Madam Chairwoman and Members of the Subcommittee, I am Belinda Collins, Director, Office of Standards Services, National Institute of Standards and Technology (NIST) part of the Department of Commerce’s Technology Administration.  NIST has a key role to play in the implementation of Section 12, Standards Conformity, of the National Technology Transfer and Advancement Act, P.L. 104-113, of 1995.

I am pleased to be here today to discuss NIST’s role in implementing the law through its coordination with other Federal agencies and with the private sector on standards and conformity assessment activities.

Background

The National Technology Transfer and Advancement Act (P.L. 104-113), which was signed into law on March 7, 1996, charges Federal Departments and agencies with new responsibilities for using and participating in the development and use of voluntary consensus standards.  The Act also required agencies and departments to submit to the Office of Management and Budget an  explanation for using technical standards1 rather than  voluntary standards.

The Act also assigned special responsibilities to NIST.  It directed NIST to transmit a plan to Congress for implementing Section 12 of the Act; and “to coordinate Federal, State and local technical standards activities and conformity assessment activities, with private sector technical activities and conformity assessment activities, with the goal of eliminating unnecessary duplication and complexity in the development and promulgation of conformity assessment requirements and measures.”

NIST developed an Implementation Plan , which defined the tasks for meeting the goals set forth in the Act.  In the plan, NIST noted that its implementation would require active cooperation among NIST, the Office of Management and Budget (OMB), and other Federal agencies.  This cooperation is now carried out through the Interagency Committee on Standards Policy (ICSP), which consists of senior level executives from all cabinet departments and many independent agencies .  The Plan identified specific high-priority tasks that NIST would complete with existing resources since NIST received no additional funding to carry out its new responsibilities.  To address the goals set forth in Section 12 of the Act, NIST diverted personnel and resources from other ongoing activities and modified some existing programmatic efforts.  To date, NIST efforts have concentrated on Federal agencies and the private sector where the most significant impact could be achieved.

In the remainder of this testimony I will describe NIST’s activities related to NTTAA.  These include: chairing the ICSP; tracking Federal standards body participants; reporting annually to Congress; coordinating with the private sector; conformity assessment-related activities and guidance; efforts with states; and information sharing.

Interagency Committee on Standards Policy

The Implementation Plan had as its central mechanism for Federal coordination the reconstitution of the Interagency Committee on Standards Policy (ICSP) .  A June 4, 1998, Memorandum to the Heads of Executive Departments and Agencies, the Secretary of Commerce notified 31 departments and agencies of the requirements of the Act and OMB Circular A-119, which had been revised to make its terminology consistent with the Act.  The Memorandum requested that each organization appoint a senior level person as the agency "Standards Executive."

Each agency’s “Standards Executive” serves on the ICSP chaired by NIST, coordinates agency standards-related activities, and provides information for the Annual Report to OMB and Congress.  All 14 Cabinet Departments and 12 other agencies and commissions with significant procurement or regulatory programs responded either formally or informally to the memorandum and their representatives now constitute the core of the ICSP.  Except for OMB and USTR, each of the 26 participating agencies is solicited annually to report on its standards activities.  (OMB and USTR participate on the ICSP for guidance on policy issues only, but do not report annually.)

Since 1996, the ICSP has met approximately five times a year.  The ICSP regularly exchanges information among its members and tackles common problems, such as input for revising Circular A-119 and development of conformity assessment guidance. In addition, agencies report on their efforts to establish standards coordination programs to address the requirements of the Law and the Circular.

NIST’s central philosophy in implementing the Act is to work with each agency to develop and implement its own program for managing its standards-related activities.  For example, DOE has instituted and Integrated Safety Management System whereby people plan, perform, assess and improve the safe conduct of work.  It is institutionalized through DOE contracts and encompasses all levels of management and work practices.  The term safety is used synonymously with environment, safety, and health to encompass protection of the public, the workers, and the environment.  DOE and its contractors systematically integrate safety into management and work practices at all levels so that missions are accomplished while protecting the public, the worker, and the environment.  In addition, the Field Management Council consisting of senior DOE managers, through a management review process; review policy, guidance, directives, and data requests that crosscut programs and the field prior to their being issued.   In some areas, such as laboratory accreditation, and standards management, DOE has established topical committees, which parallel the ICSP efforts.  These topical committees coordinate DOE internal efforts and coordinate closely with Federal efforts under way in the ICSP.

