[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19357-19360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7602]


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OFFICE OF MANAGEMENT AND BUDGET


Federal Participation in the Development and Use of Voluntary 
Consensus Standards and in Conformity Assessment Activities

ACTION: Request for Information and Notice of public workshop.

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SUMMARY: The Office of Management and Budget (OMB) invites interested 
parties to provide input on current issues regarding Federal agencies' 
standards and conformity assessment related activities. Input is being 
sought to inform OMB's consideration of whether and how to supplement 
Circular A-119 (Federal Participation in the Development and Use of 
Voluntary Consensus Standards and in Conformity Assessment Activities). 
In addition, OMB is announcing a public workshop at the Department of 
Commerce's National Institute of Standards and Technology (NIST) on May 
15, 2012. A complementary NIST workshop, ``Conformity Assessment: 
Approaches and Best Practices,'' will take place on April 11, 2012 to 
seek input from individuals on the planned update of Guidance on 
Federal Conformity Assessment Activities, issued by NIST in 2000. The 
NIST workshop was announced separately by NIST at http://www.nist.gov/director/sco/ca-workshop-2012.cfm (see also 77 FR 15719; March 16, 
2012).

DATES: Comments: Comments are due on or before April 30, 2012.

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    Public workshop: In addition to providing written comments, 
interested parties are invited to attend the public workshop on May 
15th. The workshop will include presentations from key government 
officials, industry, and experts on standards and conformity assessment 
issues, and time will be allotted for participant input and 
discussions. There is no registration fee for the workshop.
    Registration: To gain access to the NIST campus, located at 100 
Bureau Drive in Gaithersburg, MD 20899, all participants must register 
in advance no later than 5 p.m. EST on May 8, 2012. Non-U.S. citizens 
must register no later than May 1, 2012. There will be no onsite 
registration. To register online, visit the ``Register Now'' link on 
the conference web site at https://www-s.nist.gov/CRS/conf_disclosure.cfm?conf_id=5262.

ADDRESSES: All comments should be submitted via http://www.regulations.gov or faxed at 202-395-5167. Please submit comments 
only and include your name, company name (if any), and cite ``Federal 
Participation in the Development and Use of Voluntary Consensus 
Standards and in Conformity Assessment Activities'' in all 
correspondence. All comments received will be posted, without change or 
redaction, to www.regulations.gov, so commenters should not include 
information they do not wish to be posted (e.g., personal or 
confidential business information).

FOR FURTHER INFORMATION CONTACT: Jasmeet Seehra, Office of Information 
and Regulatory Affairs, at [email protected].

SUPPLEMENTARY INFORMATION: In the ``National Technology Transfer and 
Advancement Act of 1995'' (Pub L. 104-113; hereinafter ``the NTTAA''), 
Congress stated that Federal agencies ``shall use technical standards 
that are developed or adopted by voluntary consensus standards bodies, 
using such technical standards as a means to carry out policy 
objectives or activities,'' except when an agency determines that such 
use ``is inconsistent with applicable law or otherwise impractical.'' 
As amended by Section 1115 of Public Law 107-107, Section 12(d) 
provides that:
    (d) UTILIZATION OF CONSENSUS TECHNICAL STANDARDS BY FEDERAL 
AGENCIES; REPORTS.--
    (1) IN GENERAL.--Except as provided in paragraph (3) of this 
subsection, all Federal agencies and departments shall use technical 
standards that are developed or adopted by voluntary consensus 
standards bodies, using such technical standards as a means to carry 
out policy objectives or activities determined by the agencies and 
departments.
    (2) CONSULTATION; PARTICIPATION.--In carrying out paragraph (1) 
of this subsection, Federal agencies and departments shall consult 
with voluntary, private sector, consensus standards bodies and 
shall, when such participation is in the public interest and is 
compatible with agency and departmental missions, authorities, 
priorities, and budget resources, participate with such bodies in 
the development of technical standards.
    (3) EXCEPTION.--If compliance with paragraph (1) of this 
subsection is inconsistent with applicable law or otherwise 
impractical, a Federal agency or department may elect to use 
technical standards that are not developed or adopted by voluntary 
consensus standards bodies if the head of each such agency or 
department transmits to the Office of Management and Budget an 
explanation of the reasons for using such standards. Each year, 
beginning with fiscal year 1997, the Office of Management and Budget 
shall transmit to Congress and its committees a report summarizing 
all explanations received in the preceding year under this 
paragraph.
    (4) EXPENSES OF GOVERNMENT PERSONNEL.--Section 5946 of title 5, 
United States Code, shall not apply with respect to any activity of 
an employee of a Federal agency or department that is determined by 
the head of that agency or department as being an activity 
undertaken in carrying out this subsection.
    (5) DEFINITION OF TECHNICAL STANDARDS.--As used in this 
subsection, the term ``technical standards'' means performance based 
or design-specific technical specifications and related management 
systems practices.

