NIRT: Nanotechnology in the Public Interest: Regulatory Challenges, Capacity, and Policy Recommendations:

• Problem: Citizens expect government to protect them from potentially harmful effects of new technologies, yet little attention has been paid to the effective capacity of individuals and agencies faced with this important task.

• Goal: Evaluate federal, state, and local capacity -- e.g., sufficiency in scientific expertise, legal authority, organizational design, and regulatory frameworks -- to address the policy challenges posed by nanoscale innovations and products, and offer recommendations to build requisite capacity as appropriate and feasible

• Related outreach and education: Promote broader understanding of the policy implications of nanotechnology and emerging technologies among local and state public officials, public administration professionals and educators, journalists, and other leaders in the public and non-profit sectors..

NSEC: Center for High-rate Nanomfg: NSEC: Center for High-rate Nanomfg: Thrust 4 – Regulatory AssessmentThrust 4 – Regulatory Assessment

• Problem: As nanotechnology moves rapidly from development to commercialization, a more comprehensive understanding of the production costs, environmental and occupational health risks, and broader societal impacts associated with nanomanufacturing processes is required.

• GoalGoal: : Address issues with direct implications for nanomanufacturing technologies under development at CHN, with special focus on economic development and regulatory issues in the Commonwealth of Massachusetts. Results will help to guide the development of a sustainable production system for nanomanufactured products.

• Related Outreach and Education: Develop and disseminate education materials, with particular focus on front-line laboratory researchers and technicians, K-12 science teachers, students in CHN related programs, and, through partnerships with the Boston Museum of Science/NISE Network.

• Note: CHN is a collaboration among Northeastern University, the University of Massachusetts at Lowell and the University of New Hampshire. CHN Thrust 4 Research includes other research not reported here, in areas such as exposure monitoring, economic environmental assessment, risk assessment.

Overarching ProjectsOverarching Projects

1.1. NIRT – Environmental Regulation NIRT – Environmental Regulation Under Uncertainty Under Uncertainty (Bosso, lead (Bosso, lead PI): PI): addresses the question of how government can ensure effective and responsive environmental protection under conditions of rapid techn ological change, attendant lack of clarity on effects, information asymmetries, and, by extension, the greater direct role for business in regulatory outcome.

1. NIRT-- FDA Capacity (Bosso and Sandler): This project focuses on the challenges facing the U.S. Food and Drug Administration as it expects to grapple with an array of new nano-enabled technologies, in particular human therapeutics, enhancements, sensors, drug delivery systems, and, even, cosmetics

3. 3. NIRT--Capacity Building ProjectNIRT--Capacity Building Project (Kay, lead PI): (Kay, lead PI): Case studies of Case studies of previous instances where new previous instances where new technologies or their impacts technologies or their impacts required government to adapt with required government to adapt with new or revised organizational new or revised organizational featuresfeatures

4. CHN/NIRT--Patent Policy (Kay, lead PI): assess intellectual property issues as they relate to patent reform and rapid commercialization of nanotechnologies

5. CHN/NIRT--Ethical and Justice Issues (Sandler, lead PI): evaluate applications of nanotechnology on their likelihood to promote or compromise environmental values, such as ecological integrity, biodiversity, environmental justice

6. CHN--Application of Life-Cycle Analysis (Isaacs, lead PI): create methodologies to determine the economic feasibility of manufacturing in light of potential environmental consequences for scale-up of technologies.

Focus on Massachusetts Focus on Massachusetts

1. CHN--Fostering the Massachusetts Nanotechnology Sector (Bosso, lead PI): Massachusetts leads in nanotechnology because of its ability to attract major federal funding, its vibrant entrepreneurial and venture capital sectors, and rich technology presence.

To maintain its position, Massachusetts must:•Explore feasibility of a state nanotechnology R&D fund aimed at sectors not covered by the MA life sciences initiative.•Assess workforce needs and existing education opportunities in nanotechnology related fields and, support development of relevant training programs•Encourage formation of a nanotechnology stakeholder network to facilitate commercially productive communication and exchange.

