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CONSUMER PRODUCT SAFETY certified to comply with the applicable labeler of such children’s product must COMMISSION product safety rules may be increased. submit sufficient samples of the Potentially, the number of recalls for children’s product ‘‘or samples that are 16 CFR Part 1107 children’s products could be reduced, identical in all material respects to the product’’ to an accredited ‘‘third party [CPSC Docket No. CPSC–2010–0038] and, with continued assessment of compliance, the scope of necessary conformity assessment body’’ to be Testing and Labeling Pertaining to recalls could be reduced. Further, third tested for compliance with the Product Certification party testing during continuing children’s product safety rule. Based on production or importation can serve as such testing, the manufacturer or private AGENCY: Consumer Product Safety an objective assessment of the labeler, under section 14(a)(2)(B) of the Commission. effectiveness of a manufacturer’s or CPSA, must issue a certificate that ACTION: Final rule. importer’s internal processes to ensure certifies that such children’s product compliance, which would also serve to complies with the children’s product SUMMARY: The Consumer Product Safety enhance the safety of children’s safety rule based on the assessment of Commission (‘‘CPSC,’’ ‘‘Commission,’’ products in the market. a third party conformity assessment or ‘‘we’’) is issuing a final rule that body accredited to perform such tests. establishes protocols and standards with II. Statutory Authority Section 14(i)(2)(A) of the CPSA respect to certification and continued A. The Consumer Product Safety Act, as requires the Commission to initiate a testing for children’s products. The final Amended by the Consumer Product program by which a manufacturer or rule also establishes requirements for Safety Improvement Act of 2008 private labeler may label a consumer labeling of consumer products to show product as complying with the Section 14(a)(1) of the CPSA, (15 that the product complies with the certification requirements. This U.S.C. 2063(a)(1)), as amended by certification requirements under section provision applies to all consumer section 102 of the CPSIA, establishes 14(a) of the Consumer Product Safety products that are subject to a product requirements for the testing and Act (‘‘CPSA’’). The final rule safety rule administered by the certification of products subject to a implements section 14(a)(2) and (i) of Commission. (On August 12, 2011, the consumer product safety rule under the the CPSA, as amended by section 102(b) President signed into law H.R. 2715, CPSA or similar rule, ban, standard, or of the Consumer Product Safety which amended both the CPSA and the regulation under any other act enforced Improvement Act of 2008 (‘‘CPSIA’’). CPSIA. Section 10(a) of H.R. 2715 by the Commission and which are DATES: The rule will become effective redesignates what was identified as imported for consumption or section 14(d) of the CPSA in the on February 8, 2013 and applies to warehousing or distributed in products manufactured after that date. preamble of the proposed rule as section commerce. Under section 14(a)(1)(A) of 14(i) of the CPSA; consequently, except The incorporation by reference of the the CPSA, manufacturers and private publications listed in this rule is where we are citing language from the labelers must issue a certificate, which proposed rule, the remainder of this approved by the Director of the Federal ‘‘shall certify, based on a test of each Register as of February 8, 2013.1 document will refer to section 14(i) of product or upon a reasonable testing the CPSA.) FOR FURTHER INFORMATION CONTACT: program, that such product complies Section 14(i)(2)(B) of the CPSA Randy Butturini, Project Manager, with all rules, bans, standards, or requires the Commission to establish Office of Hazard Identification and regulations applicable to the product protocols and standards for: Reduction, U.S. Consumer Product under the CPSA or any other Act • Ensuring that a children’s product Safety Commission, 4330 East West enforced by the Commission.’’ CPSC tested for compliance with a children’s Highway, Bethesda, Maryland 20814; regulations, at 16 CFR part 1110, limit product safety rule is subject to testing (301) 504–7562; email: the certificate requirement to importers periodically and when there has been a [email protected]. and domestic manufacturers. Section material change in the product’s design SUPPLEMENTARY INFORMATION: 14(a)(1)(B) of the CPSA further requires or manufacturing process, including the that the certificate provided by the sourcing of component parts; I. Purpose of the Final Rule importer or domestic manufacturer • Testing of representative samples; The purpose of this final rule is to ‘‘specify each such rule, ban, standard, • Verifying that a children’s product reduce the incidents of deaths and or regulation applicable to the product.’’ tested by a conformity assessment body injuries associated with children’s The certificate described in section complies with applicable children’s products. This will be accomplished by 14(a)(1) of the CPSA is known as a product safety rules; and increasing the safety of children’s General Conformity Certification (GCC). • Safeguarding against the exercise of products. The likelihood of a Section 14(a)(2) of the CPSA (15 undue influence on a third party noncompliant product being detected U.S.C. 2063(a)(2)) establishes testing conformity assessment body by a before it is introduced to the public will requirements for children’s products manufacturer or private labeler. be increased. Consequently, consumer that are subject to a children’s product Section 14(i)(2)(B)(iii) of the CPSA confidence in children’s products safety rule. (Section 3(a)(2) of the CPSA provides for verification that a (15 U.S.C. 2052(a)(2)) defines a children’s product tested by a 1 The Commission voted 3–2 to publish this final children’s product, in part, as a conformity assessment body complies rule, with changes, in the Federal Register. consumer product designed or intended with applicable children’s product Chairman Inez M. Tenenbaum, Commissioners primarily for children 12 years of age or safety rules. At this time, we are not Robert S. Adler and Thomas H. Moore voted to publish the final rule with changes. Commissioners younger.) Section 14(a)(2)(A) of the imposing any verification obligations on Nancy A. Nord and Anne M. Northup voted against CPSA also states that, before a manufacturers because we intend to publication of the final rule. Chairman Tenenbaum, children’s product subject to a conduct the verification ourselves under Commissioner Adler, and Commissioner Moore children’s product safety rule is our inherent authorities while we gain issued a joint statement. Commissioner Nord and more experience with the testing and Commissioner Northrup issued statements. The imported for consumption or statements can be found at http://www.cpsc.gov/pr/ warehousing or distributed in certification requirements. When we statements.html. commerce, the manufacturer or private find that a children’s product

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accompanied by a certificate of standard, or regulation.’’ H.R. 2715 lists ‘‘covered products’’ manufactured by conformity does not pass the tests upon seven topics for public comment: small batch manufacturers or to exempt which the certification was based, we Æ The extent to which the use of small batch manufacturers from third may initiate an investigation of the materials subject to regulations of party testing requirements. H.R. 2715 manufacturer, third party conformity another government agency that defines a ‘‘covered product’’ as ‘‘a assessment body, and any other relevant requires third party testing of those consumer product manufactured by a party in the supply chain, to determine materials may provide sufficient small batch manufacturer where no the cause of the discrepancy. assurance of conformity with an more than 7,500 units of the same To implement sections 14(a) and (d) applicable consumer product safety product were manufactured in the (now renumbered by H.R. 2715 as rule, ban, standard, or regulation previous calendar year.’’ It defines a section 14(i)) of the CPSA, as amended without further third party testing; ‘‘small batch manufacturer,’’ in part, as Æ by section 102 of the CPSIA, we The extent to which modification of ‘‘a manufacturer that had no more than published a proposed rule in the the certification requirements may have $1,000,000 in total gross revenue from Federal Register on May 20, 2010 (75 the effect of reducing redundant third sales of all consumer products in the FR 28336). The proposed rule would: party testing by or on behalf of 2 or previous calendar year.’’ • Define the elements of a more importers of a product that is H.R. 2715 also contains (among other ‘‘reasonable testing program’’ for substantially similar or identical in all things) provisions on registration of material respects; small batch manufacturers and purposes of section 14(a)(1)(A) of the Æ CPSA; The extent to which products with exclusions of certain materials from • Establish the protocols and a substantial number of different third party testing. For example, H.R. standards for continuing testing of components subject to third party 2715 created a new section 14(i)(5)(A)(i) children’s products under section testing may be evaluated to show of the CPSA, which states that the third 14(d)(2)(B)(i), (ii), and (iv) (renumbered compliance with an applicable rule, party testing requirements do not apply as sections 14(i)(2)(B)(i), (ii), and (iv)) of ban, standard, or regulation by third to ‘‘ordinary books or ordinary paper- the CPSA; and party testing of a subset of such based printed materials.’’ components selected by a third party The Commission has chosen to • Describe the label that conformity assessment body; finalize those parts of the proposed rule manufacturers may place on a consumer Æ The extent to which manufacturers that were not affected directly or product to show that the product with a substantial number of significantly by H.R. 2715, and we will complies with the certification substantially similar products subject to reserve other subparts or provisions in requirements for purposes of what was third party testing may reasonably make the final rule, pending our consideration numbered previously as section use of sampling procedures that reduce and implementation of H.R. 2715. For 14(d)(2)(A) of the CPSA (now the overall test burden without example, because section 14(i)(2)(B)(ii) renumbered by H.R. 2715 as section compromising the benefits of third party of the CPSA, as amended by H.R. 2715, 14(i)(2)(A) of the CPSA). testing; now refers to the testing of B. H.R. 2715 and Its Impact on This Æ The extent to which evidence of ‘‘representative samples,’’ we have Rulemaking conformity with other national or decided to remove § 1107.22 from international governmental standards On August 12, 2011, the President subpart C of the final rule, which would may provide assurance of conformity to have pertained to ‘‘Random Samples.’’ signed into law H.R. 2715. H.R. 2715 consumer product safety rules, bans, amended the CPSA and the CPSIA in standards, or regulations applicable III. Comments on the Proposed Rule several ways. For example, section 2, under the CPSA; and Our Responses ‘‘Application of Third Party Testing Æ The extent to which technology, Below, we describe and explain each Requirements,’’ of H.R. 2715, revised other than the technology already subpart and section of the final rule, as section 14(d) of the CPSA, in part, by: approved by the Commission, exists for • well as describe and respond to the Renumbering the second paragraph third party conformity assessment comments on the proposed rule. A of section 14(d) of the CPSA as section bodies to test or to screen for testing summary of each of the commenters’ 14(i) of the CPSA. (When the CPSIA was consumer products subject to a third topics is presented, and each topic is enacted, it created, mistakenly, two party testing requirement; and followed by our response. For ease of paragraph (d)s in section 14 of the Æ Other techniques for lowering the reading, each comment will be prefaced CPSA. The paragraph at issue in the cost of third party testing consistent by a numbered ‘‘Comment’’; and each proposed rule was the second of the two with assuring compliance with the response will be prefaced by a paragraphs numbered (d); H.R. 2715 applicable consumer product safety corresponding numbered ‘‘Response.’’ contained a technical amendment to rules, bans, standards, and regulations. Each ‘‘Comment’’ is numbered to help renumber the second paragraph (d) as a • Creating a new section 14(i)(3)(B) of distinguish between different topics. new paragraph (i) of section 14 of the the CPSA, requiring us to review the The number assigned to each comment CPSA); public comments and stating that we is for organizational purposes only and • Revising section 14(i)(2)(B)(ii) of the ‘‘may prescribe new or revised third does not signify the comment’s value or CPSA to require the testing of party testing regulations if [we importance or the order in which it was ‘‘representative samples,’’ rather than determine] that such regulations will received. Comments on similar topics the testing of ‘‘random samples’’; reduce third party testing costs are grouped together. • Creating a new section 14(i)(3)(A) of consistent with assuring compliance the CPSA requiring, no later than 60 with the applicable consumer product A. General Comments days after the date of enactment, that we safety rules, bans, standards, and Several commenters addressed issues ‘‘seek public comment on opportunities regulations; and regarding testing and costs, generally. to reduce the cost of third party testing • Creating a new section 14(i)(4) of (Comment 1)—One commenter requirements consistent with assuring the CPSA, titled, ‘‘Special rules for warned that because the overwhelming compliance with any applicable small batch manufacturers,’’ to provide majority of consumer products sold in consumer product safety rule, ban, ‘‘alternative testing requirements’’ for the United States are produced overseas,

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nearly all of the work necessary to consumer product safety rules, bans, kept in the United States, nor does it ensure compliance with the regulations standards, and regulations. require records to be translated into will be performed overseas. The (Comment 2)—Two commenters English, unless requested. commenter stated that because the cost stated that we should conduct a full Additionally, we note that a cost- of compliance for foreign manufacturers cost-benefit analysis of the rule. One benefit analysis would not necessarily can be relatively high—while the risks commenter added that costs of be confined to manufacturers or those in associated with noncompliance can be complying with the testing and a supply chain (as implied by one relatively low—it is important that our certification rule, in combination with commenter). We expect, for instance, regulation balance the need for a high other requirements under the CPSIA that consumers will benefit from the degree of assurance of compliance and other rules administered by the testing and certification of consumer against the need to develop a practical CPSC, will result in a major rule with products, particularly if such testing regulatory structure that foreign major implications to consumer product revealed potential problems associated manufacturers can and will implement. manufacturers, particularly children’s with a product or its components, or if (Response 1)—The final rule is product manufacturers, as well as to the such testing prompted a manufacturer to designed not to be overly prescriptive, entire supply chain. The commenter redesign or remanufacture the product thereby giving manufacturers some urged us to examine in greater detail, to make it safer. flexibility in designing their testing and and to quantify, the full cost and burden (Comment 3)—One commenter stated certification programs to be consistent of these rules. A third commenter that some retailers are requiring many with the statutory requirements. For implored us to consider the reduction in manufacturers to submit their products example, the final rule allows the risk, if any, associated with each to as many as four different laboratories manufacturer to determine the number regulatory requirement and impose only because the retailers want to see test of samples that are tested, as long as the those requirements that meaningfully results from specific laboratories. The manufacturer has a high degree of enhance consumer safety in a way that commenter stated that we should clarify assurance that the products represented makes increased costs and use of to retailers that this redundant testing is by the samples are in compliance with resources worthwhile. not necessary. all applicable children’s product safety (Response 2)—This rule is being (Response 3)—The preamble to the rules. Further, while the final rule promulgated under the Administrative proposed rule stated that retailers and requires that manufacturers document Procedure Act and also section 3 of the sellers of children’s products can rely their compliance, it gives manufacturers CPSIA; neither authority requires us to on certificates provided by finished the flexibility to determine how to conduct a cost-benefit analysis. product certifiers—without conducting maintain this information. In addition, Moreover, by allowing in CPSIA additional testing themselves—if those the final rule does not require any expedited rulemaking, Congress made it certificates are based on testing documentation to be maintained in clear that it did not want the conducted by a CPSC-accepted third English or kept in the United States, Commission engaging in any party conformity assessment body (75 except the certificate. unnecessary delay in promulgating this FR at 28337). We also note that, on August 12, 2011, rule. However, we agree that the final B. Proposed Subpart A—General the President signed into law H.R. 2715, rule constitutes a major rule, as defined Provisions which amended the CPSIA in several by the Congressional Review Act of respects. One provision in H.R. 2715 1996. While, in recognition of 1. Proposed § 1107.1—Purpose requires us to seek public comment on Congress’s view as reflected in CPSIA, Proposed § 1107.1 would state that opportunities to reduce the cost of third we decline to conduct a cost-benefit party testing requirements consistent part 1107 establishes the requirements analysis for the final rule, we have for a reasonable testing program for non- with assuring compliance with any changed the final rule to address some applicable consumer product safety children’s products; third party of the economic burden on conformity assessment body testing to rule, ban, standard, or regulation. H.R. manufacturers. Among the changes 2715 directs us to seek public comment support certification and continuing made to the final rule to reduce the testing of children’s products; and on seven specific issues, including the burden are: (1) Reserving the subpart B extent to which modification of the labeling of consumer products to requirements regarding a reasonable certification requirements may have the indicate that the certification testing program; 2 (2) eliminating certain effect of reducing redundant third party requirements have been met pursuant to requirements of the proposed rule for testing by or on behalf of two or more sections 14(a)(1), and (a)(2), (d)(2)(B) of children’s products such as the remedial importers of a product that is the CPSA (15 U.S.C. 2063(a)(1), (a)(2), action plan; (3) reducing the substantially similar or identical in all (d)(2)(B)). recordkeeping requirements in several material respects, and other techniques We did not receive any comments on respects; and (4) allowing the use of in- for lowering the cost of third party this section. However, because we have house ISO/IEC 17025:2005 laboratories testing consistent with assuring decided to reserve subpart B, which to reduce the frequency of third party compliance with the applicable would pertain to the reasonable testing consumer product safety rules, bans, periodic testing. By way of further program for non-children’s products, we standards, and regulations. Elsewhere in example, with regard to the reduction in have removed the reference to the this issue of the Federal Register, we the recordkeeping requirements, the ‘‘reasonable testing program for non- have published a notice seeking public final rule does not require records to be children’s products.’’ (We explain our comment on the issues in H.R. 2715. decision to reserve subpart B of the 2 It should be noted, however, that although we H.R. 2715 further requires us to review are not finalizing subpart B at this time, proposed rule in part B.2 of this the public comments and states that we manufacturers of non-children’s products that are preamble below.) may prescribe new or revised third subject to a product safety rule, ban, standard, or Additionally, because H.R. 2715 party testing regulations if we determine regulation are still obligated by the CPSA, as revised section 14(i)(2)(B)(ii) of the amended by the CPSIA, to certify that their that such regulations will reduce third products comply with all applicable safety rule[s] CPSA to refer to testing of party testing costs consistent with based on a test of each product or a reasonable ‘‘representative’’ rather than ‘‘random’’ assuring compliance with the applicable testing program. samples, we have, on our own initiative,

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elected to simplify § 1107.1 to reflect the list of the raw materials, subassemblies, manufacture can serve as a basis for final rule’s narrower purpose and have intermediate assemblies, subcomponent determining what steps are necessary to made minor, non-substantive changes to parts, component parts, and the achieve a high degree of assurance that follow the language of the statute. This quantities of each needed to their products comply with the helps clarify which requirements in the manufacture a finished product. applicable product safety rules. Based statute this final rule is intended to We received no comments on this on that knowledge, manufacturers are address and which have been reserved definition. However, because the term uniquely situated to know what actions for a later date. Additionally, proposed ‘‘detailed bill of materials’’ appeared are necessary to exercise due care and § 1107.1 was silent regarding procedures only in proposed § 1107.10(b)(1) (which demonstrate a high degree of assurance to safeguard against the exercise of would require a product specification as regarding their specific circumstances. undue influence by a manufacturer on part of the reasonable testing program), On our own initiative, we have a third party conformity assessment and because the final rule now reserves revised the definition of ‘‘due care’’ in body, even though proposed § 1107.24, subpart B, we have removed the the final rule. The final rule’s definition ‘‘Undue influence,’’ would contain such definition of ‘‘detailed bill of materials’’ of ‘‘due care’’ includes a sentence safeguards. Consequently, the final rule from the final rule. stating that ‘‘Due care does not permit willful ignorance.’’ This is not intended now mentions the establishment of e. Due Care procedures to safeguard against the to be a substantive change because any exercise of undue influence by a Proposed § 1107.2 would define ‘‘due party who is willfully ignorant of manufacturer on a third party care’’ to mean the degree of care that a material facts, by definition, would not conformity assessment body. Thus, prudent and competent person engaged be exercising due care. However, the § 1107.1 now states that the part in the same line of business or endeavor Commission wants to emphasize in the would exercise under similar establishes the protocols and standards final rule that a party cannot purposely circumstances. for ensuring continued testing of avoid knowing their business partner’s (Comment 4)—One commenter noted children’s products periodically and testing and certification practices to that the due care requirement only avoid violating section 19 of the CPSA. when there has been a material change applies to a few specific provisions of in the product’s design or A party will not be shielded from the proposed rule, such as proposed violating section 19 of the CPSA when manufacturing process and safeguarding § 1107.23(a) regarding ‘‘material against the exercise of undue influence that party knows or should know about change’’ in the product’s design, testing and/or certification problems by a manufacturer on a third party manufacturing process, or sourcing of conformity assessment body. It also which may affect the ability of a component parts. In some instances, consumer product to be compliant with establishes a program for labeling of this defined duty of ‘‘due care’’ would consumer products to indicate that the all rules, bans, standards, or regulations. be coupled with a CPSC-created Certifiers and testing parties have an certification requirements have been standard of ‘‘high degree of assurance.’’ met pursuant to sections 14(a)(2) and obligation to resolve known or The commenter appreciated our knowable problems with testing and/or (i)(2)(B) of the Consumer Product Safety recognition that both the ‘‘due care’’ Act (CPSA) (15 U.S.C. 2063(a)(2) and certification before relying upon or standard of conduct and the ‘‘high passing on test reports or certifications. (i)(2)(B)). degree of assurance’’ standard for f. High Degree of Assurance 2. Proposed § 1107.2—Definitions compliance are anchored in the judgment and knowledge of the Proposed § 1107.2 would define ‘‘high Proposed § 1107.2 would define manufacturer. For that reason, the degree of assurance’’ as ‘‘an evidence- various terms used in the rule. commenter felt that the due care based demonstration of consistent a. CPSA requirement should have general performance of a product regarding Proposed § 1107.2 would define applicability to all elements of compliance based on knowledge of a ‘‘CPSA’’ to mean the Consumer Product compliance for implementation of the product and its manufacture.’’ Safety Act. CPSIA’s testing and certification (Comment 5)—Multiple commenters We received no comments on this requirements. The commenter stated questioned the definition of a ‘‘high definition and have finalized it without that manufacturers should not have to degree of assurance.’’ One commenter change. wonder whether more than their would like the rule to define the term exercise of reasonable judgment and ‘‘high degree of assurance’’ in a more b. CPSC practice, based on their manufacturing understandable or quantitative way. The Proposed § 1107.2 would define experience and sound knowledge of the commenter considered the term to be ‘‘CPSC’’ to mean the Consumer Product product, is required for aspects of the confusing and misleading and believed Safety Commission. rules that do not explicitly reference this could lead to unnecessary conflicts We received no comments on this these standards. between manufacturers and conformity definition and have finalized it without (Response 4)—The definition of ‘‘due assessment bodies when a judgment has change. care’’ in § 1107.2 refers to the actions of to be made in certain cases. The a prudent and competent person. We commenter wondered if this c. CPSIA expect that all parties will exercise requirement is targeting the design area, Proposed § 1107.2 would define prudence and competence in the testing manufacturing process control, quality ‘‘CPSIA’’ to mean the Consumer Product and certification of products. The final control, or testing procedures. Safety Improvement Act of 2008. rule emphasizes due care in particular Another commenter said that We received no comments on this sections, as noted by the commenter, manufacturers would benefit from definition and have finalized it without because these are areas that require additional guidance on how to achieve change. additional care in order to prevent a ‘‘high degree of assurance’’ through noncompliant products from being their testing programs. The preamble to d. Detailed Bill of Materials produced and certified. the proposed rule referred to a 95 Proposed § 1107.2 would define We recognize that manufacturers’ percent statistical significance level as ‘‘detailed bill of materials’’ to mean a knowledge of their products and their constituting a ‘‘high degree’’ of

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assurance, but the proposed rule would demonstrate a ‘‘high degree of GMP-based programs are industry- not mandate a 95 percent confidence assurance.’’ specific, we disagree with the threshold. The commenter asked what As for the commenter asking us to commenter’s assertion that the programs factors would permit a manufacturer to clarify that testing to applicable are preferable to other accepted process satisfy the ‘‘high degree of assurance’’ standards is required, § 1107.20 (a) of controls in all manufacturing situations. requirement with a statistical the final rule states that manufacturers The final rule defines a ‘‘high degree significance level below 95 percent and must submit samples of a children’s of assurance’’ in general terms because asked us to provide an example of a product to a third party conformity the definition is intended to be applied situation where a manufacturer could assessment body for testing. We believe to a wide variety of products that use still achieve a high degree of assurance these statements are clear enough to many different manufacturing with less than 95 percent assurance. convey that certification testing involves processes. Customizing the definition of Another commenter argued that the tests. ‘‘high degree of assurance’’ to fit one (Comment 6)—Two commenters term ‘‘high degree of assurance’’ is type of product or GMP-based program agreed that a numerical target for subjective and subject to varied will necessarily increase the difficulty defining what constitutes a high degree interpretations. The commenter of manufacturers applying the definition of assurance—in the context of suggested that a statistical confidence to dissimilar products or manufacturing limit would help remove the programs based on good manufacturing practices (GMP)—is misplaced. One processes. Further, because GMP-based subjectivity and set a specific threshold programs vary across industries—and by which we can enforce our rules commenter noted that the explanation of the definition of ‘‘high degree of the comments were not specific about better. The commenter also was which aspect(s) of a GMP program we concerned that the wording may lead assurance’’ provided in the preamble to the proposed rule (75 FR at 28344) should adopt, or which GMPs we some manufacturers to believe that they implies that we prefer the 95 percent should adopt—we cannot revise the do not have to test to the standard in all statistical level of confidence for a high- definition, as requested by the cases, as long as they foresee little risk degree-of-assurance approach and commenter. of noncompliance, or assume that the consider it the default. The commenter As for the commenter who interpreted risk is low of being discovered having is concerned that the 95-percent- the preamble to the proposed rule as noncompliant products in the confidence-level language may prompt expressing a preference for a 95 percent marketplace. The commenter said the third party conformity assessment confidence level, we do not consider a final rule should clarify that testing to bodies and retailers to adopt numerically based definition of a ‘‘high applicable standards is required. standardized testing protocols that degree of assurance’’ to be the default (Response 5)—The determination of a demand large sample sizes, which will position. Defining a ‘‘high degree of ‘‘high degree of assurance’’ for a given be a particular burden for the initial assurance’’ with respect to a 95 percent product will vary by industry, product, certification and may not be warranted probability or confidence level would be component part, and by manufacturer. in many cases. The commenter difficult to apply to all manufacturing Therefore, selecting an example using a expressed the belief that the goal, across processes for children’s products. hypothetical certifier would be of little a broad range of different products that Defining a ‘‘high degree of assurance’’ as value to manufacturers. We have are subject to different manufacturing a 95 percent, or higher, probability or intentionally defined the term in a requirements and material sourcing, confidence level could result in greater manner that allows the manufacturer must be a standard that correlates ‘‘a testing demands on small the flexibility to develop a testing high degree of assurance’’ with an manufacturers. As discussed in the program to ensure their product ‘‘evidence-based demonstration of preamble of the proposed rule (75 FR at complies with all applicable children’s consistent performance’’ that relies 28344), a statistical definition is not product safety rules. This rule provides more appropriately upon process needed in order to provide an evidence- broad protocols and standards for controls to assure conformance. The based high degree of assurance. regulated firms to follow and adapt to commenter indicated that, while Regarding the concern that conformity their particularized needs given their generally accepted process controls may assessment bodies and retailers may products and processes. The use of include statistical sampling as part of require large numbers of samples for quantitative values for the definition of process control programs, in and of certification testing, the children’s ‘‘high degree of assurance’’ could lead to themselves, they are not preferable to product certifier (not the conformity difficulties for some manufacturers. The good manufacturing practices. The assessment body or retailer) specifies preamble to the proposed rule stated: commenter said that the final rule must the number of samples to be tested. The ‘‘We decided against defining ‘high be clear in this regard. final rule requires the number of degree of assurance’ with respect to a 95 (Response 6)—Standards for GMPs are samples to be sufficient to give the percent probability or confidence level generally industry-specific in areas such certifier a high degree of assurance that because there may be difficulty in as: Cosmetics, pharmaceutical the tests conducted demonstrate applying the statistical methods to all operations, food handling, and medical accurately the ability of the product to manufacturing processes’’ (75 FR devices. It is unlikely that any GMP- comply with the applicable children’s 28344). The intent of the definition is to based program would be deemed product safety rules. As we previously enable a manufacturer to have a degree workable or acceptable for all children’s stated in the preamble to the proposed of confidence, based on evidence (rather product manufacturing methods. rule: than only on a belief) that all of the A certifier’s determination that a products manufactured are compliant product complies—with a high degree The Commission wants to emphasize to with the applicable product safety rules. of assurance—with the applicable retailers and sellers of children’s products Knowledge of a product’s design and children’s product safety rules, may that they can rely on certificates provided by how it is manufactured, control over derive from statistically based testing, product suppliers if those certificates are based on testing conducted by a third party component parts, and measurements the application of good manufacturing conformity assessment body. showing consistent performance, are practices, or other knowledge of the some elements that can be used to product and its manufacture. Because 75 FR at 28337.

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(Comment 7)—Two commenters determination of consistent performance they should not be included in the contended that the proposed definition of a product regarding compliance based definition of ‘‘a high degree of of a ‘‘high degree of assurance’’ lacks on knowledge of a product and its assurance.’’ Any such list necessarily clarity. Both commenters said that the manufacture. Acceptable determinations would be underinclusive or possibly rule should have additional examples of may be based on evidence derived confusing or misleading. Additionally, what constitutes ‘‘a high degree of through any appropriate tool or control certification and periodic testing of assurance.’’ One commenter methodology (or combination of tools children’s products must be based on acknowledged that the discussion in the and/or control methodologies), such as tests of the finished product, or its preamble to the proposed rule makes but not limited to: component parts, sufficient to show clear that the definition mandates no • Design Validation compliance (or continuing compliance, • specific formula (75 FR at 28344). Process Validation in the case of periodic testing) with all • However, the commenter noted that the Manufacturing Process Control applicable children’s product safety Audits preamble to the proposed rule gave no • rules. A definition of a ‘‘high degree of specific examples, other than the use of Raw material validation and assurance,’’ that includes methods other statistical methods. The commenter controls than testing, might lead some certifiers • In-process manufacturing controls, argued that the final rule should to conclude mistakenly that certification recognize other means of achieving this measurements, and tests • Component and material testing as or periodic test requirements might be confidence level, including ways that do defined at 16 CFR part 1109 met by means other than testing. not rely solely on product testing or • Finished Product Testing’’ (Comment 8)—One commenter statistical methods. These methods (Response 7)—The commenters are suggested that the final rule allow a include appropriate quality assurance correct that certifiers can use process company’s prior safety record to replace processes and risk management. Quality controls, mathematical techniques, product safety testing as evidence that a assurance processes can include: simulations, and other aspects of a company has met the requirement for a Factory/supplier evaluations, design product and its manufacture, as part of high degree of assurance (‘‘HDA’’). The reviews, manufacturing process the basis for determining whether a commenter wrote: controls, process auditing, or similar particular product complies with the The ‘‘high degree of assurance’’ should be controls or reviews. Risk management applicable product safety rules with a based on an overall assessment of the safety includes: Analysis of a given possible high degree of assurance. The record of the company. It should NOT be failure, the likelihood of the failure, and commenters also are correct that the based on the results of an individual product, even if recalled or deemed dangerous. the potential consequences associated preamble to the proposed rule (75 FR at with the failure. The commenter argued 28344) provided statistically based The commenter pointed out that its that importers can use these activities to examples in the definition of a ‘‘high company had a very good safety record. boost desired outcomes and reduce degree of assurance.’’ However, a The commenter added: unexpected outcomes; and the method on the commenters’ list may be With this record over so many years, our commenter further maintained that the adequate for one rule, but inadequate for company should be deemed to have satisfied activities can be performed in a another. As an example, Design this HDA requirement and be endorsed as feedback loop that facilitates true root- Validation may be a good technique to having a reasonable testing program without cause analysis and correction, if there is ensure that a toy does not have a hole further inquiry. a failure. large enough to allow access to a sharp (Response 8)—Section 14(a)(2) of the The commenters suggested substitute edge or point. However, Design CPSA makes clear that children’s definitions for ‘‘a high degree of Validation may be inadequate for product certification is based upon third assurance’’ that are practically identical. controlling lead content because its party testing of the product and not a One suggested definition reads: ‘‘A high techniques are ill-suited for controlling company’s safety record. For this degree of assurance means an evidence- continuing production of component reason, the final rule does not provide based determination of consistent parts. As another example, component relief from the testing requirements in performance of a product regarding part testing is a useful technique for the statute. In addition, the commenter’s compliance based on knowledge of a determining the chemical content of suggestion that a manufacturer should product and its manufacture.’’ lead and the prohibited phthalates, but be allowed to rely upon its prior safety Acceptable evidence-based it is inadequate for determining record to demonstrate a high degree of determinations may be based on compliance to the pacifier pull tests assurance would be a difficult concept evidence derived through any because the entire product is required to to apply in practice because of the likely appropriate process or control or conduct the test. ‘‘A high degree of changes in any given manufacturer’s combination of processes and/or assurance’’ is defined in general terms safety record over time and potential controls, such as (but not limited to): because it is intended to be applied to disagreements as to whether a product • Design validation; • Manufacturing process control a wide variety of products that use caused a safety problem, whether the audits; many different manufacturing safety problem resulted from product • In-process manufacturing controls, processes. Providing a list of the misuse, and whether safety issues had measurements, and tests; intended applications as part of the to occur at a particular rate of frequency • Component and material testing, as definition would introduce the risk of a before testing was warranted. defined in 16 CFR part 1109; manufacturer applying techniques that (Comment 9)—One commenter stated • Finished product testing; are inappropriate for evaluating the that a ‘‘high degree of assurance’’ could • Raw materials certification; and applicable children’s product safety be provided best by using an accredited • Other controls or processes that rule. product certification program that meets provide information about the safety or Therefore, we decline to amend the the requirements of the International compliance of a product. definition of ‘‘a high degree of Standards Organization/International The other commenter’s suggested assurance,’’ as suggested by the Electrotechnical Commission (ISO/IEC) definition reads: ‘‘High degree of commenters. Specific examples are not Guide 65, General requirements for assurance means an evidence-based universally applicable; and therefore, bodies operating product certification

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systems, and the fundamentals of assurance.’’ The commenter expressed determine the best way to comply with System 5 product certification the belief that the testing program the testing requirements. requirements of ISO/IEC Guide 67, should be statistically based, such that The intent of the definition is for a Conformity assessment—Fundamentals a confidence level of 95 percent must be manufacturer to have a high degree of of product certification. achieved to indicate compliance. This assurance based upon evidence (rather (Response 9)—The various activities a requirement would eliminate the than only a belief) that all of the certification body undertakes, such as possibility of testing only a single products manufactured are compliant testing, conformity assessment, and sample to indicate compliance, the with the applicable safety rules. surveillance can be used to demonstrate commenter asserted. Knowledge of the product’s design and a high degree of assurance that a (Response 10)—In the preamble to the how the product is manufactured, product complies with the applicable proposed rule, under the response to control over component parts, product safety rules. However, the comments section, Additional Third measurements showing consistent or techniques used by certification bodies Party Testing Requirements for inconsistent performance, the associated are not the only means a manufacturer Children’s Products (75 FR at 28342), hazard, and many other elements such could use. Process control techniques, we stated the following: as these, can be used to determine the failure modes and effects analyses, and If a high degree of assurance is interpreted number of samples required for other quality assurance methods, to be a statistical likelihood of not producing certification and for the periodic testing depending upon the product under noncompliant products, the sample size for intervals, as noted in the final rule. consideration, could be as effective as periodic testing will depend upon the g. Identical in All Material Respects certification body methods. Because we number of samples that need to be tested to want to give certifiers the flexibility to provide that statistical assurance (italics Proposed § 1107.2 would define decide which methods apply best to added) * * * ‘‘identical in all material respects’’ to their particular products, we decline to The word ‘‘that’’ refers to ‘‘a high mean that there is no difference with define a ‘‘high degree of assurance’’ degree of assurance,’’ which appears at respect to compliance to the applicable using ISO/IEC Guide 65 and Guide 67 the beginning of the sentence. With rules between the samples and the requirements. A manufacturer who respect to the other alleged finished product. wishes to use those requirements to inconsistencies mentioned in the (Comment 11)—Several commenters ensure a high degree of assurance of comment, it is worth noting that the asked us to clarify the definition of compliance may do so. However, we preamble to the proposed rule uses the ‘‘identical in all material respects.’’ One reiterate that testing in support of phrase ‘‘high degree of assurance’’ 20 commenter said that the definition certification of a children’s product times; whereas, the codified text of the appears absolute in that it does not must be performed by a CPSC-accepted proposed rule does not use the term allow any ‘‘difference with respect to third party conformity assessment body ‘‘reasonable assurance’’ at all. The term compliance.’’ The commenter indicated whose scope of accreditation includes ‘‘reasonable assurance’’ appears only that such a definition would make the tests required for certification, and once in the preamble to the proposed testing requirements unnecessarily rigid certification of a product cannot be rule, in the introduction to the response and costly. delegated to another party, such as a to comments section titled, The Another commenter contended that certification body. Reasonable Testing Program, where it is the definition of ‘‘identical in all (Comment 10)—A commenter listed as one of the previous questions material respects’’ cannot be absolute. suggested that the language related to that we asked in the Federal Register One commenter would revise the periodic testing intervals and sample notice announcing the December 2009 definition to read: ‘‘ ‘Identical in all sizes is inconsistent in the preamble to public workshop. material respects’ means there is no the proposed rule. The commenter We also do not agree with the difference between the sample and the conceded that it is difficult to specify commenter that there should be a finished product that could affect the exact number of products that must specific probability level (i.e., 95 compliance to the applicable rules.’’ be tested in order to reach a high degree percent) in the definition of ‘‘a high Another commenter suggested revising of assurance that a product is compliant. degree of assurance.’’ As previously the definition of ‘‘identical in all The commenter noted that the response noted in the preamble to the proposed material respects’’ to mean ‘‘to a high to comments section of the preamble to rule (75 FR at 28344), ‘‘we decided degree of assurance, there is no the proposed rule titled, Additional against defining ‘high degree of difference between the samples and the Third Party Testing Requirements for assurance’ with respect to a 95 percent finished product that is material to Children’s Products, stated that ‘‘the probability or confidence level because compliance of the applicable rule.’’ One sample size for periodic testing will there may be difficulty in applying the commenter suggested that the definition depend upon the number of samples statistical methods to all manufacturing of ‘‘identical in all material respects’’ that need to be tested to provide that processes.’’ Many manufacturing should mean ‘‘a manufacturer possess statistical assurance’’ (75 FR at 28342). processes, such as low-volume and [sic] a reasonable belief that, there is no The commenter agreed with this continuous manufacturing, are ill-suited difference between the samples and the statement but noted the inconsistency to use a sampling technique for quality finished product is not materially between the language used in that control purposes. In addition, for small- compliant.’’ section and the language found in the volume manufacturers, the number of (Response 11)—We do not regard the response to comments section titled, samples required to achieve 95 percent definitions suggested by the The Reasonable Testing Program, which confidence could be excessive, even to commenters to be improvements of the specifies that the testing intervals must the point of requiring all of the products existing definition of ‘‘identical in all provide ‘‘reasonable assurance’’ that the manufactured to be tested. Because the material respects.’’ For example, product meets the requirements of the final rule’s testing requirements apply to defining ‘‘identical in all material applicable product safety rules (75 FR at a wide variety of products, respects’’ to mean ‘‘there is no 28338). The commenter noted that there manufacturers, and manufacturing difference between the sample and the is a difference between a ‘‘high degree processes, the rule must give finished product that could affect of assurance’’ and ‘‘reasonable manufacturers the flexibility to compliance to the applicable rules’’

