 

include the tests to be conducted, the 

intervals at which the tests will be 

conducted, the number of samples 

tested, and the basis for determining 

that the periodic testing plan provides a 

high degree of assurance that the 

product being tested continues to 

comply with all applicable children’s 

product safety rules. The manufacturer 

must have a separate periodic testing 

plan for each manufacturing site 

producing a children’s product. 

(2) Testing Interval. The periodic 

testing interval selected must be short 

enough to ensure that, if the samples 

selected for periodic testing pass the 

test, there is a high degree of assurance 

that the other untested children’s 

products manufactured during the 

interval comply with the applicable 

children’s product safety rules. The 

interval for periodic testing may vary 

depending upon the specific children’s 

product safety rules that apply to the 

children’s product. Factors to be 

considered when determining the 

periodic testing interval include, but are 

not limited to, the following: 

(i) High variability in test results, as 

indicated by a relatively large sample 

standard deviation in quantitative tests; 

(ii) Measurements that are close to the 

allowable numerical limit for 

quantitative tests; 

(iii) Known manufacturing process 

factors which could affect compliance 

with a rule. For example, if the 

manufacturer knows that a casting die 

wears down as the die nears the end of 

its useful life, the manufacturer may 

wish to test more often as the casting die 

wears down; 

(iv) Consumer complaints or warranty 

claims; 

(v) Nonmaterial changes, such as 

introduction of a new set of component 

parts into the assembly process, or the 

manufacture of a fixed number of 

products; 

(vi) Potential for serious injury or 

death resulting from a noncompliant 

children’s product; 

(vii) The number of children’s 

products produced annually, such that 

a manufacturer should consider testing 

a children’s product more frequently if 

the product is produced in very large 

numbers or distributed widely 

throughout the United States; 

(viii) The children’s product’s 

similarity to other children’s products 

with which the manufacturer is familiar 

and/or whether the children’s product 

has many different component parts 


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compared to other children’s products 

of a similar type; or 

(ix) Inability to determine the 

children’s product’s noncompliance 

easily through means such as visual 

inspection. 

(d) For a product produced or 

imported at low volumes, a 

manufacturer is not subject to the 

periodic testing requirements of 

paragraphs (a) and (b) or (c) of this 

section unless it produces 10,000 units 

of the product. Once a manufacturer has 

produced or imported 10,000 units of 

the product, the frequency at which the 

manufacturer must engage in periodic 

testing must comply with paragraph (a), 

and (b) or (c) of this section and does 

not depend on how often the 

manufacturer produces or imports every 

10,000 units of the product. 

§ 1107.22 Random samples. 

Each manufacturer must select 

samples for periodic testing by using a 

process that assigns each sample in the 

production population an equal 

probability of being selected. For 

purposes of this section, the production 

population is the number of products 

manufactured or imported after the 

initial certification or last periodic 

testing of a children’s product. A 

manufacturer may use a procedure that 

randomly selects items from a list to 

determine which samples are the 

random samples used for periodic 

testing before production begins. A 

manufacturer may select samples for 

testing as they are manufactured. 

Manufacturers who produce children’s 

products that continue to be distributed 

in commerce as they are manufactured 

may wish to test the samples as they 

become available instead of waiting 

until all the random samples have been 

selected before conducting testing. 

§ 1107.23 Material change. 

(a) General Requirements. If a 

children’s product undergoes a material 

change in product design or 

manufacturing process, including the 

sourcing of component parts, that a 

manufacturer exercising due care 

knows, or should know, could affect the 

product’s ability to comply with the 

applicable children’s product safety 

rules, the manufacturer must submit a 

sufficient number of samples of the 

materially changed product for testing 

by a third party conformity assessment 

body. Such testing must occur before a 

manufacturer can certify the children’s 

product. The extent of such testing may 

depend on the nature of the material 

change. When a material change is 

limited to a component part of the 

finished children’s product and does 

not affect the ability of the children’s 

product to comply with other applicable 

children’s product safety rules, a 

manufacturer may issue a children’s 

product certificate based on the earlier 

third party certification tests and on test 

results of the changed component part 

conducted by a third party conformity 

assessment body. Changes that cause a 

children’s product safety rule to no 

longer apply to a children’s product are 

not considered to be material changes. 

A manufacturer must exercise due care 

to ensure that reliance on anything other 

than retesting of the finished product 

after a material change would not allow 

a noncompliant children’s product to be 

distributed in commerce. A 

manufacturer should resolve any doubts 

in favor of retesting the finished product 

for certification. Additionally, a 

manufacturer must exercise due care to 

ensure that any component part 

undergoing component-part-level 

testing is the same as the component 

part on the finished children’s product 

in all material respects. 

(b) Product Design. For purposes of 

this subpart, the term product design 

includes all component parts, their 

composition, and their interaction and 

functionality when assembled. To 

determine which children’s product 

safety rules apply to a children’s 

product, a manufacturer should 

examine the product design for the 

children’s product as received by the 

consumer. 

(c) Manufacturing Process. A material 

change in the manufacturing process is 

a change in how the children’s product 

is made that could affect the finished 

children’s product’s ability to comply 

with the applicable children’s product 

safety rules. For each change in the 

manufacturing process, a manufacturer 

should exercise due care to determine if 

compliance to an existing applicable 

children’s product safety rule could be 

affected, or if the change results in a 

newly-applicable children’s product 

safety rule. 

