UNITED STATES CONSUMER PRODUCT SAFETY …

UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MD 20814

BALLOT VOTE SHEET

CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

Date:

TO : The Commission Alberta E. Mills, Secretary

THROUGH: Jennifer Sultan, Acting General Counsel Mary T. Boyle, Executive Director

FROM : Daniel R. Vice, Acting Assistant General Counsel David M. DiMatteo, Attorney

SUBJECT : Draft Direct Final Rule: Amendments to the incorporations by reference in 16 CFR parts 1107 and 1112

BALLOT VOTE DATE: ____________________________________

Staff is forwarding to the Commission a briefing memorandum recommending that the Commission issue a direct final rule updating the references to the ISO/IEC standards ISO/IEC 17011 and ISO/IEC 17025 cited in the Commission’s regulations for testing and certification and laboratory accreditation, 16 CFR parts 1107 and 1112. A draft Federal Register notice for that purpose is attached. The draft notice will be sent to the Federal Register for publication after we receive approval of the incorporation by reference from the Office of the Federal Register.

Please indicate your vote on the following options:

I. Approve publication of the attached document in the Federal Register, as drafted.

(Signature) (Date)

March 31, 2021

Tuesday, April 6, 2021

THIS DOCUMENT HAS NOT BEEN REVIEWED OR ACCEPTED BY THE COMMISSION

CLEARED FOR PUBLIC RELEASE UNDER CPSA 6(b)(1)

This document has been electronically approved and signed.

II. Approve publication of the attached document in the Federal Register, with the specified changes.

(Signature) (Date)

III. Do not approve publication of the attached document in the Federal Register.

(Signature) (Date)

IV. Take other action specified below.

(Signature) (Date)

Attachment: Draft Federal Register notice, titled, “Testing and Labeling Pertaining to Product Certification; Requirements Pertaining to Third Party Conformity Assessment Bodies” Page 2 of 2



DRAFT: March 31, 2021

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[Billing Code 6355-01-P]

CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2021-00XX]

16 CFR Parts 1107 and 1112

Testing and Labeling Pertaining to Product Certification; Requirements Pertaining

to Third Party Conformity Assessment Bodies

AGENCY: Consumer Product Safety Commission.

ACTION: Direct final rule.

SUMMARY: In November 2011, the U.S. Consumer Product Safety Commission

(CPSC) issued a final rule that established protocols and standards for certification and

continued testing of children’s products. That rule, among other things, incorporated by

reference the voluntary standards, ISO/IEC 17025:2005(E) and ISO/IEC 17011:2004(E),

which were in effect at the time the rule was promulgated. In March 2013, CPSC issued

a final rule establishing requirements pertaining to third party conformity assessment

bodies (laboratories), whose accreditations are accepted to test children’s products in

support of the certification required by the Consumer Product Safety Act (CPSA). The

third party conformity assessment bodies rule, among other things, incorporated by

reference the voluntary standard, ISO/IEC 17025:2005(E), that was in effect at the time

the rule was promulgated. In 2017, ISO revised ISO/IEC 17025:2005(E) and ISO/IEC

17011:2004(E). This direct final rule updates the testing and third party conformity

assessment body rules to incorporate by reference the revised voluntary standards,

ISO/IEC 17025:2005(E) and ISO/IEC 17011:2004(E), to the current versions of those

voluntary standards, ISO/IEC 17025:2017 and ISO/IEC 17011:2017.


2

DATES: The rule is effective on [INSERT DATE 90 DAYS AFTER DATE OF

PUBLICATION IN THE FEDERAL REGISTER], unless CPSC receives a significant

adverse comment by [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN

THE FEDERAL REGISTER]. If CPSC receives such a comment, it will publish a notice

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 [INSERT DATE OF PUBLICATION IN THE

FEDERAL REGISTER].

ADDRESSES: You can submit comments, identified by Docket No. CPSC-2021-00XX,

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 (e-

mail), 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 can 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

https://www.regulations.gov/


mailto:[email protected]


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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-

00XX, 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, 5 Research Place, Rockville, MD 20850;

301-504-7646; email: [email protected].