Even before passage of the Act, the Department of Defense undertook a major reform initiative that emphasized replacing military-unique documents (MILSPECs) with voluntary consensus standards wherever there was a dual-use application.  As a result of this initiative, DOD carefully reviewed all of its 40,000 military specifications and standards and identified documents with voluntary standards potential.  DOD has adopted approximately 9,000 voluntary consensus standards as of the end of FY 99.  DOD also instituted a very stringent system to review each new request for a document to determine if a voluntary consensus document would be more appropriate.  A DOD senior executive must now approve all new DOD documents and revisions to existing documents.  In addition, DOD staff must review all available sources to locate an appropriate voluntary consensus document rather than create a military-unique document.  Furthermore, the DOD 5-year review process identifies documents that did not have a voluntary consensus counterpart at one time, but for which an appropriate document may now have been created.  Other agencies, which have established internal programs for tracking use of voluntary consensus standards and participating in their development, include EPA, NRC, NIST-DOC, and NASA.  In each case, these programs leverage the efforts and activities of the ICSP and broaden its reach.

Another way in which the ICSP leverages agency resources is through the establishment of working groups.  The ICSP currently has seven working groups, including strategic standards management, Federal participation, ISO 9000, ISO 14000, directory databases, laboratory accreditation, and regulatory activities.  For example, the Regulatory Agency Working Group (led by CPSC) is currently considering means for improving the process for referencing and updating standards, as well as discussing issues related to regulatory use of conformity assessment.  The Participation Working Group, headed by DOD, is focusing on issues surrounding Federal participation in standards developing committees, including an apparent significant decline in participation in recent years.  The ISO 14000 Working Group, under the leadership of EPA and DOE, focuses on implementing the ISO 14000 series of environmental standards by Federal agencies.  The Directory Database Working Group, led by NIST, is developing procedures for identifying Federal participants in standards activities and for using electronic means of sharing standards-related information.

In addition, as part of its outreach to the private sector, NIST, as Chair of the ICSP, regularly invites representatives of private sector standards developers, such as the American Society for Testing and Materials (ASTM), the American Society of Mechanical Engineers (ASME), the International Conference of Building Officials, and Underwriters Laboratories, Inc., to address the ICSP on matters of mutual interest.  For example, ASTM addressed the committee on the timely update of standards.  More recently, the American National Standards Institute (ANSI) discussed procedures for accrediting standards developers and developing national standards, as well as the need for a national standards strategy.  All the discussions have benefited both the ICSP and the standards developers.

Tracking Federal Standards Body Participants

As part of its coordination activities, NIST develops and maintains a database of all Department of Commerce (DOC) agency participants in standards activities.  Termed the Standards Assistance and Management Information (SAMI) database, it is a key tool in determining participation by DOC (including NIST) staff members in standards-related activities, and in collecting and disseminating information needed to promote effective standards management, and to assist DOC managers in making decisions about the allocation of their resources to maximize public benefit from their standardization activities. When a key upgrade to the database is completed, it will also serve as a means of encouraging communication among DOC standards committee participants, resulting in the exchange of information and the coordination of agency positions on standards-related matters.

NIST works with ICSP members that are developing similar tools for tracking standards-committee participation, as required by the Act and Circular A-119.  NIST has written guidelines for providing access to information on agencies’ participation and it has supplied other agencies with information on SAMI and a similar database at DOD.

Annual Report to OMB and Congress

Each year NIST prepares the Annual Report on Agency Standards-Related Activities as requested by Congress and OMB.  NIST requests from each of the 26 ICSP participating agencies a report of their annual standards-related activities.  Agencies report on their use of voluntary consensus standards, participation in the development of such standards, use of government-unique standards, and any suggestions for improving the process.  NIST collates the agency annual reports on NTTAA activities, analyzes the data, develops recommendations, and then transmits to OMB the Annual Report on the implementation of the NTTAA and Circular A-119.  OMB, in turn, transmits the report to Congress.  Once the report has been transmitted to Congress, NIST publishes it in both hard copy and on its website (http://ts.nist.gov/nttaa).  The 1997 and 1998 reports are currently available.

