Testing and Labeling Pertaining to Product Certification

Federal RegisterNov 8, 2011

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1107

[CPSC Docket No. CPSC-2010-0038]

Testing and Labeling Pertaining to Product Certification

AGENCY:

Consumer Product Safety Commission.

ACTION:

Final rule.

SUMMARY:

The Consumer Product Safety Commission (“CPSC,” “Commission,” or “we”) is issuing a final rule that establishes protocols and standards with respect to certification and continued testing for children's products. The final rule also establishes requirements for labeling of consumer products to show that the product complies with the certification requirements under section 14(a) of the Consumer Product Safety Act (“CPSA”). The final rule implements section 14(a)(2) and (i) of the CPSA, as amended by section 102(b) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”).

DATES:

The rule will become effective on February 8, 2013 and applies to products manufactured after that date. The incorporation by reference of the publications listed in this rule is approved by the Director of the Federal Register as of February 8, 2013.

The Commission voted 3-2 to publish this final rule, with changes, in the

Federal Register

. Chairman Inez M. Tenenbaum, Commissioners Robert S. Adler and Thomas H. Moore voted to publish the final rule with changes. Commissioners Nancy A. Nord and Anne M. Northup voted against publication of the final rule. Chairman Tenenbaum, Commissioner Adler, and Commissioner Moore issued a joint statement. Commissioner Nord and Commissioner Northrup issued statements. The statements can be found at

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

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; email:

RButturini@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Purpose of the Final Rule

The purpose of this final rule is to reduce the incidents of deaths and injuries associated with children's products. This will be accomplished by increasing the safety of children's products. The likelihood of a noncompliant product being detected before it is introduced to the public will be increased. Consequently, consumer confidence in children's products certified to comply with the applicable product safety rules may be increased. Potentially, the number of recalls for children's products could be reduced, and, with continued assessment of compliance, the scope of necessary recalls could be reduced. Further, third party testing during continuing production or importation can serve as an objective assessment of the effectiveness of a manufacturer's or importer's internal processes to ensure compliance, which would also serve to enhance the safety of children's products in the market.

II. Statutory Authority

A. The Consumer Product Safety Act, as Amended by the Consumer Product Safety Improvement Act of 2008

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 years of age or 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(i)(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. (On August 12, 2011, the President signed into law H.R. 2715, which amended both the CPSA and the CPSIA. Section 10(a) of H.R. 2715 redesignates what was identified as section 14(d) of the CPSA in the preamble of the proposed rule as section 14(i) of the CPSA; consequently, except where we are citing language from the proposed rule, the remainder of this document will refer to section 14(i) of the CPSA.)

Section 14(i)(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 representative 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(i)(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, we are not imposing any verification obligations on manufacturers because we intend to conduct the verification ourselves under our inherent authorities while we gain more experience with the testing and certification requirements. When we find that a children's product

accompanied by a certificate of conformity does not pass the tests upon which the certification was based, we 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.

To implement sections 14(a) and (d) (now renumbered by H.R. 2715 as section 14(i)) of the CPSA, as amended by section 102 of the CPSIA, we published a proposed rule in the

Federal Register

on May 20, 2010 (75 FR 28336). The proposed rule would:

• Define the elements of a “reasonable testing program” for purposes of section 14(a)(1)(A) of the CPSA;

• Establish the protocols and standards for continuing testing of children's products under section 14(d)(2)(B)(i), (ii), and (iv) (renumbered as sections 14(i)(2)(B)(i), (ii), and (iv)) of the CPSA; and

• Describe the label that manufacturers may place on a consumer product to show that the product complies with the certification requirements for purposes of what was numbered previously as section 14(d)(2)(A) of the CPSA (now renumbered by H.R. 2715 as section 14(i)(2)(A) of the CPSA).

B. H.R. 2715 and Its Impact on This Rulemaking

On August 12, 2011, the President signed into law H.R. 2715. H.R. 2715 amended the CPSA and the CPSIA in several ways. For example, section 2, “Application of Third Party Testing Requirements,” of H.R. 2715, revised section 14(d) of the CPSA, in part, by:

• Renumbering the second paragraph of section 14(d) of the CPSA as section 14(i) of the CPSA. (When the CPSIA was enacted, it created, mistakenly, two paragraph (d)s in section 14 of the CPSA. The paragraph at issue in the proposed rule was the second of the two paragraphs numbered (d); H.R. 2715 contained a technical amendment to renumber the second paragraph (d) as a new paragraph (i) of section 14 of the CPSA);

• Revising section 14(i)(2)(B)(ii) of the CPSA to require the testing of “representative samples,” rather than the testing of “random samples”;

• Creating a new section 14(i)(3)(A) of the CPSA requiring, no later than 60 days after the date of enactment, that we “seek public comment on opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation.” H.R. 2715 lists seven topics for public comment:

○ The extent to which the use of materials subject to regulations of another government agency that requires third party testing of those materials may provide sufficient assurance of conformity with an applicable consumer product safety rule, ban, standard, or regulation without further third party testing;

○ The extent to which modification of the certification requirements may have the effect of reducing redundant third party testing by or on behalf of 2 or more importers of a product that is substantially similar or identical in all material respects;

○ The extent to which products with a substantial number of different components subject to third party testing may be evaluated to show compliance with an applicable rule, ban, standard, or regulation by third party testing of a subset of such components selected by a third party conformity assessment body;

○ The extent to which manufacturers with a substantial number of substantially similar products subject to third party testing may reasonably make use of sampling procedures that reduce the overall test burden without compromising the benefits of third party testing;

○ The extent to which evidence of conformity with other national or international governmental standards may provide assurance of conformity to consumer product safety rules, bans, standards, or regulations applicable under the CPSA;

○ The extent to which technology, other than the technology already approved by the Commission, exists for third party conformity assessment bodies to test or to screen for testing consumer products subject to a third party testing requirement; and

○ Other techniques for lowering the cost of third party testing consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.

• Creating a new section 14(i)(3)(B) of the CPSA, requiring us to review the public comments and stating that we “may prescribe new or revised third party testing regulations if [we determine] that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations; and

• Creating a new section 14(i)(4) of the CPSA, titled, “Special rules for small batch manufacturers,” to provide “alternative testing requirements” for “covered products” manufactured by small batch manufacturers or to exempt small batch manufacturers from third party testing requirements. H.R. 2715 defines a “covered product” as “a consumer product manufactured by a small batch manufacturer where no more than 7,500 units of the same product were manufactured in the previous calendar year.” It defines a “small batch manufacturer,” in part, as “a manufacturer that had no more than $1,000,000 in total gross revenue from sales of all consumer products in the previous calendar year.”

H.R. 2715 also contains (among other things) provisions on registration of small batch manufacturers and exclusions of certain materials from third party testing. For example, H.R. 2715 created a new section 14(i)(5)(A)(i) of the CPSA, which states that the third party testing requirements do not apply to “ordinary books or ordinary paper-based printed materials.”

The Commission has chosen to finalize those parts of the proposed rule that were not affected directly or significantly by H.R. 2715, and we will reserve other subparts or provisions in the final rule, pending our consideration and implementation of H.R. 2715. For example, because section 14(i)(2)(B)(ii) of the CPSA, as amended by H.R. 2715, now refers to the testing of “representative samples,” we have decided to remove § 1107.22 from subpart C of the final rule, which would have pertained to “Random Samples.”

III. Comments on the Proposed Rule and Our Responses

Below, we describe and explain each subpart and section of the final rule, as well as describe and respond to the comments on the proposed rule. A summary of each of the commenters' topics is presented, and each topic is followed by our response. For ease of reading, each comment will be prefaced by a numbered “Comment”; and each response will be prefaced by a corresponding numbered “Response.” Each “Comment” is numbered to help distinguish between different topics. The number assigned to each comment is for organizational purposes only and does not signify the comment's value or importance or the order in which it was received. Comments on similar topics are grouped together.

A. General Comments

Several commenters addressed issues regarding testing and costs, generally.

(Comment 1)—One commenter warned that because the overwhelming majority of consumer products sold in the United States are produced overseas,

nearly all of the work necessary to ensure compliance with the regulations will be performed overseas. The commenter stated that because the cost of compliance for foreign manufacturers can be relatively high—while the risks associated with noncompliance can be relatively low—it is important that our regulation balance the need for a high degree of assurance of compliance against the need to develop a practical regulatory structure that foreign manufacturers can and will implement.

(Response 1)—The final rule is designed not to be overly prescriptive, thereby giving manufacturers some flexibility in designing their testing and certification programs to be consistent with the statutory requirements. For example, the final rule allows the manufacturer to determine the number of samples that are tested, as long as the manufacturer has a high degree of assurance that the products represented by the samples are in compliance with all applicable children's product safety rules. Further, while the final rule requires that manufacturers document their compliance, it gives manufacturers the flexibility to determine how to maintain this information. In addition, the final rule does not require any documentation to be maintained in English or kept in the United States, except the certificate.

We also note that, on August 12, 2011, the President signed into law H.R. 2715, which amended the CPSIA in several respects. One provision in H.R. 2715 requires us to seek public comment on opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation. H.R. 2715 directs us to seek public comment on seven specific issues, including the extent to which modification of the certification requirements may have the effect of reducing redundant third party testing by or on behalf of two or more importers of a product that is substantially similar or identical in all material respects, and other techniques for lowering the cost of third party testing consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations. Elsewhere in this issue of the

Federal Register

, we have published a notice seeking public comment on the issues in H.R. 2715. H.R. 2715 further requires us to review the public comments and states that we may prescribe new or revised third party testing regulations if we determine that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.

(Comment 2)—Two commenters stated that we should conduct a full cost-benefit analysis of the rule. One commenter added that costs of complying with the testing and certification rule, in combination with other requirements under the CPSIA and other rules administered by the CPSC, will result in a major rule with major implications to consumer product manufacturers, particularly children's product manufacturers, as well as to the entire supply chain. The commenter urged us to examine in greater detail, and to quantify, the full cost and burden of these rules. A third commenter implored us to consider the reduction in risk, if any, associated with each regulatory requirement and impose only those requirements that meaningfully enhance consumer safety in a way that makes increased costs and use of resources worthwhile.

(Response 2)—This rule is being promulgated under the Administrative Procedure Act and also section 3 of the CPSIA; neither authority requires us to conduct a cost-benefit analysis. Moreover, by allowing in CPSIA expedited rulemaking, Congress made it clear that it did not want the Commission engaging in any unnecessary delay in promulgating this rule. However, we agree that the final rule constitutes a major rule, as defined by the Congressional Review Act of 1996. While, in recognition of Congress's view as reflected in CPSIA, we decline to conduct a cost-benefit analysis for the final rule, we have changed the final rule to address some of the economic burden on manufacturers. Among the changes made to the final rule to reduce the burden are: (1) Reserving the subpart B requirements regarding a reasonable testing program;

(2) eliminating certain requirements of the proposed rule for children's products such as the remedial action plan; (3) reducing the recordkeeping requirements in several respects; and (4) allowing the use of in-house ISO/IEC 17025:2005 laboratories to reduce the frequency of third party periodic testing. By way of further example, with regard to the reduction in the recordkeeping requirements, the final rule does not require records to be kept in the United States, nor does it require records to be translated into English, unless requested.

It should be noted, however, that although we are not finalizing subpart B at this time, manufacturers of non-children's products that are subject to a product safety rule, ban, standard, or regulation are still obligated by the CPSA, as amended by the CPSIA, to certify that their products comply with all applicable safety rule[s] based on a test of each product or a reasonable testing program.

Additionally, we note that a cost-benefit analysis would not necessarily be confined to manufacturers or those in a supply chain (as implied by one commenter). We expect, for instance, that consumers will benefit from the testing and certification of consumer products, particularly if such testing revealed potential problems associated with a product or its components, or if such testing prompted a manufacturer to redesign or remanufacture the product to make it safer.

(Comment 3)—One commenter stated that some retailers are requiring many manufacturers to submit their products to as many as four different laboratories because the retailers want to see test results from specific laboratories. The commenter stated that we should clarify to retailers that this redundant testing is not necessary.

(Response 3)—The preamble to the proposed rule stated that retailers and sellers of children's products can rely on certificates provided by finished product certifiers—without conducting additional testing themselves—if those certificates are based on testing conducted by a CPSC-accepted third party conformity assessment body (75 FR at 28337).

B. Proposed Subpart A—General Provisions

1. Proposed § 1107.1—Purpose

Proposed § 1107.1 would state that part 1107 establishes the requirements for a reasonable testing program for non-children'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)).

We did not receive any comments on this section. However, because we have decided to reserve subpart B, which would pertain to the reasonable testing program for non-children's products, we have removed the reference to the “reasonable testing program for non-children's products.” (We explain our decision to reserve subpart B of the proposed rule in part B.2 of this preamble below.)

