Cross-posted from The Risk Science Blog:
Back in 2007 the White House Office of Science and Technology Policy (OSTP) issued a set of “Principles for Nanotechnology Environmental, Health and Safety Oversight” (no longer available on the OSTP website it seems, but you can read them in this Nanowerk article). At the time, I was less than enamored with the “don’t mess with business” tone of the principles. So I was particularly interested to read what the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) had to say on a very similar issue last month.
ETIPC was formed last year, and consists of assistant secretary-level representation from about twenty federal agencies. From the White House blog, the group is
…part of an effort to give special attention to technologies so new—such as nanotechnology and synthetic biology—that their policy implications are still being gauged. Created jointly by OSTP, the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA), and the Office of the United States Trade Representative (USTR), the ETIPC consists of assistant secretary-level representatives from about 20 Federal agencies.
The same post goes on to explain that
Emerging technologies promise to have significant scientific, economic, and perhaps societal impacts because of their potential to revolutionize fields as varied as materials science, electronics, medicine, communications, agriculture, and energy. Rapid scientific and technological advances in these fields are resulting in a variety of new products and processes with unique and transformational characteristics. But full realization of the economic and public benefits of these applications will require open consideration of policy questions with the full range of stakeholders, including governments, industry, non-governmental organizations, academia, and the public.
The first publicly released outcomes of ETIPC were released last month. On March 11 2011, John Holdren (Director of OSTP and Assistant to the President for Science and Technology), Cass Sunstein (Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget) and Islam Siddiqui (Chief Agricultural Negotiator, United States Trade Representative) issued a joint memorandum on Principles for Regulation and Oversight of Emerging Technologies, developed by ETIPC.
These are consistent with the President’s Executive Order 13563 (issued on January 18 2011) on Improving Regulation and Regulatory Review. They also include much of the same language of the 2007 principles. But the tone and emphasis are markedly different.
The memorandum starts by noting that
Innovation with respect to emerging technologies — such as nanotechnology, synthetic biology, and genetic engineering, among others — requires not only coordinated research and development but also appropriate and balanced oversight.
It then frames the issues at stake by stating:
We share a fundamental desire for regulation and oversight that ensure the fulfillment of legitimate objectives such as the protection of safety, health, and the environment. Regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.
This is in stark contrast to the 2007 principles, which have a much stronger primary focus on not intrfereing with business and innovation.
The principles follow up this focus on safety, health and the environment with an emphasis on science-based decision-making, public participation, and flexibility. These reflect emerging thinking on the challenges and opportunities presented by emerging technologies, and appear to offer a firm foundation for moving forward.
However, reading the principles (which are included below) I do have a couple of concerns.
The first is that these principles are extremely general. While establishing laudable objectives such as basing regulation on scientific evidence, engaging stakeholders in the process of developing regulation, balancing the costs and benefits of regulations and ensuring regulatory flexibility, they lack the details which would transform them from a set of nice ideas to something that has impact. This is understandable in a document of this type, but it would be good to see a move toward actionable recommendations coming out of this group.
I’m also concerned that some of the principles hint at less than innovative thinking to address the safe and sustainable development of technology innovation. For instance, while the emphasis on public participation is welcome, the principles are written in terms of modes of public consultation that rarely allow engagement with and input from citizens as opposed to mobilized interest groups. Rather than supporting the idea that posting details of public meetings and consultation periods in the Federal Register constitutes public participation, (it doesn’t), it would be good to see some innovative thinking on what true engagement means in terms of developing effective regulations for emerging technologies.
I am also unsure what “Risk assessment should be distinguished from risk management” means – especially when risk experts are beginning to explore more integrative approaches to risk assessment and management as a way of addressing complex and emerging issues.
But these concerns aside, there is a lot to applaud here. In particular, the combination of science-driven, participatory and flexible approaches to emerging technologies regulation should lay the groundwork for approaches to oversight that both protect people and the environment, and support technology innovation.
It is also worth noting that the principles align closely with the University of Michigan Risk Science Center’s vision of evidence-informed and socially-responsive action on human health risks. And they set the scene rather well for this September’s Risk Science Symposium on Risk, Uncertainty and Sustainable Innovation.
So although there is still a long way to go before technology innovation is accompanied by innovations in governance that will support rather than hinder its safe and sustainable development, these principles are an important step toward the federal government coordinating approaches to ensuring emerging technologies and emergent risks are regulated effectively.
From the memorandum:
…the following principles, consistent with Executive Order 13563 and discussed and approved by the ETIPC, should be respected to the extent permitted by law:
- Scientific Integrity: Federal regulation and oversight of emerging technologies should be based on the best available scientific evidence. Adequate information should be sought and developed, and new knowledge should be taken into account when it becomes available. To the extent feasible, purely scientific judgments should be separated from judgments of policy.
