nanotechnology interdisciplinary research team ses #0609078 (2006-2010) the regulatory landscape:...
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Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
The Regulatory Landscape:
Trends, Common Concerns, and Prospects for New Governance Approaches
Christopher BossoNortheastern University
Overarching Themes
1. Uncertainty – While properties and risk profiles of some nano-materials are understood enough to be covered under existing laws and guidelines (e.g., best practices in occupational EHS), uncertainty about others pose challenges to businesses and government alike.
2. Constraints on industry discretion – Conditions of uncertainty may require some delegation of discretion (e.g., limited self-regulation), but demands for accountability will require greater transparency and stakeholder involvement. Freer markets, stricter rules?
3. Connected citizens – Greater access to information, networked citizenry poses new challenges to relationship between regulators and the regulated
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Contexts
•New social context – end of dominance of free market / deregulation narrative
•Greater overall citizen wariness about business autonomy
•New administration -- Less reflexively opposed to regulation
•An era of more assertive government action
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Recent Actions: Federal Level
•More assertive EPA – moved cautiously during the 2000s, ceding greater latitude for leadership to the states. This has already changed.
• Cancellation of National Environmental Performance Track
• Perceived failures of Materials Stewardship Program – lack of data from program; EPA will consider how best to use Toxic Substances Control Act (TSCA) to gather more risk data.
•More aggressive use of TSCA on CNTs, nano silica and alumina as “new” substances and therefore subject to stricter scrutiny
•Congressional assessment of TSCA after 30 years – Nano has spurred debate over law’s relevance and utility
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
State Governments
•Growing consideration of environmental protection concerns even as states continue economic development strategies to promote nanotechnology R&D.
•Several state governments – e.g., CA, MA, MN, WI -- have significant expertise and regulatory capacity
•History of diffusion and assimilation of state innovations in regulatory approaches
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
State Governments
California: leading the way
•January 2009 -- issues notices to companies that manufacture CNTs, requesting health and safety information•first time a state requires disclosures for a nanomaterial•looking to fill in gaps in knowledge
•California law (Prop. 65) stricter than federal TRI in terms of disclosure -- strong incentive for firms to remove chemicals that would necessitate the application of a warning label to their products
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
State Governments
Massachusetts—Proceeding with caution
•Experience -- perchlorate on Cape Cod led to creation of interagency Emerging Contaminants Workgroup in 2007 to identify new environmental challenges and determine the types of policy responses warranted.
• Institutional capacity Toxics Use Reduction Institute based at the University of Massachusetts at Lowell, authorized by state law to support implementation of the state’s Toxics Use Reduction Act (TURA)
•State experience with biotechnology also gives it capacity to act
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
State Governments
Minnesota and Wisconsin
•Two states with long traditions of innovation in environmental policy
•Possible expansion from the Massachusetts case on using an “emerging contaminants process” to highlight the issue of nanotechnology and begin to formulate policy options.
•Wisconsin has outlined four broad options for state governance of nanotechnology concerns, including a cross-cutting Nanotechnology and Natural Resources Team.
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Local Governments
Local – prompted by citizen concerns
•Berkeley – •2006 ordinance for “nano-disclosure”•Most restrictive regulatory program for nanotechnology of any government in the United States
•Cambridge –•Cambridge Nanomaterials Advisory Committee process•Adopted a voluntary approach on explicit recognition of the lack of information
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
International
•Impacts of non-U.S. law in shaping global governance regime
•More reflexive grounding in precautionary principle
•More transparent, iterative risk governance frameworks
•Impacts on U.S. companies engaged in global trade
•Eventual impacts on U.S. law
Canada – Proposed rule would require companies to detail use of engineered nanomaterials as significant new activity (still not released)
France -- Mandatory nanomaterial declaration proposed (January 2009)
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
International
European Union –utility of REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) for nanomaterials
•Framework applies to approximately 30,000 chemicals •Does not differentiate by size, form or identified uses•Places more responsibility on industry than does TSCA•Likely to have significant impacts on global nanotech regulation
ISO / OECD – significant research and standards setting efforts to reduce uncertainty, create common metrics
Greater likelihood of convergence of EU and U.S. approaches?
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Summary
•Voluntary efforts have not panned out despite efforts by industry associations to bolster participation – businesses not inclined to volunteer.
•Citizen demands for more vigilant government in general will shape responses to emerging technologies -- and existing materials/chemicals.
•Likelihood of greater demand for information transparency – including trade secrets – in return for more nuanced view on risk?
•Case by case assessment for foreseeable future, but the challenges posed by nano- and other emerging technologies (e.g., synthetic biology) may force realignment of regulatory approaches
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Toward 21st Century Regulatory Regimes
•Multi-agency roles in regulating nanotechnology will necessitate a type of governance that defies conventional, hierarchical patterns.
•Networked approaches to governance -- finding ways to secure collaboration among diverse stakeholders will be key, whether it involves disclosure, regulation, or other forms.
•“The question is really how to move beyond simplistic notions, such as self-regulation, to building systems of accountability and governance that are conducive to appropriate expansion of both science and democracy.” -- (International Risk Governance Council 2005, 119)
January 2010 -- RFF Press
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Nanotechnology Interdisciplinary Research Team
SES #0609078 (2006-2010)
Christopher Bosso
Nanotechnology and Society Research Group
http://nsrg.neu.edu