Additionally, because H.R. 2715 revised section 14(i)(2)(B)(ii) of the CPSA to refer to testing of “representative” rather than “random” samples, we have, on our own initiative,

elected to simplify § 1107.1 to reflect the final rule's narrower purpose and have made minor, non-substantive changes to follow the language of the statute. This helps clarify which requirements in the statute this final rule is intended to address and which have been reserved for a later date. Additionally, proposed § 1107.1 was silent regarding procedures to safeguard against the exercise of undue influence by a manufacturer on a third party conformity assessment body, even though proposed § 1107.24, “Undue influence,” would contain such safeguards. Consequently, the final rule now mentions the establishment of procedures to safeguard against the exercise of undue influence by a manufacturer on a third party conformity assessment body. Thus, § 1107.1 now states that the part establishes the protocols and standards for ensuring continued testing of children's products periodically and when there has been a material change in the product's design or manufacturing process and safeguarding against the exercise of undue influence by a manufacturer on a third party conformity assessment body. It also establishes a program for labeling of consumer products to indicate that the certification requirements have been met pursuant to sections 14(a)(2) and (i)(2)(B) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2063(a)(2) and (i)(2)(B)).

2. Proposed § 1107.2—Definitions

Proposed § 1107.2 would define various terms used in the rule.

a. CPSA

Proposed § 1107.2 would define “CPSA” to mean the Consumer Product Safety Act.

We received no comments on this definition and have finalized it without change.

b. CPSC

Proposed § 1107.2 would define “CPSC” to mean the Consumer Product Safety Commission.

We received no comments on this definition and have finalized it without change.

c. CPSIA

Proposed § 1107.2 would define “CPSIA” to mean the Consumer Product Safety Improvement Act of 2008.

We received no comments on this definition and have finalized it without change.

d. Detailed Bill of Materials

Proposed § 1107.2 would define “detailed bill of materials” to mean a list of the raw materials, subassemblies, intermediate assemblies, subcomponent parts, component parts, and the quantities of each needed to manufacture a finished product.

We received no comments on this definition. However, because the term “detailed bill of materials” appeared only in proposed § 1107.10(b)(1) (which would require a product specification as part of the reasonable testing program), and because the final rule now reserves subpart B, we have removed the definition of “detailed bill of materials” from the final rule.

e. Due Care

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.

(Comment 4)—One commenter noted that the due care requirement only applies to a few specific provisions of the proposed rule, such as proposed § 1107.23(a) regarding “material change” in the product's design, manufacturing process, or sourcing of component parts. In some instances, this defined duty of “due care” would be coupled with a CPSC-created standard of “high degree of assurance.” The commenter appreciated our recognition that both the “due care” standard of conduct and the “high degree of assurance” standard for compliance are anchored in the judgment and knowledge of the manufacturer. For that reason, the commenter felt that the due care requirement should have general applicability to all elements of compliance for implementation of the CPSIA's testing and certification requirements. The commenter stated that manufacturers should not have to wonder whether more than their exercise of reasonable judgment and practice, based on their manufacturing experience and sound knowledge of the product, is required for aspects of the rules that do not explicitly reference these standards.

(Response 4)—The definition of “due care” in § 1107.2 refers to the actions of a prudent and competent person. We expect that all parties will exercise prudence and competence in the testing and certification of products. The final rule emphasizes due care in particular sections, as noted by the commenter, because these are areas that require additional care in order to prevent noncompliant products from being produced and certified.

We recognize that manufacturers' knowledge of their products and their manufacture can serve as a basis for determining what steps are necessary to achieve a high degree of assurance that their products comply with the applicable product safety rules. Based on that knowledge, manufacturers are uniquely situated to know what actions are necessary to exercise due care and demonstrate a high degree of assurance regarding their specific circumstances.

On our own initiative, we have revised the definition of “due care” in the final rule. The final rule's definition of “due care” includes a sentence stating that “Due care does not permit willful ignorance.” This is not intended to be a substantive change because any party who is willfully ignorant of material facts, by definition, would not be exercising due care. However, the Commission wants to emphasize in the final rule that a party cannot purposely avoid knowing their business partner's testing and certification practices to avoid violating section 19 of the CPSA. A party will not be shielded from violating section 19 of the CPSA when that party knows or should know about testing and/or certification problems which may affect the ability of a consumer product to be compliant with all rules, bans, standards, or regulations. Certifiers and testing parties have an obligation to resolve known or knowable problems with testing and/or certification before relying upon or passing on test reports or certifications.

f. High Degree of Assurance

Proposed § 1107.2 would define “high degree of assurance” as “an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.”

(Comment 5)—Multiple commenters questioned the definition of a “high degree of assurance.” One commenter would like the rule to define the term “high degree of assurance” in a more understandable or quantitative way. The commenter considered the term to be confusing and misleading and believed this could lead to unnecessary conflicts between manufacturers and conformity assessment bodies when a judgment has to be made in certain cases. The commenter wondered if this requirement is targeting the design area, manufacturing process control, quality control, or testing procedures.

Another commenter said that manufacturers would benefit from additional guidance on how to achieve a “high degree of assurance” through their testing programs. The preamble to the proposed rule referred to a 95 percent statistical significance level as constituting a “high degree” of

assurance, but the proposed rule would not mandate a 95 percent confidence threshold. The commenter asked what factors would permit a manufacturer to satisfy the “high degree of assurance” requirement with a statistical significance level below 95 percent and asked us to provide an example of a situation where a manufacturer could still achieve a high degree of assurance with less than 95 percent assurance.

Another commenter argued that the term “high degree of assurance” is subjective and subject to varied interpretations. The commenter suggested that a statistical confidence limit would help remove the subjectivity and set a specific threshold by which we can enforce our rules better. The commenter also was concerned that the wording may lead some manufacturers to believe that they do not have to test to the standard in all cases, as long as they foresee little risk of noncompliance, or assume that the risk is low of being discovered having noncompliant products in the marketplace. The commenter said the final rule should clarify that testing to applicable standards is required.

(Response 5)—The determination of a “high degree of assurance” for a given product will vary by industry, product, component part, and by manufacturer. Therefore, selecting an example using a hypothetical certifier would be of little value to manufacturers. We have intentionally defined the term in a manner that allows the manufacturer the flexibility to develop a testing program to ensure their product complies with all applicable children's product safety rules. This rule provides broad protocols and standards for regulated firms to follow and adapt to their particularized needs given their products and processes. The use of quantitative values for the definition of “high degree of assurance” could lead to difficulties for some manufacturers. The preamble to the proposed rule stated: “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” (75 FR 28344). The intent of the definition is to enable a manufacturer to have a degree of confidence, based on evidence (rather than only on a belief) that all of the products manufactured are compliant with the applicable product safety rules. Knowledge of a product's design and how it is manufactured, control over component parts, and measurements showing consistent performance, are some elements that can be used to demonstrate a “high degree of assurance.”

As for the commenter asking us to clarify that testing to applicable standards is required, § 1107.20 (a) of the final rule states that manufacturers must submit samples of a children's product to a third party conformity assessment body for testing. We believe these statements are clear enough to convey that certification testing involves tests.

(Comment 6)—Two commenters agreed that a numerical target for defining what constitutes a high degree of assurance—in the context of programs based on good manufacturing practices (GMP)—is misplaced. One commenter noted that the explanation of the definition of “high degree of assurance” provided in the preamble to the proposed rule (75 FR at 28344) implies that we prefer the 95 percent statistical level of confidence for a high-degree-of-assurance approach and consider it the default. The commenter is concerned that the 95-percent-confidence-level language may prompt third party conformity assessment bodies and retailers to adopt standardized testing protocols that demand large sample sizes, which will be a particular burden for the initial certification and may not be warranted in many cases. The commenter expressed the belief that the goal, across a broad range of different products that are subject to different manufacturing requirements and material sourcing, must be a standard that correlates “a high degree of assurance” with an “evidence-based demonstration of consistent performance” that relies more appropriately upon process controls to assure conformance. The commenter indicated that, while generally accepted process controls may include statistical sampling as part of process control programs, in and of themselves, they are not preferable to good manufacturing practices. The commenter said that the final rule must be clear in this regard.

(Response 6)—Standards for GMPs are generally industry-specific in areas such as: Cosmetics, pharmaceutical operations, food handling, and medical devices. It is unlikely that any GMP-based program would be deemed workable or acceptable for all children's product manufacturing methods.

A certifier's determination that a product complies—with a high degree of assurance—with the applicable children's product safety rules, may derive from statistically based testing, the application of good manufacturing practices, or other knowledge of the product and its manufacture. Because GMP-based programs are industry-specific, we disagree with the commenter's assertion that the programs are preferable to other accepted process controls in all manufacturing situations.

The final rule defines a “high degree of assurance” in general terms because the definition is intended to be applied to a wide variety of products that use many different manufacturing processes. Customizing the definition of “high degree of assurance” to fit one type of product or GMP-based program will necessarily increase the difficulty of manufacturers applying the definition to dissimilar products or manufacturing processes. Further, because GMP-based programs vary across industries—and the comments were not specific about which aspect(s) of a GMP program we should adopt, or which GMPs we should adopt—we cannot revise the definition, as requested by the commenter.

As for the commenter who interpreted the preamble to the proposed rule as expressing a preference for a 95 percent confidence level, we do not consider a numerically based definition of a “high degree of assurance” to be the default position. Defining a “high degree of assurance” with respect to a 95 percent probability or confidence level would be difficult to apply to all manufacturing processes for children's products. Defining a “high degree of assurance” as a 95 percent, or higher, probability or confidence level could result in greater testing demands on small manufacturers. As discussed in the preamble of the proposed rule (75 FR at 28344), a statistical definition is not needed in order to provide an evidence-based high degree of assurance.

Regarding the concern that conformity assessment bodies and retailers may require large numbers of samples for certification testing, the children's product certifier (not the conformity assessment body or retailer) specifies the number of samples to be tested. The final rule requires the number of samples to be sufficient to give the certifier a high degree of assurance that the tests conducted demonstrate accurately the ability of the product to comply with the applicable children's product safety rules. As we previously stated in the preamble to the proposed rule:

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.

75 FR at 28337.

(Comment 7)—Two commenters contended that the proposed definition of a “high degree of assurance” lacks clarity. Both commenters said that the rule should have additional examples of what constitutes “a high degree of assurance.” One commenter acknowledged that the discussion in the preamble to the proposed rule makes clear that the definition mandates no specific formula (75 FR at 28344). However, the commenter noted that the preamble to the proposed rule gave no specific examples, other than the use of statistical methods. The commenter argued that the final rule should recognize other means of achieving this confidence level, including ways that do not rely solely on product testing or statistical methods. These methods include appropriate quality assurance processes and risk management. Quality assurance processes can include: Factory/supplier evaluations, design reviews, manufacturing process controls, process auditing, or similar controls or reviews. Risk management includes: Analysis of a given possible failure, the likelihood of the failure, and the potential consequences associated with the failure. The commenter argued that importers can use these activities to boost desired outcomes and reduce unexpected outcomes; and the commenter further maintained that the activities can be performed in a feedback loop that facilitates true root-cause analysis and correction, if there is a failure.

The commenters suggested substitute definitions for “a high degree of assurance” that are practically identical. One suggested definition reads: “A high degree of assurance means an evidence-based determination of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.” Acceptable evidence-based determinations may be based on evidence derived through any appropriate process or control or combination of processes and/or controls, such as (but not limited to):

• Design validation;

• Manufacturing process control audits;

• In-process manufacturing controls, measurements, and tests;

• Component and material testing, as defined in 16 CFR part 1109;

• Finished product testing;

• Raw materials certification; and

• Other controls or processes that provide information about the safety or compliance of a product.

The other commenter's suggested definition reads: “

High degree of assurance

means an evidence-based determination of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture. Acceptable determinations may be based on evidence derived through any appropriate tool or control methodology (or combination of tools and/or control methodologies), such as but not limited to:

• Design Validation

• Process Validation

• Manufacturing Process Control Audits

• Raw material validation and controls

• In-process manufacturing controls, measurements, and tests

• Component and material testing as defined at 16 CFR part 1109

• Finished Product Testing”

(Response 7)—The commenters are correct that certifiers can use process controls, mathematical techniques, simulations, and other aspects of a product and its manufacture, as part of the basis for determining whether a particular product complies with the applicable product safety rules with a high degree of assurance. The commenters also are correct that the preamble to the proposed rule (75 FR at 28344) provided statistically based examples in the definition of a “high degree of assurance.” However, a method on the commenters' list may be adequate for one rule, but inadequate for another. As an example,

Design Validation

may be a good technique to ensure that a toy does not have a hole large enough to allow access to a sharp edge or point. However,

Design Validation

may be inadequate for controlling lead content because its techniques are ill-suited for controlling continuing production of component parts. As another example, component part testing is a useful technique for determining the chemical content of lead and the prohibited phthalates, but it is inadequate for determining compliance to the pacifier pull tests because the entire product is required to conduct the test. “A high degree of assurance” is defined in general terms because it is intended to be applied to a wide variety of products that use many different manufacturing processes. Providing a list of the intended applications as part of the definition would introduce the risk of a manufacturer applying techniques that are inappropriate for evaluating the applicable children's product safety rule.

