Jeannie Layson: [0:00] Next, we have Mary Saunders, who is the director of the Standards Coordination Office for the National Institute of Standards and Technology.

Mary Saunders: [0:08] OK. Thank you. Just a few brief words about NIST and the role that I'll be speaking to today. NIST is an agency of the US Department of Commerce. We are the national measurement institute for the United States. [0:21] I am going to be speaking specifically to NIST's role, as directed by Congress and the Office of Management and Budget, to coordinate the federal agency use of standards in regulation procurement and other mission-related activities and also participation in the development of relevant standards.

[0:41] That has been a responsibility of NIST since the passage of the Technology Transfer and Advancement Act, which was signed into law on March 7, 1996.

[0:50] Section 12 of the Act codifies the direction to federal agencies to use technical standards developed or adopted by voluntary consensus, standards bodies in carrying out agency policy objectives or activities, rather than developing their own standards. That's a direct quote from section 12 of the Act.

[1:09] The term "standard" includes a wide variety of technical works that prescribe rules, guidelines, best practices, best vacations, test methods, design or installation procedures and the like. The size, the scope and the subject matter of standards varies widely, ranging from lengthy model building or electrical codes to narrowly scoped test methods or product specifications.

[1:34] The Act also directs agencies to consult with voluntary private sector consensus standards bodies, and to participate in the development of technical standards, when that participation is in the public interest and is consistent with agency missions, authorities, priorities and budget resources.

[1:51] The Act directs NIST to coordinate these activities, both the use of standards as noted in the Act as well as participation in development of technical standards across the government, across the executive branch, working in cooperation with the executive branch departments, agencies and independent commissions, more than 25 in all.

[2:13] The Office of Management and Budget's Office of Information and Regulatory Affairs, OIRA, undertook a major update of Circular A-119, which is Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities to be consistent with the law. The revised circular was published in 1998.

[2:36] To date, the OMB circular has been a remarkably successful policy document. A few statistics to prove the point, or to support the point that Emily was making earlier. Since 1998, more than 3,000 government-specific standards, so these are standards developed by government agencies, were replaced by voluntary industry consensus standards.

[2:57] NIST reports, based on reports from individual agencies to the institute, we report to OMB every year on activities under the OMB circular. In fiscal year 2010, federal agencies reported the adoption or use of more than 300 voluntary consensus standards.

[3:17] In addition, agencies reported that 112 voluntary consensus standards replaced government-specific standards that were already on the books. At the same time, only 46 new unique government-developed standards were adopted.

[3:32] We have submitted the report for fiscal year 2011 to OMB. It is not yet publicly available, but these are an example of the types of statistics we see annually--very little new use of government-unique standards and a continuing effort to replace government-unique standards with voluntary consensus standards at the direction of Congress.

[3:53] There are substantial benefits from greater use of consensus standards. These have included lower costs, both to the agencies, obviously, since they're not developing government unique standards, as well as to the regulated communities, or the communities that provide products and services to the government, a reduced regulatory or procurement burden, greater flexibility in government purchasing and improved effectiveness in meeting technical requirements.

[4:21] Each of the annual reports, the summary report that NIST publishes and sends to the Office of Management and Budget, as well as the individual agency reports are available on the web at www.standards.gov.

[4:35] You can go back and look at any of the historical reports, either summary or individual agency. You will see examples of areas where costs have been lowered, regulatory or procurement burdens have been reduced coming from individual, specific agencies.

[4:53] Today, through the policy guidance of A-119 more than 3,000 government staff participate in over 500 private sector standards development organizations. That is a contribution to the technical content of the standards that may be referenced in regulation or procurement activities.

[5:11] A little bit about the benefits of the law, and also the OMB circular and agency implementation of both of those.

[5:20] Executive branch policy on the use of voluntary consensus standards by federal agencies in regulation, which is the topic of discussion today, but also in procurement and policy activities explicitly recognizes multiple benefits of that, including, as I said, decreasing the burden of complying with agency regulations and also promoting efficiency and economic competition.

[5:41] The law specifically says, as I noted earlier, that agencies should use technical standards. The OMB circular defines "use" very specifically. I'm just going to quote briefly from the circular.

[5:53] Your agency must use voluntary consensus standards, both domestic and international, in its regulatory and procurement activities in lieu of government-unique standards, unless use of such standards would be inconsistent with applicable law or otherwise impractical.