SUPPLEMENTARY INFORMATION:

A. Background

Section 14(a)(2) of the 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.





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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.

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


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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 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. 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


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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 accreditation body’s website.

When the final rule was promulgated, ISO/IEC 17025:2005(E) was incorporated

by reference in part 1112.

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 among

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 additional testing, which, in turn, facilitates

international trade.

ISO/IEC 17025:2017 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

https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100424.pdf


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• 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. Recognizing 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 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 that include evaluation of measurement uncertainty,

validation of methods, handling of test items, and reporting of results.


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• 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

ILAC and ISO issued a “Joint ILAC-ISO Communiqué on the recognition

of ISO/IEC 17025 during a Three-Year Transition.2”

The communiqué 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.

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

https://ilac.org/?ddownload=123170


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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 communiqué 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(E) have transitioned to the

2017 version, and an additional 73 accreditation bodies confirming more than 75 percent

laboratories had completed this transition.


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.


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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

The transition from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017 was

completed in December 2020. All ILAC-MRA signatory accreditation bodies are now

conducting assessment activities according to ISO/IEC 17011:2017.

C. Description of the Direct Final Rule

The 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 and ISO/IEC 17011:2017, as applicable, in the sections listed below:

16 CFR part 1107

• §1107.21(d)(1)

• §1107.21(g)

• §1107.26(a)(3)(iii)

16 CFR part 1112

• §1112.3(1)

• §1112.13(a)(2)(i)


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• §1112.13(i)

• §1112.43(a)(3)

The DFR makes no other changes to parts 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 before the rule’s effective date. Thus, the

effective date for the rule is [INSERT DATE 90 DAYS AFTER DATE OF

PUBLICATION IN THE FEDERAL REGISTER].

E. Incorporation by Reference

The direct final rule updates the provisions of 16 CFR parts 1107 and 1112 that

incorporates by reference ISO/IEC 17025 and ISO/IEC 17011. 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 the 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 and ISO/IEC 17011:2017 that the

Commission incorporates by reference into sections of 16 CFR parts 1107 and 1112. The


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standard is reasonably available to interested parties, and interested parties can purchase a

copy of ISO/IEC 17025:2017 and ISO/IEC 17011:2017 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; http://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 and ISO/IEC 17011:2017, notice and comment are unnecessary.

The sole 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 and ISO/IEC 17011:2017 updates to the voluntary standards are not

controversial, and the testing and accreditation community involved in CPSA required

testing are almost universally in compliance. We do not expect any adverse comments

http://www.iso.org/iso/home.htm


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regarding the updates to the references to ISO/IEC 17025:2017 and ISO/IEC 17011:2017

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 [INSERT DATE 90 DAYS AFTER DATE

OF PUBLICATION IN THE FEDERAL REGISTER]. 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 and ISO/IEC 17011:2017 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


14

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 are 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


15

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 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, Product testing and

certification, Records, Record retention, Toys.

16 CFR Part 1112

Consumer protection, Third party conformity assessment body requirements, Audit.

For the reasons discussed in the preamble, the Commission amends Title 16 CFR

chapter II, as follows:


16

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; section 3, 102 Pub. L., 122 Stat. 3016, 3017 (2008).

2. Amend § 1107.21 by:

a. Revising (d)(1) to replace the five references to “ISO/IEC 17025:2005(E)” with

“ISO/IEC 17025:2017” and to replace the one reference to “ISO/IEC 17011:2004(E)”

with “ISO/IEC 17011:2017”; and

b. Revising (g) to read as follows;

§ 1107.21 Periodic testing

* * * * *

(g) The Director of the Federal Register approves the incorporations 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; http://www.iso.org/iso/home.htm.


http://www.archives.gov/federal-register/cfr/ibr-locations.html




17

(i) ISO/IEC 17011:2017, “Conformity assessment - Requirements for accreditation

bodies accrediting conformity assessment bodies,” Approved November 10, 2017;

(ii) ISO/IEC 17025:2017, “General requirements for the competence of testing and

calibration laboratories,” Approved November 10, 2017.