Therefore, we decline to amend the definition of “a high degree of assurance,” as suggested by the commenters. Specific examples are not universally applicable; and therefore, they should not be included in the definition of “a high degree of assurance.” Any such list necessarily would be underinclusive or possibly confusing or misleading. Additionally, certification and periodic testing of children's products must be based on tests of the finished product, or its component parts, sufficient to show compliance (or continuing compliance, in the case of periodic testing) with all applicable children's product safety rules. A definition of a “high degree of assurance,” that includes methods other than testing, might lead some certifiers to conclude mistakenly that certification or periodic test requirements might be met by means other than testing.

(Comment 8)—One commenter suggested that the final rule allow a company's prior safety record to replace product safety testing as evidence that a company has met the requirement for a high degree of assurance (“HDA”). The commenter wrote:

The “high degree of assurance” should be based on an overall assessment of the safety record of the company. It should NOT be based on the results of an individual product, even if recalled or deemed dangerous.

The commenter pointed out that its company had a very good safety record. The commenter added:

With this record over so many years, our company should be deemed to have satisfied this HDA requirement and be endorsed as having a reasonable testing program without further inquiry.

(Response 8)—Section 14(a)(2) of the CPSA makes clear that children's product certification is based upon third party testing of the product and not a company's safety record. For this reason, the final rule does not provide relief from the testing requirements in the statute. In addition, the commenter's suggestion that a manufacturer should be allowed to rely upon its prior safety record to demonstrate a high degree of assurance would be a difficult concept to apply in practice because of the likely changes in any given manufacturer's safety record over time and potential disagreements as to whether a product caused a safety problem, whether the safety problem resulted from product misuse, and whether safety issues had to occur at a particular rate of frequency before testing was warranted.

(Comment 9)—One commenter stated that a “high degree of assurance” could be provided best by using an accredited product certification program that meets the requirements of the International Standards Organization/International Electrotechnical Commission (ISO/IEC) Guide 65,

General requirements for bodies operating product certification

systems,

and the fundamentals of System 5 product certification requirements of ISO/IEC Guide 67,

Conformity assessment—Fundamentals of product certification.

(Response 9)—The various activities a certification body undertakes, such as testing, conformity assessment, and surveillance can be used to demonstrate a high degree of assurance that a product complies with the applicable product safety rules. However, the techniques used by certification bodies are not the only means a manufacturer could use. Process control techniques, failure modes and effects analyses, and other quality assurance methods, depending upon the product under consideration, could be as effective as certification body methods. Because we want to give certifiers the flexibility to decide which methods apply best to their particular products, we decline to define a “high degree of assurance” using ISO/IEC Guide 65 and Guide 67 requirements. A manufacturer who wishes to use those requirements to ensure a high degree of assurance of compliance may do so. However, we reiterate that testing in support of certification of a children's product must be performed by a CPSC-accepted third party conformity assessment body whose scope of accreditation includes the tests required for certification, and certification of a product cannot be delegated to another party, such as a certification body.

(Comment 10)—A commenter suggested that the language related to periodic testing intervals and sample sizes is inconsistent in the preamble to the proposed rule. The commenter conceded that it is difficult to specify the exact number of products that must be tested in order to reach a high degree of assurance that a product is compliant. The commenter noted that the response to comments section of the preamble to the proposed rule titled,

Additional Third Party Testing Requirements for Children's Products,

stated that “the sample size for periodic testing will depend upon the number of samples that need to be tested to provide that statistical assurance” (75 FR at 28342). The commenter agreed with this statement but noted the inconsistency between the language used in that section and the language found in the response to comments section titled,

The Reasonable Testing Program,

which specifies that the testing intervals must provide “reasonable assurance” that the product meets the requirements of the applicable product safety rules (75 FR at 28338). The commenter noted that there is a difference between a “high degree of assurance” and “reasonable assurance.” The commenter expressed the belief that the testing program should be statistically based, such that a confidence level of 95 percent must be achieved to indicate compliance. This requirement would eliminate the possibility of testing only a single sample to indicate compliance, the commenter asserted.

(Response 10)—In the preamble to the proposed rule, under the response to comments section,

Additional Third Party Testing Requirements for Children's Products

(75 FR at 28342), we stated the following:

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 (italics added) * * *

The word “that” refers to “a high degree of assurance,” which appears at the beginning of the sentence. With respect to the other alleged inconsistencies mentioned in the comment, it is worth noting that the preamble to the proposed rule uses the phrase “high degree of assurance” 20 times; whereas, the codified text of the proposed rule does not use the term “reasonable assurance” at all. The term “reasonable assurance” appears only once in the preamble to the proposed rule, in the introduction to the response to comments section titled,

The Reasonable Testing Program,

where it is listed as one of the previous questions that we asked in the

Federal Register

notice announcing the December 2009 public workshop.

We also do not agree with the commenter that there should be a specific probability level (

i.e.,

95 percent) in the definition of “a high degree of assurance.” As previously noted in the preamble to the proposed rule (75 FR at 28344), “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.” Many manufacturing processes, such as low-volume and continuous manufacturing, are ill-suited to use a sampling technique for quality control purposes. In addition, for small-volume manufacturers, the number of samples required to achieve 95 percent confidence could be excessive, even to the point of requiring all of the products manufactured to be tested. Because the final rule's testing requirements apply to a wide variety of products, manufacturers, and manufacturing processes, the rule must give manufacturers the flexibility to determine the best way to comply with the testing requirements.

The intent of the definition is for a manufacturer to have a high degree of assurance based upon evidence (rather than only a belief) that all of the products manufactured are compliant with the applicable safety rules. Knowledge of the product's design and how the product is manufactured, control over component parts, measurements showing consistent or inconsistent performance, the associated hazard, and many other elements such as these, can be used to determine the number of samples required for certification and for the periodic testing intervals, as noted in the final rule.

g. Identical in All Material Respects

Proposed § 1107.2 would define “identical in all material respects” to mean that there is no difference with respect to compliance to the applicable rules between the samples and the finished product.

(Comment 11)—Several commenters asked us to clarify the definition of “identical in all material respects.” One commenter said that the definition appears absolute in that it does not allow any “difference with respect to compliance.” The commenter indicated that such a definition would make testing requirements unnecessarily rigid and costly.

Another commenter contended that the definition of “identical in all material respects” cannot be absolute. One commenter would revise the definition to read: “ ‘

Identical in all material respects'

means there is no difference between the sample and the finished product that could affect compliance to the applicable rules.” Another commenter suggested revising the definition of “identical in all material respects” to mean “to a high degree of assurance, there is no difference between the samples and the finished product that is material to compliance of the applicable rule.” One commenter suggested that the definition of “identical in all material respects” should mean “a manufacturer possess [sic] a reasonable belief that, there is no difference between the samples and the finished product is not materially compliant.”

(Response 11)—We do not regard the definitions suggested by the commenters to be improvements of the existing definition of “identical in all material respects.” For example, defining “identical in all material respects” to mean “there is no difference between the sample and the finished product that could affect compliance to the applicable rules”

appears to be so similar to the proposed definition that adopting the commenter's suggested definition would not alter the rule. Samples used for certification testing and the finished product may be different—just not different in any way that would affect the sample's ability to demonstrate compliance of the finished product. The definition of “identical in all material respects” is intended to emphasize that if anything other than the finished product is subjected to testing, then the characteristics of that sample must be identical to the testing of the finished product, insofar as complying with the applicable product safety rule. Otherwise, the test may not indicate that the finished product, in fact, complies with the applicable product safety rule.

The second definition suggested for “identical in all material respects” (“To a high degree of assurance, there is no difference between the samples and the finished product that is material to compliance of the applicable rule”) also does not emphasize adequately that the finished product is what must comply with the applicable rules. In addition, using the phrase “to a high degree of assurance” in describing the similarity (with respect to conformance to the applicable rules), results in some doubt that the samples, in fact, are “identical in all material respects.” Further, § 1107.20(a) of the final rule states that 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. Using a “high degree of assurance” in the definition of “samples” would involve a double use of the term with no corresponding increase in clarity.

In a similar manner, the third definition suggested for “identical in all material respects,” which uses the phrase “a reasonable belief,” introduces doubt that the samples are identical to the finished product with respect to compliance. Additionally, “a reasonable belief” standard in the definition would result in an inquiry into the state of mind of a particular manufacturer and could lead to disagreements between the CPSC and manufacturers over whether a manufacturer's belief was “reasonable” in a specific instance. Further, the commenter did not explain or clarify their interpretation of the phrase “materially compliant”; the absence of such an explanation or interpretation would result in additional uncertainty in the definition.

Nevertheless, on our own initiative, we have revised the definition of “identical in all material respects” to make minor clarifications to improve the definition's accuracy and consistency with the statute. For example, the proposed definition would refer to “compliance to the applicable rules;” the final definition now adds: “bans, standards, or regulations” after “rules,” to be more consistent with section 14(f)(1) of the CPSA. We also have revised the phrase “between the samples and the finished product” to read: “between the samples to be tested for compliance and the finished product distributed in commerce,” to reflect that, under the final rule, the items that must be “identical in all material respects” are the samples that are to be tested for compliance (as opposed to samples that are tested for any other purpose) and the product that is actually distributed in commerce.

(Comment 12)—One commenter urged us to state that the phrase “identical in all material respects” is intended to be consistent with the “objectively reasonable basis” standard from 16 CFR part 1633, and that we would consider individual subordinate mattresses that meet the requirements of 16 CFR 1633 to be “identical in all material respects” to the qualified prototype to which a specific mattress is subordinate.

(Response 12)—We agree with the commenter that “identical in all material respects” is consistent with a demonstration on an “objectively reasonable basis,” as stated in 16 CFR §thnsp;1633.4(b)(3). We consider individual subordinate mattresses that meet the requirements of 16 CFR part 1633 to be “identical in all material respects” to the qualified prototype to which a specific mattress is subordinate.

h. Manufacturer

Proposed § 1107.2 would define “manufacturer” as “the parties responsible for certification of a consumer product pursuant to 16 CFR part 1110.”

We received no comments on this definition and have finalized it without change.

i. Manufacturing Process

Proposed § 1107.2 would define “manufacturing process” as “the techniques, fixtures, tools, materials, and personnel used to create the component parts and assemble a finished product.”

(Comment 13)—Two commenters noted that the proposed definition includes “personnel used to create the component parts and assemble a finished product.” The commenters argued that this should not be construed to mean that any change in the employees who are involved in the production of a part or product is equivalent to a change in the manufacturing process.

(Response 13)—Regarding the commenters' suggestion on the definition of “manufacturing process,” the commenters may be confusing a change in the manufacturing process with a material change that could affect compliance to an applicable product safety rule. The commenters are partly correct that any change in personnel involved with a manufacturing process does not necessarily constitute a material change with respect to the product's compliance. However, for manufacturing processes that rely on high levels of craftsmanship or technical expertise, such a personnel change could affect compliance and, therefore, might be considered a material change to the manufacturing process.

Therefore, we have finalized the definition of “manufacturing process” without change.

j. Production Testing Plan

Proposed § 1107.2 would define “production testing plan” as “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.”

We received no comments on this definition, but, on our own initiative, we have chosen to remove it from the final rule. We have removed the definition because it is duplicative of the description and requirements of “a production testing plan” in § 1107.21(c)(2) of the final rule.

k. Third Party Conformity Assessment Body

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.

We received no comments on this definition. However, on our own initiative, we have revised the definition by making editorial changes to describe more accurately our accreditation process and to indicate that the third party conformity assessment body's scope of accreditation must include the

applicable CPSC-required tests. Thus, the final rule now defines “third party conformity assessment body” as “a testing laboratory whose accreditation has been accepted by the CPSC to conduct certification testing on children's products. Only third party conformity assessment bodies whose scope of accreditation includes the applicable required tests can be used for children's product certification or periodic testing purposes.”

C. Proposed Subpart B—Reasonable Testing Program for Non-Children's Products

Proposed subpart B would consist of one provision and would describe the “reasonable testing program” for non-children's products. For example, proposed § 1107.10(a) would explain that, except as otherwise provided by a specific CPSC regulation or a specific standard prescribed by law, a manufacturer certifying a product pursuant to a reasonable testing program must ensure that the 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.” Proposed § 1107.10(b) would state that a reasonable testing program must consist of five elements: (1) Product specification; (2) certification tests; (3) a production testing plan; (4) a remedial action plan; and (5) recordkeeping. The proposal would describe, in greater detail, the requirements for each element of the reasonable testing program.

We received many comments on proposed subpart B. The comments addressed issues regarding the proposed provisions of a reasonable testing program on topics such as: product specifications, certification tests, samples for certification testing, production testing, remedial action, and recordkeeping. The commenters raised many concerns about the cost and burden of the proposal as well as practical issues, which illustrates the difficulty of drafting a regulation that can apply to many different types of products and manufacturing processes, yet still provide sufficient guidance to enable manufacturers to implement the requirements of a reasonable testing program effectively. Consequently, we are deferring action with respect to finalizing subpart B. We will reserve subpart B in the final rule and, except as stated otherwise in this preamble, continue evaluating the issues raised in the comments regarding a reasonable testing program. We note, however, that our deferral of action does not remove the responsibility of manufacturers, under section 14(a)(1) of the CPSA to certify based on tests of their products or based on reasonable testing programs that their products comply with all rules, bans, standards, or regulations applicable to such products.

