L,?A,''742/R-9-7/010,
Federal Agencies
Participation in the Development
and Use of Voluntary Standards
Prepared for: U.S. EPA/OPPT
Prepared by: ICF Kaiser
Submitted: September 23,1997 .
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*_
1. PURPOSE , .
As part of its efforts at regulatory reinvention and reform, the U.S. Environmental
Protection Agency (EPA) is interested in how other Federal agencies participate in the
development and use of voluntary standards. Federal agencies, including EPA have
actively participated in and incorporated voluntary standards into procurement efforts
and regulations for decades. The increased use of voluntary standards is dnven by
both internal government reinvention and reform efforts as well as by recent Federal -
law This review is pertinent at present because of the codification of the Office, of
Management and Budget (OMB) Circular A-1191 in the National Technology Transfer
and Advancement Act of 1995 (NTTAA) (PL 104-113).2. The Act requires Federal
agencies to use technical standards developed or adopted by voluntary consensus
standards bodies that are consistent with their missions, and to submit yearly reports on
their progress in this regard. EPA can obtain valuable information from a review of the
experience and suggestionsof other Federal agencies who have participated in
standards development efforts. .
The purpose of this report is threefold:
1. Review participation of Federal agencies in the development of voluntary
standards and in standards bodies;
2. Review use.of voluntary standards in regulatory and procurement
activities by* Federal agencies; and
3 Identify essential program elements that support implementation of the
provisions of the NTTAA and OMB Circular A-119.
II. INTRODUCTION
For over four decades, voluntary standards have been used by Federal agencies
in their regulatory and procurement activities. Committed to regulatory reform, the
Clinton Administration and'Congress have enacted the necessary recrements in
recent years .to ensure utilization of appropriate voluntary standards by Federal
agencies. ,
On October 2Q, 1993, OMB issued a revised Circular A-119 entitled "Fee/era/
Participation in the Development and Use of Voluntary Standards: OMBi Circular-A-
119 establishes the policy for participation of Federal employees in the development of
technical standards and the use of voluntary standards by Federal agenc.es. In
addition, OMB Circular A-119 delegates to the Secretary of Commerce the .
responsibility for coordinating-implementation of the circular's policies amongj the
Federal agencies as well as establishing an interagency consultative mechan.srn to
"provide for participation by all affected agencies and ensure that their v.ews are
1 http://www.whitehouse.gov/WH/EOP/OMB/html/circulars/a119/a119.html
2 ftp://ftp.loc.gov/pub/thomas/c104/H2196L.enr.txt
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considered." Importantly, the circular requires tjiat the Secretary of Commerce report to
OMB regarding its implementation. On December 27, 1996, QMB proposed revisions
to the 1S93 version of Circular A-1193-to reflect Section 12(d) of the NTTAA; the public
comment period on the proposed revisions closed on February 25, 1997.
On MarchI 7, 1-996, President Clinton signed the NTTAA. Under the Act, Federal
agencies are'required to: '
Use technical standards that are developed by voluntary consensus standards
bodies,'using such, technical standards as a means to carry out policy objectives
or activities determined by the agencies or departments.,.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. ' ' . . '-".-..
The Act specifically directs the National Institute of Standards and Technology
(NIST),4 part of the Department of Commerce.(DOC): . ;
to compare standards used in scientific investigations, engineering,
manufacturing, commerce, industry, and educational institutions with the
standards adopted or recognized by the Federal government and to coordinate
the use by Federal agencies of private sector standards, emphasizing where :
possible the use of standards developed by private, consensus organizations.
In January 1997, NIST submitted The National Technology Transfer and Advancement
Act -Plan for Implementation5 io Congress. The plan, required by the Act, specifies the
activities NIST w'rll undertake or oversee in fulfilling its legal mandate. "The plan calls for
. NIST to prepare two reports to Congress that summarize: (1) Federal agencies' use of -
voluntary standards and conformity assessment mechanisms and (2) participation of
Federal agencies staff in the development of voluntary standards, respectively. NIST
will provide leadership and guidance to the Federal agencies in their standardization-
activities through the. Interagency Committee on Standards Policy (ICSP), which it
.chairs... . :
" - - '^ ','.',"''
Originally established in 1968 to encourage coordination among Federal
agencies with regard tp standards, the Secretary of Commerce reconstituted the ICSP
in 1992 to serve a similar role. The ICSP seeks:
To promote effective and consistent standards policies in furtherance of U.S.
domestic and foreign goals and, to this end, to foster cooperative participation by.
'3 http://www.whitehouse.gov/WH/EOP/PMB/html/fedreg/a119rev.html
* http://www.nist.gov
shttp:/As.nsit.govAs/htdocs/210/plan.htm .
6 http://ts.nist.gov/ts/htdocs/210/215/icspdes.htm
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the Federal government and U.S. industry' and other private organizations-in
standards activities, including the related activities of product testing, quality
system regratration, certification, and accreditation.
Considerations for EPA:
The NTTAA and OMB Circular A-119 establish new requirements for Federal
agencies In order to achieve and maintain compliance with these requirements,
Federal agencies need to address the following policy and programmatic issues:
Publish a clear agency policy on voluntary consensus standards. Develop clear
objectives concerning the agency standards program.
Develop an effective organization, with the capability to coordinate agency
internal and external -standards activity. Delineate specific roles, responsibilities,
and accountabilities to implement agency policy. .
. Understand -the human and financial resource requirements and commit
adequate resources to implement the agency standards policy and meet
program objectives.
. Develop sufficient organizational infrastructure and support (procedures,
guidance manuals, employee awareness and training, information management
systems) to support meeting the agency standards policy and objectives. Utilize
this infrastructure to effectively meet agency statutory and other commitments
(NTTAA, OMB Circular A-119, etc.).
. Establish mechanisms for tracking program implementation, taking corrective
action when necessary to assure that program objectives are obtained.
llf. FINDINGS :.."..
A prevalent trend across Federal agencies is an increased reliance on voluntary
standards. NTTAA and OMB Circular A-119 are the. legal forces driving this trend.
Nevertheless, important factors outside legal mandates must also be taken into
account; these factors include ongoing regulatory and procurement reform initiatives
and reduced Federal agency budgets.
This report is based on discussions with staff from 10 Federal agencies and two
Standards Developing Organizations (SDOs) (see Appendix 1).and the supporting
. documents they provided form the basis of this investigatingI the initial findings in
this section, the findings described below highlight areas of particular .merest to the
establishment and implementation of an agency's voluntary standards program. Where
possible, specific agency policies and practices are referenced.
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FINDINGS:
To an increasing degree, Federal agencies have participated in
the develdpment of a significant number of voluntary standards,
subsequently adopted into Federal procurement and regulatory
activities. There was an unmistakable trend toward the --utilization of
the voluntary standards-development process even prior to the NTTAA.