(2) [Reserved]

3. Amend § 1107.26 by:

a. Revising (26)(a)(3)(iii) to replace the one reference to “ISO/IEC 17025:2005(E)” with

“ISO/IEC 17025:2017”.

PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY

CONFORMITY ASSESSMENT BODIES

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

Authority: 15 U.S.C. 2063; 15 U.S.C. 2065; 15 U.S.C. 2068; 15 U.S.C. 2076; sec 3,

Pub. L. 110–314, 122 Stat. 3016 (2008).

4. Amend § 1112.3 by:

a. Revising (1) to replace the one reference to “ISO/IEC 17025:2005(E)” with “ISO/IEC

17025:2017”;

5. Amend § 1112.13 by:

a. Revising (a)(2)(i) to replace the one reference to “ISO/IEC 17025:2005(E)” with

“ISO/IEC 17025:2017”; and

b. Revising (i) to read as follows:

§ 1112.13 How does a third party conformity assessment body apply for CPSC

acceptance?


18

* * * * *

(i) The Director of the Federal Register approves this incorporation by reference in

paragraph (a)(2)(i) in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may

obtain a copy of ISO/IEC 17025:2017, “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; http://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.

6. Amend § 1112.43 by:

a. Revising paragraph (a)(3) to replace the one reference to “ISO/IEC 17025:2005(E)”

with “ISO/IEC 17025:2017”.

Dated: _______________________

____

____________________________________

Alberta E. Mills, Secretary

U.S. Consumer Product Safety Commission





i

Staff Briefing Package

Draft Direct Final Rule:

Amendments to 16 CFR Parts 1107 and 1112 to Incorporate by Reference

ISO/IEC 17025:2017 and ISO/IEC 17011:2017

March 31, 2021



ii

Table of Contents

Briefing Memorandum: DRAFT Direct Final Rules: Amendments to 16 CFR Parts 1107

and 1112 to Incorporate by Reference ISO/IEC 17025:2017

and ISO/IEC 17011:2017 ………………………………………………………………….…. 1

Tab A: DRAFT Regulatory Flexibility Analysis of Amendments to the Requirements

Pertaining to Conformity Assessment Bodies and Certification (16 CFR part 1107

and 16 CFR part 1112) to Reference the Most Recent ISO/IEC Standards………………….… 8



iii

BRIEFING MEMORANDUM




Memorandum

1

March 31, 2021

TO : The Commission Alberta E. Mills, Secretary

THROUGH : Jennifer S. Sultan, Acting General Counsel Mary T. Boyle, Executive Director J. DeWane Ray, Deputy Executive Director for Operations

FROM : Duane E. Boniface, Assistant Executive Director Office of Hazard Identification and Reduction

Scott Heh, Program Manager, Third Party Laboratory Accreditation Directorate for Laboratory Sciences

SUBJECT : Draft Direct Final Rule: Amendments to 16 CFR part 1107 and 16 CFR part 1112 to incorporate by reference ISO/IEC 17025:2017 and ISO/IEC 17011:2017

This memorandum presents staff’s recommendation for revising 16 CFR part 1107 and 16 CFR part 1112 to update references from ISO/IEC 17025:2005(E) to ISO/IEC 17025:2017 and from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017.

I. Introduction

Staff is recommending the proposed amendments in the draft direct final rule (DFR) to update the incorporations by reference in 16 CFR parts 1107 and 1112 to the most recent standards that are used by testing laboratories and accreditation bodies, ISO/IEC 17025:2017 and ISO/IEC 17011:2017. The 2017 revisions of these ISO/IEC standards are adopted by the testing community in the United States and abroad, and the older versions of these standards have been phased out.



This document has been electronically approved and signed.

