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   .

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.


       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
                                      Page 1
                           - «=•'

 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

                                       Page 2

       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.
                                       Page 3

         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    -..-•'.    ,.-'..  '       ;          ,.   '   /
-. •* GPO
' Treasury
Number of Voluntary Standards Adopted by Agency
, ""3 •
5 '.-•...
, '1171
. . 3 '

; 2 .
. .. • .--: 1 '
,-.-... 10

' . 1
• •-• • . 1 . - -
'. 7 .

. . ' 2 •'.•;...

25 ,

: : - 25.' . . , -
' . 18
• • • 15 .

* 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
                                    Page 4

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

   •  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.
                                     Page 5

Aqency > Principal National Standards Bodies and SDOs by Agency
•"  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.                             .


     •  Agencies should consider funding specific projects to obtain the maximum
        benefit from their SDO involvement.              '                     -.

      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.

   »   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.


       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.

   •   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
                	       •      '      •    «         .• ,     * •  •   • •  ,     ' •    '
    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:                                             .
      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.                        ,
                                     Page 10

      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.


      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.
                                      Page 11

   •   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,

     •          :           '...-•"  ."' . Pa9e 12-

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

     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

• . DOC
' DOE • , '
' DOT ,
' . - • GPO
• , , ,: .HHS
. - HUD
Number of Employees Participating in at Least One ;
Standards Developing Group
FY95 ,
23 '
' 459 .
' -. • ,846
51., •• -
• . 12
207. ;•
7 . •
"• ' . 6 •
'. - 2 •'. •'.. '
As of December 96
. 14 -..:.
' : 21 - .-
. . 520
. : 848 .
•not available , j
: •: 32
12 . N ••;.
330 .
• 7 • .
not. available
26 /..
' -:- ' :'3:. -• -, • • .
not available
. ' '40
, 43
16 •
      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

      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

     V  Ensuring that a consistent standards policy is known and applied across an
        agency;                 •               •
                                      Page 15

  . •.  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.  -
                                     Page 16

  •  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.                   .


   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.
                                    Page 17

 ".:•- 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    _        ;

     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.
      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
                                   Page 19

      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.
      '-     •                ''."••                         "     •     '

   •  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.     •                  '
                                     Page 20

   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.


     .  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
                                     Page 21

 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
 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:
                                     Page 22

  .  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).        •

                              «•*                   '       "",'*•
   ' •  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...                 ,             ,                     .
                                     Page 23


       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.                    ,.                            ;
                                      Page 24

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
       •  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
                                                                   •            '

 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.           ,
                                      Page 26
                            ,- «=•

                •   Essential Elements for Management of a
               . Federal Agency Voluntary Standards Program
            Review Program
           — Performance
           — Corrective
            Action Program
             Establish Agency
             Standards Policy
 Create Reports
• Directory - Personnel
•Agency SDO Activity
• Exception Report
  Implement Program
  — Regulation
  —SDO involvement,
                                                              Establish Organization
                                                              Allocate Resources
 Develop Program Infrastructure
— Procedures   — Interagency coordination
— Guidance   — SDO Coordination
— Training    — Information •
               and Distribution
                                       Page 27

Appendix 1:  Agencies/Organizations Consulted





NSF International




CPSC  -'•'•



 Mary Saunders,
.Belinda Collins,
 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
                                 Page 28

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)?
                                     Page 29

 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
                                   Page 30

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
                                    Page 31

               •       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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