Regulating Nanotechnology: The Vicious Circle

  Sonia E. Miller, J.D., M.B.A., M.S.Ed., Founder
  Converging Technologies Bar Association

The term "nanotechnology" elicits controversial debate regarding its risks. Proponents, as well as opponents to its advance, call for new laws and regulations.
Is this warranted?

In Breaking the Vicious Circle: Toward Effective Risk Regulation, U.S. Supreme Court Justice Stephen Breyer identified three elements that impact the federal regulatory schema and that reinforce each other: (1) public perception; (2) Congressional reaction; and (3) the uncertainties of the regulatory process.¹ He called these elements "the vicious circle . . . a problem that combines substance, procedure, politics, and administration."²

Public Perception
In a recently released study entitled "Informed Public Perceptions of Nanotechnology and Trust in Government,"³ Jane Macoubrie questioned the public's perception of government, nanotechnology, and regulation. Her findings cited that 54% of those surveyed reported knowing almost nothing about nanotechnology.⁴ Yet, in the same study, the majority of respondents reported that they expected major benefits from nanotechnology.⁵ In general, respondents expressed a lack of trust in government regulatory agencies and suspicion of industry pushing inadequately tested products into the market.⁶

Congressional Reaction
In 2003, Congress reacted to the nanotechnology phenomenon by passing an act establishing the National Nanotechnology Initiative while authorizing $3.7 billion for its research across several federal agencies for the purpose of accelerating the discovery, development, and deployment of nanoscale science, engineering, and technology.⁷ The act also provided for a one-time study to be conducted to assess the need for standards, guidelines, or strategies for ensuring "the responsible development of nanotechnology,"⁸ a phrase not clearly defined.

The President's Council of Advisors in Science and Technology (PCAST), in early 2004, heard about research being conducted on the health and environmental impacts of nanomaterials and the efforts of federal agencies to regulate them. Some of the comments were that: no consensus existed in the scientific community regarding he need for regulation; little was known about the impact of nanoparticles on biological systems; consistent terminology was non-existent; and it was unclear what nanomaterials and products would require FDA or EPA approval before going to market.⁹ Today, resolution to those comments is still pending.

The Uncertainties of the Regulatory Process
There exist two major schools of thought around the issue of regulation for nanotechnology.¹⁰ The first school is prevalent in the United States and is defined by a laissez-faire regulatory approach: nanoparticles pose no risk due to their small size and, therefore, do not warrant new regulation, positing that current safety and health regulations are adequate.¹¹ The other school of thought, championed by advocacy groups and non-governmental organizations, proposes that tinkering with existing regulations is insufficient to manage the potential risks of nanotechnology, and calls for the drafting of entirely new regulations.¹²

The question remains: Do regulations now in place need to be amended as a result of its [nanotechnology] capabilities?¹³ According to J. Clarence Davies: "Given all the difficulties of using existing laws to address the potential adverse effects of nanotechnology, there is much to be said for considering a completely new law."¹⁴ At the other end of the continuum, recommended is a regulatory process emphasizing a regime of modest regulation, civilian research, industry self-regulation, and a responsible professional culture.¹⁵

The uncertainties of the current regulatory process as it pertains to yet unproven risks related to nanoscale technologies continue to demand further inquiry and research. In the interim, developing appropriate monitoring and warning systems when current regulations prove insufficient16 might begin to break the "vicious circle" and bring resolve to the interaction of three disparate elements lacking a unified and cohesive regulatory approach.

Sonia E. Miller, J.D., M.B.A., M.S.Ed. is founder and global president of the Converging Technologies Bar Association (CTBA), the first and only professional association in the world dedicated to addressing the multi-faceted impact of converging technologies. Miller serves on the Center on Nanotechnology and Society's Advisory Panel.

¹ STEPHEN BREYER, BREAKING THE VICIOUS CIRCLE: TOWARD EFFECTIVE RISK REGULATION. MA: Harvard University Press (1993).
² Id.
³ JANE MACOUBRIE, INFORMED PUBLIC PERCEPTIONS OF NANOTECHNOLOGY AND TRUST IN GOVERNMENT 8 (2005).
³ Id.
⁴ Id.
⁵ Id. at 3.
⁶ Id. at 4.
⁷21st Century Nanotechnology Research and Development Act, Pub. L. No. 108-153, 117 stat. 1923.
⁸ Id.
⁹ Id.
¹⁰Sonia E. Miller, Regulating Nanotechnology: The EPA and FDA are Likely Watchdogs. 10 N.Y. L J. 5,Apr. 5, 2005.
¹¹ Id.
¹² Id.
¹³ Sonia E. Miller, The Convergence of N: On Nanotechnology, Nanobiotechnology and Nanomedicine. 13 N.Y. L.J. 5, Dec. 2, 2003.
¹⁴ J. CLARENCE DAVIES, MANAGING THE EFFECTS OF NANOTECHNOLOGY (2006).
¹⁵ Glenn Harlan Reynolds, Nanotechnology and Regulatory Policy: Three Futures, 17 HARV. J. LAW & TEC. 179, 200 (2003).
¹⁶ INTERNATIONAL RISK GOVERNANCE COUNCIL WORKING GROUP ON NANOTECHNOLOGY, SURVEY ON NANOTECHNOLOGY AND GOVERNANCE, VOLUME A. THE ROLE OF GOVERNMENT 17-19 (2005).