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Section 14(a)(2) of the Consumer Product Safety Act (CPSA) requires manufacturers 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 U.S. Consumer Product Safety Commission (CPSC) to publish a notice of requirements (NOR) for the accreditation of third party testing laboratories to assess whether a children’s product conforms to the applicable children’s product safety rule. The CPSC regulation for acceptance of third-party testing laboratories is 16 CFR part 1112. The CPSC regulation for testing and labeling pertaining to product certification is 16 CFR part 1107.

The regulation at 16 CFR part 1112 establishes the baseline requirement that to be considered for CPSC acceptance, a laboratory must be accredited to International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories” (ISO/IEC 17025). The laboratory’s accreditation body must be a signatory to the International Laboratory Accreditation Cooperation – Mutual Recognition Arrangement (ILAC-MRA). 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 accreditation body’s website.

The regulation at 16 CFR part 1107 incorporates by reference ISO/IEC 17025:2005(E) “General Requirements for the Competence of Testing and Calibration Laboratories” and ISO/IEC 17011:2004(E) “Conformity assessment - Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies” in §1107.21 Periodic testing. All manufacturers of children’s products must conduct periodic testing. All periodic testing must be conducted by a third party conformity assessment body. In the context of this rule, a third party conformity assessment body is a CPSC-accepted third party testing laboratory. 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 for manufacturers to extend the time between required periodic testing to 2 or 3 years, as described below:

Extend to 2 years – Required periodic testing by third party conformityassessment body may be extended to 2 years if the manufacturer implements aproduction testing plan as described in §1107.21(c)(2).

Extend to 3 years – Required periodic testing by a third party conformityassessment body may be extended to 3 years for manufacturers conducting testingto ensure continued compliance with the applicable children's product safety rulesusing a testing laboratory accredited to ISO/IEC 17025:2005(E). The testinglaboratory used to ensure continued compliance during the 3-year period is notrequired to be a CPSC-accepted testing laboratory. However, any ISO/IEC17025:2005(E)-accredited testing laboratory used for ensuring continued



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compliance must be accredited by an accreditation body that is accredited to ISO/IEC 17011:2004(E) (§1107.21(d)(1).

In December 2017, ISO issued new versions of the standards, “ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories” and “ISO/IEC 17011:2017 Conformity assessment - Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies.”

II. Updates to ISO/IEC 17025:2017 and ISO/IEC 17011:2017


ISO/IEC 17025 accredited laboratories have demonstrated that they operate competently and generate valid results, thereby promoting confidence in their testing around the world. The standard facilitates cooperation between laboratories and other bodies by generating wider acceptance of test results among countries. Specifically, the standard enables international acceptance of test reports and certificates without the need for additional testing, which, in turn, facilitates international trade.

ISO/IEC 17025:2017 was developed to address market conditions and technology changes that have occurred since publication of the 2005 version of the standard. ISO published a brochure1 that highlights the reasons for the revised standard and the substantive changes included in the new version. 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 conformityassessment activities), putting the emphasis on the results of a process instead of thedetailed description of its tasks and steps.

The standard has a stronger focus on information technologies. In recognition of the factthat hard-copy manuals, records and reports are slowly being phased out in favor ofelectronic versions, it incorporates the use of computer systems, electronic records andthe production of electronic results and reports.

A new section has been added introducing the concept of risk-based thinking anddescribes the commonalities with ISO 9001:2015, Quality management systems –Requirements.”

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



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The main sections in ISO/IEC 17025:2017 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 that 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 ILAC and ISO issued a “Joint ILAC-ISO Communiqué on the recognition of ISO/IEC 17025 during a Three-Year Transition.2” The communiqué 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 17025:2005(E) 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.

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



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In June 2020, because of the ongoing worldwide pandemic, ILAC and ISO issued a revision to the communiqué 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 at 30 November 2020) that 100 percent of their laboratories accredited to ISO/IEC 17025(E) have transitioned to the 2017 version, and an additional 73 accreditation bodies confirming more than 75 percent 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. Like 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 The transition from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017 was completed in December 2020. All ILAC-MRA signatory accreditation bodies are now conducting assessment activities according to ISO/IEC 17011:2017.

