Testing and Labeling Pertaining to Product Certification; Requirements Pertaining to Third Party Conformity Assessment Bodies, 22863-22866 [2021-08819]

Download as PDF Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Rules and Regulations information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If you wish to submit such information, please submit it according to the instructions for mail/hand delivery/courier written submissions. Docket: For access to the docket to read background documents or comments received, go to: https:// www.regulations.gov, and insert the docket number, CPSC–2021–0013, into the ‘‘Search’’ box, and follow the prompts. CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1107 and 1112 [Docket No. CPSC–2021–0013] Testing and Labeling Pertaining to Product Certification; Requirements Pertaining to Third Party Conformity Assessment Bodies Consumer Product Safety Commission (CPSC). ACTION: Direct final rule. AGENCY: This direct final rule updates the testing and third party conformity assessment body rules to incorporate by reference current versions of ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E). SUMMARY: The rule is effective on July 29, 2021, unless CPSC receives a significant adverse comment by June 1, 2021. If CPSC receives such a comment, it will publish a document in the Federal Register, withdrawing this direct final rule before its effective date. The incorporation by reference of the publication listed in this rule is approved by the Director of the Federal Register as of July 29, 2021. ADDRESSES: You can submit comments, identified by Docket No. CPSC–2021– 0013, by any of the following methods: Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: https:// www.regulations.gov. Follow the instructions for submitting comments. CPSC does not accept comments submitted by electronic mail (email), except through https:// www.regulations.gov and as described below. CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above. Mail/Hand Delivery/Courier Written Submissions: Submit comments by mail/hand delivery/courier to: Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504–7479. Alternatively, as a temporary option during the COVID–19 pandemic, you may email such submissions to: cpscos@cpsc.gov. Instructions: All submissions must include the agency name and docket number for this notice. CPSC may post all comments without change, including any personal identifiers, contact information, or other personal information provided, to: https:// www.regulations.gov. Do not submit electronically: Confidential business jbell on DSKJLSW7X2PROD with RULES DATES: VerDate Sep<11>2014 16:13 Apr 29, 2021 Jkt 253001 FOR FURTHER INFORMATION CONTACT: Scott Heh, Program Manager, Third Party Laboratory Accreditation, U.S. Consumer Product Safety Commission, National Product Testing and Evaluation Center, Five Research Place, Rockville, MD 20850; 301–504–7646; email: sheh@cpsc.gov. SUPPLEMENTARY INFORMATION: A. Background Section 14(a)(2) of the Consumer Product Safety Act (CPSA) requires manufacturers and importers of children’s products to certify that their products comply with all applicable children’s product safety rules. Certification must be based on third party testing by a CPSC-accepted laboratory. Section 14(a)(3) of the CPSA requires the CPSC to publish a notice of requirements for the accreditation of third party testing laboratories to determine whether a children’s product conforms to the applicable children’s product safety rule. CPSC promulgated regulations implementing these statutory requirements as described below. 16 CFR Part 1107 The CPSC regulation for testing and labeling is 16 CFR part 1107. The Commission promulgated the final rule in November 2011. 76 FR 69482. The regulation at 16 CFR part 1107, among other things, incorporated by reference International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard ISO/IEC 17025:2005(E), ‘‘General Requirements for the Competence of Testing and Calibration Laboratories’’ (ISO/IEC 17025) and ISO/ IEC 17011:2004(E) ‘‘Conformity assessment—General requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies’’ (ISO/ IEC 17011) in § 1107.21 regarding periodic testing. All manufacturers of children’s products must conduct periodic testing. All periodic testing must be conducted by a CPSC-accepted third party conformity assessment body. PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 22863 Under part 1107 a manufacturer must conduct periodic testing to ensure compliance with the applicable children’s product safety rules at least once a year. The rule allows manufacturers to extend the time between required periodic testing to either two or three years, as follows: • Two years—Required periodic testing by third party conformity assessment body may be extended to two years if the manufacturer implements a production testing plan as described in 16 CFR 1107.21(c)(2). • Three years—Required periodic testing by a third party conformity assessment body may be extended to three years for manufacturers conducting testing to ensure continued compliance with the applicable children’s product safety rules using a testing laboratory accredited to ISO/IEC 17025:2005(E). The testing laboratory used to ensure continued compliance during the three-year period is not required to be a CPSC-accepted testing laboratory. However, any ISO/IEC 17025:2005(E)-accredited testing laboratory used for ensuring continued compliance must be accredited by an accreditation body that is accredited to ISO/IEC 17011:2004(E) 16 CFR 1107.21(d)(1)). Both ISO/IEC 17025:2005(E) and ISO/ IEC 17011:2004(E) were incorporated by reference in the periodic testing section (§ 1107.21) of part 1107. 16 CFR Part 1112 The CPSC regulation for acceptance of third-party testing laboratories is 16 CFR part 1112. The Commission promulgated the final rule in March 2013. 