D. Proposed Subpart C—Certification of Children's Products

Proposed subpart C would contain the requirements for the certification of children's products. The proposed subpart C would consist of seven sections and would implement most requirements in section 14(i)(2)(B) of the CPSA.

1. General Comments

Several commenters raised issues with respect to proposed subpart C generally, or on general concepts, such as testing.

(Comment 14)—One commenter argued that the terms “reasonable assurance” and “sufficient number of samples” are likely to result in widely disparate interpretations. The commenter urged that “reasonable assurance” should be defined as a statistically significant number with a confidence level of 95 percent, based on testing enough samples to provide statistical validity. The commenter said that setting a specific confidence limit would enable us to enforce this section by avoiding subjectivity and by creating uniformity and consistency among manufacturers and conformity assessment bodies.

The commenter noted that “upstream” controls (

i.e.,

processes, inspections, and tests conducted prior to or during product assembly intended to assure product quality), product risk assessments, and design analyses are reasonable tools for manufacturers to use but currently are not rigorous or specific enough to ensure “downstream” compliance. Until they are, compliance must be determined by final product testing, the commenter asserted.

(Response 14)—We decline to adopt the suggestion to set a 95 percent confidence level based on testing enough samples to provide statistical validity. Many manufacturing processes, such as those using continuous flow processes, are ill-suited to use a sampling technique for quality control purposes. In addition, for small-volume manufacturers, the number of samples required to achieve 95 percent confidence could be excessive, even to the point of requiring all of the products manufactured to be tested.

Because the final rule's testing requirements apply to a wide variety of children's products, as well as to manufacturers of various sizes and different manufacturing processes, the rule must be flexible enough to allow the manufacturer to determine the best way to comply with the rule's requirements. We are aware of numerous “upstream” quality assurance tools and processes that are widely used to ensure high levels of product performance. For example, techniques such as component part testing are particularly well-suited for determining compliance with the lead content limits for accessible parts on children's products. Numerous international standards address quality control and assurance processes applied “upstream” in the product production process and can be used to extend the maximum periodic testing interval. Thus, we disagree with the commenter that none of these quality assurance tools and processes is rigorous or specific enough to ensure compliance.

(Comment 15)—One commenter recommended a system of product risk assessment that would tailor the third party certification schedule for low-volume firms, as follows:

Children's products: High-risk children's products would require third party certification annually. Low-risk children's products would require third party certification every three years.

The commenter said that any test failure automatically would move the product into the next most stringent category. This system would focus the inspection of products on products that are the most dangerous to public safety. The commenter stated that an unintended consequence of this strategy would be to reward firms that make the safest products.

(Response 15)—The commenter appears to be applying the proposed low-volume exception to periodic testing (stated in proposed § 1107.21(d)) to certification testing. The low-volume exception did not apply to certification testing. There is no schedule for any manufacturer for when a product is subject to certification testing, regardless of production volume. Instead, periodic testing is required for children's products to ensure continued compliance with a high degree of assurance.

Section 14(a)(2) of the CPSA requires certification testing for children's products before they may be imported for consumption or warehousing or distributed in commerce. This initial testing of children's products does not depend on product risk. Continuing compliance is demonstrated through periodic testing for children's products, which specifies a maximum testing

interval, based on the implementation of a periodic testing plan by the manufacturer. The final rule allows a manufacturer to consider risk to the extent it permits consideration of “the potential for serious injury or death resulting from a noncompliant product” as a factor in determining the appropriate periodic testing interval under a periodic testing plan.

Regarding the commenter's suggestion of devising a system of categorizing all children's and non-children's products subject to an applicable rule into risk categories, such a system would require a separate rulemaking effort and is beyond the scope of this rule.

(Comment 16)—One commenter noted that the proposed rule did not use recognized industry terminology consistently. The commenter noted that the proposed rule relies on the terms “test” or “testing,” as if all consumer product safety requirements could be evaluated by performing tests to ensure ongoing compliance. The commenter noted that, while full product testing is appropriate in some cases, current consumer product safety regulations imply or specify evaluation activities, not considered to be actual testing (

e.g.,

inspections, reviews, audits), may be appropriate.

The commenter noted that it recommended previously that we refer to Annex A of ISO/IEC 17000,

Conformity assessment—Vocabulary and general principles,

which provides a general description of the functional approach to activities that constitute conformity assessment, to address the question of the interpretation of the use of the terms “test” or “testing.”

(Response 16)—The word “test” was chosen because of its use in section 14(a) of the CPSA. “Certification tests” are tests on samples of the product that are identical in all material respects to the finished product. Section 14(i) (2)(B)(i) of the CPSA states that children's products are subject to testing periodically and after a material change.

The words “test” and “testing” are used throughout the final rule to mean a process used to determine whether a product is compliant with the applicable product safety rules. The process is geared to the particular product and specific safety rule. As such, testing may include inspection of labels and manuals, audits, and measurements to determine compliance with the applicable product safety rules. We believe that the definition of “test” and “testing” are clear.

(Comment 17)—One commenter noted that we are not allowing the use of existing federally registered certification marks of third party conformity assessment bodies as an acceptable substitute for a certificate of conformity. The commenter added that introducing the new certificate of conformity will cause immediate confusion in the marketplace. The commenter suggested that we should have to justify, through a comprehensive and independent study, why we are departing from the existing system and why our proposed system would be better and more reliable.

Another commenter stated that we should recognize certification marks issued by established third party certification programs as a substitute for the certificates of conformity described in the proposed rule when the product has been certified as compliant with associated product standards through a program that reflects CPSA requirements by an ISO/IEC Guide 65-accredited certification body.

(Response 17)—Certification marks are symbols that a manufacturer is authorized to affix to their product to indicate that the product has been certified by a certification body. Third party certification involves testing, declarations of conformance, factory inspections, and continuing surveillance activities. The certification body attests that the product complies with the specified product safety rules that were evaluated.

A certification mark does not contain the information required on a certificate by section 14(g) of the CPSA and cannot be used as a substitute for a Children's Product Certificate. Section 14(a)(2) of the CPSA requires manufacturers of a consumer product that is subject to an applicable children's product safety rule to issue a certificate certifying conformance of the children's product to the applicable children's product safety rules. Section 14(a)(2) of the CPSA does not allow a party other than the manufacturer, importer, or private labeler to issue a Children's Product Certificate.

Since the CPSIA was enacted in 2008, we have not observed immediate confusion in the marketplace regarding certificates. As noted above, certification marks cannot be used as a substitute for certificates if there is confusion in the marketplace. Thus, because section 14(a) of the CPSA requires the manufacturer to issue a certificate of conformity, an independent study is not warranted.

Federal Register

(Comment 18)—One commenter noted that a publisher of ordinary books may have varying titles and content, but all of the books are made of the same materials in the same manner. The commenter asserted that the differences between ordinary books are not material to compliance with the applicable rules. Accordingly, the commenter said that having accredited third party conformity assessment body testing for a finished book would constitute finished product testing for all other books (International Standard Book Numbers, or ISBNs) that do not materially differ from the tested book with respect to compliance with CPSC safety standards. The commenter said a publisher with a reasonable testing program and a product without material changes could rely on the component part certifications for all materials published within a 2-year period.

(Response 18)—Section 14(i)(5)(A)(i) of the CPSA, as amended by H.R. 2715, excludes ordinary books and ordinary paper-based printed materials from the third party testing requirements in 14(a)(2) of the CPSA. Additionally, the final rule reserves subpart B, which would pertain to a reasonable testing program for non-children's products. Therefore, it is unnecessary for us to consider how third party testing results for a book might be extended to all other books.

(Comment 19)—One commenter asserted that only good design and comprehensive design review by qualified individuals will improve the safety of products. Therefore, the commenter suggested that we require “design hazard analysis” in the certification of children's products section of the final rule. “Design hazard analysis,” according to the commenter, identifies potential safety hazards in a consumer product that result from the design of the product. It involves determinations made by skilled professionals including engineers, chemists, and biologists about the features of a product that might result in

safety hazards. The commenter asserted that the CPSC has the legal authority to require design hazard analysis of consumer products.

The commenter suggested the following changes:

• In Subpart C,

Certification of Children's Products,

insert a new subsection 1107.20(a),

Children's Product Certification.

(

Note:

The commenter may have meant to create a new subsection (a) and renumber the remaining subsections accordingly.) The new subsection would state:

Prior to submitting samples of a children's product for testing by a third party conformity assessment body, manufacturers must conduct a design hazard analysis and produce a design appraisal of the product that identifies and characterizes the potential hazards associated with that consumer product that are related to the design of a product. The design appraisal should include, at a minimum, an engineering, chemical, and biological analysis of the product, as appropriate to the type of product and the materials contained in the product.

• Insert in § 1107.26(c), Remedial Action, after “* * * children's product safety rules”:

If the manufacturer knows or reasonably should know that the failure of the product is related to the product's design, the manufacturer shall conduct a revised design hazard review and produce a new design appraisal.

(Response 19)—We agree that designing safety into a children's product is an important part of a comprehensive quality control program. We decline, however, the commenter's suggestion to include in the final rule requirements mandating design hazard analyses for children's products. The current rulemaking is intended to implement the testing and certification requirements of section 14(a) and section 14(i)(2)(B) of the CPSA. Requiring a design hazard analysis goes beyond the statutory requirements because such an analysis would consider factors other than the factors required to demonstrate compliance with the applicable product safety rules. This action would extend the final rule to address activities that would occur before a product is manufactured.

Currently, given the range of products that are subject to section 14 of the CPSA, we have no practical means of identifying or evaluating individuals whose credentials and experience, under the commenter's suggested changes, would render them qualified to conduct design hazard analyses on products. Although the final rule does not require manufacturers to conduct a design hazard analysis on their products, manufacturers are free to engage in such analyses when developing or manufacturing a product.

Further, as explained the section on remedial action in part III.D.7. below, we have removed from the final rule, the requirement for a remedial action plan for children's products.

(Comment 20)—One commenter suggested that final testing and certification should defer to the Occupational Safety and Health Administration (OSHA)-designated Nationally Recognized Testing Laboratory (NRTL) certification program by determining that such products, as they are manufactured and distributed for consumer use, are

per se

compliant with the proposed testing and certification rules. The commenter said we would still maintain our authority to recall products, seek civil penalties, and other remedies available to the Commission, if violations are found.

(Response 20)—Pursuant to section 14(a)(3)(C) of the CPSA, we have chosen to designate accrediting bodies that are full-member signatories to the International Laboratory Accreditation Cooperation—Mutual Recognition Arrangement (ILAC-MRA) to conduct third party testing. Given that children's products intended for the U.S. market are manufactured in nations throughout the world, we decided to avoid designating accreditation programs or entities that are recognized only in a specific region, nation, or locality. The reasons for this are: (1) To keep the program as simple as possible for use by manufacturers, private labelers, importers, testing laboratories, and other interested parties; (2) to establish uniform requirements regardless of location; (3) to establish a program that is manageable within agency resources; and (4) to maintain a degree of consistency in the procedures used by the designated accrediting bodies.

Moreover, the commenter appears to misstate testing requirements. Consumer products are not tested for whether they are compliant with the testing and certification rules (

i.e.,

parts 1107 and 1109), rather, consumer products are tested for compliance with the applicable rules, bans, standards, and regulations which the CPSC enforces. Moreover, section 14(i)(2)(B)(i) of the CPSA requires such testing periodically and when there has been a material change. Therefore, continued testing is required by the statute and “

per se

conformance” with the applicable product safety rules is not allowed. Additionally, section 14(a) of the CPSA requires manufacturers (including importers) to certify that their products comply with the applicable product safety rules. This responsibility cannot be delegated to another party, such as a certification body.

The qualifications of testing laboratories performing certification tests are outside the scope of this final rule. Such qualifications are addressed in the various notices of requirements that we have published pursuant to section 14(a)(3) of the CPSA.

Finally, we acknowledge that the recently-enacted H.R. 2715 requires us to seek public comment on “opportunities to reduce the cost of third part testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation.” One topic which H.R. 2715 requires us to address pertains to “the extent to which evidence of conformity with other national or international governmental standards may provide assurance of conformity to consumer product safety rules, bans, standards, or regulations applicable under [the Consumer Product Safety Act].” Elsewhere in this issue of the

Federal Register

, we have published a notice inviting public comment on the issues identified in H.R. 2715, so the commenter's argument would be more appropriately raised and addressed in that proceeding. We note, however, that very few products covered under the OSHA-designated Nationally Recognized Testing Laboratory certification program would be children's products for which third party testing would be required. Moreover, those products that are subject to the OSHA certification program would likely be covered by CPSC regulations, if at all, for which the only requirement is a General Conformity Certificate based on a reasonable testing program. OSHA certification testing may be a sufficient basis for such certifications depending on the product and the type of testing involved. Given that CPSC does not have jurisdiction over products when the risks of injury associated with the consumer product could be eliminated or reduced to a sufficient extent by the actions of OSHA, there may be very little overlap between a particular product's results under OSHA's testing program and any CPSC required testing.