III. Amendments to CPSC Regulations

Staff recommends updating the reference from ISO/IEC 17025:2005(E) to ISO/IEC 17025:2017 in 16 CFR parts 1107 and 1112 in the sections below:

§1107.21(d)(1)

§1107.21(g)(1)(ii)

§1107.26(a)(2)(iii)

§1112.3(1)

§1112.13(a)(2)(i)

§1112.13(i)



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§1112.43(a)(3)

Staff recommends updating the reference from ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017 in 16 CFR part 1107 in the sections below:

§1107.21(d)(1)

§1107.21(g)(1)(i) The CPSC would provide notice of these amendments to the public through publication of the final rule in the Federal Register and through direct email to all CPSC-accepted laboratories and their accreditation bodies. IV. Summary of Regulatory Flexibility Analysis

The Directorate for Economic Analysis conducted a Regulatory Flexibility Analysis [Tab A]. The impact of the draft 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 laboratory only if it expected to make sufficient revenue from third party testing under the CPSA to justify the expense. Updating 16 CFR part 1112 to refer to the current version of ISO/IEC 17025 is necessary to ensure that conformity assessment bodies can continue to be accredited to conduct third party testing in accordance with section 14 of the CPSA. Once the transition period is over, conformity assessment bodies will no longer be able to obtain accreditation to ISO/IEC Standard 17025:2005(E), which is the version currently required by 16 CFR part 1112. Additionally, updating 16 C.F.R. § 1107.21 to reference the current version of ISO/IEC 17011 is necessary for any manufacturer who wished to take advantage of the opportunity to reduce the frequency of periodic tests by testing for conformity in an accredited laboratory that has not sought CPSC acceptance. Therefore, updating the reference to this standard would not impose any additional burden; failure to update the reference could have an adverse impact on some manufacturers who wish to use the three-year period. For these reasons, the Commission could certify that the draft direct final rule will not have a significant impact on a substantial number of small entities.

V. Staff Recommendation Staff recommends that the Commission publish the draft direct final rule amending the applicable sections of 16 CFR parts 1107 and 1112 to update the references to ISO/IEC 17025:2005(E) with ISO/IEC 17025:2017 and to update references to ISO/IEC 17011:2004(E) to ISO/IEC 17011:2017. The Office of the General Counsel is providing a draft Federal Register notice for the direct final rule.



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The staff recommends an effective date for the rule 90 days after publication in the Federal Register. All testing laboratories that are already CPSC-accepted and testing laboratories that are seeking CPSC-acceptance will have completed their accreditation renewal to ISO/IEC 17025:2017 before the rule’s effective date.



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TAB A - Regulatory Flexibility Analysis of Amendments to the Requirements Pertaining to Conformity Assessment Bodies and Certification (16 CFR Part 1112 and 16 CFR Part 1107) to Reference the Most Recent ISO/IEC Standards




Memorandum

CPSC Hotline: 1-800-638-CPSC (2772) CPSC's Web Site: http://www.cpsc.gov

Date: March 31, 2021

TO : Scott Heh Program Manager, Third Party Laboratory Accreditation Directorate for Laboratory Sciences

THROUGH : Gregory B. Rodgers, Ph.D. Associate Executive Director Directorate for Economic Analysis

FROM : Robert Franklin Economist Directorate for Economic Analysis

SUBJECT : Regulatory Flexibility Analysis of Amendments to the Requirements Pertaining to Conformity Assessment Bodies and Certification (16 CFR part 1112 and 16 CFR part 1107) to Reference the Most Recent ISO/IEC Standards

Introduction The Regulatory Flexibility Act requires agencies to consider the impact of rulemaking on small entities. The Consumer Product Safety Commission (CPSC or Commission) is considering a draft direct final rule that would amend the requirements pertaining to third party testing and conformity assessment bodies to update the references for two ISO/IEC standards. This memorandum discusses the potential impact of the draft direct final rule on small entities. The memorandum concludes that the draft direct final rule would not have a significant impact on a substantial number of small entities. The Standards Manufacturers of children’s products that are subject to a children’s product safety standard must certify that their product complies with all children’s product safety rules based on testing by a third party conformity assessment body. The regulations that pertain to third party conformity assessment bodies are at 16 CFR part 1112. Among other things, 16 CFR part 1112