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appears to be so similar to the proposed ‘‘materially compliant’’; the absence of (Comment 13)—Two commenters definition that adopting the such an explanation or interpretation noted that the proposed definition commenter’s suggested definition would would result in additional uncertainty includes ‘‘personnel used to create the not alter the rule. Samples used for in the definition. component parts and assemble a certification testing and the finished Nevertheless, on our own initiative, finished product.’’ The commenters product may be different—just not we have revised the definition of argued that this should not be construed different in any way that would affect ‘‘identical in all material respects’’ to to mean that any change in the the sample’s ability to demonstrate make minor clarifications to improve employees who are involved in the compliance of the finished product. The the definition’s accuracy and production of a part or product is definition of ‘‘identical in all material consistency with the statute. For equivalent to a change in the respects’’ is intended to emphasize that example, the proposed definition would manufacturing process. if anything other than the finished refer to ‘‘compliance to the applicable (Response 13)—Regarding the product is subjected to testing, then the rules;’’ the final definition now adds: commenters’ suggestion on the characteristics of that sample must be ‘‘bans, standards, or regulations’’ after definition of ‘‘manufacturing process,’’ identical to the testing of the finished ‘‘rules,’’ to be more consistent with the commenters may be confusing a product, insofar as complying with the section 14(f)(1) of the CPSA. We also change in the manufacturing process applicable product safety rule. have revised the phrase ‘‘between the with a material change that could affect Otherwise, the test may not indicate that samples and the finished product’’ to compliance to an applicable product the finished product, in fact, complies read: ‘‘between the samples to be tested safety rule. The commenters are partly with the applicable product safety rule. for compliance and the finished product correct that any change in personnel The second definition suggested for distributed in commerce,’’ to reflect involved with a manufacturing process ‘‘identical in all material respects’’ (‘‘To that, under the final rule, the items that does not necessarily constitute a a high degree of assurance, there is no must be ‘‘identical in all material material change with respect to the difference between the samples and the respects’’ are the samples that are to be product’s compliance. However, for finished product that is material to tested for compliance (as opposed to manufacturing processes that rely on compliance of the applicable rule’’) also samples that are tested for any other high levels of craftsmanship or technical does not emphasize adequately that the purpose) and the product that is expertise, such a personnel change finished product is what must comply actually distributed in commerce. could affect compliance and, therefore, with the applicable rules. In addition, (Comment 12)—One commenter might be considered a material change using the phrase ‘‘to a high degree of urged us to state that the phrase to the manufacturing process. assurance’’ in describing the similarity ‘‘identical in all material respects’’ is Therefore, we have finalized the (with respect to conformance to the intended to be consistent with the definition of ‘‘manufacturing process’’ applicable rules), results in some doubt ‘‘objectively reasonable basis’’ standard without change. that the samples, in fact, are ‘‘identical from 16 CFR part 1633, and that we j. Production Testing Plan in all material respects.’’ Further, would consider individual subordinate § 1107.20(a) of the final rule states that mattresses that meet the requirements of Proposed § 1107.2 would define manufacturers must submit a sufficient 16 CFR 1633 to be ‘‘identical in all ‘‘production testing plan’’ as ‘‘a number of samples of a children’s material respects’’ to the qualified document that shows what tests must be product, or samples that are identical in prototype to which a specific mattress is performed and the frequency at which all material respects to the children’s subordinate. those tests must be performed to product, to a third party conformity (Response 12)—We agree with the provide a high degree of assurance that assessment body for testing to support commenter that ‘‘identical in all the products manufactured after certification. The number of samples material respects’’ is consistent with a certification continue to meet all the selected must provide a high degree of demonstration on an ‘‘objectively applicable safety rules.’’ assurance that the tests conducted for reasonable basis,’’ as stated in 16 CFR We received no comments on this certification purposes accurately §thnsp;1633.4(b)(3). We consider definition, but, on our own initiative, demonstrate the ability of the children’s individual subordinate mattresses that we have chosen to remove it from the product to meet all applicable children’s meet the requirements of 16 CFR part final rule. We have removed the product safety rules. Using a ‘‘high 1633 to be ‘‘identical in all material definition because it is duplicative of degree of assurance’’ in the definition of respects’’ to the qualified prototype to the description and requirements of ‘‘a ‘‘samples’’ would involve a double use which a specific mattress is subordinate. production testing plan’’ in of the term with no corresponding § 1107.21(c)(2) of the final rule. increase in clarity. h. Manufacturer k. Third Party Conformity Assessment In a similar manner, the third Proposed § 1107.2 would define Body definition suggested for ‘‘identical in all ‘‘manufacturer’’ as ‘‘the parties material respects,’’ which uses the responsible for certification of a Proposed § 1107.2 would define phrase ‘‘a reasonable belief,’’ introduces consumer product pursuant to 16 CFR ‘‘third party conformity assessment doubt that the samples are identical to part 1110.’’ body’’ to mean a third party conformity the finished product with respect to We received no comments on this assessment body recognized by the compliance. Additionally, ‘‘a reasonable definition and have finalized it without CPSC to conduct certification testing on belief’’ standard in the definition would change. children’s products. result in an inquiry into the state of We received no comments on this mind of a particular manufacturer and i. Manufacturing Process definition. However, on our own could lead to disagreements between the Proposed § 1107.2 would define initiative, we have revised the definition CPSC and manufacturers over whether a ‘‘manufacturing process’’ as ‘‘the by making editorial changes to describe manufacturer’s belief was ‘‘reasonable’’ techniques, fixtures, tools, materials, more accurately our accreditation in a specific instance. Further, the and personnel used to create the process and to indicate that the third commenter did not explain or clarify component parts and assemble a party conformity assessment body’s their interpretation of the phrase finished product.’’ scope of accreditation must include the

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applicable CPSC-required tests. Thus, under section 14(a)(1) of the CPSA to manufacturers of various sizes and the final rule now defines ‘‘third party certify based on tests of their products different manufacturing processes, the conformity assessment body’’ as ‘‘a or based on reasonable testing programs rule must be flexible enough to allow testing laboratory whose accreditation that their products comply with all the manufacturer to determine the best has been accepted by the CPSC to rules, bans, standards, or regulations way to comply with the rule’s conduct certification testing on applicable to such products. requirements. We are aware of children’s products. Only third party D. Proposed Subpart C—Certification of numerous ‘‘upstream’’ quality assurance conformity assessment bodies whose Children’s Products tools and processes that are widely used scope of accreditation includes the to ensure high levels of product applicable required tests can be used for Proposed subpart C would contain the performance. For example, techniques children’s product certification or requirements for the certification of such as component part testing are periodic testing purposes.’’ children’s products. The proposed particularly well-suited for determining subpart C would consist of seven C. Proposed Subpart B—Reasonable compliance with the lead content limits sections and would implement most for accessible parts on children’s Testing Program for Non-Children’s requirements in section 14(i)(2)(B) of the Products products. Numerous international CPSA. standards address quality control and Proposed subpart B would consist of 1. General Comments assurance processes applied ‘‘upstream’’ one provision and would describe the in the product production process and Several commenters raised issues ‘‘reasonable testing program’’ for non- can be used to extend the maximum with respect to proposed subpart C children’s products. For example, periodic testing interval. Thus, we generally, or on general concepts, such proposed § 1107.10(a) would explain disagree with the commenter that none that, except as otherwise provided by a as testing. (Comment 14)—One commenter of these quality assurance tools and specific CPSC regulation or a specific processes is rigorous or specific enough standard prescribed by law, a argued that the terms ‘‘reasonable assurance’’ and ‘‘sufficient number of to ensure compliance. manufacturer certifying a product (Comment 15)—One commenter samples’’ are likely to result in widely pursuant to a reasonable testing program recommended a system of product risk disparate interpretations. The must ensure that the program ‘‘provides assessment that would tailor the third commenter urged that ‘‘reasonable a high degree of assurance that the party certification schedule for low- assurance’’ should be defined as a consumer products covered by the volume firms, as follows: program will comply with all applicable statistically significant number with a rules, bans, standards, or regulations.’’ confidence level of 95 percent, based on Children’s products: High-risk children’s Proposed § 1107.10(b) would state that a testing enough samples to provide products would require third party reasonable testing program must consist statistical validity. The commenter said certification annually. Low-risk children’s that setting a specific confidence limit products would require third party of five elements: (1) Product certification every three years. specification; (2) certification tests; (3) a would enable us to enforce this section production testing plan; (4) a remedial by avoiding subjectivity and by creating The commenter said that any test action plan; and (5) recordkeeping. The uniformity and consistency among failure automatically would move the proposal would describe, in greater manufacturers and conformity product into the next most stringent detail, the requirements for each assessment bodies. category. This system would focus the element of the reasonable testing The commenter noted that inspection of products on products that program. ‘‘upstream’’ controls (i.e., processes, are the most dangerous to public safety. We received many comments on inspections, and tests conducted prior The commenter stated that an proposed subpart B. The comments to or during product assembly intended unintended consequence of this strategy addressed issues regarding the proposed to assure product quality), product risk would be to reward firms that make the provisions of a reasonable testing assessments, and design analyses are safest products. program on topics such as: product reasonable tools for manufacturers to (Response 15)—The commenter specifications, certification tests, use but currently are not rigorous or appears to be applying the proposed samples for certification testing, specific enough to ensure low-volume exception to periodic production testing, remedial action, and ‘‘downstream’’ compliance. Until they testing (stated in proposed § 1107.21(d)) recordkeeping. The commenters raised are, compliance must be determined by to certification testing. The low-volume many concerns about the cost and final product testing, the commenter exception did not apply to certification burden of the proposal as well as asserted. testing. There is no schedule for any practical issues, which illustrates the (Response 14)—We decline to adopt manufacturer for when a product is difficulty of drafting a regulation that the suggestion to set a 95 percent subject to certification testing, can apply to many different types of confidence level based on testing regardless of production volume. products and manufacturing processes, enough samples to provide statistical Instead, periodic testing is required for yet still provide sufficient guidance to validity. Many manufacturing processes, children’s products to ensure continued enable manufacturers to implement the such as those using continuous flow compliance with a high degree of requirements of a reasonable testing processes, are ill-suited to use a assurance. program effectively. Consequently, we sampling technique for quality control Section 14(a)(2) of the CPSA requires are deferring action with respect to purposes. In addition, for small-volume certification testing for children’s finalizing subpart B. We will reserve manufacturers, the number of samples products before they may be imported subpart B in the final rule and, except required to achieve 95 percent for consumption or warehousing or as stated otherwise in this preamble, confidence could be excessive, even to distributed in commerce. This initial continue evaluating the issues raised in the point of requiring all of the products testing of children’s products does not the comments regarding a reasonable manufactured to be tested. depend on product risk. Continuing testing program. We note, however, that Because the final rule’s testing compliance is demonstrated through our deferral of action does not remove requirements apply to a wide variety of periodic testing for children’s products, the responsibility of manufacturers, children’s products, as well as to which specifies a maximum testing

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interval, based on the implementation of conformity assessment bodies as an with assuring compliance with any a periodic testing plan by the acceptable substitute for a certificate of applicable consumer product safety manufacturer. The final rule allows a conformity. The commenter added that rule, ban, standard, or regulation. manufacturer to consider risk to the introducing the new certificate of Elsewhere in this issue of the Federal extent it permits consideration of ‘‘the conformity will cause immediate Register, we have published a notice potential for serious injury or death confusion in the marketplace. The seeking public comment on the issues in resulting from a noncompliant product’’ commenter suggested that we should H.R. 2715. H.R. 2715 further requires us as a factor in determining the have to justify, through a to review the public comments and appropriate periodic testing interval comprehensive and independent study, states that we may prescribe new or under a periodic testing plan. why we are departing from the existing revised third party testing regulations if Regarding the commenter’s suggestion system and why our proposed system we determine that such regulations will of devising a system of categorizing all would be better and more reliable. reduce third party testing costs children’s and non-children’s products Another commenter stated that we consistent with assuring compliance subject to an applicable rule into risk should recognize certification marks with the applicable consumer product categories, such a system would require issued by established third party safety rules, bans, standards, and a separate rulemaking effort and is certification programs as a substitute for regulations. beyond the scope of this rule. the certificates of conformity described (Comment 18)—One commenter (Comment 16)—One commenter in the proposed rule when the product noted that a publisher of ordinary books noted that the proposed rule did not use has been certified as compliant with may have varying titles and content, but recognized industry terminology associated product standards through a all of the books are made of the same consistently. The commenter noted that program that reflects CPSA materials in the same manner. The the proposed rule relies on the terms requirements by an ISO/IEC Guide 65- commenter asserted that the differences ‘‘test’’ or ‘‘testing,’’ as if all consumer accredited certification body. between ordinary books are not material product safety requirements could be (Response 17)—Certification marks to compliance with the applicable rules. evaluated by performing tests to ensure are symbols that a manufacturer is Accordingly, the commenter said that ongoing compliance. The commenter authorized to affix to their product to having accredited third party noted that, while full product testing is indicate that the product has been conformity assessment body testing for appropriate in some cases, current certified by a certification body. Third a finished book would constitute consumer product safety regulations party certification involves testing, finished product testing for all other imply or specify evaluation activities, declarations of conformance, factory books (International Standard Book not considered to be actual testing (e.g., inspections, and continuing Numbers, or ISBNs) that do not inspections, reviews, audits), may be surveillance activities. The certification materially differ from the tested book appropriate. body attests that the product complies with respect to compliance with CPSC The commenter noted that it with the specified product safety rules safety standards. The commenter said a recommended previously that we refer that were evaluated. publisher with a reasonable testing to Annex A of ISO/IEC 17000, A certification mark does not contain program and a product without material Conformity assessment—Vocabulary the information required on a certificate changes could rely on the component and general principles, which provides by section 14(g) of the CPSA and cannot part certifications for all materials a general description of the functional be used as a substitute for a Children’s published within a 2-year period. approach to activities that constitute Product Certificate. Section 14(a)(2) of (Response 18)—Section 14(i)(5)(A)(i) conformity assessment, to address the the CPSA requires manufacturers of a of the CPSA, as amended by H.R. 2715, question of the interpretation of the use consumer product that is subject to an excludes ordinary books and ordinary of the terms ‘‘test’’ or ‘‘testing.’’ applicable children’s product safety rule paper-based printed materials from the (Response 16)—The word ‘‘test’’ was to issue a certificate certifying third party testing requirements in chosen because of its use in section conformance of the children’s product 14(a)(2) of the CPSA. Additionally, the 14(a) of the CPSA. ‘‘Certification tests’’ to the applicable children’s product final rule reserves subpart B, which are tests on samples of the product that safety rules. Section 14(a)(2) of the would pertain to a reasonable testing are identical in all material respects to CPSA does not allow a party other than program for non-children’s products. the finished product. Section 14(i) the manufacturer, importer, or private Therefore, it is unnecessary for us to (2)(B)(i) of the CPSA states that labeler to issue a Children’s Product consider how third party testing results children’s products are subject to testing Certificate. for a book might be extended to all other periodically and after a material change. Since the CPSIA was enacted in 2008, books. The words ‘‘test’’ and ‘‘testing’’ are we have not observed immediate (Comment 19)—One commenter used throughout the final rule to mean confusion in the marketplace regarding asserted that only good design and a process used to determine whether a certificates. As noted above, comprehensive design review by product is compliant with the certification marks cannot be used as a qualified individuals will improve the applicable product safety rules. The substitute for certificates if there is safety of products. Therefore, the process is geared to the particular confusion in the marketplace. Thus, commenter suggested that we require product and specific safety rule. As because section 14(a) of the CPSA ‘‘design hazard analysis’’ in the such, testing may include inspection of requires the manufacturer to issue a certification of children’s products labels and manuals, audits, and certificate of conformity, an section of the final rule. ‘‘Design hazard measurements to determine compliance independent study is not warranted. analysis,’’ according to the commenter, with the applicable product safety rules. Furthermore, on August 12, 2011, the identifies potential safety hazards in a We believe that the definition of ‘‘test’’ President signed into law H.R. 2715, consumer product that result from the and ‘‘testing’’ are clear. which amended the CPSIA in several design of the product. It involves (Comment 17)—One commenter respects. One provision in H.R. 2715 determinations made by skilled noted that we are not allowing the use requires us to seek public comment on professionals including engineers, of existing federally registered opportunities to reduce the cost of third chemists, and biologists about the certification marks of third party party testing requirements consistent features of a product that might result in

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safety hazards. The commenter asserted engage in such analyses when be delegated to another party, such as a that the CPSC has the legal authority to developing or manufacturing a product. certification body. require design hazard analysis of Further, as explained the section on The qualifications of testing consumer products. remedial action in part III.D.7. below, laboratories performing certification The commenter suggested the we have removed from the final rule, tests are outside the scope of this final following changes: the requirement for a remedial action rule. Such qualifications are addressed • In Subpart C, Certification of plan for children’s products. in the various notices of requirements Children’s Products, insert a new (Comment 20)—One commenter that we have published pursuant to subsection 1107.20(a), Children’s suggested that final testing and section 14(a)(3) of the CPSA. Product Certification. (Note: The certification should defer to the Finally, we acknowledge that the commenter may have meant to create a Occupational Safety and Health recently–enacted H.R. 2715 requires us new subsection (a) and renumber the Administration (OSHA)-designated to seek public comment on remaining subsections accordingly.) The Nationally Recognized Testing ‘‘opportunities to reduce the cost of new subsection would state: Laboratory (NRTL) certification program third part testing requirements Prior to submitting samples of a children’s by determining that such products, as consistent with assuring compliance product for testing by a third party they are manufactured and distributed with any applicable consumer product conformity assessment body, manufacturers for consumer use, are per se compliant safety rule, ban, standard, or must conduct a design hazard analysis and with the proposed testing and regulation.’’ One topic which H.R. 2715 produce a design appraisal of the product certification rules. The commenter said requires us to address pertains to ‘‘the that identifies and characterizes the potential we would still maintain our authority to extent to which evidence of conformity hazards associated with that consumer recall products, seek civil penalties, and with other national or international product that are related to the design of a other remedies available to the governmental standards may provide product. The design appraisal should Commission, if violations are found. assurance of conformity to consumer include, at a minimum, an engineering, (Response 20)—Pursuant to section chemical, and biological analysis of the product safety rules, bans, standards, or product, as appropriate to the type of product 14(a)(3)(C) of the CPSA, we have chosen regulations applicable under [the and the materials contained in the product. to designate accrediting bodies that are Consumer Product Safety Act].’’ • full-member signatories to the Elsewhere in this issue of the Federal Insert in § 1107.26(c), Remedial International Laboratory Accreditation Register, we have published a notice Action, after ‘‘* * * children’s product Cooperation—Mutual Recognition inviting public comment on the issues safety rules’’: Arrangement (ILAC–MRA) to conduct identified in H.R. 2715, so the If the manufacturer knows or reasonably third party testing. Given that children’s commenter’s argument would be more should know that the failure of the product products intended for the U.S. market appropriately raised and addressed in is related to the product’s design, the are manufactured in nations throughout that proceeding. We note, however, that manufacturer shall conduct a revised design the world, we decided to avoid very few products covered under the hazard review and produce a new design designating accreditation programs or OSHA–designated Nationally appraisal. entities that are recognized only in a Recognized Testing Laboratory (Response 19)—We agree that specific region, nation, or locality. The certification program would be designing safety into a children’s reasons for this are: (1) To keep the children’s products for which third product is an important part of a program as simple as possible for use by party testing would be required. comprehensive quality control program. manufacturers, private labelers, Moreover, those products that are We decline, however, the commenter’s importers, testing laboratories, and other subject to the OSHA certification suggestion to include in the final rule interested parties; (2) to establish program would likely be covered by requirements mandating design hazard uniform requirements regardless of CPSC regulations, if at all, for which the analyses for children’s products. The location; (3) to establish a program that only requirement is a General current rulemaking is intended to is manageable within agency resources; Conformity Certificate based on a implement the testing and certification and (4) to maintain a degree of reasonable testing program. OSHA requirements of section 14(a) and consistency in the procedures used by certification testing may be a sufficient section 14(i)(2)(B) of the CPSA. the designated accrediting bodies. basis for such certifications depending Requiring a design hazard analysis goes Moreover, the commenter appears to on the product and the type of testing beyond the statutory requirements misstate testing requirements. Consumer involved. Given that CPSC does not because such an analysis would products are not tested for whether they have jurisdiction over products when consider factors other than the factors are compliant with the testing and the risks of injury associated with the required to demonstrate compliance certification rules (i.e., parts 1107 and consumer product could be eliminated with the applicable product safety rules. 1109), rather, consumer products are or reduced to a sufficient extent by the This action would extend the final rule tested for compliance with the actions of OSHA, there may be very to address activities that would occur applicable rules, bans, standards, and little overlap between a particular before a product is manufactured. regulations which the CPSC enforces. product’s results under OSHA’s testing Currently, given the range of products Moreover, section 14(i)(2)(B)(i) of the program and any CPSC required testing. that are subject to section 14 of the CPSA requires such testing periodically (Comment 21)—One commenter CPSA, we have no practical means of and when there has been a material suggested an evidenced-based approach identifying or evaluating individuals change. Therefore, continued testing is to certification, based on historical whose credentials and experience, required by the statute and ‘‘per se performance and risk for the product under the commenter’s suggested conformance’’ with the applicable type and manufacturing process. The changes, would render them qualified to product safety rules is not allowed. commenter suggested that an importer/ conduct design hazard analyses on Additionally, section 14(a) of the CPSA retailer may implement a program products. Although the final rule does requires manufacturers (including requiring: not require manufacturers to conduct a importers) to certify that their products • Sample testing using materially design hazard analysis on their comply with the applicable product identical components to be completed products, manufacturers are free to safety rules. This responsibility cannot before production begins;

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• Certification from samples selected requirements of §§ 1107.20 and 1107.21, suggested removing references to during the start of production; and then the requirements to demonstrate statistical sampling and the use of • Periodic testing as the item remains the product’s ability to meet all ANSI/ASQ Z1.4, Sampling Procedures in production. applicable children’s product safety and Tables for Inspection by Attributes At each of these stages, a rules and ensure that continuing and Z1.9, Sampling Procedures and representative set of samples would be production is compliant may be met in Tables for Inspection by Variables for pulled to cover all tests related to the this manner. If the manufacturer has a Percent Nonconforming, for determining applicable rules, bans, standards, and high degree of assurance of the the number of samples required for regulations. children’s product compliance, and the certification testing, production testing, The commenter suggested the production run does not extend beyond and periodic testing. The commenter following example: the maximum periodic testing interval, said the frequency of testing and the For a child’s solid rubber ball, more than then no third party periodic tests may number of samples tested should be set 10,000 finished products that are materially be required. However, no children’s or determined by retailers and identical could be made in less than one product may enter into commerce manufacturers to assure compliance manufacturing shift. In this scenario, it without a Children’s Product Certificate with all applicable rules, bans, would be appropriate to select samples when based on passing test results from a standards and regulations. The material changes occur and or meet CPSC-accepted third party conformity commenter stated that referencing the historically defined frequency intervals in assessment body certification. use of statistical sampling, confidence order to maintain and validate that products (Comment 22)—Some commenters meet all rules, bans, standards, and levels, and ANSI/ASQ Z1.4 & Z1.9 regulations. stated that the safety performance of a implies a very significant increase in the finished product may not be able to be number of samples required for product The commenter would like the CPSC based solely on the compliance of its testing. to acknowledge that for children’s component parts. The commenters (Response 23)—For manufacturers or products, samples selected from a lot of asserted that some requirements can be importers using tests on samples of a finished product over 10,000 pieces, but evaluated only with finished product product to ensure continued compliance produced in a short time period, may be samples. The commenters asked us to to the applicable product safety rules, used to satisfy certification testing and clarify which products and which the rule permits manufacturers or periodic testing requirements. regulations would be amenable to importers to determine the frequency of (Response 21)—Section 14(a)(2) of the component part testing. One commenter testing and the number of samples CPSA requires a manufacturer or suggested that electrical safety standards tested to ensure compliance. Retailers importer of a children’s product subject and regulations (i.e., fire and shock only have testing or certification to a children’s product safety rule to hazard testing) should not be allowed to obligations if they are importers. The submit sufficient samples of the rely solely on component part testing. commenter did not explain how children’s product, or samples that are (Response 22)—The commenters are removing references to quality identical in all material respects to the correct that some requirements can be management and control standards and product, to a third party conformity evaluated only with finished product sampling procedures, which are not assessment body whose accreditation samples, and not with tests on required, but may be used voluntarily has been accepted by us to be tested for component parts. However, both this by certifiers, would address the issue of compliance with the applicable final rule and the final rule on third party conformity assessment body children’s product safety rules. This Conditions and Requirements for testing capacity. However, the proposed requirement is also set forth in Relying on Component Part Testing or rule’s reference to ASNI/ASQ Z1.4 and § 1107.20(a) of the final rule. Thus, the Certification, or Another Party’s Z1.9 had the potential to mislead commenter’s first two suggestions—to Finished Product Testing or manufacturers because it would use the choose samples for testing using Certification, to Meet Requirements in term ‘‘Acceptable Quality Level (AQL).’’ materially identical components, and to Sections 14(a) and 14(i) of the An AQL can be interpreted as an select samples during the start of Consumer Product Safety Act (16 CFR acceptable percentage of nonconforming production, would likely fulfill the part 1109) contain restrictions on the products, which is not appropriate statutory requirement to submit samples use of component part testing. For when applied to the case of compliance that are identical in all material respects example, § 1107.20(c) of the final rule of products to health and safety to the product, for purposes of states that except where otherwise standards. Therefore, we have deleted certification testing. specified by a children’s product safety references to these standards in the final Section 14(i)(2)(B)(i) of the CPSA rule, component part testing pursuant to rule. requires, in part, that we establish 16 CFR part 1109 may be used to (Comment 24)—One commenter protocols and standards to ensure that a support the certification testing noted that the Labeling of Hazardous certified children’s product is tested for requirements of this section. The final Art Materials Act (LHAMA) established compliance periodically. Section rule for 16 CFR part 1109 states that if the requirements for the labeling of art 1107.21 of the final rule details periodic a certifier has doubts about whether materials in ASTM D–4236, which is testing requirements for children’s component part testing is sufficient to referenced in 16 CFR 1500.14(b)(8). The products. Accordingly, the commenter’s demonstrate compliance with all the commenter asked that we: (1) Clarify the suggestion regarding periodic testing is applicable rules, bans, standards, or meaning of this provision with respect required by the statute, and our regulations, those doubts should be to the certification of art materials under expectation with regard to periodic resolved in favor of testing the finished section 14 of the CPSA; and (2) state testing is articulated in the final rule. product. whether LHAMA is a labeling rule Regarding the commenter’s suggestion Therefore, the commenters’ concerns under the Federal Hazardous regarding short-period production runs are addressed by the requirements of the Substances Act (FHSA) that would not of children’s products, the same two rules. require testing and certification to samples may be used for certification (Comment 23)—One commenter LHAMA under the CPSA. The and periodic tests. If a testing plan is expressed concern about the final rule’s commenter further proposed the use of designed and implemented to meet the effect on laboratory testing capacity and existing facilities and procedures

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allowed for LHAMA to certify (Comment 25)—Multiple commenters seeking public comment on the issues in compliance with the CPSIA. noted that manufacturers have H.R. 2715. H.R. 2715 further requires us (Response 24)—LHAMA requires that established first party testing to review the public comments and the manufacturer, importer, or laboratories that are accredited to ISO/ states that we may prescribe new or repackager of art materials have a IEC 17025:2005(E) (more commonly revised third party testing regulations if product’s formulation reviewed by a known as ISO/IEC 17025:2005 and how we determine that such regulations will toxicologist for its potential to cause it will be referred to in the preamble), reduce third party testing costs, chronic adverse health effects. A General requirements for the consistent with assuring compliance conformance statement on the product competence of testing and calibration with the applicable consumer product is used to certify that the product has laboratories. The commenters suggested safety rules, bans, standards, and been so reviewed. However, section 101 that for manufacturers with such regulations. of the CPSIA introduces additional laboratories, we should allow test (Comment 26)—One commenter testing requirements for lead in results from those facilities to be used noted that carpets and rugs currently children’s products beyond what is for children’s product certification require flammability testing in required under LHAMA, so certification purposes. Many commenters suggested accordance with 16 CFR parts 1630 and of art materials under LHAMA is not that one half of the testing for 1631 and suggested that there is no need necessarily equivalent to testing for lead certification should be allowed at in- for an additional flammability testing pursuant to section 101 of the CPSIA house testing facilities; others procedure for youth carpets and rugs. and section 14 of the CPSA. recommended that the number of (Response 26)—Section 14(a)(2) of the Regarding whether LHAMA is a samples sent to third party conformity CPSA requires third party conformity labeling requirement under the FHSA assessment bodies for certification assessment body testing of children’s that would not require testing and purposes be reduced ‘‘to a minimum.’’ products (or samples that are identical certification, we note that LHAMA does Some commenters stated that we should in all material respects) subject to a not contain a performance standard recognize internal laboratories as a way children’s product safety rule for initial similar to those in consumer product to reduce dependence on third party certification purposes. Further, section safety rules but rather, requires labeling conformity assessment bodies. The 14(f)(1) of the CPSA defines a in the form of a conformance statement reasons for the suggestions include: A ‘‘children’s product safety rule’’ as a that the product formulation has been desire to reduce testing costs, to consumer product safety rule enforced reviewed by a toxicologist. The encourage other manufacturers to by the Commission. Section 3(a)(2) of requirements of LHAMA are similar to develop their own internal testing the CPSA defines a ‘‘children’s product’’ the labeling requirements of the FHSA, facilities, and to promote continuous as a consumer product designed or of which LHAMA is a part. Therefore, product improvements. intended primarily for children 12 years third party testing for conformance to (Response 25)—Section 14(a)(2) of the of age or younger. Thus, because youth LHAMA is not required. Art materials CPSA explicitly requires that testing of carpets and rugs are children’s products designed or intended primarily for children’s products be conducted by a and are subject to the consumer product children 12 years of age or younger third party conformity assessment body safety rules 16 CFR parts 1630 and 1631, would have to be tested by a CPSC- as a condition of certification. Further, third party testing is required. accepted third party conformity third party conformity assessment For these reasons, initial certification assessment body to demonstrate bodies must have a CPSC-accepted testing for youth carpets and rugs must compliance with the lead content limits, accreditation for the scope of the testing be performed by a CPSC-accepted third but they would not require third party undertaken in support of product party conformity assessment body testing and certification to the LHAMA certification. Unless the manufacturer’s whose accreditation includes the scope requirements. laboratory is a CPSC-accepted firewalled of the tests. Second, children’s products Regarding using facilities for LHAMA conformity assessment body, first party are subject to requirements for periodic to certify to CPSIA requirements, testing facilities, regardless of ISO/IEC testing, material changes, undue section 14(f)(2)(C) of the CPSA states 17025:2005 accreditation status, cannot influence, and recordkeeping in subpart that a certifying organization, as defined be used for children’s product C of the final rule. The test methods in in appendix A to 16 CFR 1500.14(b)(8), certification purposes. 16 CFR parts 1630 and 1631 are still ‘‘meets the requirements’’ for We note that, in response to these applicable. consideration as a third party comments and concerns raised about (Comment 27)—One commenter conformity assessment body ‘‘with cost, § 1107.21(d) of the final rule allows stated that the statutory requirements respect to the certification of art manufacturers using in-house testing for certificates in section 14(a) of the materials and art products required laboratories accredited to ISO/IEC CPSA impose strict and detailed under this section or by regulations 17025:2005 to ensure continued requirements for the contents and prescribed under the Federal Hazardous compliance, to conduct periodic testing availability of certificates of conformity Substances Act.’’ Thus, an organization at a maximum testing interval of three that document compliance of a that is a certifying organization with years. children’s product as demonstrated respect to LHAMA is a third party We further note that on August 12, through test results. A certificate based conformity assessment body and may 2011, the President signed into law H.R. on accredited third party conformity test children’s art materials and art 2715, which amended the CPSIA in assessment body testing must be issued products for compliance with LHAMA. several respects. One provision in H.R. by the manufacturer and private labeler Thus, insofar as certifying organizations 2715 requires us to seek public of any children’s product that is subject and LHAMA are concerned, no changes comment on opportunities to reduce the to a CPSC rule, and it must comply not to the proposed rule are necessary. cost of third party testing requirements, only with the requirements of section Accreditation requirements for testing consistent with assuring compliance 14(g) of CPSA, but also with the for compliance with the CPSIA, other with any applicable consumer product requirements of a finished product than LHAMA, are beyond the scope of safety rule, ban, standard, or regulation. certifier’s reliance on component this rulemaking and may be addressed Elsewhere in this issue of the Federal materials testing certification. Thus, a in a separate rulemaking. Register, we have published a notice finished product certifier could rely on

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a test report showing passing test results the proposed rule under-recognizes the number of samples of a children’s for one or more component materials in-house quality assurance and testing product, or samples that are identical in used in the product, based upon capabilities of manufacturers. all material respects to the children’s accredited third party conformity (Response 28)—We are aware of many product, to a third party conformity assessment body testing conducted by effective quality assurance techniques assessment body for testing to support another person. that are widely used to control quality certification. The proposal would The commenter stated that including in product manufacturing. However, require that the number of samples this information in the certificate section 14(a)(2) of the CPSA requires selected provide a high degree of accompanying the finished children’s third party conformity assessment body assurance that the tests conducted for product would create logistical testing of children’s products for initial certification purposes accurately nightmares for the manufacturers and certification. Unless the manufacturer’s demonstrate the ability of the children’s private labelers of children’s products. in-house testing facility is a CPSC- product to meet all applicable children’s The commenter did not object to the accepted firewalled conformity product safety rules. ‘‘recordkeeping’’ requirements in assessment body, data from those (Comment 29)—Two commenters proposed § 1107.26; however, the facilities cannot be used for children’s wanted more detail on what is meant by commenter urged us to note that product certification purposes. No ‘‘a sufficient number of samples.’’ The compliance with these requirements exclusion is included in the statute for commenters expressed concern that, if should make it unnecessary for the first party certification or periodic the number is left to conformity manufacturer or private labeler of the testing of children’s products based on assessment bodies, there will be too finished children’s product, to ensure the costs of testing. much variability among conformity that every certificate required under In response to these comments, and in assessment bodies about what is a section 14 of the CPSA accompanies the response to concerns about the cost of sufficient number. product or shipment of products, is third party testing, § 1107.21(d) of the (Response 29)—A ‘‘sufficient number furnished to each distributor or retailer final rule allows manufacturers who are of samples’’ are the number of samples of the product. implementing a production testing plan necessary to give the manufacturer or The commenter also urged us to adopt to ensure the compliance of continuing importer a high degree of assurance of certificate requirements that reflect the production, to conduct third party the product’s compliance with the key concept in the tracking label periodic testing at a maximum testing applicable rules when tested. Because a provisions, which require that the interval of two years. Further, the final high degree of assurance is based upon manufacturer (as well as the ‘‘ultimate rule allows manufacturers using in- the manufacturer’s or importer’s purchaser’’) of the finished children’s house testing laboratories accredited to knowledge of the product and its product be able to ‘‘ascertain’’ certain ISO/IEC 17025:2005 to ensure manufacture, a sufficient number of information similar to what is required continued compliance by conducting samples will vary based on those for certificates of conformity. The third party periodic testing at a factors. For example, for products with commenter suggested that certificates, maximum testing interval of three years. highly consistent part-to-part like ‘‘tracking labels,’’ for children’s We believe this balances the desire for manufacturing processes (e.g., die products under section 103 of CPSIA, unbiased objective test results with the casting), fewer samples may be necessary to give the manufacturer/ could be mandated to use codes or other cost concerns expressed in the means to point all interested parties to importer a high degree of assurance of comments. compliance. For processes with more a source where such information readily Additionally, on August 12, 2011, the can be found. This code could be variability (such as hand assembly), it is President signed into law H.R. 2715, contact information, where the likely that more samples will be which amended the CPSIA in several manufacturer or private labeler could necessary to achieve the same high respects. One provision in H.R. 2715 include an Internet URL for the degree of assurance. requires the CPSC to seek public manufacturer’s Web site, where the The commenters also may have comment on opportunities to reduce the information could be accessed. misunderstood the role of conformity (Response 27)—Section 14(g)(1) of the cost of third party testing requirements assessment bodies in the testing and CPSA and 16 CFR 1110.11 require consistent with assuring compliance certification requirements of the rule. specific information on each certificate. with any applicable consumer product The conformity assessment body does In addition, section 14(g)(3) of the CPSA safety rule, ban, standard, or regulation. not specify the number of samples to be states that the required certificate shall Elsewhere in this issue of the Federal tested. The manufacturer or importer accompany the applicable product or Register, we have published a notice specifies to the conformity assessment shipment of products covered by the seeking public comment on the issues in body the number of samples to be same certificate and a copy of the H.R. 2715. H.R. 2715 further requires us tested. certificate shall be furnished to each to review the public comments and Finally, on our own initiative, we distributor or retailer of the product. states that we may prescribe new or revised the second sentence to say that However, 16 CFR 1110.9 allows a revised third party testing regulations if the number of samples selected must manufacturer to file certificates we determine that such regulations will ‘‘be sufficient to’’ provide a high degree electronically by providing an Internet reduce third party testing costs of assurance. We added this language to URL for the manufacturer’s Web site, consistent with assuring compliance be consistent with the requirement to where the information could be with the applicable consumer product ‘‘submit a sufficient number of samples’’ accessed, as the commenter suggested. safety rules, bans, standards, and language in the first sentence of the We note that the listing of component regulations. section. This change is also consistent parts or component part test results does 2. Proposed § 1107.20—General with section 14(a)(2)(A) of the CPSA, not have to be included on the finished Requirements which requires a manufacturer to product certificate. ‘‘submit sufficient samples of the a. The Number of Samples (Comment 28)—Multiple commenters children’s product’’ for testing. mentioned the high costs associated Proposed § 1107.20(a) would require (Comment 30)—One commenter with third party testing and noted that manufacturers to submit a sufficient stated that the language covering

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samples needs to be clarified. The with bicycle helmets. The commenter compliance with the applicable commenter stated that the proposal expressed the belief that this is the kind children’s product safety rules may be would require testing with a ‘‘sufficient of evidence-based decision making we greater, or fewer, than 12. number of samples’’ to provide a ‘‘high envisioned in rejecting a single The commenter may be degree of assurance’’ (for minimum definition of ‘‘high degree of assurance’’ misunderstanding the rule as it relates certification testing), while maintaining within a reasonable testing program for to random samples. In proposed that the sampling does not have to meet non-children’s products. § 1107.22, the testing of random samples minimum standards of statistical (Response 30)—Although subpart B, was required only during periodic tests confidence. However, the commenter describing a reasonable testing program, of children’s products subject to an noted that the comments accompanying has been reserved in the final rule, the applicable children’s product safety the proposed rule recognize that ‘‘there concept of certification testing and rule. Pursuant to H.R. 2715, the testing may be difficulty in applying statistical testing a sufficient number of samples to of ‘‘random samples’’ to ensure methods to all manufacturing provide a high degree of assurance of continued compliance has been processes.’’ compliance with applicable rules, bans, replaced with testing of ‘‘representative The commenter further stated that if standards, and regulations remains in samples’’ to ensure continued testing a ‘‘sufficient number of samples the final rule with regard to children’s compliance. Given the change in the to provide a high degree of assurance’’ products in § 1107.20(a). We disagree statute, we have decided to remove is required when applying a reasonable with the commenter’s assertion that § 1107.22 in the final rule. Regardless, testing program to children’s products, ‘‘testing with a sufficient number of certification testing in the proposed rule then we should provide guidance on samples to provide a high degree of never required the selection of random alternatives that certifiers may use to assurance’’ requires the testing method samples for children’s products. fulfill the duty to justify their plan, were to meet minimum standards of For children’s products, section they to choose anything less than a statistical confidence. In the preamble to 14(a)(2)(A) of the CPSA requires that random statistical sample. The the proposed rule (75 FR at 28344), the every manufacturer or private labeler of commenter noted that historically, we discussion of a high degree of assurance a children’s product: have relied on a sample of 12 or fewer intentionally avoided choosing a units, without regard to the size of the statistically based definition for the Submit sufficient samples of the children’s production run and that certain term. Therefore, the certifier is allowed product, or samples that are identical in all material respects to the product, to a third statistical models used by auditors to choose other means, using its party conformity assessment body accredited impose a maximum sample of 25 units, knowledge of the product and how it is * * * to be tested for compliance with such no matter the size of the cohort from manufactured, to determine what would children’s product safety rule. which the samples are selected. be a sufficient number of samples. A Based on these points, the commenter certifier may use statistical methods, but Therefore, the statute requires recommended that we delete the the determination of a sufficient number children’s products to be tested before requirement to test a ‘‘sufficient number of samples to achieve a high degree of they can be certified, and the statutory of samples to provide a high degree of assurance is not required to be requirement for third party periodic assurance’’ under a reasonable testing statistically based. testing applies. program. The commenter said that the We decline to provide guidance on We agree that there are instances in premise of a ‘‘reasonable testing alternatives that certifiers may use to which it may be preferable to specify a program’’—in order to differentiate it fulfill the duty to justify their plan if testing program in a particular from the mandatory periodic testing they were to choose anything other than regulation, and several of our existing required for children’s products not a random statistical sample. With the regulations require such programs. relying upon a reasonable testing wide variety of children’s products, Should a particular standard at some program—must be that, for some manufacturers, and manufacturing point necessitate consideration of such specific products, testing will not be the processes that will be subject to the final an approach, we will provide due basis for certifying to the applicable rule, it would be impractical to attempt consideration of how to specify, within rule. The commenter stated that we to provide guidance applicable to all or the statutory framework that requires appropriately acknowledged the to attempt to provide individualized third party certification and third party implications of differences between guidance for some or all products, as periodic testing, such a particular product categories and industries requested by the commenter. Because testing program. attempting to develop programs when, the certifier typically possesses greater (Comment 31)—One commenter in the preamble to the proposed rule, we knowledge of the product and how it is expressed concern about the observed: ‘‘A manufacturer may develop made than other parties possess, the requirement to perform certification the scope and details of each element of certifier is in the best position to tests. The commenter said they did not a reasonable testing program based on determine how to achieve a high degree believe that a requirement to test pre- knowledge and expertise regarding the of assurance that its products are production samples should be part of a product and its manufacturing compliant with all the applicable reasonable testing program, adding that processes’’ (75 FR at 28345). The children’s product safety rules. it may be impractical for seasonal items commenter stated that this discretion Regarding the commenter’s or short production runs. The also must extend to the sample selection observation of the CPSC’s use of 12 or commenter stated that preproduction method of test programs, provided that fewer samples, those samples were not samples cannot be tested because we all population elements have a chance used for children’s product certification will not accept the test results on of selection and due care is exercised to purposes. Thus, tests run by CPSC staff samples as test results on the finished avoid selection bias through are not germane to the discussion of product. The commenter asked: if the documented procedures. product certification. Depending upon preproduction samples fail and the The commenter also stated that we the manufacturer’s knowledge of a retailer/importer has the product should suggest separate regulations for children’s product and its manufacture, reworked by the manufacturer to correct specific products that may warrant a sufficient number of samples to any defects, and the production units prescribed methods, as has been done provide a high degree of assurance of pass tests to meet all applicable