78 FR 15836. The regulation at 16 CFR part 1112, among other things, establishes the baseline requirement for a laboratory to be CPSC accepted to conduct required third party testing on children’s products. In order for a testing laboratory to be considered CPSC accepted, it must, among other things, be accredited to ISO/IEC 17025:2005(E), ‘‘General Requirements for the Competence of Testing and Calibration Laboratories’’ (ISO/IEC 17025). The testing laboratory’s accreditation body must be a signatory to the International Laboratory Accreditation Cooperation— Mutual Recognition Arrangement (ILAC-MRA). Testing laboratories that are ISO/IEC 17025 accredited are assessed to have the technical and managerial competence to conduct testing in accordance with the standards and test methods that are listed in the laboratory’s scope of accreditation. The accreditation body issues the accreditation scope for the laboratory and posts it for public viewing on the E:\FR\FM\30APR1.SGM 30APR1 22864 Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Rules and Regulations accreditation body’s website. When the final rule was promulgated, ISO/IEC 17025:2005(E) was incorporated by reference in part 1112 (§ 1112.13). jbell on DSKJLSW7X2PROD with RULES B. Revisions to the ISO/IEC Standards In 2017, ISO/IEC published updated versions of ISO/IEC 17025 and ISO/IEC 17011. A general description of the standards and what changes were made in the revisions follows. Scope and Purpose of ISO/IEC 17025 Testing laboratories that are accredited to ISO/IEC 17025 have demonstrated that they operate competently and generate valid results, thereby promoting confidence in their testing results around the world. The standard facilitates cooperation between laboratories and other bodies by generating wider acceptance of test results among countries. Specifically, ISO/IEC 17025 enables the international acceptance of test reports and certificates without the need for further testing, which, in turn, facilitates international trade. ISO/IEC 17025:2017(E) was developed to address market conditions and technology changes that have occurred since publication of the 2005 version of the standard. ISO has highlighted the reasons for the revised standard and the substantive changes included in the new version.1 The changes include: • A process approach that now matches that of newer standards such as ISO 9001 (quality management), and the ISO/IEC 17000 series (standards for conformity assessment activities), putting the emphasis on the results of a process instead of the detailed description of its tasks and steps. • The standard has a stronger focus on information technologies. In recognition of the fact that hard-copy manuals, records and reports are slowly being phased out in favor of electronic versions, it incorporates the use of computer systems, electronic records and the production of electronic results and reports. • A new section has been added introducing the concept of risk-based thinking and describes the commonalities with ISO 9001:2015, ‘‘Quality management systems— Requirements.’’ The main sections in ISO/IEC 17025:2017(E) are: • General Requirements that include a provision stating that the laboratory shall identify risks to its impartiality on 1 International Organization for Standardization— Brochure summarizes the key changes adopted in the 2017 version of ISO/IEC 17025. https:// www.iso.org/files/live/sites/isoorg/files/store/en/ PUB100424.pdf. VerDate Sep<11>2014 16:13 Apr 29, 2021 Jkt 253001 an ongoing basis and demonstrate how it minimizes such risk. • Structural requirements that cover provisions for defining the organization and management of the laboratory and the role and authorities for laboratory management. • Resource requirements that address aspects of personnel, facilities, and equipment. • Process requirements include evaluation of measurement uncertainty, validation of methods, handling of test items, and reporting of results. • Management System Requirements that include control of system documents and records, actions to address risks and opportunities, corrective actions, internal audits, and management reviews. Transition Period From ISO/IEC 17025:2005(E) to ISO/IEC 17025:2017(E) ILAC and ISO issued a ‘‘Joint ILAC– ISO Communique´ on the recognition of ISO/IEC 17025 during a Three-Year Transition.’’ 2 The communique´ states: Laboratories wishing to demonstrate their technical competence can do so via conformity with the international standard ISO/IEC 17025 ‘‘General requirements for the competence of testing and calibration laboratories.’’ Conformity with this standard also means that the laboratory generally operates a management system in accordance with the principles of ISO 9001. In 2017, ISO published a revision to ISO/ IEC 17025 (previously published in 2005) to ensure that requirements continue to meet the demands of the modern market place. As a consequence, it has been agreed that laboratories that demonstrate conformity through third party accreditation will need to transition their processes to the new version within a defined timeframe. ILAC, in consultation with ISO, agreed that a threeyear period from the date of publication shall be allowed for this transition. During this transition period, it is important to note that both ISO/IEC 17025:2005E and ISO/IEC 17025:2017 are equally valid and applicable. Formal accreditation to either standard granted by an accreditation body that is a signatory to the ILAC Arrangement should be recognized by the market place, and it is strongly recommended that specifiers equally recognize both versions until after the 3-year transition period has closed. In June 2020, because of the ongoing worldwide pandemic, ILAC and ISO issued a revision to the communique´ that states: The end of the transition period has been extended from November 2020 to 1 June 2021. ILAC and ISO have agreed to this extension to ensure all laboratories are able to be transitioned following the restrictions imposed as a result of the global coronavirus disease 2019 (COVID–19) outbreak. 2 https://ilac.org/?ddownload=123170. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 In January 2021, ILAC reported good progress towards achieving the revised June 2021 deadline, with 12 accreditation bodies confirming (as of November 30, 2020) that 100 percent of their laboratories accredited to ISO/IEC 17025 have transitioned to the 2017 version, and an additional 73 accreditation bodies confirming more than 75 percent laboratories had completed this transition. Scope and Purpose of ISO/IEC 17011 ISO/IEC 17011 specifies requirements for the competence, consistent operation, and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies. For CPSC purposes, the conformity assessment bodies are third party testing laboratories. As is the case for the ISO/IEC 17025 revision, the new version of ISO/IEC 17011 includes alignment with the common structure for the ISO 17000 series standards. The revised standard adds concepts of risk and risk-based assessments. The revised standard also incorporates competence criteria in the document, including an informative annex on knowledge and skills. Transition Period from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017(E) The transition from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017(E) was completed in December 2020. All ILAC–MRA signatory accreditation bodies are now conducting assessment activities according to ISO/IEC 17011:2017(E). C. Description of the Direct Final Rule The direct final rule (DFR) only amends those sections of 16 CFR parts 1107 and 1112 that incorporate by reference or refer to ISO/IEC 17025:2005(E) and