Section 12(d) is found as a ``note'' to 15 U.S.C. 272.
    In response to the enactment of the NTTAA, OMB prepared a proposed 
set of revisions to Circular A-119 (entitled ``Federal Participation in 
the Development and Use of Voluntary Consensus Standards and in 
Conformity Assessment Activities'') and issued a Federal Register 
notice seeking public comment on the proposed revisions. 61 FR 68312 
(December 27, 1996). After consideration of the comments, OMB issued 
the final revision of the Circular. 63 FR 8546 (February 19, 1998). In 
the preamble to the final notice, OMB responded to the public comments 
and provided explanatory background regarding the revised Circular. A 
copy of the Circular is on OMB's Web site at http://www.whitehouse.gov/omb/circulars_a119/.
    The policies in the Circular are intended to reduce to a minimum 
the reliance by agencies on government-unique standards. In accordance 
with Section 12(d) of the NTTAA, Circular A-119 directs Federal 
agencies to use voluntary consensus standards in lieu of government-
unique standards except where inconsistent with law or otherwise 
impractical. The Circular also provides guidance for agencies 
participating in the work of bodies that develop voluntary consensus 
standards and describes procedures for satisfying the NTTAA's agency-
reporting requirements. In addition, consistent with Section 12(b) of 
the NTTAA, the Circular directs the Secretary of Commerce to issue 
guidance to agencies in order to coordinate conformity assessment 
activities.
    On January 17, 2012, the Office of Information and Regulatory 
Affairs, the Office of Science and Technology Policy, and the United 
States Trade Representative built on the Circular and issued guidance 
on Federal engagement in standards activities to address national 
priorities.\1\ We note more generally the requirements of Executive 
Order 13563, which emphasizes that our regulatory system ``must protect 
public health, welfare, safety, and our environment while promoting 
economic growth, innovation, competitiveness, and job creation'' 
(emphasis added), and which stresses the importance of public 
participation and of careful consideration of both benefits and costs.
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    \1\ See http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08_1.pdf.
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    Purpose: The purpose of this Request for Information (RFI) and 
related public workshop on May 15, 2012, is to allow interested 
stakeholders to provide input to OMB, NIST, Federal regulators and 
other relevant agencies on how the Federal government should address 
issues in standards and conformity assessment that have emerged or 
moved to the forefront since the Circular was promulgated in 1998. Such 
input could help improve U.S. agencies' implementation of the NTTAA and 
the Circular.
    In addition, input received through the RFI and during the workshop 
could be used to inform OMB's consideration of whether and how to 
supplement Circular A-119 to provide additional or more specific 
guidance on standards and conformity assessment to agencies engaged in 
rulemaking, procurement, and other activities. Any such supplemental 
guidance would be developed in conjunction with NIST's effort to update 
its conformity assessment guidelines, in order to ensure consistency 
between the two documents. The NIST conformity assessment guidelines 
are available at http://gsi.nist.gov/global/docs/FR_FedGuidanceCA.pdf. 
Additional information on the conformity assessment workshop objectives 
was provided by NIST in a separate Federal

[[Page 19359]]