Nearly 3,000 voluntary standards were adopted into federal procurement and
regulatory documents during .the' last two fiscal years/The table below presents data ,
on the number of voluntary standards adopted by various Federal agencies, where,the
agencies'participated in the development of the standards. These data are contained
in the NIST Annual Report to OMB for FY. 1995 and the draft version of the FY 1996
Annual.Report. V -..-'. ,.-'.. ' ; ,. ' /
Agency
Archives
CPSC
DoD
DOE
DOT
FCC
GSA
-. * GPO
HHS ,
HUD
DOJ
DOL
NASA
NRC
' Treasury
USDA
VA
Number of Voluntary Standards Adopted by Agency
FY95
, ""3
5 '.-...
, '1171
15
. . 3 '
53
; 2 .
365
30
. .. .--: 1 '
,-.-... 10
3
7
' . 1
- . 1 . - -
FY96*
'. 7 .
566
0
277
. . ' 2 '.;...
.25
306
25 ,
12
: : - 25.' . . , -
' . 18
15 .
7
* Information provided in this column is draft; not all agencies have submitted this data
- to NIST, '."'."-' ..."'. : -
The Department of Defense:(DoD), the Department of Energy (DOE), and the
General Services Administration (GSA) experienced reductions in the number of
voluntary standards adopted over the two time periods despite their well-developed
standardization programs, In fact, such a reduction may be a direct result of the
progress achieved by their standardization programs in previous years. As more _ ...
procurement-related documents are transferred to non-governmental standards bodies,
fewer specifications remain "in trie queue." DoD, for example, has adopted over 7,400
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ncn-governrrertal standards and has identified, only some 2,000 current military
specifications remaining with the potential to be transferred to.voluntary standards.
The Department of Transportation (DOT), National Aeronautics and Space
Administration (NASA), and the Nuclear Regulatory Commission (NRC), on the other
hand, showed marked increases in the number of standards adopted. Such, increases
may reflect a trend among regulatory.agencies as they move to establish structured
voluntary standards programs to implement the provisions of the NTTAA.
Considerations: .
. Agencies that have not yet done so will need to develop a more structured
voluntary standards program to accommodate the requirements of the NTTAA.
There is considerable experience and expertise within the Federal government to
. guide agencies in the development and improvement of their voluntary standards
programs.
The elements of such a program, including policies, organization, resource-
allocation, infrastructure development,'implementation and management
effectiveness reviews are described in Section IV.
FINDING #2:
Most Federal agencies have regularly consulted with and/or participated in a
relatively small number of Standards Developing Organizations (SDOs),
principally those related to their Agency mandates.
The following exhibit identifies the organizations.with which a listed agency
regularly coordinates on standards-related activities, either by: -
adopting or using standards developed under the purview of the SDO;
contributing to the development of standards by the SDO;
, transferring agency governmental standards to the SDO; or
. otherwise consulting with the SDO for standards-related purposes.
The exhibit shows that Federal agencies, both separately and collectively, tend to
consult with and/or participate in a relatively small number of SDOs.
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Aqency > Principal National Standards Bodies and SDOs by Agency
DOE
DOD
NRC
DOT/CG '
DOT/ITS:
OSHA -
'CPSC
NASA ,
,GSA
FDA/CDRH-
ANSI, ASTM, NFPA, ANS, UL, ASME, ASHRAE
ANSI, ASTM, NFPA, AIAA, SAE, IEEE, AWS '
ANSI, ASTM, ANS, IEEE, HPS, ASME, ASCE .
ANSI, ASTM, SAE, ASME
SAE, ASTM, IEEE, AASHTO, ITE
ANSI. ASTM. .NFPA', ASSE, NSC, API, GMA
ANSI, ASTM, UL -
ANSI, ASTM, SAE, ASME, AIAA '
ANSI, ASTM, ASQC . ,
AAAI, AABB, AACC, ADA, AHA; AIUM.'ANSI, APA, ASTM, AAMI, ,
CGA, HIMA, IESNA, IEEE, ICSH, IEC, ISO, NCCLS, NEMA, NCRPM,
NFPA. NSF. OMA; RESNA, UL . : >'
" See Appendix 3: List of Acronyms
This practice is driven in large part by the need to spend available government'
resources cost-effectively, since participation in standards-development activities with .
an organization can incur a variety of costs to the Federal agency (e'.g., travel costs,
SDO membership dues, and seed money). It also is driven by the nature of expertise
available at a typical SDO and the interests of the agency.
Some SDOs (e.g., American Nuclear. Society .(ANS)) are dedicated to developing
standards to meet the needs of a particular industry sector.-An agency
coordinates with such an SDO when the industry sector coincides, either wholly
or partially, with the universe an agency governs or whose services or products
th.at, agency uses. - .. . "..:'
Other SDOs (e.g., American- Society of Testing and Materials (ASTM)) develop
standards for multiple industries or that are cross-cutting (e.g., standards that
affect many industry sectors). By coordinating with such an SDO, an agency can
: benefit from a considerable number and range of standards and-expertise, for a
limited cost of participation. It can also promote wide recognition and distribution
of-the resulting standards into the multiple sectors associated with the SDO.
' In contrast to the finding, the Center for Devices and Radiological Health (CDRH)
at the Food and Drug Administration (FDA) participates in a wide range of SDOs.
CDRH develops and.implements national programs to protect public health in the fields
of medical devices and radiological health. These efforts encompass activities ,
conducted by a broad range of SDOs^ including 26 national organizations and 10
international. .
Considerations:
Agencies should consider funding specific projects to obtain the maximum
benefit from their SDO involvement. ' -.
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Agencies should evaluate opportunities";to transfer governmental standards tp
SDQs for adoption as voluntary standards.
FINDING #3:
Federal agencies have developed and adopted varying
policies concerning their use of voluntary standards, which
creates different standards practices among agencies.
The NTTAA and OMB Circular A-119 require Federal agencies to use consensus
standards in achieving their missions, without specifying how the agencies shall
accomplish this requirement. This approach provides Federal agencies with the
flexibility to comply with standards in a manner most consistent with and suitable for
accomplishing their missions. Inevitably, this has resulted'in the development and
adoption of different policies and practices among Federal agencies. There is a
significant difference in the development and use of voluntary standards between
agencies which primarily use voluntary standards for procurement and those who,use
standards primarily in regulatory functions. - .
Many but not all, Federal agencies have published policies on participation In
the development and use of voluntary consensus standards in their regulatory and/or
procurement activities. A number of agency policies are described below.
DoD's adoption policies have been in place for over.30 years: as part of DoD's
military-commercial integration efforts, DoD activities are directed to use non-
governmental standards to the fullest extent practicable to fulfill their acquisition
needs. The passage of OMB Circular A-119 reinforced these existing efforts.
Subsequently, DoD drafted new standards policies in the Defense
Standardization Manual (DoD 4120.3-M). The new procedures make adoption a
one-time event; that is, once a standard is adopted, all future updates will
automatically be'adopted. Adoption status may be rescinded at a later date if
revisions cause a standard to fail DoD's requirements. Further, the new
procedures deem usage of existing standards, by default, equal to adoption.
DOE fortified its policies concerning use of consensus standards in the 1990s.