Data obtained over the last three years by NIST since the reporting requirement went into effect indicate that slightly over half of the agencies meet the December 31 reporting deadline.  The remaining agencies typically report by the end of February, although several agencies (four or fewer) respond even later.  Nonetheless, agencies are complying with the requirements to report in both the Act and the Circular.

Based on experience in preparing the FY 1997, 1998, and 1999 Annual Reports, NIST is reviewing and strengthening its interagency and internal procedures to produce and clear the annual report in a more timely fashion.  We have identified a number of bottlenecks both internally and externally in the process and are taking steps to eliminate these problems for the FY 2000 reporting process.  ICSP members have also agreed to examine their own internal processes and to remove unnecessary obstacles in their agencies’ reporting.  ICSP members suggested ways that NIST could assist them in preparing their annual reports for FY 2000 in a more timely fashion.

Because the annual report currently contains information requested in both the OMB Circular A-119 and P.L. 104-113, it is a more complex document than required by the Act alone.  In future years, NIST plans to work with OMB and the Congress to determine if only the portion covering use of government-unique standards (as required by the Act) should be transmitted to Congress, while NIST publishes the complete report once agencies finish reporting.  However, this approach may lessen attention on use of voluntary consensus standards and participation in their development.

Coordination with the Private Sector

In addition to the activities with specific standards developers cited for the ICSP, NIST has worked diligently with ANSI and other private sector standards and conformity assessment bodies to increase public and private understanding of NTTAA-related issues.  A key event was the signing of a revised Memorandum of Understanding (MOU) of cooperation on September 24, 1998, between NIST and ANSI.  This revision of the July 1995 MOU strengthened the recognition of ANSI as the representative of U.S. interests at the international level; focused on the need to improve domestic communication and coordination among both private and public sector parties in the United States on voluntary standards issues; and called on NIST to work with other agencies to increase the effectiveness of U.S. Government agency participation in the national and international voluntary standards-setting process.  ANSI and NIST also agreed to work together to ensure the flow of relevant information about developments that affect government and private sector standards and conformity assessment interests.

As the Implementation Plan states, NIST identified issues related to international standardization as an extremely important topic for both the public and private sectors.  To further national understanding of this topic, NIST and ANSI co-sponsored a major Standards Summit in 1998, bringing together nationally recognized leaders to begin the development of a national standards strategy.  Many meetings have subsequently been held with both public and private sector interests to build consensus.  NIST, along with several ICSP members, has been working with the ANSI federation on a draft national standard strategy, expected to be ready for public distribution later this year.

Conformity Assessment-Related Activities

NIST was also directed to coordinate conformity assessment activities of Federal, state and local entities to eliminate any unnecessary duplication of conformity assessment activities.  NIST’s Implementation Plan identified overlap and duplication in laboratory accreditation as a central issue in conformity assessment.  In response, NIST has been a driving force behind the creation of NACLA, the National Cooperation for Laboratory Accreditation.  NACLA is composed of organizations in the United States, with observers from Mexico and Canada, that actively support development of a system for recognizing the competence of testing and calibration laboratories leading to worldwide acceptance of test and calibration reports from those laboratories.  Concerned with costly, multiple, duplicate assessments and the lack of domestic or international recognition of laboratory accreditations, the group has explored solutions which could lead the United States, and perhaps eventually its North American Free TradeAagreement partners, towards the goal of having only one assessment of a laboratory in a given field of testing, based on internationally accepted procedures.  The NACLA vision is for a U.S. and eventually a North American laboratory accreditation system that achieves the following goals:

1.  For the testing laboratory, a single accreditation in a given field of testing, with worldwide recognition of the laboratory's competence;

2. For the manufacturer/supplier, a test performed once, with worldwide acceptance;

3. For the acceptance body (that is a government agency or an industry specifier), an accreditation based on uniform criteria and intended to ensure that a laboratory is qualified to provide data of consistent quality.

