[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Rules and Regulations]
[Pages 60059-60061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18294]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 285

[Docket No.: 200128-0034]
RIN 0693-AB67


National Voluntary Laboratory Accreditation Program--Amendment to 
the Procedures and Requirements To Accredit Testing and Calibration 
Laboratories

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Final rule.

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SUMMARY: The Director of the National Institute of Standards and 
Technology (NIST) is issuing a final rule amending the regulations 
pertaining to the operation of the National Voluntary Laboratory 
Accreditation Program (NVLAP) and the operation of its accreditation 
programs. The regulations are being revised to include recognition of 
proficiency testing as an accreditation activity, add or revise terms, 
and update NVLAP mailing information, in accordance with the applicable 
international standard. These changes will not impact the public 
directly, and will only result in minor changes to NIST's internal 
practices.

DATES: This rule is effective on September 24, 2020. The incorporation 
by reference of certain publications listed in the rule is approved by 
the Director of the Federal Register as of September 24, 2020.

ADDRESSES: Dana S. Leaman, Chief, National Voluntary Laboratory 
Accreditation Program, 100 Bureau Drive, Stop 2140, Gaithersburg, MD 
20899-2140 or by sending email to [email protected].

FOR FURTHER INFORMATION CONTACT: Dana S. Leaman, Chief, NIST/NVLAP, 100 
Bureau Drive, Stop 2140, Gaithersburg, MD 20899-2140, Phone: (301) 975-
4016 or email: [email protected]. Information regarding NVLAP and 
the accreditation process can be obtained from http://www.nist.gov/nvlap.

SUPPLEMENTARY INFORMATION:

I. Background

    Title 15, part 285 of the Code of Federal Regulations sets out 
procedures and general requirements under which NVLAP operates as an 
unbiased third party to accredit both testing and calibration 
laboratories. The NVLAP procedures were first published in the Federal 
Register on February 25, 1976, and have been revised several times.
    NVLAP currently operates in accordance with ISO/IEC 17011:2004, 
Conformity assessment--Requirements for accreditation bodies 
accrediting conformity assessment bodies. The Laboratory Accreditation 
Programs operated by NVLAP are established based on the criteria in 
ISO/IEC 17025, General requirements for the competence of testing and 
calibration laboratories. Revisions to ISO/IEC 17011 and ISO/IEC 17025 
were published in November 2017 with a three-year implementation 
period. These revisions include recognition of proficiency testing as 
an accreditation activity, addition and/or revision of terms, and 
update of the NVLAP mailing information. The purpose of this amendment 
is to incorporate these revised requirements into the regulations.

II. Incorporation by Reference

    NIST Handbook 150 presents the basic procedures under which NVLAP 
operates, and considers the requirements contained in ISO/IEC 17025, 
General requirements for the competence of testing and calibration 
laboratories. ISO/IEC 17025 and NIST Handbook 150 contain the general 
requirements that testing and calibration

[[Page 60060]]

laboratories must meet if they wish to demonstrate that they operate an 
appropriate management system, are technically competent, and are able 
to generate technically valid results.
    The provisions of NIST Handbook 150 are being incorporated by 
reference into 15 CFR 285.8 and 285.14, as this will substantially 
reduce the volume of material published in the Federal Register and the 
CFR. NIST Handbook 150 is available at no-cost at https://nvlpubs.nist.gov/nistpubs/hb/2020/NIST.HB.150-2020.pdf.

III. Regulatory Analysis

    Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior 
notice and an opportunity for public comment on this action, as notice 
and comment are unnecessary. This final rule makes minor, technical 
amendments in order to conform the regulations to changes that were 
made to the applicable international standard. These changes will not 
impact the public directly, and will only result in minor changes to 
NIST's internal practices. None of these changes will have a 
substantive impact beyond those already considered in previous 
supporting documents. For the same reasons, there is good cause under 5 
U.S.C. 553(d)(3) to waive the 30-day delay in effective date.

Executive Order 12866

    This final rule was determined to be not significant for purposes 
of Executive Order 12866.

Executive Order 13132

    This final rule does not contain policies with Federalism 
implications as defined in Executive Order 13132.

Regulatory Flexibility Act

    Because prior notice and opportunity for public comment are not 
required for this rule by 5 U.S.C. 553, or any other law, the 
analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 
et seq., do not apply.

Paperwork Reduction Act

    This final rule contains no new collection of information subject 
to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

National Environmental Policy Act

    This final rule will not significantly affect the quality of the 
human environment. Therefore, an environmental assessment or 
Environmental Impact Statement is not required to be prepared under the 
National Environmental Policy Act of 1969.

List of Subjects in 15 CFR Part 285

    Accreditation, Business and industry, Calibration, Commerce, 
Conformity assessment, Incorporation by reference, Laboratories, 
Measurement standards, Testing.

    For the reasons stated in the preamble, NIST amends 15 CFR part 285 
as follows:

PART 285--NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM

0
1. The authority citation for 15 CFR part 285 continues to read as 
follows:

    Authority: 15 U.S.C. 272 et seq.


0
2. Revise Sec.  285.1 to read as follows:


Sec.  285.1  Purpose.

    The purpose of this part is to set out procedures and general 
requirements under which the National Voluntary Laboratory 
Accreditation Program (NVLAP) operates as an unbiased third party to 
accredit both testing and calibration laboratories. Supplementary 
technical and administrative requirements are provided in supporting 
handbooks and documents as needed, depending on the criteria 
established for specific Laboratory Accreditation Programs (LAPs).

0
3. Revise Sec.  285.6 to read as follows:


Sec.  285.6  Application for accreditation.

