National Voluntary Laboratory Accreditation Program-Amendment to the Procedures and Requirements To Accredit Testing and Calibration Laboratories, 60059-60061 [2020-18294]
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Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Rules and Regulations
program office within ten days of
receipt of the notice to request
consideration for a prompt settlement of
the legal enforcement action. The FAA
will send the notification in conjunction
with the LOI.
Following an individual’s request to
be considered for application of this
policy, the FAA will determine the
individual’s eligibility for the policy.
The policy is not available when there
is a question about an individual’s
qualification to hold a part 61, 63, or 65
certificate other than that presented by
the 14 CFR 67.403(a)(1) through (4)
violation. It is also not available for
individuals who the FAA has found to
have previously violated 14 CFR
67.403(a)(1) through (4).
If the FAA deems application of the
prompt settlement policy is appropriate,
AGC–300 enforcement counsel will
provide the individual, or his or her
legal representative, a formal agreement
that sets forth the conditions for prompt
settlement. The terms of this settlement
agreement will normally include the
following provisions.
(1) The settlement agreement must be
executed by the parties within ten days
after the FAA sends the agreement to
the individual.
(2) The FAA will issue an emergency
order revoking all airman, ground
instructor, and unexpired medical
certificates the individual holds
immediately upon receiving the fully
executed settlement agreement.
(3) The order of revocation will (i)
require the immediate surrender of all
airman, ground instructor, and
unexpired medical certificates the
individual holds to enforcement
counsel; (ii) notify the individual that
the failure to immediately surrender
these certificates could subject the
individual to further legal enforcement
action, including a civil penalty; and
(iii) inform the individual that the FAA
will not accept an application for any
new airman or ground instructor
certificate for a period of one year from
the date of the issuance of the order of
revocation.
(4) The individual will waive all
appeal rights from the order of
revocation.
(5) The individual acknowledges that
this agreement only concerns this
enforcement action brought by the FAA
and does not affect any actions that
might be brought by State or other
Federal agencies (whether civil or
criminal), and that this agreement does
not prevent the FAA from providing
information about this matter to State or
other Federal agencies.
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(6) The parties will agree to bear their
own costs and attorney fees, if any, in
connection with the matter.
(7) The individual will agree to not
initiate any litigation before any court,
tribunal, or administrative entity
concerning any costs, damages, or
attorney fees, including applications
under the Equal Access to Justice Act,
incurred as a result of the abovereferenced matter.
(8) The individual will agree to waive
any and all causes of action against the
FAA and its current and/or former
officials and employees relating to the
above-referenced matter.
This policy is expected to allow
eligible individuals to more quickly
apply for new certificates under 14 CFR
parts 61, 63, and 65 following violations
of 14 CFR 67.403(a)(1)–(4). It will also
reduce uncertainty about the date of
issuance of orders of revocation related
to such violations, eliminate the
unpredictability of litigation, and
promote better resource allocation.
Issued in Washington, DC, on September
21, 2020.
Naomi Tsuda,
Assistant Chief Counsel for Enforcement.
[FR Doc. 2020–21111 Filed 9–23–20; 8:45 am]
BILLING CODE 4910–13–P
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
National Institute of Standards
and Technology, Commerce.
ACTION: Final rule.
AGENCY:
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
SUMMARY:
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60059
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
nvlap@nist.gov.
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: dana.leaman@
nist.gov. Information regarding NVLAP
and the accreditation process can be
obtained from https://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
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Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Rules and Regulations
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.
List of Subjects in 15 CFR Part 285
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.
VerDate Sep<11>2014
16:01 Sep 23, 2020
Jkt 250001
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
1. The authority citation for 15 CFR
part 285 continues to read as follows:
Authority: 15 U.S.C. 272 et seq.
■
2. Revise § 285.1 to read as follows:
§ 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).
■ 3. Revise § 285.6 to read as follows:
§ 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.
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 wellcharacterized 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.
■ 6. Revise § 285.10(b) to read as
follows:
§ 285.10
Renewal of accreditation.
4. In § 285.7, remove the word
‘‘deficiencies’’ wherever it occurs and
add in its place the word
‘‘nonconformities.’’
■ 5. Revise § 285.8 to read as follows:
*
*
*
*
(b) On-site assessments of currently
accredited laboratories are performed in
accordance with the procedures in
§ 285.7. If nonconformities are found
during the assessment of an accredited
laboratory, the laboratory must follow
the procedures set forth in § 285.7(e)(2)
or face possible suspension or
revocation of accreditation.
■ 7. Revise § 285.12 to read as follows:
§ 285.8
§ 285.12
§ 285.7
[Amended]
■
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 § 285.16), where
applicable, including revisions from
time to time. Laboratories must
participate in proficiency testing as
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*
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
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Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Rules and Regulations
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.