Register notice published on March 16, 2012 (77 FR 15719).
    If OMB determines, based on the responses to the RFI, discussions 
at the workshops, and further consideration of the issues, that it 
would be useful to develop supplemental guidance for the Circular to 
address some or all of the issues raised, then OMB will publish a draft 
notice in the Federal Register at a subsequent date and request public 
comment.
    In response to this RFI and at the workshop, OMB is interested in 
receiving input from interested stakeholders pertaining to one or more 
of the following issues relating to standards and conformity 
assessment, specifically with respect to how these issues may affect 
agencies engaged in rulemaking, procurement, and other activities.
    Agency Implementation of Circular A-119 in Rulemakings. Are Federal 
agencies generally following the guidance set out in the Circular and 
providing an adequate explanation of how they considered standards and 
conformity assessment-related issues in the preambles to rulemakings?
    Standardization Activities. OMB A-119 does not establish a 
preference between consensus and non-consensus standards developed in 
the private sector. A limited set of foundational attributes of 
standardization activities are identified in the Circular, focusing on 
voluntary consensus standard activities. It may also be important to 
recognize the contributions of standardization activities that take 
place outside of the voluntary consensus process, in particular certain 
activities in emerging technology areas.
     What factors should agencies use in evaluating whether to 
use voluntary non-consensus standards in regulation, procurement 
solicitations, or other non-regulatory uses? OMB also invites comments 
on the respective roles of voluntary consensus standards vs. voluntary 
non-consensus standards for agency responsibilities in rulemaking, 
procurement, and other activities.
    Conformity Assessment. Circular A-119 directs the Secretary of 
Commerce to issue guidance to Federal agencies on conformity 
assessment. NIST issued such guidance in 2000 and plans to update the 
guidance.
    In conjunction with NIST's efforts to update its conformity 
assessment guidance, should a supplement to Circular A-119 be issued to 
set out relevant principles on conformity assessment? If so, what 
issues should be addressed in such a supplement? The following are 
among the topics that could be considered:
     Factors agencies should use in selecting the appropriate 
conformity assessment procedure, including product/sector specific 
issues and the level of risk of non-fulfillment of legitimate 
regulatory, procurement, or other mission-related objectives;
     Guidance for regulatory agencies on compliance with 
relevant international obligations pertaining to conformity assessment 
and accreditation activities;
     Factors agencies should consider in determining whether to 
recognize the results of conformity assessment and accreditation 
activities conducted by private sector bodies in support of regulation;
     Non-regulatory uses of standards (including vendor 
conformity for purposes of response to procurement solicitations); and
     Ensuring that agencies consider how to minimize conformity 
assessment costs and delays for businesses, especially small and medium 
sized enterprises, subject to statutory and budgetary constraints and 
the ability of agencies to fulfill their legitimate regulatory, 
procurement, or other mission-related objectives.
    Protection of Copyright Associated With Standards. Standards 
themselves are considered to be intellectual property and are typically 
copyrighted by the standards developing bodies that administer the 
process by which specific standards are developed and maintained. The 
rights of copyright holders are protected under U.S. law, and standards 
developers typically charge fees to access their copyrighted materials. 
Some parties have raised transparency concerns with respect to the 
availability of copyrighted materials in instances where standards are 
referenced or incorporated in regulation and compliance with such 
standards is mandatory.
    In this respect, we take note of three recent developments relevant 
to this issue:
    At its Plenary Session on December 8, 2011, the Administrative 
Conference of the United States (ACUS) considered and adopted a 
Recommendation on Incorporation by Reference, specifically addressing 
the place of voluntary consensus standards in that process and how to 
determine ``reasonable availability.'' http://www.acus.gov/wp-content/uploads/downloads/2011/12/Recommendation-2011-5-Incorporation-by-Reference.pdf.
    Second, the Pipeline Safety, Regulatory Certainty, and Job Creation 
Act of 2011 (the Act) was signed into law on January 3, 2012 (Pub. L. 
112-90). Section 24 of the Act created a new subsection (p) of Section 
60102 of Title 49 of the U.S. Code. Section 60102(p) prohibits the 
Secretary of Transportation from issuing ``guidance or a regulation'' 
pursuant to Title 49 of the U.S. Code, Chapter 601 (pipeline safety) 
``that incorporates by reference any documents or portions thereof 
unless those documents or portions thereof are made available to the 
public, free of charge, on an Internet Web site.'' Section 60102(p) 
takes effect one year from the date of its enactment, i.e., January 3, 
2013.
    Third, the National Archives and Records Administration, Office of 
the Federal Register, recently published a petition for rulemaking 
received on February 13, 2012, to amend its regulations governing the 
approval of agency requests to incorporate material by reference into 
the Code of Federal Regulations, and requested public comment. 77 FR 
11414 (February 27, 2012). OMB notes that the petition raises issues 
that are closely related to some of the issues discussed in this RFI 
and encourages interested stakeholders to provide comments in response 
to the petition.
    Circular A-119 specifically contemplates incorporation by reference 
of voluntary consensus standards by Federal agencies, defining agency 
``use'' of a voluntary consensus standard as ``incorporation of a 
standard in whole, in part, or by reference for procurement purposes, 
and the inclusion of a standard in whole, in part, or by reference in 
regulation(s).'' Circular A-119 also directs agencies to respect 
intellectual property rights that may exist in voluntary consensus 
standards that are incorporated into regulation by reference: ``If a 
voluntary standard is used and published in an agency document, your 
agency must observe and protect the rights of the copyright holder and 
any other similar obligations.''
    Since passage of the NTTAA, major strides have been made by Federal 
agencies in their use of voluntary consensus standards. The NIST 
``Standards Incorporated by Reference Database'' includes thousands of 
such standards incorporated by reference in the CFR--http://standards.gov/sibr/query/index.cfm?fuseaction=rsibr.total_regulatory_sibr.
     Is lack of access to standards incorporated by reference 
in regulation an issue for commenters responding to a request for 
public comment in rulemaking or for stakeholders that require access to 
such standards? Please provide specific examples.
     What are the best practices for providing access to 
standards incorporated by reference in regulation