While DOE's original policy on standards lacked strong advocacy by top
management, the Energy Secretary issued a new policy in 1991 that strongly
endorsed: (1) the use of consensus standards for successful implementation of
DOE's mission and (2) the use of consensus standards wherever applicable.
Similar to DoD's policy, DOE's policy expedites adoption of a consensus
standard. Consensus standards that are referenced in DOE Orders are
considered adopted without further action. Alternatively, standards may.be
adopted by the publication of an adoption notice. Adoption also is one-time and
approval of standards also may be withdrawn.
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» The Food and Drug Administration (FDA) has been involved in standards
activities for 20 years. Since 1977, the FDA has had provisions in place (21 CFR
10.95) covering the participation by FDA employees in standards-setting
activities outside the agency. Qn'October 1 f, 1995, the FDA published a
standards policy addressing conditions under which the FDA will participate with
. national and" international standards bodies outside of the FDA and the
conditions under which the FDA intends to use the resultant standards in fulfilling
its statutory mandates for safeguarding the public health. To further clarify -
agency standards policy, the FDA published on February 27, 1997 a document
entitled "Good Guidance Practices,", which sets forth the agency's policies and
procedures for the development, issuance, and use'of FDA guidance documents
"" , -containing references to standards. FDA's policy stipulates that FDA is "not
bound to use standards developed with FDA participation."
The Occupational Safety and Health Administration's (OSHA)7 policy concerning
- standards use is found in the Occupational Safety and Health Act of 1970 (PL
91-596):8 ; ' '. .'...-.'
Whenever a rule promulgated by the.Secretary differs substantially from an
existing national consensus standard, the Secretary shall, at the same time,
publish in the Federal Register a statement of the reasons why the.rule, as
adopted, will better effectuate the purposes of this Act than the national
consensus standard. ,
- The Consumer Product Safety Commission's (CPSC) policy concerning
standards use is found in the Consumer Product Safety Act of 1972 (PL 92-573):
v The Commission shall rely upon voluntary consumer product standards
rather than promulgate a consumer product safety standard prescribing
" requirements in subsection (a) [performance requirements, requirements that
a consumer, product be marked with or accompanied by clear and adequate
warnings or instructions, or requirements respecting the form of warnings or
instruction] whenever compliance with such voluntary standards would
.eliminate or adequately reduce the risk of injury addressed and it is likely that
there will be substantial compliance with such voluntary standards.
Considerations:
DOE, DoD, and FDA/CDRH standards programs are furthest along in
implementing the requirements of NTTAA and OMB Circular A-119 concerning use of
voluntary standards. Based upon their experience/effective policy concerning use of
consensus standards should consider the following key elements: ,
7 http://www.osha.gov
8 http://www.osha-slc.gov/OshAet_data/100006.html
Page 8.
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Strong commitment and advocacy by top management to ensure progress;
. Development of specific goals and objectives of the standards program,
appropriate to the procurement and regulatory objectives of the agency;
» , ,t '
Legal requirements with which a-program must comply;
» Designation of a Standards Executive position, to coordinate the development of
specific program policies and implementing procedures; and
. Commitment to support the development and implementation of the program.
FINDING #4:
The rulemaking requirements of the Administrative Procedures Act (APA)
have inhibited Federal executive branch agencies from regularly updating
voluntary consensus standards referenced in regulations.
The standards updating policies of regulatory and procurement agencies
significantly differ in large part due to the rulemaking requirements of the APA (5 USC
553) The rulemaking provisions established in the APA delineate a detailed process
with which regulatory agencies must comply. Specifically, the APA dictates minimum
requirements for public notification and comment in the rulemaking process. In order
for a regulatory agency to adopt an updated standard into a specific regulation, the
process set forth in the APA must be followed. This is a potentially lengthy and
resource-intensive process, which, in some cases, has had the effect of agencies
leaving outdated standards-in place rather than embarking on a rulemaking. In many
instances revisions to voluntary standards often reflect the newest technology and
information available, rather than substantive modifications to the compliance
requirements.
' « . , * , ' '
Procurement Activities
GSA and DoD, which primarily use standards in procurement, .are relatively free
from the APA's burden, thus enabling them to establish a. more effective means to
incorporate revisions to adopted consensus standards. GSA's Federal Standardaation
Manual directs "when referencing the-voluntary standard the, issue date is not cited in
the FPD [Federal Product Description], unless a specific issue of the voluntary standard
; is needed." By establishing such a policy, GSA has implemented an automatic
updating process, with exceptions as necessary. Similarly, DoD has implemented an
automatic standards updating process. The Defense Standardization Program (DSP)
Policies & Procedures specifies: .
9
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Adoption is a one-time event, so it is not necessary to adopt, updates for adopted.
NGSs. [DoD refers to consensus standards as non-governmental standards
(NGSs)]...While this automatic'adoptio'n pfocedure ensures the availability of the
latest NGS issues for DoD, it is not a substitute for participation and awareness
-on NGS technical committees.- The Adopting Activity [the DoD technical, focal
-. point for adopted NGSs] must ensure:that DoD requirements are met by any
NGS updates. Should an occasion arise when an adopted NGS does not meet
the DoD needs, adoption should be withdrawn.
Regulatory Activities
The APA essentially inhibits regulatory agencies from, adopting such automatic
updating procedures. If a standard referenced in a regulation is updated by the SDO
but the citation in the regulation does not change to reflect this, confusion is created as
the regulated community does not know which- standard should be followed the most
up-to-date standard-or the one-referenced in the regulation. - . ."
Several'agencies have developed alternative approaches to address this ..- .
-problem". ' ., . .
OSHA implicitly allows industry to comply with the most current issue of a
standard referenced in a regulation if that standard provides equivalent or
greater safety than the baseline established in the 'regulation.. OSHA compliance
officers make such determinations in the field'on an individual case basis.
DOE, which has both procurement and regulatory authorities, has also exercised
a resourceful approach to incorporating updated standards into select policies.
DOE often establishes performance standards in regulations and references
corresponding voluntary consensus standards in their guidance documents.
- Therefore, the Department can revise.their guidance documents, incorporating
an updated standard, without exposing the referring regulation to the provisions
of the APA. However, guidance is generally not binding to the same degree as a
.regulation.
FDA's policy concerning use of voluntary standards includes incorporating
standards into guidance documents, compliance policy guides, or serving as a
memorandum of understanding with national and international governments.
FDA also can use voluntary standards to serve as the basis for mandatory
standards in their regulations. ~The CDRH also tends to incorporate standards
into guidance documents since the technology the Center regulates changes
rapidly. Keeping pace with such changes through rulemakings would be
"resource-intensive..In addition, CDRH has used standards for conducting
reviews of applications for products, conducting reviews of manufacturing test
protocols used by firms, and conducting reviews of market study protocols used
by firms. ,
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Several Federal agencies have considered using the "direct and final"
rulemaking approach in order to circumvent the time and resource intensive activities
associated with the APA. Using the "direct and final" approach, agencies forgo the
formal rulemaking process, including the public comment period and comment
response, and directly issue the regulation. With one substantive complaint or
challenge to the regulation, however, the agency must initiate the formal rulemaking
procedures of the APA.