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standards, then why should it matter if would not increase safety. The have a CPSC-accepted accreditation for the samples failed, as long as the final commenter would revise the rule to the scope of the testing undertaken in product meets the requirements? The make it clear that component parts that support of product certification. ‘‘Food commenter expressed the belief that are materially similar to the finished grade’’ materials and CONEG sample testing should be optional, not part can be used for certification testing. requirements are not conducted by these required. (Response 32)—We agree with the laboratories and do not necessarily (Response 31)—Although subpart B, commenter regarding the testing of demonstrate compliance with the describing a reasonable testing program, samples. Section 1107.20(a) states that requirements of applicable children’s has been reserved in the final rule, the samples must be identical in all material product safety rules or compliance with concept of certification testing and respects to the children’s product. the third party testing requirement in testing a sufficient number of samples to We also agree with the commenter’s section 14(a)(2) of the CPSA. provide a high degree of assurance of suggestion that we clarify the rule; Accordingly, we cannot adopt those compliance with applicable rules, bans, therefore, we have revised § 1107.20(c) certifications in lieu of the certification standards, and regulations remains in to state that component part testing may required under section 14(a)(2) of the the final rule with regard to children’s be used for certification of a finished CPSA. products in § 1107.20(a). Section product. While manufacturer-supplied 1107.20(a) states that certification tests (Comment 33)—One commenter certificates stating that these materials must be performed on samples that are expressed the belief that the meet FFDCA or CONEG requirements manufacturer should determine the identical in all material respects to the may not be used as the basis for a third number of units to be tested, but added children’s product distributed in party-supported product certification, that they do not believe that statistical commerce. Thus, finished children’s they can be used as part of a production sampling is appropriate. product samples or preproduction testing plan implemented to extend the samples are acceptable for certification (Response 33)—A manufacturer may use statistical or qualitative means to maximum periodic testing interval from test purposes if their performance for one year to two years if they are the test under consideration is the same determine how many units of a product are needed for certification testing to sufficient to demonstrate compliance as the finished product. with a children’s product safety rule The commenter did not explain why give the manufacturer a high degree of such as the lead content limits. We note they believe that certification tests may assurance that the product complies that some food additives are GRAS, or be impractical for seasonal or short with the applicable rules. The ‘‘generally recognized as safe.’’ production run items. Thus, we cannot manufacturer is not required to use However, these designations might not respond to the commenter’s concern. statistical methods, but they should be be based on scientific analyses or The final rule requires passing prepared to describe how their testing. Instead, the GRAS status for a certification test results before a technique shows the product’s material might be based on longstanding Children’s Product Certificate can be compliance. acceptance or belief. issued. (Comment 34)—One commenter With regard to the commenter’s noted that products using ‘‘food grade’’ Furthermore, on August 12, 2011, the concern regarding a test failure of materials have supplier certificates President signed into law H.R. 2715, preproduction samples, the commenter stating that these materials meet the which amended the CPSIA in several may have misunderstood the requirements of the Federal Food, Drug, respects. One provision in H.R. 2715 requirements of certification testing. and Cosmetic Act (FFDCA) and/or the requires us to seek public comment on The commenter described a packaging requirements for the opportunities to reduce the cost of third circumstance in which a manufacturer Coalition of Northeastern Governors party testing requirements, consistent tested samples for compliance to a (CONEG). The commenter suggested with assuring compliance with any regulation. Upon receiving a failing test supplementing these certificates with applicable consumer product safety result, the manufacturer addressed the other analyses, as part of the rule, ban, standard, or regulation. H.R. causes of the failing test results and certification (e.g., gas chromatography— 2715 directs us to seek public comment conducted new certification tests on mass spectrometry, GC–MS) and a on seven specific issues, including the samples of the ‘‘corrected’’ product and reasonable testing program. The extent to which the use of materials received passing test results. This commenter said that such assurances subject to regulations of another describes an acceptable process for also can be used, consistent with the government agency that requires third initial product certification. Commission’s authority under section 3 party testing of those materials may We disagree with the commenter’s of the CPSIA, to reduce the burden of provide sufficient assurance of suggestion that certification tests should testing on manufacturers of consumer conformity with an applicable consumer be optional. Section 14(a)(2) of the products. Because the proposed rule product safety rule, ban, standard, or CPSA expressly refers to testing as being would acknowledge that children’s regulation without further third party the basis of a certification and does not product manufacturers who implement testing. Elsewhere in this issue of the make such testing optional. a reasonable testing program have a Federal Register, we have published a (Comment 32)—A commenter reduced third party test burden from the notice seeking public comment on the suggested that the final rule not require standpoint of third party periodic issues in H.R. 2715. finished product/component part testing testing, the commenter said that such H.R. 2715 further requires us to and should allow samples that are compliance assurances can be review the public comments and states identical in all material respects to the incorporated into a program for that we may prescribe new or revised finished product to be tested. The children’s products as well. third party testing regulations if we commenter added that testing on (Response 34)—Section 14(a)(2) of the determine that such regulations will samples since the 1950s has not resulted CPSA requires third party conformity reduce third party testing costs in a recall for failing to comply with the assessment body testing of children’s consistent with assuring compliance applicable rule. Thus, requiring finished products as a condition of certification. with the applicable consumer product product/component testing would be Additionally, those third party safety rules, bans, standards, and extremely costly and burdensome and conformity assessment bodies must regulations. Should new information

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become available, the Commission may (Response 36)—Section 1107.20(b) of this comment under the proposed rule revisit this issue in the future. the final rule states, in part, that if the for component part testing. manufacturing process for a children’s On our own initiative, we have b. The Interaction Between the product consistently creates finished revised § 1107.20(c) to state: ‘‘Except Manufacturing Process and Samples products that are uniform in where otherwise specified by a Proposed § 1107.20(b) would state composition and quality, a children’s product safety rule, that, if the manufacturing process for a manufacturer may submit fewer samples component part testing pursuant to 16 children’s product consistently creates to provide a high degree of assurance CFR part 1109 may be used to support parts that are uniform in composition that the finished product complies with the certification testing requirements of and quality, a manufacturer may submit the applicable children’s product safety this section.’’ We made these changes to fewer samples to provide a high degree rules. We interpret the comment to simplify the language in § 1107.20(c) of assurance that the finished product assert that internal manufacturing and to remove descriptions of 16 CFR complies with the applicable children’s controls and regular testing should part 1109 to avoid potential confusion product safety rules. If the obviate the need for numerous samples over what the final rule requires and manufacturing process for a children’s for product certification. The what 16 CFR part 1109 mandates. product results in variability in the commenter is correct in that the (Comment 38)—One commenter composition or quality of children’s manufacturer’s internal controls and stated that raw (or base) material testing products, a manufacturer may need to testing can provide information to use is critical to its ability to develop submit more samples to provide a high in determining how many certification programs to comply with the law. The degree of assurance that the finished test samples would be required to give commenter noted that, although it is a product complies with the applicable the certifier a high degree of assurance component manufacturer, it has more children’s product safety rules. of the product’s compliance with the than 384,000 stock-keeping units (Comment 35)—One commenter applicable rule. (SKUs). These hundreds of thousands of stated that phrases, such as ‘‘sufficient products could be seen as different number of samples’’ and ‘‘variability in c. Component Part Testing combinations of a smaller population of composition or quality,’’ can be Proposed § 1107.20(c) would state subcomponents and raw materials. The confusing. The commenter said that that, except where otherwise specified commenter stated that it is through regular internal monitoring and periodic by a children’s product safety rule, a working with this smaller population of testing should be able to provide manufacturer may substitute component subcomponents and raw materials that sufficient data and information to part testing for finished product testing they can effectively manage quality in support any assessment of product pursuant to 16 CFR part 1109, if the areas such as lead levels. quality. component part, without the remainder (Response 38)—Component part (Response 35)—The commenter is of the finished product, is sufficient to testing of raw materials is beyond the correct that internal monitoring and determine compliance for the finished scope of this rule and is considered in testing can provide data to support the product. the final rule on Conditions and assessment of product quality. Because (Comment 37)—One commenter Requirements for Relying on Component § 1107.20 applies to both tightly and requested that we make an explicit Part Testing or Certification, or Another loosely controlled manufacturing statement about component testing Party’s Finished Product Testing or processes, we emphasize in § 1107.20(b) indicating that certain components are Certification, to Meet Testing and of the final rule that the number of exempt from testing and certification. Certification Requirements (16 CFR part samples needed to give the certifier a The commenter was concerned that, 1109). However, in that final rule, in high degree of assurance of the without specific language, the final many cases, raw materials or product’s compliance is affected by how customer will not accept component subcomponents may be considered well the product’s manufacturing testing if exempt parts are not tested. component parts, as long as due care process controls those variables The commenter recommended revising has been taken to ensure that no action associated with compliance. A sufficient proposed § 1107.20(c) as follows: subsequent to component part testing number of samples would be the has adversely affected the raw materials’ quantity of samples selected for (c) Except where otherwise specified by a or subcomponents’ compliance with the children’s product safety rule, a certification testing that gives the manufacturer may substitute component part applicable product safety rules. certifier a high degree of assurance that testing for complete product testing pursuant d. Remedial Action the product complies with all the to 16 CFR [part] 1109 if the component part, applicable children’s product safety without the remainder of the finished Proposed § 1107.20(d) would state rules. product, is sufficient to determine that, if a product sample fails ‘‘Variability in the composition or compliance for the entire product. certification testing, even if other quality,’’ for purposes of § 1107.20, Component part testing can be used to samples have passed the same means unit-to-unit differences of a substantiate compliance for those children’s certification test, the manufacturer must product that can affect its compliance products where part of the product has been investigate the reasons for the failure with the applicable children’s product exempted from testing pursuant to Section and take remedial action. A 1500.91. (Italics indicate proposed language.) safety rules. manufacturer would not be allowed to We have finalized this paragraph (Response 37)—We agree that certify the children’s product until the without change. language similar to what the commenter manufacturer establishes with a high (Comment 36)—One commenter suggested would be helpful, but we degree of assurance that the finished stated that regular internal monitoring believe that the commenter’s change is product complies with all applicable and periodic testing should be able to more appropriate in the rulemaking children’s product safety rules. provide sufficient data and information pertaining to component part testing, (Comment 39)—Two commenters to support any assessment of product specifically with component part testing raised questions about what action must quality. The commenter noted that this for the lead content of children’s be taken when a product fails a test. One procedure is commonly practiced by products under proposed 16 CFR commenter interpreted the proposed many manufacturers at present. 1109.12. Therefore, we have considered rule to mean that all similar toys are

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also not compliant, resulting in a factory remedial action plan requirement in clarifications. For example, § 1107.21(a) shutdown. The other commenter noted part III.D.7. of this document, below. of the final rule states: ‘‘All periodic that different products vary in design testing must be conducted by a third 3. Proposed § 1107.21 Periodic Testing and manufacture, and if one product party conformity assessment body.’’ The fails, it does not mean that other a. General Periodic Testing proposed rule had mentioned third products would have the same problem. Requirements party testing in proposed § 1107.21(b), (Response 39)—Section 1107.20(d) of Proposed § 1107.21(a) would but not in proposed § 1107.21(a), so the final rule states that if a product implement the periodic testing adding this sentence to a revised sample fails certification testing to the requirement in section 14(i)(2)(B)(i) § 1107.21(a) of the final rule reinforces applicable children’s product safety (renumbered by H.R. 2715 from section the notion that periodic testing of rule(s), even if other samples have 14(d)(2)(B)(i)) of the CPSA by requiring children’s products must be done by a passed the same certification test, the each manufacturer to conduct third third party conformity assessment body. manufacturer must investigate the party periodic testing at least annually, We have reorganized § 1107.21 to state reasons for the failure and take the except as otherwise provided in the general requirements at § 1107.21(a) necessary steps to address the reasons proposed § 1107.21(b) and (d), or as and then identify different options for for the failure. Generally, certification provided in regulations under this title. third party periodic testing frequencies testing of a children’s product requires The proposal also would explain that at § 1107.21(b), (c), and (d). Thus, for all samples tested to pass the applicable manufacturers may need to conduct example, we have modified and moved children’s product safety standard. third party periodic tests more the annual periodic testing mentioned Otherwise, the certifier cannot ensure frequently than on an annual basis to in proposed § 1107.21(a) to § 1107.21(b) with a high degree of assurance that the ensure a high degree of assurance that in the final rule, and we have combined tests conducted for certification the product being tested complies with it with the periodic test elements that purposes accurately demonstrate the were at proposed § 1107.21(c). ability of the children’s product to meet all applicable children’s product safety rules and that more frequent third party Consequently, § 1107.21(b) of the final all applicable children’s product safety rule states that a manufacturer must rules. However, some regulations allow periodic testing may help a manufacturer identify noncompliant conduct third party periodic testing to for some individual samples of a test set ensure compliance with the applicable to exceed the limit but still comply with products quicker and, as a result, may limit the scope of any potential product children’s product safety rules at least the regulation. For example, in the once a year, except as otherwise Standard for the Surface Flammability recall. In addition, more frequent third party periodic testing may reduce the provided in § 1107.21(c) and (d), or as of Small Carpets and Rugs (FF 2–70) in provided in our regulations. (The final 16 CFR part 1631, there is an allowance manufacturer’s liability for civil penalties resulting from a noncompliant rule states that the periodic testing within the standard for a failure during under § 1107.21(b) must be done ‘‘once a test and a prescribed action. Because product, reduce potential damage to a manufacturer’s reputation, and increase a year,’’ as opposed to ‘‘annually,’’ to the regulation specifies the procedure eliminate potential confusion in for dealing with a sample test failure, or the manufacturer’s confidence in the effectiveness of the third party periodic determining how to calculate the proper through labeling, we would view such interval for periodic testing.) Under a properly labeled product as meeting testing. (Comment 40)—One commenter § 1107.21(b), the manufacturer must the applicable product safety standard. conduct periodic testing at least once a A test failure for one children’s asserted that the language of proposed year when using a periodic test plan. product applies only to that product and § 1107.21 is not explicitly limited to Section 1107.21(b)(1) of the final rule is not necessarily representative of all children’s products. The commenter (regarding the periodic test plan) is products in the factory. An exception to recommended that the language in the this might be a test on a component part final rule be revised so that the term substantially the same as proposed used in many products. In that ‘‘manufacturer’’ is changed to the phrase § 1107.21(c)(1), except that the final rule circumstance, the nature of the test ‘‘manufacturer of a children’s product’’ states that manufacturers must develop failure and the component part’s use in to clarify that § 1107.21 applies only to a periodic test plan to ‘‘ensure with a the other products would affect which children’s products. The commenter high degree of assurance’’ that products the failing test result applies. also stated that the same revision should children’s products continue to comply For example, if a component part over be made throughout subpart C, with all applicable children’s product the lead content limit is inaccessible, wherever the term ‘‘manufacturer’’ safety rules. (The proposed rule stated the use of that component part would appears without the qualifier ‘‘of a that the manufacturer must develop a not make the children’s product children’s product.’’ periodic test plan to ‘‘assure that noncompliant. (Response 40)—We believe it is clear children’s products’’ continue to Additionally, on our own initiative, that Subpart C applies only to children’s comply.) Section 1107.21(b)(2), ‘‘Testing we have revised § 1107.20(d) by adding products. While we believe the Interval,’’ is substantially the same as the phrase: ‘‘to the applicable children’s commenter’s suggested change is proposed § 1107.21(c)(2), except that, product safety rule(s)’’ after the phrase unnecessary, we have made other for consistency, the final rule refers ‘‘if a product sample fails certification revisions to the text and have added a simply to a ‘‘testing interval,’’ rather testing.’’ This change is for clarification reference to manufacturers of children’s than a ‘‘periodic testing interval.’’ (The purposes and is not intended to have a product in § 1107.21(a) of the final rule proposed rule had used different terms, substantive effect on the final rule. We to reiterate that the requirement applies such as ‘‘periodic testing interval,’’ also replaced the phrase ‘‘take remedial only to children’s products. ‘‘testing interval,’’ ‘‘interval,’’ and action’’ with the phrase ‘‘take the On our own initiative, we have ‘‘interval for periodic testing,’’ for the necessary steps to address the reasons revised § 1107.21 to reflect changes to same concept.) for the failure’’ because we have the periodic testing frequency in (Comment 41)—One commenter removed the remedial action plan § 1107.21(b), (c), and (d) of the final supported third party testing for the requirement in § 1107.25 from the final rule, to mention component part testing, initial certification for any new products rule. We discuss the removal of the and to make nonsubstantive and said that any major changes in

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design, critical component changes, or status be created for a children’s have determined that these materials meeting changing regulations should product that has passed certification fall under the lead content limit, and no require recertification by third party testing—but currently is not being testing is required. testing bodies. The commenter also produced. Once production resumes, (Comment 44)—One commenter supported periodic testing by third periodic testing can be performed on the stated that the testing frequency should party conformity assessment bodies of new units. be left to the manufacturer and to the any products, providing that a much (Response 42)—A new ‘‘Inactive’’ market; and the commenter further more refined and more specific status is unnecessary because periodic asserted that a rule requiring requirement can be presented and testing of children’s products is only manufacturers to test according to these confirmed by a proper authority. The required for continuing production after standards every year is an unaffordable commenter noted that it would be certification. If, in the commenter’s economic burden. The commenter difficult and extremely risky to leave example, more than a year passes indicated that it is unrealistic to imagine such a decision and ruling to the related between production runs, when that testing cost savings from parties. However, the commenter production recommences, the final rule maintaining a reasonable testing supported the earlier proposal of requires periodic tests on new program (as described in the proposed component part testing that certifies production runs to assure continued rule) will be useful because that recognized components for toy compliance. The certifier must use due program is ‘‘wasteful and gargantuan.’’ production because it would enhance care to ensure that no material change The commenter asserted that a the elimination of certain repetitive and has occurred in the product’s design or firewalled conformity assessment body redundant testing on the finished manufacturing process, including the would be unrealistic for small product. sourcing of component parts. Otherwise, businesses. The commenter also (Response 41)—The commenter was new certification tests must be maintained that component part and unclear what it meant by a ‘‘proper conducted on the newly manufactured composite testing likewise, will provide authority’’ or which parties are the product. no relief. The commenter asked: If a ‘‘related parties’’ dealing with the (Comment 43)—One commenter firm has a good long-term record of noted that while the proposed rule difficulty and risk of periodic testing. In safety, then why are they required to would accept the use of component part the final rule, the certifier (domestic test according to the proposed rule? manufacturer or importer) of a testing for certification purposes, it does (Response 44)—Section 14(i)(2)(B)(i) children’s product must determine the not address its use for periodic testing. of the CPSA requires us to establish frequency of periodic testing and the The commenter would revise proposed protocols and standards for ensuring number of samples to be tested. The § 1107.21(c)(1) to include language that children’s products are subject to frequency of testing (within specified allowing for the use of a component part testing periodically. We have revised maximum periodic testing intervals) testing program to meet the periodic § 1107.21 to allow third party periodic and the number of samples required testing requirements. The commenter testing: At least once per year for must be sufficient to give the certifier a stated that it could foresee customers high degree of assurance that continuing requiring the development of a periodic children’s product with a periodic production or importation of the testing program as a contractual testing plan; at least once every two children’s product continues to meet the requirement. years for children’s products with a requirements of all applicable children’s Another commenter remarked that the production testing plan; or at least once product safety rules. proposed rule does not recognize items every three years for a production The commenter did not indicate what that are exempt from testing pursuant to testing plan using an ISO/IEC factors should be added to the periodic 16 CFR 1500.91, Determinations 17025:2005-accredited testing laboratory testing requirements to make them more regarding lead content for certain (and provided other requirements are refined or specific. Thus, we have no materials or products under section 101 met, including, but not limited to, using basis to modify the rule to account for of the Consumer Product Safety that lab to test to the children’s product such factors. Further, identifying or Improvement Act. safety rule(s) to which the product is creating a ‘‘proper authority’’ to confirm (Response 43)—Section 1107.21(a) of subject). Allowing firms with a good periodic testing programs would present the final rule states that manufacturers long-term record of safety to forego practical difficulties due to the number must conduct third party periodic testing their children’s products would of products requiring periodic testing testing. This testing is to ensure that not comply with the law, which plans and the variety of manufacturing children’s products manufactured after requires periodic testing of children’s techniques used in their production. the issuance of a Children’s Product products, regardless of past Because periodic testing requirements Certificate, or since the previous performance. apply to many different types of periodic testing was conducted, Regarding the commenter’s assertion children’s products and manufacturers, continue to comply with all applicable that children’s product manufacturers and because manufacturing techniques children’s product safety rules. Periodic will not attempt to save on testing costs for those products vary widely, one set testing can use component part testing because implementing a reasonable of refined or specific requirements for to ensure compliance with some or all testing program is ‘‘wasteful and periodic testing is unlikely to be of the applicable children’s product gargantuan,’’ the final rule does not applicable to all children’s products that safety rules. We have clarified the require manufacturers of children’s require periodic testing. language of § 1107.21(a) of the final rule products to have a reasonable testing (Comment 42)—One commenter to state that component part testing may program in order to save on third party noted that some children’s products are be used to meet the periodic testing conformity assessment body testing not produced on a regular basis, and requirements, subject to the conditions costs. By increasing the manufacturer’s more than one year may pass between of § 1107.21. options to qualify for an extension of the production runs. Because there are no Regarding items that are exempt from maximum periodic testing interval, we production units on which to perform testing for lead content, those items are hope that more manufacturers wishing periodic testing, the commenter also exempt from any periodic testing to implement such a program will find suggested that an ‘‘Inactive’’ product requirements. In 16 CFR 1500.91, we it advantageous to do so.

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Additionally, pursuant to H.R. 2715, CPSC-accepted third party conformity product, then it should treat each elsewhere in this issue of the Federal assessment body. China Entry-Exit shipment as a discrete lot and subject it Register, we have published a notice Inspection and Quarantine Bureaus do to certification testing because the seeking comment on other techniques not currently meet the conditions importer does not know whether for lowering the cost of third party specified in the Consumer Product material changes have been made to the testing, consistent with assuring Safety Improvement Act for product since its last shipment. In this compliance with the applicable governmental conformity assessment circumstance, the shipment that has consumer product safety rules, bans, bodies to participate in the CPSC’s undergone certification testing is not standards, and regulations. program. Further, the third party testing considered continuing production of the As for the commenter’s remark about requirements apply irrespective of the product, and is not subject to the firewalled conformity assessment level of a manufacturer’s self- periodic testing requirements. bodies, the final rule does not require supervision of product safety. that small businesses have a firewalled With regard to internal testing b. Periodic Testing and Reasonable conformity assessment body. facilities, these are considered first party Testing Programs Finally, regarding the commenter’s laboratories, and their tests are not Proposed § 1107.21(b) would state statements on component part and allowed for periodic test purposes, that if a manufacturer has implemented composite part testing, we address those unless the laboratory is a CPSC-accepted a reasonable testing program, as comments in the preamble to the final firewalled conformity assessment body. described in subpart B of this part (with rule, Conditions and Requirements for However, if the third party laboratories the exception of the certification Relying on Component Part Testing or testing the manufacturer’s products for element which, for children’s products, Certification, or Another Party’s the customer are CPSC-accepted for the would have to comply with the Finished Product Testing or scope of the testing, test results from requirements in proposed § 1107.20), it Certification, to Meet Testing and those laboratories may be used for would have to submit samples of its Certification Requirements (16 CFR part fulfilling the periodic testing product to a third party conformity 1109). requirements. We note that internal assessment body for periodic testing to (Comment 45)—One commenter testing facilities can be used to extend all applicable children’s product safety stated that periodic testing is the maximum testing interval for rules at least once every two years. If a unnecessary because when a product is periodic testing from one year to two manufacturer’s reasonable testing manufactured in China, the initial years. Further, if the internal testing program fails to provide a high degree product sample is inspected by the facility is ISO/IEC 17025:2005- of assurance of compliance with all China Entry-Exit Inspection and accredited and other conditions are met, applicable children’s product safety Quarantine Bureau to ensure that it the maximum testing interval for rules, proposed § 1107.21(b) would state complies with all European Union, periodic testing is extended to three that we may require the manufacturer to United States, and China product safety years. meet the periodic testing requirements standards. Additionally, the commenter (Comment 46)—One commenter in proposed § 1107.21(c) or modify their observed, the China Entry-Exit stated that the importer who purchases reasonable testing program to ensure a Inspection and Quarantine Bureau will a product from a manufacturer and takes high degree of assurance. One element conduct the random sample in-line possession of the product prior to of the reasonable testing program in inspection to inspect a number of importation does not have full visibility proposed subpart B would be the samples in the production twice a year. and knowledge of the manufacturing ‘‘production testing plan’’ in proposed The commenter said that products that process and must treat each shipment § 1107.10(b)(3); a production testing fail the inspection will not be allowed produced by the manufacturer as a plan would describe what tests must be to be exported. The commenter said that discrete lot. performed and the frequency with the strict product safety inspections by (Response 46)—An importer is which those tests must be performed to China Entry-Exit Inspection and responsible for issuing a Children’s provide a high degree of assurance that Quarantine Bureau are enough to have Product Certificate for the children’s the products manufactured after the high degree of product safety products they import. If a foreign certification continue to meet all assurance and that a periodic testing manufacturer tests or certifies a applicable safety rules, bans, standards, requirement would be duplicative. children’s product and provides the or regulations. The commenter also said that periodic importer with the test results or (Comment 47)—One commenter testing was unnecessary because, as the certificate and other required recommended that we require children’s manufacturer, they have a high degree documentation, then the importer, products to be tested by a third party of self-discipline and strictly supervise exercising due care, using the conformity assessment body at least their products’ safety. Furthermore, the manufacturer’s test data or certificate as every year, not every two years, as commenter stated that 90 percent of a basis, may issue its own Children’s proposed. The commenter felt that manufacturers have their own testing Product Certificate. many changes can occur over time in laboratories that conform to In this circumstance, due care by the the manufacturing process, materials, international laboratory standards and importer involves ensuring that the test standards, and test protocols that already have a series of internal product foreign manufacturer conducts periodic could cause products tested safety testing in place to maintain a high tests. If the foreign manufacturer does infrequently to drift away from degree of product safety and quality not certify the children’s product, but compliance with applicable children’s assurance. In addition, the commenter the importer has documentation of the product safety rules. The commenter felt stated that most customers require manufacture and testing of the that more frequent independent testing testing by the third party conformity children’s product, then the importer is would be able to keep this in check assessment body per order before the responsible for certifying the children’s better. manufacturer exports the goods to product and is subject to the (Response 47)—We disagree with the ensure a high degree of product safety. requirement for periodic testing. commenter’s inference that a production (Response 45)—The final rule requires However, if the importer has no testing plan will not be capable of periodic testing to be conducted by a knowledge of the manufacture of the detecting ‘‘drift’’ in a product’s

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compliance with the applicable safety manufacturer’s knowledge of the ‘‘Any production test method used to rules. We are aware of numerous forms product and its manufacturing conduct production testing must be as of production testing techniques that processes’’ for the factors to consider effective in detecting noncompliant have been implemented successfully to when determining the periodic testing products as the test used for control product quality and ensure interval under proposed § 1107.21(c)(2) certification’’ to ‘‘Any production test continuing compliance. (renumbered to § 1107.21(b)(2) in the method used to conduct production Manufacturers are free, however, to final rule) (75 FR at 28349). This testing must be effective in determining test their products more frequently than concept applies equally to the compliance’’ in the final rule. The the rule would require. information obtained from production language of the proposed rule could Additionally, on our own initiative, testing. Information gained from practically be interpreted to require the we have reorganized § 1107.21 to move production testing can be used to use of the test method mandated for the requirements that were at proposed determine the appropriate testing certification because a manufacturer § 1107.21(b) to § 1107.21(c) of the final interval (up to two years), and so we would be unclear about what ‘‘as rule. Furthermore, because we have added this concept to § 1107.21(c)(1). effective’’ means and therefore, use the reserved subpart B (which would Section § 1107.21(c)(2) of the final test method for certification. We pertain to a reasonable testing program), rule describes the production testing changed the language in the final rule to we have removed references to a plan, and it is substantially the same as clarify the point that production testing ‘‘reasonable testing program’’ in subpart the production testing plan in proposed does not require the use of the test C and replaced them with the key § 1107.10(b)(3) (which is reserved in the method for certification. Additionally, element of the ‘‘reasonable testing final rule, along with the rest of subpart § 1107.10(b)(3)(iii)(C) of the proposed program,’’ which is the ‘‘production B). Section 1107.21(c)(2) explains that rule would state: ‘‘If a manufacturer is testing plan.’’ We decided to maintain the production testing plan describes uncertain whether a production test is the requirement for a production testing ‘‘the production management as effective as the certification test, the plan because children are a vulnerable techniques and tests that must be manufacturer must use the certification population, and traditionally, we have performed to provide a high degree of test.’’ This provision has been had a greater interest in ensuring the assurance that the products eliminated from the final rule because it safety of children’s products. manufactured after certification is no longer necessary after the above Additionally, with the passage of the continue to meet all the applicable clarification that production testing CPSIA, Congress indicated that it children’s product safety rules.’’ It does not require use of the test method intended for children’s products to be further explains that a production for certification. subject to more stringent requirements testing plan may include: recurring Finally, § 1107.21(c)(3) of the final than non-children’s products, as testing or the use of process rule states that if a production testing demonstrated by the requirements for management techniques, such as control plan fails to provide a high degree of third party testing and the protocols and charts, statistical process control assurance of compliance with the standards for continuing third party programs, or failure modes and effects applicable children’s product safety testing for children’s products analyses (FMEAs), designed to control rules, we may require the manufacturer promulgated in this rulemaking. potential variations in product to meet the requirements of § 1107.21(b) Section 1107.21(c)(1) of the final rule manufacturing that could affect the for a periodic testing plan to ensure a states that if a manufacturer implements product’s ability to comply with the high degree of assurance of compliance. a production testing plan, as described applicable children’s product safety This is not a new requirement. Proposed in § 1107.21(c)(2), to ensure continued rules. § 1107.21(b) had the same requirement compliance of the children’s product Section 1107.21(c)(2) also states that a for manufacturers with a reasonable with a high degree of assurance to the manufacturer may use measurement testing program. Because we have applicable children’s product safety techniques that are nondestructive and removed the reasonable testing program rules, the manufacturer must submit that are tailored to the needs of an and reserved subpart B in the final rule, samples of its children’s product to a individual product to ensure that a the periodic testing requirement is no third party conformity assessment body product complies with all applicable longer linked to the reasonable testing for periodic testing to the applicable children’s product safety rules. Thus, program. However, we have moved this children’s product safety rules at least the tests in a production testing plan requirement to the production testing once every two years. The 2-year period under § 1107.21(c)(2) do not have to be plan option in § 1107.21(c)(3) and the is derived from proposed § 1107.21(b) the tests described in the applicable ISO/IEC 17025:2005-accredited for manufacturers who have a children’s product safety rule, and they laboratories option in § 1107.21(d) of the reasonable testing program. Section do not have to be conducted by a CPSC- final rule. 1107.21(c)(1) further states that a accepted third party conformity (Comment 48)—A commenter manufacturer may consider the assessment body. However, the strongly recommended that we information obtained from production implementation of the production recognize or endorse certain internal in- testing when determining the testing plan still requires some testing. house testing facilities that conform to appropriate testing interval (up to two Purely mathematical techniques, such ISO 17025:2000 standard. The years) and the number of samples as a Failure Modes and Effects Analysis commenter felt that this recognition needed for periodic testing to ensure only, or a computer simulation of the would greatly expedite testing that there is a high degree of assurance product alone, are not allowed. Purely procedures and the time for certain that the other untested children’s mathematical techniques, without required testing and reduce costs and products manufactured during the verifying measurements, may not lessen dependence on the third party testing interval comply with the characterize the product with sufficient conformity assessment bodies. Another applicable children’s product safety fidelity to predict accurately its commenter stated that we should rules. The preamble to the proposed compliance to the applicable rules. recognize internal laboratories as a way rule noted: ‘‘[t]he appropriate periodic Section 1107.21(c)(2) of the final rule to reduce dependence on third party testing interval may vary for a has revised the requirement in proposed conformity assessment bodies. The manufacturer depending on the § 1107.10(b)(3)(iii)(B), which stated: reasons for the suggestions include:

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Better monitoring of product safety, a of the final rule states that a economically. The commenter noted desire to reduce testing costs, encourage manufacturer may consider the that smaller manufacturers may have to other manufacturers to develop their information obtained from testing use the services of third party own internal testing facilities, and conducted by an ISO/IEC 17025:2005- conformity assessment bodies per the promote continuous product accredited testing laboratory when agreed schedule, which needs to be improvements. determining the appropriate testing defined and specified. (Response 48)—We recognize that interval and the number of samples for (Response 49)—The final rule requires using ISO/IEC 17025:2005-accredited periodic testing that are needed to periodic testing to be conducted by a laboratories for testing purposes ensure that there is a high degree of CPSC-accepted third party conformity provides an added measure of assurance assurance that the other untested assessment body. If the ‘‘qualified to production testing. The laboratories children’s products manufactured internal testing facility’’ is a CPSC- are accredited by an independent body during the testing interval comply with accepted firewalled conformity as competent to perform specified tests. the applicable children’s product safety assessment body, then tests from that They are also recognized as having rules. conformity assessment body can be used instituted a management system that Section 1107.21(d)(2) of the final rule for periodic testing purposes. establishes procedures and properly states that if the continued testing Otherwise, an internal testing facility is maintains records. Laboratory described in § 1107.21(d)(1) fails to considered a first party laboratory, and accreditation also establishes controls provide a high degree of assurance of its test results would not be allowed for concerning data integrity, equipment compliance with all applicable third party periodic testing purposes. calibration, and procedures to resist children’s product safety rules, then we Regarding the commenter’s assertion undue influence over testing results. may require the manufacturer to comply of significant costs, the commenter did For these reasons, we have amended with § 1107.21(b) or modify the testing not describe how third party testing the final rule to include a new frequency or number of samples would result in significant costs and § 1107.21(d), which provides a required to ensure a high degree of production difficulties relative to maximum periodic testing interval of assurance of continued compliance. internal testing. However, a three years for a manufacturer using an Section 1107.21(d)(2) is substantially manufacturer with internal testing ISO/IEC 17025:2005-accredited the same, in this respect, as proposed facilities may use product test data from laboratory for production testing § 1107.21(b), in requiring the use of those facilities to increase its knowledge purposes. The laboratory must be other third party periodic testing of the product and its manufacture, and accredited by an ISO/IEC 17011:2004(E) options if a manufacturer’s testing thus, may reduce the number of samples (more commonly known as ISO/IEC program fails to provide a high degree required for periodic testing purposes as 17011:2004 and how it will be referred of assurance of compliance, except that a means of controlling costs. Section to in the preamble) (Conformity § 1107.21(d)(2) refers to ‘‘continuing 1107.21(c)(1) of the final rule states that assessment—General requirements for testing,’’ rather than a ‘‘reasonable if a manufacturer has implemented a accreditation bodies accrediting testing program.’’ production testing plan, the maximum conformity assessment bodies) Section 1107.21(g) of the final rule testing interval for periodic testing is accreditation body, and must use the describes the incorporation by reference extended to two years. Additionally, same test method(s) used for of ISO/IEC 17025:2005 and ISO/IEC under § 1107.21(d)(1) of the final rule, if certification testing when conducting 17011:2004, as required by the Director the manufacturer uses an ISO/IEC testing to ensure continued compliance. of the Federal Register. This 17025:2005-accredited testing laboratory We chose the 3-year time period incorporation by reference is necessary for the production testing (and other because: (1) Having a laboratory because § 1107.21(d)(1) references ISO/ requirements are met), the maximum accredited by an independent body as IEC 17025:2005 and ISO/IEC testing interval is extended to three competent to perform specified tests 17011:2004. years. These methods may be used by a provides an additional measure of (Comment 49)—Two commenters manufacturer to reduce the costs of assurance in the accuracy and the stated that periodic testing or auditing third party conformity assessment body integrity of the testing results; (2) a should be considered a regular internal testing. (We explain the reasons for laboratory accredited to ISO/IEC function. One commenter stated that adding § 1107.21(d) to the final rule at 17025:2005 must have implemented a any manufacturer with qualified part III.D.3.b. of the preamble.) management system that establishes and internal testing facilities should perform We agree with the commenter on the follows procedures, properly maintains such duties easily and regularly to undesirability of specifying testing records, and establishes controls ensure product quality. Having a third frequencies for different manufacturing concerning data integrity equipment party conformity assessment body conditions. Thus, the final rule specifies calibration, and procedures to resist conduct periodic testing would result in only the maximum testing interval for undue influence; and (3) using the same a significant cost impact and would periodic testing and lists some factors to tests as the tests used for product create production delays and be considered by manufacturers in certification provides a more direct difficulties. The commenter suggested developing their periodic test plans. We assessment of compliance to the that we not specify the frequencies of also agree with the commenter that applicable children’s product safety testing under different manufacturing product safety rules should apply to rules than process control techniques. conditions. The commenter stated that finished products. Section 1107.21(d)(1) of the final rule product safety rules should apply to As noted above, pursuant to H.R. also states that manufacturers must finished products. 2715, elsewhere in this issue of the conduct testing using the ISO/IEC Another commenter noted that a Federal Register, we have published a 17025:2005-accredited testing laboratory consistently good product testing record notice seeking public comment on other frequently enough to provide a high should reflect the competency of techniques for lowering the cost of third degree of assurance that the children’s qualified internal testing facilities and party testing consistent with assuring product continues to comply with the expertise. Accredited and qualified in- compliance with the applicable applicable children’s product safety house testing facilities should be able to consumer product safety rules, bans, rules. In addition, section 1107.21(d)(1) handle this effectively and standards, and regulations.

