## Thursday,

May 20, 2010



# Part II



# Consumer Product
Safety Commission

16 CFR Part 1107

Testing and Labeling Pertaining to
Product Certification; Proposed Rule


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

1 The 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


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

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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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 testingprograms, 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


### 28342 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

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


### 28343 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

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


### 28344 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

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 smallmanufacturers. 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—E XISTING 

### T ESTING 

### P ROGRAMS 

### T HAT 

### W OULD 

### N OT 

### B E 

### S UPERSEDED BY 

### P ROPOSED 

### § 1107.10 R EGARDING A



### R EASONABLE 

### T ESTING 

### P ROGRAM

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.


### 28345 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

TABLE 

### 1—E XISTING 

### T ESTING 

### P ROGRAMS 

### T HAT 

### W OULD 

### N OT 

### B E 

### S UPERSEDED BY 

### P ROPOSED 

### § 1107.10 R EGARDING A



### R EASONABLE 

### T ESTING 

### P ROGRAM 

### —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 theCommission 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.


### 28346 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

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 certificationtests 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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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 anycomponent 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


### 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—M ANUFACTURERS

NAICS code Description Small firms Total firms

31411 .......... Carpet and Rug Mills ............................................................................................ ......................... 261 284 31519 .......... Other Apparel Knitting Mills (Outerwear, Underwear, and Sleepwear) ......................................... 235 2 46 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


### 28353 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

TABLE 

### 2—M ANUFACTURERS

### —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—W HOLESALERS

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 4,5 52 42392 .......... Toy and Hobby Goods and Supplies Merchant Wholesalers ....................................................... 2,17 0 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 .............................................. 3,2353,393 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 .................................................. 12,49 7 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.


### 28354 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

TABLE 

### 4—R ETAILERS

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


### 28355 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Proposed Rules

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


### 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—S AMPLE 

### S IZES 

### R EQUIRED 

### T O 

### P ROVIDE AT 

### L EAST 

### 95 P ERCENT 

### P ROBABILITY 

### T HAT THE 

### L OT IS 

### C OMPLIANT 

### (G IVEN THE 

### AVAILABILITY OF 

### Q UANTITATIVE 

### T EST 

### D ATA 

### )

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


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

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


### 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 onlow-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


### 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


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

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:


### 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 certificationtests 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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**§ 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**