(Comment 21)—One commenter suggested an evidenced-based approach to certification, based on historical performance and risk for the product type and manufacturing process. The commenter suggested that an importer/retailer may implement a program requiring:

• Sample testing using materially identical components to be completed before production begins;

• Certification from samples selected during the start of production; and

• Periodic testing as the item remains in production.

At each of these stages, a representative set of samples would be pulled to cover all tests related to the applicable rules, bans, standards, and regulations.

The commenter suggested the following example:

For a child's solid rubber ball, more than 10,000 finished products that are materially identical could be made in less than one manufacturing shift. In this scenario, it would be appropriate to select samples when material changes occur and or meet historically defined frequency intervals in order to maintain and validate that products meet all rules, bans, standards, and regulations.

The commenter would like the CPSC to acknowledge that for children's products, samples selected from a lot of finished product over 10,000 pieces, but produced in a short time period, may be used to satisfy certification testing and periodic testing requirements.

(Response 21)—Section 14(a)(2) of the CPSA requires a manufacturer or importer of a children's product subject to a children's product safety rule 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 body whose accreditation has been accepted by us to be tested for compliance with the applicable children's product safety rules. This requirement is also set forth in § 1107.20(a) of the final rule. Thus, the commenter's first two suggestions—to choose samples for testing using materially identical components, and to select samples during the start of production, would likely fulfill the statutory requirement to submit samples that are identical in all material respects to the product, for purposes of certification testing.

Section 14(i)(2)(B)(i) of the CPSA requires, in part, that we establish protocols and standards to ensure that a certified children's product is tested for compliance periodically. Section 1107.21 of the final rule details periodic testing requirements for children's products. Accordingly, the commenter's suggestion regarding periodic testing is required by the statute, and our expectation with regard to periodic testing is articulated in the final rule.

Regarding the commenter's suggestion regarding short-period production runs of children's products, the same samples may be used for certification and periodic tests. If a testing plan is designed and implemented to meet the requirements of §§ 1107.20 and 1107.21, then the requirements to demonstrate the product's ability to meet all applicable children's product safety rules and ensure that continuing production is compliant may be met in this manner. If the manufacturer has a high degree of assurance of the children's product compliance, and the production run does not extend beyond the maximum periodic testing interval, then no third party periodic tests may be required. However, no children's product may enter into commerce without a Children's Product Certificate based on passing test results from a CPSC-accepted third party conformity assessment body certification.

(Comment 22)—Some commenters stated that the safety performance of a finished product may not be able to be based solely on the compliance of its component parts. The commenters asserted that some requirements can be evaluated only with finished product samples. The commenters asked us to clarify which products and which regulations would be amenable to component part testing. One commenter suggested that electrical safety standards and regulations (

i.e.,

fire and shock hazard testing) should not be allowed to rely solely on component part testing.

(Response 22)—The commenters are correct that some requirements can be evaluated only with finished product samples, and not with tests on component parts. However, both this final rule and the final rule on

Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Requirements in Sections 14(a) and 14(i) of the Consumer Product Safety Act

(16 CFR part 1109) contain restrictions on the use of component part testing. For example, § 1107.20(c) of the final rule states that except where otherwise specified by a children's product safety rule, component part testing pursuant to 16 CFR part 1109 may be used to support the certification testing requirements of this section. The final rule for 16 CFR part 1109 states that if a certifier has doubts about whether component part testing is sufficient to demonstrate compliance with all the applicable rules, bans, standards, or regulations, those doubts should be resolved in favor of testing the finished product.

Therefore, the commenters' concerns are addressed by the requirements of the two rules.

(Comment 23)—One commenter expressed concern about the final rule's effect on laboratory testing capacity and suggested removing references to statistical sampling and the use of ANSI/ASQ Z1.4,

Sampling Procedures and Tables for Inspection by Attributes

and Z1.9,

Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming,

for determining the number of samples required for certification testing, production testing, and periodic testing. The commenter said the frequency of testing and the number of samples tested should be set or determined by retailers and manufacturers to assure compliance with all applicable rules, bans, standards and regulations. The commenter stated that referencing the use of statistical sampling, confidence levels, and ANSI/ASQ Z1.4 & Z1.9 implies a very significant increase in the number of samples required for product testing.

(Response 23)—For manufacturers or importers using tests on samples of a product to ensure continued compliance to the applicable product safety rules, the rule permits manufacturers or importers to determine the frequency of testing and the number of samples tested to ensure compliance. Retailers only have testing or certification obligations if they are importers. The commenter did not explain how removing references to quality management and control standards and sampling procedures, which are not required, but may be used voluntarily by certifiers, would address the issue of third party conformity assessment body testing capacity. However, the proposed rule's reference to ASNI/ASQ Z1.4 and Z1.9 had the potential to mislead manufacturers because it would use the term “Acceptable Quality Level (AQL).” An AQL can be interpreted as an acceptable percentage of nonconforming products, which is not appropriate when applied to the case of compliance of products to health and safety standards. Therefore, we have deleted references to these standards in the final rule.

(Comment 24)—One commenter noted that the Labeling of Hazardous Art Materials Act (LHAMA) established the requirements for the labeling of art materials in ASTM D-4236, which is referenced in 16 CFR 1500.14(b)(8). The commenter asked that we: (1) Clarify the meaning of this provision with respect to the certification of art materials under section 14 of the CPSA; and (2) state whether LHAMA is a labeling rule under the Federal Hazardous Substances Act (FHSA) that would not require testing and certification to LHAMA under the CPSA. The commenter further proposed the use of existing facilities and procedures

allowed for LHAMA to certify compliance with the CPSIA.

(Response 24)—LHAMA requires that the manufacturer, importer, or repackager of art materials have a product's formulation reviewed by a toxicologist for its potential to cause chronic adverse health effects. A conformance statement on the product is used to certify that the product has been so reviewed. However, section 101 of the CPSIA introduces additional testing requirements for lead in children's products beyond what is required under LHAMA, so certification of art materials under LHAMA is not necessarily equivalent to testing for lead pursuant to section 101 of the CPSIA and section 14 of the CPSA.

Regarding whether LHAMA is a labeling requirement under the FHSA that would not require testing and certification, we note that LHAMA does not contain a performance standard similar to those in consumer product safety rules but rather, requires labeling in the form of a conformance statement that the product formulation has been reviewed by a toxicologist. The requirements of LHAMA are similar to the labeling requirements of the FHSA, of which LHAMA is a part. Therefore, third party testing for conformance to LHAMA is not required. Art materials designed or intended primarily for children 12 years of age or younger would have to be tested by a CPSC-accepted third party conformity assessment body to demonstrate compliance with the lead content limits, but they would not require third party testing and certification to the LHAMA requirements.

Regarding using facilities for LHAMA to certify to CPSIA requirements, section 14(f)(2)(C) of the CPSA states that a certifying organization, as defined in appendix A to 16 CFR 1500.14(b)(8), “meets the requirements” for consideration as a third party conformity assessment body “with respect to the certification of art materials and art products required under this section or by regulations prescribed under the Federal Hazardous Substances Act.” Thus, an organization that is a certifying organization with respect to LHAMA is a third party conformity assessment body and may test children's art materials and art products for compliance with LHAMA. Thus, insofar as certifying organizations and LHAMA are concerned, no changes to the proposed rule are necessary. Accreditation requirements for testing for compliance with the CPSIA, other than LHAMA, are beyond the scope of this rulemaking and may be addressed in a separate rulemaking.

(Comment 25)—Multiple commenters noted that manufacturers have established first party testing laboratories that are accredited to ISO/IEC 17025:2005(E) (more commonly known as ISO/IEC 17025:2005 and how it will be referred to in the preamble),

General requirements for the competence of testing and calibration laboratories.

The commenters suggested that for manufacturers with such laboratories, we should allow test results from those facilities to be used for children's product certification purposes. Many commenters suggested that one half of the testing for certification should be allowed at in-house testing facilities; others recommended that the number of samples sent to third party conformity assessment bodies for certification purposes be reduced “to a minimum.” Some commenters stated that we should recognize internal laboratories as a way to reduce dependence on third party conformity assessment bodies. The reasons for the suggestions include: A desire to reduce testing costs, to encourage other manufacturers to develop their own internal testing facilities, and to promote continuous product improvements.

(Response 25)—Section 14(a)(2) of the CPSA explicitly requires that testing of children's products be conducted by a third party conformity assessment body as a condition of certification. Further, third party conformity assessment bodies must have a CPSC-accepted accreditation for the scope of the testing undertaken in support of product certification. Unless the manufacturer's laboratory is a CPSC-accepted firewalled conformity assessment body, first party testing facilities, regardless of ISO/IEC 17025:2005 accreditation status, cannot be used for children's product certification purposes.

We note that, in response to these comments and concerns raised about cost, § 1107.21(d) of the final rule allows manufacturers using in-house testing laboratories accredited to ISO/IEC 17025:2005 to ensure continued compliance, to conduct periodic testing at a maximum testing interval of three years.

We further note that on August 12, 2011, the President signed into law H.R. 2715, which amended the CPSIA in several respects. One provision in H.R. 2715 requires us to seek public comment on opportunities to reduce the cost of third party testing requirements, consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation. Elsewhere in this issue of the

Federal Register

, we have published a notice seeking public comment on the issues in H.R. 2715. H.R. 2715 further requires us to review the public comments and states that we may prescribe new or revised third party testing regulations if we determine that such regulations will reduce third party testing costs, consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.

(Comment 26)—One commenter noted that carpets and rugs currently require flammability testing in accordance with 16 CFR parts 1630 and 1631 and suggested that there is no need for an additional flammability testing procedure for youth carpets and rugs.

(Response 26)—Section 14(a)(2) of the CPSA requires third party conformity assessment body testing of children's products (or samples that are identical in all material respects) subject to a children's product safety rule for initial certification purposes. Further, section 14(f)(1) of the CPSA defines a “children's product safety rule” as a consumer product safety rule enforced by the Commission. Section 3(a)(2) of the CPSA defines a “children's product” as a consumer product designed or intended primarily for children 12 years of age or younger. Thus, because youth carpets and rugs are children's products and are subject to the consumer product safety rules 16 CFR parts 1630 and 1631, third party testing is required.

For these reasons, initial certification testing for youth carpets and rugs must be performed by a CPSC-accepted third party conformity assessment body whose accreditation includes the scope of the tests. Second, children's products are subject to requirements for periodic testing, material changes, undue influence, and recordkeeping in subpart C of the final rule. The test methods in 16 CFR parts 1630 and 1631 are still applicable.

(Comment 27)—One commenter stated that the statutory requirements for certificates in section 14(a) of the CPSA impose strict and detailed requirements for the contents and availability of certificates of conformity that document compliance of a children's product as demonstrated through test results. A certificate based on accredited third party conformity assessment body testing must be issued by the manufacturer and private labeler of any children's product that is subject to a CPSC rule, and it must comply not only with the requirements of section 14(g) of CPSA, but also with the requirements of a finished product certifier's reliance on component materials testing certification. Thus, a finished product certifier could rely on

a test report showing passing test results for one or more component materials used in the product, based upon accredited third party conformity assessment body testing conducted by another person.

The commenter stated that including this information in the certificate accompanying the finished children's product would create logistical nightmares for the manufacturers and private labelers of children's products. The commenter did not object to the “recordkeeping” requirements in proposed § 1107.26; however, the commenter urged us to note that compliance with these requirements should make it unnecessary for the manufacturer or private labeler of the finished children's product, to ensure that every certificate required under section 14 of the CPSA accompanies the product or shipment of products, is furnished to each distributor or retailer of the product.

The commenter also urged us to adopt certificate requirements that reflect the key concept in the tracking label provisions, which require that the manufacturer (as well as the “ultimate purchaser”) of the finished children's product be able to “ascertain” certain information similar to what is required for certificates of conformity. The commenter suggested that certificates, like “tracking labels,” for children's products under section 103 of CPSIA, could be mandated to use codes or other means to point all interested parties to a source where such information readily can be found. This code could be contact information, where the manufacturer or private labeler could include an Internet URL for the manufacturer's Web site, where the information could be accessed.

(Response 27)—Section 14(g)(1) of the CPSA and 16 CFR 1110.11 require specific information on each certificate. In addition, section 14(g)(3) of the CPSA states that the required certificate shall accompany the applicable product or shipment of products covered by the same certificate and a copy of the certificate shall be furnished to each distributor or retailer of the product. However, 16 CFR 1110.9 allows a manufacturer to file certificates electronically by providing an Internet URL for the manufacturer's Web site, where the information could be accessed, as the commenter suggested. We note that the listing of component parts or component part test results does not have to be included on the finished product certificate.

(Comment 28)—Multiple commenters mentioned the high costs associated with third party testing and noted that the proposed rule under-recognizes the in-house quality assurance and testing capabilities of manufacturers.

(Response 28)—We are aware of many effective quality assurance techniques that are widely used to control quality in product manufacturing. However, section 14(a)(2) of the CPSA requires third party conformity assessment body testing of children's products for initial certification. Unless the manufacturer's in-house testing facility is a CPSC-accepted firewalled conformity assessment body, data from those facilities cannot be used for children's product certification purposes. No exclusion is included in the statute for first party certification or periodic testing of children's products based on the costs of testing.