ISO/IEC 17011:2004(E). The DFR updates the incorporation by reference provisions of the regulations and references to the standards in 16 CFR parts 1107 and 1112 from ISO/IEC 17025:2005(E) and ISO/IEC 17011:2004(E) to ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E), as applicable, in the sections listed below: 16 CFR Part 1107 • Section 1107.21(d)(1) • Section 1107.21(g) • Section 1107.26(a)(3)(iii) 16 CFR Part 1112 • Section 1112.3 definition of Accreditation body • Section 1112.13(a)(2)(i) • Section 1112.13(i) • Section 1112.43(a)(3) E:\FR\FM\30APR1.SGM 30APR1 Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Rules and Regulations The DFR makes no other changes to part 1107 or 1112. jbell on DSKJLSW7X2PROD with RULES D. Effective Date The Administrative Procedure Act (APA) generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). The DFR sets an effective date of 90 days after publication in the Federal Register. CPSC staff determined that all testing laboratories that are currently CPSCaccepted, and testing laboratories that are seeking CPSC-acceptance, will have completed their accreditation renewal to ISO/IEC 17025:2017(E) before the rule’s effective date. Thus, the effective date for rule is July 29, 2021. E. Incorporation by Reference The DFR updates the sections of 16 CFR parts 1107 and 1112 that incorporate by reference ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E). The Office of the Federal Register (OFR) has regulations regarding incorporation by reference. 1 CFR part 51. Under these regulations, agencies must discuss, in the preamble to a final rule, ways in which the material the agency incorporates by reference is reasonably available to interested parties, and how interested parties can obtain the material. In addition, the preamble to the final rule must summarize the material. 1 CFR 51.5(b). In accordance with the OFR regulations, section B, of this preamble summarizes the major provisions of ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E) that the Commission incorporates by reference into sections of 16 CFR parts 1107 and 1112. The standard is reasonably available to interested parties and interested parties can purchase a copy of ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E) from the International Organization for Standardization (ISO), ISO Central Secretariat Chemin de Blandonnet 8 CP 401—1214 Vernier, Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 30; https:// www.iso.org/iso/home.htm. Interested parties can also schedule an appointment to inspect a copy of the standards at CPSC’s Division of the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone: 301–504–7479; email: cpsc-os@cpsc.gov. F. Direct Final Rule Process The Commission is issuing this rule as a direct final rule. Although the Administrative Procedure Act (APA; 5 U.S.C. 551–559) generally requires VerDate Sep<11>2014 16:13 Apr 29, 2021 Jkt 253001 agencies to provide notice of a rule and an opportunity for interested parties to comment on it, section 553 of the APA provides an exception when the agency, ‘‘for good cause finds,’’ that notice and comment are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Id. 553(b)(B). The Commission concludes that when merely updating the incorporations by references contained in 16 CFR parts 1107 and 1112 to reflect the current versions of ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E), notice and comment is unnecessary. The purpose of this direct final rule is to update the references in the CFR so that it reflects the versions of the voluntary standards currently in effect. The ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E) updates to the voluntary standards are not controversial, and are almost universally complied with by the testing and accreditation community involved in CPSA required testing. We do not expect any adverse comments regarding the updates to the references to ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E) in the CFR. In Recommendation 95–4, the Administrative Conference of the United States (ACUS) endorses direct final rulemaking as an appropriate procedure to expedite rules that are noncontroversial and that are not expected to generate significant adverse comments. See 60 FR 43108 (Aug. 18, 1995). ACUS recommends that agencies use the direct final rule process when they act under the ‘‘unnecessary’’ prong of the good cause exemption in 5 U.S.C. 553(b)(B). Consistent with the ACUS recommendation, the Commission is publishing this rule as a direct final rule, because CPSC does not expect any significant adverse comments. Unless CPSC receives a significant adverse comment within 30 days of this notification, the rule will become effective on July 29, 2021. In accordance with ACUS’s recommendation, the Commission considers a significant adverse comment to be ‘‘one where the commenter explains why the rule would be inappropriate,’’ including an assertion challenging ‘‘the rule’s underlying premise or approach,’’ or a claim that the rule ‘‘would be ineffective or unacceptable without change.’’ 60 FR 43108, 43111. As noted, this rule simply updates the references in the CFR to reflect noncontroversial changes to ISO/ IEC 17025:2017(E) and ISO/IEC 17011:2017(E) and are almost universally complied with by the testing and accreditation community involved in CPSA required testing. If the Commission receives a significant adverse comment, the PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 22865 Commission will withdraw this direct final rule. Depending on the comment and other circumstances, the Commission may then incorporate the adverse comment into a subsequent direct final rule or publish a notice of proposed rulemaking, providing an opportunity for public comment. G. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) generally requires that agencies review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604. The RFA applies to any rule that is subject to notice and comment procedures under section 553 of the APA. 5 U.S.C. 603 and 604. As explained above, the Commission has determined that notice and comment is not necessary for this direct final rule. Thus, the RFA does not apply. We also note the limited nature of this document. The amendments to parts 1107 and 1112 simply update the incorporations by reference provisions and citations in the regulations to the current versions of ISO/IEC 17025 and ISO/IEC 17011 and will not result in any substantive changes to the regulations. Rather, with this action, the CFR will reflect the current versions of ISO/IEC 17025 and ISO/IEC 17011 in 16 CFR parts 1107 and 1112. However, the impact of the direct final rule on any testing laboratory that maintains its accreditation solely to conduct third party testing is not expected to be large and would be undertaken by the testing laboratory only if it expected to make sufficient revenue from third party testing under the CPSA to justify the expense. H. Environmental Considerations The Commission’s regulations provide a categorical exclusion for the Commission’s rules from any requirement to prepare an environmental assessment or an environmental impact statement because they ‘‘have little or no potential for affecting the human environment.’’ 