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during rulemaking and during the effective period of the regulation 
while respecting the copyright associated with the standard?
     What are the best practices for incorporating standards by 
reference in regulation while respecting the copyright associated with 
the standard?
    Voluntary Consensus Standards and Cost-Benefit Analysis. Standards 
developing bodies, including not-for-profit organizations, use a 
variety of cost-recovery models as part of their overall way of doing 
business. OMB believes that it may be helpful for the purposes of the 
Circular and for the evaluation of costs and benefits of significant 
regulatory actions pursuant to Executive Orders 12866 and 13563 for 
Federal agencies to have a basic understanding of the costs associated 
with the development of private sector standards, in addition to the 
purchase costs of standards. Similarly, agencies and the public should 
have an understanding of the overall resources and costs that would be 
involved if Federal agencies were to develop government-unique 
standards. Both of these can be elements in determining when it is 
practical or impractical to incorporate a voluntary standard into 
regulation or otherwise adopt a standard in the course of carrying out 
an agency's mission, as compared to developing a government-unique 
standard.
     What resource and other costs are involved in the 
development and revision of voluntary standards?
     What economic and other factors should agencies take into 
consideration when determining that the use of a voluntary standard is 
practical for regulatory or other mission purposes?
     How often do standards-developing bodies review and 
subsequently update standards? If standards are already incorporated by 
reference in regulations, do such bodies have mechanisms in place for 
alerting the relevant agencies and the public, especially in regard to 
the significance of the changes in the standards?
    Using and Updating Standards in Regulation. Federal agencies have 
adopted various methods of using standards as a basis for regulation. 
They have also developed different approaches to updating standards 
that have been referenced or incorporated in regulations.
     Should OMB set out best practices on how to reference/
incorporate standards (or the relevant parts) in regulation? If so, 
what are the best means for doing so? Are the best means of reference/
incorporation context-specific? Are there instances where incorporating 
a standard or part thereof into a regulation is preferable to 
referencing a standard in regulation (or vice versa)?
     Should an OMB supplement to the Circular set out best 
practices for updating standards referenced in regulation as standards 
are revised? If so, what updating practices have worked well and which 
ones have not?
    OMB recognizes that changes in technology and the need for 
innovation can result in the updating of private sector standards in a 
turn-around time of two years or even less. Where such standards are 
already incorporated into regulations, these changes can suggest a need 
to update the relevant regulations as well and, in some cases, can 
result in a need for regulated entities to purchase the newly updated 
standards on a fairly routine basis. In addition to the costs 
associated with the continuing purchase of such standards, rapid update 
cycles may make it difficult for the regulated public to understand the 
nature and significance of the changing regulations.
     Is there a role for OMB in providing guidance on how 
Federal agencies can best manage the need for relevant regulations in 
the face of changing standards?
     How should agencies determine the cost-effectiveness of 
issuing updated regulations in response to updated standards?
     Do agencies consult sufficiently with private sector 
standards bodies when considering the update of regulations that 
incorporate voluntary standards, especially when such standards may be 
updated on a regular basis?
    Use of More Than One Standard or Conformity Assessment Procedure in 
a Regulation or Procurement Solicitation. OMB recognizes that, in some 
instances, it may be best, in terms of economic activity, if a 
regulation or procurement solicitation sets out a requirement that can 
be met by more than one standard and more than one conformity 
assessment procedure. In some cases, however, allowing the use of more 
than one standard or conformity assessment procedure may not be 
possible or meet the regulatory or procurement objective. For example, 
doing so may be precluded by statute, and an alternate standard or 
conformity assessment procedure may not provide an equivalent level of 
protection as the standard or conformity assessment procedure selected 
by the regulator.
     Should OMB provide guidance to agencies on when it is 
appropriate to allow the use of more than one standard or more than one 
conformity assessment procedure to demonstrate conformity with 
regulatory requirements or solicitation provisions?
     Where an agency is requested by stakeholders to consider 
allowing the demonstration of conformity to another country's standard 
or the use of an alternate conformity assessment procedure as adequate 
to fulfilling U.S. requirements, should OMB provide guidance to 
agencies on how to consider such requests?

Other Developments

     Have there been any developments internationally--
including but not limited to U.S. regulatory cooperation initiatives--
since the publication of Circular A-119 that OMB should take into 
account in developing a possible supplement to the Circular?
     Does the significant role played by consortia today in 
standards development in some technology areas have any bearing on (or 
specific implications for) Federal participation?
     Are there other issues not set out above that OMB might 
usefully seek to address in a supplement?

Cass Sunstein,
Administrator, Office of Information and Regulatory Affairs, Office of 
Management and Budget.
[FR Doc. 2012-7602 Filed 3-29-12; 8:45 am]
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