[6:08] "Use" means, according to the circular, incorporation of a standard in whole, in part, or by reference for procurement purposes and the inclusion of a standard in whole, in part, or by reference in regulations. We are talking about the third in that clause, incorporation of a standard by reference in regulations.

[6:27] "Impractical," which is an important consideration here, includes circumstances in which such use would fail to serve the agency's program needs, would be infeasible, would be inadequate, ineffectual, inefficient, or inconsistent with agency mission, or--this is the final clause--would impose more burdens, or would be less useful, than the use of another standard or another approach in regulation.

[6:50] Separately, the circular also directs agencies to respect the rights of copyright holders when they are using voluntary consensus standards developed by private technical organizations.

[7:02] When agencies rely on voluntary consensus standards to support their regulatory missions, both Congress and the executive branch have recognized that this reliance creates benefits for regulated populations as well as for the agencies. These benefits are at least threefold.

[7:16] The representatives of a regulated population, as well as all affected parties more broadly, have the opportunity to participate in the development of relevant technical standards. The process is open, transparent and it is consensus-based.

[7:30] Second, the use of the resulting standards by an agency also lowers the cost to the regulated population of complying with the regulation compared to the cost of complying with a government-unique standard to which they had no direct input.

[7:43] Third, use of the resulting standards lowers the cost to the agency of enforcing the regulation as a result. These voluntary consensus standards are typically widely used in the market by industry, and when an agency references the same standard that's already being used for business purposes, it facilitates the compliance of the regulated community with that regulation.

[8:08] Agencies do invest in private sector standards developing process through their participation. Costs of developing a voluntary consensus standard are currently shared across a broad range of constituencies, lowering the share that each constituency has to commit.

[8:22] Standards developing organization marshal the vast expertise, diverse perspectives and technical resources available outside of the government to develop consensus standards that are made available at very low cost, typically.

[8:38] The major organizations that develop health and safety standards used by government are independent. They're public service organizations that operation on a non-profit basis.

[8:46] The standards, as I noted earlier, are also in broad use in the private sector separate from regulatory uses. That has an important competitive advantage for US industry.

[8:57] Standards organization participation fees are generally low for those organizations the work in the health and safety arena. Those are typically the organizations whose standards are considered for adoption for regulatory use. We're talking about protection of health, safety and the environment broadly.

[9:13] Revenue generated from the publication and sale of standards allows standards developing organizations to keep barriers to participation low, and to retain their independence and freedom from potential influence by any industry or group, including the government.

[9:28] This funding model is consistent with the wide and reasonable availability of standards, and standards developing organizations are committed to working with government agencies to provide both pre and post adoption access to standards through a variety of means that are appropriate to the many different circumstances in which standards are adopted and used by agencies.

[9:49] Agency missions differ, as do regulated populations. Agency authorizing legislation differs substantially across agencies, so use, including the impact of incorporation by reference, will vary according to the agency and according to its authorizing legislation, its enforcement rights and responsibilities and other factors.

[10:10] Government agencies current have the option to use many types of private sectors standards that have been developed by a wide variety of private entities. That flexibility is very important for agencies.

[10:21] Government agencies are committed to working with standards organizations to provide access to such documents before and after adoption in a variety of ways appropriate to the many different circumstances in which those standards are adopted and used.

[10:33] We have specific examples from individual agencies regarding working with standards developing organizations, as Emily mentioned, to make read-only copies of standards that are proposed for adoption, incorporation by reference, and regulation during the comment period, as well as examples of different modes of availability once the regulation has been implemented.

[10:56] Reasonable access to standards referenced and regulation currently includes electronic purchasing and viewing models, such as read-only models employed by most standards organizations. In addition, many standards developers, as I mentioned earlier, make some or all of their standards available without charge to selected users.

[11:14] I'm very much looking forward to the discussion today regarding Section 24 in the Pipeline Safety Act, and possible ways to build on current practice to make basic information on specific standards and, where relevant, those standards themselves referencing regulation more widely available. As Emily noted, this is a very important conversation.

[11:35] The challenge is specific to PHSMA at this point and, as Emily noted and I agree, I see there's nothing in the existing law or executive branch policy which directs full availability on the Internet, freely available to the public, but there is quite a bit going on, in terms of expanding the definition of reasonable availability to take into account the Internet age in which we live.

[12:00] I'm looking very much forward to the discussion. Thank you.