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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > What's New in the U.S. on Nano?

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
With GlobalChem 2011 concluding this week, it is timely to take stock in the status of nanotechnology governance activities underway at the federal level. Representatives from the U.S. Environmental Protection Agency (EPA) provided a brief update on regulatory initiatives in their remarks at the conference. Here is a quick summary of key initiatives.

March 26th, 2011

What's New in the U.S. on Nano?

What's New in the U.S. on Nano?

By

Lynn L. Bergeson*



With GlobalChem 2011 concluding this week, it is timely to take stock in the status of nanotechnology governance activities underway at the federal level. Representatives from the U.S. Environmental Protection Agency (EPA) provided a brief update on regulatory initiatives in their remarks at the conference. Here is a quick summary of key initiatives.

Federal Legislation

On December 28, 2010, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010 (H.R. 5116) was presented to President Obama for signature. Importantly for nano stakeholders, the bill, as unanimously passed by the Senate on December 17, 2010, does not include reauthorization of the National Nanotechnology Initiative (NNI). A spokesperson for the House Committee on Science and Technology stated that the Senate version does not reauthorize the NNI because objections to the provision were raised by the Senate. The House passed similar legislation on May 28, 2010, and that legislation would have reauthorized the NNI.

This last minute legislative change was not what nano stakeholders wanted or expected. It means, of course that the NNI, the program that just celebrated with much fanfare its 10-year anniversary, the program created to coordinate U.S. nanotechnology research and development (R&D), has eluded reauthorization for the third straight Congressional session.

As most nano stakeholders know, work at the federal level to coordinate U.S. federal agency nano initiatives began years earlier, but it was not until the Clinton Administration・s 2001 budget submission to Congress that nanoscale science and technology was raised to the level of a federal initiative and officially referred to as the NNI. The NNI is managed within the framework of the Nanoscale Science Engineering and Technology (NSET) Subcommittee of the National Science and Technology Council (NSTC). The NSTC is composed of representatives from federal agencies participating in the NNI and is a Cabinet-level council through which the President coordinates science, space, and technology policies across the federal government.

The 21st Century Research and Development Act (Public Law 108-153) was enacted in 2003. The Act established a more formal organizational framework for the NNI and defined the role of the National Nanotechnology Coordination Office (NNCO) as the Secretariat of the NSET Subcommittee managing its day-to-day activities. The NNCO・s Director, Dr. Clayton Teague, and its Deputy Director, Dr. Sally Tinkle, are two high-profile international nano stakeholders whose contributions and leadership have been indispensible to the success of the NNI and the commercialization of nanotechnology generally.

When originally passed by Congress in 2007, the America COMPETES Act reauthorized the NNI and gave it some direction in terms of grant funding and goals. The House of Representatives has been trying to reauthorize this program since 2008 and has deliberated on the legislation over the last three sessions of Congress.

In 2010, by a vote of 228-130, the House cleared legislation to reauthorize spending on a variety of science, education, and technology programs at federal agencies, including the National Science Foundation and the National Institute of Standards and Technology, and it included a provision to reauthorize the NNI. The Senate unanimously passed the measure, which would reauthorize the 2007 America COMPETES Act, on December 17, 2011. As noted, however, some in the Senate objected to the provision reauthorizing the NNI and the version that passed the Senate and was enacted into law contains no reference to nanotechnology.

Given this background, and the fact that NNI reauthorization has been in play for years, the question presented is what does the absence of reauthorization mean? In the near term and operationally, the answer is probably not much. The NNI will continue to operate under its original legislation and its operation is not time-limited. The absence of reauthorization over the longer term, however, may invite potentially adverse implications. In that the purpose of a reauthorization is to provide guidance and instruction to the NNCO regarding what Congress wishes, the absence of such guidance and direction could be misinterpreted as a lack of Congressional interest and/or fiscal year support. The fact that President Obama・s (FY) 2012 budget request submitted on February 14, 2011, seeks an increase of $201 million in the NNI・s budget to $2.1 billion suggests that the Administration appreciates the importance of the NNI and the value of its work in supporting R&D efforts to commercialize nanotechnology. It remains to be seen, however, how the Congressional budget approval process responds to this budget request. It is possible this request will be flattened or reduced. As the relentless pressure to reduce federal funding increases, the absence of reauthorization could cause the NNI to get lost in the shuffle, and diminish the stature and critical role of the NNI as a :central locus of communication, cooperation, and collaboration for all Federal agencies; for all things nano.

