[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19357-19360]
From the Federal Register Online via the Government Printing 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.
[[Page 19358]]
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 jseehra@omb.eop.gov.
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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