Considerations:
Agencies especially those that use voluntary standards in regulations, need
flexibility to adopt revisions to those voluntary standards. Some alternatives to
accomplish this include the following:
* ,A ,,,,,," ,, ,
, . Reference voluntary standards in guidance documents rather than
regulations;
. Attempt to update voluntary standards in regulations through the "direct and
final" approach; and .
. Investigate coordinating the Federal and SDO public comment processes to
expedite adoption of revised voluntary standards in regulations.
FINDING #5:
Policies for participation in voluntary standards bodies
have varied among Federal agencies.
OMB Circular A-119 calls for the Federal Government in its procurement and
regulatory activities to:
Coordinate agency participation in voluntary standards bodies so that...the views
expressed by such representatives are in the public interest and, as a minimum,
do not conflict with the interests and established views of the agencies.
Accordingly, this provision furnishes Federal agencies with flexibility to establish
agency-specific policies for employee participation in voluntary standards, boj.es For
example, the current draft of the directive governing NASA's standards policy,
delegates NASA Centers with the responsibility to:
''' Encourage, support and authorize the participation of employees in voluntary
consensus standards activities which are in furtherance of NASA s mission.
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The resulting policies governing agency participation in- standards development
tend to differ in four'areas: -
Eligibility for participation; . ' ' '''".".'-.
Serving as a standards development committee chairperson;
Voting in committees and subcommittees; and ' .
'.' Membership in and participation on SDO boards. .
1. Eligibility
- Some of the participation policies exclude the participation of certain agency
personnel'on voluntary" standards bodies.' For example, the OSHA directive governing
participation (ADC 1.1), OSHA Personnel Participation on Voluntary Standards
Organizations Committees in the Development and Writing of Occupational Safety and
. Health Standards, states: . . . ' . .
OSHA personnel charged with the responsibility and authority,for setting OSHA
policy or rendering the final decision regarding occupational safety and health
standards shall not participate in the development of voluntary standards. Other
OSHA employees may participate and attend meetings of selected committees
. concerning occupational safety and health.
t _ - ^ . , _
Similarly, CPSC excludes certain employees, including its Commissioners, from.
participation in voluntary standards bodies because of their integral role in establishing
the agency's policy and regulatory priorities. Other agencies, such as Dob and DOE,
do not specify such exclusions.
2/Service as a Committee Chairperson
' Another differentiating issue among agency participation policies is whether an"
agency representative can serve as a-committee chairman. The OSHA directive
governing participation explicitly prohibits^such service:
OSHA personnel shall not .direct the committee's course, such as serving as.
" , committee chairperson or as secretary, or assume responsibilities .that would
dominate the nature of the committee's technical output.
'Prior to. 1982, Nuclear Regulatory Commission (NRC) followed a similar policy;
however the agency now permits its employees to serve in such a capacity. Other
agencies, including DoD, NASA, and DOE, also allow for their employees to serve as
committee chairpersons. Regardless of whether employees can serve as chairpeople,
http:www.osha-slc.gov/OshDoc/Directive_data>DIRECT^19781030AJ.html
: '...-" ."' . Pa9e 12-
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ail agencies operate under the provisions of OMB Circular A-119, which caution agency
personnel against assuming dominant positions on the committees.
3. Voting on Technical Committees
Agencies also differ in whether their personnel may serve as voting members of
the committee. CPSC and OSHA explicitly prohibit their employees from exercising
voting privileges: .
OSHA personnel shall serve only in a non-voting advisory capacity. They shall
indicate that their suggestions or recommendations do not imply OSHA approval
of a voluntary standard or part of a standard.
NRC specified that its employees vote as individuals and not on behalf of the agency
The official letter nominating the NRC representative to a committee specifies that staff
participation "does not connote agency agreement with committee decisions.
Therefore NRC representatives exercise their limited voting powers by either
abstaining or voting against the measure. CPSC staff noted that their employees are.
encouraged to "abstain with comment" from voting in order to further disseminate and
officially record the agency's position. DoD and DOE, on the other hand, are^two
agencies that do not restrict the voting rights of their representatives on standards,
developing bodies.
4. Membership on SDO boards
Several Federal agencies allow their employees to serve on SDO boards, in
accordance with the provisions of OMB Circular A-119:
Participation by agency representatives in the policymaking process of voluntary
standards bodies, in accordance with the procedures of those bodies, is
encouraged particularly in matters such as establishing priorities, developing
procedures for preparing, reviewing, and approving standards, and creating
standards-developing groups= In order to maintain the private, nongovernmental
nature of such bodies, however, agency representatives should refrain from
decisionmaking involvement in the internal day-to-day management of such
bodies.
Participation Levels .
The following table contains information on the number of agency employees
participating in at least 1 standards developing 9^P for Fiscal Year 1995land asoff
' December 1996. These data are contained in the NIST Annual Report to OMB for FY
1995 and" the'draft version of the FY 1996 Annual Report.
,: Page 13
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Agency.
Archives
CPSC
. DOC
DOD
' DOE , '
' DOT ,
EPA'
' FCC
GSA,
' . - GPO
, , ,: .HHS
. - HUD
DOL
. DOJ
NASA /
NSF '
NRC ,
State
Treasury
. USDA
VA
Number of Employees Participating in at Least One ;
Standards Developing Group
FY95 ,
15
23 '
' 459 .
>2200
' -. ,846
9
270
32
51., -
. 12
207. ;
7 .
" ' . 6
25
138
4
170
'. - 2 '. '.. '
50
42
11
As of December 96
. 14 -..:.
' : 21 - .-
. . 520
>2200
. : 848 .
420
not available , j
100
: : 32
12 . N ;.
330 .
7 .
not. available
26 /..
139
' -:- ' :'3:. - -, .
,163
not available
. ' '40
, 43
16
Considerations:
Establish policy governing participating in standards developing bodies,
specifying employee eligibility, service capabilities, and voting capacity.
Encourage employees to abstain with, comment when abstaining from voting.
FINDING #6:
Agencies differ significantly in preparing their staff
a--: to participate in standards-related activities.
- Agencies have adopted different approaches to preparihg their staff members to
participate in standards-related activities, Staff training and development provided may
address one or more of the following activities: the use and availability of voluntary
standards; participation in intra- and inter-agency standards activities; involvement as
an agency member of a standard development committee; and membership on the
board committee of a standards body: . ,
- =
Page 14
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t
Seme agencies train their staff on effectively'participating in standards-related
activities. For example:
. DOE provides staff training on how to participate in standards-related activities. ,
Such training may be used to increase awareness, understanding, and active
use of and participation in standards activities of interest to DOE. Through in-
house programs, DOE trains so.me of its key players on how to interact with
other stakeholders and how to identify, use, and prepare technical standards for
accomplishing DOE's mission. DOE administers training through a number of
methods, including workshops, discussion forums, and instructional materials
(e.g., the "Standards Tool Kit" developed for the DOE Technical Standards
Program). .