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(Comment 50)—One commenter said product testing plan’’: (1) The Additionally, because the final rule we should clarify what level of detail or requirement for each site to have a does not require a remedial action plan generality we would allow in mandating separate production testing plan, and (2) for children’s products, the suggestion that a production test plan describe the the production testing interval should to replace the term ‘‘remedial action tests to be conducted or the be short enough to ensure that, if the plan’’ with ‘‘remedial action plan or measurements to be tested. The samples selected for production testing procedures’’ is no longer applicable. commenter assumed that a comply with an applicable rule, ban, (Comment 52)—One commenter manufacturer would have the flexibility standard, or regulation, there is a high supported the acknowledgement that to create a test plan that could be degree of assurance that the untested the same production testing plan that is applied to multiple products. For product will comply with the applicable available to the manufacturing site and example, the commenter suggested that rule, ban, standard, or regulation. The the importer of record (retailers) is a production testing plan could address commenter urged us to acknowledge sufficient. The commenter gave the testing by generic specifications of more clearly that the elements of a example of a manufacturer who products, such as die-cast cars or production test plan enumerated in the developed a production testing plan and fashion dolls. However, the commenter rule are not the only elements that we demonstrated to their customers (the said that if we expect a production will recognize and that other processes, importers of record or retailers) that testing plan to specify the testing details such as statistical process control their production testing plan provides a for each product, then it would be so mechanisms, also may be used to show high degree of assurance of compliance. burdensome as to be economically not compliance. The commenter said that importers feasible. One commenter suggested that the could validate critical aspects of the (Response 50)—The use of production terms ‘‘production testing plan’’ and plan through factory audits and testing as a means to increase the ‘‘remedial action plan’’ be replaced with evaluations, production inspections that maximum periodic test interval to two ‘‘production testing plan or procedures’’ ensure that the testing plan records are years is intended to be general in nature and ‘‘remedial action plan or present and match the specifications, and flexible enough to be adaptable to procedures’’ because the use of the word and periodic testing using a CPSC- many different products and ‘‘plan’’ may be interpreted too narrowly accepted third party conformity manufacturing processes. It is the to allow for the range of methods that assessment body. (Response 52)—An importer can manufacturer’s responsibility to tailor manufacturers may use to meet the arrange for another party (e.g., a foreign its production testing to its specific requirements. products. As stated in § 1107.21(c)(2) of manufacturer) to develop and conduct (Response 51)—Manufacturers may the final rule, production testing is production testing for a product. The use production testing plans with any intended to ensure continued same production testing plan from procedure that is effective in detecting compliance of the product to the another party may be used by multiple noncompliant products (with the applicable children’s product safety importers as a means of increasing the requirement that purely mathematical rules with a high degree of assurance. It importers’ maximum periodic test is not required that a manufacturer’s methods with no testing are not interval to two years. The importer, as production testing plan specify all allowed). Statistical process control the product certifier, must use due care testing details for each product. mechanisms, properly applied, are to ensure that the implementation of a However, § 1107.21(c)(2)(i) of the final acceptable methods for production production testing plan ensures with a rule specifies that a production testing testing. The production testing plan high degree of assurance that continuing plan must include a description of the implemented at each manufacturing site production complies with the process management techniques used, may be identical, if appropriate; but applicable product safety rules. the tests to be conducted, or the each site must have identifiable (Comment 53)—One commenter measurements to be taken; the intervals production testing specific to the noted that proposed § 1107.21(b) would at which the tests or measurements will products produced at that site. On our specify that if a manufacturer’s be made; the number of samples tested; own initiative, we have added language reasonable testing program fails to and the basis for determining that the to § 1107.21(c)(2)(ii) that clarifies this provide a high degree of assurance of combination of process management point. This is a matter of compliance with all applicable techniques and tests provide a high documentation, and the commenter has children’s product safety rules, we may degree of assurance of compliance if not provided a reason why this creates require the manufacturer to meet the they are not the tests prescribed for the a problem. The final rule does not requirements of proposed § 1107.21(c) applicable children’s product safety mandate a specific testing interval for or modify its reasonable testing program rule. This is necessary because all products. Rather, the requirement in to ensure a high degree of assurance of techniques and test methods other than the final rule is for production testing to compliance. The commenter asked who those prescribed in the applicable be effective in detecting noncompliant would determine whether a reasonable children’s product safety rules may be products with whatever fixed or testing program provides a high degree used in production testing and are variable testing interval achieves a high of assurance of compliance, and how. needed to show the effectiveness of the degree of assurance of compliance to the (Response 53)—With regard to the production testing plan. applicable product safety rules. language in proposed § 1107.21(b) (Comment 51)—Two commenters We decline to adopt the suggestion to referenced by the commenter, because stated that, although we acknowledged change ‘‘production testing plan’’ to we have reserved the reasonable testing that a production testing plan could ‘‘production testing plan or program option for periodic testing in include procedures such as process procedures.’’ Dictionary definitions of the final rule, we have moved that management techniques, statistical ‘‘plan’’ and ‘‘procedure’’ are so similar language to §§ 1107.21(c)(3) and (d)(2) process control programs, or failure that, to use both terms would be (renumbered in the final rule) and mode analysis, the proposed rule would redundant. We believe that the modified it to refer to the production describe a rather rigid product testing description of a production testing plan testing plan option with a maximum plan. One commenter characterized the in § 1107.21(c) of the final rule provides periodic testing interval of two years following two requirements as ‘‘a rigid a sufficient description of its scope. and/or the testing by an ISO/IEC

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17025:2005-accredited testing laboratory proposed § 1107.10(b)(3). This increase excludes ordinary books from the third option with a maximum periodic test in the maximum testing interval was not party testing requirements in section interval of three years. With these based on the costs of third party testing 14(a) of the CPSA. Additionally, we changes in mind, we will decide, based or on the costs of implementing a have decided to reserve, rather than on the available evidence, whether a production testing plan. When a finalize, subpart B, which would have children’s product’s production testing manufacturer implements a production pertained to a reasonable testing plan provides a high degree of assurance testing plan and conducts production program for nonchildren’s products. of continuing compliance to the testing, such testing provides more Therefore, it is unnecessary for us to applicable children’s product safety information about a product’s address the commenter’s suggestion. rules. manufacture and compliance with the c. Periodic Testing in the Absence of a (Comment 54)—One commenter applicable children’s product safety Reasonable Testing Program noted that the voluntary establishment rules, which justifies allowing a longer of a reasonable testing program for a period of time between third party Proposed § 1107.21(c) would state children’s product increases the period periodic tests. If a manufacturer uses an that if a manufacturer has not between periodic tests to—at least once ISO/IEC 17025:2005-accredited testing implemented a reasonable testing every two years—from the requirement laboratory for testing to assure program, as described in subpart B of of annual periodic testing for children’s continued compliance, the maximum this part, then all periodic testing would products without a reasonable testing third party periodic testing interval is be required to be conducted by a third program. The commenter suggested that extended to three years. party conformity assessment body, and we consider the costs involved in The commenter is correct that the the manufacturer would be required to establishing and maintaining a preamble to the proposed rule stated conduct periodic testing, described in reasonable testing program, and noted that not every periodic test has to be proposed § 1107.21(c)(1) and (c)(2). that a reasonable testing program done by a third party conformity Proposed § 1107.21(c)(1) would reasonably warrants a more relaxed assessment body if the manufacturer has require the manufacturer to develop a periodic testing frequency standard, implemented four elements of a periodic testing plan to ensure that particularly when the manufacturing reasonable testing program. However, children’s products manufactured after process inherently results in uniform § 1107.21(c) of the final rule states that issuance of a children’s product production, with very little variability a manufacturer who has implemented a certification, or when the previous in the composition or quality. production testing plan for a children’s periodic testing was conducted, The commenter also noted that the product must submit samples of the continue to comply with all applicable preamble to the proposed rule stated product to a third party conformity children’s product safety rules. that not all periodic testing was required assessment body for periodic testing at Proposed § 1107.21(c)(2) would to be conducted by a third party least once every two years. We require the periodic testing interval conformity assessment body (75 FR at recognize that these two statements may selected to be short enough to ensure 28348). In addition, the commenter be confusing, and we have clarified the that, if the samples selected for periodic pointed out that the preamble to the text in § 1107.21(a) of the final rule to testing pass the test, then there is a high proposed rule also stated that the state that all third party periodic testing degree of assurance that the other appropriate periodic testing interval must be conducted by a CPSC-accepted untested children’s products ‘‘may vary for a manufacturer third party conformity assessment body manufactured during the interval depending on the manufacturer’s accredited to the scope of the tests comply with the applicable children’s knowledge of the product and its required. product safety rules. The interval for manufacturing processes’’ (75 FR at Additionally, on August 12, 2011, the periodic testing may vary, depending 28349). President signed into law H.R. 2715 upon the specific children’s product The commenter urged us to permit a which amended the CPSIA in several safety rules that apply to the children’s manufacturer of a children’s product respects. One provision in H.R. 2715 product. Proposed § 1107.21(c)(2)(i) with a reasonable testing program in requires us to seek public comment on through (c)(2)(ix) listed factors to be place to determine when to obtain third opportunities to reduce the cost of third considered when determining the party conformity assessment body party testing requirements consistent periodic testing interval. testing of ordinary children’s books or with assuring compliance with any On our own initiative, we made other children’s paper-based printed applicable consumer product safety several editorial and complementary products under a testing frequency rule, ban, standard, or regulation. changes to proposed § 1107.21(c). In standard of at least once every four Elsewhere in this issue of the Federal brief: years. The commenter noted that third Register, we have published a notice • We have renumbered proposed party conformity assessment body seeking public comment on the issues in § 1107.21(c) as § 1107.21(b) in the final testing still would occur in response to H.R. 2715. H.R. 2715 further requires us rule. a material change to the children’s to review the public comments and • In § 1107.21(b), we have revised the product. states that we may prescribe new or text to state the periodic testing options (Response 54)—The final rule extends revised third party testing regulations if more clearly. Section 1107.21(b) now the maximum testing interval for we determine that such regulations will states that a manufacturer ‘‘must periodic testing from one to two years reduce third party testing costs conduct periodic testing to ensure for manufacturers who have consistent with assuring compliance compliance with the applicable implemented a production testing plan with the applicable consumer product children’s product safety rules at least as a means of ensuring continued safety rules, bans, standards, and once a year,’’ except as otherwise compliance of the product to the regulations. provided in § 1107.21(c) and (d) (the applicable children’s product safety Regarding the commenter’s suggestion other periodic testing options in the rules. The production testing plan in on testing ordinary children’s books or final rule), or as provided in regulations § 1107.21(c) of the final rule is the same other children’s ordinary paper-based under this title. Section 1107.21(b) of production testing plan in the printed materials, section 14(i)(4) of the the final rule further states that if a reasonable testing program described in CPSA, as amended by H.R. 2715, manufacturer does not conduct

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production testing under § 1107.21(c), § 1107.21(b), the periodic testing must 10,000 units or less.) Yet another or testing by a testing laboratory under occur at least once a year. commenter interpreted the provision as § 1107.21(d), the manufacturer must • Section 1107.21(b)(2)(i) through (x) an acknowledgement by the CPSC that conduct periodic testing pursuant to the lists the factors to be considered in the periodic testing frequency standard periodic test plan requirements at determining the testing interval. This is not essential to safety because it § 1107.21(b)(1) and the testing interval list is almost identical to proposed dispenses with periodic testing requirements in § 1107.21(b)(2). § 1107.21(b)(2)(i) through (ix), except altogether in the case of manufacturers • In § 1107.21(b)(1) (formerly that the final rule separates the who produce or import no more than proposed § 1107.21(c)(1)), we have examples of nonmaterial changes that 10,000 units of a product. replaced ‘‘assure’’ with ‘‘ensure with a were at proposed § 1107.21(b)(2)(v). On August 12, 2011, the President high degree of assurance.’’ We made this Proposed § 1107.21(b)(2)(v) would signed H.R. 2715 into law. H.R. 2715 change to be consistent with other mention ‘‘Nonmaterial changes, such as requires, among other things, that we language used throughout the final rule. introduction of a new set of component seek public comment on opportunities We also replaced ‘‘children’s product parts into the assembly process, or the to reduce the cost of third party testing certification’’ with ‘‘Children’s Product manufacture of a fixed number of requirements consistent with assuring Certificate,’’ for consistency throughout products.’’ Upon further consideration, compliance with any applicable the final rule, and we eliminated the we felt that the two examples were consumer product safety rule, ban, requirement of providing a basis for dissimilar, so § 1107.21(c)(2)(v) of the standard, or regulation. It also contains determining that the periodic testing final rule now states: ‘‘Introduction of a special rules for small batch plan provides a high degree of assurance new set of component parts into the manufacturers and directs us to that the product being tested continues assembly process’’; and consider alternative testing to comply with all applicable children’s § 1107.21(c)(2)(vi) of the final rule requirements or exempt small batch product safety rules. We eliminated the states: ‘‘The manufacture of a fixed manufacturers from certain third party requirement that a manufacturer number of the products.’’ We have testing requirements. Given these new provide the basis for determining that a renumbered the remaining statutory obligations resulting from H.R. periodic test plan provides a high subparagraphs in § 1107.21(c)(2), 2715, and, as part of the overall degree of assurance because accordingly. reorganization of § 1107.21, proposed manufacturers would need to § 1107.21(d) is being renumbered and d. Periodic Testing Frequency for Low- demonstrate how their production reserved as § 1107.21(e), so that we may Volume Manufacturers testing plan provides a high degree of consider issues relating to cost, low- assurance if we requested that Proposed § 1107.21(d) would pertain volume products, and small batch information. However, it is to the periodic testing frequency for manufacturers more fully. unnecessarily burdensome to require a low-volume manufacturers. In brief, the We are also reserving § 1107.21(f) for manufacturer to provide the basis for proposal would not require a an amendment to this rule where, this in every instance, when we may manufacturer to conduct periodic elsewhere in this issue of the Federal never inquire about the basis for a testing unless it has produced or Register, we have published a proposed particular periodic test plan. Therefore, imported more than 10,000 units of a rule that would implement the we have eliminated this requirement particular product; instead, once that ‘‘representative samples’’ provision in from the final rule. In addition, we have threshold has been reached, the section 14(i)(2)(B)(ii) of the CPSA. added language to § 1107.21(b)(1) to manufacturer would be subject to the periodic testing requirements of 4. Proposed § 1107.22—Random clarify that a manufacturer must have a Samples periodic testing plan specific to each proposed § 1107.21(a), and (b), or (c). children’s product manufactured at a Several commenters addressed Proposed § 1107.22 would implement manufacturing site. proposed § 1107.21(d). The comments the testing of random samples • In § 1107.21(b)(2) (pertaining to spanned a range of issues. For example, requirement in former section testing intervals), we have revised the one commenter said that the production 14(d)(2)(B)(ii) of the CPSA (renumbered text to refer to ‘‘testing interval’’ or or importation volumes for different by H.R. 2715 as section 14(i)(2)(B)(ii) of ‘‘testing,’’ instead of ‘‘periodic testing children’s products may vary the CPSA), by requiring each interval’’ or ‘‘periodic testing.’’ ‘‘Testing substantially, such as large electrical manufacturer of a children’s product to Interval,’’ is substantially the same as motorcycles and small stuffed toys, so select samples for periodic testing by proposed § 1107.21(c)(2), except that, the commenter said it is not reasonable using a process that assigns each sample for consistency, the final rule refers to apply the same volume of 10,000 to in the production population an equal simply to a ‘‘testing interval,’’ rather all children’s products. The commenter probability of being selected. than a ‘‘periodic testing interval.’’ (The asked whether periodic testing is We received many comments on proposed rule had used different terms, necessary when a large number of proposed § 1107.22. The commenters such as ‘‘periodic testing interval,’’ products are produced in a short made numerous assertions, such as: ‘‘testing interval,’’ ‘‘interval,’’ and timeframe, for example, 100,000 toys Product samples should be reasonably ‘‘interval for periodic testing,’’ for the produced in three months. Other representative of the product same concept.) We removed the word commenters also focused on the 10,000 population; samples should not be ‘‘periodic’’ because it is redundant in figure, asking whether the figure applies golden samples; samples should be the context of the section, which only to the number of children’s selected blindly; samples should not be addresses ‘‘periodic testing.’’ products produced, whether the number selected with overt bias; and the rule Additionally, § 1107.21(b)(2) states that applies to each distinct product or to all should not use a statistical definition for the testing interval may vary, depending children’s products made at a facility, or random sample. Commenters also upon the specific children’s product whether the figure of 10,000 units is too expressed concern over practical safety rules that apply to the children’s high or too low. (One commenter stated problems with the proposed section for product, ‘‘but may not exceed one year.’’ that its analysis of CPSC-announced random sampling. However, on August We added ‘‘but may not exceed one recalls in 2009, showed that 47 percent 12, 2011, the President signed H.R. 2715 year’’ to clarify that, consistent with of the recalls involved products of into law. H.R. 2715 revised section

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14(i)(2)(B)(ii) of the CPSA, by replacing change in the product’s component would be difficult for a manufacturer to testing of ‘‘random samples’’ to ensure parts, would not be a ‘‘material change’’ identify every conceivable theoretical continued compliance with testing of under proposed § 1107.23(a) for the effect a change could have on a ‘‘representative samples’’ to ensure purposes of complying with the lead children’s product’s compliance. continued compliance. Given this content limits. However, for other Therefore, manufacturers should change in the statute, we have removed children’s product safety rules, such as exercise prudence and competence in § 1107.22 from the final rule. Elsewhere small parts, the change may be a determining the effects of a change to in this issue of the Federal Register, we material change. the product and in considering whether have published a proposed rule that Additionally, proposed § 1107.23(a) that change is material. This prudence would implement the ‘‘representative would require a manufacturer to and competence is encompassed in the samples’’ provision in H.R. 2715. exercise due care to ensure that reliance manufacturer’s use of due care in on anything other than retesting of the evaluating the change. 5. Proposed § 1107.23—Material Change finished product after a material change We decline the commenters’ a. General Requirements would not allow a noncompliant suggestion to modify the definition of Proposed § 1107.23(a) would state children’s product to be distributed in ‘‘material change’’ because the that if a children’s product undergoes a commerce. A manufacturer should definition now in § 1107.2 of the final material change in product design or resolve any doubts in favor of retesting rule includes the phrase ‘‘a manufacturer exercising due care.’’ manufacturing process, including the the finished product for certification. A manufacturer also would be required to Because the definition of ‘‘due care’’ sourcing of component parts, that a exercise due care to ensure that any includes the exercise of prudence and manufacturer exercising due care knows component part undergoing component- competence by the manufacturer, the or should know that such material part-level testing is the same as the addition of ‘‘reasonably could’’ is change could affect the product’s ability component part on the finished duplicative. to comply with the applicable children’s children’s product in all material (Comment 57)—One commenter product safety rules, the manufacturer respects. stated that different versions of the same must submit a sufficient number of We received several comments product (e.g., color, packaging) should samples of the materially changed regarding ‘‘material change’’ and not require different tests. product for testing by a third party proposed § 1107.23, as well as the (Response 57)—The commenter is conformity assessment body. Such corresponding provision at proposed correct that different versions of the testing would be required before a § 1107.10(b)(2)(ii). Although we have same product that are not materially manufacturer could certify the decided to reserve subpart B in the final different do not require separate children’s product. The extent of such rule, to the extent that comments on certification tests. The final rule defines testing would depend on the nature of proposed § 1107.10(b)(2)(ii) were a ‘‘material change’’ as any change in the material change. Proposed equally applicable to proposed the product’s design, manufacturing § 1107.23(a) also would state that, when § 1107.23, we have considered those process, or sourcing of component parts a material change is limited to a comments here. that a manufacturer exercising due care component part of the finished (Comment 55)—A commenter knows, or should know, could affect the children’s product and does not affect suggested that the definition of product’s ability to comply with the the ability of the children’s product to ‘‘material change’’ should be moved applicable rules, bans, standards, or meet other applicable children’s from proposed § 1107.10(b)(2)(ii) to the regulations. Therefore, if the differences product safety rules, a manufacturer definitions in § 1107.2. between various versions of the same may issue a Children’s Product (Response 55)—Section 1107.10 has product are not material changes, no Certificate based on the earlier third been reserved in the final rule. We agree additional testing is required. It is the party certification tests and on test with the commenter, and we have manufacturer’s responsibility to results of the changed component part moved the definition of ‘‘material determine if a difference between conducted by a third party conformity change’’ to § 1107.2 in the final rule, as versions of a product constitutes a assessment body. For example, if the this definition still applies to § 1107.23 ‘‘material change.’’ paint is changed on a children’s regarding material changes in children’s (Comment 58)—One commenter product, issuance of a Children’s products. Thus, § 1107.2 defines suggested that after certification testing Product Certificate may be based on ‘‘material change’’ as ‘‘any change in the of a product, if another product differs previous product testing and on tests of product’s design, manufacturing by a few minor components from the the new paint for compliance to lead, process, or sourcing of component parts certified product, and proper proof of heavy metal, and phthalate that a manufacturer exercising due care equivalent specifications are concentrations. Proposed § 1107.23(a) knows, or should know, could affect the documented, a reduced sample size for also would state that changes that cause product’s ability to comply with the certification should be allowed. a children’s product safety rule to no applicable rules, bans, standards, or (Response 58)—In the circumstance longer apply to a children’s product are regulations.’’ described by the commenter, if a new not considered to be material changes. (Comment 56)—Some commenters product differs from an existing certified For example, assume that a children’s suggested revising the proposed product by a few component parts, the product consists of a cotton sweater definition of ‘‘material change’’ to refer manufacturer’s knowledge of the new with metal buttons and that the only to changes that ‘‘reasonably could product and its manufacture might be children’s product would be subject to affect’’ compliance. extensive enough to result in requiring the lead limits in section 101 of the (Response 56)—The commenters are fewer samples for certification testing CPSIA. If the manufacturer decided to concerned about a remote possibility than the number required for the use wooden buttons instead of metal that some set of circumstances could existing certified product. We reiterate buttons, the use of wooden buttons combine, such that a seemingly that if a new product is based on would eliminate the need to test the innocuous change could affect the changes to an existing certified product, product for lead, and the change to product’s compliance to an applicable only the applicable product safety rules wooden buttons, while arguably a product safety rule. We realize that it affected by the changes require

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certification testing. The number of accompanying component part testing plan and to achieve passing production test samples still must be sufficient to give rule. results before the manufacturer may resume the manufacturer a high degree of (Comment 59)—Two commenters production of that product. assurance of the new product’s raised issues related to products subject (Response 59)—Although regulated compliance with the applicable to 16 CFR part 1201, Safety Standard for non-children’s products still must meet children’s product safety rules. The Architectural Glazing Materials, the certification requirements in section certifier also may use component part although the issues they raised have 14(a)(1) of the CPSA, we have reserved testing as a means of reducing the wider implications that involve other subpart B, including the reasonable number of finished samples needed for products, including children’s products. testing program described in proposed certification. If the changes from the The products subject to that safety § 1107.10. However, the broader issue existing certified product to the newer standard are glazing materials (glass) presented by this commenter, which product are not material, then the used or intended for use in doors and relates to adjustments in equipment or certification tests on the existing enclosures. The commenters noted that machinery, is applicable to children’s certified product can be used for these types of glass normally are products as well, so we will address this certification purposes on the newer manufactured in a continuous process issue with regard to children’s products. product. that is subject to numerous minor and In order for a change to be a ‘‘material Thus, on our own initiative, we have ongoing adjustments to respond to change,’’ it should be one that could revised § 1107.23(a) to make several atmospheric and other factors and to adversely affect the product’s ability to make sure that the tempering process clarifying changes to the paragraph. comply with the rule, ban, standard, or continues properly. In addition, there First, we have added language to the regulation. Minor and ongoing can be numerous minor variations in adjustments during manufacturing, final rule to require the number of format, size, and thickness of the glass, especially in continuous flow processes, samples submitted to be sufficient to as well as other product characteristics to maintain compliance with the provide a high degree of assurance that that are a normal part of shifting from applicable product safety rules are not the materially changed component part one product to another to meet considered material changes. However, or finished product complies with the customers’ orders. This industry’s we do not agree entirely with the applicable children’s product safety current process of certification and commenters’ suggested language rules. This language was added because quality control involves periodic third because that language would include third party testing that occurs after a party ‘‘certification’’ testing to the adjustments made to ‘‘achieve’’ material change serves as recertification requirements of 16 CFR part 1201 and compliance (i.e., to change a product of the product for the applicable uses alternate means for checking from noncompliance to compliance). children’s product safety rules affected breakage performance of samples from Such a change would constitute a by the material change. This language is subsequent production, such as a center ‘‘material change’’; thus, additional essentially the same requirement punch test for tempered glass and the certification testing would be required. contained in § 1107.20(a) of the final drop-ball and/or pummel test for (Comment 60)—One commenter rule for initial certification of children’s laminated glass, in order to monitor suggested that, in proposed products. Additionally, § 1107.23(a) was ongoing compliance with the standard. § 1107.10(b)(2), it also should be noted revised to add the following: ‘‘A If a potential failure of the standard is that testing of units within a common manufacturer of a children’s product detected by these alternate tests, family of products should allow a test that undergoes a material change cannot corrective action is taken, and product of one unit to represent all others within issue a new Children’s Product distribution is not resumed until a the family of products if the other Certificate for the product until the subsequent production test shows that models are materially the same. The product meets the requirements of the the breakage performance has been commenter added that, regarding applicable children’s product safety restored. proposed § 1107.10(b)(2)(ii)(B), a rules.’’ Also, we added the following The commenters requested manufacturer should not be required to words to the first sentence: ‘‘and issue clarification that the ongoing conduct additional ‘‘certification’’ a new Children’s Product Certificate.’’ adjustments described above would not testing upon a change to the parts or These are not intended to be substantive be ‘‘material changes’’ that would materials, if the change does not affect changes, but rather, meant to make clear require recertification of the product. the overall safety of the system. The what is already the case—that material The proposed rule defines ‘‘material commenter suggested that we revise the changes require recertification based on change’’ as one that ‘‘could affect the section to give manufacturers the ability passing test results. Finally, we have product’s ability to comply with the to make changes to parts and materials removed the language in proposed applicable rules * * *’’ One commenter without having to undergo costly and § 1107.23(a) that would require a requested that we state: time-consuming certification testing. manufacturer to exercise due care to The commenter would allow ensure that reliance on anything other An adjustment to equipment or machinery manufacturers to conduct in-house retesting of the finished product after a made in order to maintain, achieve, or assure compliance with the applicable rules * * * testing that would show that the results material change would not allow a is not a material change within the meaning of any change do not materially alter the noncompliant children’s product to be of section 1107.10. performance of that part or system with distributed in commerce. This provision regard to the safety elements in the The other commenter suggested the was removed because this issue is applicable rule. addressed in § 1109.5(a)(1) of the following addition to the rule: (Response 60)—Although regulated accompanying component part testing Adjustments in the equipment or non-children’s product must still meet rule. We also removed the requirement machinery to affect the product’s ability to the certification requirements in section that a manufacturer should resolve any comply with any applicable rules or 14(a)(1) of the CPSA, we have reserved standards should not be considered a doubts in favor of retesting the finished ‘‘material change’’ in the manufacturing subpart B, including the reasonable product for certification. This provision process * * * but will require the testing program described in proposed was removed because the issue is manufacturer, following those adjustments to § 1107.10. However, the broader issue addressed in § 1109.5(c) of the subject the product to its production testing presented by this commenter related to

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certification testing of units within a adversely affect compliance to the product change that could occur to all common family and when there has applicable children’s product safety affected products that might adversely been a material change to a product is rules are not ‘‘material changes’’ under affect compliance to an applicable applicable to children’s products as the final rule and do not require product safety rule and provide specific well, so we will address this issue with recertification testing. However, language. Therefore, the final rule is regard to children’s products. manufacturers may wish to consider written using general language to allow The final rule does allow what the possible material change testing as part manufacturers the flexibility to commenter is suggesting—that testing of of their product improvement processes. determine, in each particular units within a common family of (Comment 62)—Three commenters circumstance, whether a product change products be allowed to represent all of characterized the testing requirements could adversely affect the product’s the other units within the family. resulting from the proposed definition compliance with an applicable Section 1107.20(a) of the final rule of ‘‘material change’’ as ‘‘overly children’s product safety rule. states that samples used for certification burdensome’’ and ‘‘very unreasonable.’’ Manufacturers should use their special must be identical in all material respects The commenters differed in their knowledge of a product’s design, to the finished children’s product. If, as reasons for arriving at this conclusion. components, and manufacturing the commenter has stated, the tested One commenter characterized the processes to differentiate what changes units are identical in all material proposed rule’s material change testing may constitute a ‘‘material change,’’ and respects as others within the product requirements as too ‘‘open ended’’ require certification testing, as opposed family, then the test results can be because of imprecise language. The to nonmaterial changes. applied to the other units within the consequence of this lack of specificity, After initial certification of a product, product family. according to the commenter, is that a ‘‘material change’’ is a change that Section 1107.23(a) describes testing ‘‘either you will always test or you take ‘‘could affect the product’s ability to requirements when there has been a a big risk. This is completely unfair and comply with applicable rules, standards material change in a children’s product. unreasonable.’’ or regulations.’’ The ability to adversely If a change could adversely affect Another commenter expressed affect compliance is what distinguishes compliance with the applicable concern with the examples in proposed a ‘‘material change’’ from nonmaterial children’s product safety rules, then it is § 1107.23(c). Specifically, the changes. The final rule acknowledges considered a ‘‘material change,’’ and commenter stated that manufacturing that a manufacturer has special retesting is required. If the commenter’s process changes, ‘‘such as new solvents knowledge of its product design, phrase ‘‘does not affect the overall safety to clean equipment or a new mold for components and, production processes, of the system’’ means that the change an accessible metal component part of a and the rule states that a ‘‘manufacturer does not affect compliance with the children’s product pose undue burdens exercising due care knows or should applicable rules, then the change is not on manufacturers without advancing know’’ when a change is material. For considered a ‘‘material change,’’ and no safety goals.’’ The commenter example, a new solvent that does not recertification testing is required. contended that ‘‘to require companies to (Comment 61)—Some commenters develop new product specifications for contain any of the prohibited chemicals stated that the requirement to submit a every new solvent used in a facility or (lead and the prohibited phthalates), or sufficient number of samples of a installation of a new mold made to the a replacement mold shown to be made materially changed product for third exact specifications as a prior mold’’ to the same specifications as a party testing before certifying the would require new third party testing, compliant mold, would not be examples changes would be costly and would and this could not have been Congress’ of ‘‘material changes.’’ inhibit manufacturers from making intent. The commenter suggested: ‘‘it (Comment 63)—One commenter continuous product improvements. should be left to the consumer product noted that proposed Ultimately, according to the manufacturer to assess whether changes § 1107.10(b)(2)(ii)(A) would state that, commenters, this will reduce the safety are likely to affect the ability of the for material changes that only affect of children’s products. particular product to meet a specific product compliance to certain rules, (Response 61)—Section 14(i)(2)(B)(i) standard, ban, rule, or regulation.’’ certification may be based on the of the CPSA requires children’s The third commenter stated that the materially changed component, unless products to be subject to third party proposed definition is not clear and the change affects the finished product. conformity assessment body testing asked whether ‘‘using the same quality If the change affects the finished when there has been a material change level of component part but just the product, then the certification must be in the product’s design or different brand is a material change.’’ based on the finished product. (The manufacturing process. These types of The commenter stated that if third party commenter is referring to proposed changes may introduce new hazards or testing of each such change is necessary, § 1107.10(b)(2)(ii)(A) and (C).) The may result in the product no longer then ‘‘it is very unreasonable.’’ commenter asked, when a disagreement being in compliance with the applicable (Response 62)—The intent of arises, who makes the final children’s product safety rules. After a § 1107.23 for children’s products is not determination of whether the material material change to the product, only to be overly burdensome, but rather, to change affects the finished product’s those applicable product safety rules demonstrate the product’s continued compliance? that could adversely be affected require compliance with applicable children’s (Response 63)—We have reserved recertification. The samples selected product safety rules when a change in subpart B, including the reasonable must be of a sufficient number to the product’s design, manufacturing testing program described in proposed provide a high degree of assurance that process, or component part sourcing has § 1107.10. However, the broader issue the test, conducted accurately, been made that could adversely affect a presented by this commenter relates to demonstrates the ability of the previously certified product’s certification testing of units when there children’s product to meet all applicable compliance. Because the final rule has been a material change is applicable children’s product safety rules. applies to a variety of products and to children’s products as well, so we Regarding continuous product manufacturing methods, it is will address this issue with regard to improvements, changes that do not impractical to anticipate every type of children’s products.

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The commenter is correct that when initiative, we have revised the second children’s product with another a material change to a product occurs, sentence in § 1107.23(b) to state that a component part could affect compliance only product safety rules affected by the manufacturer should examine the with the applicable children’s product material change would require product design for the children’s safety rules. This would include, but recertification. If the material change product ‘‘as received or assembled by would not be limited to, changes in solely affects a component part of a the consumer.’’ We inserted the words component part composition, children’s product and does not affect ‘‘or assembled’’ because some children’s component part supplier, or use of a the ability of other component parts or product safety rules require the product different component part from the same the finished product to comply with to be tested in the finished product state supplier who provided the initial applicable children’s product safety in order to assess compliance with the component part. rules, then § 1107.23(a) allows a applicable children’s product safety We received no comments on this manufacturer to base certification on rule. For example, assessing compliance paragraph. However, on our own earlier third party certification tests and with the inaccessibility requirements for initiative, we have revised the first on third party testing of the changed the lead requirements mandates testing sentence to replace the phrase component part. of the finished product in order to ‘‘applicable children’s product safety With regard to disagreements determine whether a component part of rules’’ with ‘‘applicable children’s regarding whether the finished the product is accessible. The new product safety rule.’’ We made this children’s product is needed for language, ‘‘or assembled,’’ was added to change to avoid creating any certification after a material change, a make it clear to the manufacturer that misunderstanding of whether a material manufacturer must use due care in products must be tested as received or change results only if multiple determining whether testing the assembled by the consumer in those children’s product safety rules are finished product or a component part is instances where the product is not affected; in other words, a material required. This due care is applied on a received in assembled form. change can result, even if compliance per-rule basis. Some rules, such as with only one children’s product safety prohibited phthalate content, can be c. Manufacturing Process rule is affected. evaluated on component parts. Other Proposed § 1107.23(c) would state 6. Proposed § 1107.24—Undue rules, such as the safety standard for that a material change in the Influence cribs, always require the use of the manufacturing process is a change in finished product for certification testing. how the children’s product is made that Proposed § 1107.24(a) would Assuming the disagreement is between could affect the finished children’s implement the requirement to safeguard the manufacturer and the CPSC product’s ability to comply with the against undue influence, pursuant to regarding whether a finished product is applicable children’s product safety section 14(i)(2)(B)(iv) of the CPSA, by required for certification after a product rules. For each change in the requiring each manufacturer to establish change, we will decide, based on the manufacturing process, a manufacturer procedures to safeguard against the available evidence, whether a material should exercise due care to determine if exercise of undue influence by a change requires samples of the finished compliance to an existing applicable manufacturer on a third party product for certification. children’s product safety rule could be conformity assessment body. b. Product Design affected or if the change results in a a. Procedures To Safeguard Against the newly applicable children’s product Exercise of Undue Influence Proposed § 1107.23(b) would state safety rule. The following are some that, for purposes of subpart C, the term examples of a material change to the Proposed § 1107.24(a) would require ‘‘product design’’ includes all manufacturing process of a children’s the manufacturer to establish component parts, their composition, product: procedures to safeguard against the and their interaction and functionality • A new technique is used to fasten exercise of undue influence by a when assembled. To determine which buttons to a doll’s dress that could affect manufacturer on a third party children’s product safety rules apply to the children’s product’s ability to conformity body. a children’s product, a manufacturer comply with the small parts rule; (Comment 64)—Several commenters should examine the product design for • New solvents are used to clean disagreed with the requirement in the children’s product as received by equipment employed in the proposed § 1107.24(a) that the consumer. For example, if a manufacture of children’s products; the manufacturers must establish children’s product has a component part new solvents could affect the children’s procedures to safeguard against the that contains lead or has a sharp edge, product’s ability to comply with the exercise of undue influence on a third but is inaccessible when the product is lead content and phthalates party conformity assessment body. One assembled, then the lead and sharp edge requirements; and commenter noted that we already requirements would not be applicable to • A new mold for an accessible metal require third party conformity the finished product. Changes to a component part of a children’s product assessment bodies to train their staff to product’s design may result in a product is introduced into the assembly line that detect, avoid, and report undue being subject to additional children’s could affect the children’s product’s influence. Another commenter stated product safety rules. For example, if a ability to comply with requirements for that third party testing facilities already wooden button on a children’s product sharp edges. have these training programs in place. is replaced with a plastic button, the We received no comments on this Two commenters asserted that third wooden button previously excluded paragraph and have finalized it without party conformity assessment bodies are from testing for lead content has been change. not likely to be influenced unduly replaced with a component part (the because their accreditation would be plastic button) that would be subject to d. Sourcing of Component Parts withdrawn. testing for compliance with the lead Proposed § 1107.23(d) would state (Response 64)—Section 14(i)(2)(B)(iv) content requirements. that a material change in the sourcing of of the CPSA requires us to establish, by We received no comments on this component parts results when the rule, protocols and standards for paragraph. However, on our own replacement of one component part of a safeguarding against the exercise of

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undue influence by a manufacturer or on test reports from a third party Two commenters stated that the training private labeler on a third party conformity assessment body over whom program and recordkeeping conformity assessment body. This undue influence has been exercised requirements (proposed § 1107.26(a)(5)) provision applies to manufacturers and provides a basis for the CPSC to deem are burdensome and redundant because private labelers as opposed to third the certificate invalid. We will hold the companies already have requirements to party conformity assessment bodies. finished product certifier responsible for prohibit unethical behavior, such as Consequently § 1107.24 of the final rule exercising due care that component part exerting undue influence over third requires manufacturers of children’s or finished product manufacturers or party conformity assessment body staff. products to establish procedures to suppliers have not exercised undue Other commenters described this avoid actions that could undermine the influence over third party conformity requirement as excessive and integrity of laboratory test data. We have assessment bodies. unreasonable. One commenter stated an interest in ensuring the integrity of (Comment 66)—Two commenters that the requirements for training are laboratory test results used in the stated that because the term ‘‘undue’’ is vague and urged us to describe what certification of children’s products. undefined, nothing should be construed needs to be included. Another In a separate rulemaking, we will to prohibit a manufacturer from commenter raised questions about the address the issue of requiring third exercising its rights to challenge third content and form of the training, party conformity assessment bodies to party conformity assessment body test especially whether a written manual report undue influence. results based upon the manufacturer’s would be enough. Another commenter (Comment 65)—Some commenters belief that they are inaccurate. recommended deleting these expressed concern regarding foreign (Response 66)—Section 1107.24 is not requirements. manufacturers and the undue influence intended to preclude a manufacturer One commenter urged us to delete the requirement. One commenter suggested from challenging failing test results in requirement for appropriate staff to that we will be unable to enforce the appropriate circumstances. If a receive ‘‘annual training’’ on how to undue influence requirement on foreign manufacturer has reason to think a test avoid undue influence. The commenter manufacturers and importers. Another result received from a third party felt that an annual training mandate commenter said that the importer of conformity assessment body is in error, would be unnecessary and impose record should not be responsible for it is appropriate to ask the third party excessive costs and burdens on undue influence initiated by people not conformity assessment body about the manufacturers of children’s products. directly employed by the importer of test result. Such inquiry does not (Response 67)—Section 14(i)(2)(B)(iv) record. The commenter requested constitute undue influence. of the CPSA requires us to establish confirmation that importers will be Additionally, § 1107.20(d) requires a protocols and standards, by rule, for responsible for training their employees manufacturer to investigate the reasons safeguarding against the exercise of only, and will not have the for a negative certification test result undue influence on third party responsibility of training the employees and to take action to address failing test conformity assessment bodies by a of other companies, such as results before a Children’s Product manufacturer or private labeler. manufacturers, vendors, freight Certificate can be issued. This Therefore, we decline the suggestion to handlers, or laboratories. investigation may involve discussions delete these requirements from the final (Response 65)—Section 1107.24 of the about the test results with the third rule. final rule requires ‘‘each manufacturer’’ party conformity assessment body. Section 1107.24 of the final rule to establish procedures to safeguard implements the statutory mandate by against the exercise of undue influence b. Minimum Requirements requiring manufacturers to establish by a manufacturer on a third party Proposed § 1107.24(b) would require procedures to safeguard against the conformity assessment body. Section the procedures described in § 1107.24(a) exercise of undue influence by a 1107.2 of the final rule defines a to include minimal requirements. manufacturer on a third party ‘‘manufacturer’’ as ‘‘the parties Proposed § 1107.24(b)(1) would require conformity assessment body. The rule responsible for certification of a safeguards to prevent attempts by the does not prescribe the form or content consumer product pursuant to 16 CFR manufacturer to exercise undue of these programs in order to provide part 1110.’’ Under 16 CFR part 1110, a influence on a third party conformity manufacturers flexibility in foreign manufacturer is not required to assessment body, including a written implementing the requirements. For certify a finished product; only a policy statement from company officials example, manufacturers may wish to domestic manufacturer or the importer that the exercise of undue influence is create written manuals and may include of a product made outside the United not acceptable, and directing that this training along with other forms of States is required to issue a finished appropriate staff receive annual training employee training. Manufacturers must product certificate. Thus, under on avoiding undue influence and sign a keep records of employee participation § 1107.24, it is a domestic manufacturer statement attesting to participation in in the training to be able to ensure that or the importer who must establish such training. Proposed § 1107.24(b)(2) all relevant staff members receive this procedures to safeguard against undue would impose a requirement to notify training pursuant to § 1107.26(a)(6). influence. the Commission immediately of any We do agree, however, with the We agree that an importer is not attempt by the manufacturer to hide or commenter who suggested that an directly responsible for training exert undue influence over test results. annual training requirement reiterating employees of other companies. This Proposed § 1107.24(b)(3) would impose previously presented procedures can fact, however, does not absolve the a requirement to inform employees that impose costs and burdens the benefits of importer issuing a finished product allegations of undue influence may be which are unclear. Thus, we have certificate of its duty to exercise due reported confidentially to the replaced the proposed requirement for care when relying on test results Commission and describe to employees annual training with a requirement for provided by another company or third the manner in which such a report can retraining when a substantive change to party conformity assessment body. A be made. the rule is made regarding undue manufacturer or importer who issues a (Comment 67)—Several commenters influence; this requirement appears as a finished product certificate that is based made remarks about training programs. new § 1107.24(b)(2), and we have