Another regrettable implication is the message that Congress may inadvertently be sending in repeatedly not reauthorizing the NNI. To ensure the U.S. remains competitive and that the NNI receives the benefit of Congressional guidance and direction on priorities that reflect Congressional constituent interests, the NNI should be reauthorized. Also, in some international forums, the lack of Congressional reauthorization might be taken as a sign of reduced interest on the part of our government in maintaining its current leadership role. The hope is reauthorization legislation is initiated promptly, and nano stakeholders do what they can to make this happen.

Federal Policies

A March 11, 2011, memorandum from the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) sets forth the Obama Administration・s principles for regulation and oversight of emerging technologies, including nanotechnology. According to some U.S. trade press reports, the memorandum reportedly was not especially welcome news in some NGO camps, which claim the memorandum reflects further retreat from regulatory initiatives intended to regulate manufactured nanoscale materials. That aside, the tone and content of the missive is promising, and consistent with President Obama・s State of the Union remarks in January linking innovation with jobs and a robust economy.

The ETIPC Co-Chairs include John P. Holdren, Assistant to the President for Science and Technology, Director, Office of Science and Technology Policy (OSTP); Cass R. Sunstein, Administrator, Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB); and Islam A. Siddiqui, Chief Agricultural Negotiator, United States Trade Representative. The memorandum is directed to the heads of executive departments and agencies, and outlines broad principles intended to guide the development and implementation of policies for oversight of emerging technologies at the agency level.

The nano community is mindful of the delicate balance between appropriate government oversight that is essential to win over and maintain the public・s trust and innovation-killing over-regulation that hampers commercial opportunities without providing value. Perhaps in response to a regulation-wary House of Representatives, the memorandum reflects a renewed commitment to nurture new technologies and seek to avoid the excesses that can thwart innovation. The memorandum outlines the following general principles:

- Scientific Integrity: Federal regulation and oversight of emerging technologies should be based on the best available scientific evidence;

- Public Participation: To the extent feasible, relevant information should be developed with ample opportunities for stakeholder involvement and public participation;

- 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;

- Flexibility: 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;

- Coordination: Federal agencies should seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues associated with the commercialization of an emerging technology in an effort to craft a coherent approach;

- International Cooperation: The federal government should encourage coordinated and collaborative research across the international community; and

- Regulation: The federal government should adhere to President Obama・s January 21, 2011, Executive Order 13563 and, consistent with that order, the following principles when regulating emerging technologies:

- Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;

- Regulations should be developed with a firm commitment to fair notice and to public participation;

- The benefits of regulation should justify the costs;

- 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.

While the principles are broad and very general, it remains unclear how this directive will be implemented in real time. That said, it is nonetheless comforting that the Administration, at a pretty high level, has renewed its pledge to promote innovation and emerging technologies while remaining flexible and predictable on the regulatory front. The memo is available at http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies-new.pdf . Executive Order 13563 is available at http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf .

The EPA Office of Pesticide Programs continues to consider adopting a policy that would require any pesticide registrant that is aware that a constituent of a registered pesticide product is at the nanoscale to submit the information to EPA pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2). EPA is also expected to confirm its view that substitution of a nanoscale active or inert ingredient for a conventionally-sized active or inert ingredient in a FIFRA-registered product requires the registrant to submit an application to amend that registration.

Federal Nano Rulemakings

EPA stated at GlobalChem that it has received more than 100 new chemical notices for nanomaterials since 2005. EPA also confirmed that it will seek to propose this year a Significant New Use Rule (SNUR) under Toxic Substances Control Act (TSCA) Section 5 for nanoscale chemical substances under TSCA. The SNUR would require TSCA reporting of new nanoscale uses of materials that are existing chemicals.

EPA is also working on a TSCA Section 4 test rule under which chemical manufacturers would be required to develop data production to determine the health effects of certain multi-wall carbon nanotubes and nanosized clays and alumina.

Finally, EPA is working on a proposed TSCA Section 8(a) rule to require reporting of available use, production volume, exposure, and toxicity data for existing nanoscale materials.

Stay tuned. There is much going on and stakeholders are urged to monitor these initiatives and comment on them when the opportunities to do so present themselves.




* Lynn L. Bergeson is Managing Director of Bergeson & Campbell, P.C., a Washington, D.C. law firm focusing on conventional and engineered nanoscale chemical, pesticide, and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation, and associated business issues, and President of The Acta Group, L.L.C. and The Acta Group EU, Ltd with offices in Washington, D.C. and Manchester, UK.

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