In response to these comments, and in response to concerns about the cost of third party testing, § 1107.21(d) of the final rule allows manufacturers who are implementing a production testing plan to ensure the compliance of continuing production, to conduct third party periodic testing at a maximum testing interval of two years. Further, the final rule allows manufacturers using in-house testing laboratories accredited to ISO/IEC 17025:2005 to ensure continued compliance by conducting third party periodic testing at a maximum testing interval of three years. We believe this balances the desire for unbiased objective test results with the cost concerns expressed in the comments.

Additionally, on August 12, 2011, the President signed into law H.R. 2715, which amended the CPSIA in several respects. One provision in H.R. 2715 requires the CPSC to seek public comment on opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation. Elsewhere in this issue of the

Federal Register

2. Proposed § 1107.20—General Requirements

a. The Number of Samples

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 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.

(Comment 29)—Two commenters wanted more detail on what is meant by “a sufficient number of samples.” The commenters expressed concern that, if the number is left to conformity assessment bodies, there will be too much variability among conformity assessment bodies about what is a sufficient number.

(Response 29)—A “sufficient number of samples” are the number of samples necessary to give the manufacturer or importer a high degree of assurance of the product's compliance with the applicable rules when tested. Because a high degree of assurance is based upon the manufacturer's or importer's knowledge of the product and its manufacture, a sufficient number of samples will vary based on those factors. For example, for products with highly consistent part-to-part manufacturing processes (

e.g.,

die casting), fewer samples may be necessary to give the manufacturer/importer a high degree of assurance of compliance. For processes with more variability (such as hand assembly), it is likely that more samples will be necessary to achieve the same high degree of assurance.

The commenters also may have misunderstood the role of conformity assessment bodies in the testing and certification requirements of the rule. The conformity assessment body does not specify the number of samples to be tested. The manufacturer or importer specifies to the conformity assessment body the number of samples to be tested.

Finally, on our own initiative, we revised the second sentence to say that the number of samples selected must “be sufficient to” provide a high degree of assurance. We added this language to be consistent with the requirement to “submit a sufficient number of samples” language in the first sentence of the section. This change is also consistent with section 14(a)(2)(A) of the CPSA, which requires a manufacturer to “submit sufficient samples of the children's product” for testing.

(Comment 30)—One commenter stated that the language covering

samples needs to be clarified. The commenter stated that the proposal would require testing with a “sufficient number of samples” to provide a “high degree of assurance” (for minimum certification testing), while maintaining that the sampling does not have to meet minimum standards of statistical confidence. However, the commenter noted that the comments accompanying the proposed rule recognize that “there may be difficulty in applying statistical methods to all manufacturing processes.”

The commenter further stated that if testing a “sufficient number of samples to provide a high degree of assurance” is required when applying a reasonable testing program to children's products, then we should provide guidance on alternatives that certifiers may use to fulfill the duty to justify their plan, were they to choose anything less than a random statistical sample. The commenter noted that historically, we have relied on a sample of 12 or fewer units, without regard to the size of the production run and that certain statistical models used by auditors impose a maximum sample of 25 units, no matter the size of the cohort from which the samples are selected.

Based on these points, the commenter recommended that we delete the requirement to test a “sufficient number of samples to provide a high degree of assurance” under a reasonable testing program. The commenter said that the premise of a “reasonable testing program”—in order to differentiate it from the mandatory periodic testing required for children's products not relying upon a reasonable testing program—must be that, for some specific products, testing will not be the basis for certifying to the applicable rule. The commenter stated that we appropriately acknowledged the implications of differences between product categories and industries attempting to develop programs when, in the preamble to the proposed rule, we observed:

“

A manufacturer may develop the scope and details of each element of a reasonable testing program based on knowledge and expertise regarding the product and its manufacturing processes” (75 FR at 28345). The commenter stated that this discretion also must extend to the sample selection method of test programs, provided that all population elements have a chance of selection and due care is exercised to avoid selection bias through documented procedures.

The commenter also stated that we should suggest separate regulations for specific products that may warrant prescribed methods, as has been done with bicycle helmets. The commenter expressed the belief that this is the kind of evidence-based decision making we envisioned in rejecting a single definition of “high degree of assurance” within a reasonable testing program for non-children's products.

(Response 30)—Although subpart B, describing a reasonable testing program, has been reserved in the final rule, the concept of certification testing and testing a sufficient number of samples to provide a high degree of assurance of compliance with applicable rules, bans, standards, and regulations remains in the final rule with regard to children's products in § 1107.20(a). We disagree with the commenter's assertion that “testing with a sufficient number of samples to provide a high degree of assurance” requires the testing method to meet minimum standards of statistical confidence. In the preamble to the proposed rule (75 FR at 28344), the discussion of a high degree of assurance intentionally avoided choosing a statistically based definition for the term. Therefore, the certifier is allowed to choose other means, using its knowledge of the product and how it is manufactured, to determine what would be a sufficient number of samples. A certifier may use statistical methods, but the determination of a sufficient number of samples to achieve a high degree of assurance is not required to be statistically based.

We decline to provide guidance on alternatives that certifiers may use to fulfill the duty to justify their plan if they were to choose anything other than a random statistical sample. With the wide variety of children's products, manufacturers, and manufacturing processes that will be subject to the final rule, it would be impractical to attempt to provide guidance applicable to all or to attempt to provide individualized guidance for some or all products, as requested by the commenter. Because the certifier typically possesses greater knowledge of the product and how it is made than other parties possess, the certifier is in the best position to determine how to achieve a high degree of assurance that its products are compliant with all the applicable children's product safety rules.

Regarding the commenter's observation of the CPSC's use of 12 or fewer samples, those samples were not used for children's product certification purposes. Thus, tests run by CPSC staff are not germane to the discussion of product certification. Depending upon the manufacturer's knowledge of a children's product and its manufacture, a sufficient number of samples to provide a high degree of assurance of compliance with the applicable children's product safety rules may be greater, or fewer, than 12.

The commenter may be misunderstanding the rule as it relates to random samples. In proposed § 1107.22, the testing of random samples was required only during periodic tests of children's products subject to an applicable children's product safety rule. Pursuant to H.R. 2715, the testing of “random samples” to ensure continued compliance has been replaced with testing of “representative samples” to ensure continued compliance. Given the change in the statute, we have decided to remove § 1107.22 in the final rule. Regardless, certification testing in the proposed rule never required the selection of random samples for children's products.

For children's products, section 14(a)(2)(A) of the CPSA requires that every manufacturer or private labeler of a children's product:

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 body accredited * * * to be tested for compliance with such children's product safety rule.

Therefore, the statute requires children's products to be tested before they can be certified, and the statutory requirement for third party periodic testing applies.

We agree that there are instances in which it may be preferable to specify a testing program in a particular regulation, and several of our existing regulations require such programs. Should a particular standard at some point necessitate consideration of such an approach, we will provide due consideration of how to specify, within the statutory framework that requires third party certification and third party periodic testing, such a particular testing program.

(Comment 31)—One commenter expressed concern about the requirement to perform certification tests. The commenter said they did not believe that a requirement to test pre-production samples should be part of a reasonable testing program, adding that it may be impractical for seasonal items or short production runs. The commenter stated that preproduction samples cannot be tested because we will not accept the test results on samples as test results on the finished product. The commenter asked: if the preproduction samples fail and the retailer/importer has the product reworked by the manufacturer to correct any defects, and the production units pass tests to meet all applicable

standards, then why should it matter if the samples failed, as long as the final product meets the requirements? The commenter expressed the belief that sample testing should be optional, not required.

(Response 31)—Although subpart B, describing a reasonable testing program, has been reserved in the final rule, the concept of certification testing and testing a sufficient number of samples to provide a high degree of assurance of compliance with applicable rules, bans, standards, and regulations remains in the final rule with regard to children's products in § 1107.20(a). Section 1107.20(a) states that certification tests must be performed on samples that are identical in all material respects to the children's product distributed in commerce. Thus, finished children's product samples or preproduction samples are acceptable for certification test purposes if their performance for the test under consideration is the same as the finished product.

The commenter did not explain why they believe that certification tests may be impractical for seasonal or short production run items. Thus, we cannot respond to the commenter's concern. The final rule requires passing certification test results before a Children's Product Certificate can be issued.

With regard to the commenter's concern regarding a test failure of preproduction samples, the commenter may have misunderstood the requirements of certification testing. The commenter described a circumstance in which a manufacturer tested samples for compliance to a regulation. Upon receiving a failing test result, the manufacturer addressed the causes of the failing test results and conducted new certification tests on samples of the “corrected” product and received passing test results. This describes an acceptable process for initial product certification.

We disagree with the commenter's suggestion that certification tests should be optional. Section 14(a)(2) of the CPSA expressly refers to testing as being the basis of a certification and does not make such testing optional.

(Comment 32)—A commenter suggested that the final rule not require finished product/component part testing and should allow samples that are identical in all material respects to the finished product to be tested. The commenter added that testing on samples since the 1950s has not resulted in a recall for failing to comply with the applicable rule. Thus, requiring finished product/component testing would be extremely costly and burdensome and would not increase safety. The commenter would revise the rule to make it clear that component parts that are materially similar to the finished part can be used for certification testing.

(Response 32)—We agree with the commenter regarding the testing of samples. Section 1107.20(a) states that samples must be identical in all material respects to the children's product.

We also agree with the commenter's suggestion that we clarify the rule; therefore, we have revised § 1107.20(c) to state that component part testing may be used for certification of a finished product.

(Comment 33)—One commenter expressed the belief that the manufacturer should determine the number of units to be tested, but added that they do not believe that statistical sampling is appropriate.

(Response 33)—A manufacturer may use statistical or qualitative means to determine how many units of a product are needed for certification testing to give the manufacturer a high degree of assurance that the product complies with the applicable rules. The manufacturer is not required to use statistical methods, but they should be prepared to describe how their technique shows the product's compliance.

(Comment 34)—One commenter noted that products using “food grade” materials have supplier certificates stating that these materials meet the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) and/or the packaging requirements for the Coalition of Northeastern Governors (CONEG). The commenter suggested supplementing these certificates with other analyses, as part of the certification (

e.g.,

gas chromatography—mass spectrometry, GC-MS) and a reasonable testing program. The commenter said that such assurances also can be used, consistent with the Commission's authority under section 3 of the CPSIA, to reduce the burden of testing on manufacturers of consumer products. Because the proposed rule would acknowledge that children's product manufacturers who implement a reasonable testing program have a reduced third party test burden from the standpoint of third party periodic testing, the commenter said that such compliance assurances can be incorporated into a program for children's products as well.

(Response 34)—Section 14(a)(2) of the CPSA requires third party conformity assessment body testing of children's products as a condition of certification. Additionally, those third party conformity assessment bodies must have a CPSC-accepted accreditation for the scope of the testing undertaken in support of product certification. “Food grade” materials and CONEG requirements are not conducted by these laboratories and do not necessarily demonstrate compliance with the requirements of applicable children's product safety rules or compliance with the third party testing requirement in section 14(a)(2) of the CPSA. Accordingly, we cannot adopt those certifications in lieu of the certification required under section 14(a)(2) of the CPSA.

While manufacturer-supplied certificates stating that these materials meet FFDCA or CONEG requirements may not be used as the basis for a third party-supported product certification, they can be used as part of a production testing plan implemented to extend the maximum periodic testing interval from one year to two years if they are sufficient to demonstrate compliance with a children's product safety rule such as the lead content limits. We note that some food additives are GRAS, or “generally recognized as safe.” However, these designations might not be based on scientific analyses or testing. Instead, the GRAS status for a material might be based on longstanding acceptance or belief.

Furthermore, on August 12, 2011, the President signed into law H.R. 2715, which amended the CPSIA in several respects. One provision in H.R. 2715 requires us to seek public comment on opportunities to reduce the cost of third party testing requirements, consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation. H.R. 2715 directs us to seek public comment on seven specific issues, including the extent to which the use of materials subject to regulations of another government agency that requires third party testing of those materials may provide sufficient assurance of conformity with an applicable consumer product safety rule, ban, standard, or regulation without further third party testing. Elsewhere in this issue of the

Federal Register

, we have published a notice seeking public comment on the issues in H.R. 2715.

H.R. 2715 further requires us to review the public comments and states that we may prescribe new or revised third party testing regulations if we determine that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations. Should new information

become available, the Commission may revisit this issue in the future.

b. The Interaction Between the Manufacturing Process and Samples

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.

(Comment 35)—One commenter stated that phrases, such as “sufficient number of samples” and “variability in composition or quality,” can be confusing. The commenter said that regular internal monitoring and periodic testing should be able to provide sufficient data and information to support any assessment of product quality.

(Response 35)—The commenter is correct that internal monitoring and testing can provide data to support the assessment of product quality. Because § 1107.20 applies to both tightly and loosely controlled manufacturing processes, we emphasize in § 1107.20(b) of the final rule that the number of samples needed to give the certifier a high degree of assurance of the product's compliance is affected by how well the product's manufacturing process controls those variables associated with compliance. A sufficient number of samples would be the quantity of samples selected for certification testing that gives the certifier a high degree of assurance that the product complies with all the applicable children's product safety rules.