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renumbered proposed §§ 1107.24(b)(2) either for certification or for ensuring suspicion about the manner in which a and 1107.24(b)(3) as §§ 1107.24(b)(3) continued compliance of consumer sample was handled or processed, or the and 1107.24(b)(4), respectively, in the products. Ultimately, the manufacturer certifier is challenging the results of a final rule. Manufacturers of children’s is responsible for ensuring that the third party test. products are free to modify their product that they make complies with One commenter asserted that if the procedures and conduct retraining as the applicable product safety rules. For manufacturer documents and supports often as they feel it is necessary to some products and types of failing test any assertions related to the faulty test institute effectively their policies for reports, ad hoc methods may be as and the product’s compliance, there safeguarding against the exercise of effective as preestablished plans in should be no need for remedial action. undue influence. addressing the test failures and ensuring Another commenter suggested that the Additionally, on our own initiative, that products are compliant. For these implication in the rule is that any test we have revised § 1107.24(b) of the final reasons, we have removed the failure, no matter how trivial, would rule to make minor editorial or requirements for remedial action plans trigger the need for remedial action, grammatical changes. We have revised for children’s products from the final which would be costly. The commenter § 1107.24(b)(1) to direct that ‘‘every rule. We encourage manufacturers who suggested that establishing tolerances appropriate staff member’’ receive believe that remedial action plans for test results is necessary to reduce training on how to avoid undue would be advantageous for their product testing costs, as well as the burden of influence. The proposal would state that to develop such plans as part of their remedial actions, and at the same time ‘‘appropriate staff receive annual overall quality assurance system. ensure product safety. The commenter training.’’ By referring to ‘‘every (Comment 69)—One commenter added that children’s products are not appropriate staff member,’’ the final rule appreciated the acknowledgement that a so consistent that every test produces clarifies that the emphasis is on training remedial action plan could be a formal the same test result. The commenter individuals rather than collections of standard operating procedure (SOP), asserted that retesting is a valid means individuals. Additionally, in along with recordkeeping of each event. of responding to a failing test result. § 1107.24(b(4), we have replaced The commenter asked whether, when a Banning retesting out of fear that some ‘‘Commission’’ with ‘‘CPSC’’ and particular component causes a product unscrupulous parties will attempt to test replaced ‘‘to describe the manner’’ with to become noncompliant with a rule, the product into compliance will create ‘‘a description of the manner.’’ and the remedial action eliminates this severe problems. specific component from the product, (Response 70)—We have removed the 7. Proposed § 1107.25 Remedial would certification have to be repeated. requirement for a remedial action plan Action The commenter noted that for children’s products from the final Proposed § 1107.25 would require documentation would be provided that rule. However, we recognize that an each manufacturer of a children’s the noncompliant component had been error or failure in the testing of a sample product to have a remedial action plan removed and that the product may lead to a failing test result, and that contains procedures that the specification was revised. The therefore, investigating the test method manufacturer must follow to investigate commenter stated that there would be and test execution is a legitimate avenue and address failing test results. an SOP that requires a corrective action, of investigation in those instances. Such (Comment 68)—One commenter along with documentation of the an investigation can include examining stated that requiring each manufacturer instance of noncompliance, to provide the test procedures, sample preparation to have an actual remedial action plan evidence that the product has been steps, equipment calibration, and other to address failing test results is corrected and is compliant. factors, in addition to tests on samples unnecessary because the remedial (Response 69)—As noted in our of the product as part of the action will likely be different, response to Comment 68, we have investigation, which may affect test depending upon the situation. Another removed the requirement for a remedial results, but are not indicative of a commenter stated that because they are action plan for children’s products from noncompliant product. Additionally, familiar with how to resolve compliance the final rule. If a finished product has § 1107.20(d) of the final rule states that and quality issues, the preparation of a a noncompliant component part (such if a product sample fails certification detailed written remedial action plan is as an accessory item), and that item is testing to the applicable children’s a waste of time, money, resources, and removed from the finished product, the product safety rule(s), even if other intellect. finished product certifier does not have samples have passed the same (Response 68)—The commenter is to repeat certification testing on the certification test, the manufacturer must correct that, depending on the product newly constituted finished product investigate the reasons for the failure and the nature of the test failure, because the certifier has certification and take the necessary steps to address remedial actions may take many test data demonstrating compliance the reasons for the failure. A different forms. The development of a with all applicable product safety rules manufacturer cannot certify the remedial action plan before production for that product. The certifier should children’s product until the commences could help in the make sure that eliminating the manufacturer establishes, with a high determination of factors, such as lot size noncompliant component part does not degree of assurance that the finished or what tracking information to affect compliance with another product does comply with all applicable maintain. These factors could help limit applicable children’s product safety rule children’s product safety rules. While the number of production units subject for the finished product. the final rule no longer refers to to recall in the event that noncompliant (Comment 70)—Several comments remedial action plans, a manufacture products are introduced into commerce. addressed the issue of retesting samples. still ‘‘must investigate the reasons for However, although it may be efficient Some commenters noted that often, a the failure and take the necessary steps and useful to have a formal process testing failure might result from a faulty to address the reasons for the failure.’’ (such as the remedial action plan in laboratory test and not from a Retesting a product without proposed § 1107.25) to follow after noncompliant product. The commenters investigating why the test yielded receiving failing test reports, such said that the rule should allow retesting failing results, and taking whatever preformulated plans are not essential, in appropriate situations when there is action addresses the situation (for

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example, calibrating the testing machine certificate’’ to ‘‘A copy of the Children’s be maintained for five years. All records before retesting, or correcting a Product Certificate.’’ This change is would be required to be available in the manufacturing problem) to achieve intended to simplify the language in the English language. passing results, is not acceptable for codified text and use a consistent style (Comment 72)—One commenter certification purposes because the throughout part 1107 when referring to expressed concern about the certifier would not have a high degree the Children’s Product Certificate. recordkeeping requirements in proposed of assurance that the products produced • We have finalized § 1107.26(a)(2) § 1107.10(b)(5) and asked for will be compliant with the applicable without change. clarification of the phrase ‘‘for as long • product safety rules. In § 1107.26(a)(3), we have revised as the product is in production or Retesting should not be conducted to the recordkeeping elements to reflect imported.’’ The commenter noted that ‘‘shop’’ for passing test results or to keep changes to the periodic testing provision the requirements would lead to a testing the product until a sample at § 1107.21. Thus, the final rule massive undertaking for any finally passes (and disregarding all other requires records of: (1) The periodic test manufacturer or importer, especially if tests that suggest the product is not in plan and periodic test results; (2) a all of the records must be maintained compliance). production testing plan, production test within the United States. With regard to establishing tolerances results, and periodic test results; or (3) Another commenter stated that we for test results, the acceptable values for testing results of tests conducted by a should clarify the relationship between test results are established in each rule, testing laboratory accredited to ISO/IEC the requirement to maintain records and ban, regulation, or standard and are 17025:2005 and periodic test results. • the proposed rule’s treatment of beyond the scope of this rule. We have reserved § 1107.26(a)(4). material changes requiring (Comment 71)—One commenter We intend to place any recordkeeping recertification, and thus, effectively stated that some standards, such as the requirement associated with the testing creating a new product. To simplify the standard for the surface flammability of of ‘‘representative samples’’ at recordkeeping requirements, the carpets and rugs (16 CFR part 1630), § 1107.26(a)(4). As we stated earlier in commenter asked that the recordkeeping have alternative requirements for part III.D.4 of this document, the final requirements apply ‘‘for as long as the products that fail tests. The commenter rule removes § 1107.22 because H.R. product, without a material change, is suggested modifying the language to 2715 amended the CPSA to change in production or imported by the refer to a product that does not pass the ‘‘random samples’’ to ‘‘representative manufacturer plus five years’’ (emphasis samples.’’ applicable product safety standard, • in original). Otherwise, the commenter rather than a product that ‘‘fails’’ a test. We have renumbered proposed stated, manufacturers of long-running (Response 71)—In 16 CFR part 1630, § 1107.26(a)(4) as § 1107.26(a)(5), and products would have to maintain the standard allows for a single failure we have finalized it without change. records in perpetuity, which would • We have renumbered proposed in eight tests. Because there is an increase costs without assisting safety or § 1107.26(a)(5) as § 1107.26(a)(6), and allowance in the standard for a failing compliance. we have finalized it with one change to test result, we would view such a (Response 72)—Although the final product as compliant with the standard. clarify that manufacturers must retain copies of the attestations required under rule reserves subpart B (which includes 8. Proposed § 1107.26 Recordkeeping § 1107.24(b)(1). proposed § 1107.10(b)(5)), the issues • raised by the commenters are applicable a. The Records To Be Kept We have deleted proposed § 1107.26(a)(6), which would pertain to to the recordkeeping requirement for Proposed § 1107.26(a) would require a records of all remedial actions. We have children’s products, so we address this children’s product manufacturer to deleted this provision from the issue here for children’s products. maintain records pertaining to: recordkeeping requirements because the We agree that the burden of • The Children’s Product Certificate final rule does not establish remedial maintaining records for the life of a for each product (proposed action requirements for children’s product, plus five years, could be § 1107.26(a)(1)); products. unduly burdensome and difficult to • Each third party certification test implement, in cases where products (proposed § 1107.26(a)(2)); b. The Location Where Records Are To undergo changes over time. Moreover, • The periodic test plan and periodic Be Kept, the Recordkeeping Period, and having a different time period for the test results (proposed § 1107.26(a)(3)); the Records’ Availability in the English retention of test reports versus other • Descriptions of all material changes Language records may be confusing. Accordingly, in product design, manufacturing Proposed § 1107.26(b) would require a we have revised the recordkeeping process, and sourcing of component manufacturer to maintain the records provision, such that all records must be parts, and the certification tests run and specified in subpart C at the location maintained for at least five years from the test values (proposed within the United States set forth in 16 the date of their creation. If a product § 1107.26(a)(4)); CFR 1110.11(d) or, if the records are not does not comply with an applicable • Undue influence procedures maintained at the custodian’s address, children’s product safety rule in a (proposed § 1107.26(a)(5)); and at a location within the United States significant way, it is likely that the • All remedial actions taken specified by the custodian. The noncompliant aspect of the product following a failing test result (proposed manufacturer would be required to would become apparent within the 5- § 1107.26(a)(6)). make these records available, either in year period. This change should result We did not receive any comments hard copy or electronically, for in less confusion for the regulated directly addressing proposed inspection by the CPSC, upon request. community regarding how long records § 1107.26(a). However, on our own Proposed § 1107.26(c) also would for a particular product must be initiative, or to complement other require a manufacturer to maintain maintained. changes in the final rule, we have records (except for test records) for as Additionally, on our own initiative, revised § 1107.26(a) as follows: long as the product is in production or we have reorganized proposed • In § 1107.26(a)(1), we have changed imported by the manufacturer, plus five § 1107.26(b) and (c), by combining them ‘‘Records of the children’s product years. Test records would be required to into § 1107.26(b) of the final rule. We

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describe other changes in § 1107.26 negotiated with CPSC staff. Given this be kept in the United States, we decline immediately below. change to the final rule, we decline to to adopt the suggestion of a 3-year stay (Comment 73)—Several commenters adopt the suggestion that a 3-year stay of enforcement of this part of the rule. expressed concern about the of enforcement be implemented for this Regarding harmonization with the requirement that records be maintained part of the rule. requirements of ISO 9001, the in English. Some commenters stated (Comment 74)—Many commenters commenter did not specify which that we should allow records to be kept expressed concern about the requirements in ISO 9001 should be in the local language and only require requirement in proposed § 1107.26(b) harmonized. However, eliminating the translation into English by the that all records be maintained in the requirement that records be maintained manufacturer or importer when we United States. Several commenters at a location within the United States request documentation. One commenter suggested that instead of requiring would be consistent with sections noted that the proposed rule will manufacturers to maintain records at a 4.2.3.d of ISO 9001 (to ensure that require millions of test reports and location within the United States, we relevant versions of applicable records to be created and maintained in should allow the records to be documents are available at points of English, even though only a small maintained outside the United States, so use), and section 4.2.3.g of ISO 9001 (to fraction of a percent of these test reports long as the records can be accessed from prevent the unintended use of obsolete will ever be reviewed by the CPSC or a location within the United States that documents, and to apply suitable other third parties. The commenter is specified on the certificate. Some identification to them if they are maintained that this would be very commenters noted that this requirement retained for any purpose). expensive for the manufacturer because would be a burdensome and massive (Comment 75)—One commenter they must find and hire English- undertaking. One commenter did not stated that some of the required speaking technicians to perform the believe that storing foreign recordkeeping is ‘‘redundant and testing. manufacturing documents in the United unnecessarily duplicative,’’ such as The commenter also contended that States for every regulated product production testing plans for multiple this requirement could be potentially increases product safety. The factories. Fees for outsourcing these hazardous. The commenter posed this commenter noted that these documents services could be significant and example: could be stored in their existing location burdensome to many small businesses, and be submitted to the CPSC, upon the commenter asserted. For example, a quality assurance request. Alternatively, the commenter (Response 75)—Section 1107.21(c)(2) technician in Vietnam may be excellent at of the final rule sets forth the option to maintaining the quality of a product, and she suggested that a 3-year stay of the may even have a passable grasp of English, requirement that documents be implement a production testing plan to but her English skills may not be sufficient maintained in the United States would increase the maximum periodic test to communicate precise technical findings in allow a transition period to establish interval, and § 1107.21(c)(2)(ii) of the English. If she is nonetheless required to and implement appropriate final rule requires that each record her findings in English, then there is infrastructure and processes for manufacturing site conduct separate a risk the test results will be transcribed, expanded recordkeeping. production testing because the location described and maintained inaccurately. Another commenter noted that ISO at which a product is manufactured Thus, we ask that the Commission reconsider 9001, Quality management systems— could have a material effect on the this English-only requirement in the Requirements, requires manufacturers to product’s ability to comply with the proposed rule. maintain these types of records at the applicable rules. Factors such as power Another commenter asserted that a factory where a product subject to quality, climate, personnel, and factory method for making documents available certification is manufactured. Rather equipment could materially affect the in English in the United States would than requiring foreign manufacturers to manufacture of a product. Because it need to be created to comply with the maintain duplicate records in the cannot be assumed that units of the rule. The commenter contended that the United States, the commenter suggested same product manufactured in more requirement to have English language that the final rule should harmonize than one location are identical in all documents available within the United CPSC requirements with ISO’s, and material respects, the finished product States does not offer additional require records to be made available to certifier must conduct separate confidence in product safety for U.S. us for inspection, either in hard copy or production testing for the product for consumers. Alternatively, the electronically, through the U.S. each manufacturing site. We have taken commenter suggested that a 3-year stay subsidiary or other U.S. corporate other steps to reduce the recordkeeping of the requirement that documents be entity, within a reasonable time after the burden, such as not requiring that maintained in English would allow a CPSC requests them, pursuant to section records be kept in the United States, and transition period to establish and 16(b) of the Consumer Product Safety we are eliminating the requirement that implement appropriate infrastructure Act. all records must be maintained in and processes for expanded (Response 74)—We agree that it may English. recordkeeping. be burdensome and duplicative in many (Comment 76)—One commenter (Response 73)—We agree that it cases to maintain all records in the noted that companies have established would be burdensome in many cases for United States. To reduce this burden processes and formats and, in many all records to be maintained in English. and still maintain prompt access to cases, invested in information Therefore, § 1107.26(b) in the final rule records when needed, § 1107.26(b) of technology solutions to prepare and allows records to be maintained in the final rule no longer requires records transmit these certificates in accordance languages other than English, if the to be maintained in the United States. with the law. The commenter added: records in the original language can be However, all records must be made ‘‘Retailers are relying upon such provided immediately by the available, either in hard copy or certificates as they can with the benefit manufacturer to the CPSC, and if an electronically, such as through an of reduced liability under section 19 of accurate English translation can be Internet Web site, for inspection by the the CPSA’’ as evidence that the products provided within 48 hours, or within CPSC, upon request. Because the change comply with all the applicable product such longer period of time, as may be eliminates the requirement that records safety rules. The commenter stated that

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we need to clarify that the form of with recordkeeping requirements, such build and program such a system. These delivery of title, in and of itself, should as reducing and simplifying the record furniture companies will require not require additional testing, retention period to five years from the additional staff to maintain and update documentation, and certification. The date of creation for all records, the system, and that will require the commenter also asked us to clarify that eliminating the requirement that records expenditure of at least $30,000 to retailers can rely upon domestically must be maintained in English, and $50,000 a year, per person. located supplier certifications without eliminating the requirement that records (Response 78)—We acknowledge that duplication of testing and certification must be maintained in the United there will be costs for tracking the data requirements. States. Moreover, removal of the and maintaining the records, which (Response 76)—A certificate must remedial action plan requirement for could involve the development of accompany the product, as specified in children’s products should further software for tracking and managing the 16 CFR part 1110. Certificates can be in reduce the recordkeeping burden for data and hiring additional staff. paper or electronic form, as described manufacturers. However, the final rule’s recordkeeping by the commenter. The commenter is Even with these changes, the burden requirements give manufacturers correct that the issuance of a Children’s associated with the rule’s recordkeeping flexibility in determining how to meet Product Certificate means that the requirements will vary among them. Further, we have revised the final children’s product has passed its manufacturers or importers. As the rule to reduce costs associated with certification tests. If the commenter is commenters indicate, some recordkeeping requirements, such as referring to additional third party tests manufacturers will consider the burden reducing and simplifying the record requested by retailers after the issuance to be significant, whereas others will retention period to five years from the of a certificate, we emphasize, as we did feel that the recordkeeping requirements date of creation for all records, in the preamble to the proposed rule, are comparable to those at ‘‘any eliminating the requirement that records that retailers and sellers of children’s responsible firm.’’ The recordkeeping must be maintained in English, and products can rely on certificates burden could be fairly heavy for some eliminating the requirement that records provided by product certifiers without products and relatively light for others, must be maintained in the United having to conduct additional testing, if depending upon the complexity of the States. those certificates are based on testing product, the number of product safety (Comment 79)—One commenter conducted by a CPSC-accepted third rules that are applicable to the product, stated that as long as the manufacturer party conformity assessment body. and the amount of testing required. can use existing documentation, then (Comment 77)—One commenter However, as stated in the preamble to there should not be an undue burden on stated that the proposed recordkeeping the proposed rule (75 FR at 28360), the regulated community to comply requirements will have the largest documentation and recordkeeping are with third party testing requirements for immediate impact to the retail industry. required to establish the identity of the children’s products. However, the The commenter stated that to meet these product and to demonstrate that the commenter noted that if we intend to provisions, a process to centrally product complies with the applicable require that the manufacturer maintain maintain records for an estimated safety rules, not only when it is documentation in a different format, 300,000 items per year would need to be certified, but also on a continuing basis then there will be a cost associated with created. The number of pages of after certification. maintaining this information. documentation covering a portion of The final rule gives manufacturers (Response 79)—The final rule does products for one large general and importers the flexibility to maintain not require manufacturers to develop merchandise retailer acting as importer records. The final rule does not require codes, numbering systems, or special of record, would range from a low of that the records be maintained in a data formats. A manufacturer is free to 375,000,000 pages to more than specific CPSC format. While the final use any format, provided that the 1,000,000,000 pages per year. The rule specifies what records or required information is available to the commenter’s estimate was based upon information must be maintained, a CPSC, when requested. (Comment 80)—One commenter the following: manufacturer may maintain the • Full product specification (150–200 records—as the commenter suggested— objected to the requirement that records pages); within their own recordkeeping must be maintained for five years. The • Certification testing (30–100 pages); systems, if those systems meet the commenter pointed out that the larger • Production testing plan (inspection traceability requirements and ensure suppliers to the U.S. market, including records, testing documents, and that products are certified properly chain stores, divide an order and ship production plans quality control before they enter into commerce. separately to different states. Without documents) (1,000–3,000 pages); and (Comment 78)—One commenter giving details, the commenter implied • Periodic testing (50–200 pages). stated that manufacturers of children’s that this would make the requirement to This estimate did not include records furniture cannot provide any data on the keep all required records for five years of remedial action, if necessary. cost of the recordkeeping requirements a heavy burden on manufacturers. Another commenter stated that the because they do not know yet the (Response 80)—This comment is from standards of recordkeeping outlined in storage capacity that will be required to a trade association for a foreign the proposed rule are clear and should comply with the rule. Furniture manufacturer of children’s products that not present an unreasonable burden on manufacturers of non-children’s may have misinterpreted the proposed manufacturers or importers. The products have reported that the cost of rule. The proposed rule would require commenter asserted that any creating the system to collect their data test records to be maintained for five responsible firm would maintain these on 16 CFR part 1303 compliance was years; other records would be records even without the rule, and they approximately $100,000, and the cost of maintained for as long as the product further asserted that establishing a records maintenance was in the range of was in production or imported (without reasonable baseline for product safety $30,000 to $50,000 per year. Based on a material change), plus five years. In recordkeeping is crucial to enforcement. this, furniture manufacturers of any event, a foreign manufacturer has (Response 77)—We have revised the children’s products are certain that it no obligation to keep the records final rule to reduce costs associated will cost them in excess of $100,000 to specified under § 1107.26, unless it

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agrees contractually to maintain the the font type or size of the label for use of symbols or a mark, rather than records on behalf of the importer. Even marketing purposes. words or initials, as proposed. Symbols under these circumstances, only the (Response 81)—Section 14(i)(2)(A) of also would help overcome language importer has the obligation to keep the the CPSA requires us to initiate a barriers for communicating compliance. records. The importer, as the certifier, is program by which a manufacturer or The commenter said that the guidelines responsible for maintaining the records private labeler may label a consumer should allow variations in the label’s or having another party maintain the product as complying with the size to accommodate products of records on its behalf. As for the retailer certification requirements of section different physical dimensions, but the in the distribution chain, they are not 14(a) of the CPSA. Section 1107.30 of general appearance of the label must required to keep the records unless they the final rule (formerly proposed remain consistent. They recommended are also the importer. An importer’s § 1107.40) implements this requirement. that the labels appear as a permanent obligation to maintain the records for Use of the labeling program is at the mark on the product packaging, as well the product is independent of how discretion of the manufacturer or private as on the product itself. many different retailers distribute the labeler, and the manufacturer or private (Response 82)—We agree with the product. Regarding the burden of labeler must determine costs versus commenters that specifying particular keeping records for five years, the 5-year benefits for their particular products. fonts and minimum sizes for the label record retention requirement was The label specifications are designed to could make adding a label difficult for selected to be consistent with the 5-year avoid giving consumers the false some products. Depending on the statute of limitations in 28 U.S.C. 2462. impression that the product is CPSC- product’s characteristics, such as size, However, this requirement is not tested, -approved, or -endorsed. Section surface finish, and the presence of a intended to supersede record retention 1107.30(d) of the final rule prohibits smooth, flat area for the label, a label times that are specified in existing manufacturers or private labelers from with a minimum font size may be regulations. implying, through manipulation of the difficult to apply. Therefore, font type, font size, or other means that § 1107.30(b) of the final rule E. Proposed Subpart D—Consumer the CPSC has tested, approved, or (renumbered from proposed Product Labeling Program endorsed the product. § 1107.40(b)) specifies that the label 1. Introduction Other than renumbering this section, must be visible and legible and does not we have finalized paragraph (a) without specify a font and a minimum size. This Proposed subpart D, consisting of one change. change will give manufacturers the section, would implement the label 3. Label Specifications flexibility to implement a labeling provision at section 14(i)(2)(A) of the system tailored to their product. CPSA. Section 14(i)(2)(A) of the CPSA Proposed § 1107.40(b) would require the label to be printed in bold typeface, The text of the message on the label requires the Commission to initiate a remains: ‘‘Meets CPSC Safety program by which a manufacturer or using an Arial font of not less than 12 points, be visible and legible, and state: Requirements.’’ The label may be private labeler may label a consumer affixed to the product or provided with product as complying with the ‘‘Meets CPSC Safety Requirements.’’ (Comment 82)—One commenter the product to provide flexibility for the certification requirements in section manufacturer or private labeler in their 14(a) of the CPSA. stated that the final rule should not specify the features that must be used implementation of the labeling 2. General Requirements for the optional label indicating that a requirements. Because the labeling product meets the CPSC’s safety requirements will apply to all consumer Proposed § 1107.40(a) would allow requirements. The commenter did not products covered by an applicable manufacturers and private labelers of a think we should specify features such as product safety rule, it would be consumer product to indicate, by a size, color, font, or location because impossible to design a label that would uniform label on or provided with the these will depend on the product. The work with every firm’s internal system. product, that the product complies with commenter noted that there is the Regarding the labeling requirements any consumer product safety rule under possibility that the specified text type in the Federal Hazardous Substances the CPSA, or with any similar rule, ban, and size will not be compatible with the Act (FHSA), the commenter did not standard or regulation under any other different internal systems developed by specify which labeling requirements act enforced by the CPSC. retailers and manufacturers to meet the should be used. The general labeling (Comment 81)—One commenter needs of the affected product. The requirements for labeling certain toys contended that allowing manufacturers commenter said that to specify any and games in section 24(d) of the FHSA to place an optional label on their requirements other than what works states that the label shall be displayed products that states: ‘‘Meets CPSC with a firm’s internal systems would in the English language in conspicuous Safety Requirements,’’ could give have absolutely no benefit at all. and legible type in contrast by manufacturers who use such a label an Another commenter expressed typography, layout, or color with other unfair market advantage over concern with the font size being ‘‘no printed matter. The changes to the final manufacturers who choose not to less than 12 points’’ because that could rule are consistent with the FHSA in include the label. The commenter stated be a problem on some small containers. this regard. that some manufacturers will not use The commenter said that we should use The final rule does not allow for the the label because it will increase their instead, the font size requirements in use of a symbol or mark because a product’s cost. The commenter the Federal Hazardous Substances Act. symbol or mark might be misinterpreted suggested that some consumers may One commenter agreed with our as a CPSC certification mark or CPSC choose the labeled product based upon approach of labeling products to endorsement of the product. a false assumption that a product indicate compliance with the rules. The Additionally, the recommendation that without the label is somehow less safe. commenter recommended that the a label be affixed to the product and its The commenter stated that some CPSC’s labeling program include packaging may reduce the flexibility of manufacturers will use the label as a guidelines for the type, style, color, and manufacturers who choose to use the misleading marketing tool or even alter font of such labels and should consider labeling program.

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In reviewing the comments submitted and with all rules, bans, standards, or such safe harbors, claiming the CPSIA regarding labels and the provisions of regulations applicable to the product did not make such specific provision subpart D of the proposed rule, we under any other act enforced by the (75 FR at 28339). According to the noticed that proposed § 1107.40(d) Consumer Product Safety Commission. commenters, specific statutory authority (renumbered as § 1107.30(d) in the final We received no comments on this is not a precondition to an agency acting rule) could be misunderstood to imply paragraph and, other than renumbering under its rulemaking and enforcement that an alternative label may be used in § 1107.40 as § 1107.30, we have authority to recognize such safe harbors. place of the label specified in proposed finalized it without change. The commenters contended that we § 1107.40(b). We have revised 5. Use of Other Labels should provide such recognition. § 1107.30(d) in the final rule to state that (Response 84)—As we noted other labels, in addition to the label Proposed § 1107.40(d) would allow a previously in the preamble to the specified in § 1107.30(b), may be placed manufacturer or private labeler to use proposed rule (75 FR at 28339), section on the product, as long as the additional another label on the consumer product, 14 of the CPSA does not contain a safe labels do not change the meaning of the as long as such label does not alter or harbor exception, nor does it establish label specified in § 1107.30(b). mislead consumers as to the meaning of any criteria by which the Commission (Comment 83)—One commenter the label described in proposed could recognize testing programs for argued that the requirement to provide § 1107.40(b). A manufacturer or private purposes of a safe harbor. only the statement: ‘‘Meets CPSC Safety labeler would not be allowed to imply The final rule does not contain a safe Requirements,’’ is not adequate for that the CPSC has tested, approved, or harbor provision based upon a indicating compliance. The commenter endorsed the product. manufacturer’s participation in a asserted that a registered certification In reviewing the comments submitted voluntary or industry-sponsored mark is the only way to indicate regarding labels and proposed subpart program; nor have we recognized any adequately full compliance, and they D, we noticed that proposed such program to indicate compliance noted further that the use of a registered § 1107.40(d) (renumbered as with the final rule. We note that ISO certification mark is also used as a tool § 1107.30(d) in the final rule) could be standards for good manufacturing to address counterfeiting activities. misunderstood to imply that an practices are generally industry-specific (Response 83)—The consumer alternative label may be used in place of in areas such as cosmetics, product labeling program described in the label specified in § 1107.40(b). pharmaceutical operations, food proposed § 1107.40 (renumbered as Therefore, on our own initiative, we handling, and medical devices, products § 1107.30 in the final rule) is voluntary have revised § 1107.30(d) to state that largely beyond the CPSC’s jurisdiction. on the part of a manufacturer, importer, other labels, in addition to the label It is unlikely that any one GMP standard or private labeler. Section 14(a) of the specified in § 1107.30(b), may be placed would be deemed workable or CPSA requires the manufacturer, on the product, as long as the additional acceptable for all manufacturing importer, and private labeler to issue a labels do not change the meaning of the methods for children’s products. General Conformity Certificate or a label specified in § 1107.30(b). (Comment 85)—One commenter noted that the preamble to the proposed Children’s Product Certificate for any F. Other Comments Received product covered by an applicable rule refers to a 95 percent statistical product safety rule, regardless of Several commenters raised questions significance level as constituting a ‘‘high whether a manufacturer elects to label on whether the final rule should contain degree’’ of assurance. The commenter their product under § 1107.30. A ‘‘safe harbors’’ (where certain actions asked whether the CPSC would consider registered certification mark authorized are considered to be complying with a 95 percent probability or confidence by a certification body for a particular requirement), and questioned level to be a safe harbor level. manufacturer to include with the the rule’s effective date. Other (Response 85)—In the preamble to the product does not contain the commenters raised issues that were proposed rule, the 95 percent information required by a certificate, as outside the scope of the rulemaking, probability level was discussed as an specified in 16 CFR part 1110, and it such as whether a particular product alternative definition of a ‘‘high degree cannot be used in place of the was a ‘‘children’s product’’ or raised of assurance’’ that we considered and certificate. Thus, we disagree with the concerns on matters pertaining to the subsequently rejected. We ‘‘decided commenter that certification marks are accreditation of third party conformity against defining ‘high degree of the only way to indicate full assessment bodies. assurance’ with respect to a 95 percent compliance. Other products, such as (Comment 84)—Two commenters probability or confidence level (or any mattress sets, indicate compliance (in suggested that the rule clearly should other level of statistical confidence) this case to 16 CFR part 1633) without allow for recognition of ‘‘safe harbors’’ because there may be difficulty in the use of certification marks. based upon adherence to national applying the statistical methods to all Furthermore, we are aware of multiple standards for good manufacturing manufacturing processes’’ (75 FR at instances of counterfeit certification practices, international ISO standards 28344). Therefore, we do not consider a marks on consumer products. As a governing GMP, and industry-based 95 percent confidence level to constitute result, we decline to revise the rule as GMP category-specific guidelines that automatically a ‘‘high degree of suggested by the commenter. manufacturers may use as evidence of assurance’’; nor do we consider it to their good faith commitment to attaining constitute a safe harbor level for 4. Conditions Under Which a Consumer a high degree of assurance that their purposes of compliance with the final Product May Bear the Label products meet or exceed applicable rule. Determining what constitutes a Proposed § 1107.40(c) would allow a federal safety standards. The ‘‘high degree of assurance’’ varies, consumer product to bear the label if the commenters noted that we have depending upon the product manufacturer or private labeler has recognized that such programs may be manufactured and the manufacturing certified, pursuant to section 14 of the considered evidence of meeting the processes used. The determination must CPSA, that the consumer product requirements under the proposed rule be made by individual manufacturers, complies with all applicable consumer but noted as well that we have not yet based upon their knowledge of their product safety rules under the CPSA recognized our authority to provide for products and manufacturing processes.

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(Comment 86)—One commenter Consequently, we have finalized those (Comment 88)—One commenter noted that, for most major retailers, the provisions that H.R. 2715 did not affect objected to the application of the creation of a product begins with a directly. We also have decided to make regulation to some juvenile furniture. design specification that originates 12 the final rule effective 15 months after The commenter stated that it is difficult months or more prior to manufacture or date of publication in the Federal to estimate the cost of testing for import into the United States. The Register so that parties can begin taking children’s products when we have not commenter said that retroactively steps to develop internal processes, yet decided on the definition of a applying all the requirements of the such as recordkeeping, and so that we, children’s product. Another commenter final rule would be unduly burdensome. and interested parties, can consider how generally supported the idea of third The commenter added that H.R. 2715 interacts with the final rule. party testing of children’s products but manufacturers of compliant products We note that the effective date for the was unclear about what products are that are currently on retailers’ shelves final rule is not calculated based on included in the category of children’s may not have any or all of the when development of a product begins, products. components of a reasonable testing but rather, is calculated based on the (Response 88)—The final rule does program. Generating this documentation date the product is manufactured. The not address what products fall within ‘‘after the fact’’ is simply not possible. requirements of the final rule apply only the definition of ‘‘children’s products’’; The commenter asked that the rule to products manufactured on or after the and therefore, the comment is outside apply only to products whose effective date of the final rule, and they the scope of the rule. However, after the development begins 180 days on or after do not apply retroactively to products comment was submitted, we issued an adoption. Accordingly, products would already manufactured and certified. interpretative rule (now codified at 16 begin to be certified based upon a (Comment 87)—One commenter CFR part 1200) regarding the definition reasonable testing program with all expressed concern that the rule has the of children’s product, providing the accompanying documentation potential to multiply the current volume guidance the commenter is seeking. approximately 18 months after adoption of product testing by several fold and (Comment 89)—One commenter of the final rule. that third party conformity assessment wondered whether a manufacturer or One commenter suggested that we set bodies will be unable to provide importer of a children’s product subject the effective date at one year from the accurately and efficiently the increased to a children’s product safety rule for publication of the final rule because that testing capacity needed by retailers/ which no third party testing conformity is how long it would take their industry importers to comply with this rule. The assessment bodies have been accredited to change its manufacturing processes to commenter asserted that currently, by CPSC, is required to certify the be able to comply with the requirements without the rule being in effect, retailers product based on such testing. The of a reasonable testing program. already are experiencing delayed commenter also wondered whether an Another commenter said that they turnarounds in product testing, and it is importer is prohibited from importing simply do not have the staff or the not uncommon to have special requests the children’s product until we accredit resources to get the third party testing denied due to the current backlog in third party testing conformity done on all of the products that could testing. assessment bodies for the children’s fall within the definition of ‘‘children’s The commenter also expressed product safety rule. product’’ and record it in a data concern that the increased testing (Response 89)—The final rule does collection and storage system (yet to be demand may affect laboratory not address the issuance of notices of designed and implemented) within the execution, potentially resulting in requirements for accreditation of third 180-day timeframe mentioned in the incorrect laboratory results, which may party conformity assessment bodies; and preamble to the proposed rule. That cause compliant product to be lost, or therefore, the comment is outside the commenter suggested that they needed may allow noncompliant product to scope of the rule. However, if there are at least 365 days, and therefore, they enter commerce. The commenter said no CPSC-accepted third party requested that we extend the stay of that if the capacity of the third party test conformity assessment bodies whose enforcement until February 2012. conformity assessment bodies is scope includes a rule applicable to a (Response 86)—The preamble to the exceeded, retailers’ and manufacturers’ children’s product, those products are proposed rule indicated that a final rule ability to meet the rule’s effective date not prohibited from being imported. The would become effective 180 days after could be jeopardized. The commenter children’s products must still comply its date of publication in the Federal asked that the third party conformity with the requirements of the applicable Register (75 FR at 28361). However, on assessment body capacity issue be taken children’s product safety rules. For August 12, 2011, the President signed into consideration when establishing example, if a rule established a limit of H.R. 2715 into law. H.R. 2715 revised the effective date of the final rule. X for a particular chemical in children’s the CPSIA in several different ways, and (Response 87)—We are aware that products, but there were no CPSC- it also affected section 14(i)(2)(B)(ii) of implementation of section 14(a)(2) of accepted third party conformity the CPSA. H.R. 2715 also created a new the CPSA potentially could result in assessment bodies to test for X, the section 14(i)(3)(B) of the CPSA, which insufficient testing capacity at CPSC- children’s product would still be subject requires us, no later than one year after accepted third party conformity to the limit of X for that particular H.R. 2715’s date of enactment, to review assessment bodies. We note that in the chemical; the absence of a CPSC- the public comments (on opportunities majority of the notices of requirements accepted third party conformity to reduce the costs of third party testing that have issued since 2008, there have assessment body would not mean that requirements), and it permits us to been very few claims of insufficient the limit no longer applies. ‘‘prescribe new or revised third party capacity, and when such issues have (Comment 90)—One commenter testing regulations,’’ if we determine arisen, we have taken steps to address recommended that conformity that ‘‘such regulations will reduce third the matter (see 75 FR 34360, June 17, assessment bodies should: (a) Comply party testing costs consistent with 2010). We intend to monitor and with the standards in ISO/IEC Guide 65, assuring compliance with the applicable address, if possible, any capacity issues or (b) in fulfillment of the requirements consumer product safety rules, bans, that arise after the final rule becomes in ISO/IEC 17025:2005, during each standards, and regulations.’’ effective. audit review and resubmission of CPSC

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Form 223, demonstrate independence defines third party, firewalled, and part 1610. They argued that the from ‘‘* * * financial and other governmental conformity assessment regulation exempts plain surface fabrics pressures and influences that may bodies. weighing at least 2.6 ounces per square adversely affect the quality of their work (Comment 91)—Two commenters yard and fabrics made from acrylic, * * *’’; the commenter also suggested recommended that we consider a modacrylic, nylon, olefin, polyester, and requirements for audits of conformity number of steps to ensure that third wool, but not silk. The commenters assessment bodies. party conformity assessment bodies are stated that silk’s reaction to fire is Another commenter expressed protected against undue influence. comparable to wool and better than the ongoing concern over the distinct These included the following: (1) synthetics that are exempted. possibility that accredited testing Adopting the requirements in Clause 4.2 (Response 94)—The final rule does organizations, especially ‘‘firewalled’’ of the ISO/IEC Guide 65; (2) using the not address 16 CFR part 1610; and and ‘‘government laboratories,’’ could OSHA NRTL program as a model for therefore, the comments are outside the be subject to influence and threats to laboratory accreditation; and (3) scope of this rule. impartiality by outside or related requiring all laboratories applying to the (Comment 95)—One commenter interests. The commenter expressed Commission to submit evidence that noted that heavy element and phthalates concern that the new audit procedures they fulfilled ISO/IEC 17025:2005 testing use some chemicals. The stated that all types of third party section 4.1.5 b. One commenter made commenter stated that, with increased conformity assessment bodies: the recommendation for ‘‘firewalled’’ testing, there will be more chemical Independent, firewalled suppliers, and conformity assessment bodies. Another waste, which may not be desirable. government-owned or -controlled would commenter would require annual (Response 95)—The final rule does be treated the same and were all called reassessments of third party conformity not address testing methods for specific third party conformity assessment assessment bodies. substances; and therefore, the comment bodies. The commenter stated that these (Response 91)—The final rule does is outside the scope of the rule. different types of conformity assessment not address undue influence (Comment 96)—One commenter bodies have different modes of requirements for third party conformity suggested developing an exemption list operation, and they need to be treated assessment bodies; and therefore, the for vinyl fabrics produced in accordance differently by us in both the auditing comments are outside the scope of this with 16 CFR part 1611, Standard for the and accreditation requirements. The rule. This rule establishes the Flammability of Vinyl Plastic Film, commenter suggested that we require requirements for manufacturers to using a process similar to that used to applicants to submit the evidence used safeguard against the exercise of undue develop the exemption list in 16 CFR to validate the fulfillment of ISO/IEC influence on third party conformity part 1610, Standard for the 17025:2005 requirements for the assessment bodies. Flammability of Clothing Textiles. In the laboratory to ‘‘have arrangements to (Comment 92)—Several commenters latter case, testing over a number of ensure that its management and submitted comments on the concurrent years showed that certain types of personnel are free from any undue rulemaking for component part testing fabrics always produce passing results internal and external commercial, in proposed 16 CFR part 1109. when tested according to 16 CFR part financial and other pressures and (Response 92)—The final rule does 1610, and those types of fabrics influences that may adversely affect the not establish the requirements for eventually were exempted from the quality of their work,’’ not only as part component part testing; and therefore, standard. of their application to the CPSC, but these comments are outside the scope of (Response 96)—The final rule does also on an ongoing basis, as part of each this rule. We have, instead, considered not address 16 CFR part 1611; and audit review and resubmission of CPSC those comments in that rulemaking. therefore, the comment is outside the Form 223. (See Conditions and Requirements for scope of the rule. Two commenters stated that the Relying on Component Part Testing or (Comment 97)—One commenter proposed rule fails to differentiate Certification, or Another Party’s disagreed that a standard of general between firewalled and independent Finished Product Testing or application to all consumer products in conformity assessment bodies. Certification, to Meet Testing and a category should be considered a According to one commenter, a Certification Requirements (16 CFR part ‘‘children’s product safety rule’’ for manufacturer can submit samples to its 1109)). purposes of the CPSIA. firewalled conformity assessment body (Comment 93)—One commenter (Response 97)—The final rule even if its reasonable testing program opined that an existing third party establishes the requirements for the fails to provide a high degree of certification system under the OSHA testing and certification of children’s assurance of compliance with the NRTL program, in conjunction with products and for the labeling of applicable children’s product safety testing being carried out in testing compliant consumer products. rules. The commenter sought facilities accredited to ISO/IEC 17025, is Determinations of whether a particular clarification of the provision that a the preferred method for product safety standard is a children’s product manufacturer of children’s products certification for the CPSC. The safety rule are outside the scope of this with a reasonable testing program may commenter recommended that we rule. submit samples to its firewalled consider a similar program or an (Comment 98)—One commenter conformity assessment body every two accredited certification program that suggested that we consider developing years. meets the requirements of ISO/IEC training guidelines for the regulated (Response 90)—The final rule does Guide 65 and ISO/IEC Guide 67. community and testing laboratories that not address the requirements for (Response 93)—The final rule does explain key elements of a reasonable conformity assessment bodies; and not address certification systems or testing program for non-children’s and therefore, the comments are outside the accreditation, such as ISO/IEC Guides children’s products. The guidelines scope of the rule. Conformity 65 and 67; and therefore, the comment could include helpful training aids and assessment body requirements will be is outside the scope of this rule. presentations to increase knowledge and addressed in a separate rulemaking. (Comment 94)—Several commenters understanding. The guidelines could Further, section 14(f) of the CPSA asked us to exempt silk from 16 CFR include helpful examples and scenarios

