Jul 26, 2016

2013 Chairman of the ASTM International Board of Directors

As standards executive for the U.S. Environmental Protection Agency, Mary C. McKiel, Ph.D., brings expertise both in government service and in standards development to her term as 2013 chairman of the ASTM International board. Here she talks about federal use of consensus standards, incorporation by reference and other challenges and opportunities at the intersection of government and standards development.

The U.S. Office of Management and Budget's Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, has long guided federal agency participation in and use of voluntary standards. What is the status of the circular and how has it impacted the participation of U.S. Environmental Protection Agency employees in standards development?

In its first iteration, the OMB Circular did not focus very much on federal agency participation in standards development or even on regulations. Federal procurement was the big focus. Of all agencies, the U.S. Department of Defense had the greatest initial influence on the circular, along with the U.S. Department of Commerce and the National Institute of Standards and Technology. But by the 1993 revision, regulatory use and agency participation were emphasized far more, and then with the passage of the National Technology Transfer and Advancement Act in 1996, the circular was again revised in 1998 and has had growing influence ever since.

So what changes happened that drove the legislation and the revisions of the circular since it was first conceived and which might indicate an increase in federal government participation in the development of standards? Clearly, one factor is that trade now means big business even to small businesses because it's a global marketplace with global supply chains. Everyone is looking for bigger markets, broader markets - domestically and internationally. As a result, standards have to enable not only the production of those goods but also communication among buyers and sellers in different economies. Standards are at the very center of not only the cross-border trade element of business, but all of the economic elements - production, resources, design, testing and so forth - that go into the making and distribution of goods and services around the globe.

So as the trade world expands, how do we ensure that the environment and public health are adequately cared for? The answer to that is going to include both regulations and the participation of regulators in developing standards that help produce those globally traded goods. The OMB Circular language reflects the fact that agencies have the authority to participate and are encouraged to participate.

In 1993, the U.S. Department of Justice issued a statement that said not only are federal employees able to participate in standards development, but that we are able to participate at all levels. It was encouraging to know that we could lead technical committees and serve on boards of directors where policies are made that impact strategic, standards-related goals. Federal agencies have become more aware of their ability to contribute their own expertise and leverage the expertise available in the private sector by participating in standards development organizations.

The EPA wants to be able to interface with standards to coordinate its mission - its mandate for environmental protection - with the needs of industry and others in developing technologies. Within the standards development arena, to have the combined perspective of industry, consumers, nongovernment organizations and academia has become more and more important to EPA, especially in areas such as sustainability, clean technologies, energy usage and efficiency, the built environment, water and others. So our participation in standards development has grown.

OMB has been looking at developments since the last time the circular was revised. One issue revolves around incorporation by reference. Some say that, since a regulation has the impact of law, all information in that regulation, including the referenced standards, should be freely available to the public. This presents a challenge for agencies and ASTM International and other standards developing organizations - to accommodate the needs of the public sector for access to information while at the same time ensuring that intellectual property is protected. The Office of the Federal Register has been petitioned in the last year to require that standards referenced in notices of regulation or final regulations be freely available. In addition to this, OMB is also exploring the impact of the digitization of information on the federal use of standards.

OMB held a workshop last year to address some of these questions with the public sector and is determining whether to revise the circular. As far as I know, at this point OMB has not made any final decisions. I expect we may see more about this in 2013.

You mention the incorporation of standards by reference in regulation. How can EPA and ASTM International address this issue in a way that will benefit all affected parties?

The issue of incorporation by reference and free accessibility is a difficult one. On the one hand, it is difficult to argue against the accessibility of something that is referenced in a law. On the other hand, standards developing organizations possess the copyright to these standards.

One of the advantages of having copyrighted information in a document is that you have a source you can go to in order to discover how the content of that document was developed and assess the value and quality of that content. Without that ability, one is less sure of how that information might be useful in a regulation. The fact is that federal agencies such as EPA do not have the ability to develop all of our own standards. We rely on the private sector for the various reasons I mentioned earlier.

When EPA issues a rule for public comment and it has an ASTM standard incorporated into it, which happens quite often, ASTM International makes that standard available on a read-only basis during the public comment period. In addition, ASTM has recently made available all standards referenced in U.S. regulations on a read-only basis. This is a big help for the agency as well as the regulated community and the public.

 

When seeking public comment on proposed regulations, what value is there in having utilized the consensus standards development process?

For regulatory purposes in particular, there is a huge value in knowing that the deliberative consensus process includes the broad array of stakeholders that are necessary to produce a quality standard and to enable the applicability of that standard. It is of value to the regulator to know that the regulated community itself has likely participated in the development of the standard. Given this approach, it's far less likely that we're going to get feedback in the public comment period saying that a standard is too narrow, or that it only serves the interest of a certain sector, or is monopolistic. Any of these things that could hinder the usefulness of a standard within a regulation are reduced dramatically when the consensus process is used.

Sometimes, when there is a need to issue a regulation quickly, and a required standard is under development, it can be difficult to get the standard finished quickly enough within the consensus process. But ASTM does have the ability to accommodate the need for faster turnaround. That is extremely helpful for the agency, as it is for industry.

