[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Rules and Regulations]
[Pages 78814-78815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32256]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 285

[Docket No 110125063-1687-02]
RIN 0693-AB61


National Voluntary Laboratory Accreditation Program; Operating 
Procedures

AGENCY: National Institute of Standards and Technology (NIST), 
Commerce.

ACTION: Final rule.

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SUMMARY: The Director of the National Institute of Standards and 
Technology (NIST), United States Department of Commerce, is issuing a 
final rule amending the regulations pertaining to the National 
Voluntary Laboratory Accreditation Program (NVLAP). Regulations 
concerning the establishment of laboratory accreditation programs 
(LAPs) within NVLAP are being amended to clarify the original intent of 
this section and to improve the readability and understanding of the 
agency's regulations.

DATES: This rule is effective on December 20, 2011.

ADDRESSES: David F. Alderman, Acting Chief, National Voluntary 
Laboratory Accreditation Program, National Institute of Standards and 
Technology, 100 Bureau Drive, Stop 2140, Gaithersburg, MD 20899-2140.

FOR FURTHER INFORMATION CONTACT: David F. Alderman, Acting Chief, 
National Voluntary Laboratory Accreditation Program, National Institute 
of Standards and Technology, 100 Bureau Drive, Stop 2140, Gaithersburg, 
MD 20899-2140; telephone number: (301) 975-4019; email address: 
[email protected]; NVLAP Web site: www.nist.gov/nvlap.

SUPPLEMENTARY INFORMATION:

Background

    Title 15 Part 285 of the Code of Federal Regulations sets 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. NVLAP 
establishes laboratory accreditation programs (LAPs) in response to 
legislation or requests from government agencies and private sector 
entities.
    The NVLAP procedures were first published in the Federal Register 
on February 25, 1976, and have been revised several times. In 2001, 
major revisions to the procedures were published to ensure their 
consistency with certain international standards and guidance 
documents, and to reorganize and simplify Part 285 for ease of use and 
understanding. While the existing regulations were accurate, the 
language was complex and difficult to understand; therefore, the 
procedures were rewritten in plain English and their subparts 
consolidated in order to make the regulations more user friendly.

Description and Explanation of Change

    The purpose of this rule is to amend section 285.4, Establishment 
of laboratory accreditation programs (LAPs) within NVLAP, so that it 
conforms to the intent of the 2001 revisions to Part 285 of Title 15 of 
the CFR and makes the regulations easier to understand. NIST is 
amending the last sentence in section 285.4 as follows: change the 
third instance of the word ``and'' to ``or,'' and add the words ``to 
ensure open participation'' after the phrase ``other means.''
    As a signatory to the International Laboratory Accreditation 
Cooperation (ILAC) Mutual Recognition Arrangement (MRA), NVLAP complies 
with the requirements of ISO/IEC 17011, Conformity assessment--General 
requirements for accreditation bodies accrediting conformity assessment 
bodies. The change will allow NVLAP more flexibility in determining how 
to best fulfill the requirements for impartiality found in ISO/IEC 
17011, 4.3.2, by assuring a balanced representation of interested 
parties when evaluating the need for a requested LAP.
    The original intent of the last sentence of section 285.4 was to 
allow NVLAP the flexibility to employ the most appropriate means to 
ensure open participation of stakeholders; however, the use of the word 
``and'' may be misinterpreted to mean that a public workshop is 
required for each and every LAP request. There are numerous means by 
which consultation with interested parties may be accomplished 
exclusive of a workshop, which include, but are not limited to meeting 
with government and individual industry stakeholders on a frequent 
basis, attending consortia and conferences at which regulators, 
specifiers, and requesters are in attendance, and soliciting public 
comments via public notices, electronic communications, and news 
articles. Further, the use of the word ``or'' does not preclude the use 
of both workshops and other means to collect the necessary information.

Summary of Comments

    On March 29, 2011, the National Institute of Standards and 
Technology published a notice of proposed rulemaking and request for 
comments in the Federal Register (76 FR 17367) pertaining to the 
proposed amendment to section 285.4 of Part 285 of Title 15 of the CFR. 
The comment period closed on April 28, 2011. No comments were received 
and there is no other reason to believe that any alteration to the 
proposed rule is necessary; therefore,

[[Page 78815]]

NIST will implement the rulemaking as proposed.

Classification

Executive Order 12866

    This rule is not a significant rule for the purposes of Executive 
Order 12866.

Executive Order 12612

    This rule does not contain policies with Federalism implications 
sufficient to warrant preparation of a Federalism assessment under 
Executive Order 12612.

Regulatory Flexibility Act

    The Chief Counsel for Regulation, Department of Commerce, certified 
to the Chief Counsel for Advocacy, Small Business Administration, at 
the proposed rule stage, under the provisions of the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), that this rule will not have a 
significant economic impact on a substantial number of small entities 
for the following reasons: (1) The regulation is procedural and has no 
impact on any entity unless that entity chooses to participate, in 
which case, the cost to the participant is the same cost for any size 
participant; (2) access to NVLAP's accreditation system is not 
conditional upon the size of a laboratory or membership of any 
association or group, nor are there undue financial conditions to 
restrict participation; and (3) the technical criteria, against which 
individual laboratories are assessed, are not changed by this rule. No 
comments were received on this certification; therefore no regulatory 
flexibility analysis is required and none was prepared.

Paperwork Reduction Act

    This rule does not involve a new collection of information subject 
to the Paperwork Reduction Act (PRA). The collection of information for 
NVLAP has been approved by the Office of Management and Budget (OMB) 
under control number 0693-0003. Notwithstanding any other provision of 
the law, no person is required to comply, nor shall any person be 
subject to penalty for failure to comply with, a collection of 
information, subject to the requirements of the Paperwork Reduction 
Act, unless that collection of information displays a currently valid 
OMB Control Number.

National Environmental Policy Act

    This 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, Laboratories, Measurement standards, Testing.

    For the reasons set forth in the preamble, title 15 of the Code of 
Federal Regulations is amended 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. Section 285.4 is amended by revising the last sentence to read as 
follows:


Sec.  285.4  Establishment of laboratory accreditation programs (LAPs) 
within NVLAP.

    * * * For requests from private sector entities and government 
agencies, the Chief of NVLAP shall analyze each request, and, after 
consultation with interested parties through public workshops or other 
means to ensure open participation, shall establish the requested LAP, 
if the Chief of NVLAP determines there is need for the requested LAP.

    Dated: December 8, 2011.
Willie E. May,
Associate Director for Laboratory Programs.
[FR Doc. 2011-32256 Filed 12-19-11; 8:45 am]
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