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for most common issues (e.g., label a product to comply with the (Comment 102)—One commenter, developing a random sampling program) certification requirements of section who manufactures die-cast metal toys, and even infrequent but complex issues 14(a) of the CPSA. However, the CPSC commented that the 90 ppm lead (e.g., traceability for raw materials and staff has issued Age Determination content limit is too low to allow use of product components). Guidelines: Relating Children’s Ages to the usual aluminum for casting their (Response 98)—The final rule is Toy Characteristics and Play Behavior, products, even though the same metal is limited to establishing the requirements T. P. Smith (Ed.) (2002) (which can be used to make cooking utensils. for testing and certification for found on the CPSC Web site at http:// Furthermore, the commenter stated children’s products and for labeling of www.cpsc.gov/BUSINFO/adg.pdf) that it costs $3,700 to test one unit and consumer products as compliant; which addresses the issue raised by the that the market will not absorb the costs therefore, the comment is outside the commenter. of testing multiple units per batch. The scope of the rule. Further, we have (Comment 101)—One commenter commenter implied that these costs reserved proposed subpart B (the asserted that the best approach would would cause it to go out of business or reasonable testing program for non- be to allow businesses to manage their make its products in China. The children’s products) for future compliance risks as best they can commenter expressed the belief that it consideration. We may consider because ‘‘* * * the prophylactic should not have to test using third party establishing training programs in the approach to testing adopted by the conformity assessment bodies because: implementation of the final rule. CPSC will inevitably put many small or 1. They are ISO 9001:2008 compliant. (Comment 99)—One commenter micro businesses into bankruptcy 2. They document all of their supplier noted that the proposed rule had to be * * *. If the law does not permit the receipts of metal, plastic, and powder worded very generally to be applicable agency to adopt sensible rules that allow paint materials. to a wide range of products. This has businesses to manage their compliance 3. They conduct a metal analysis for had the effect of making it more difficult risk as best they can (where the each production run with their to understand how the rules will be standards remain in place, but the spectrometer. applied in any specific industry. The government stops trying to tell (Response 102)—The final rule does commenter suggested that we conduct businesses HOW to comply), then the not address lead content and surface regional, industry-specific workshops to Commission must finally tell Mr. coating limits and; therefore, comments explain to the regulated manufacturers Waxman what he doesn’t want to hear— on the allowable concentration levels how these general rules will apply to that his law is broken and can’t be fixed are outside the scope of this rule. their existing procedures and where * * *.’’ The commenter then wrote: However, H.R. 2715 directs the CPSC new regulatory obligations exist. to seek public comment on seven (Response 99)—The final rule is ‘‘* * * I don’t believe the agency can devise sensible regulations to fix this specific issues, including the extent to limited to establishing the requirements which evidence of conformity with for testing and certification for problem short of a legislative change.’’ (Response 101)—Comments about the other national or international children’s products and for labeling of governmental standards may provide consumer products as compliant; merits of section 14 of the CPSA or the CPSIA are beyond the scope of this assurance of conformity to consumer therefore, the comment is outside the product safety rules, bans, standards, or scope of the rule. We may consider rulemaking. However, on August 12, 2011, the President signed into law H.R. regulations, and the extent to which establishing regional industry-specific technology, other than the technology workshops in the implementation of the 2715, which amended the CPSIA in several respects. One provision provides already approved by the Commission, final rule. exists for third party conformity (Comment 100)—One commenter relief for small batch manufacturers. assessment bodies to test or to screen for recommended that the labels for toys be Another provision in H.R. 2715 requires testing consumer products subject to a used to communicate not only the CPSC to seek public comment on third party testing requirement. compliance with the standards, but also opportunities to reduce the cost of third Elsewhere in this issue of the Federal the appropriate age range for the toy. party testing requirements consistent Register, we have published a notice The commenter said that the European with assuring compliance with any seeking public comment on the issues in Union uses a universal mark that applicable consumer product safety H.R. 2715. indicates the inappropriate age ranges of rule, ban, standard, or regulation. H.R. a toy if it presents a choking hazard. The 2715 directs the CPSC to seek public IV. Regulatory Flexibility Act commenter said that the CPSC’s comment on seven specific issues, A. Introduction program could expand on that concept, including other techniques for lowering by recommending labeling that the cost of third party testing consistent We have examined the impacts of the caregivers can use to separate toys with assuring compliance with the final rule under the Regulatory intended for siblings of differing ages, applicable consumer product safety Flexibility Act (5 U.S.C. 601–612). The while also preventing parents and other rules, bans, standards, and regulations. Regulatory Flexibility Act requires caregivers from buying toys that may be Elsewhere in this issue of the Federal agencies to analyze regulatory options inappropriate for the age of the child. Register, we have published a notice that would reduce any significant The commenter believes that this could seeking public comment on the issues in impact of a rule on small entities. help enhance toy safety by reducing H.R. 2715. H.R. 2715 further requires Several sections that were included in children’s exposure to inappropriate the CPSC to review the public the proposed rule are not included in toys. comments and states that the CPSC may the final rule, but they are being (Response 100)—The final rule does prescribe new or revised third party reserved for future rulemaking. not address labeling for the appropriate testing regulations if we determine that Proposed subpart B, pertaining to a ages ranges for a toy; therefore, the such regulations will reduce third party reasonable testing program for non- comment is outside the scope of the testing costs consistent with assuring children’s products, is not included in rulemaking. Section 14(i)(2)(A) of the compliance with the applicable the final rule, but we may address the CPSA requires us to implement a consumer product safety rules, bans, issue in a future rulemaking. The program by which a manufacturer may standards, and regulations. proposed section pertaining to the

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selection of random samples for policy, and legal reasons for selecting firms that could be impacted by the children’s products (§ 1107.22) is not the alternative adopted in the final rule proposed rule, the book publishing included in the final rule, and it is and why each one of the other industry (NAICS code 511130) and addressed in a separate rulemaking significant alternatives to the rule printing industry (NAICS code 323117) published elsewhere in this issue of the considered by the agency which affect were not included. The commenter Federal Register. Proposed § 1107.21(d), the impact on small entities was recommended their inclusion for the which would provide a partial rejected. final regulatory flexibility analysis. exemption from periodic testing for low- (Response 103)—We acknowledge B. Need for, and Objectives of, the Rule volume products is not included in the that the initial regulatory flexibility final rule. The reason for omitting Section 14(a)(2) of the CPSA requires analysis inadvertently omitted these proposed § 1107.21(d) from the final that every manufacturer of a children’s industries. However, the recently rule is that H.R. 2715 asked us to product that is subject to a children’s enacted H.R. 2715 exempts ordinary examine means to reduce the cost of product safety rule certify that the books and ordinary paper-based printed third party testing requirements product complies with the applicable materials from the third party testing consistent with assuring compliance children’s product safety rule based on requirements, so the commenter’s with any applicable consumer product testing conducted by a third party concern no longer applies. safety rule, ban, standard, or regulation. conformity assessment body accredited (Comment 104)—One commenter It also contained special rules for small to conduct such tests. The final rule indicated that the cost of complying batch manufacturers and directed us to establishes requirements and with the reasonable testing program consider alternative testing procedures for manufacturers to certify requirements for furniture will vary requirements or to exempt small batch children’s products under this section of according to: (1) Whether the furniture manufacturers from certain third party the CPSA. is children’s or non-children’s furniture; testing requirements. Given these new Section 14(i)(2)(A) of the CPSA (2) whether the furniture is produced statutory obligations resulting from H.R. requires that we initiate a program by domestically or imported; and (3) 2715, we are reserving § 1107.21(e) which a manufacturer or private labeler whether the manufacturer produces a (formerly proposed § 1107.21(d)) so that may label a product as complying with high or low-volume of products. High- we may consider issues related to cost, the applicable safety rules. The statute volume producers can rely on a low-volume products, and small batch also requires us to establish protocols component part certificate from their manufacturers more fully. Finally, and standards: (i) For ensuring that a paint suppliers, and the cost of testing proposed § 1107.25, which would children’s product is tested periodically would be relatively low. Higher quality, establish requirements for remedial and when there has been a material lower volume producers would have action for children’s products, has not change in the product, (ii) for the testing greater difficulty because these items been included in the final rule. of representative samples to ensure often are ‘‘made to order’’ and ‘‘as Before promulgating a final rule, the continued compliance, (iii) for verifying needed.’’ These producers will use Regulatory Flexibility Act requires that a product tested by a conformity small batches of finishes issued in a agencies to prepare a final regulatory assessment body complies with number of different finishing materials, flexibility analysis of the rule that applicable safety rules, and (iv) for each of which would need to be tested. analyzes the impact that the rule will safeguarding against the exercise of (Response 104)—We agree that the have on small entities. The final undue influence on a conformity costs of complying with the regulatory flexibility analysis must assessment body by a manufacturer or requirements will vary among products contain: private labeler. With the exception of and manufacturers. Generally, the costs (1) A succinct statement of the need items (ii) (standards and protocols for will be more significant for for, and objectives of, the rule; the testing representative samples), and manufacturers of lower volume (2) a summary of the significant issues (iii) (establish protocols and standards products. It should also be noted that raised by the public comments in for verifying that a product tested by a proposed subpart B, which would response to the initial regulatory conformity assessment body complies contain the requirements applicable to flexibility analysis, a summary of the with applicable safety rules), the final non-children’s products, is not being assessment of the agency of such issues, rule implements these requirements. finalized at this time. Therefore, the and a statement of any changes made in The objective of the final rule is to final rule does not impose any the proposed rule as a result of such reduce the number of children’s requirements on non-children’s comments; products that are distributed each year furniture. (3) a description of and an estimate of that fail to comply with one or more (Comment 105)—Two commenters the number of small entities to which children’s product safety rules. The expressed concern about costs. One the rule will apply, or an explanation of applicable children’s product safety commenter noted that reliance on third why no such estimate is available; rules were established to reduce the party conformity assessment body (4) a description of the projected unreasonable risk of injury or death due testing raises costs and imposes reporting, recordkeeping, and other to foreseeable hazards associated with production delays. Another commenter, compliance requirements of the rule, particular children’s products. a charitable organization that makes including an estimate of the classes of wooden toys for donation to needy small entities which will be subject to C. Comments on the Initial Regulatory children, commented that it lacks the the requirement and the type of Flexibility Analysis, and Our Responses resources to pay for certification testing professional skills necessary for The preamble to the proposed rule and would need to discontinue preparation of the report or record; and contained our initial regulatory activities unless granted an exemption (5) a description of the steps the flexibility analysis (76 FR at 28352 or some other type of relief. agency has taken to minimize the through 28360). Several commenters (Response 105)—Section 14(a)(2) of significant economic impact on small addressed issues pertaining to that the CPSA requires third party entities consistent with the stated analysis. conformity assessment bodies to test objectives of applicable statutes, (Comment 103)—One commenter children’s products for compliance with including a statement of the factual, noted that in estimating the number of applicable children’s product safety

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rules. We recognize that testing costs management time; legal expenses, requires that every children’s product may be substantial and may have a among other costs. The commenter subject to a children’s product safety significant adverse affect on some estimated that, depending on the scale rule be tested periodically by a third manufacturers, especially small of the business, these costs will add 15 party conformity assessment body, the businesses that may have limited to 50 percent to the out-of-pocket testing commenter might need to conduct more financial resources. We also recognize costs. testing than the commenter believes is that the testing will take time and could The commenter also noted that the necessary. result in some delays in the production initial regulatory flexibility analysis We acknowledge that the rule is process. considered the probability that some complex, and some small businesses Recently enacted H.R. 2715 requires manufacturers or private labelers will might have to hire outside consultants, us to seek public comment on have to test multiple samples to obtain such as lawyers, statisticians, or quality opportunities to reduce the cost of third the high degree of assurance required by control experts to help them comply party testing requirements consistent the proposed rule. The commenter with the regulations. As a result, some with assuring compliance with any asserted that over the last 20 years of small firms may exit the market for applicable consumer product safety product testing at his company, children’s products. rule, ban, standard, or regulation. H.R. multiple safety tests of the same product (Comment 107)—One commenter 2715 directs us to seek public comment have not revealed anything useful. The stated that the testing rule would on seven specific issues, including commenter asserted that the testing rule accelerate the decline of domestic techniques for lowering the cost of third is complex; that many small businesses manufacturing firms, as more party testing consistent with assuring will not have the skills necessary to manufacturers go offshore to minimize compliance with the applicable understand what is expected of them in the cost of testing. The commenter consumer product safety rules, bans, terms of compliance; and that many asserted that the furniture industry will standards, and regulations. Elsewhere in small businesses will exit the market for have no choice but to close down more this issue of the Federal Register, we children’s products. and more factories in the United States have published a notice seeking public (Response 106)—The initial and take those jobs off shore to benefit comment on the issues in H.R. 2715. regulatory flexibility analysis focused from the lower testing costs. The H.R. 2715 further requires us to review on the cost of third party testing because commenter stated that some small the public comments and states that we it will likely be the most significant cost manufacturers have abandoned plans to may prescribe new or revised third for small manufacturers of children’s offer products intended for the youth party testing regulations if we determine products. Considering only the third market. that such regulations will reduce third party testing costs, the initial regulatory (Response 107)—The initial party testing costs consistent with flexibility analysis found that the rule regulatory flexibility analysis noted that assuring compliance with the applicable could have a significant impact on a the costs of some third party tests are consumer product safety rules, bans, substantial number of small entities. less expensive abroad than they are in standards, and regulations. The initial regulatory flexibility analysis the United States. For example, while H.R. 2715 also requires us to consider explicitly stated that the only costs typical prices for lead content tests alternative requirements for the covered considered in the analysis were the range from $50 to more than $100 in the products of small batch manufacturers costs that the laboratories would charge United States, the same lead content and, if no alternative requirements are to conduct the testing. The commenter test, in some cases, can be obtained for available or economically practical, is correct that the rule would impose as little as $20 in China (75 FR at exempts small batch manufacturers other costs, including the cost of the 28355). Higher third party testing costs from the third party testing samples destroyed in testing and freight, in the United States would be an requirements, with some exceptions. as well as the costs involved in incentive for manufacturers to produce Covered products are those for which administering and managing the testing children’s products abroad, to take fewer than 7,500 units were produced in and paperwork. The commenter’s advantage of the lower testing costs. the previous year, and a small batch estimate that these costs would add 15 Given all of the factors that go into a manufacturer is one whose gross sales to 50 percent to the out-of-pocket testing decision by a manufacturer to produce revenue from all consumer products in costs, depending upon factors such as consumer products abroad rather than the previous calendar year was less than the product involved and the scale of in the United States, the impact of third $1 million. In the case of toys, however, the business, seems reasonable. party testing costs on such a decision no alternative requirements or The commenter also is correct that the might be small. It seems unlikely that exemptions would be permitted for initial regulatory flexibility analysis the independent effect of higher third third party testing for the lead content considered the impact on firms that had party testing costs, by itself, would of paint, small parts, and pacifiers. to test more than one sample of a result in a large number of factories in Where possible, we tried to reduce product in order for the manufacturer to the United States closing down. With testing costs by allowing the use of obtain a high degree of assurance that regard to small domestic manufacturers, component part testing. the product complies with the it is possible that the third party testing (Comment 106)—One commenter applicable product safety rules. costs associated with the children’s noted that the initial regulatory However, the final rule does not specify furniture could lead some to flexibility analysis acknowledged that the number of samples that must be manufacturers to reduce their children’s the examples used only considered the tested. It is possible that if the furniture product lines or even cease out-of-pocket testing costs. Costs not commenter, as asserted, has never found their production of children’s furniture. considered in the examples include: multiple tests on its products to reveal Any small manufacturer of children’s Samples destroyed or damaged in anything useful, then the products furniture who qualifies as a small batch testing; transportation of the samples; manufactured could be of such uniform manufacturer might be offered relief by administrative costs for managing composition and quality that the the alternative requirements or testing; administrative costs for number of samples that the commenter exemptions that are provided by H.R. managing the testing data and will be required to submit for testing 2715; however, matters regarding the recordkeeping; an allocation of general will be small. However, because the rule small batch manufacturer’s exception in

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H.R. 2715 are outside the scope of this An x-ray fluorescence (XRF) gun is then children’s and youth furniture. rulemaking. Elsewhere in this issue of used to verify that the finished piece, in Depending upon the structure of the the Federal Register, we have published fact, complies with the lead-in-paint market and market conditions, some or a notice seeking public comment on the standard. It is estimated that 6 to 10 all of the testing costs may be passed on issues in H.R. 2715, including other employees will be required to track the to consumers. We cannot determine techniques for lowering the cost of third testing and compile the certificates of whether passing on these costs will party testing consistent with assuring conformity. It is estimated that the cost make children’s furniture—in any compliance with the applicable to comply with the rule for non- absolute sense—to be more expensive to consumer product safety rules, bans, children’s products could range from purchase than adult furniture; but standards, and regulations, pursuant to $200,000 to $410,000, annually. passing on these costs to consumers is H.R. 2715. (Response 109)—We received many likely to increase the relative price of (Comment 108)—One commenter comments on proposed subpart B, children’s furniture, and it could stated that the cost to test a finish used which was concerned with reasonable provide a price incentive for parents to in the furniture industry is about $50 testing programs for non-children’s substitute adult furniture for children’s (which is consistent with the discussion products. The comments raised many furniture. of testing costs in the initial regulatory practical issues, which illustrates the (Comment 111)—One commenter flexibility analysis). A youth bed, which difficulty of drafting a regulation that stated that the proposed rule will is also subject to the lead content can apply to many different types of impose significant new costs on the requirements of section 101 of the products and manufacturing processes mattress industry because mattresses are CPSIA, might require 29 tests at a third and still provide sufficient guidance to already subject to an expensive party testing facility, which would bring enable manufacturers to implement the mandatory testing program pursuant to the total cost of lead testing to $1,450. requirements effectively. Consequently, 16 CFR part 1633. The commenter In addition, testing to the bunk bed we are deferring action with respect to asserted that because most standard would add $600 to $800 to the finalizing subpart B. Instead, we will manufacturers of mattresses are small cost. A crib or toddler bed would cost reserve subpart B in the final rule and businesses, the proposed rule would an additional $750 to $765 ($450 to continue evaluating the issues raised in have a substantially greater impact on $520 in China) to test to the relevant the comments. the mattress industry, given the nature It should be noted, however, that children’s product safety rules. The cost of the products, the types of standards although we are not finalizing subpart B of testing other items of youth furniture, that the products must meet, the at this time, manufacturers of non- such as desks, entertainment centers, destructive nature of the testing children’s products that are subject to a and bookcases, averages approximately involved, and the cost of the samples product safety rule, ban, standard, or $235. These costs do not include the tested. cost of the samples, freight, random regulation are still obligated by the The commenter also noted that sampling, or the cost for employees to CPSA, as amended by the CPSIA, to mattress testing entails other costs, such track and administer the recordkeeping certify that their products comply with as: the cost of the samples tested, the requirements. all applicable safety rule, based on a test (Response 108)—As described in the of each product or a reasonable testing laboratory test fees, freight costs to ship initial regulatory flexibility analysis (75 program. samples to the laboratory, and the FR at 28352 through 28362), the testing In the case of testing the lead content manufacturers’ staff sent to witness the of some children’s products by third of paint, which the commenter test. The total cost of conducting a full party conformity assessment bodies can mentioned, the use of component part test for 16 CFR part 1633 can range from be costly. The testing costs described by or composite testing—as would be $850 to $1,650 per sample tested, plus the commenter do not appear to be allowed by the final rule on component added travel costs and salary expenses unreasonable estimates, based on cost part testing—might allow some for company personnel to witness the estimates we obtained. In cases where manufacturers to reduce their testing test. The commenter urged us to take the same component is used in more costs. For example, if the same 10 raw into account the significant new costs than one product, manufacturers may be materials (and only those materials) are that the rules will impose on the able to reduce their testing costs by combined in different portions to mattress industry, which is comprised using component part testing. However, produce 30 different finishes, a overwhelmingly of small businesses. component part testing will not offer manufacturer could test the lead content (Response 111)—We acknowledge any relief from the costs of tests that of each of the materials, and if each of that the rule could impose additional must be performed on the finished the materials met the lead content costs on some firms. However, section product, such as tests for conformity to requirement, then the manufacturer 14(a)(2) if the CPSA requires third party the crib and bunk bed standards. would not need to test each of the 30 testing of children’s products that are (Comment 109)—One commenter finishes separately. subject to an applicable children’s stated that furniture manufacturers who (Comment 110)—One commenter product safety rule. deal in high-quality but lower volume stated that because the cost of testing Additionally, on August 12, 2011, the furniture manufacturing may offer and recordkeeping will be passed on to President signed into law H.R. 2715, products with between 30 and more the consumer, this could create an which amended the CPSIA in several than 2,000 possible combinations of ‘‘upside down’’ market in furniture, in respects. One provision in H.R. 2715 finishes. Many of these finishes are which youth furniture is more requires us to seek public comment on custom or made to order, so that a batch expensive than adult furniture. This opportunities to reduce the cost of third can range from a 5-gallon bucket to a 55- could lead some consumers to purchase party testing requirements consistent gallon drum. Each custom finish ‘‘adult’’ furniture for children instead of with assuring compliance with any consists of at least 10 different purchasing youth furniture that has applicable consumer product safety materials. The manufacturer must create been third party tested. rule, ban, standard, or regulation. H.R. a panel for each possible combination of (Response 110)—Section 14(a)(2) of 2715 directs us to seek public comment finishing materials and then have it the CPSA requires third party testing of on seven specific issues. These issues analyzed by a third party testing facility. children’s products, including include:

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• The extent to which manufacturers the initial regulatory flexibility analysis such tests. The definition of a with a substantial number of that provided the sample sizes that ‘‘children’s product’’ is broad, and it substantially similar products subject to would be required to meet a specified includes bicycles, books, furniture, third party testing may reasonably make statistical confidence level, assuming apparel, jewelry, televisions, electronic use of sampling procedures that reduce that both the historical variability games, toys, and so on, if designed or the overall test burden without (standard deviation) and the historical intended primarily for a child 12 years compromising the benefits of third party mean of the variable (lead content) are of age or younger. Virtually all testing; and known. The commenter stated that children’s products are subject to one or • Other techniques for lowering the continuously variable data on more children’s product safety rules. cost of third party testing consistent commonly available testing reports is For example, the lead content of paint with assuring compliance with the generally not provided by the and all non-excluded accessible applicable consumer product safety laboratories, and data for samples with component parts of children’s products rules, bans, standards, and regulations. a result below the method detection are subject to limits. Therefore, virtually Elsewhere in this issue of the Federal limit is generally provided in the form all manufacturers of children’s products Register, we have published a notice ‘‘< X ppm,’’ where X is the method seeking public comment on the issues in will have to certify, based on tests by detection limit. The commenter noted accredited third party conformity H.R. 2715. H.R. 2715 further requires us that these data cannot be included for assessment bodies that their products to review the public comments and calculations of the mean or standard comply with the lead content limits. We states that we may prescribe new or deviation. The commenter stated that have excluded from the requirement to revised third party testing regulations if the example used is invalid, unless the we determine that such regulations will data can be captured and tracked in full test for lead content a few materials that reduce third party testing costs resolution, which is not the current inherently do not contain lead. The consistent with assuring compliance state. excluded materials are limited to with the applicable consumer product (Response 112)—To the extent that materials such as: most fabrics, precious safety rules, bans, standards, and continuously variable data from testing metals, paper, gemstones, and a limited regulations. results are unavailable, the discussion of number of other items, and the list can Another provision of H.R. 2715 sample size in the initial regulatory be found at 16 CFR 1500.91. We also created a new section 14(i)(4) of the flexibility analysis may be unrealistic. have issued a rule excluding from the CPSA to provide for special rules for Because the example is not widely lead content requirements (16 CFR small batch manufacturers. The applicable, and because we are not 1500.87) inaccessible component parts provision contemplates the possible requiring that the periodic third party in children’s products. Section 1(b)(3) of development of alternative testing testing be used to provide a high degree H.R. 2715 excludes certain used requirements for ‘‘covered products’’ of statistical assurance (e.g., 95 percent children’s products from testing for lead made by ‘‘small batch manufacturers.’’ confidence) that no children’s products content. All other materials used in The provision also provides for possible violate consumer product safety products intended for children must be exemptions of small batch standards, we have omitted the example tested for lead content. manufacturers from the third party from the final regulatory flexibility In addition to the requirements to test testing requirements and imposes analysis. certain limits on third party testing for lead content, manufacturers must requirements. A covered product is a D. Small Entities To Which the Rule test for conformity with a wide variety consumer product where no more than Will Apply of other children’s product safety rules. 7,500 units of the same product were By regulation (16 CFR part 1110), the For example, there are product safety manufactured by a small batch domestic manufacturer or importer is rules that establish standards for manufacturer in the previous calendar responsible for ensuring that a children’s products, such as toys, cribs, year, and a small batch manufacturer is consumer product is tested properly, bicycles, bicycle helmets, youth all- a manufacturer that had no more than and, based on the testing results, must terrain vehicles, bunk beds, baby $1 million in gross revenue from sales certify that the product conforms to all walkers, and flammable clothing of all consumer products in the previous applicable consumer product safety textiles. The CPSIA also limits the calendar year. Any small mattress rules. Manufacturers of children’s amount of six phthalates that can be manufacturer who meets the definition products that are subject to a children’s present in children’s toys and child care of a ‘‘small batch manufacturer’’ might product safety rule must certify that the articles; thus, many plastic component benefit from this provision when it is children’s products comply with all parts will need to be tested for phthalate implemented. applicable children’s product safety content. A full list of the children’s (Comment 112)—One commenter rules, based on testing conducted by product safety rules for which third stated that the discussion of sample size third party conformity assessment party testing and certification will be is unrealistic. An example was used in bodies that are accredited to conduct required is given in Table 1.

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

16 CFR part # (or test method or standard) Description

1420 ...... All-Terrain Vehicles. 1203 ...... Bicycle Helmets. 1512 ...... Bicycles. 1513 ...... Bunk Beds. 1500.86(a)(5) ...... Clacker Balls. 1500.86(a)(7) and (8) ...... Dive Sticks and Other Similar Articles. 1505 ...... Electrically Operated Toys or Articles. 1615 ...... Flammability of Children’s Sleepwear, Sizes 0 through 6X. 1616 ...... Flammability of Children’s Sleepwear, Sizes 7 through 14.

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

16 CFR part # (or test method or standard) Description

1610 ...... Flammability of Clothing Textiles. 1632 ...... Flammability of Mattresses and Mattress Pads. 1633 ...... Flammability (Open Flame) of Mattress Sets. 1611 ...... Flammability of Vinyl Plastic Film. 1219 ...... Full-Size Cribs. 1215 ...... Infant Bath Seats. 1216 ...... Infant Walkers. Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08, CPSC–CH– Lead Content in Children’s Metal Jewelry. E1001–08.1 or 2005 CPSC Laboratory SOP). Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08 or CPSC–CH– Lead Content in Children’s Metal Products. E1001–08.1). Sec. 101 of CPSIA (Test Method CPSC–CH–E1002–08 and/or CPSC– Lead Content in Children’s Non-Metal Products. CH–E1002–08.1). 1303 ...... Lead Paint. 1220 ...... Non-Full-Size Cribs. 1511 ...... Pacifiers. Sec. 108 of CPSIA (Test Method CPSC–CH–C1001–09.3 ) ...... Phthalate Content of Children’s Toys and Child Care Articles. 1510 ...... Rattles. 1501 ...... Small Parts Rule. 1630 ...... Surface Flammability of Carpets and Rugs. 1631 ...... Surface Flammability of Small Carpets and Rugs. 1217 ...... Toddler Beds. (ASTM F963) ...... Toys.

E. Number of Small Firms Affected NAICS category for importers. Firms to a product safety rule. Although there We estimated the number of firms that that import products might be classified are more than 26,000 manufacturers that could be impacted, by reviewing every as manufacturers, wholesalers, or would be considered small in these industry in the North American retailers. categories, not all of these firms are Industrial Classification System 1. Manufacturers engaged in manufacturing children’s (NAICS), and selecting industries with products that are subject to a product firms that could manufacture or sell any According to the criteria established safety rule. It would be expected that children’s product potentially covered by the U.S. Small Business most firms engaged listed in the by a consumer product safety rule. Administration (SBA), manufacturers category, Doll, Toy, and Game, produce Firms are classified in the NAICS are generally considered to be small some products that are intended for category that describes their primary entities if they have fewer than 500 children age 12 and younger. On the activity. Therefore, firms that might employees. Table 2 shows the number other hand, the Surgical Appliance and manufacture or import consumer of manufacturing firms by the North Supplies Manufacturing category products covered by a safety rule as a American Industrial Classification includes crash helmets, but most other secondary or tertiary activity may not System (NAICS) categories that cover products in this category are not under have been counted. There is no separate most children’s products that are subject our jurisdiction.

TABLE 2—MANUFACTURERS

Small Total NAICS Code Description firms firms

31411 ...... Carpet and Rug Mills ...... 244 262 315 ...... Apparel Manufacturing ...... 7,126 7,195 316211 ...... Rubber and Plastic Footwear Manufacturing ...... 43 45 316212 ...... House Slipper Manufacturing ...... 1 1 316219 ...... Other Footwear Manufacturing ...... 53 54 326299 ...... All Other Rubber Product Manufacturing ...... 622 666 336991 ...... Motorcycle, Bicycle, and Parts Manufacturing ...... 447 452 33712 ...... Household and Institutional Furniture Manufacturing ...... 6,058 6,154 33791 ...... Mattress Manufacturing ...... 427 441 339113 ...... Surgical Appliance and Supplies Manufacturing ...... 1,817 1,916 33991 ...... Jewelry and Silverware Manufacturing ...... 2,470 2,484 33992 ...... Sporting and Athletic Goods Manufacturing ...... 1,707 1,748 33993 ...... Doll, Toy and Game Manufacturing ...... 694 705 339942 ...... Lead Pencil and Art Good Manufacturing ...... 124 129 339999 ...... All Other Miscellaneous Manufacturing ...... 4,646 4,695

Total Manufacturers ...... 26,479 26,947 Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. (Available at: http://www2. census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011.

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In addition to the manufacturers in 2. Wholesalers 100 employees. Although there are more Table 3, there were 25,184 nonemployer than 78,000 wholesalers that would be businesses classified in NAICS 315 Wholesalers would be impacted by considered small in these categories, not (Apparel Manufacturing) and 61,180 the rule if they import any children’s all of these firms are engaged in classified in NAICS 3399 (Other product that is subject to a product importing children’s products that are Miscellaneous Manufacturers) in 2008. safety rule. Wholesalers who obtain subject to a consumer product safety Nonemployer businesses are generally their products strictly from domestic rule. A significant proportion of the manufacturers, or from other very small businesses with no firms classified as Toy and Hobby wholesalers, would not be impacted by employees. They are typically sole Goods and Supplies Merchant the rule because the manufacturer or proprietorships, and they may or may Wholesalers probably import at least importer would be responsible for not be the owner’s principal source of some children’s products. However, the certifying the products. Table 3 shows income. The average receipts for the only firms classified as Motor Vehicle nonemployer businesses classified in the number of wholesalers by NAICS and Motor Vehicle Parts and Suppliers Apparel Manufacturing was about code that would cover most children’s that would be impacted by the final rule $31,000, and the average receipts for the products that are subject to a product nonemployer businesses classified safety rule. According to SBA criteria, are those that import all-terrain vehicles Other Miscellaneous Manufacturers was wholesalers are generally considered to intended for children 12 years old or about $41,000.3 be small entities if they have fewer than younger.

TABLE 3—WHOLESALERS

Small Total NAICS Code Description firms firms

4231 ...... Motor Vehicle and Motor Vehicle Parts and Suppliers ...... 17,734 18,769 4232 ...... Furniture and Home Furnishing Merchant Wholesalers ...... 11,353 11,844 42362 ...... Electrical and Electronic Appliance, Television, and Radio Set Merchant 2,444 2,591 Wholesalers. 42391 ...... Sporting and Recreational Goods and Supplies Merchant Wholesalers ...... 5,019 5,196 42392 ...... Toy and Hobby Goods and Supplies Merchant Wholesalers ...... 2,227 2,302 42394 ...... Jewelry, Watch, Precious Stone, and Precious Metal Merchant Wholesalers ... 7,363 7,447 42399 ...... Other Miscellaneous Durable Goods Merchant Wholesalers ...... 9,040 9,302 42432 ...... Men’s and Boy’s Clothing and Furnishings Merchant Wholesalers ...... 3,557 3,722 42433 ...... Women’s, Children’s, and Infant’s Clothing, and Accessories Merchant Whole- 6,797 7,029 salers. 42434 ...... Footwear Merchant Wholesalers ...... 1,521 1,593 42499 ...... Other Miscellaneous Nondurable Goods Merchant Wholesalers ...... 11,203 11,490

Total ...... 78,258 81,285 Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. (Available at: http:// www2.census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011.

In addition to the wholesalers wholesalers will not be directly less than $7 million to $30 million, tabulated in Table 3, the U.S. Census impacted by the rule because the depending on the specific NAICS Bureau estimated that there were manufacturers or wholesalers would be category. Because of the way in which 206,072 nonemployer businesses responsible for the testing and the data were reported by the Bureau of classified in NAICS categories that certification of the products. However, the Census, the estimates of the number could include wholesalers of children’s there are some retailers that of small firms in each category in Table products. Nonemployer businesses are manufacture or directly import some 4 are based on similar, but different generally very small sole products; and therefore, they will be criteria. Although there are more than proprietorships. The average receipts for responsible for ensuring that these 100,000 firms that would be considered the nonemployer business wholesalers products are properly tested and ‘‘small businesses’’ in these categories, were about $86,000.4 An unknown certified. The number of such retailers it is not known how many of these firms number of nonemployer wholesalers is not known. Table 4 shows the number are engaged in importing or could import children’s products. of retailers by NAICS code that would manufacturing children’s products. cover most children’s products. Many firms probably obtain all of their 3. Retailers According to SBA size standards, products from domestic wholesalers or Retailers that obtain their products retailers are generally considered to be manufacturers and would not be from domestic manufacturers or small entities if their annual sales are directly impacted by the rule.

3 U.S. Department of Commerce, Bureau of the %20With%202009%20Methodology%20 Table.’’ available at http://www.census.gov/econ/ Census, ‘‘Revised 2008 Nonemployer Statistics Applied.xls (last accessed 16 August 2011). nonemployer/Revised%202008%20Data%20With Table.’’ Available at: http://www.census.gov/econ/ 4 U.S. Department of Commerce, Bureau of the %202009%20Methodology%20Applied.xls (last nonemployer/Revised%202008%20Data Census, ‘‘Revised 2008 Nonemployer Statistics accessed 16 August 2011).

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TABLE 4—RETAILERS

Criteria used SBA Size for estimate of standard (mil- small firms Small Total NAICS Code Description lions of dollars (millions of firms firms of annual dollars of sales) annual sales)

441221 ...... Motorcycle, ATV, and Personal Watercraft Dealers ...... < 30 < 25 4,794 4,879 4421 ...... Furniture Stores ...... < 19 < 10 16,033 16,611 44813 ...... Children’s and Infant’s Clothing Stores ...... < 30 < 25 2,057 2,074 44814 ...... Family Clothing Stores ...... < 25.5 < 25 6,588 6,684 44815 ...... Clothing Accessories Stores ...... < 14 < 10 2,757 2,774 44819 ...... Other Clothing Stores ...... < 19 < 10 6,331 6,393 4482103 ...... Children’s & Juveniles’ Shoe Stores ...... < 25.5 < 25 227 230 4482104 ...... Family Shoe Stores ...... < 25.5 < 25 2,905 2,941 45111 ...... Sporting goods stores ...... < 14 < 10 14,388 14,545 45112 ...... Hobby, toy, & game stores ...... < 25.5 < 25 4,612 4,629 452 ...... General Merchandise Stores ...... < 30 < 25 6,873 6,971 45322 ...... Gift, Novelty, and Souvenir Store ...... < 30 < 25 19,297 19,339 454111 ...... Electronic Shopping ...... < 30 < 25 11,374 11,646 454113 ...... Mail Order Houses ...... < 35.5 < 25 5,281 5,645 4542 ...... Vending machine operators ...... < 10 < 10 3,796 3,887

Total ...... 107.313 124,700 Source: U.S. Census Bureau, 2007 Economic Census, Release date 11/02/2010.