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required. I. Congressional Review Act The Congressional Review Act (CRA; 5 U.S.C. 801–808) states that before a rule may take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA E:\FR\FM\30APR1.SGM 30APR1 22866 Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Rules and Regulations submission must indicate whether the rule is a ‘‘major rule.’’ The CRA states that the Office of Information and Regulatory Affairs (OIRA) determines whether a rule qualifies as a ‘‘major rule.’’ Pursuant to the CRA, this rule does not qualify as a ‘‘major rule,’’ as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit the required information to each House of Congress and the Comptroller General. List of Subjects 16 CFR Part 1107 Business and industry, Children, Consumer protection, Imports, Incorporation by reference, Product testing and certification, Records, Record retention, Toys. § 1107.26 PART 1107—TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION 1. The authority citation for part 1107 continues to read as follows: ■ Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. L. 110–314, 122 Stat. 3016, 3017, 3022. 2. Amend § 1107.21 by: a. In paragraph (d)(1), removing the phrases ‘‘ISO/IEC 17025:2005(E)’’ and ‘‘ISO/IEC 17011:2004(E)’’ everywhere they appear and adding in their places the phrases ‘‘ISO/IEC 17025’’ and ‘‘ISO/ IEC 17011’’, respectively; and ■ b. Revising paragraph (g). The revision reads as follows: ■ ■ Periodic testing. jbell on DSKJLSW7X2PROD with RULES * * * * * (g) Incorporation by reference. The Director of the Federal Register approves the incorporation by reference of the standards in this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy at the Division of the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone (301) 504–7479, email: cpsc-os@cpsc.gov, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@ nara.gov, or go to: www.archives.gov/ federal-register/cfr/ibr-locations.html. (1) International Organization for Standardization (ISO), ISO Central VerDate Sep<11>2014 16:13 Apr 29, 2021 Jkt 253001 [Amended] 3. In § 1107.26(a)(3)(iii), remove the phrase ‘‘ISO/IEC 17025:2005(E)’’ and add in its place the phrase ‘‘ISO/IEC 17025 (see § 1107.21 for availability)’’. ■ 16 CFR Part 1112 Audit, Consumer protection, Incorporation by reference, Third party conformity assessment body requirements. For the reasons discussed in the preamble, the Commission amends 16 CFR chapter II as follows: § 1107.21 Secretariat Chemin de Blandonnet 8 CP 401—1214 Vernier, Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 30; https:// www.iso.org/iso/home.htm. (i) ISO/IEC 17011:2017(E) (ISO/IEC 17011), ‘‘Conformity assessment— Requirements for accreditation bodies accrediting conformity assessment bodies,’’ November 10, 2017; and (ii) ISO/IEC 17025:2017(E) (ISO/IEC 17025), ‘‘General requirements for the competence of testing and calibration laboratories,’’ November 10, 2017. (2) [Reserved] PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES 4. The authority citation for part 1112 is continues to read as follows: ■ Authority: Pub. L. 110–314, section 3, 122 Stat. 3016, 3017 (2008); 15 U.S.C. 2063. § 1112.3 5. In § 1112.3, in paragraph (1) under the definition for ‘‘Accreditation body’’, remove the phrase ‘‘ISO/IEC 17025:2005’’ and add in its place the phrase ‘‘ISO/IEC 17025 (see § 1107.21 of this chapter for availability)’’. ■ 6. Amend § 1112.13 by: ■ a. In paragraph (a)(2)(i)(A), removing the phrase ‘‘ISO/IEC Standard 17025:2005(E)’’ and adding in its place the phrase ‘‘ISO/IEC 17025’’; and ■ b. Revising paragraph (i). The revision reads as follows: § 1112.13 How does a third party conformity assessment body apply for CPSC acceptance? * * * * * (i) Incorporation by reference. The Director of the Federal Register approves the incorporation by reference in paragraph (a)(2)(i) of this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of ISO/IEC 17025:2017(E), ‘‘Requirements for the competence of testing and calibration laboratories,’’ approved November 10, 2021 from the International Organization for Standardization (ISO), ISO Central Secretariat Chemin de Blandonnet 8 CP 401–1214 Vernier, Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 30; https://www.iso.org/iso/ home.htm. You may inspect a copy at the Division of the Secretariat, U.S. Consumer Product Safety Commission, Frm 00028 Fmt 4700 § 1112.43 [Amended] 7. In § 1112.43(a)(3), remove the phrase ‘‘ISO/IEC 17025:2005(E)’’ and add in its place the phrase ‘‘ISO/IEC 17025:2017(E)’’. ■ Alberta E. Mills, Secretary, U.S. Consumer Product Safety Commission. [FR Doc. 2021–08819 Filed 4–29–21; 8:45 am] BILLING CODE 6355–01–P RAILROAD RETIREMENT BOARD 20 CFR Part 200 RIN 3220–AB 76 Guidance Documents Railroad Retirement Board. Final rule; rescission of regulation. AGENCY: [Amended] ■ PO 00000 Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone (301) 504–7479, email: cpsc-os@cpsc.gov, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@ nara.gov, or go to: www.archives.gov/ federal-register/cfr/ibr-locations.html. Sfmt 4700 ACTION: In accordance with Executive Order 13992, ‘‘Revocation of Certain Executive Orders Concerning Federal Regulation,’’ issued by President Biden on January 20, 2021, this final rule rescinds the Railroad Retirement Board’s rule on guidance. DATES: This final rule is effective April 30, 2021. FOR FURTHER INFORMATION CONTACT: Marguerite P. Dadabo, Assistant General Counsel, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611–1275, telephone (312) 751–4945, TTD (312) 751–4701. SUPPLEMENTARY INFORMATION: On August 28, 2020, the Railroad Retirement Board published an interim final rule on guidance implementing Executive Order 13891, ‘‘Promoting the Rule of Law Through Improved Agency Guidance Documents,’’ signed by President Donald Trump on October 9, 2019 (85 FR 53160). As required by the Executive Order, the rule contained policy and requirements for issuing, modifying, withdrawing, and using guidance, making guidance available to the public, a notice and comment process for significant guidance, and taking and responding to petitions about guidance. On January 20, 2021, President Joseph Biden issued Executive Order 13992, ‘‘Revocation of Certain Executive Orders SUMMARY: E:\FR\FM\30APR1.SGM 30APR1