“Variability in the composition or quality,” for purposes of § 1107.20, means unit-to-unit differences of a product that can affect its compliance with the applicable children's product safety rules.

We have finalized this paragraph without change.

(Comment 36)—One commenter stated that regular internal monitoring and periodic testing should be able to provide sufficient data and information to support any assessment of product quality. The commenter noted that this procedure is commonly practiced by many manufacturers at present.

(Response 36)—Section 1107.20(b) of the final rule states, in part, that 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. We interpret the comment to assert that internal manufacturing controls and regular testing should obviate the need for numerous samples for product certification. The commenter is correct in that the manufacturer's internal controls and testing can provide information to use in determining how many certification test samples would be required to give the certifier a high degree of assurance of the product's compliance with the applicable rule.

c. Component Part Testing

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.

(Comment 37)—One commenter requested that we make an explicit statement about component testing indicating that certain components are exempt from testing and certification. The commenter was concerned that, without specific language, the final customer will not accept component testing if exempt parts are not tested. The commenter recommended revising proposed § 1107.20(c) as follows:

(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.

Component part testing can be used to substantiate compliance for those children's products where part of the product has been exempted from testing pursuant to Section 1500.91.

(Italics indicate proposed language.)

(Response 37)—We agree that language similar to what the commenter suggested would be helpful, but we believe that the commenter's change is more appropriate in the rulemaking pertaining to component part testing, specifically with component part testing for the lead content of children's products under proposed 16 CFR 1109.12. Therefore, we have considered this comment under the proposed rule for component part testing.

On our own initiative, we have revised § 1107.20(c) to state: “Except where otherwise specified by a children's product safety rule, component part testing pursuant to 16 CFR part 1109 may be used to support the certification testing requirements of this section.” We made these changes to simplify the language in § 1107.20(c) and to remove descriptions of 16 CFR part 1109 to avoid potential confusion over what the final rule requires and what 16 CFR part 1109 mandates.

(Comment 38)—One commenter stated that raw (or base) material testing is critical to its ability to develop programs to comply with the law. The commenter noted that, although it is a component manufacturer, it has more than 384,000 stock-keeping units (SKUs). These hundreds of thousands of products could be seen as different combinations of a smaller population of subcomponents and raw materials. The commenter stated that it is through working with this smaller population of subcomponents and raw materials that they can effectively manage quality in areas such as lead levels.

(Response 38)—Component part testing of raw materials is beyond the scope of this rule and is considered in the final rule on

Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Testing and Certification Requirements

(16 CFR part 1109). However, in that final rule, in many cases, raw materials or subcomponents may be considered component parts, as long as due care has been taken to ensure that no action subsequent to component part testing has adversely affected the raw materials' or subcomponents' compliance with the applicable product safety rules.

d. Remedial Action

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 complies with all applicable children's product safety rules.

(Comment 39)—Two commenters raised questions about what action must be taken when a product fails a test. One commenter interpreted the proposed rule to mean that all similar toys are

also not compliant, resulting in a factory shutdown. The other commenter noted that different products vary in design and manufacture, and if one product fails, it does not mean that other products would have the same problem.

(Response 39)—Section 1107.20(d) of the final rule states that if a product sample fails certification testing to the applicable children's product safety rule(s), even if other samples have passed the same certification test, the manufacturer must investigate the reasons for the failure and take the necessary steps to address the reasons for the failure. Generally, certification testing of a children's product requires all samples tested to pass the applicable children's product safety standard. Otherwise, the certifier cannot ensure with 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. However, some regulations allow for some individual samples of a test set to exceed the limit but still comply with the regulation. For example, in the

Standard for the Surface Flammability of Small Carpets and Rugs

(FF 2-70) in 16 CFR part 1631, there is an allowance within the standard for a failure during a test and a prescribed action. Because the regulation specifies the procedure for dealing with a sample test failure, or through labeling, we would view such a properly labeled product as meeting the applicable product safety standard.

A test failure for one children's product applies only to that product and is not necessarily representative of all products in the factory. An exception to this might be a test on a component part used in many products. In that circumstance, the nature of the test failure and the component part's use in the other products would affect which products the failing test result applies. For example, if a component part over the lead content limit is inaccessible, the use of that component part would not make the children's product noncompliant.

Additionally, on our own initiative, we have revised § 1107.20(d) by adding the phrase: “to the applicable children's product safety rule(s)” after the phrase “if a product sample fails certification testing.” This change is for clarification purposes and is not intended to have a substantive effect on the final rule. We also replaced the phrase “take remedial action” with the phrase “take the necessary steps to address the reasons for the failure” because we have removed the remedial action plan requirement in § 1107.25 from the final rule. We discuss the removal of the remedial action plan requirement in part III.D.7. of this document, below.

3. Proposed § 1107.21 Periodic Testing

a. General Periodic Testing Requirements

Proposed § 1107.21(a) would implement the periodic testing requirement in section 14(i)(2)(B)(i) (renumbered by H.R. 2715 from section 14(d)(2)(B)(i)) of the CPSA by requiring each manufacturer to conduct third party periodic testing at least annually, except as otherwise provided in proposed § 1107.21(b) and (d), or as provided in regulations under this title. The proposal also would explain that manufacturers may need to conduct third party 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 and that more frequent third party periodic testing may help a manufacturer identify noncompliant products quicker and, as a result, may limit the scope of any potential product recall. In addition, more frequent third party periodic 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 third party periodic testing.

(Comment 40)—One commenter asserted that the language of proposed § 1107.21 is not explicitly limited to children's products. The commenter recommended that the language in the final rule be revised so that the term “manufacturer” is changed to the phrase “manufacturer of a children's product” to clarify that § 1107.21 applies only to children's products. The commenter also stated that the same revision should be made throughout subpart C, wherever the term “manufacturer” appears without the qualifier “of a children's product.”

(Response 40)—We believe it is clear that Subpart C applies only to children's products. While we believe the commenter's suggested change is unnecessary, we have made other revisions to the text and have added a reference to manufacturers of children's product in § 1107.21(a) of the final rule to reiterate that the requirement applies only to children's products.

On our own initiative, we have revised § 1107.21 to reflect changes to the periodic testing frequency in § 1107.21(b), (c), and (d) of the final rule, to mention component part testing, and to make nonsubstantive clarifications. For example, § 1107.21(a) of the final rule states: “All periodic testing must be conducted by a third party conformity assessment body.” The proposed rule had mentioned third party testing in proposed § 1107.21(b), but not in proposed § 1107.21(a), so adding this sentence to a revised § 1107.21(a) of the final rule reinforces the notion that periodic testing of children's products must be done by a third party conformity assessment body. We have reorganized § 1107.21 to state the general requirements at § 1107.21(a) and then identify different options for third party periodic testing frequencies at § 1107.21(b), (c), and (d). Thus, for example, we have modified and moved the annual periodic testing mentioned in proposed § 1107.21(a) to § 1107.21(b) in the final rule, and we have combined it with the periodic test elements that were at proposed § 1107.21(c). Consequently, § 1107.21(b) of the final rule states that a manufacturer must conduct third party periodic testing to ensure compliance with the applicable children's product safety rules at least once a year, except as otherwise provided in § 1107.21(c) and (d), or as provided in our regulations. (The final rule states that the periodic testing under § 1107.21(b) must be done “once a year,” as opposed to “annually,” to eliminate potential confusion in determining how to calculate the proper interval for periodic testing.) Under § 1107.21(b), the manufacturer must conduct periodic testing at least once a year when using a periodic test plan. Section 1107.21(b)(1) of the final rule (regarding the periodic test plan) is substantially the same as proposed § 1107.21(c)(1), except that the final rule states that manufacturers must develop a periodic test plan to “ensure with a high degree of assurance” that children's products continue to comply with all applicable children's product safety rules. (The proposed rule stated that the manufacturer must develop a periodic test plan to “assure that children's products” continue to comply.) Section 1107.21(b)(2), “Testing Interval,” is substantially the same as proposed § 1107.21(c)(2), except that, for consistency, the final rule refers simply to a “testing interval,” rather than a “periodic testing interval.” (The proposed rule had used different terms, such as “periodic testing interval,” “testing interval,” “interval,” and “interval for periodic testing,” for the same concept.)

(Comment 41)—One commenter supported third party testing for the initial certification for any new products and said that any major changes in

design, critical component changes, or meeting changing regulations should require recertification by third party testing bodies. The commenter also supported periodic testing by third party conformity assessment bodies of any products, providing that a much more refined and more specific requirement can be presented and confirmed by a proper authority. The commenter noted that it would be difficult and extremely risky to leave such a decision and ruling to the related parties. However, the commenter supported the earlier proposal of component part testing that certifies recognized components for toy production because it would enhance the elimination of certain repetitive and redundant testing on the finished product.

(Response 41)—The commenter was unclear what it meant by a “proper authority” or which parties are the “related parties” dealing with the difficulty and risk of periodic testing. In the final rule, the certifier (domestic manufacturer or importer) of a children's product must determine the frequency of periodic testing and the number of samples to be tested. The frequency of testing (within specified maximum periodic testing intervals) and the number of samples required must be sufficient to give the certifier a high degree of assurance that continuing production or importation of the children's product continues to meet the requirements of all applicable children's product safety rules.

The commenter did not indicate what factors should be added to the periodic testing requirements to make them more refined or specific. Thus, we have no basis to modify the rule to account for such factors. Further, identifying or creating a “proper authority” to confirm periodic testing programs would present practical difficulties due to the number of products requiring periodic testing plans and the variety of manufacturing techniques used in their production. Because periodic testing requirements apply to many different types of children's products and manufacturers, and because manufacturing techniques for those products vary widely, one set of refined or specific requirements for periodic testing is unlikely to be applicable to all children's products that require periodic testing.

(Comment 42)—One commenter noted that some children's products are not produced on a regular basis, and more than one year may pass between production runs. Because there are no production units on which to perform periodic testing, the commenter suggested that an “Inactive” product status be created for a children's product that has passed certification testing—but currently is not being produced. Once production resumes, periodic testing can be performed on the new units.

(Response 42)—A new “Inactive” status is unnecessary because periodic testing of children's products is only required for continuing production after certification. If, in the commenter's example, more than a year passes between production runs, when production recommences, the final rule requires periodic tests on new production runs to assure continued compliance. The certifier must use due care to ensure that no material change has occurred in the product's design or manufacturing process, including the sourcing of component parts. Otherwise, new certification tests must be conducted on the newly manufactured product.

(Comment 43)—One commenter noted that while the proposed rule would accept the use of component part testing for certification purposes, it does not address its use for periodic testing. The commenter would revise proposed § 1107.21(c)(1) to include language allowing for the use of a component part testing program to meet the periodic testing requirements. The commenter stated that it could foresee customers requiring the development of a periodic testing program as a contractual requirement.

Another commenter remarked that the proposed rule does not recognize items that are exempt from testing pursuant to 16 CFR 1500.91,

Determinations regarding lead content for certain materials or products under section 101 of the Consumer Product Safety Improvement Act.

(Response 43)—Section 1107.21(a) of the final rule states that manufacturers must conduct third party periodic testing. This testing is to ensure that children's products manufactured after the issuance of a Children's Product Certificate, or since the previous periodic testing was conducted, continue to comply with all applicable children's product safety rules. Periodic testing can use component part testing to ensure compliance with some or all of the applicable children's product safety rules. We have clarified the language of § 1107.21(a) of the final rule to state that component part testing may be used to meet the periodic testing requirements, subject to the conditions of § 1107.21.

Regarding items that are exempt from testing for lead content, those items are also exempt from any periodic testing requirements. In 16 CFR 1500.91, we have determined that these materials fall under the lead content limit, and no testing is required.

(Comment 44)—One commenter stated that the testing frequency should be left to the manufacturer and to the market; and the commenter further asserted that a rule requiring manufacturers to test according to these standards every year is an unaffordable economic burden. The commenter indicated that it is unrealistic to imagine that testing cost savings from maintaining a reasonable testing program (as described in the proposed rule) will be useful because that program is “wasteful and gargantuan.” The commenter asserted that a firewalled conformity assessment body would be unrealistic for small businesses. The commenter also maintained that component part and composite testing likewise, will provide no relief. The commenter asked: If a firm has a good long-term record of safety, then why are they required to test according to the proposed rule?

(Response 44)—Section 14(i)(2)(B)(i) of the CPSA requires us to establish protocols and standards for ensuring that children's products are subject to testing periodically. We have revised § 1107.21 to allow third party periodic testing: At least once per year for children's product with a periodic testing plan; at least once every two years for children's products with a production testing plan; or at least once every three years for a production testing plan using an ISO/IEC 17025:2005-accredited testing laboratory (and provided other requirements are met, including, but not limited to, using that lab to test to the children's product safety rule(s) to which the product is subject). Allowing firms with a good long-term record of safety to forego testing their children's products would not comply with the law, which requires periodic testing of children's products, regardless of past performance.

Regarding the commenter's assertion that children's product manufacturers will not attempt to save on testing costs because implementing a reasonable testing program is “wasteful and gargantuan,” the final rule does not require manufacturers of children's products to have a reasonable testing program in order to save on third party conformity assessment body testing costs. By increasing the manufacturer's options to qualify for an extension of the maximum periodic testing interval, we hope that more manufacturers wishing to implement such a program will find it advantageous to do so.