■ 8. Revise § 285.14 to read as follows:
§ 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 § 285.16).
■ 9. Revise § 285.15(b) to read as
follows:
§ 285.15
Kevin A. Kimball,
Chief of Staff.
[FR Doc. 2020–18294 Filed 9–23–20; 8:45 am]
BILLING CODE 3510–13–P
Obtaining documents.
*
*
*
*
*
(b) Copies of all ISO/IEC documents
are available for purchase from the
American National Standards Institute’s
eStandards Store at https://
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 NVLAP@nist.gov to obtain
instructions for visitor registration.
■ 10. Add § 285.16 to read as follows:
§ 285.16
B119, Gaithersburg, MD, 301–975–4016
NVLAP@nist.gov, 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.1502020.pdf; into §§ 285.8(a) and § 285.14.
(2) [Reserved]
(b) [Reserved]
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 NVLAP@
nist.gov to obtain instructions for visitor
registration. 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.
(a) National Institute of Standards and
Technology (NIST), U.S. Department of
Commerce, 100 Bureau Drive, Room
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16:01 Sep 23, 2020
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DEPARTMENT OF COMMERCE
15 CFR Chapter VII
[Docket Number 200917–0247]
RIN 0605–XD009
Identification of Prohibited
Transactions To Implement Executive
Order 13942 and Address the Threat
Posed by TikTok and the National
Emergency With Respect to the
Information and Communications
Technology and Services Supply
Chain
Office of the Secretary, U.S.
Department of Commerce.
ACTION: Identification of prohibited
transactions.
AGENCY:
Pursuant to Executive Order
13942, the Secretary of Commerce is
publishing the list of prohibited
transactions by any person, or with
respect to any property, subject to the
jurisdiction of the United States, with
ByteDance Ltd. (a.k.a. Zı`jie´ Tia`odo`ng),
Beijing, China, or its subsidiaries,
including TikTok Inc., in which any
such company has any interest, to
address the national emergency with
respect to the information and
communications technology and
services supply chain declared in
Executive Order 13873, May 15, 2019
(Securing the Information and
Communications Technology and
Services Supply Chain), and
particularly to address the threat
identified in Executive Order 13942
posed by mobile application TikTok.
DATES: Transactions identified in
paragraph 1 below will be prohibited at
11:59 p.m. eastern standard time on
September 27, 2020; transactions
identified in paragraphs 2, 3, 4, and 5
below will be prohibited at 11:59 p.m.
SUMMARY:
PO 00000
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60061
eastern standard time on November 12,
2020.
FOR FURTHER INFORMATION CONTACT:
Kathy Smith, U.S. Department of
Commerce, 1401 Constitution Avenue
NW, Washington, DC 20230; telephone:
(202) 482–1859.
For media inquiries: Meghan Burris,
Director, Office of Public Affairs, U.S.
Department of Commerce, 1401
Constitution Avenue NW, Washington,
DC 20230; telephone: (202) 482–4883.
SUPPLEMENTARY INFORMATION: In
Executive Order 13873 of May 15, 2019
(Securing the Information and
Communications Technology and
Services Supply Chain), the President
found that foreign adversaries are
increasingly creating and exploiting
vulnerabilities in information and
communications technology and
services (ICTS), which store and
communicate vast amounts of sensitive
information, facilitate the digital
economy, and support critical
infrastructure and vital emergency
services, in order to commit malicious
cyber-enabled actions, including
economic and industrial espionage
against the United States and its people.
The President further found that the
unrestricted acquisition or use in the
United States of ICTS designed,
developed, manufactured, or supplied
by persons owned by, controlled by, or
subject to the jurisdiction or direction of
foreign adversaries augments the ability
of foreign adversaries to create and
exploit vulnerabilities in ICTS, with
potentially catastrophic effects, and
thereby constitutes an unusual and
extraordinary threat to the national
security, foreign policy, and economy of
the United States, and declared a
national emergency with respect to this
threat. The President directed that
additional steps are required to protect
the security, integrity, and reliability of
ICTS provided and used in the United
States.
On August 6, 2020, in Executive
Order 13942 (Addressing the Threat
Posed by TikTok, and Taking
Additional Steps To Address the
National Emergency With Respect to the
Information and Communications
Technology and Services Supply
Chain), the President further found that
the spread in the United States of
mobile applications developed and
owned by companies in the People’s
Republic of China (China) continues to
threaten the national security, foreign
policy, and economy of the United
States. The President directed that
action must be taken to address the
threat posed by the mobile application
TikTok.
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]]>Agencies
[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.
-----------------------------------------------------------------------
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 https://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 https://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]
BILLING CODE 3510-13-P