- Public Participation: To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), relevant information should be developed with ample opportunities for stakeholder involvement and public participation. Public participation is important for promoting accountability, for improving decisions, for increasing trust, and for ensuring that officials have access to widely dispersed information.
- Communication: The Federal Government should actively communicate information to the public regarding the potential benefits and risks associated with new technologies.
- Benefits and costs: Federal regulation and oversight of emerging technologies should be based on an awareness of the potential benefits and the potential costs of such regulation and oversight, including recognition of the role of limited information and risk in decision making.
- Flexibility: To the extent practicable, Federal regulation and oversight should provide sufficient flexibility to accommodate new evidence and learning and to take into account the evolving nature of information related to emerging technologies and their applications.
- Risk Assessment and Risk Management: Risk assessment should be distinguished from risk management. The Federal Government should strive to reach an appropriate level of consistency in risk assessment and risk management across various agencies and offices and across various technologies. Federally mandated risk management actions should be appropriate to, and commensurate with, the degree of risk identified in an assessment.
- Coordination: Federal agencies should seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues, including health and safety, economic, environmental, and ethical issues (where applicable) associated with the commercialization of an emerging technology, in an effort to craft a coherent approach. There should be a clear recognition of the statutory limitations of each Federal and state agency and an effort to defer to appropriate entities when attempting to address the breadth of issues.
- International Cooperation: The Federal Government should encourage coordinated and collaborative research across the international community. It should clearly communicate the regulatory approaches and understanding of the United States to other nations. It should promote informed choices and both sharing and development of relevant data, particularly with respect to the benefits and costs of regulation and oversight. The Federal Government should participate in the development of international standards, consistent with U.S. law and guidance (e.g., the National Technology Transfer and Advancement Act and OMB Circular A-119). When appropriate, international approaches should be coordinated as far in advance as possible, to help ensure that such approaches are consistent with these principles.
- Regulation: The Federal Government should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principles, to the extent permitted by law, when regulating emerging technologies:
- Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandates of each agency;
- Regulations should be developed with a firm commitment to fair notice and to public participation;
- The benefits of regulation should justify the costs (to the extent permitted by law and recognizing the relevance of uncertainty and the limits of quantification and monetary equivalents);
- Where possible, regulatory approaches should promote innovation while also advancing regulatory objectives, such as protection of health, the environment, and safety;
- When no significant oversight issue based on a sufficiently distinguishing attribute of the technology or the relevant application can be identified, agencies should consider the option not to regulate;
- Where possible, regulatory approaches should be performance-based and provide predictability and flexibility in the face of fresh evidence and evolving information; and
- Regulatory approaches shall comply with established requirements and guidance such as the following:
- Executive Order 13563 – Improving Regulation and Regulatory Review. Federal Register, Vol. 76, No. 14, Friday, January 21, 2011, 3821-3823, available at http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf;
- Executive Order 12866 – Regulatory Planning and Review. Federal Register Vol. 58, No. 190, Monday, October 4, 1993, 51735-51744, available at http://www.whitehouse.gov/omb/inforeg/eo12866.pdf;
- Information Quality Act (Sec. 515 of the Treasury and General Government Appropriations Act for FY 2001, Pub. L. No. 106-554); Information Quality Guidelines: OMB (2002) Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452 (Feb. 22, 2002), available at http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf;
- National Technology Transfer and Advancement Act of 1995 (“NTTAA”). Public Law 104-113, available at http://standards.gov/standards_gov/nttaa.cfm;
- Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (02/10/1998), available at http://www.whitehouse.gov/omb/circulars/a119/a119.html;
- OMB Final Information Quality Bulletin for Peer Review (December 16, 2004), available at http://www.whitehouse.gov/omb/memoranda/fy2005/m05-03.pdf;
- OMB Bulletin No. 07-02 (M-07-07), Issuance of OMB’s “Final Bulletin for Agency Good Guidance Practices” (January 18,2007), available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-07.pdf;
- OMB/OSTP Memorandum: M-07-24, Updated Principles for Risk Analysis (September 19, 2007), available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf;
- The Trade Agreements Act of 1979, as amended (Pub.L. 96-39, 93 Stat.
144, enacted July 26, 1979, codified at 19 U.S.C. ch.13 (19 U.S.C. §
- A Strategy for American Innovation: Driving Towards Sustainable
Growth and Quality Jobs” (September 2009), available at: http://www.whitehouse.gov/assets/documents/SEPT_20_Innovation_Whitepaper_FINAL.pdf; and
- Office of Information and Regulatory Affairs, Disclosure and Information As Regulatory Tools (June 18, 2010), available at http://www.whitehouse.gov/sites/default/files/omb/assets/inforeg/disclosure_principles.pdf