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requires third party conformity assessment bodies to be accredited to ISO/IEC 17025:2005(E) “General Requirements for the Competence of Testing and Calibration Laboratories” as a baseline requirement. Additionally, to provide manufacturers an additional option for reducing the cost of the periodic third party testing required in 16 CFR part 1107, manufacturers may reduce their periodic third party testing by a CPSC-accepted laboratory to once every 3 years, if during the 3-year interval they are testing their products for conformity in a laboratory that is accredited to ISO/IEC 17025:2005(E) and that accreditation was provided by an accreditation body that is accredited to ISO/IEC 17011:2004(E) “Conformity assessment - Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies.” The Need for and Objectives of the Rule In 2017, ISO/IEC issued new versions of both of these standards. The new versions are ISO/IEC 17025:2017 and ISO/IEC 17011:2017. Initially, there was to be a transition period during which both the old versions of the standards and new or current versions would be accepted. This transition period was extended to June of 2021 for the ISO/IEC 17025 standard due to the COVID-19 pandemic. The draft direct final rule would update 16 CFR parts 1107 and 1112 to reference the current versions of the standards. Description and Estimate of the Small Entities to which the Draft Direct Final Rule Would Apply The draft direct final rule would apply to laboratories that intend to test children’s products for conformance to children’s product safety rules under Section 14 of the CPSA. The draft direct final rule would not impose any requirements on laboratories that do not intend to provide this service. Although there are 5,273 firms in the United States classified as “testing laboratories” (NAICS code 54138),3 only a small subset of these laboratories is expected to provide third party conformity assessments of children’s products for purposes of section 14 of the CPSA. CPSC currently accepts the accreditation of 79 laboratories located in the United States.4

According to criteria established by the U.S. Small Business Administration (SBA), a testing laboratory is considered small if its revenue is less than $16.5 million a year. Of the 79 laboratories located in the United States with CPSC-accepted accreditations, about one-half could be small businesses according to the SBA criteria. This is less than one percent of all testing laboratories in the United States. 3 United States Census Bureau, Summary Statistics for the U.S., States, and Selected Geographies: 2017. 4 As of January 28, 2021, the CPSC has recognized the accreditation of about 585 testing laboratories worldwide. However, most of the laboratories are located in other countries. Only domestic firms are considered for the purposes of the RFA.



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Impact of the Draft Direct Final Rule on Small Entities Currently, 16 CFR part 1112 requires that laboratories seeking CPSC acceptance of their accreditation must be accredited to ISO/IEC Standard 17025:2005(E), “General requirements for the competence of testing and calibration laboratories.” On August 8, 2018 the CPSC issued guidance to all CPSC-accepted laboratories and their accreditation bodies that CPSC will accept accreditation to either ISO/IEC 17025:2005(E) or ISO/IEC 17025:2017 during the transition period. The draft direct final rule would require that laboratories be accredited to ISO/IEC 17025:2017. The draft direct final rule would make no other change to the CPSC regulation that impact small entities. The changes that have been made to the ISO/IEC Standard 17025 in the 12 years since the 2005 version was published are generally intended to better align the standard with other conformity assessment standards, including an emphasis “on the results of a process instead of a detailed description of the tasks and steps.” The changes also include more emphasis on information technologies, recognizing that hard copies of manuals, reports, and other records are being replaced by electronic versions. Additionally, the scope “has been revised to cover all laboratory activities, including testing, calibration, and a new section on the concept of risk-based thinking.” The requirements of the draft direct final rule would apply only to those laboratories that intend to provide the third party testing services for purposes of certifying children’s products under section 14 of the CPSA and 16 CFR part 1107. This includes laboratories that seek CPSC acceptance of their accreditation and laboratories that do not seek CPSC acceptance of their accreditation but conduct periodic testing for firms under 16 CFR §1107.21(d)(1). The only laboratories that are expected to provide such services are those that anticipate receiving sufficient revenue from providing the testing services to justify accepting the requirements as a business decision. Laboratories that do not expect to receive sufficient revenue from these services to justify accepting these requirements would not be expected to pursue accreditation solely for this purpose. Laboratory accreditation predates the third party testing requirements in the CPSA by several decades. Accreditation is pursued by many testing laboratories for reasons other than CPSC testing requirements. Among other things, accreditation provides laboratories with a credential that provides evidence of their competence and conformance with internationally accepted assessment practices. Worldwide there are more than 60,000 accredited testing laboratories or conformity assessment bodies.5 Many of the laboratories which have sought CPSC recognition of their accreditation would be expected to maintain their accreditation even in the absence of any CPSC regulations. The draft direct final rule will have no impact on these laboratories. For the laboratories that have become accredited solely to conduct testing under section 14 of the CPSA, the impact of the draft direct final rule should be minimal. It is possible that