Agencies

[Federal Register Volume 86, Number 82 (Friday, April 30, 2021)]
[Rules and Regulations]
[Pages 22863-22866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08819]



[[Page 22863]]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1107 and 1112

[Docket No. CPSC-2021-0013]


Testing and Labeling Pertaining to Product Certification; 
Requirements Pertaining to Third Party Conformity Assessment Bodies

AGENCY: Consumer Product Safety Commission (CPSC).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: This direct final rule updates the testing and third party 
conformity assessment body rules to incorporate by reference current 
versions of ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E).

DATES: The rule is effective on July 29, 2021, unless CPSC receives a 
significant adverse comment by June 1, 2021. If CPSC receives such a 
comment, it will publish a document in the Federal Register, 
withdrawing this direct final rule before its effective date. The 
incorporation by reference of the publication listed in this rule is 
approved by the Director of the Federal Register as of July 29, 2021.

ADDRESSES: You can submit comments, identified by Docket No. CPSC-2021-
0013, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. CPSC does not accept comments 
submitted by electronic mail (email), except through https://www.regulations.gov and as described below. CPSC encourages you to 
submit electronic comments by using the Federal eRulemaking Portal, as 
described above.
    Mail/Hand Delivery/Courier Written Submissions: Submit comments by 
mail/hand delivery/courier to: Division of the Secretariat, Consumer 
Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, 
MD 20814; telephone: (301) 504-7479. Alternatively, as a temporary 
option during the COVID-19 pandemic, you may email such submissions to: 
[email protected].
    Instructions: All submissions must include the agency name and 
docket number for this notice. CPSC may post all comments without 
change, including any personal identifiers, contact information, or 
other personal information provided, to: https://www.regulations.gov. 
Do not submit electronically: Confidential business information, trade 
secret information, or other sensitive or protected information that 
you do not want to be available to the public. If you wish to submit 
such information, please submit it according to the instructions for 
mail/hand delivery/courier written submissions.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2021-0013, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Scott Heh, Program Manager, Third 
Party Laboratory Accreditation, U.S. Consumer Product Safety 
Commission, National Product Testing and Evaluation Center, Five 
Research Place, Rockville, MD 20850; 301-504-7646; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

A. Background

    Section 14(a)(2) of the Consumer Product Safety Act (CPSA) requires 
manufacturers and importers of children's products to certify that 
their products comply with all applicable children's product safety 
rules. Certification must be based on third party testing by a CPSC-
accepted laboratory. Section 14(a)(3) of the CPSA requires the CPSC to 
publish a notice of requirements for the accreditation of third party 
testing laboratories to determine whether a children's product conforms 
to the applicable children's product safety rule. CPSC promulgated 
regulations implementing these statutory requirements as described 
below.

16 CFR Part 1107

    The CPSC regulation for testing and labeling is 16 CFR part 1107. 
The Commission promulgated the final rule in November 2011. 76 FR 
69482. The regulation at 16 CFR part 1107, among other things, 
incorporated by reference International Organization for 
Standardization (ISO)/International Electrotechnical Commission (IEC) 
Standard ISO/IEC 17025:2005(E), ``General Requirements for the 
Competence of Testing and Calibration Laboratories'' (ISO/IEC 17025) 
and ISO/IEC 17011:2004(E) ``Conformity assessment--General requirements 
for Accreditation Bodies Accrediting Conformity Assessment Bodies'' 
(ISO/IEC 17011) in Sec.  1107.21 regarding periodic testing. All 
manufacturers of children's products must conduct periodic testing. All 
periodic testing must be conducted by a CPSC-accepted third party 
conformity assessment body.
    Under part 1107 a manufacturer must conduct periodic testing to 
ensure compliance with the applicable children's product safety rules 
at least once a year. The rule allows manufacturers to extend the time 
between required periodic testing to either two or three years, as 
follows:
     Two years--Required periodic testing by third party 
conformity assessment body may be extended to two years if the 
manufacturer implements a production testing plan as described in 16 
CFR 1107.21(c)(2).
     Three years--Required periodic testing by a third party 
conformity assessment body may be extended to three years for 
manufacturers conducting testing to ensure continued compliance with 
the applicable children's product safety rules using a testing 
laboratory accredited to ISO/IEC 17025:2005(E). The testing laboratory 
used to ensure continued compliance during the three-year period is not 
required to be a CPSC-accepted testing laboratory. However, any ISO/IEC 
17025:2005(E)-accredited testing laboratory used for ensuring continued 
compliance must be accredited by an accreditation body that is 
accredited to ISO/IEC 17011:2004(E) 16 CFR 1107.21(d)(1)).
    Both ISO/IEC 17025:2005(E) and ISO/IEC 17011:2004(E) were 
incorporated by reference in the periodic testing section (Sec.  
1107.21) of part 1107.

16 CFR Part 1112

    The CPSC regulation for acceptance of third-party testing 
laboratories is 16 CFR part 1112. The Commission promulgated the final 
rule in March 2013. 78 FR 15836. The regulation at 16 CFR part 1112, 
among other things, establishes the baseline requirement for a 
laboratory to be CPSC accepted to conduct required third party testing 
on children's products. In order for a testing laboratory to be 
considered CPSC accepted, it must, among other things, be accredited to 
ISO/IEC 17025:2005(E), ``General Requirements for the Competence of 
Testing and Calibration Laboratories'' (ISO/IEC 17025). The testing 
laboratory's accreditation body must be a signatory to the 
International Laboratory Accreditation Cooperation--Mutual Recognition 
Arrangement (ILAC-MRA). Testing laboratories that are ISO/IEC 17025 
accredited are assessed to have the technical and managerial competence 
to conduct testing in accordance with the standards and test methods 
that are listed in the laboratory's scope of accreditation. The 
accreditation body issues the accreditation scope for the laboratory 
and posts it for public viewing on the

[[Page 22864]]

accreditation body's website. When the final rule was promulgated, ISO/
IEC 17025:2005(E) was incorporated by reference in part 1112 (Sec.  
1112.13).