The value of consensus is that you have a much higher chance of getting the work done right the first time. The accuracy, the quality of it, the chances of it being the right solution, are much higher.

 

What is the future of public policy and government use of voluntary consensus standards? How will changes that you see on the horizon impact EPA and standards developers such as ASTM?

We've already talked about some of the challenges faced by the public-private partnership in standards development. Another challenge is one of discerning the appropriate role of government when it comes to developing standards for national crises or priorities. In establishing its own Subcommittee on Standards, the National Science and Technology Council of the White House has put a marker down for thinking strategically about standards. We are now asking how to determine the federal government's role when systemic concerns such as national security, national energy issues such as smart grid, or cybersecurity arise that require a collaborative and strategic approach. Each of these has a standards component to it.

Are there cases where it would be appropriate for the government to take over the development of standards in a given area? What would be the metrics for that? Are there cases where the government's appropriate role would be a leading one but still within the sphere of private-sector standards developing organizations? These are issues we are actively exploring. Another way to engage would be to determine where industry and other sectors are already involved in standards development in broad areas such as environmental risk assessment and sustainability, for example. In those cases our proper role might be to bring our agencies' views and expertise to the table; perhaps not taking the sole leading role in those instances, but addressing the issue in a way that we can support. And finally, there might be times when private sector standards development might be enough and, while we're interested in the outcome, we do not have to participate.

This is where the challenge is going to be for federal policy - to help federal agencies identify and discern what their roles are so that we leverage and maximize public resources. I see ASTM International as one of the essential connections in the deliberation and communication between government and the private sector.

I would like to recognize the excellent work of the National Institute of Standards and Technology in assisting federal agencies, coordinating across agencies by chairing the Interagency Committee on Standards Policy, and particularly the efforts of NIST director, Patrick Gallagher, Ph.D., in helping to establish the White House Subcommittee on Standards, which is a real boon to the U.S. federal government as well as to industry. The U.S. standards system as a whole and industry have been looking for leadership at the executive level. For those of us in the federal sector, it can be difficult to think about systemic national challenges in terms of needed standards in a strategic way when you have also to think about it primarily in terms of your own agency's mission. Where will that integrated approach occur? With NIST's management of the ICSP and the Subcommittee on Standards, when it comes to national crises and issues, we now have a solid base of cross-agency information sharing, collaboration and idea-building relative to standards that is going up to the executive level; the public and industry can only benefit from this. There's a lot of good information on the ICSP and the subcommittee on the standards.gov website.

 

Efforts to increase sustainability in everything from manufacturing processes to construction to event planning often highlight the need for various systems to interact holistically. How can the standards community come together to address common areas for their varied constituencies?

The classic perception of sustainability is that it's a coming together of environmental, economic and social issues. One way to think about it is to approach any given situation or challenge, any activity or decision, whether it be in manufacturing or public policy or in healthcare or agriculture or food services, and ask: If I'm going to make a decision, will that decision result in something that improves the interface between these three broad areas? Is it sustainable if I look at it from an environmental perspective? Is it sustainable economically? Is it sustainable for the community that will be involved or impacted? Or am I missing an essential element that will severely handicap one or more of these three "legs"?

And this is where standards are particularly key. Let's say I am going to make a decision on where to build a manufacturing plant, and I know that sustainability is important to my company. The questions I ask myself include: Where is the best location in terms of reducing environmental impacts, preventing pollution, sustaining the environment? What business models and management tools in this chosen location will be sustainable in terms of growth and prosperity for the company, welfare of my employees and the surrounding community? Am I going to be able to meet the requirements of regulations? And what are the tools I can find to help me make the decision? Are there tools for environmental risk assessment? There are. Are there tools for green building products and processes? There are. Are there business management tools and economic incentive tools? There are. These are all found in standards. Standardization communities have to be prepared to assist companies, industries, government agencies and consumers in addressing situational issues holistically, based on principles of sustainability. This will probably require suites of standards. ASTM is already taking this approach and offers this kind of assistance; for example, ASTM has a suite of green meeting standards.

In determining what you need in order to assess the sustainability of any of your decisions, you need to engage the community - the community of people in your company, the community of people in the surrounding area, the community of experts who can give you information. And that is where organizations like ASTM International offer a tremendous advantage, because ASTM is composed of thousands of high-level experts from around the globe who can help you make those decisions.

 

As EPA's standards executive, you are aware of the creation of a broad array of standards for sustainability and ecolabeling, some of which are created with more balanced and industry-accepted processes than others. How does EPA decide which standards to utilize?

EPA has a basic mission to protect human health and the environment. We do that through regulatory processes, but also through partnership programs such as WaterSense and ENERGY STAR, where we leverage our resources with those of industry, to envision what sustainability goals we can push for. Some ASTM standards undergird the ENERGY STAR program.