(d) Sourcing of Component Parts. A 

material change in the sourcing of 

component parts results when the 

replacement of one component part of a 

children’s product with another 

component part could affect compliance 

with the applicable children’s product 

safety rules. This includes, but is not 

limited to, changes in component part 

composition, component part supplier, 

or the use of a different component part 

from the same supplier who provided 

the initial component part. 

§ 1107.24 Undue influence. 

(a) Each manufacturer must establish 

procedures to safeguard against the 

exercise of undue influence by a 

manufacturer on a third party 

conformity assessment body. 

(b) The procedures required in 

paragraph (a) of this section, at a 

minimum, must include: 

(1) Safeguards to prevent attempts by 

the manufacturer to exercise undue 

influence on a third party conformity 

assessment body, including a written 

policy statement from company officials 

that the exercise of undue influence is 

not acceptable, and directing that 

appropriate staff receive annual training 

on avoiding undue influence, and sign 

a statement attesting to participation in 

such training; 

(2) A requirement to notify the 

Commission immediately of any attempt 

by the manufacturer to hide or exert 

undue influence over test results; and 

(3) A requirement to inform 

employees that allegations of undue 

influence may be reported 

confidentially to the Commission and to 

describe the manner in which such a 

report can be made. 

§ 1107.25 Remedial action. 

(a) Each manufacturer of a children’s 

product must have a remedial action 

plan that contains procedures the 

manufacturer must follow to investigate 

and address failing test results. A 

manufacturer must take remedial action 

after any failing test result to ensure, 

with a high degree of assurance, that the 

children’s products manufactured after 

the remedial action has been taken 

comply with all applicable children’s 

product safety rules. 

(b) A manufacturer must not certify a 

product if any certification test by a 

third party conformity assessment body 

results in a failure until the 

manufacturer has taken remedial action 

and the product manufactured after the 

remedial action passes certification 

testing. 

(c) Following a failing test result, a 

manufacturer must take remedial action 

to ensure, with a high degree of 

assurance, that the children’s product 

complies with all applicable children’s 

product safety rules. Remedial action 

can include, but is not limited to, 

redesign, changes in the manufacturing 

process, or changes in component part 

sourcing. For existing production, 

remedial action may include rework, 

repair, or scrap of the children’s 

product. If a remedial action results in 

a material change a manufacturer must 

have a third party conformity 

assessment body retest the redesigned or 

remanufactured product before the 

manufacturer can certify the product. 


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28366 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules 

§ 1107.26 Recordkeeping. 

(a) A manufacturer of a children’s 

product subject to an applicable 

children’s product safety rule must 

maintain the following records: 

(1) Records of the children’s product 

certificate for each product. The 

children’s product covered by the 

certificate must be clearly identifiable 

and distinguishable from other 

products; 

(2) Records of each third party 

certification test. The manufacturer 

must have separate certification tests 

records for each manufacturing site; 

(3) Records of the periodic test plan 

and periodic test results for a children’s 

product; 

(4) Records of descriptions of all 

material changes in product design, 

manufacturing process, and sourcing of 

component parts, and the certification 

tests run and the test values; 

(5) Records of the undue influence 

procedures, including training materials 

and training records of all employees 

trained on these procedures; and 

(6) Records of all remedial actions 

taken following a failing test result, 

including the rule that was tested, the 

specific remedial action taken, the date 

the action was taken, the person who 

authorized the action, any test failure 

which necessitated the action, and the 

results from certification tests showing 

compliance after the remedial action 

was taken. 

(b) A manufacturer must maintain the 

records specified in this subpart at the 

location within the United States 

specified in 16 CFR 1110.11(d) or, if the 

records are not maintained at the 

custodian’s address, at a location within 

the United States specified by the 

custodian. The manufacturer must make 

these records available, either in hard 

copy or electronically, for inspection by 

the CPSC upon request. 

(c) A manufacturer must maintain 

records (except for test records) for as 

long as the product is in production or 

imported by the manufacturer plus five 

years. Test records must be maintained 

for five years. All records must be 

available in the English language. 

Subpart D—Consumer Product 

Labeling Program 

§ 1107.40 Labeling consumer products to 

indicate that the certification requirements 

of section 14 of the CPSA have been met. 

(a) Manufacturers and private labelers 

of a consumer product may indicate, by 

a uniform label on or provided with the 

product, that the product complies with 

any consumer product safety rule under 

the CPSA, or with any similar rule, ban, 

standard or regulation under any other 

act enforced by the CPSC. 

(b) The label must be printed in bold 

typeface, using an Arial font of not less 

than 12 points, be visible and legible, 

and consist of the following statement: 

Meets CPSC Safety Requirements 

(c) A consumer product may bear the 

label if the manufacturer or private 

labeler has certified, pursuant to section 

14 of the CPSA, that the consumer 

product complies with all applicable 

consumer product safety rules under the 

CPSA and with all rules, bans, 

standards, or regulations applicable to 

the product under any other act 

enforced by the Consumer Product 

Safety Commission. 

(d) A manufacturer or private labeler 

may use another label on the consumer 

product as long as such label does not 

alter or mislead consumers as to the 

meaning of the label described in 

paragraph (b) of this section. A 

manufacturer or private labeler must not 

imply that the CPSC has tested, 

approved, or endorsed the product. 

Dated: May 7, 2010. 

Todd A. Stevenson, 

Secretary. 

[FR Doc. 2010–11365 Filed 5–19–10; 8:45 am] 

BILLING CODE 6355–01–P 


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