[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Proposed Rules]
[Pages 17367-17368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7336]
[[Page 17367]]
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DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
15 CFR Part 285
[Docket No: 110125063-1062-02]
RIN 0693-AB61
National Voluntary Laboratory Accreditation Program; Operating
Procedures
AGENCY: National Institute of Standards and Technology (NIST),
Commerce.
ACTION: Notice of proposed rulemaking: Request for comments.
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SUMMARY: The Director of the National Institute of Standards and
Technology (NIST), United States Department of Commerce, requests
comments on a proposed amendment to regulations pertaining to the
operation of the National Voluntary Laboratory Accreditation Program
(NVLAP). NIST proposes to revise the description of how NVLAP
establishes laboratory accreditation programs (LAPs). The amendment is
needed to clarify the original intent of this section and to improve
the readability and understanding of the agency's regulations.
DATES: Submit comments on or before April 28, 2011.
ADDRESSES: Interested parties may submit comments, identified by RIN
0693-AB61, by any one of the following methods:
Federal eRulemaking Portal at http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected].
Mail: Sally S. Bruce, Chief, National Voluntary Laboratory
Accreditation Program, National Institute of Standards and Technology,
100 Bureau Drive, Stop 2140, Gaithersburg, MD 20899-2140.
Fax: (301) 926-2884, Attention: Sally S. Bruce.
Instructions: All comments received must include the agency name
and Regulatory Information Number (RIN 0693-AB61) for this proposed
rulemaking. Comments will be posted without change to http://www.regulations.gov, including any personal information provided. All
Personal Identifying Information (for example, name, address, etc.)
voluntarily submitted by the commenter may be publicly accessible. Do
not submit Confidential Business Information or otherwise sensitive or
protected information. NIST will accept anonymous comments (please
enter N/A in the required fields if you wish to remain anonymous).
FOR FURTHER INFORMATION CONTACT: Sally S. Bruce, Chief, National
Voluntary Laboratory Accreditation Program, National Institute of
Standards and Technology, 100 Bureau Drive, Stop 2140, Gaithersburg, MD
20899-2140; telephone number: (301) 975-4016; e-mail address:
[email protected]; NVLAP Web site: http://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 Proposed 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 proposes
to amend 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 proposed 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.
Request for Comments
The Director of the National Institute of Standards and Technology,
United States Department of Commerce, requests comments on the proposed
amendments to regulations found at 15 CFR part 285 pertaining to the
National Voluntary Laboratory Accreditation Program.
Interested parties may submit comments by any one of several
methods (see ADDRESSES). All comments received in response to this
notice will become part of the public record and will be posted without
change to http://www.regulations.gov.
Classification
Executive Order 12866
This proposed rule is not a significant rule for the purposes of
Executive Order 12866.
Executive Order 12612
This proposed 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, has
certified to the Chief Counsel for Advocacy, Small Business
Administration, under the provisions of the Regulatory Flexibility Act
(5 U.S.C. 605(b)), that
[[Page 17368]]
this proposed 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 proposal.
Paperwork Reduction Act
This proposed 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 proposed 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, it is proposed that
title 15 of the Code of Federal Regulations be amended 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. 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: March 21, 2011.
Charles H. Romine,
Acting Associate Director for Laboratory Programs.
[FR Doc. 2011-7336 Filed 3-28-11; 8:45 am]
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