On February 9, 1999, NIST co-sponsored a major national workshop on conformity assessment issues with ANSI and ACIL, formerly the American Council of Independent Laboratories.  This meeting concluded that:  (1) The U.S. conformity assessment system is very complex and all parties need to work together to simplify it; and (2) Both the Federal Government and the private sector need to harmonize their conformity assessment activities to reduce duplication and complexity.  One outcome of the meeting was the formation of a public/private sector organization, known as the Conformity Assessment Network.  This organization identified the lack of basic information on conformity assessment related topics as a key concern for the community.  To address this need, NIST created a “one-stop-shopping” website for conformity assessment related information, ranging from ISO 9000 issues to conformity assessment topics under the U.S.-EU MRA.

Conformity Assessment Guidance

OMB Circular A-119, recognized the conformity assessment requirements and obligations defined in the Act and the role of the Department of Commerce in this area.  The Circular directed the Secretary of Commerce to issue guidance to agencies to ensure effective coordination of Federal conformity assessment activities.  On November 3, 1999, NIST published proposed guidance on Federal conformity assessment activities in the Federal Register.  The proposed guidance focuses on the desirability and procedures for Federal agencies to eliminate unnecessary duplication and complexity in their conformity assessment activities.  The comment period on the proposed guidance ended January 18, 2000, and comments, including recommendations appearing in a recent GAO report, are currently being reviewed.  Final guidance will be published later this year.

Other Standards Management Guidance

NIST has further recognized that to address the tenets of the NTTAA, a new style of managing standards activities is required.  To this end, NIST created a model plan for strategic management of standards activities.  Because each agency’s standards efforts tend to be unique, the generic plan can be tailored to suit the needs of individual agencies.  NIST is also updating its Guidelines to Standards Participants in coordination with EPA’s revision of its Rule Writer’s Guide for Standards Participants and has provided an outline of these Guidelines to the ICSP to serve as a model for other agencies’ efforts.

To coordinate internal standards activities, NIST established a Standards Advisory Committee (SAC).  The SAC created a NIST Voluntary Standards Policy (attached), which is now being implemented at NIST.  This policy directs NIST organizational units to review their standards-related activities to ensure that they are in line with the agency’s mission and goals so that resources and participation are targeted most effectively.  NIST currently has about 330 employees participating in more than 1,200 standards committee activities.  The policy is expected to assist in aligning this participation as closely as possible with applicable NIST and industry needs.  Because NIST also coordinates standards activities within the Department of Commerce, including publishing the Annual Directory  and providing DOC input for the Annual Report, NIST chartered a Commerce Standards Committee to improve communication and coordination on standards-related activities among DOC agencies.

Efforts with the States

Although at a lower level of effort, NIST has begun to implement its standards obligations under the NTTAA at the State and local levels.  NIST met with the National Conference of State Legislatures and the State Science and Technology Institute, while working with the State of Maine as a pilot state in implementing the NTTAA.  NIST also opened a dialogue with the U.S. Innovation Partnership, an initiative of the President, Vice President, and the Nation’s Governors, and spoke about standards-related activities at an invitational global trade conference for Ohio manufacturers.

The Implementation Plan also identified the importance of working with the states on building codes and related issues.  In September 1996, National Conference of States and Building Codes and Standards launched a five-year regulatory reform project in support of several national initiatives, such as the NTTAA.  This streamlining project is a cooperative effort among 55 national organizations and Federal, state, regional, and local governments (including NIST) to improve economic development, public safety, and environmental quality by bringing better management practices to the regulation of the siting, design, and construction of all types of buildings throughout the United States.  Among the goals of the project is a 60 percent reduction in regulatory processing time for construction projects.  NIST will soon undertake an ancillary project to work with representatives of the various model building code, state and local organizations toward the development of a common policy for conformity assessment issues relating to building products.
Information Sharing
 
A central activity that NIST performs under the NTTAA is sharing of information about standards and conformity assessment procedures.  NIST does this through its reference information center, publications, workshops, and talks.

NIST established the National Center for Standards and Certification Information (NCSCI) to provide information on U.S., foreign and international voluntary standards; government regulations; and rules of conformity assessment for non-agricultural products.  The Center serves as a referral service and focal point in the United States for information about standards and standards-related information and is a particularly useful service to Federal agency staff who need information on standards and conformity assessment procedures.