B. Revisions to the ISO/IEC Standards

    In 2017, ISO/IEC published updated versions of ISO/IEC 17025 and 
ISO/IEC 17011. A general description of the standards and what changes 
were made in the revisions follows.

Scope and Purpose of ISO/IEC 17025

    Testing laboratories that are accredited to ISO/IEC 17025 have 
demonstrated that they operate competently and generate valid results, 
thereby promoting confidence in their testing results around the world. 
The standard facilitates cooperation between laboratories and other 
bodies by generating wider acceptance of test results among countries. 
Specifically, ISO/IEC 17025 enables the international acceptance of 
test reports and certificates without the need for further testing, 
which, in turn, facilitates international trade.
    ISO/IEC 17025:2017(E) was developed to address market conditions 
and technology changes that have occurred since publication of the 2005 
version of the standard. ISO has highlighted the reasons for the 
revised standard and the substantive changes included in the new 
version.\1\ The changes include:
---------------------------------------------------------------------------

    \1\ International Organization for Standardization--Brochure 
summarizes the key changes adopted in the 2017 version of ISO/IEC 
17025. https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100424.pdf.
---------------------------------------------------------------------------

     A process approach that now matches that of newer 
standards such as ISO 9001 (quality management), and the ISO/IEC 17000 
series (standards for conformity assessment activities), putting the 
emphasis on the results of a process instead of the detailed 
description of its tasks and steps.
     The standard has a stronger focus on information 
technologies. In recognition of the fact that hard-copy manuals, 
records and reports are slowly being phased out in favor of electronic 
versions, it incorporates the use of computer systems, electronic 
records and the production of electronic results and reports.
     A new section has been added introducing the concept of 
risk-based thinking and describes the commonalities with ISO 9001:2015, 
``Quality management systems--Requirements.''
    The main sections in ISO/IEC 17025:2017(E) are:
     General Requirements that include a provision stating that 
the laboratory shall identify risks to its impartiality on an ongoing 
basis and demonstrate how it minimizes such risk.
     Structural requirements that cover provisions for defining 
the organization and management of the laboratory and the role and 
authorities for laboratory management.
     Resource requirements that address aspects of personnel, 
facilities, and equipment.
     Process requirements include evaluation of measurement 
uncertainty, validation of methods, handling of test items, and 
reporting of results.
     Management System Requirements that include control of 
system documents and records, actions to address risks and 
opportunities, corrective actions, internal audits, and management 
reviews.
Transition Period From ISO/IEC 17025:2005(E) to ISO/IEC 17025:2017(E)
    ILAC and ISO issued a ``Joint ILAC-ISO Communiqu[eacute] on the 
recognition of ISO/IEC 17025 during a Three-Year Transition.'' \2\
---------------------------------------------------------------------------

    \2\ https://ilac.org/?ddownload=123170.
---------------------------------------------------------------------------

    The communiqu[eacute] states:

    Laboratories wishing to demonstrate their technical competence 
can do so via conformity with the international standard ISO/IEC 
17025 ``General requirements for the competence of testing and 
calibration laboratories.'' Conformity with this standard also means 
that the laboratory generally operates a management system in 
accordance with the principles of ISO 9001.
    In 2017, ISO published a revision to ISO/IEC 17025 (previously 
published in 2005) to ensure that requirements continue to meet the 
demands of the modern market place. As a consequence, it has been 
agreed that laboratories that demonstrate conformity through third 
party accreditation will need to transition their processes to the 
new version within a defined timeframe. ILAC, in consultation with 
ISO, agreed that a three-year period from the date of publication 
shall be allowed for this transition.
    During this transition period, it is important to note that both 
ISO/IEC 17025:2005E and ISO/IEC 17025:2017 are equally valid and 
applicable. Formal accreditation to either standard granted by an 
accreditation body that is a signatory to the ILAC Arrangement 
should be recognized by the market place, and it is strongly 
recommended that specifiers equally recognize both versions until 
after the 3-year transition period has closed.
    In June 2020, because of the ongoing worldwide pandemic, ILAC 
and ISO issued a revision to the communiqu[eacute] that states:
    The end of the transition period has been extended from November 
2020 to 1 June 2021. ILAC and ISO have agreed to this extension to 
ensure all laboratories are able to be transitioned following the 
restrictions imposed as a result of the global coronavirus disease 
2019 (COVID-19) outbreak.

    In January 2021, ILAC reported good progress towards achieving the 
revised June 2021 deadline, with 12 accreditation bodies confirming (as 
of November 30, 2020) that 100 percent of their laboratories accredited 
to ISO/IEC 17025 have transitioned to the 2017 version, and an 
additional 73 accreditation bodies confirming more than 75 percent 
laboratories had completed this transition.

Scope and Purpose of ISO/IEC 17011

    ISO/IEC 17011 specifies requirements for the competence, consistent 
operation, and impartiality of accreditation bodies assessing and 
accrediting conformity assessment bodies. For CPSC purposes, the 
conformity assessment bodies are third party testing laboratories.
    As is the case for the ISO/IEC 17025 revision, the new version of 
ISO/IEC 17011 includes alignment with the common structure for the ISO 
17000 series standards. The revised standard adds concepts of risk and 
risk-based assessments. The revised standard also incorporates 
competence criteria in the document, including an informative annex on 
knowledge and skills.
Transition Period from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017(E)
    The transition from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017(E) 
was completed in December 2020. All ILAC-MRA signatory accreditation 
bodies are now conducting assessment activities according to ISO/IEC 
17011:2017(E).