. FDA has provisions (21 CFR 10.95) covering .participation by FDA employees in
standards-setting activities. FDA also participates in training provided by oDOs
with which the agency works (e.g., UL). Further, as part of FDA+s Good
' Guidance Practices (GGPs)," the agency "will provide all current and new FDA
employees involved in the development, issuance, or application of guidance
documents a copy of the GGPs," which include a section that describes the lega
effect of guidance. FDA will direct these employees to review the GGP s and will
provide additional training that describes, in more detail, how to develop and use
guidance documents.
. DoD has purchased several units of training from the American National
" Standards Institute (ANSI) for personnel involved in its Defense Standardization
Program This training, available through ANSI's Education and Training
Services, provides instruction to Federal personnel on how to participate in
standards development activities.
. EPA provided ANSI a special grant to develop education and training materials
related to environmental management standards.
. . . Standards organizations, such as ANSI and ASTM, indicated tha£ other Federal
agencies also have expressed interest in receiving training from SDOs related to
use of and participation in standards development; in addition, some agencies
may be in the process of developing in-house training.
Those agencies that do actively incorporate training into their standards program
practices (e.g., DoD and DOE) emphasize that training is critical to promoting the
progress andquality of programs they have in place to support their standards
'initiatives. In particular, training is credited with attaining the following three key
objectives:
V Ensuring that a consistent standards policy is known and applied across an
agency;
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. . Ensuring that agency staff know how to participate effectively with other
stakeholders and understand the rules governing voluntary consensus standards
development and.the agency's role in such development (he,, "equal partner"
approach to standards); and. : /
'/",."" " v "
Promoting commitment to agency initiatives by educating its staff on the
. importance, value, use of, and participation in the development of voluntary
standards. . ' .,'..;.;.
Considerations: ,
Given the requirements of the NTTA and OMB Circular A-119, investment in
awareness and training may increase an agency's utilization of voluntary
: standards, enhance their.level and degree of participation in standards-setting
. activities,' and improve the quality of final standards developed and their utility to
the agency., ".--- ; ' ' '.
Agencies can profit by reviewing the voluntary standards-related awareness and
training programs of other agencies and SDOs before developing their own
programs or revising existing programs.
FINDING #7:
Federal agencies differ greatly in how they are internally organized
to support their participation in standards-related activities.
Supporting infrastructure is the cornerstone of success of any agency's. -
standards program. At this time,-however, relatively few agencies have a well-
developed and comprehensive program in place to support their standards-related
activities. As agencies are ramping up their standards activities in response to the
requirements of NTTAA and OMB Circular A-119, it is useful to examine the design of
an existing program to better understand which key elements comprise infrastructure
essential to standards-related Federal programs.
Among agencies with a more established program, DOE attributes its progress
- to date concerning use of and participation in the development of voluntary standards to
' strong commitment from top management. This commitment ensures that the
necessary personnel and financial resources are available to develop the appropriate
organizations, procedures, communication networks, and information systems within
DOE to support its standards activities. Key elements regarding the design of. DOE's
program infrastructure are highlighted below: ' '. '
DOE's Technical Standards Program organizes its participants into a hierarchy
of individuals and committees with well-defined roles and responsibilities. -
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The organization, roles, and responsibilities establish a network for
communicating within the program and for discharging tasks.
1 i1' , ' .
Participants are drawn, from different staff levels, with senior level DOE officials
to provide leadership and management and subject-matter experts to focus
activities at the working level. -
Participants in the Technical Standards Managers' Committee represent every
DOE headquarters program office, DOE operations and field office, and
contractor organization.
. Managers and committee members participate proactively through periodic
meetings and forums.
The Technical Standards Program establishes clear procedures and
mechanisms for:
- accessing procedures and guidance;
- tracking participation;
- tracking adopted standards; .
- tracking updates to adopted standards;
- tracking standards for potential use;
- providing staff training;
- obtaining and exchanging documents;
- managing and disseminating information; and
- coordinating with stakeholders.
DOE strategically employs electronic systems throughout its program.
Databases are used to manage large amounts of information, such as training
materials, standards, and other documents. The Technical Standards Home Page
harnesses the World Wide Web to broadly disseminate program documents and other
information. .
Considerations:
Agencies may wish to benchmark their current standards practices and
infrastructure against other agencies and adopt best-in-class practices. In addition, the
following steps can facilitate more effective participation in development of voluntary
standards and use of existing and forthcoming standards:
Provide employees with access to available voluntary standards.
" Develop procedures and guidance materials governing eligibility .and capacity for
participation in standard developing bodies.
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".:- Develop guidance defining roles and expectations of agency personnel-involved.
in standards development activities. , ;' .<.
Write and disseminate procedures and guidance materials governing the '
processes for adopting voluntary standards (in whole or in part), tracking
adopted standards, and updating adopted standards. ."','
' .- -Build information management systems to support intra-agency coordination as
well as cpordination with other Federal agencies and SDOs.
FINDING #8:
Federal agencies have both developed and have access
to numerous tools to provide their employees with information on
standards available from SDOs, the standards development process,
key internal and external contacts, and current agency activities.
Under OMB Circular A-119, "voluntary standards that will serve agencies;
purposes and are consistent with applicable laws and regulations should be adopted
and used by Federal agencies..." Accordingly, many Federal agencies have
established voluntary standards policies to comply with this provision (see Finding #3).
Federal employee access to voluntary standards information is crucial for effective
implementation of the OMB Circular. Specifically, Federal employees must have
access to information on available standards to avoid initiating duplicative efforts where
an existing standard is consistent with applicable laws and regulations.
Federal agencies employ various toojs to provide their employees with access to
voluntary standards information. In general, these resources are electronic and include:
Federal agency Internet Web sites. Several Federal agencies reference their
= standards programs on their home pages. Others have dedicated separate
home pages to their standardization programs and standards resources. These
include: NASA;11 DoD;12 DOE13; FDA/CDRH,14 and DOT/ITS.15 These sites are
also used to facilitate electronic review of standards within the agency.
. ' SDO Internet Web Sites.16 SDOs (e.g., ASTM,17 Society of Automotive
Engineers (SAE),18 ASQC,T9 and ASME International20) .frequently have their
11 http://standards.nasa.gov ' .. .
12 httD-//www.acq.osd.mil/es/'std/stdhofne.html ' (
13.http://apollo.osti.gov/html/techstdsAechstds.htnnl; http://www.expiorer.doe.gov; http://www.dsc.doe.gov
14 http://www.fda.gov/cdrh/mdsar.htmlScontents, .
15 http://www.its.dot.gov/standards '" . . '
16 http://www.ansi.org/resource.htmltDev "
17 http://www.astm.org .'.-''.-.-'' :'..-.'
18 http://www.sae:org - . ,
' . , Page 18 _ ;
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own internet web sites, which Federal employees can review for information.
Federal agencies, such as GSA and OSHA, rely on these SDO web sites to
provide their employees with voluntary-standards-reJated information. Lists of
SDO resources on the web can be found on both the web sites of Federal
agencies and SDOs. ASTM is currently experimenting with an electronic
standards development process which may reduce the costs of standards
development and facilitate Federal agencies participation.