Another key NIST activity is the development and sharing of standards related information with other Federal agencies and with the public.  NIST has published a plethora of publications on the NTTAA and related standards and conformity assessment topics.  These publications include various databases; policy guidance documents; informational reports; etc.  To make this information widely accessible, NIST created an NTTAA website (http://ts.nist.gov/nttaa) that contains full text of all pertinent publications and information, including the annual report.

To reach both the public and private sector, NIST has conducted 12 public workshops to educate government agencies at all levels as well as the public on NTTAA-related issues.   Additionally, NIST staff has given numerous speeches at conferences, meetings and training seminars on NTTAA.   These are just a few examples of the kinds of information sharing NIST has undertaken as part of its coordination function under the NTTAA.

Agency concerns in complying with NTTAA requirements

As part of its coordination efforts NIST works with ICSP members to improve Federal use of, and participation in, standards and conformity assessment.  During several ICSP meetings, agency representatives raised a number of issues for the ICSP to discuss and resolve to make implementation of the NTTAA as complete as possible.  Concerns include the following issues:

1. Appointment of Standards Executives may not be at an appropriate level within a department/agency making it difficult to obtain cooperation from other agency or departmental units to meet reporting requirements;

2. Decreasing Federal resources and staff can lower the priorities for standards and conformity assessment activities within a department or agency, causing some agencies to be inactive in ICSP or its working groups;

3. Lack of substantive feedback on the annual report may lead agencies to believe that their reports are not being read or not being used.  Because of this and decreasing resources, some agencies have reduced or eliminated reporting.  However, failure to report has not yet led to negative consequences for agencies.

4. Agencies conduct standards related activities for a variety of reasons.  These different reasons may create difficulty in reporting due to confusion in determining which activities to report and how to how to report them.  The ICSP continues to address these issues in its meetings.

5. Some agencies report difficulty in updating out-of-date standards in their regulations.  In a l997 survey of the U.S. Code of Federal Regulations, ASTM found that of the 1,000 references to ASTM standards, more than 90% were at least 10 years out of date, some were more than 30 years.  Current standards may reflect new technology; new products; more precise methods of testing; faster, cheaper, and better ways of doing things.  The ICSP Regulatory Agency Working Group is focusing on procedures for improving the timeliness of updates of standards used in regulation.

6. Some agencies have invested resources in converting to greater use of voluntary standards to facilitate the regulatory process only to find that industry is more comfortable doing things the old, familiar way.  FDA’s greater use of voluntary standards to facilitate approvals in the medical device area has not yet received strong support from industry.  It may be that industry is just more comfortable doing things the old, familiar way.

Results of Implementation of the NTTAA

Briefly, the 1997 and 1998 Annual Reports on OMB Circular A-119 and NTTAA implementation demonstrated that Federal agencies are shifting from the use of government-unique to voluntary consensus standards by a factor of almost 100 to 1.  During this time Federal agencies reported using 2,419 additional voluntary consensus standards in FY 97 and FY 98, while 333 voluntary consensus standards were substituted for government-unique standards.  Only 27 government-unique standards were reported as having been developed/used during those two years.

Unfortunately, the 1997 report showed a significant decline in participation in standards committees from the informal 1996 report - from about 5,200 to 3,300.  The 1998 report indicated that decline in participation had continued, with about 3,200 participants reported in 1998, while the preliminary data for the 1999 report suggest that while the trend continues, the rate of decline has been markedly reduced.  Agencies report, however, that they are finding efficiencies by assigning personnel to represent them on a number of standards committees and that this results in better and more efficient communication with and participation in the committee activities.  They report advantageous streamlining of their internal operations as a result.

Coordination by NIST, through the ICSP, has led to a marked increase in communication between the private sector and the Federal Government on standards issues.  For example, the private sector was instrumental in bringing specific instances of out-of-date references to the attention of Federal agencies.  Following a meeting with the ICSP, ASTM actively worked with several Federal agencies, including EPA, to update hundreds of references to ASTM standards in the U.S. Code of Federal Regulations (CFR).  In their l997 survey of the CFR, ASTM found about 1,000 references to ASTM standards - tangible evidence of how important voluntary standards are to the Federal Government.  Instead of having to develop each of these standards in-house, the Federal Government relies on the expertise of, and participates directly in, the voluntary standards system, as directed by the NTTAA.  Similarly, the Occupational Safety and Health Administration (OSHA) and ASME set up a joint working group in 1999 to facilitate the updating of currently referenced ASME standards in the portion of the CFR maintained by OSHA (29 CFR 1910 and 1926).  Many of these standards are decades old and can no longer be obtained, even from the standards developer.