    A laboratory may apply for accreditation in any of the established 
LAPs. The applicant laboratory shall provide a completed application to 
NVLAP, pay all required fees and agree to certain conditions as set 
forth in the NVLAP Application for Accreditation, and provide 
management system documentation to NVLAP (or a designated NVLAP 
assessor) prior to the assessment process.


Sec.  285.7  [Amended]

0
4. In Sec.  285.7, remove the word ``deficiencies'' wherever it occurs 
and add in its place the word ``nonconformities.''

0
5. Revise Sec.  285.8 to read as follows:


Sec.  285.8  Proficiency testing.

    (a) Proficiency testing requirements. Proficiency testing 
undertaken to meet the criteria for NVLAP accreditation shall be 
consistent with the provisions contained in NIST Handbook 150, NVLAP 
Procedures and General Requirements (incorporated by reference, see 
Sec.  285.16), where applicable, including revisions from time to time. 
Laboratories must participate in proficiency testing as specified for 
each LAP in the NVLAP program handbooks.
    (b) Analysis and reporting. Proficiency testing results are 
analyzed by NVLAP and results of the analysis are made known to the 
participants. Any result not meeting the criteria specified in the 
NVLAP LAP program handbook is identified as a nonconformity.
    (c) Proficiency testing nonconformities. (1) Unsatisfactory 
participation in any proficiency testing program is a technical 
nonconformity which must be resolved in order to obtain initial 
accreditation or maintain accreditation.
    (2) Proficiency testing nonconformities are defined as, but not 
limited to, one or more of the following:
    (i) Failure to meet specified proficiency testing performance 
requirements prescribed by NVLAP;
    (ii) Failure to participate in a regularly scheduled ``round'' of 
proficiency testing for which the laboratory has received instructions 
and/or materials;
    (iii) Failure to submit laboratory control data as required; or
    (iv) Failure to produce acceptable test or calibration results when 
using NIST Standard Reference Materials or special artifacts whose 
properties are well-characterized and known to NIST/NVLAP.
    (3) NVLAP will notify the laboratory of proficiency testing 
nonconformities and actions to be taken to resolve the nonconformities. 
Denial or suspension of accreditation will result from failure to 
resolve nonconformities.

0
6. Revise Sec.  285.10(b) to read as follows:


Sec.  285.10  Renewal of accreditation.

* * * * *
    (b) On-site assessments of currently accredited laboratories are 
performed in accordance with the procedures in Sec.  285.7. If 
nonconformities are found during the assessment of an accredited 
laboratory, the laboratory must follow the procedures set forth in 
Sec.  285.7(e)(2) or face possible suspension or revocation of 
accreditation.

0
7. Revise Sec.  285.12 to read as follows:


Sec.  285.12  Monitoring visits.

    (a) In addition to regularly scheduled assessments, monitoring 
visits may be conducted by NVLAP at any time during the accreditation 
period. They may occur for cause or on a random selection basis. While 
most monitoring visits will be scheduled in advance with the 
laboratory, NVLAP may conduct unannounced monitoring visits.
    (b) The scope of a monitoring visit may range from checking a few

[[Page 60061]]

designated items to a complete review. The assessors may review 
nonconformity resolutions, verify reported changes in the laboratory's 
personnel, facilities or operations, or evaluate proficiency testing 
activities, when appropriate.

0
8. Revise Sec.  285.14 to read as follows:


Sec.  285.14  Criteria for accreditation.

    The requirements for laboratories to be recognized by the National 
Voluntary Laboratory Accreditation Program as competent to carry out 
tests and/or calibrations are contained in NIST Handbook 150, NVLAP 
Procedures and General Requirements (incorporated by reference, see 
Sec.  285.16).

0
9. Revise Sec.  285.15(b) to read as follows:


Sec.  285.15  Obtaining documents.

* * * * *
    (b) Copies of all ISO/IEC documents are available for purchase from 
the American National Standards Institute's eStandards Store at http://webstore.ansi.org. You may inspect copies of all applicable ISO/IEC 
documents at the National Voluntary Laboratory Accreditation Program, 
National Institute of Standards and Technology, 100 Bureau Drive, Room 
B119, Gaithersburg, MD. For access to the NIST campus, please contact 
NVLAP by phone at 301-975-4016 or by email at [email protected] to obtain 
instructions for visitor registration.

0
10. Add Sec.  285.16 to read as follows:


Sec.  285.16  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. All approved material is available for 
inspection at National Institute of Standards and Technology, National 
Voluntary Laboratory Accreditation Program (NVLAP), National Institute 
of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, 
MD and is available from the source(s) listed in the following 
paragraph(s). It is also available for inspection at the National 
Archives and Records Administration (NARA). For access to the NIST 
campus, please contact NVLAP by phone at 301-975-4016 or by email at 
[email protected] to obtain instructions for visitor registration. 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.
    (a) National Institute of Standards and Technology (NIST), U.S. 
Department of Commerce, 100 Bureau Drive, Room B119, Gaithersburg, MD, 
301-975-4016 [email protected], www.nist.gov/publications/.
    (1) NIST Handbook 150, National Voluntary Laboratory Accreditation 
Program Procedures (NVLAP) and General Requirements, authored by Dana 
S. Leaman and Bethany Hackett, 2020 Edition, August 2020, 2020 (NVLAP 
Procedures and General Requirements) https://nvlpubs.nist.gov/nistpubs/hb/2020/NIST.HB.150-2020.pdf; into Sec. Sec.  285.8(a) and Sec.  
285.14.
    (2) [Reserved]
    (b) [Reserved]

Kevin A. Kimball,
Chief of Staff.
[FR Doc. 2020-18294 Filed 9-23-20; 8:45 am]
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