In addition to the retailers tabulated The final rule will impact virtually all rely upon testing of component parts in Table 4, the U.S. Census Bureau manufacturers and importers of that was procured by their suppliers, estimated that there were 324,918 children’s products because nearly all provided that the testing meets all of the nonemployer businesses classified in children’s products are subject to some requirements in 16 CFR part 1109. The NAICS categories that could include children’s product safety rules. For requirements include that the testing be retailers of children’s products. example, the restrictions on lead performed by a third party conformity Nonemployer businesses are generally content cover almost all children’s assessment body whose accreditation very small sole proprietorships. The products. Even products that contain has been accepted by the CPSC. To rely average receipts for the nonemployer some of the materials that have been upon component part testing—whether business retailers were about $40,000.5 excluded from the restrictions (see 16 conducted by the children’s product An unknown number of nonemployer CFR 1500.88) or that have been manufacturer or by a supplier of the retailers could import children’s determined inherently not to contain component part—there must be products. lead in excess of the legal requirement sufficient documentation so that the (see 16 CFR 1500.91) might have to be component part can be traced back to F. Compliance, Reporting, and tested for compliance with other rules. the party who procured the third party Recordkeeping Requirements of Rule For example, although the fabric in test results demonstrating that the wearing apparel might be excluded from component part complies with the The final rule establishes some the requirement to test for lead content, applicable safety rules. Provisions in 16 requirements for the certification of it may have to be tested for compliance CFR part 1109 also allow an importer to children’s products. It also establishes with flammability requirements. Any rely upon testing procured by, or a protocols and standards for ensuring other non-excluded objects on the certificate issued by, a supplier of a that children’s products are subject to apparel, such as buttons, snaps, zippers, finished good in issuing their own testing periodically, when there has or applique´s will also need to be tested certificate for a product. Therefore, if a been a material change in the product’s for lead content. foreign manufacturer has tested and design or manufacturing process, In meeting the requirements of the certified a children’s product in including the sourcing of component final rule, manufacturers and importers accordance with the requirements of 16 parts, and for safeguarding against the can use component part testing, as CFR part 1109, an importer may rely exercise of undue influence on a third provided by 16 CFR part 1109. This upon that testing or certification in party conformity assessment body by a means, for example, that manufacturers issuing their own certificate for the children’s product manufacturer or could submit samples of paint that they product. private labeler. The requirements are are using on their products to a third G. Partial Exemption for Small Batch discussed in more detail below, and the party testing laboratory to be tested for Manufacturers impact that these could have on lead and heavy metal content. This manufacturers is discussed in a later could reduce the amount of testing H.R. 2715, which was enacted on section of this preamble. required because the results from the August 12, 2011, provides some relief component part tests could be relied for small batch manufacturers from the 5 U.S. Department of Commerce, Bureau of the upon for demonstrating the compliance third party testing requirements Census, ‘‘Revised 2008 Nonemployer Statistics of all products on which that paint was contained in the final rule. H.R. 2715 Table.’’ Available at: http://www.census.gov/econ/ used, rather than retesting the paint requires that we consider alternative nonemployer/ multiple times because it was used on requirements for small batch Revised%202008%20Data%20With%202009%20 Methodology%20Applied.xls (last accessed 16 multiple products. The final rule also manufacturers. Until we determine what August 2011). allows manufacturers and importers to alternative requirements are suitable for

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small batch manufacturers, small batch has been accepted by the CPSC for made. The test methods used in the manufacturers are not required to obtain testing to ensure their products continue production testing plan need not be the third party testing results to confirm to comply with all applicable children’s same test methods used for certification, that their children’s products conform product safety rules. Manufacturers but they must be effective in to several children’s product safety need to conduct periodic third party determining compliance with the rules. However, small batch testing frequently enough to ensure, applicable children’s product safety manufacturers are still subject to the with a high degree of assurance, that the rules. third party testing requirements of the product continues to comply with all Manufacturers or importers who final rule with respect to the lead applicable children’s product safety choose this second option, will need to content of paint; full-size and non full- rules, but in no case can the interval ensure that their quality assurance or size cribs; pacifiers; small parts; between periodic tests exceed the testing program meets the requirements children’s metal jewelry; and baby maximum periodic testing interval of the final rule for production testing bouncers, walkers, and jumpers. applicable to the manufacturer. and that their testing program provides H.R. 2715 defines a ‘‘small batch Depending upon other testing a high degree of assurance that all manufacturer’’ as a manufacturer who procedures that a manufacturer may opt products manufactured or imported had no more than $1 million in total to use, one of three possible maximum continue to comply with all applicable gross revenue from sales of all consumer periodic testing intervals will apply to children’s product safety rules. In products in the previous calendar year a children’s product manufacturer. The addition, at least once every two years, (which will be adjusted annually by the first option applies to manufacturers this option requires the manufacturer or percentage increase in the Consumer who do not conduct other production importer to submit samples to a CPSC- Price Index for all urban consumers). testing of a children’s product. accepted third party conformity We will implement the small batch Manufacturers who do not undertake assessment body to be tested for manufacturer provision of H.R. 2715 in other production testing must conduct conformity with all applicable a separate proceeding. periodic third party testing of the children’s product safety rules. The product at least once a year. The final final rule does not specify how many H. Certification Tests rule requires manufacturers to develop samples must be submitted to the third To certify that a children’s product a periodic test plan that will ensure that party conformity assessment body, nor complies with all applicable children’s the children’s products manufactured does it set forth what constitutes an product safety rules, the final rule after the certification, or since the appropriate periodic testing interval requires that manufacturers submit previous periodic testing was (other than stating it must not be greater samples of the product to a third party conducted, continue to comply with all than two years). However, the conformity assessment body whose applicable children’s product safety expectation is that this option will accreditation has been accepted by the rules. The periodic test plan must require less testing by third party CPSC. The final rule requires that the include the tests to be conducted, the conformity assessment bodies because, number of samples submitted must be intervals at which the tests will be under this option, the (first party or sufficient to provide a high degree of conducted, and the number of samples third party) production testing provides assurance that the tests conducted for to be tested. Although the manufacturer the manufacturer or importer with a certification purposes accurately has some discretion in determining the high degree of assurance that the demonstrate the ability of the children’s interval between periodic tests, the products continue to comply with the product to meet all applicable children’s interval must be short enough to ensure applicable children’s product safety product safety rules. Fewer samples are that if the samples selected for periodic rules and can provide manufacturers needed if the manufacturing process third party testing pass the tests, then with information that can be used to consistently results in products that are there is a high degree of assurance that determine the interval and number of uniform in composition and quality. the untested products manufactured samples required for the periodic third More samples will be needed if there is during the interval comply with all party testing. more variability in the finished applicable children’s product safety The third option applies to products. If any product fails rules; and the interval must be no longer manufacturers who conduct testing to certification testing, the manufacturer than one year. ensure continuing compliance with the must investigate and address the cause The second option applies to applicable children’s product safety of the failure, even if other samples manufacturers who implement a rules using a testing laboratory passed the certification tests. production testing plan (which can use accredited to ISO/IEC 17025:2005, The cost of the third party testing is first or third party testing). If a General requirements for the discussed in more detail later in part manufacturer has implemented a competence of testing and calibration IV.N. of the preamble. Manufacturers production testing plan that meets the laboratories, but whose accreditation also may incur costs for any consultants requirement of § 1107.21(c) of the final has not been accepted by the CPSC. In to provide advice for determining the rule, the manufacturer must conduct most cases, these will be in-house number of samples that should be third party periodic testing at least once testing laboratories. If a manufacturer submitted for testing and to ensure that every two years. The production testing conducts testing using such a testing it was in compliance with the plan must describe the production laboratory, the manufacturer must requirements. There also will be some management techniques and tests that conduct periodic third party testing at administrative and recordkeeping costs must be performed to provide a high least once every three years. Any testing associated with this requirement. degree of assurance that products laboratory used under this option must manufactured after certification be accredited by an accreditation body I. Periodic Third Party Testing continue to meet all applicable that is accredited to ISO/IEC The final rule requires manufacturers children’s product safety rules. The 17011:2004, Conformity assessment— and importers of children’s products to production testing plan must also General requirements for accrediting periodically submit samples of their include additional information, such as conformity assessment bodies. The tests products to third party conformity the intervals at which tests must be used under this option must be the same assessment bodies whose accreditation conducted or measurements will be tests used for certification to the

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applicable children’s product safety addition to the cost of the third party commenters stated that establishing rules. The testing must be conducted testing, which is described in more these safeguards would be burdensome, frequently enough to provide a high detail later in this analysis. none provided estimates of what the degree of assurance that the product cost would be. The final rule gives firms J. Third Party Testing Due to Material continues to comply with all applicable great flexibility in meeting these Changes children’s product safety rules. requirements. For example, the final The final rule does not specify how If a children’s product undergoes a rule does not prescribe the form of the many samples a manufacturer using the material change in product design or training, and firms may include this third option must submit to the third manufacturing processes, including the training along with other types of party conformity assessment body, nor sourcing of component parts that could employee training. does it set forth what constitutes an affect the product’s ability to comply appropriate periodic testing interval with the applicable children’s product L. Recordkeeping (other than stating it must not be greater safety rules, the final rule requires the The final rule requires manufacturers than three years). However, as with the manufacturer to submit samples of the of children’s products to keep the second option, the intent behind materially changed product to a third following records: including this option in the final rule is party conformity assessment body for • A copy of the Children’s Product to reduce the cost that the rule imposes testing. The number of samples must be Certificate for each product. The on children’s product manufacturers, by sufficient to provide a high degree of children’s product covered by the reducing the amount of testing that they assurance that the materially changed certificate must be clearly identifiable must obtain from third party conformity product complies with all applicable and distinguishable from other assessment bodies. The testing that the children’s product safety rules. The products; manufacturer performs in an ISO/IEC testing can be limited to the portion or • Records of each certification test. 17025:2005-accredited testing laboratory component part of the finished product The manufacturer must have separate provides the high degree of assurance that was changed and for compliance certification test records for each that the products comply with the with those children’s product safety manufacturing site; applicable children’s product safety rules for which compliance might have • Records of one of the following for rules, and it also can provide been affected. periodic tests of a children’s product: manufacturers with information that can The primary cost of this requirement Æ will be the cost of the third party Periodic test plan and periodic test be used to determine interval and results; number of samples required for the testing. There also will be some Æ administrative and recordkeeping costs Production testing plan, production periodic third party testing. test results, and periodic test results; or Like the second option, the intent of associated with this requirement. The Æ the third option is to reduce the final professional skills required by the Testing results of tests conducted rule’s cost to manufacturers, by manufacturer are the same skills by a testing laboratory accredited to reducing the amount of testing that they required for the initial certification and ISO/IEC 17025:2005 and periodic test results. must conduct using third party periodic tests. • conformity assessment bodies. However, Records of descriptions of all K. Protection Against Undue Influence the manufacturers that are most likely to material changes in product design, benefit from this third option are The final rule requires that each manufacturing processes, and sourcing manufacturers who have their own in- manufacturer of children’s products of component parts, the certification house ISO/IEC 17025:2005-accredited establish procedures to safeguard tests, the test results, and the actual testing laboratories. These are likely to against the exercise of undue influence values of the tests, if any; and • be larger manufacturers, so this option by a manufacturer on a third party Records of the undue influence is not expected to provide much relief conformity assessment body. At a procedures, including training materials to smaller manufacturers. To the extent minimum, these procedures must and training records of all employees that the smaller manufacturers compete include written policy statements from trained on these procedures. with the larger manufacturers, this company officials that the exercise of These records must be maintained for option may adversely affect the undue influence is not acceptable and five years. The records must be made competitiveness of the smaller directing that every appropriate staff available for inspection by the CPSC, manufacturers relative to larger member receives training on avoiding upon request. The records may be manufacturers because any cost undue influence and signs a statement maintained in languages other than reduction will disproportionately attesting to their participation in the English, if the records can be provided benefit larger manufacturers. training. The procedures also must immediately to us and translated Under all periodic testing options, a include a requirement to retrain the accurately into English within 48 hours manufacturer may need statistical or appropriate staff if there are substantive of a request by the CPSC or a longer other knowledge in order to develop changes in the requirements for period, as negotiated with CPSC staff. their testing plans, including safeguarding against the exercise of We have estimated that, on average, it determining the appropriate testing undue influence. The training will take three to five hours for intervals and number of samples procedures must include a requirement recordkeeping per product. However, required to provide the manufacturer to notify us immediately of any attempt the time needed for recordkeeping for with a high degree of assurance that its by the manufacturer to hide or exert any particular product could be children’s products are in compliance undue influence over test results, and a substantially higher or lower. For with all applicable children’s product requirement to inform employees that example, recordkeeping for products safety rules. If these services are not allegations of undue influence may be that are subject to multiple standards, or available in-house, the firm may have to reported confidentially to us and to products that require a substantial hire outside consultants. Additionally, describe how such a report can be made. amount of testing, could need firms will incur administrative and Firms will incur some costs in substantially more hours. For other recordkeeping costs associated with the establishing the safeguards against products, such as those subject to only periodic testing requirement, in undue influence. Although several one standard, and for which little

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testing is required, the number of hours the testing laboratory and the homogenous polymer products would needed for recordkeeping might be less. manufacturer. Manufacturers who do a be between $3 and $10 per test. large volume of business with a testing For testing the lead content of paint, M. Consumer Product Labeling Program laboratory frequently can obtain we have approved the use of a specific The final rule establishes a program discounts on the testing laboratory’s XRF test method described in ASTM by which any manufacturer or private normal charges; but manufacturers who F2853 that uses energy dispersive XRF labeler of a consumer product may label do only a small volume of business may using multiple monochromatic beams. product as complying with the not be able to negotiate a discount on Generally, fewer tests can be conducted applicable certification requirements for the testing. in an hour using this test method. If 6 the product. If the manufacturer has Information on the cost of third party to 12 tests can be conducted in an hour certified that a consumer product testing to determine compliance with at a rate of $100 an hour, then the cost complies with all applicable consumer some children’s product safety rules is of testing a paint for lead content using product safety rules, the manufacturer provided below. The information was the approved XRF technique would be or private labeler may affix a label to the collected from a number of sources, about $8 to $17. product which states that the product: including published price lists from Other than for homogenous polymer ‘‘Meets CPSC Safety Requirements.’’ The some testing laboratories, conversations components and the lead content of label must be visible and legible. This with representatives of testing paint, we have not approved the use of program is voluntary in that laboratories, actual invoices provided by XRF techniques for testing any other manufacturers and private labelers are consumer product manufacturers, and materials. For other materials, such as not required to affix this label to their public comments we received. The data metal components, manufacturers will products. However, opting not to affix are not based upon a statistically valid need to use ICP analyses techniques to the label to the product would not survey of testing laboratories. test for lead content. relieve the firm of its responsibility to Additionally, the costs include only the 3. Phthalates ensure that the products comply with costs that would be charged by the the applicable safety rules and with all testing laboratory. Not included in the The cost of testing for phthalate other provisions of the rule. This information are the costs of the samples content will range from around $100 (a provision is not expected to have a consumed in destructive tests, the cost discounted price by a testing laboratory significant impact on firms, however, of shipping the samples to the testing in China) to about $350. These are the because the program is voluntary, and laboratories, and any related costs per component part, and they the costs of adding or modifying a label administrative or recordkeeping include testing for all six of the on a product are expected to be low. activity. According to one commenter, individual phthalates whose content is restricted. N. Cost of Third Party Testing and these costs could add 15 to 50 percent Potential Impact of the Rule to the third party testing costs. 4. Bicycle Standard (16 CFR part 1503) The costs of the third party testing 2. Lead Content and Lead-in-Paint According to one testing laboratory, it requirements are expected to be takes one to two days to test a bicycle. The cost per component part for significant for some manufacturers and The estimated price for testing one testing lead content and lead-in-paint are expected to have a disproportionate bicycle may range from around $700, if using inductive coupled plasma (ICP) impact on small and low-volume the testing is performed in China, to analysis will range from a low of about manufacturers. This section discusses around $1,100, if the testing is $20 per test, to more than $100 per test. the cost of third party testing and the performed in the United States. A The lowest per-unit cost represents a potential impact of the third party manufacturer who needs several models substantially discounted price charged testing and other requirements of the of bicycles tested at the same time, to a particular customer by a testing final rule on manufacturers. might be able to obtain discounts on laboratory in China, and therefore, the these prices. This does not include 1. Cost of Third Party Testing price might not be typical. Within the testing for lead or phthalates in United States, typical prices range from The cost of third party testing is nonmetal component parts. H.R. 2715, around $50, to more than $100 per test. influenced by many factors, including however, exempted the metal the amount and skill of the labor The cost of testing for lead content components of bicycles from the third required to conduct the tests, the cost of using X–Ray fluorescence (XRF) party testing requirements for lead the equipment involved, the cost of technology is significantly less content. transporting the product samples to the expensive. Some firms have offered to test facility, and the geographic area screen products for lead content for as 5. Bicycle Helmets where the tests are conducted. Some little as $2 per test. These offers are One testing laboratory quoted a price tests require a substantial amount of generally directed to stores or of $600 for testing one model of a time to conduct the tests, including the businesses that want to check their bicycle helmet to the CPSC bicycle preparation of the samples. It might take inventory for conformity with the helmet standard. A price list from a couple of days, for example, to test a retroactive lead content requirements another testing laboratory stated that bicycle for compliance with the bicycle contained in the CPSIA. Some testing conducting the certification testing to standard (16 CFR part 1512). Similarly, laboratories will charge for XRF testing the Snell Foundation’s bicycle helmet a chemist testing the lead content of a at an hourly rate, which can cost around standard, which is similar to the CPSC product might be able to test only a few $100. Ten to 30 tests can be conducted standard, is $830. metal component parts per day, due to in an hour. the amount of time required to prepare We have approved XRF test methods 6. Full-Size Cribs the samples and clean and calibrate the for determining the lead content of As with bicycles, testing cribs equipment between tests. homogenous polymer products. requires a substantial amount of labor It should be noted that the price that Assuming that 10 to 30 tests can be time to assemble the crib, take the a given manufacturer pays for testing is conducted in an hour at a rate of $100 appropriate measurements, and perform often the result of negotiations between per hour, the cost of XRF testing for the required tests. The cost of testing a

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full-size crib to the pre-2010 standard intended to provide only some manufactured during the interval was about $750 to $1,200 for testing perspective on the potential impact. comply with the applicable children’s performed in the United States. The cost product safety rules. Manufacturers who 9. Number of Samples Required of testing a full-size crib to the current have implemented a production testing standard may be somewhat higher. The The final rule does not specify the plan or test in an ISO/IEC 17025:2005- cost can vary, depending on the features exact number of samples that must be accredited testing laboratory may of the individual cribs that require submitted to third party conformity consider the information obtained from testing and among the various testing assessment bodies, nor does it specify the testing in determining the testing laboratories. Some manufacturers might the testing interval, other than to interval and the number of samples that receive discounted prices. This does not provide maximum intervals. Instead, the are needed. include testing the crib for lead and final rule requires manufacturers to 10. Hypothetical Toy Testing Example phthalates, which, to the extent determine the number samples and the necessary, would add to the cost of necessary testing interval based on To provide some information on what testing a crib to all applicable safety factors such as: The variability of the the magnitude of the third party testing rules. product, manufacturing processes, and costs may be for some manufacturers of information obtained from other testing. children’s products, this section 7. Toys However, it is likely that between discusses the potential cost of obtaining The children’s product safety rules certification testing, testing after a third party testing for a hypothetical toy. applicable to toys, including the ASTM material change, and periodic testing, This example is hypothetical and is F963 standard made mandatory by the many manufacturers will need to submit intended to illustrate some potential CPSIA, include a wide variety tests, more than one sample of a given cost implications of the rule. The including tests for soluble heavy metals product to third party conformity example is not intended be in surface coatings and for various assessment bodies during a given year. representative of every product or physical and mechanical criteria. Based Because some children’s product safety manufacturer. The costs per test that are on the itemized prices on several rules require more than one unit of the assumed in the examples are based on invoices provided to us by testing product to complete all of the required the cost of tests discussed above; but the laboratories or otherwise made public, tests, one sample may consist of actual costs can vary significantly the cost of the physical and mechanical multiple units of the product. between conformity assessment bodies. tests range from about $50 to $245. The For purposes of certifying a children’s The testing costs for any particular cost of the chemical test for the presence product (including testing after a manufacturer also depend upon factors of heavy metals ranges from about $60 material change), the final rule requires such as the complexity of the products, to $190 per surface coating. Again, these manufacturers to submit enough the variation in the materials used, costs do not include testing for lead and samples to a third party conformity manufacturing processes used, phthalates, which add to the total cost. assessment body to provide a high opportunities to use component part The flammability requirements of degree of assurance that tests conducted testing, and so on. We used a similar ASTM F963 were not made mandatory for certification purposes accurately example in the initial regulatory by the CPSIA, but we were directed to demonstrate the ability of the product to flexibility analysis. The discussion has examine the flammability requirements comply with all applicable children’s been changed to reflect the fact that and consider promulgating rules product safety rules. In determining energy dispersive XRF analysis can be addressing the issue. If some how many samples to submit, a used to test for lead in paint in addition flammability tests are eventually manufacturer is to consider the to XRF testing in homogenous polymer required, the cost per test could be in variability in the product and products. We also have modified the the range of $20 to $50, based on some manufacturing processes. If the discussion to deemphasize references to observed costs for the ASTM F963 manufacturing process for a children’s statistical measurements because, flammability tests. product consistently creates finished although statistical measurements might products that are uniform in be useful, the number of samples that 8. Cost of Third Party Testing by composition and quality, such as with must be tested need not be one that Product die casting, a manufacturer may be able provides a particular confidence level, The cost to obtain the required third to submit a relatively small number of such as 95 percent confidence level that party testing for a product depends on samples to the third party conformity all products in a lot are compliant. the types and number of tests that must assessment body. If the manufacturing Toys must meet requirements be performed, as well as the number of process for a children’s product results concerning lead and phthalate content, samples that are required to provide a in variability in the composition or as well as several physical and high degree of assurance that the tests quality of children’s products, such as mechanical requirements, including the conducted for certification purposes what might be expected with hand requirements of ASTM F963, which was accurately demonstrate the ability of the assembly, a manufacturer may need to made a mandatory standard by the product to meet the applicable submit a greater number of samples. CPSIA. In this example, we assume that children’s product safety rules or ensure For periodic testing, the final rule the testing costs are at the low to middle continuing compliance with the requires that the number of samples part of the ranges discussed above, and applicable children’s product safety selected must be sufficient to assess— we also assume that the hypothetical toy rules. The cost of the testing also will be with a high degree of assurance—the contains one metal component part that affected by the extent to which the continuing compliance of the children’s must be tested for lead content using manufacturer can use component part product with all applicable safety rules. ICP analysis (at $50) and two plastic testing. Because of the wide variety of Additionally, the testing interval for component parts for which XRF manufacturers and products that would periodic testing must be short enough to analysis can be used for determining the be affected by the rule, we cannot ensure that, if the samples selected for lead content (two tests at $6 each). The provide comprehensive estimates of the periodic testing pass the test, there is a plastic component parts also must be impact of the rule on all manufacturers high degree of assurance that the other tested for phthalate content (two tests at or products. The discussion below is untested children’s products $225 each). Additionally, we assume

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that the toy contains four different For example, if the plastic resins, metal on a firm depends upon the individual paints that must be tested for both lead component part, and paints are used on circumstances of the firm. One factor is content ($13/test, assuming energy other products, the manufacturer could the magnitude of the impact in relation dispersive XRF analysis) and soluble test the component parts independently to the revenue of the firm. A typical heavy metals ($125/test). Finally, we of the individual finished products and profit rate is about five percent of assume that the toy is subject to some spread the cost of the chemical content revenue. In other words, for every one mechanical requirements that include tests over more than one finished dollar of revenue, only five cents might use and abuse testing ($50 per test). product. If the average cost of the remain after paying all expenses. Thus, the cost of testing the chemical content tests could be reduced Therefore, a new cost that amounted to hypothetical toy for compliance to each by a factor of four through component one percent of revenue could, all other applicable rule one time would be part testing, then the cost of testing the things equal, reduce the profit by 20 $1,114: $1,064 is associated with the toy in this example for conformity with percent and would be considered to be chemical (lead, heavy metal, and all applicable safety rules one time a significant impact by most firms. This phthalate) testing, and $50 is associated would be $316 (cost of chemical testing would be consistent with what some with the mechanical testing (including of $1,064/4 and cost of the mechanical other agencies consider to be significant. use and abuse testing). and use and abuse testing of $50). The Occupational Safety and Health Having one sample tested by a third However, the cost of third party testing Administration (OSHA), for example, party conformity assessment body will for the manufacturer would likely be considers an impact to be significant if probably not be sufficient to meet the higher because testing one sample will the costs exceed 1 percent of revenue or requirements of the final rule. seldom be sufficient to provide the 5 percent of profit.6 Therefore, the cost of the third party required high degree of assurance. For Some insight on the disparate impact testing for the manufacturer of this example, if each component part that the final rule could have on small hypothetical toy would be greater than required four tests, and the mechanical businesses can be provided by $1,114. For example, if four samples are testing required must be repeated four examining how the rule might impact needed, the cost would be $4,456. The times to provide the required high three hypothetical toy manufacturers of cost would be higher if some tests had degree of assurance, then the cost of the different sizes. The costs associated to be conducted more than four times to third party testing for the hypothetical with third party testing that the provide the required high degree of toy would be $1,264. hypothetical manufacturers would face assurance. The manufacturer might be will be described, and the potential 11. Impact of Final Rule on Firms able to reduce the third party testing impact on the hypothetical costs if it is able to use component part Whether the third party testing costs manufacturers will be discussed. This testing for the chemical content tests. would have a substantial adverse impact discussion is summarized in Table 5.

TABLE 5—IMPACT OF RULE ON THREE HYPOTHETICAL FIRMS

Hypothetical Hypothetical Hypothetical firm C—small firm A—large firm B—small batch manufacturer manufacturer manufacturer

1 ...... Number of Different Products ...... 1,000 100 10 2 ...... Annual Production Volume per Product ...... 100,000 10,000 1,000 3 ...... Total Annual Production Volume (Row 1 × Row 2) ...... 100,000,000 1,000,000 10,000 4 ...... Revenue per unit sold ...... $4 $4 $4 5 ...... Total Annual Revenue (Row 4 × Row 3) ...... $400,000,000 $4,000,000 $40,000 6 ...... Cost of testing each product for compliance with all rule once ...... $1,114 $1,114 $102 7 ...... Cost of Testing Each Product 4 Times (Row 6 × 4) ...... $4,456 $4,456 $408 8 ...... Total Third Party Testing Cost (Row 7 × Row 1) ...... $4,456,000 $445,600 $4,080 9 ...... Cost of Samples (4 samples of 2 units of each product) ...... $32,000 $3,200 $320 10 ...... Recordkeeping (5 hours/product at $36.43/hour) ...... $182,150 $18,215 $1,822 11 ...... Total Testing Cost for One Year (Sum of Rows 8 through 10) ...... $4,670,150 $467,015 $6,222 12 ...... Testing Cost as Percent of Revenue (Row 11/Row 5) ...... 1.2% 11.7% 15.6%

12. Three Hypothetical Manufacturers manufacturer offers 100 different 13. Revenue products with an annual production or 7 The first hypothetical manufacturer, sales volume of 10,000 units each. The average price of a toy is $7 to $8. Firm A, is a large toy manufacturer that Finally, the third hypothetical toy However, because the retailer and any offers 1,000 different toys with an manufacturer is a small batch wholesalers or distributors would also annual production or sales volume of manufacturer that offers only 10 get a share of the revenue, the 100,000 units each. Its total annual products that with an annual manufacturer would be expected to get production volume is then 100 million a fraction of the retail price. Therefore, production or sales volume of about units (1,000 products × 100,000 units the revenue received by a manufacturer 1,000 units each. each), which is shown in Row 3 of Table of a toy that retails for $7 to $8 might 5. The second hypothetical be about $4 per unit. For some toys, the manufacturer, Firm B, is a smaller toy revenue per unit received by the

6 OSHA, Assigned Protection Factors, Final Rule, 7 Retail sales of toys in the United States are about about 3 billion individual toys sold annually in the Federal Register (71 FR 50121–50192), 24 August $22 billion per year (Toy Industry Association press United States. This suggests an average retail price 2006. release dated 27 June 2011). A representative of the of $7 to $8 ($22 billion x 3 billion). Toy Industry Association estimated that there are

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manufacturer might be lower, and for manufacturer with the necessary high the recordkeeping is $36.43,8 the others it might be higher. To begin the degree of assurance, whether for the recordkeeping cost would be about $182 example, we assume that the average initial certification of the product, or to per product. The total recordkeeping revenue is $4 per unit. The Total meet the periodic testing requirement. burden (given in Row 10) is the cost per Annual Revenue of the Firm (Row 5) is Therefore, the total cost that the product ($182), multiplied by the found by multiplying the Revenue per manufacturer will be charged by a third number of products (Row 1). This unit (Row 4) by the Total Annual party conformity assessment body is estimate of the recordkeeping burden Production Volume (Row 3). $4,456 per product for Firms A and B, assumes that the manufacturer will not be required to acquire any additional 14. Third Party Testing Costs and $408 per product for Firm C (Row 7). Because each manufacturer produces equipment or software to comply with The final rule requires manufacturers more than one product, total third party the recordkeeping requirements of the to have children’s products tested by a testing costs (Row 8) is equal to the cost final rule. third party conformity assessment body per product times the number of before the products are distributed, 16. Total Testing Cost products produced multiplied by the periodically after that, and when there × The total cost of testing for one year has been a material change in the number of products produced (Row 7 is the sum of the cost of the third party product. In these hypothetical Row 1). testing, the cost of the samples examples, we assume that the In this hypothetical example, we consumed in the testing, the cost of the manufacturers must submit samples of further assume that, to conduct each test recordkeeping, and the cost of their products to third party conformity at least once, the manufacturer must developing the sampling plans. This is assessment bodies annually, whether for submit two units of the toy to the given in Row 11 of Table 5. initial certification of products, periodic conformity assessment body. In other Manufacturers may incur other costs testing, or recertification after a material words, a sample consists of two units of that were not considered above. For change. the product. The cost of the samples example, the proposed rule contained The cost of the third party testing for consumed by testing is the revenue that provisions requiring manufacturers to a toy is a function of the characteristics the manufacturer forgoes because the select the samples for periodic testing, of the toy, such as the number and type units were used for testing and not sold. using techniques that would result in a of component parts, the materials used Therefore, the cost of the samples statistical simple random sample. There in its construction, and the specific toy consumed in the testing (given in Row will likely be costs associated with such standards and tests that apply to it. The 9) is calculated as the product of the 8 requirements. These potential costs cost of third party tests would not be units required to conduct the tests, the include: The cost of hiring consultants expected to be affected by the size of the revenue per product, and the number of to design a sampling plan for selecting manufacturer (although some a sample that meets established different products (i.e., 8 × Row 4 × Row conformity assessment bodies might requirements and the cost of the added 1). offer discounts to firms for whom they time and effort that might be required in conduct a lot of testing). In the Although component part testing has selecting such a sample. However, H.R. hypothetical example, we assume that the potential to reduce third party 2715 revised section 14(i)(2)(B)(ii) of the the conformity assessment bodies will testing costs, component part testing is CPSIA by replacing the phrase: ‘‘the charge the manufacturer $1,114 to test not considered initially in these testing of random samples to ensure the toy for conformance with each examples. One reason we did not continued compliance’’ with the phrase: applicable children’s product safety rule consider it is that it has not been ‘‘the testing of representative samples to (Row 6), which is the same cost used in determined how extensively component ensure continued compliance.’’ Because the earlier discussion of the cost to test part testing will be used in practice. of this change in the statute, we are not a hypothetical toy. In the case of Firm Component part testing generally might finalizing the section of the proposed C, a small batch manufacturer, the third not be an option for component parts rule pertaining to random samples. party testing costs may be lower. Unless that are not used in multiple products, These costs will be addressed in more we establish alternate requirements for or for which only a small portion of the detail when we consider how to small batch manufacturers, H.R. 2715 production is used in children’s implement section 14(i)(2)(B)(ii) of the may effectively exempt the qualifying products. It also might not be applicable CPSA, as amended by the CPSIA and products of small batch manufacturers to some importers or manufacturers who H.R. 2715. from many third party testing obtain products from suppliers that do 17. Impact on Hypothetical Firms requirements, including the not have the capability for component The impact of the testing costs on requirements for phthalates, heavy part testing, or for which the each of the hypothetical firms is metal content of paints, and the lead manufacturer or importer, exercising summarized in Row 12 of Table 5. For content of substrates (but not from other due care, has not yet developed the the large manufacturer, Firm A, the requirements, such as lead-in-paint or degree of confidence in the supplier to children’s metal jewelry). In the case of testing costs could amount to 1.2 rely upon test reports and records percent of the firm’s revenue (total the toy example, Firm C will need to provided by the supplier. have the paints used tested for lead testing cost, divided by the total content and the toys themselves tested 15. Recordkeeping revenue) if the firm received about $4 for small parts. Using the costs assumed per product. This could be considered a in the hypothetical toy example, the Firms will incur costs for preparing cost to Firm C for testing each product and maintaining the records and 8 This is based on the assumption that about half documentation required by the final the labor is management or professional and the once to the two applicable requirements other half is sales or office labor. For all workers would be $102 (4 paints at $13 each and rule. In this example, we assume that in private industry, the total hourly compensation for small parts at $50). the recordkeeping will require for management, professional, and related This hypothetical example assumes approximately five hours per toy. occupations is $50.08 and $22.78 office and Assuming that the total compensation, administrative occupations (Bureau of Labor that it is necessary to conduct each Statistics, Employer Cost for Employee applicable test four times to provide the per hour, for the employees involved in Compensations, March, 2011).

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significant impact. (A typical profit is have a significant impact on even a large product requires a substantial amount of about 5 percent of total revenue. Thus, manufacturer. The significance of the skilled labor to create. Table 6 shows a 1.2 percent increase in costs could impact increases as the production or what the impact would be on Firm C, decrease profit for a typical firm by 24 sales volume of the manufacturer the hypothetical small batch percent.) If the average revenue that this decreases. manufacturer, if it received an average firm received is somewhat higher, The example of Firm C can be used of $50 per unit for each unit it sold. Its however, the impact probably would to demonstrate the relief that H.R. 2715 total revenue would increase to not be considered significant. may be able to provide to small batch $500,000 per year. The cost of the For Hypothetical Firm B, a smaller manufacturers. If Firm C is unable to samples consumed in testing would manufacturer, the testing costs would benefit from the testing exemptions increase to $4,000 (Row 9), which amount to about 11.8 percent of the provided by H.R. 2715, then Firm C would increase the cost of testing to firm’s revenue, if the firm received an would have faced the same per-unit average of $4 for each unit produced. testing costs as the other firms in this $9,902 (Row 11). The testing costs For the small batch manufacturer, Firm example: $1,114 instead of $102. Under would amount to about 1.9 percent of C, the testing costs would amount to that scenario, the total testing cost for the firm’s revenue, which might be about 15.6 percent of its revenue. In Firm C would have been more than considered significant, but it is much both cases (i.e., Firms B and C), costs $46,000, which would have exceeded its lower than it would have been if its amounting to 11.8 percent and 15.6 revenue of $40,000. revenue per unit was lower. It should be percent, respectively, of revenue would Some small manufacturers probably noted that if the manufacturer receives be considered a significant impact. have average revenues per product that $50 per unit sold of a product, the retail These hypothetical examples illustrate exceed $4. This might be the case price is likely substantially higher the disproportionate impact that the especially if it is a specialty or niche (unless the manufacturer sells a final rule may have on small businesses. market, in which only a few substantial portion of the product As illustrated, the final rule could also manufacturers participate, or if the directly to the final consumer).

TABLE 6—IMPACT ON HYPOTHETICAL FIRM C IF REVENUE PER UNIT IS $50

Hypothetical firm C—very small manufacturer

1 ...... Number of Different Products ...... 10 2 ...... Annual Production Volume per Product ...... 1,000 3 ...... Total Annual Production Volume (Row 1 × Row 2) ...... 10,000 4 ...... Revenue per unit sold ...... $50 5 ...... Total Annual Revenue (Row 4 × Row 3) ...... $500,000 6 ...... Cost of testing each product for compliance with all rule once ...... $102 7 ...... Cost of Testing Each Product 4 Times (Row 6 × 4) ...... $408 8 ...... Total Third Party Testing Cost (Row 7 × Row 1) ...... $4,080 9 ...... Cost of Samples (4 samples of 2 units of each product) ...... $4,000 10 ...... Recordkeeping (5 hours/product at $36.43/hour) ...... $1,822 11 ...... Total Testing Cost for One Year (Sum of Rows 8 through 11) ...... $9,902 12 ...... Testing Cost as Percent of Revenue (Row 12/Row 5) ...... 1.9%

There also will be other costs that receiving test reports that indicate may allow the cost of the third party could be associated with the rule for inaccurately that the product did not testing to be spread over more units of which no quantification was attempted comply with a children’s product safety the component part, which ultimately in the above hypothetical examples. rule. When a manufacturer receives a lowers the cost of third party testing per One cost that was not considered is the test report that indicates inaccurately unit of the finished product. For additional administrative costs that are that a product does not meet a standard, example, if the hypothetical firms in the likely associated with the final rule’s the manufacturer could assume that the above examples were able to reduce the requirements; these include the cost of test was accurate and needlessly dispose cost of third party testing by a factor of tracking when each product or of, or attempt to rework, the products four using component part testing, in component part needs to be tested. It covered by the test result; or, it might several (but not all) of the scenarios also includes the cost of monitoring the suspect that the test report was examined, the impact on those small suppliers and component parts that are inaccurate and investigate the reason for firms could be reduced to the point that used, the production techniques used, the test failure. This could involve it would no longer be considered and any changes in product design to retesting samples of the product by significant. However, component part determine when products need to be other conformity assessment bodies and testing is not likely to be an option for tested due to material changes. There having the conformity assessment body all manufacturers, for all component also may be administrative costs in that produced the inaccurate result parts, or for all tests. Moreover, although matching up test reports to finished attempt to determine if any error was it can reduce the cost of the third party goods and giving the approval to ship made in testing the product. In any case, products that the manufacturer has this could result in delays in shipping testing, it may not reduce other costs certified. product and lost sales. associated with the final rule, such as the cost of samples, the cost of the Another cost that could impact Component part testing may offer recordkeeping, and other administrative manufacturers for which quantification some manufacturers relief from some costs. was not attempted is the cost of testing costs. Component part testing

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It should be noted that the examples implementing some improvements to a The other provisions of the rule above were for illustration purposes product’s design or manufacturing related to protections against undue only. The number of times a product process in order to avoid the costs of influence over a conformity assessment may have to be tested for certification third party testing. body and the voluntary consumer purposes or for periodic testing Although component part testing has product labeling program are likely to purposes may be more or less than four the potential to reduce the costs of have less significant impacts on small times. The cost of testing some toys and testing, component part testing might businesses. other children’s products could be not be an option for all products or higher or lower than the cost used in the P. Federal Rules Which May Duplicate, manufacturers. Component part testing Overlap, or Conflict With the Final Rule above examples. The cost would be most likely is an option for component higher, for example, for products that parts that are common to multiple The final rule implements certain had more component parts or for which products (e.g., paints, bolts of a standard provisions of the CPSIA pertaining to the variability in the test results is size). The potential for component part the certification and continued testing greater, which could require more testing to reduce the cost of testing of children’s products for compliance samples to be tested. The cost of testing would be less for products that have with children’s product safety rules. could be lower for products that are component parts that are unique to the Certain children’s product safety rules subject to fewer safety rules or that particular product. Component part contain some requirements for contain fewer component parts. For testing is also not likely to offer certification tests and reasonable test some articles of apparel, for example, significant cost savings for low-volume programs. However, any duplication, the only tests required might be for component parts or for component parts overlap, or conflict should be minimal. flammability and lead content on some from which the component part For example, the third party component parts, for which component manufacturer derives only a small certification tests required by the final part testing might be possible. Although percentage of revenue on regulated or rule would satisfy the requirements for the examples suggest that some small children’s products. Moreover, to use certification tests in any existing businesses will be significantly component part testing, the children’s product safety rule. Any adversely impacted by the final rule, manufacturer must be able to trace each production testing required by an some small businesses may have component part for which component existing children’s product safety rule sufficient volume, sufficiently low part testing was used, to the party who can be used to increase the maximum testing costs, or sufficiently high procured the test. Maintaining this period between periodic tests according revenue that the impact will not be traceability will involve some to the provisions of the final rule. significant. administrative and recordkeeping costs, Q. Alternatives for Reducing the which will reduce the potential benefit 18. Possible Market Reactions and Adverse Impact on Small Businesses Caveats of component part testing. Manufacturers can be expected to Manufacturers may be able to mitigate We recognize that the final rule will react to a significant increase in their the adverse impacts if they are able to have a disproportionate impact on small costs due to the final rule in several raise their prices to cover these costs. and low-volume manufacturers. To a ways. Some manufacturers might However, because few companies have large degree, the impact is not avoidable attempt to redesign their products to perfectly inelastic demand curves, most because the CPSA, as amended by the reduce the number of tests required, by firms will likely have to absorb some of CPSIA, requires that the certification of reducing the features or the number of the cost increases that result from the children’s products be based on test component parts used in the products final rule. results from accredited third party conformity assessment bodies. However, that require testing. Manufacturers and O. Conclusion importers could also be expected to we have incorporated into the final rule, reduce the number of children’s The final rule will have a significant some provisions that are intended to products that they offer or, in some adverse impact on a substantial number lessen the impact on small businesses. cases, exit the market for children’s of small businesses. The provisions of These include: Provisions allowing for products entirely. Some may go out of the rule that are expected to have the longer maximum intervals between business altogether. most significant impact are provisions periodic testing if the manufacturer The requirements of the final rule related to requirements for the third conducts certain other testing; allowing could be a barrier that inhibits new party testing of children’s products and manufacturers to use component part firms from entering the children’s the associated administrative and testing; and permitting manufacturers product market, unless they expect to recordkeeping requirements. The impact and importers to rely upon the have relatively high-volume products. is expected to be disproportionate on certifications issued by other parties as This could be an important factor for small and low-volume manufacturers. a basis for issuing their own finished firms that expected to serve a niche This is because testing costs are product certificates, as provided by 16 market, such as firms with products relatively fixed. Therefore, the impact of CFR part 1109. intended for children with special testing costs, per unit, will be greater on We also identified and considered needs. Although H.R. 2715 may provide low-volume producers than on high- several alternatives that could have significant relief to small batch volume producers. reduced the impact on small businesses, manufacturers, the requirements could H.R. 2715 may provide significant but which for reasons discussed below, still be a barrier for some small batch relief from the third party testing costs were not adopted in the final rule. manufacturers, home-based to certain manufacturers who meet the These include: Providing additional manufacturers, and craftspeople. The definition of a ‘‘small batch testing relief for low-volume products; requirement for third party testing when manufacturer.’’ However, although the reducing the number of samples that there is a material change in a product’s impact will be substantially reduced, must be tested by third party conformity design or manufacturing process could some small batch manufacturers may assessment bodies; basing the frequency cause some small or low-volume still be significantly impacted by the of third party testing on the risk of manufacturers to forgo or delay requirements in the final rule. injury from the product; and allowing