Additionally, pursuant to H.R. 2715, elsewhere in this issue of the

Federal Register

, we have published a notice seeking comment on other techniques for lowering the cost of third party testing, consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.

As for the commenter's remark about firewalled conformity assessment bodies, the final rule does not require that small businesses have a firewalled conformity assessment body.

Finally, regarding the commenter's statements on component part and composite part testing, we address those comments in the preamble to the final rule,

Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Testing and Certification Requirements

(16 CFR part 1109).

(Comment 45)—One commenter stated that periodic testing is unnecessary because when a product is manufactured in China, the initial product sample is inspected by the China Entry-Exit Inspection and Quarantine Bureau to ensure that it complies with all European Union, United States, and China product safety standards. Additionally, the commenter observed, the China Entry-Exit Inspection and Quarantine Bureau will conduct the random sample in-line inspection to inspect a number of samples in the production twice a year. The commenter said that products that fail the inspection will not be allowed to be exported. The commenter said that the strict product safety inspections by China Entry-Exit Inspection and Quarantine Bureau are enough to have the high degree of product safety assurance and that a periodic testing requirement would be duplicative.

The commenter also said that periodic testing was unnecessary because, as the manufacturer, they have a high degree of self-discipline and strictly supervise their products' safety. Furthermore, the commenter stated that 90 percent of manufacturers have their own testing laboratories that conform to international laboratory standards and already have a series of internal product safety testing in place to maintain a high degree of product safety and quality assurance. In addition, the commenter stated that most customers require testing by the third party conformity assessment body per order before the manufacturer exports the goods to ensure a high degree of product safety.

(Response 45)—The final rule requires periodic testing to be conducted by a CPSC-accepted third party conformity assessment body. China Entry-Exit Inspection and Quarantine Bureaus do not currently meet the conditions specified in the Consumer Product Safety Improvement Act for governmental conformity assessment bodies to participate in the CPSC's program. Further, the third party testing requirements apply irrespective of the level of a manufacturer's self-supervision of product safety.

With regard to internal testing facilities, these are considered first party laboratories, and their tests are not allowed for periodic test purposes, unless the laboratory is a CPSC-accepted firewalled conformity assessment body. However, if the third party laboratories testing the manufacturer's products for the customer are CPSC-accepted for the scope of the testing, test results from those laboratories may be used for fulfilling the periodic testing requirements. We note that internal testing facilities can be used to extend the maximum testing interval for periodic testing from one year to two years. Further, if the internal testing facility is ISO/IEC 17025:2005-accredited and other conditions are met, the maximum testing interval for periodic testing is extended to three years.

(Comment 46)—One commenter stated that the importer who purchases a product from a manufacturer and takes possession of the product prior to importation does not have full visibility and knowledge of the manufacturing process and must treat each shipment produced by the manufacturer as a discrete lot.

(Response 46)—An importer is responsible for issuing a Children's Product Certificate for the children's products they import. If a foreign manufacturer tests or certifies a children's product and provides the importer with the test results or certificate and other required documentation, then the importer, exercising due care, using the manufacturer's test data or certificate as a basis, may issue its own Children's Product Certificate.

In this circumstance, due care by the importer involves ensuring that the foreign manufacturer conducts periodic tests. If the foreign manufacturer does not certify the children's product, but the importer has documentation of the manufacture and testing of the children's product, then the importer is responsible for certifying the children's product and is subject to the requirement for periodic testing. However, if the importer has no knowledge of the manufacture of the product, then it should treat each shipment as a discrete lot and subject it to certification testing because the importer does not know whether material changes have been made to the product since its last shipment. In this circumstance, the shipment that has undergone certification testing is not considered continuing production of the product, and is not subject to the periodic testing requirements.

b. Periodic Testing and Reasonable Testing Programs

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 have to comply with the requirements in proposed § 1107.20), it would have 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, proposed § 1107.21(b) would state that we may require the manufacturer to meet the periodic testing requirements in proposed § 1107.21(c) or modify their reasonable testing program to ensure a high degree of assurance. One element of the reasonable testing program in proposed subpart B would be the “production testing plan” in proposed § 1107.10(b)(3); a production testing plan would describe what tests must be performed and the frequency with which those tests must be performed to provide a high degree of assurance that the products manufactured after certification continue to meet all applicable safety rules, bans, standards, or regulations.

(Comment 47)—One commenter recommended that we require children's products to be tested by a third party conformity assessment body at least every year, not every two years, as proposed. The commenter felt that many changes can occur over time in the manufacturing process, materials, test standards, and test protocols that could cause products tested infrequently to drift away from compliance with applicable children's product safety rules. The commenter felt that more frequent independent testing would be able to keep this in check better.

(Response 47)—We disagree with the commenter's inference that a production testing plan will not be capable of detecting “drift” in a product's

compliance with the applicable safety rules. We are aware of numerous forms of production testing techniques that have been implemented successfully to control product quality and ensure continuing compliance.

Manufacturers are free, however, to test their products more frequently than the rule would require.

Additionally, on our own initiative, we have reorganized § 1107.21 to move the requirements that were at proposed § 1107.21(b) to § 1107.21(c) of the final rule. Furthermore, because we have reserved subpart B (which would pertain to a reasonable testing program), we have removed references to a “reasonable testing program” in subpart C and replaced them with the key element of the “reasonable testing program,” which is the “production testing plan.” We decided to maintain the requirement for a production testing plan because children are a vulnerable population, and traditionally, we have had a greater interest in ensuring the safety of children's products. Additionally, with the passage of the CPSIA, Congress indicated that it intended for children's products to be subject to more stringent requirements than non-children's products, as demonstrated by the requirements for third party testing and the protocols and standards for continuing third party testing for children's products promulgated in this rulemaking.

Section 1107.21(c)(1) of the final rule states that if a manufacturer implements a production testing plan, as described in § 1107.21(c)(2), to ensure continued compliance of the children's product with a high degree of assurance to the applicable children's product safety rules, the manufacturer must submit samples of its children's 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. The 2-year period is derived from proposed § 1107.21(b) for manufacturers who have a reasonable testing program. Section 1107.21(c)(1) further states that a manufacturer may consider the information obtained from production testing when determining the appropriate testing interval (up to two years) and the number of samples needed for periodic testing to ensure that there is a high degree of assurance that the other untested children's products manufactured during the testing interval comply with the applicable children's product safety rules. The preamble to the proposed rule noted: “[t]he appropriate periodic testing interval may vary for a manufacturer depending on the manufacturer's knowledge of the product and its manufacturing processes” for the factors to consider when determining the periodic testing interval under proposed § 1107.21(c)(2) (renumbered to § 1107.21(b)(2) in the final rule) (75 FR at 28349). This concept applies equally to the information obtained from production testing. Information gained from production testing can be used to determine the appropriate testing interval (up to two years), and so we added this concept to § 1107.21(c)(1).

Section § 1107.21(c)(2) of the final rule describes the production testing plan, and it is substantially the same as the production testing plan in proposed § 1107.10(b)(3) (which is reserved in the final rule, along with the rest of subpart B). Section 1107.21(c)(2) explains that the production testing plan describes “the production management techniques and tests that must be performed to provide a high degree of assurance that the products manufactured after certification continue to meet all the applicable children's product safety rules.” It further explains that 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 children's product safety rules.

Section 1107.21(c)(2) also states that a manufacturer may use measurement techniques that are nondestructive and that are tailored to the needs of an individual product to ensure that a product complies with all applicable children's product safety rules. Thus, the tests in a production testing plan under § 1107.21(c)(2) do not have to be the tests described in the applicable children's product safety rule, and they do not have to be conducted by a CPSC-accepted third party conformity assessment body. However, the implementation of the production testing plan still requires some testing. Purely mathematical techniques, such as a Failure Modes and Effects Analysis only, or a computer simulation of the product alone, are not allowed. Purely mathematical techniques, without verifying measurements, may not characterize the product with sufficient fidelity to predict accurately its compliance to the applicable rules.

Section 1107.21(c)(2) of the final rule has revised the requirement in proposed § 1107.10(b)(3)(iii)(B), which stated: “Any production test method used to conduct production testing must be as effective in detecting noncompliant products as the test used for certification” to “Any production test method used to conduct production testing must be effective in determining compliance” in the final rule. The language of the proposed rule could practically be interpreted to require the use of the test method mandated for certification because a manufacturer would be unclear about what “as effective” means and therefore, use the test method for certification. We changed the language in the final rule to clarify the point that production testing does not require the use of the test method for certification. Additionally, § 1107.10(b)(3)(iii)(C) of the proposed rule would state: “If a manufacturer is uncertain whether a production test is as effective as the certification test, the manufacturer must use the certification test.” This provision has been eliminated from the final rule because it is no longer necessary after the above clarification that production testing does not require use of the test method for certification.

Finally, § 1107.21(c)(3) of the final rule states that if a production testing plan fails to provide a high degree of assurance of compliance with the applicable children's product safety rules, we may require the manufacturer to meet the requirements of § 1107.21(b) for a periodic testing plan to ensure a high degree of assurance of compliance. This is not a new requirement. Proposed § 1107.21(b) had the same requirement for manufacturers with a reasonable testing program. Because we have removed the reasonable testing program and reserved subpart B in the final rule, the periodic testing requirement is no longer linked to the reasonable testing program. However, we have moved this requirement to the production testing plan option in § 1107.21(c)(3) and the ISO/IEC 17025:2005-accredited laboratories option in § 1107.21(d) of the final rule.

(Comment 48)—A commenter strongly recommended that we recognize or endorse certain internal in-house testing facilities that conform to ISO 17025:2000 standard. The commenter felt that this recognition would greatly expedite testing procedures and the time for certain required testing and reduce costs and lessen dependence on the third party conformity assessment bodies. Another commenter stated that we should recognize internal laboratories as a way to reduce dependence on third party conformity assessment bodies. The reasons for the suggestions include:

Better monitoring of product safety, a desire to reduce testing costs, encourage other manufacturers to develop their own internal testing facilities, and promote continuous product improvements.

(Response 48)—We recognize that using ISO/IEC 17025:2005-accredited laboratories for testing purposes provides an added measure of assurance to production testing. The laboratories are accredited by an independent body as competent to perform specified tests. They are also recognized as having instituted a management system that establishes procedures and properly maintains records. Laboratory accreditation also establishes controls concerning data integrity, equipment calibration, and procedures to resist undue influence over testing results.

For these reasons, we have amended the final rule to include a new § 1107.21(d), which provides a maximum periodic testing interval of three years for a manufacturer using an ISO/IEC 17025:2005-accredited laboratory for production testing purposes. The laboratory must be accredited by an ISO/IEC 17011:2004(E) (more commonly known as ISO/IEC 17011:2004 and how it will be referred to in the preamble) (

Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies

) accreditation body, and must use the same test method(s) used for certification testing when conducting testing to ensure continued compliance. We chose the 3-year time period because: (1) Having a laboratory accredited by an independent body as competent to perform specified tests provides an additional measure of assurance in the accuracy and the integrity of the testing results; (2) a laboratory accredited to ISO/IEC 17025:2005 must have implemented a management system that establishes and follows procedures, properly maintains records, and establishes controls concerning data integrity equipment calibration, and procedures to resist undue influence; and (3) using the same tests as the tests used for product certification provides a more direct assessment of compliance to the applicable children's product safety rules than process control techniques. Section 1107.21(d)(1) of the final rule also states that manufacturers must conduct testing using the ISO/IEC 17025:2005-accredited testing laboratory frequently enough to provide a high degree of assurance that the children's product continues to comply with the applicable children's product safety rules. In addition, section 1107.21(d)(1) of the final rule states that a manufacturer may consider the information obtained from testing conducted by an ISO/IEC 17025:2005-accredited testing laboratory when determining the appropriate testing interval and the number of samples for periodic testing that are needed to ensure that there is a high degree of assurance that the other untested children's products manufactured during the testing interval comply with the applicable children's product safety rules.

Section 1107.21(d)(2) of the final rule states that if the continued testing described in § 1107.21(d)(1) fails to provide a high degree of assurance of compliance with all applicable children's product safety rules, then we may require the manufacturer to comply with § 1107.21(b) or modify the testing frequency or number of samples required to ensure a high degree of assurance of continued compliance. Section 1107.21(d)(2) is substantially the same, in this respect, as proposed § 1107.21(b), in requiring the use of other third party periodic testing options if a manufacturer's testing program fails to provide a high degree of assurance of compliance, except that § 1107.21(d)(2) refers to “continuing testing,” rather than a “reasonable testing program.”

Section 1107.21(g) of the final rule describes the incorporation by reference of ISO/IEC 17025:2005 and ISO/IEC 17011:2004, as required by the Director of the Federal Register. This incorporation by reference is necessary because § 1107.21(d)(1) references ISO/IEC 17025:2005 and ISO/IEC 17011:2004.

(Comment 49)—Two commenters stated that periodic testing or auditing should be considered a regular internal function. One commenter stated that any manufacturer with qualified internal testing facilities should perform such duties easily and regularly t

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