Take the green meetings or green hospitality issue again. There are large hotels that have already undertaken a lot of greening in their processes and operations. When EPA chooses a hotel for a conference, should we look for facilities where there is a focus on sustainability? If we say yes to that as a principle, it's not just EPA making this decision. It means we are already supporting the decisions and goals for greening set by the industry. Which is why all stakeholders - the industry, EPA, customers, suppliers - need to come together in the development of useful, high quality standards that support the greening process and the ability of customers to identify which institutions are working toward that. The same holds true for products. What EPA is looking for in an area like this is not generally standards to put in regulations, but standards that will help push the envelope, which is why agency folks participate in work such as the suite of standards mentioned above.

EPA is interested in contributing our expertise, but we want to involve the public and stakeholders in across-the-board, life-cycle thinking. Our approach is to meet people and organizations where they are and lead them to the extent we can and have expertise to achieve their own vision of how to be sustainable and how to integrate that with their own business model and their interactions with their communities. We are especially in need of standards that will enable data comparisons so that consumers, industry and anyone can readily assess which products and services they are most interested in relative to their own environmental or sustainability goals. So I would say the agency is interested in a range of different standards types.

 

 

ASTM is committed to validating its test methods and assists technical committees in doing so through its Interlaboratory Study Program. What value does this validation have to EPA?

This has a tremendous value for EPA, particularly in our regulatory work. When we incorporate a standard by reference, it's very important to have access to validation studies, particularly in communicating to the private sector - and the public as a whole - why we've chosen a particular test method and how that test method fits with the purpose of the regulation. Validation helps us show that if the regulated community uses this test method, they can be assured they're in compliance with the testing requirements of the regulation.

Occasionally, rule writers may feel they cannot use a given standard because they don't have the validation data. ASTM is quite flexible in responding to requests from the EPA and other government agencies. If they can make validation data available to us, it can mean the difference between being able to use a standard that would work really well in regulation and not being able to use it.

 

Do you have anything to add?

I am excited, honored and humbled all at once at the privilege of serving as chairman of the ASTM International board of directors. I also want to express my appreciation for the network of people and circumstances that have enabled me to do this. ASTM International has a wonderful, sustaining ethic and culture. The entire team of officers and the ASTM staff are the highest quality of people one could hope to work with. The standards produced by this organization, the expertise that you draw upon from around the world, are very valuable to EPA, to the U.S. public and private sectors, and to the global marketplace.

I'm particularly pleased that 2013 is the Year of the Leader at ASTM. Two themes I'd like to weave through this year are, first, encouraging the mentoring and development of the coming generations of standards professionals. ASTM's leadership program for that is outstanding. Secondly, helping to bring public and private sector leaders into a greater understanding of how voluntary nongovernment consensus standards such as those developed through ASTM International are fundamental tools for achieving regulatory and business goals. We are stronger as a country and a global community when our strategies and visions are as aligned and mutually constructive as possible. As you can tell, I'm really looking forward to this year with ASTM!

 

Mary C. McKiel, Ph.D., is the standards executive with the U.S. Environmental Protection Agency in Washington, D.C.

At EPA, McKiel directs the agency's implementation of the National Technology Transfer and Advancement Act and OMB Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities. She establishes standards-related policies for the agency and aids EPA offices in using voluntary standards and participating in standards developing organizations such as ASTM International. She has been instrumental in assisting EPA offices in using ASTM and other voluntary consensus standards both in rule-making actions as well as in voluntary programs.

McKiel also represents the agency in various domestic and international standards arenas in both the public and private sectors, including the Pacific Area Standards Congress and the United Nations Work Group on Regulatory Practices in Standards. McKiel participates and contributes to government-wide standards and conformity assessment policies along with other federal regulatory, science and technical, consumer and trade agencies. She represents EPA in the Interagency Committee on Standards Policy chaired by the National Institute of Standards and Technology. EPA has honored her with bronze, silver and gold medals for her standards work.

Prior to working at EPA, McKiel was director of quality standards at what was then the Federal Supply Service of the General Services Administration, and for her first five years of public service was an analytical chemist with the then National Archives and Records Services, where she conducted and published original research leading to the production and preservation of archival quality documents. While at the National Archives, McKiel was a member of ASTM Committee D06 on Paper and Paper Products.

McKiel has worked on various ASTM committees for more than 20 years and currently serves on Committees E50 on Environmental Assessment, Risk Management and Corrective Action and E60 on Sustainability. She served three years on the ASTM International board of directors before being elected as vice chairman of the board.

In addition, McKiel is a former vice chairman of the board of the American National Standards Institute, a position she held for eight years. She currently chairs the ANSI ISO Council as well as the Government Member Forum and is an ex-officio member of the ANSI board of directors. She served as vice chair to the U.S. Technical Advisory Group during the development of the ISO 14000 series of standards on environmental management. In 2008, she was awarded the ANSI George S. Wham Leadership Medal for her contributions to standardization. She is also the recipient of the 2010 Leo B. Moore medal from the SES: the Society for Standards Professionals, for achievement, service and contributions in the field of standardization. For more than 10 years McKiel has been a member of both the Management Systems Advisory Council and the UL Environmental and Public Health Council.

McKiel has written about the federal use of nongovernment standards for a wide variety of governmental and private sector publications worldwide and has delivered presentations in person and via television to both national and international audiences.