With the enactment of the NTTAA, a number of U.S. standards bodies have reported increased participation on specific standards committees by many Federal agencies.  For example, ASTM reported that DOD and 26 other Federal agencies now participate on 93% of all of ASTM technical committees.  ASTM also noted that while some EPA offices have long participated in ASTM activities, those activities have increased markedly since the Act passed.  Thus, EPA now participates in ASTM committees on Sampling and Analysis of Atmospheres, Water, Waste Management, Biological Effects and Environmental Fate, Environmental Assessment, Corrosion, and Paint and Related Coatings.  Representatives of the Food and Drug Administration (FDA) actively and effectively participate on 16 ASTM committees, most notably on Medical and Surgical Materials and Devices, Anesthetic and Respiratory Equipment, Rubber, and Healthcare Informatics.  In fact, representatives of FDA’s Center for Devices and Radiological Health have been instrumental in expanding ASTM’s Committee on Medical and Surgical Materials and Devices to include a new division on Tissue Engineered Medical Products.

Federal agencies have increased their adoption of voluntary consensus standards.  Thus, DOT's Office of Pipeline Safety adopted the National Fire Protection Association NFPA 59A on Liquefied Natural Gas on March 1, 2000.   During the early part of 1996, DOT approached ASME to develop a standard for transport tanks.  When this ASME standard is completed, DOT expects to reference it within the CFR and to remove existing DOT technical requirements.  DOT also created a cooperative agreement with private sector standards developers, including ASTM, the Society of Automotive Engineers, the Institute for Electrical and Electronics Engineers, the Institute of Transportation Engineers, and the American Association of State Highway and Transportation Officials, as well as the International Organization for Standardization to develop national and international standards for Intelligent Transportation Systems.  Another agency, DOI’s Minerals Management Service (MMS), published a proposed rulemaking to update their reference to the ASME Boiler and Pressure Vessel Code (BPVC) to the latest edition and addenda.  MMS representatives attended the last meeting of the BPVC committee and continued participation is expected.  These are only a few of many examples where Federal departments and agencies have taken steps to use voluntary standards thereby effectively implementing the NTTAA.

Conclusion

Since the Act was signed in 1996, NIST has strengthened the ICSP and coordination among Federal agencies, with much greater attention to strategic management of standards activities and concomitant allocation of resources.  Many agencies have now developed comprehensive plans for allocating and monitoring resources dedicated to standards-related activities.  NIST is continuing to work on procedural changes for greater effectiveness and more timely reporting.  NIST has worked with OMB and Federal agencies on revisions to the OMB Circular A-119 and the proposed Guidance on Conformity Assessment.  In addition, NIST has strengthened bonds with private sector standards developing organizations, by encouraging them to work directly with individual agencies on specific problems and cooperatively with the ICSP on government-wide issues.  In particular, NIST has worked actively with ANSI to recognize the coordination role of each organization, and to build a workable national standards strategy for the future.  In addition, NIST has worked with other Federal agencies, industry, laboratories and conformity assessment bodies to build a national infrastructure for laboratory accreditation to resolve existing problems of duplicate, costly accreditations that do not add value.

The result has been a change in Federal use of voluntary consensus standards with agencies now using far more private sector standards than agency-unique standards (by a factor of about 100).  Regulatory agencies have begun to implement a process for alerting the private sector of a potential need for a voluntary standard in their Notices of Intent of Proposed Rulemaking.  The effectiveness of this approach is seen in the increased numbers of voluntary standards cited by Federal agencies.  Procurement agencies are using voluntary standards as a matter of course for new procurements, while transitioning old procurement specifications to the private sector.  While reported participation in voluntary standards activities has decreased, nonetheless Federal agencies are building a cooperative partnership with the private sector and working through existing standards organizations on problems of national concern.  In conclusion, NIST believes that Federal agencies are complying ever more effectively with Section 12 of P.L. 104-113 and that a new spirit of cooperation and participation between public and private sector on standards related matters has emerged.