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the use of XRF testing for lead content S. Alternatives That May Further testing. However, the partial exemption for more materials. Reduce the Impact on Small Businesses from periodic testing that the proposed rule would provide for products where Additional Testing Relief for Low- R. Provisions Incorporated in the Final fewer than 10,000 units had been Volume Manufacturers of Children’s Rule imported or manufactured could Products 1. Longer Maximum Periodic Testing provide some relief for some The proposed rule would include a Interval if the Manufacturer Conducts manufacturers of low-volume products provision that would provide some Other Testing that are not categorized as small batch relief to low-volume manufacturers of manufacturers by H.R. 2715. There are The final rule provides for a longer children’s products, by exempting likely some manufacturers that have maximum periodic testing interval if the products from the periodic testing low-volume products, but that also have manufacturer implements a production requirement until 10,000 units of the gross sales that exceed $1 million. These product have been manufactured or testing plan, as provided for in manufacturers will receive no relief imported. Once 10,000 units have § 1107.21(c) of the final rule. The from the small batch manufacturer manufactured or imported, the periodic exceptions in H.R. 2715, but would have manufacturer may consider the testing requirements would apply to the information obtained from the been provided some relief by the low- product. This provision did not relieve volume exemption in the proposed rule. production testing in determining the the manufacturer or importer from the Consequently, including the partial appropriate interval and number of obligation to have the product tested by exemption from periodic testing for low- samples required for third party a third party conformity assessment volume products from the proposed periodic testing, provided that third body for: (1) Certification purposes, and rule, could provide some relief to party periodic testing occurs at least (2) when there had been a material manufacturers of low-volume products once every two years. If the change in the product’s design or that do not meet the definition of a manufacturer conducts testing in an manufacturing processes or sourcing of small batch manufacturer. ISO/IEC 17025:2005-accredited testing component parts. Thus, the We have decided to reserve the laboratory in accordance with manufacturer would have still been provision of the proposed rule that § 1107.21(d) of the final rule, the obligated to submit samples to a third would provide partial relief from maximum periodic testing interval is party conformity assessment body to periodic testing for low-volume three years. However, this provision is demonstrate that the product conforms products. The reason is that H.R. 2715 expected to be of benefit primarily to with the applicable children’s product directed us to seek public comment on larger manufacturers. safety rules prior to introducing the opportunities to reduce the cost of third product and when there has been a party testing requirements consistent 2. Component Part Testing material change. The provision only with assuring compliance with any relieved the manufacturer from the The final rule allows firms to conduct applicable consumer product safety periodic testing requirements until rule, ban, standard, or regulation. It also component part testing pursuant to the 10,000 units of the children’s product contains special rules for small batch requirements in 16 CFR part 1109. This had been manufactured or imported. manufacturers and directs us to can reduce the cost to manufacturers On August 12, 2011, H.R. 2715 was consider alternative testing where one component part might be enacted into law. H.R. 2715 has the requirements or to exempt small batch common to more than one product. potential to provide substantial relief to manufacturers from certain third party Such component parts might include ‘‘small batch manufacturers,’’ which testing requirements. Thus, given these paints, polymers used in molding H.R 2751 defines as manufacturers that new statutory obligations resulting from different parts, and fasteners. In these had no more than $1 million in total H.R. 2715, we are reserving § 1107.21(e) cases, the component parts might be gross revenue from sales of all consumer so that we may consider how to address received in larger lots than the products in the previous calendar year. cost, low-volume products, and small production lots of the products in which H.R. 2751 also defines ‘‘covered batch issues more fully. they are used. Therefore, the testing product’’ as a consumer product costs for those component parts will be manufactured by a small batch 1. Reduce the Number of Repeated Third Party Tests Required for spread over more units than if they were manufacturer where no more than 7,500 Certification required to be tested on the final units of the same product were products only. manufactured in the previous calendar The final rule requires that year. Because the provisions for small manufacturers submit samples of 3. Reliance on Certifications by Other batch manufacturers in H.R. 2715 may children’s products to third party Parties provide relief to many of the same conformity assessment bodies to: (1) manufacturers at which the low-volume Certify that they comply with all The final rule allows manufacturers exemption in the proposed rule was applicable children’s product safety and importers to rely upon testing aimed, we decided to defer action on rules before they are distributed; (2) obtained by or certifications made by the low-volume exemption. after material changes; and (3) another party as the basis for their own For most small batch manufacturers, periodically to ensure continued certificates, as allowed by 16 CFR part the relief provided by H.R. 2715 may be compliance with all applicable 1109. These certifications can be for greater than the relief that would have children’s product safety rules. The component parts or for finished been provided by the low volume- number of samples required is not products. This provision would be of exemption from the proposed rule specified, but would be based upon value to importers, who may base their because the H.R. 2715 provides small factors, such as the degree to which the own certificate of conformity on the batch manufacturers with relief from manufacturing processes create certificate for a finished product issued both certification and periodic testing, products that are uniform in by a foreign manufacturer, provided that with some exceptions, while the low composition and quality, the testing the requirements of 16 CFR part 1109 volume exemption in the proposed rule interval, and the number of samples are met. only provided some relief from periodic required to ensure with a high degree of

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assurance that a certified product sample of an article indicated 3. Basing the Frequency of Periodic continues to comply with all applicable compliance with the lead content Testing on Risk of Injury or Illness children’s product safety rules. It is requirements, but tests results for a The final rule requires that periodic likely that most manufacturers will need different sample of the same article testing be performed at least once every to have a product third party tested showed lead levels that exceeded the one to three years, depending on the multiple times for both certification and standard.9 This suggests that testing one other testing that a manufacturer opts to periodic testing purposes. sample may not always be sufficient to perform. An alternative that would An alternative that could provide detect noncomplying products. reduce the burden of the rule on some some relief to small businesses is to require, for purposes of certifying a 2. Allow Increased Use of XRF Analysis small businesses is to lengthen the time product, manufacturers to submit period between required periodic tests sufficient units of the product to XRF analysis is a testing technique for products, component parts, or rules conformity assessment bodies to ensure that can be used to measure the heavy for which the risk of serious injury or that the product can be tested for metal content of materials. The cost of illness from a violation of a children’s compliance with each applicable using XRF analysis testing is generally product safety rule is low. This would children’s safety rule, at least once, or less expensive than using ICP analysis. reduce the burden on some as many times as required by the Currently, we have approved XRF manufacturers because it could reduce specific regulation, if different. The analysis for determining the lead the amount of required third party same requirement could apply to content of homogenous polymer testing. periodic testing: At least once during products and one type of XRF analysis This alternative was not accepted the periodic testing interval established (energy dispersive XRF using multiple because, given the number of children’s by the rule (e.g., once a year) monochromatic beams using the test product safety rules and the large manufacturers would be required to method in ASTM F2853–10) for paints. number and wide variety of children’s products to which they apply, its submit sufficient units of the product to We have not approved the use of XRF administration would be complex and ensure that each applicable children’s analysis for determining the lead would require a large investment of product safety rule is evaluated at least content of metal component parts. resources to analyze and rank the risk of once. In some cases, all of the required However, allowing the use of XRF serious injury or illness that could result tests could be performed on one unit of analysis for determining the lead the product. In other cases, more than from each product or product category content of metal component parts could failing to comply with each applicable one unit of the product might be substantially reduce the cost of the third required to test the product to all children’s product safety rule and then party testing. The reduction could be determining the appropriate periodic applicable children’s product safety especially significant for manufacturers rules. For example, more than one unit testing requirements for the product or of children’s products that have a lot of product category. of a toy might be required to subject the metal component parts. toy to each use and abuse test that is 4. Alternatives Not Considered Because We decided not to allow the applicable to the toy; the tests specified They Would Conflict With the Statute in the bicycle helmet standard require expanded use of XRF analysis to eight helmets. Nevertheless, each test determine lead content at this time. We are aware of some alternatives that would only need to be conducted one However, we are continuing to evaluate could reduce the burden of the rule but time. This could reduce the financial the potential use of XRF analysis, and that were not considered in this burden of the third party testing should we determine that XRF analysis rulemaking because adopting the requirements on small businesses. can be sufficiently accurate in alternative would conflict with the Under this alternative, manufacturers determining lead content, in a separate statute. For example, although we have could still be required to have a high rulemaking, we could consider been able to exempt some materials degree of assurance that their children’s expanding the allowable use of XRF from the testing requirements that products complied with all applicable analysis for third party testing. inherently do not contain lead in excess children’s product safety rules. Moreover, H.R. 2715 directed us to seek of the limits established by the CPSIA, However, the testing or inspections public comment on opportunities to we are not able to exempt materials needed to provide the manufacturer reduce the cost of third party testing from testing that can exceed those limits with a high degree of assurance of requirements consistent with assuring even if the health hazard associated compliance could be first or third party compliance with any applicable with the materials or component parts is testing, or by other process control children’s product safety rule. Further, believed to be minimal. Likewise, we means, at the option of the H.R. 2715 directs us to seek public are not be able to exempt from the manufacturer. The purpose of the comment on the extent to which testing requirements products for which required third party tests would be to technology, other than the technology compliance with the applicable safety rule is thought to be very high even provide objective evidence of already approved by the Commission, compliance. without a mandatory third party testing exists for third party conformity We did not accept this alternative requirement. because, although it arguably would assessment bodies to test or to screen for provide a greater level of evidence of testing consumer products subject to a V. Paperwork Reduction Act compliance than what existed before the third party testing requirement. The final rule contains information enactment of the CPSIA, it would not Therefore, we may consider alternatives collection requirements that are subject require enough third party testing to to reduce the cost of third party testing to public comment and review by the provide a high degree of assurance that requirements more fully at a later date. Office of Management and Budget children’s products complied with all (OMB) under the Paperwork Reduction applicable children’s product safety 9 CPSC Memorandum to the Commission, from Act of 1995 (44 U.S.C. 3501–3520). The John W. Boja, Howard N. Tarnoff, Mary F. Toro, and preamble to the proposed rule contained rules. An analysis of CPSC compliance Marc J. Schoem, ‘‘The Technological Feasibility of data for children’s shoes found several Reducing the Lead Content to 100 ppm: Compliance a discussion of the estimated burden examples where test results for one Data’’ (29 June 2011). associated with the rule’s collection of

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information requirements (75 FR at that the toy industries’ experience in in other categories, such as nursery or 28360 through 28361). meeting the recordkeeping requirements juvenile products, nontraditional toys Several commenters addressed issues of the interim enforcement policy is that (e.g., video games), CDs, bicycles, ATVs, relating to the Paperwork Reduction Act the requirements are extremely party favors, and greeting cards discussion. burdensome, and the recordkeeping intended for children, and some (Comment 113)—Some commenters requirements contained in the proposed educational materials that could be noted that the preamble to the proposed rule are much more extensive and will affected by the final rule for which rule states that we will likely request be even more costly. The commenter specific estimates have not been made. access to records only when we are stated that our estimate of 200,000– The estimates do not consider that some investigating potentially defective or 300,000 hours to manage recordkeeping, products might be produced at more noncompliant products. The equating to no more than 200 people than one location or certified by more commenters concluded that having to across all industries impacted by the than one importer. Therefore, we integrate multiple systems to compile CPSIA, is much too low. Within the toy concluded that there could be 300,000 data should not be needed, as long as industry alone, the commenter non-apparel products that are covered companies can provide the data upon estimated 10 times that many persons by the rule. request. One commenter noted that have been engaged along the global The original estimate did not account proposed § 1107.10 (b)(5)(i)(C) would supply chain to manage the data and for the very large number of apparel require not only records of each recordkeeping associated with the products that would be covered by the certification test, but also ‘‘a description CPSIA’s existing requirements. final rule. The number of apparel of how the product was certified as Although we referenced a calculation of products intended for children, meeting the requirements, including 100,000 to 150,000 products to which including footwear, is estimated to be how each applicable rule was evaluated, the recordkeeping requirements would about 1.3 million. This would bring the the test results and the actual values of apply, the commenter stated that total number of children’s products to the tests.’’ companies typically certify each SKU, about 1.6 million. One commenter stated that it receives and there is recordkeeping for every The final rule has been changed to more than a thousand finished good test version, even if it is identical in all address some of the burdens mentioned reports annually from CPSC-accepted material respects. third party labs. These reports often run by the commenters, such as not One commenter estimated that the requiring records to be kept in the 50 to 125 pages in length and contain true number of toys and games was hundreds of data points and United States or translated into English, closer to 2.5 million. The commenter’s unless requested. assessments. The commenter asserted estimate was based on a listing of Elsewhere in this issue of the Federal that adding additional descriptive text 808,465 toys and games on a popular Register, we have published a notice to explain ‘‘how’’ the product was commercial Web site (on August 3, seeking public comment on the issues in certified, simply adds no value. The 2010), plus its estimate that the Web site H.R. 2715, including other methods of commenter concluded that if the test only lists about one-third of the toys lowering the cost of third party testing report references an ASTM standard, available. Given some specialty and consistent with assuring compliance and the results are acceptable, that other submarkets, the commenter should be sufficient without additional thought that the final number of items with the applicable consumer product explanations. in the Toys, Games, and Educational safety rules, bans, standards, and (Response 113)—The final rule items category could be in excess of 4 regulations. reserves subpart B, which would to 5 million individual products or (Comment 115)—One commenter contain proposed § 1107.10 and stock-keeping units. The commenter asserted that its company’s testing requirements for a reasonable test also provided an estimate of 8 million program has been highly effective for program for non-children’s products, apparel items available for children. more than 26 years, but it does not including the recordkeeping However, the commenter did not maintain the records that would be requirements. Therefore, the final rule provide the method or data sources it required by the proposed rules, and it does not impose any recordkeeping used for the latter estimates. Another would be very costly to do so. One requirements related to non-children’s commenter noted that its company had commenter questioned whether the products. about 1,700 individual products extensive recordkeeping on every item With respect to children’s products, annually, requiring testing, certification, was necessary for the proper the recordkeeping requirements at and recordkeeping, or more than 1 performance of the CPSC’s functions. § 1107.26 of the final rule do not require percent of the CPSC’s entire estimated Another commenter echoed the descriptive text to explain ‘‘how’’ the number of products across all affected concern that the cost of the children’s product was certified. The industries. recordkeeping requirements would be certification test methods are prescribed (Response 114)—We acknowledge high without providing any clear benefit for children’s products. It should only that our original estimate of the number to the agency’s mission or product be necessary for the manufacturer or of products that would be impacted was safety. The commenter estimated that a importer to identify and store the new low, and we have increased major retailer would need to maintain requirements that are not already part of significantly our estimate of the records on 300,000 distinct products, their current recordkeeping systems and recordkeeping burden associated with which would cost the retailer $22 to be certain that the remaining the testing and certification million annually, using the estimated documentation can be produced, upon requirements of the final rule. Based on per product recordkeeping burden request, in a manner that identifies the comments, and other research, we employed in the notice of proposed clearly the requisite parts. have revised our estimate of the number rulemaking. Another commenter stated (Comment 114)—Several commenters of children’s products. In the categories that we should reduce the reporting addressed our estimated resource of toys, art and creative materials, burden by allowing manufacturers or requirements to manage the general furniture, and jewelry, we estimate that importers to maintain their own recordkeeping requirements for testing there are perhaps 241,000 different recordkeeping systems if they meet the and certification. One commenter stated products. There are additional products traceability requirements and ensure

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that products are certified properly required. The test reports are from 50 to which requires certification of before they enter into commerce. 125 pages in length and require compliance for children’s products (Response 115)—With respect to maintaining for all products tested. The subject to a children’s product safety recordkeeping requirements for commenter estimated that their rule. A certification that a children’s reasonable testing programs for non- company accounted for greater than 1 product complies with the applicable children’s products, we have reserved percent of all the hours that the CPSC children’s product safety rules must be subpart B, which would contain had estimated for all children’s supported by testing by an approved requirements for reasonable testing products. The commenter concluded third party conformity assessment body. programs for non-children’s products. that, based on this estimate, the actual The final rule imposes recordkeeping Therefore, the final rule does not number of hours required for requirements related to those testing impose any recordkeeping requirements recordkeeping by all companies would and certification mandates. The on manufacturers of non-children’s be higher than the CPSC’s estimate. recordkeeping requirements are products. Another commenter estimated that intended to allow identification of each With respect to children’s products, the recordkeeping will require about product and establish that each product we acknowledge that the recordkeeping 2.25 hours per test submitted; but due is certified properly, before it enters requirements could require considerable to varying lot sizes and requirements, commerce. In addition, the resources to track the data and manage they estimate that multiple tests per recordkeeping requirements require recordkeeping. As a result, the costs year could be required on a product. certification that a product has been associated with the recordkeeping They estimate that the burden will be 3 retested properly for conformity with all requirements could be a significant hours for one category of products that applicable rules on a continuing basis, expense for some firms. However, as it manufactures and 5 hours for another, including after a material change in the stated in the preamble to the proposed with an average across their product product’s design or manufacturing rule, the purpose of the documentation line of 3.5 hours. processes, including the sourcing of and recordkeeping requirements in the One commenter said that the time component parts. rule is to establish the identity of the required for recordkeeping would be Each manufacturer or importer of a product and to demonstrate that each higher for manufacturers that specialize children’s product subject to a product complies with the applicable in high quality, but low volume children’s product safety rule would be rules when it is certified and on a products. The commenter estimated that required to establish and maintain the continuing basis thereafter. it would take 6 to 10 employees to track following records: Additionally, we note that retailers are the testing data and compile it into • A copy of the Children’s Product not required to comply with the certificates of conformity, or about 6 to Certificate (§ 1107.26(a)(1)); recordkeeping requirements of the rule, 10 times the per-product labor required • Records of each certification test unless they are also the importer of the by the high volume, mass production (§ 1107.26(a)(2)); product. manufacturers. The commenter • Records of the periodic tests We also have revised the final rule to estimated about 3 to 7.5 hours of (§ 1107.26(a)(3)); reduce the costs associated with the recordkeeping would be required for • Records of descriptions of all recordkeeping requirements. For high-quality, low-volume products. material changes in product design, example, the final rule does not require (Response 116)—Based on these manufacturing process, and sourcing of manufacturers to maintain the records at comments, we have determined that for component parts, the certification tests a location in the United States, as long many children’s products, substantially run, and the test values (§ 1107.26(a)(5)); as they can provide the records to us, more than 2 hours will be required for and after receiving a request to do so. Also, the associated recordkeeping. For • Records of undue influence with the exception of the certificates of products, such as toys, jewelry, procedures (§ 1107.26(a)(6)). conformity, the records will not have to children’s furniture and other children’s Description of Respondents: The be maintained in the English language. products, which are subject to third recordkeeping requirements apply to all Finally, the final rule does not require party testing to several different manufacturers or importers of children’s that the records be in a specific format. standards, we have determined that 5 products that are covered by one or The final rule specifies the records or hours is a reasonable estimate. more children’s product safety rules information that is required. However, More hours will be required for some promulgated and/or enforced by the manufacturers may maintain the records products to which many rules apply. CPSC. We reviewed every industry within their own recordkeeping systems Simpler products with few, or only one, category in the NAICS and selected if, as suggested by the commenter, they applicable rule should require fewer those industry categories that included meet the traceability requirements and hours for recordkeeping. For apparel firms that could manufacture or sell ensure that products are certified and footwear products, we have such children’s products. Using data properly before they enter into determined that it is reasonable to use from the U.S. Census Bureau, we commerce. a lower estimate of the number of hours determined that there are more than (Comment 116)—Several comments required for recordkeeping, such as 3 37,000 manufacturers, almost 80,000 provided estimates on the amount of hours. This estimate recognizes that wholesalers, and about 128,000 retailers time required for recordkeeping or there could be substantial recordkeeping in these categories. However, not all of information from which estimates could required for some items, such as those the firms in these categories be derived. One commenter (a large toy that require testing for flammability and manufacture or import children’s manufacturer) stated that they had that contain various components (e.g., products that are covered by children’s added six full-time employees to zippers, snaps, buttons, accessories) product safety rules. Therefore, these manage the data and recordkeeping while other items, might require little numbers would constitute a high associated with the CPSIA’s existing testing. estimate of the number of firms that are testing and certification requirements, Title: Testing and Labeling Pertaining subject to the recordkeeping and they further indicated that they had to Product Certification. requirements. 1,700 products tested annually for Description: The final rule Estimate of the Burden: The hour which recordkeeping would be implements section 102(b) of the CPSIA, burden of the recordkeeping

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requirements will likely vary greatly support’’ occupations will be (OMB) for a control number for this from product to product, depending responsible for the other half. As of information collection, and we will upon such factors as the complexity of March 2011, these categories would publish a notice in the Federal Register the product and the amount of testing average $36.43 per hour (http:// providing the number when we receive that must be documented. We do not www.bls.gov/news.release/ approval from the OMB. have comprehensive data on the ecec.t09.htm).10 At $36.43 per hour (i.e., VI. Environmental Considerations universe of products that will be the revised hourly compensation rate), impacted. Therefore, estimates of the the total cost of the recordkeeping This final rule falls within the scope hour burden of the recordkeeping associated with the testing and of the Commission’s environmental requirements are somewhat speculative. certification rule is approximately $197 review regulations at 16 CFR The preamble to the proposed rule (75 million (5.4 million hours × $36.43 = 1021.5(c)(2), which provides a FR at 28361) estimated that, on average, $196,722,000). categorical exclusion from any approximately 2 hours would be needed Estimate Limitations: There are some requirement for the agency to prepare an for recordkeeping per product; although limitations to the above estimates that environmental assessment or we recognized that, for some products, warrant mentioning. environmental impact statement for particularly those subject to more than While the estimates of the number of product certification rules. one standard or rule, would need a products are more accurate than the VII. Executive Order 12988 substantial amount of testing, and thus, original estimates, they are not based on the recordkeeping burden could be a well-designed survey or Executive Order 12988 (February 5, much higher than 2 hours. Conversely, comprehensive database. Additionally, 1996), requires agencies to state in clear products subject to one standard or that the extent to which some products language the preemptive effect, if any, of need little testing, could have a might be certified by multiple new regulations. The final rule is issued recordkeeping burden of less than 2 importers, or are manufactured at under authority of the CPSA and the hours. different sites, has not been established. CPSIA. The CPSA provision on Based on the comments we received Recordkeeping for the flammability of preemption appears at section 26 of the on the proposed rule, however, we have children’s sleepwear might be captured CPSA. The CPSIA provision on revised the estimated number of in the OMB submission on another rule, preemption appears at section 231 of the children’s products that are affected, as but the recordkeeping associated with CPSIA. The preemptive effect of this well as the hourly recordkeeping burden the lead content rules should be rule would be determined in an estimate. We now estimate that captured here. However, no adjustment appropriate proceeding by a court of approximately 300,000 non-apparel for this has been made because we have competent jurisdiction. children’s products will be covered by not tried to separate children’s VIII. Effective Date the rule and that an average of 5 hours sleepwear from other apparel items. will be needed for the recordkeeping The recordkeeping considered here is The preamble to the proposed rule associated with these products. We also best thought of as the recordkeeping indicated that a final rule would become estimate that there are approximately mandated by the testing and effective 180 days after its date of 1.3 million children’s apparel and certification requirements of section 102 publication in the Federal Register (75 footwear products and that will require of the CPSIA. It would be impossible to FR at 28361). However, on August 12, an average of 3 hours for the separate the time associated with the 2011, the President signed H.R. 2715 recordkeeping. Thus, the total hour initial certification, from the time into law. H.R. 2715 revised the CPSIA burden of the recordkeeping associated related to periodic testing and in several different ways and also with the final rule is 5.4 million hours documenting material changes, affected section 14(i)(2)(B)(ii) of the (300,000 × 5 hours plus 1,300,000 × 3 especially because it often involves CPSA. H.R. 2715 also created a new hours). issuing a new certificate. section 14(i)(3)(B) of the CPSA, which Additionally, for the proposed rule, to For finished goods manufacturers requires us, no later than one year after calculate the cost of the recordkeeping who also perform their own component H.R. 2715’s date of enactment, to review burden, we used the total hourly testing, it is difficult to separate the the public comments (on opportunities compensation for private sector workers recordkeeping burden associated with to reduce the costs of third party testing in management, professional, and component part testing from the requirements) and directs us to related occupations, which is $48.91 per recordkeeping burden associated with ‘‘prescribe new or revised third party hour. This is based on the expectation the testing and labeling rule. This could testing regulations’’ if we determine that that much of the recordkeeping will be lead to an overestimate of the costs ‘‘such regulations will reduce third done by chemists, engineers and quality associated with the testing and labeling party testing costs consistent with control managers. Most commenters did rule and possibly result in assuring compliance with the applicable not mention the occupational mix of the underestimates associated with the consumer product safety rules, bans, workers that would be involved in the component part testing rule. Better standards, and regulations.’’ recordkeeping associated with the rule. estimates may be possible if the Consequently, we have finalized those However, one commenter stated that the recordkeeping burden is reevaluated provisions that H.R. 2715 did not affect rule would result in an increase in his after the rules are finalized. directly. We also have decided to make clerical and management staff. In compliance with the Paperwork the final rule effective on February 8, Therefore, to recognize that clerical, Reduction Act of 1995 (44 U.S.C. 2013 so that parties can begin taking professional, and management staff will 3507(d)), we have applied to the U.S. steps to develop internal processes, be involved in meeting the Office of Management and Budget such as recordkeeping, and so that we recordkeeping requirements of the rule, and interested parties can consider how we will assume that personnel in 10 U.S. Department of Labor, Bureau of Labor H.R. 2715 interacts with the final rule. ‘‘management, professional, and related Statistics, ‘‘Employer costs for Employee Compensation—March 2011, Table 9’’ (8 June List of Subjects in 16 CFR Part 1107 occupations’’ will be responsible for 2011). Available at: http://www.bls.gov/ half of the recordkeeping, while news.release/ecec.t09.htm. Last accessed 8 July Business and industry, Children, personnel in ‘‘office and administrative 2011. Consumer protection, Imports,

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Incorporation by reference, Product High degree of assurance means an rules. If the manufacturing process for a testing and certification, Records, evidence-based demonstration of children’s product results in variability Record retention, Toys. consistent performance of a product in the composition or quality of Accordingly, 16 CFR part 1107 is regarding compliance based on children’s products, a manufacturer may added to read as follows: knowledge of a product and its need to submit more samples to provide manufacture. a high degree of assurance that the PART 1107—TESTING AND LABELING Identical in all material respects finished product complies with the PERTAINING TO PRODUCT means there is no difference with applicable children’s product safety CERTIFICATION respect to compliance to the applicable rules. rules, bans, standards, or regulations (c) Except where otherwise specified Subpart A—General Provisions between the samples to be tested for by a children’s product safety rule, Sec. compliance and the finished product component part testing pursuant to 16 1107.1 Purpose. distributed in commerce. CFR part 1109 may be used to support 1107.2 Definitions. Manufacturer means the parties the certification testing requirements of Subpart B—[Reserved] responsible for certification of a this section. consumer product pursuant to 16 CFR (d) If a product sample fails Subpart C—Certification of Children’s part 1110. certification testing to the applicable Products Manufacturing process means the children’s product safety rule(s), even if 1107.20 General requirements. techniques, fixtures, tools, materials, other samples have passed the same 1107.21 Periodic testing. and personnel used to create the certification test, the manufacturer must 1107.23 Material change. component parts and assemble a investigate the reasons for the failure 1107.24 Undue influence. and take the necessary steps to address 1107.26 Recordkeeping. finished product. Material change means any change in the reasons for the failure. A Subpart D—Consumer Product Labeling the product’s design, manufacturing manufacturer cannot certify the Program process, or sourcing of component parts children’s product until the 1107.30 Labeling consumer products to that a manufacturer exercising due care manufacturer establishes, with a high indicate that the certification knows, or should know, could affect the degree of assurance that the finished requirements of section 14 of the CPSA product’s ability to comply with the product does comply with all applicable have been met. applicable rules, bans, standards, or children’s product safety rules. Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. regulations. § 1107.21 Periodic testing. L. 110–314, 122 Stat. 3016, 3017, 3022. Third party conformity assessment body means a testing laboratory whose (a) General requirements for all Subpart A—General Provisions accreditation has been accepted by the manufacturers. All manufacturers of children’s products must conduct § 1107.1 Purpose. CPSC to conduct certification testing on children’s products. Only third party periodic testing. All periodic testing This part establishes the protocols conformity assessment bodies whose must be conducted by a third party and standards for ensuring continued scope of accreditation includes the conformity assessment body. Periodic testing of children’s products applicable required tests can be used for testing must be conducted pursuant to periodically and when there has been a children’s product certification or either paragraph (b), (c), or (d) of this material change in the product’s design periodic testing purposes. section or as provided in regulations or manufacturing process and under this title. The testing interval safeguarding against the exercise of Subpart B—[Reserved] selected for periodic testing may be undue influence by a manufacturer on based on a fixed production interval, a a third party conformity assessment Subpart C—Certification of Children’s set number of units produced, or body. It also establishes a program for Products another method chosen by the labeling of consumer products to manufacturer based on the product indicate that the certification § 1107.20 General requirements. produced and its manufacturing requirements have been met pursuant to (a) Manufacturers must submit a process, so long as the applicable sections 14(a)(2) and (i)(2)(B) of the sufficient number of samples of a maximum testing interval specified in Consumer Product Safety Act (CPSA) children’s product, or samples that are paragraph (b), (c), or (d) of this section (15 U.S.C. 2063(a)(2) and (i)(2)(B)). identical in all material respects to the is not exceeded. Component part testing children’s product, to a third party § 1107.2 Definitions. pursuant to 16 CFR part 1109 may be conformity assessment body for testing used to support the periodic testing Unless otherwise stated, the to support certification. The number of requirements of this section. definitions of the Consumer Product samples selected must be sufficient to (b) A manufacturer must conduct Safety Act and the Consumer Product provide a high degree of assurance that periodic testing to ensure compliance Safety Improvement Act of 2008 apply the tests conducted for certification with the applicable children’s product to this part. The following definitions purposes accurately demonstrate the safety rules at least once a year, except apply for purposes of this part: ability of the children’s product to meet as otherwise provided in paragraphs (c), CPSA means the Consumer Product all applicable children’s product safety and (d) of this section or as provided in Safety Act. rules. regulations under this title. If a CPSC means the Consumer Product (b) If the manufacturing process for a manufacturer does not conduct Safety Commission. children’s product consistently creates production testing under paragraph (c) Due care means the degree of care that finished products that are uniform in of this section, or testing by a testing a prudent and competent person composition and quality, a laboratory under paragraph (d) of this engaged in the same line of business or manufacturer may submit fewer samples section, the manufacturer must conduct endeavor would exercise under similar to provide a high degree of assurance periodic testing as follows: circumstances. Due care does not permit that the finished product complies with (1) Periodic Testing Plan. willful ignorance. the applicable children’s product safety Manufacturers must develop a periodic

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testing plan to ensure with a high degree (x) Inability to determine the children’s product safety rules. A of assurance that children’s products children’s product’s noncompliance production testing plan must contain manufactured after the issuance of a easily through means such as visual the following elements: Children’s Product Certificate, or since inspection. (i) A description of the production the previous periodic testing was (c)(1) If a manufacturer implements a testing plan, including, but not limited conducted, continue to comply with all production testing plan as described in to, a description of the process applicable children’s product safety paragraph (c)(2) of this section to ensure management techniques used, the tests rules. The periodic testing plan must continued compliance of the children’s to be conducted, or the measurements to include the tests to be conducted, the product with a high degree of assurance be taken; the intervals at which the tests intervals at which the tests will be to the applicable children’s product or measurements will be made; the conducted, and the number of samples safety rules, the manufacturer must number of samples tested; and the basis tested. At each manufacturing site, the submit samples of its children’s product for determining that the combination of manufacturer must have a periodic to a third party conformity assessment process management techniques and testing plan specific to each children’s body for periodic testing to the tests provide a high degree of assurance product manufactured at that site. applicable children’s product safety of compliance if they are not the tests (2) Testing Interval. The testing rules at least once every two years. A prescribed for the applicable children’s interval selected must be short enough manufacturer may consider the product safety rule; to ensure that, if the samples selected information obtained from production (ii) At each manufacturing site, the for testing pass the test, there is a high testing when determining the manufacturer must have a production degree of assurance that the other appropriate testing interval and the testing plan specific to each children’s untested children’s products number of samples needed for periodic product manufactured at that site; manufactured during the testing interval testing to ensure that there is a high (iii) The production testing interval comply with the applicable children’s degree of assurance that the other selected for tests must ensure that, if the product safety rules. The testing interval untested children’s products samples selected for production testing may vary depending upon the specific manufactured during the testing interval comply with an applicable children’s children’s product safety rules that comply with the applicable children’s product safety rule, there is a high apply to the children’s product, but may product safety rules. degree of assurance that the untested not exceed one year. Factors to be (2) Production Testing Plan. A products manufactured during that considered when determining the production testing plan describes the testing interval also will comply with testing interval include, but are not production management techniques and the applicable children’s product safety limited to, the following: tests that must be performed to provide rule. Production testing intervals should (i) High variability in test results, as a high degree of assurance that the be appropriate for the specific testing or indicated by a relatively large sample products manufactured after alternative measurements being standard deviation in quantitative tests; certification continue to meet all the conducted. (ii) Measurements that are close to the applicable children’s product safety (3) If a production testing plan as allowable numerical limit for rules. A production testing plan may described in this paragraph (c) fails to quantitative tests; include recurring testing or the use of provide a high degree of assurance of (iii) Known manufacturing process process management techniques, such compliance with all applicable factors which could affect compliance as control charts, statistical process children’s product safety rules, the with a rule. For example, if the control programs, or failure modes and CPSC may require the manufacturer to manufacturer knows that a casting die effects analyses (FMEAs) designed to meet the requirements of paragraph (b) wears down as the die nears the end of control potential variations in product of this section or modify its production its useful life, the manufacturer may manufacturing that could affect the testing plan to ensure a high degree of wish to test more often as the casting die product’s ability to comply with the assurance of compliance. (d)(1) For manufacturers conducting wears down; applicable children’s product safety (iv) Consumer complaints or warranty rules. A manufacturer may use testing to ensure continued compliance claims; measurement techniques that are with the applicable children’s product (v) Introduction of a new set of nondestructive and tailored to the needs safety rules using a testing laboratory component parts into the assembly of an individual product to ensure that accredited to ISO/IEC 17025:2005(E), process; a product complies with all applicable ‘‘General requirements for the (vi) The manufacture of a fixed children’s product safety rules. Any competence of testing and calibration number of products; production test method used to conduct laboratories,’’ periodic tests by a third (vii) Potential for serious injury or production testing must be effective in party conformity assessment body must death resulting from a noncompliant determining compliance. Production be conducted at least once every three children’s product; testing cannot consist solely of years. Any ISO/IEC 17025:2005(E)- (viii) The number of children’s mathematical methods (such as an accredited testing laboratory used for products produced annually, such that FMEA, with no additional components, ensuring continued compliance must be a manufacturer should consider testing or computer simulations). Production accredited by an accreditation body that a children’s product more frequently if testing must include some testing, is accredited to ISO/IEC 17011:2004(E), the product is produced in very large although it is not required that the test ‘‘Conformity assessment—General numbers or distributed widely methods employed be the test methods requirements for accreditation bodies throughout the United States; used for certification. A manufacturer accrediting conformity assessment (ix) The children’s product’s must document the production testing bodies.’’ The test method(s) used by an similarity to other children’s products methods used to ensure continuing ISO/IEC 17025:2005(E)-accredited with which the manufacturer is familiar compliance and the basis for testing laboratory when conducting and/or whether the children’s product determining that the production testing testing to ensure continued compliance has many different component parts plan provides a high degree of assurance must be the same test method(s) used compared to other children’s products that the product being manufactured for certification to the applicable of a similar type; or continues to comply with all applicable children’s product safety rules.

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Manufacturers must conduct testing § 1107.23 Material change. with the applicable children’s product using the ISO/IEC 17025:2005(E)- (a) General Requirements. If a safety rules. For each change in the accredited testing laboratory frequently children’s product undergoes a material manufacturing process, a manufacturer enough to provide a high degree of change in product design or should exercise due care to determine if assurance that the children’s product manufacturing process, including the compliance to an existing applicable continues to comply with the applicable sourcing of component parts, which a children’s product safety rule could be children’s product safety rules. A manufacturer exercising due care affected, or if the change results in a manufacturer may consider the knows, or should know, could affect the newly applicable children’s product information obtained from testing product’s ability to comply with the safety rule. conducted by an ISO/IEC applicable children’s product safety (d) Sourcing of Component Parts. A 17025:2005(E)-accredited testing rules, the manufacturer must submit a material change in the sourcing of laboratory when determining the sufficient number of samples of the component parts results when the appropriate testing interval and the materially changed children’s product replacement of one component part of a number of samples for periodic testing for testing by a third party conformity children’s product with another that are needed to ensure that there is assessment body and issue a new component part could affect compliance a high degree of assurance that the other Children’s Product Certificate. The with the applicable children’s product untested children’s products number of samples submitted must be safety rule. This includes, but is not manufactured during the testing interval sufficient to provide a high degree of limited to, changes in component part comply with the applicable children’s assurance that the materially changed composition, component part supplier, product safety rules. component part or finished product or the use of a different component part (2) If the continued testing described complies with the applicable children’s from the same supplier who provided in paragraph (d)(1) of this section fails product safety rules. A manufacturer of the initial component part. to provide a high degree of assurance of a children’s product that undergoes a § 1107.24 Undue influence. compliance with all applicable material change cannot issue a new children’s product safety rules, the Children’s Product Certificate for the (a) Each manufacturer must establish CPSC may require the manufacturer to product until the product meets the procedures to safeguard against the meet the requirements of paragraph (b) requirements of the applicable exercise of undue influence by a of this section or modify the testing children’s product safety rules. The manufacturer on a third party frequency or number of samples extent of such testing may depend on conformity assessment body. (b) The procedures required in required to ensure a high degree of the nature of the material change. When paragraph (a) of this section, at a assurance of continued compliance. a material change is limited to a (e) [Reserved] minimum, must include: component part of the finished (f) [Reserved] (1) Safeguards to prevent attempts by children’s product and does not affect (g) The Director of the Federal the manufacturer to exercise undue the ability of other component parts of Register approves the incorporations by influence on a third party conformity the children’s product or the finished reference of the standards in this section assessment body, including a written children’s product to comply with other in accordance with 5 U.S.C. 552(a) and policy statement from company officials applicable children’s product safety 1 CFR part 51. You may inspect a copy that the exercise of undue influence is rules, a manufacturer may issue a new of the standards at the Office of the not acceptable, and directing that every Children’s Product Certificate based on Secretary, U.S. Consumer Product appropriate staff member receive the earlier third party certification tests Safety Commission, Room 820, 4330 training on avoiding undue influence, and on test results of the changed East West Highway, Bethesda, MD and sign a statement attesting to component part conducted by a third 20814, telephone (301) 504–7923, or at participation in such training; the National Archives and Records party conformity assessment body. A (2) A requirement that upon Administration (NARA). For manufacturer must exercise due care to substantive changes to the requirements information on the availability of this ensure that any component part in this section regarding avoiding undue material at NARA, call (202) 741–6030, undergoing component part-level testing influence, the appropriate staff must be or go to: http://www.archives.gov/ is identical in all material respects to retrained regarding those changed federal_register/ the component part on the finished requirements. code_of_federal_regulations/ children’s product. Changes that cause a (3) A requirement to notify the CPSC ibr_locations.html. children’s product safety rule to no immediately of any attempt by the (1) International Organization for longer apply to a children’s product are manufacturer to hide or exert undue Standardization (ISO), 1, ch. de la Voie- not considered to be material changes. influence over test results; and Creuse, Case postale 56, CH–1211 (b) Product Design. For purposes of (4) A requirement to inform Geneva 20, Switzerland; Telephone +41 this subpart, the term ‘‘product design’’ employees that allegations of undue 22 749 01 11, Fax +41 22 733 34 30; includes all component parts, their influence may be reported http://www.iso.org/iso/home.html. composition, and their interaction and confidentially to the CPSC and a (i) ISO/IEC 17011:2004(E), functionality when assembled. To description of the manner in which ‘‘Conformity assessment—General determine which children’s product such a report can be made. requirements for accreditation bodies safety rules apply to a children’s accrediting conformity assessment product, a manufacturer should § 1107.26 Recordkeeping. bodies,’’ First Edition, September 1, examine the product design for the (a) A manufacturer of a children’s 2004 (Corrected version February 15, children’s product as received or product subject to an applicable 2005); assembled by the consumer. children’s product safety rule must (ii) ISO/IEC 17025:2005(E), ‘‘General (c) Manufacturing Process. A material maintain the following records: requirements for the competence of change in the manufacturing process is (1) A copy of the Children’s Product testing and calibration laboratories,’’ a change in how the children’s product Certificate for each product. The Second Edition, May 15, 2005. is made that could affect the finished children’s product covered by the (2) [Reserved] children’s product’s ability to comply certificate must be clearly identifiable

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and distinguishable from other must make these records available, Meets CPSC Safety Requirements products; either in hard copy or electronically, (2) Records of each third party such as through an Internet Web site, for (c) A consumer product may bear the certification test. The manufacturer inspection by the CPSC upon request. label if the manufacturer or private must have separate certification tests Records may be maintained in labeler has certified, pursuant to section records for each manufacturing site; languages other than English if they can 14 of the CPSA, that the consumer (3) Records of one of the following for be: product complies with all applicable periodic tests of a children’s product: (1) Provided immediately by the consumer product safety rules under the (i) A periodic test plan and periodic manufacturer to the CPSC; and CPSA and with all rules, bans, test results; (2) Translated accurately into English standards, or regulations applicable to (ii) A production testing plan, by the manufacturer within 48 hours of the product under any other act production test results, and periodic test a request by the CPSC, or any longer enforced by the Consumer Product results; or period negotiated with CPSC staff. Safety Commission. (iii) Testing results of tests conducted (d) A manufacturer or private labeler by a testing laboratory accredited to Subpart D—Consumer Product may use a label in addition to the label ISO/IEC 17025:2005(E) and periodic test Labeling Program results. described in paragraph (b) on the (4) [Reserved]; § 1107.30 Labeling consumer products to consumer product, as long as such label (5) Records of descriptions of all indicate that the certification requirements does not alter or mislead consumers as material changes in product design, of section 14 of the CPSA have been met. to the meaning of the label described in manufacturing process, and sourcing of (a) Manufacturers and private labelers paragraph (b) of this section. A component parts, and the certification of a consumer product may indicate, by manufacturer or private labeler must not tests run and the test values; and a uniform label on, or provided with the imply that the CPSC has tested, (6) Records of the undue influence product, that the product complies with approved, or endorsed the product. any consumer product safety rule under procedures, including training materials Dated: October 21, 2011. and training records of all employees the CPSA, or with any similar rule, ban, trained on these procedures, including standard or regulation under any other Todd A. Stevenson, attestations described at § 1107.24(b)(1). act enforced by the CPSC. Secretary, Consumer Product Safety (b) A manufacturer must maintain the (b) The label must be visible and Commission. records specified in paragraph (a) of this legible, and consist of the following [FR Doc. 2011–27678 Filed 11–7–11; 8:45 am] section for five years. The manufacturer statement: BILLING CODE 6355–01–P

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