[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]]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 3510-13-P