C. Description of the Direct Final Rule

    The direct final rule (DFR) only amends those sections of 16 CFR 
parts 1107 and 1112 that incorporate by reference or refer to ISO/IEC 
17025:2005(E) and ISO/IEC 17011:2004(E). The DFR updates the 
incorporation by reference provisions of the regulations and references 
to the standards in 16 CFR parts 1107 and 1112 from ISO/IEC 
17025:2005(E) and ISO/IEC 17011:2004(E) to ISO/IEC 17025:2017(E) and 
ISO/IEC 17011:2017(E), as applicable, in the sections listed below:

16 CFR Part 1107

 Section 1107.21(d)(1)
 Section 1107.21(g)
 Section 1107.26(a)(3)(iii)

16 CFR Part 1112

 Section 1112.3 definition of Accreditation body
 Section 1112.13(a)(2)(i)
 Section 1112.13(i)
 Section 1112.43(a)(3)

[[Page 22865]]

    The DFR makes no other changes to part 1107 or 1112.

D. Effective Date

    The Administrative Procedure Act (APA) generally requires that a 
substantive rule must be published not less than 30 days before its 
effective date. 5 U.S.C. 553(d)(1). The DFR sets an effective date of 
90 days after publication in the Federal Register. CPSC staff 
determined that all testing laboratories that are currently CPSC-
accepted, and testing laboratories that are seeking CPSC-acceptance, 
will have completed their accreditation renewal to ISO/IEC 
17025:2017(E) before the rule's effective date. Thus, the effective 
date for rule is July 29, 2021.

E. Incorporation by Reference

    The DFR updates the sections of 16 CFR parts 1107 and 1112 that 
incorporate by reference ISO/IEC 17025:2017(E) and ISO/IEC 
17011:2017(E). The Office of the Federal Register (OFR) has regulations 
regarding incorporation by reference. 1 CFR part 51. Under these 
regulations, agencies must discuss, in the preamble to a final rule, 
ways in which the material the agency incorporates by reference is 
reasonably available to interested parties, and how interested parties 
can obtain the material. In addition, the preamble to the final rule 
must summarize the material. 1 CFR 51.5(b).
    In accordance with the OFR regulations, section B, of this preamble 
summarizes the major provisions of ISO/IEC 17025:2017(E) and ISO/IEC 
17011:2017(E) that the Commission incorporates by reference into 
sections of 16 CFR parts 1107 and 1112. The standard is reasonably 
available to interested parties and interested parties can purchase a 
copy of ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E) from the 
International Organization for Standardization (ISO), ISO Central 
Secretariat Chemin de Blandonnet 8 CP 401--1214 Vernier, Geneva, 
Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 30; https://www.iso.org/iso/home.htm. Interested parties can also schedule an 
appointment to inspect a copy of the standards at CPSC's Division of 
the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 
4330 East West Highway, Bethesda, MD 20814, telephone: 301-504-7479; 
email: [email protected].

F. Direct Final Rule Process

    The Commission is issuing this rule as a direct final rule. 
Although the Administrative Procedure Act (APA; 5 U.S.C. 551-559) 
generally requires agencies to provide notice of a rule and an 
opportunity for interested parties to comment on it, section 553 of the 
APA provides an exception when the agency, ``for good cause finds,'' 
that notice and comment are ``impracticable, unnecessary, or contrary 
to the public interest.'' Id. 553(b)(B). The Commission concludes that 
when merely updating the incorporations by references contained in 16 
CFR parts 1107 and 1112 to reflect the current versions of ISO/IEC 
17025:2017(E) and ISO/IEC 17011:2017(E), notice and comment is 
unnecessary.
    The purpose of this direct final rule is to update the references 
in the CFR so that it reflects the versions of the voluntary standards 
currently in effect. The ISO/IEC 17025:2017(E) and ISO/IEC 
17011:2017(E) updates to the voluntary standards are not controversial, 
and are almost universally complied with by the testing and 
accreditation community involved in CPSA required testing. We do not 
expect any adverse comments regarding the updates to the references to 
ISO/IEC 17025:2017(E) and ISO/IEC 17011:2017(E) in the CFR.
    In Recommendation 95-4, the Administrative Conference of the United 
States (ACUS) endorses direct final rulemaking as an appropriate 
procedure to expedite rules that are noncontroversial and that are not 
expected to generate significant adverse comments. See 60 FR 43108 
(Aug. 18, 1995). ACUS recommends that agencies use the direct final 
rule process when they act under the ``unnecessary'' prong of the good 
cause exemption in 5 U.S.C. 553(b)(B). Consistent with the ACUS 
recommendation, the Commission is publishing this rule as a direct 
final rule, because CPSC does not expect any significant adverse 
comments.
    Unless CPSC receives a significant adverse comment within 30 days 
of this notification, the rule will become effective on July 29, 2021. 
In accordance with ACUS's recommendation, the Commission considers a 
significant adverse comment to be ``one where the commenter explains 
why the rule would be inappropriate,'' including an assertion 
challenging ``the rule's underlying premise or approach,'' or a claim 
that the rule ``would be ineffective or unacceptable without change.'' 
60 FR 43108, 43111. As noted, this rule simply updates the references 
in the CFR to reflect noncontroversial changes to ISO/IEC 17025:2017(E) 
and ISO/IEC 17011:2017(E) and are almost universally complied with by 
the testing and accreditation community involved in CPSA required 
testing.
    If the Commission receives a significant adverse comment, the 
Commission will withdraw this direct final rule. Depending on the 
comment and other circumstances, the Commission may then incorporate 
the adverse comment into a subsequent direct final rule or publish a 
notice of proposed rulemaking, providing an opportunity for public 
comment.

G. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires that 
agencies review proposed and final rules for their potential economic 
impact on small entities, including small businesses, and prepare 
regulatory flexibility analyses. 5 U.S.C. 603 and 604. The RFA applies 
to any rule that is subject to notice and comment procedures under 
section 553 of the APA. 5 U.S.C. 603 and 604. As explained above, the 
Commission has determined that notice and comment is not necessary for 
this direct final rule. Thus, the RFA does not apply. We also note the 
limited nature of this document. The amendments to parts 1107 and 1112 
simply update the incorporations by reference provisions and citations 
in the regulations to the current versions of ISO/IEC 17025 and ISO/IEC 
17011 and will not result in any substantive changes to the 
regulations. Rather, with this action, the CFR will reflect the current 
versions of ISO/IEC 17025 and ISO/IEC 17011 in 16 CFR parts 1107 and 
1112. However, the impact of the direct final rule on any testing 
laboratory that maintains its accreditation solely to conduct third 
party testing is not expected to be large and would be undertaken by 
the testing laboratory only if it expected to make sufficient revenue 
from third party testing under the CPSA to justify the expense.

H. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
the Commission's rules from any requirement to prepare an environmental 
assessment or an environmental impact statement because they ``have 
little or no potential for affecting the human environment.'' 16 CFR 
1021.5(c)(2). This rule falls within the categorical exclusion, so no 
environmental assessment or environmental impact statement is required.

I. Congressional Review Act

    The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that 
before a rule may take effect, the agency issuing the rule must submit 
the rule, and certain related information, to each House of Congress 
and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA

[[Page 22866]]

submission must indicate whether the rule is a ``major rule.'' The CRA 
states that the Office of Information and Regulatory Affairs (OIRA) 
determines whether a rule qualifies as a ``major rule.''
    Pursuant to the CRA, this rule does not qualify as a ``major 
rule,'' as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC 
will submit the required information to each House of Congress and the 
Comptroller General.

List of Subjects

16 CFR Part 1107

    Business and industry, Children, Consumer protection, Imports, 
Incorporation by reference, Product testing and certification, Records, 
Record retention, Toys.

16 CFR Part 1112

    Audit, Consumer protection, Incorporation by reference, Third party 
conformity assessment body requirements.

    For the reasons discussed in the preamble, the Commission amends 16 
CFR chapter II as follows:

PART 1107--TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION

0
1. The authority citation for part 1107 continues to read as follows:

    Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. L. 110-314, 122 
Stat. 3016, 3017, 3022.


0
2. Amend Sec.  1107.21 by:
0
a. In paragraph (d)(1), removing the phrases ``ISO/IEC 17025:2005(E)'' 
and ``ISO/IEC 17011:2004(E)'' everywhere they appear and adding in 
their places the phrases ``ISO/IEC 17025'' and ``ISO/IEC 17011'', 
respectively; and
0
b. Revising paragraph (g).
    The revision reads as follows:


Sec.  1107.21  Periodic testing.

* * * * *
    (g) Incorporation by reference. The Director of the Federal 
Register approves the incorporation by reference of the standards in 
this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You 
may inspect a copy at the Division of the Secretariat, U.S. Consumer 
Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, 
MD 20814, telephone (301) 504-7479, email: [email protected], or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, email [email protected], 
or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
    (1) International Organization for Standardization (ISO), ISO 
Central Secretariat Chemin de Blandonnet 8 CP 401--1214 Vernier, 
Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 
30; https://www.iso.org/iso/home.htm.
    (i) ISO/IEC 17011:2017(E) (ISO/IEC 17011), ``Conformity 
assessment--Requirements for accreditation bodies accrediting 
conformity assessment bodies,'' November 10, 2017; and
    (ii) ISO/IEC 17025:2017(E) (ISO/IEC 17025), ``General requirements 
for the competence of testing and calibration laboratories,'' November 
10, 2017.
    (2) [Reserved]


Sec.  1107.26  [Amended]

0
3. In Sec.  1107.26(a)(3)(iii), remove the phrase ``ISO/IEC 
17025:2005(E)'' and add in its place the phrase ``ISO/IEC 17025 (see 
Sec.  1107.21 for availability)''.

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

0
4. The authority citation for part 1112 is continues to read as 
follows:

    Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 
(2008); 15 U.S.C. 2063.


Sec.  1112.3  [Amended]

0
5. In Sec.  1112.3, in paragraph (1) under the definition for 
``Accreditation body'', remove the phrase ``ISO/IEC 17025:2005'' and 
add in its place the phrase ``ISO/IEC 17025 (see Sec.  1107.21 of this 
chapter for availability)''.

0
6. Amend Sec.  1112.13 by:
0
a. In paragraph (a)(2)(i)(A), removing the phrase ``ISO/IEC Standard 
17025:2005(E)'' and adding in its place the phrase ``ISO/IEC 17025''; 
and
0
b. Revising paragraph (i).
    The revision reads as follows:


Sec.  1112.13   How does a third party conformity assessment body apply 
for CPSC acceptance?

* * * * *
    (i) Incorporation by reference. The Director of the Federal 
Register approves the incorporation by reference in paragraph (a)(2)(i) 
of this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
You may obtain a copy of ISO/IEC 17025:2017(E), ``Requirements for the 
competence of testing and calibration laboratories,'' approved November 
10, 2021 from the International Organization for Standardization (ISO), 
ISO Central Secretariat Chemin de Blandonnet 8 CP 401-1214 Vernier, 
Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 
30; https://www.iso.org/iso/home.htm. You may inspect a copy at the 
Division of the Secretariat, U.S. Consumer Product Safety Commission, 
Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone (301) 
504-7479, email: [email protected], or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, email [email protected], or go to: 
www.archives.gov/federal-register/cfr/ibr-locations.html.


Sec.  1112.43  [Amended]

0
7. In Sec.  1112.43(a)(3), remove the phrase ``ISO/IEC 17025:2005(E)'' 
and add in its place the phrase ``ISO/IEC 17025:2017(E)''.

Alberta E. Mills,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2021-08819 Filed 4-29-21; 8:45 am]
BILLING CODE 6355-01-P
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