2. CHN/NIRT--MA Biotech Rules: Lessons for Nanotechnology (Bosso): Massachusetts recently streamlined its regulatory regime to address the needs of its biotechnology sector. This study explores the process for revision, key actors, results, and potential relevance for nanotechnology.

3. CHN/NIRT--MA response to environmental emergency: The case of perchlorate contamination on Cape Cod.

4. CHN/NIRT--Siting the Boston University Bio-lab: A case study of the controversy over siting a Level 4 contagious diseases laboratory in a predominately low income/minority area.

5. CHN/NIRT--Monitoring City of Cambridge rule-making on nanoparticles: Real-time observation as Cambridge adapts its rDNA reporting rules to nanoparticle research

6. . CHN/NIRT--The Massachusetts experience with toxics: Case study of the MA toxics use and reduction system

7. CHN--Adapting EHS Procedures (Isaacs, lead PI): Research on methods to measure and control nanoparticles exposure in CHN laboratories; establish best practices.

NIRT: Nanotechnology in the Public Interest: Regulatory Challenges, Capacity, and

Policy Recommendations

National Science Foundation Funding is gratefully acknowledged for NIRT SES-0609078 and NSEC Center for High-Rate Nanomanufacturing EEC-0425826

PartnershipsPartnerships

NSRG researchers enjoy unique NSRG researchers enjoy unique opportunities to collaborate with opportunities to collaborate with colleagues in the NEU NSEC and colleagues in the NEU NSEC and IGERT, with state and local IGERT, with state and local officials, the Museum of Science, officials, the Museum of Science, and with NSEC partners in other and with NSEC partners in other area projects.area projects.

Education and OutreachEducation and Outreach

K-12 Science Teachers: K-12 Science Teachers: CHN-CHN-sponsored workshops, University of sponsored workshops, University of New HampshireNew Hampshire

Citizens, Journalists, Educators: Citizens, Journalists, Educators: Boston Museum of Science/NISE Boston Museum of Science/NISE Network forums and programsNetwork forums and programs

Professional Associations: Professional Associations: posters posters and presentations at meetings in public and presentations at meetings in public administration (NASPAA); political administration (NASPAA); political science (APSA); and engineering science (APSA); and engineering education (ASEE).education (ASEE).

Policymakers, Scholars, JournalistsPolicymakers, Scholars, Journalists: : Workshop--“Workshop--“Nanotechnology and Public Policy: Basic Science, Applications, and Regulatory Implications” (80 attendees).

Undergraduate Research Undergraduate Research positionspositions for students in philosophy, political for students in philosophy, political science, environmental studies, and science, environmental studies, and engineeringengineering

Graduate Research: Graduate Research: Professional Professional development for MPA and Ph.D. development for MPA and Ph.D. students in the social sciences and students in the social sciences and engineeringengineering

Cooperative Education and Cooperative Education and Internship: Internship: e.g., full time 6-month e.g., full time 6-month coop position with the Environmental coop position with the Environmental Law Institute in D.C.Law Institute in D.C.

Content Rich Website: Content Rich Website: http://nsrg.neu.edu

Bi-weekly Bi-weekly NSRG e-newsletterNSRG e-newsletter

Series on Science, Technology and Series on Science, Technology and SocietySociety: e.g., A. Nisbet, S. Jasanoff: e.g., A. Nisbet, S. Jasanoff

Courses: Courses: Science, Technology and Science, Technology and Public Policy (grad and undergrad)Public Policy (grad and undergrad)

Journalism StudentsJournalism Students: modules for : modules for JRN courses on how to cover issues of JRN courses on how to cover issues of technological complexitytechnological complexity

IGERT: IGERT: lectures in NEU Nanomedicine lectures in NEU Nanomedicine IGERT (PI Sridhar) seminarsIGERT (PI Sridhar) seminars

C. Bosso, J. Isaacs, W.D. Kay, R. Sandler, A. Busnaina

NSEC: Center for High-rate Nanomanufacturing:

Thrust 4 - Regulatory Assessment

Nanotechnology and Society Research Group