National Standards System Network (NSSN).21 NSSN is a new Internet
resource developed by NIST and ANSI. NSSN consolidates comprehensive
information on regional, national, and international standards developed and
under development by private-sector organizations and Federal government
agencies. By year's end, NSSN will include information on more than 100,000
standards. NSSN also serves as a gateway for accessing the vast network of
standards developers, providing search capabilities and links to their ,
heterogeneous databases. 'NSSN has both a free gateway for referencing and
browsing, as well-as a fee only access to the standards: The Enhanced
Standards Alert Service, available for a fee, can be used to obtain daily
notification about standards of ".interest to the user that are being initiated,
reviewed, revised, or approved. Federal agencies mentioned that they see this
resource as providing key information in a readily accessible form.
Information Handling Services (IhJS).22 This is a commercial integrated
database available on CD-ROM and on-line (by subscription) that includes
military specifications and standards and worldwide industry standards. Its index
includes more than 100,000 standards. CPSC, for example, uses IMS as a
primary tool for providing employees with voluntary standards information.
,23
National Center for Standards and Certification Information (NCSCI). This
office within NIST serves as a clearinghouse and referral service for information
on U.S., and international voluntary standards; government regulations; and
rules of conformity assessment for non-agricultural products. MCSI can be
contacted for,standards and standard-related information at (301) 975-4040.
" i ;"ii ' ' Jl n * 'i1 ', " ., . ,
Acquisition Streamlining and Standardization Information System
(ASSIST). ASSIST is an electronic catalog that includes, among other
documents, DoD-adopted non-govemment/ihdustry specifications and
standards. Both government (DoD and NASA) and industry use ASSIST to gain
information on voluntary standards.
19 http://www.asqc.org , ,
20 http://www.asrne.org
21 http://www.nssn.org
" http://www.ihs.com
23 http://ts.nist.gov/ts/htdocs/210/217/bro.htm
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Interestingly,, while there are considerable resources are, available on the.
Internet, some Federal standards employees dp not have'access to the Internet. This
is a significant deficiency for the development of ah effective standards program.
'- ''." " '
Considerations,:
Agencies seeking to develop'and improve their standards programs can review
, , the abundant information resources currently available on'the Internet, prior to
developing new information resources, : ,.- - '
Agencies can provide Internet access to staff involved in standards-related
'. activities. . : ' \
' Internal agency intranets can assist in electronic standards development and . .
review, which can reduce the costs of involvement and simultaneously increase
participation and standards quality. ..... ' - [
FINDING #9:
With some notable exceptions, Federal agencies do not have well-developed
systems to track (1) voluntary standards they have adopted or referenced; and
(2) employee participation in voluntary standards developing bodies.
Adopted Voluntary Standards
Most Federal agencies lac.k formal mechanisms to track standards adopted into
their procurement and regulatory documents. Of noteworthy exception are: .
ASSIST. DoD's integrated electronic database, which includes DoD-adopted
, noh-government/industry specifications and standards.
DOE'S Technical Standards Home Page. DOE's Technical Standards
Home Page serves as the agency's clearinghouse for standards adopted by
' the agency. .
. NRC Inventory. An inventory, compiled by Pacific Northwest National
Laboratories, listing all the voluntary standards incorporated in NRC .
documents and the status of the standards.
An effective tracking system will complement the process of updating adopted
standards. '
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Employee Participation
OMB Circular A-i 19 requires "...the development and harmpnized
implementation of an agency-wide directory identifying employees participating in
standards developing groups." This current study found that the Department of
Commerce (DOC), DoD, DOE, FDA/CDRH, DOT/ITS have developed database
directories implementing the OMB Circular A-119 provision.
The ICSP working group on directory databases developed Guidelines for
Development of Harmonized Federal Agency Directories. The guidelines detail the
purpose of an agency directory and encourage interagency cooperation in directory
development. "Common database elements will ensure the users wHI be able to identify
and find the information they need."
Every year Federal agencies are required to provide N 1ST with the number of
' employees participating in standards developing committees for the Annual Report to
OMB DOC DoD, and DOE can use their directories to provide this information. Other
Federal agencies track employee participation through biannual, rather informal.
requests to employees to report their participation in voluntary standards bodies.
SDOs may also be a resource for agencies to track participation in voluntary
standards bodies. Upon request, certain SDOs can produce a list of committee
representatives for a specific Federal agency.
Considerations:
. Agencies may find it useful to design a system to automate the tracking of
voluntary standards adopted in their procurement and regulatory activities.
' ! ' , ";' "' ',." i " " '. '" " ' i ' ... ; i ' ,
. Agencies can use the ICSP working group's Guidelines for the Development of .
Harmonized Federar Agency Directories when creating a system to compile and
update an agency directory.
FINDING #10:
Funding Issues have hampered Federal agency participation
^ in standards development activities and the
cooiinton of governmental standards into voluntary standards.
Several agencies and SDOs identified'lack of funds as a factor that hampers
both Federal agency participation in the standards development process ancI the _
conversion by SDOs of governmental standards into voluntary standards. While the
NTTAA and the OMB Circular AT119 establish Federal agency participation n the
standards development process as an important objective, compliance with this
- ir
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mandate-imposes burdens and costs for the agencies that generally are not allocated in-
;their annual budgets.- , ' '.'."' '.-.
Considerable funds may be necessary to cover a variety of costs associated with
Federal/agency participation in standards-related activities, including.the following:.
SDO membership dues; -
'- .Travel costs;. -:'. ' -, ( ' , _^. . -.''.''-
Staff opportunity;costs; " . , ",, ; -..'.-'
Staff training; ' ' -..
Reporting costs (to OMB and leSP); '. -
Costs for coordinating with other agencies and SDOs; , '
Seed money (i.e., grants) for initiating standards of interest; and
Infrastructure costs (e.g., information systems, management, and program
operation).
In addition, an agency can require significant personnel and financial resource's to
develop and ensure the continuing adequacy of infrastructure to support its standards
program initiatives. These funds would support essential infrastructure elements,
including: information systems, tracking participation and use, and performing updates.
The experiences of DOE, DoD, and FDA/GDRH, three agencies that have extensively
integrated standards activities into their agency culture, underscore the importance of a
commitment by top management to providing necessary resources for this activity.
In reality, SDOs and several agencies themselves indicated Federal participants
provide little direct financial support-to SDOs. Special arrangements can be granted to
Federal agencies by SDOs to minimize the costs for participating in SDOs. These'
gestures reflect a strong desire on the part of SDOs to encourage Federal participation
as a partner in standards development activities. For example:
-' SDOs often invite Federal agencies to participate in standards development.
activities by granting full membership rights (i.e., expertise and' balloting) even :
though an agency is not a dues-paying member; and
" - '''-- ' . * . - , , ' ' . . " .
A number of SDOs have offered to cover the cost of travel for agency staff
interested in participating in a standards development activity. An agency's
policy, however, may prevent them from taking such funds.'