5 ILAC.org (http://ilac.org/about-ilac/facts-and-figures/) accessed on January 28, 2021.



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some may have to make some changes to their procedures or documentation to conform to the requirements of ISO/IEC Standard 17025:2017 where they differ from those in ISO/IEC Standard 17025:2005(E). However, because the purpose of the changes to the standard is to better align the standard with other conformity assessment standards and update the requirements with regards to information technology, the changes are not be expected to be large. Moreover, as noted above, these laboratories will only undertake these actions if they expect to receive sufficient revenue from third party testing under section 14 of the CPSA to justify doing so. With regards to updating 16 CFR § 1107.21 to refer to ISO/IEC 17011:2017, the draft direct final rule would effectively maintain the status quo. As noted, currently some firms might be able to reduce the frequency of their required third party periodic testing costs in CPSC accepted laboratories to once every three years, if during the 3-year period they are conducting conformance testing in other laboratories that have been accredited to ISO/IEC 17025:2005 by an accreditation body accredited to ISO/IEC 17011:2004, but that has not sought CPSC acceptance of its accreditation. However, as of June 2021, laboratories will not be able to obtain accreditation to these earlier versions of the standard. This means that if the references to the standards in 16 CFR § 1107.21 are not updated to reference the current versions of the standards, this option for manufacturers to reduce their third party periodic testing costs will not be available because laboratories will be unable to obtain accreditation to the old versions of the standards. Summary and Conclusion Updating 16 CFR part 1112 to refer to the current version of ISO/IEC 17025 is necessary to ensure that conformity assessment bodies can continue to be accredited to conduct third party testing in accordance with section 14 of the CPSA. Once the transition period is over, conformity assessment bodies will no longer be able to obtain accreditation to ISO/IEC Standard 17025:2005(E), which is the version currently required by 16 CFR part 1112. Approximately half of the 79 domestic conformity assessment bodies for which CPSC has accepted their accreditation are small businesses. This is less than one percent of the more than 5,200 testing laboratories in the United States. Some number of these laboratories would be expected to maintain their accreditation even in the absence of any CPSC regulations requiring third party testing. The draft direct final rule would have no impact on these firms. The impact of the draft 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 laboratory only if it expected sufficient revenue from third party testing under the CPSA to justify the expense. Additionally, updating 16 CFR § 1107.21 to refer to the current versions of ISO/IEC Standard 17011 and ISO/IEC Standard 17025 is necessary for any manufacturer to take advantage of the opportunity to reduce the frequency of periodic tests to three years by testing for conformity in an accredited laboratory that has not sought CPSC acceptance. Therefore, updating the reference to this standard would not impose any additional burden. However, failure to update the references to the new standards could have an adverse impact on some manufacturers. For these reasons, the Commission could certify that the draft direct final rule will not have a significant impact on a substantial number of small entities.



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