Ultimately, the industry participants to SDOs bear the burden for costs to research and
develop the standards. Although Federal agencies may provide seed money to
catalyze a standards development process, this practice is infrequent.
' There are significant advantages to greater Federal agency funding of SDO
standards development or standards conversioh. The following is a non-exhaustive list:
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. Given that SDOs are developed by experts assembled from across industries, an
agency thaHinancially "supports" standards development by providing one or
some of its own staff gains, in return, an entire workforce of experts at basically
no additional cost.
i SDOs provide a forum for coordinating with other government and industry
stakeholders, which can facilitate and enhance Federal activities to comply with
NTTAA and OMB Circular A-119 requirements. Many SDOs also have
harnessed the benefits of new technologies (e.g., ASTM has initiated standards
development on-line) to provide better communication among participants.
. A number of agencies, especially DoD, are providing funds to SDOs to convert
their government standards into voluntary standards. This provides multiple
benefits to Federal agencies, including assistance in meeting agency objectives .
for the use of voluntary standards, as well as placing responsibility for distribution
and updating with the SDO. .
Finally, it is interesting to note that SDOs have demonstrated a willingness to
assist and coordinate with agencies in this regard. For example:
Principle SDOs to DoD voluntarily notify and send copies of revisions to adopted
standards to the agency to expedite tracking by and updates to DoD's Single
Stock Point, a clearing house for DoD standards information (DoDISS); and.
Both ANSI and individual SDOs are willing to consult with agencies concerning
training issues (e.g., the "equal partnership" concept).
Considerations:
«* ' "",'*
' A commitment by top management to estimate and provide personnel and
financial resources to develop sufficient infrastructure to support the agency s
standards initiative can support the continuing success of the program.
. An investment in infrastructure (task forces, training, guidance, databases etc.)
to facilitate strong coordination throughout an agency, in turn, can ensure that
the funds are used cost*effectively (e.g., minimizes duplication of efforts).
. Agencies may consider providing targeted funds to their principle SDOs to
support their standards development requirements under statutory and other
programs... , , .
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IV. ESSENTIAL PROGRAM ELEMENTS *-
Essential elements for a successful agency .voluntary standards program were
determined based oh the findings delineated in.Section III above. Themes dominating
the findings section underscore the need for a well-planned and well-structured agency
voluntary standards program. In addition, diminishing agency resources accentuate the
near-term requirement for a cost-effective and efficient standards program. This
section identifies and, organizes the essential program elements into a guide for the
' development of new or the assessment of existing voluntary standards programs.
' '''
A. Establish Agency Standards Policy
Ah agency should develop a clear and concise-voluntary standards policy. The
policy should serve as the foundation supporting the development and subsequent "
.implementation of specific program components. Fundamental to building a solid
' foundation, the policy should: , .
Outline the specific goals and objectives of the program;
Cite legal requirements with which the program must comply;
Designate a Standards Executive position, to coordinate the development of
specific program policies and implementing procedures and to foster
awareness of standards policies; and . ,
Establish agency-wide commitment to and pledge resources to develop,
support, and implement the program. ..
2. Establish Organization
The Standards Executive should be responsible for overall program design, and
implementation. In this capacity, the Standards Executive should establish the internal
organizational structure that will govern program development and implementation. In
coordination with affected agency programs, the Standards Executive should:
. Define the roles of agency staff and assign responsibilities and
accountabilities accordingly;
. Establish a time frame and resource requirements for program development
and implementation; .
" Publish a plan .for implementing the goals and objectives outlined in the
agency's standards policy,, and milestones for attainment;
Establish or reaffirm coordination mechanisms within the agency and among
other Federal agencies and SDOs as a means to achieve those objectives.
A structure also could be established where the Senior Standards Executive reports to
an executive committee with responsibility for ensuring commitment and conducting
oversight of the program. ,. ;
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3. Allocate Resources
In principle, the agency should commit in their policy (see above) to provide the
necessary resources to support the voluntary standards program. In practice,
increased budgetary constraints pose challenges to obtaining sufficient resources for
agency standards activities. Nevertheless, to achieve the goals and objectives set forth
in the agency policy and satisfy legal requirements, sufficient resources both in the
form of funding and personnel should be earmarked for the voluntary standards
program. Resources should be strategically allocated to cover:
Staff with technical expertise to participate in standards developing bodies;
Costs incurred for participation in standards development activities, (e.g.,
membership dues, travel costs, standards .purchasing fees);
' Costs for providing access to voluntary standards information and systems;
and ,
Costs for developing and operating systems for tracking standards usage and
personnel participation in standards development activities. .
4. Develop Infrastructure .
Developing an effective program infrastructure is fundamental to successful
program implementation. Infrastructure components should be consistent with and
advance the elements of the agency's voluntary standards policy, and can include the.
following elements:
Provide employees with access to existing and in-development voluntary
standards;
Develop guidance with regard to procurement and regulatory, involvement
and participation; .
Create procedures and guidance materials governing eligibility and
institutional .capacity for participation in SDOs;
', Publish guidance defining roles and expectations of agency personnel
' involved in standards development activities;
Provide staff with training oh SDO participation;
Develop procedures and guidance materials governing the processes for
adopting voluntary standards (in whole or in part), tracking adopted
standards, and updating adopted standards in procurement and regulatory
activities; and
Create information management systems to support intra-agency standards
coordination as well as coordination with other Federal agencies and SDOs,
5. 'implement Agency Voluntary Standards Program
Once the program fundamentals are in place, the agency will be able to conduct
its standards operations most effectively, including participation in SDO activities,
"'....' Page 25
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incorporation-and. update of voluntary standards into procurement requirements, agency
'guidance, and regulation. Important elements of such implementation can include:
Effective intra-agency organization and coordination;
. Support of technology to disseminate information and to network key
stakeholders inside and outside the organization; and .,
' ' Careful, ongoing review of regulatory .requirements for standards adoption.
6. Create Reports ,
Provisions in NTTAA and/or QMS Circular A-119 require a Federal agency to:
Maintain a directory ofemployees participating in voluntary standards bodies;
.. ' 'Annually report the number of employees participating in at least one
Voluntary standard body; ' . , . -.. -
Annually report the number of voluntary standards adopted; and
, Annually summarize and report explanations for hot" adopting existing
voluntary consensus standards (beginning in FY 1997)..
An effective voluntary standards program should use available information
technologies to track and manage information (e.g., to track participation in the
development and adoption of voluntary standards). Using such technologies will
. reduce administrative paperwork, while facilitating updates and access. This will result
in more accurate reporting in accordance with legal requirements. Furthermore, if the
proposed revisions to OMB Circular A-119 are adopted, such technologies will ease the
exception reporting burden.
7. Review Program Effectiveness
Compliance with provisions in NTFAA and OMB Circular A-119 .will result in
increased Federal agency reliance on voluntary standards. .In assessing program
effectiveness, the agency, should develop measures of program success as to whether:
'. . The voluntary standards program meets the objectives established by agency
policy in a timely manner;
. . , Resources are being allocated efficiently to accomplish objectives; and
The regulated community is in compliance with adopted voluntary standards.
Appropriate review and corrective action should be taken when necessary to improve
.whatever program elements'require adjustment. This regular review process should
involve the senior-management team established at the beginning of program.
development. ,
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Essential Elements for Management of a
. Federal Agency Voluntary Standards Program
Review Program
Effectiveness
Performance
Corrective
Action Program
Establish Agency
Standards Policy
Create Reports
Directory - Personnel
Agency SDO Activity
Exception Report
Implement Program
Procurement
Regulation
SDO involvement,
support
Establish Organization
Roles
Responsibilities
Allocate Resources
"Human
"Financial
-Technology
Develop Program Infrastructure
Procedures Interagency coordination
Guidance SDO Coordination
Training Information
Management
and Distribution
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Appendix 1: Agencies/Organizations Consulted
Agency/Organization
NISt
DoD
DOE
GSA
NASA
NSF International
NRG
ASTM
OSHA
CPSC -''
DOT/ITS-
FDA '
Contact
Mary Saunders,
.Belinda Collins,
PatCooke,
Joanne Overman
Steve Lowell
Dick Biack ,
Richard .Surbu
Tom Bacon
Dick Weinstein
Andrea Jensen ;
John Craig
Gil Millman
Kitty Kono
Pat Catpafesta
Collin Church
Michael Schagrin
Linda Norton
Mel Altman (CDRH)
Date of Consultation
May 22, 1997
May 27, 1997
... . - '%
May 28, 1997 ,
May 28, 1997
May 29, 1997
.May 30, 1997
May 30, 1997
June 2, 1997
June 2, 1997
June 3, 1997
. June 9, 1997
July 2, 1997
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Appendix 2: Consultation Talking Points
Does the agency have a policy concerning use/ development of consensus
standards (given A-119)?
What are the agency's current areas of interest/levels of involvement concerning
consensus standards? ,
- Does the agency participate/support financially standardization activities through
ANSI, including ISO (in what capacity, at what level, ISO 14000 series)?
- Does the agency participate/support financially standardization activities through
SDOs (in what capacity, at what level, which SDOs primarily)?
, ., ' ' - '". ''i, - *",'',' , ' . .',' ' . ' ' '
- Does the agency participate actively in national/international standards
development through other venues (in what capacity, at what level)?
. Describe the agency's experience concerning use/development of standards
(examples of effective/ineffective mechanisms).
What EHS-related standards have been adopted by the agency?
- Does the agency track standards adopted in regulations it originates?
- How do agency regulations using consensus standards incorporate subsequent
updates to the standards?
Contrast key differences in burdens and costs to the agency through adoption of
consensus standards vs. agency-specific rulemakings? .
. How does the agency -coordinate with other agencies on standardization activities?
. Are there resources the agency can refer us to (e.g., WWW, documents/persons)?
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Appendix 3: List of Acronyms
f , ' ' . ' ' . ' '
AAAI American Academy of Allergy and Immunology ,
AABB American Association of Blood Banks ... ' . , '
AACC , American Association for Clinical Chemistry.'
" AAMI American Association for the Advancement of Medical Instrumentation
AASHTO 'American Association of State Highway and Transportation Officials
ADA American Dental Association
AHA ' American Heart Association ! .;
AIAA ' ' Aerospace Industries Association of America
AIUM- American Institute of Ultrasound in Medicine
ANS American Nuclear Society ,
ANSI American National Standards Institute
APA . Administrative Procedures Act . .
API '"-. American Petroleum Institute .';.-.
Archives National Archives and Records Administration . ,
ASCE American Society of Chemical Engineers -... .
ASHRAE American Society of,Heating Refrigeration & air conditioning
ASME American Society of Mechanical Engineers ..
ASQC American Society of Quality Control . ; .
ASSE American Society of Safety Engineers
ASSIST Acquisition Streamlining and Standardization. Information System
ASTM .. American Society of Testing and Materials .
AWS American Welding Society
CDRH Center for Devices and Radiological Health
CGA Compressed Gas Association
CMA Chemical Manufacturers '
CPSC Consumer Product Safety Commission
DOC Department of Commerce
DoD Department of Defense . . ~
DOE Department of Energy
DQJ Department of Justice
DOL Department of Labor ,
DOT. Department of Transportation . .
DSP Defense Standardization Program .
EPA Environmental Protection Agency .
FCC Federal Communications Commission _.-'.-.
FDA Food and Drug Administration
FPD Federal Product Description ,
GSA General Services Administration '
GPO Government Printing Office
HHS Department of Health and Human Services
HIMA Health Industry Manufacturers Association
HPS Health Physics Society
HUD "Department of Housing and Urban Development
ICSH International Council for Standardization in Hematology
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Appendix 3: List of Acronyms (continued)
ICSP Interagency Committee on Standards Policy
IEC International Electrotechnical Commission
IEEE Institute of Electrical and Electronics Engineers
IESNA Illuminating Engineering Society of North America
IMS Information Handling Services
ISO International Organization for Standards
1TE institute of Transportation Engineers
NASA National Aeronautics and Space Commission
NCCLS National Committee for Clinical Laboratory Standards
NCRPM National Council on Radiation Protection and Measurements
NCSCI National Center for Standards and Certification Information
NEMA National Electrical Manufacturers Association
,NFPA ' National Fire Protection Association
NGS Non-governmental Standard
NIST National Institute of Standards and Technology
NRC Nuclear Regulatory Commission
NSC National Safety Council
NSF National Science Foundation
NSSN National Standards System Network
NTTAA National Technology Transfer and Advancement Act of 1995
OMA The Optical Industry Association
OMB Office of Management and Budget
OSHA Occupational Safety & Health Administration
PL Public Law
RESNA Association for the Advancement of Rehabilitation Technology
SAE Society of Automotive Engineers
SDO Standard Developing Organization
.State Department of State
Treasury Department of Treasury
UL Underwriters Laboratories
USC United States Code .
USDA , - Department of Agriculture
VA Department of Veteran Affairs
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U.S. DOT Intelligent Transportation System (JTS) Program
The US DOT'S Joint Program Office is supporting an extensive, multi-year program of accelerated
standards development to facilitate the successful deployment of. a national Intelligent Transportation
System (ITS). ITS Program goals with respect to standards development are driven by the following
direction, provided by-the Intermodal Surface Transportation Efficiency Act of 1991 (ISTEA):" "The
Secretary' shall develop and implement standards and protocols to promote widespread use and
evaluation of ITS technology...To the extent practicable, such standards and protocols shall promote
compatibility among ITS technologies implemented through the States...The Secretary may use the
services of such, existing standards-setting organizations...as appropriate." The standards chosen for the
Program include interface standards (e.g., message sets and data dictionaries) and foundation standards
(e.g., location referencing and some safety standards) needed to deploy key ITI functions safely and
efficiently, as well as other communication standards developed specific to ITI applications. The Program
' has established guidelines for developing, setting, communicating, and mapping standards within the ITS
National Architecture. The Director of the Joint.Program Office stated that the successful experience of
the ITS standards program corroborates the model presented in this paper. .
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