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Publications

Nanotechnology

“Governance of Nanotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract.”

By George Kimbrell, Journal of Law, Medicine and Ethics, Winter 2009

Grounded in the NGO group’s principles for the oversight of nanotechnology document, this article addresses the difficult question, how should oversight for nanotechnology and its products be formulated? The first section of this article summarizes the principles of oversight that are necessary in the author’s view to support good governance for nanotechnology and grow out of the NGO effort discussed above. The second, third, and fourth sections delve into the application of these principles in greater detail, roughly in order of potential implementation difficulty and time. Thus, the second section explains why mandatory oversight, not voluntary programs, is needed. The third section discusses the need for regulatory action and adjustment that accounts for the challenges presented by nanomaterials. The fourth outlines the larger need for legislative action to ensure regulators have the tools they need and connect nanotechnology oversight with larger governance themes. It also discusses the opportunity that nanotechnology presents to fix long-standing problems in the environmental and health oversight. Finally, the last section makes a case for precaution as the touchstone of oversight.

Principles for the Oversight of Nanotechnologies and Nanomaterials
January 31, 2008

The undersigned, a broad coalition of civil society, public interest, environmental and labor organizations concerned about various aspects of nanotechnology’s human health, environmental, social, ethical, and other impacts, submit the following Declaration, Principles for the Oversight of Nanotechnologies and Nanomaterials.

Governments, universities, and businesses around the world are racing to commercialize nanotechnologies and nanomaterials.   Already, hundreds of consumer products either contain nanomaterials (nano-scale chemicals) in the finished product, or are made using nanotechnologies.   At the same time, mounting evidence indicates that this new materials revolution poses significant health, safety, and environmental hazards as well as profound social, economic, and ethical challenges.  Those speeding the commercialization of nanotechnologies have barely begun the research needed both to clarify and reduce risks and to develop urgently needed ethical, legal and regulatory oversight mechanisms.   These mechanisms are required if we are to avoid repeating failures of past ‘wonder’ materials and technologies.

The current situation does not give us hope that we will ‘get it right’ with nanotechnology.  Manufacturing and laboratory settings operate without proper safety guidance or protection measures.  Consumers are involuntarily exposed to unlabeled nanomaterial ingredients in products, without being informed of potential risks.  Nanomaterials are disposed of and released into the environment despite unknown impacts and inadequate means to detect, track or remove the new materials.  Governments and industry developers of nanotechnologies provide few meaningful opportunities for informed public participation in discussions and decisions about how, or even whether, to proceed with the ‘nano’-ization of the world.

This document declares eight fundamental principles that we believe must provide the foundation for adequate and effective oversight and assessment of the emerging field of nanotechnology, including those nanomaterials that are already in widespread commercial use.

The Principles
  • A Precautionary Foundation
  • Mandatory Nano-specific Regulations
  • Health and Safety of the Public and Workers
  • Environmental Protection
  • Transparency
  • Public Participation
  • Inclusion of Broader Impacts
  • Manufacturer Liability

A precautionary approach is fundamental. A precautionary approach requires mandatory, nano-specific oversight mechanisms to account for the unique characteristics of the materials.  Within those mechanisms, the protection of public health and worker safety requires a committed focus on critical risk research and immediate action to mitigate potential exposures until safety is demonstrated.  Similar emphasis and action must be taken with regard to safeguarding the natural environment.  Throughout, oversight must be transparent and provide public access to information regarding decision-making processes, safety testing and products.  Open, meaningful and full public participation at every level is essential.  These discussions and analyses should include consideration of nanotechnology’s wide-ranging effects, including ethical and social impacts.  Finally, developers and manufacturers must be stewards responsible for the safety and effectiveness of their processes and products, and retain liability for any adverse impacts stemming from them.   Governmental bodies, organizations, and relevant parties should implement comprehensive oversight mechanisms enacting, incorporating and internalizing these basic principles as soon as possible.

American Bar Association Meeting Presentation on Nanotechnology Nanomaterials in Consumer Products, and FDA Regulation
August 12, 2007

CTA Staff Attorney George Kimbrell spoke on nanotechnology oversight issues at the American Bar Association’s 2007 conference in San Francisco, CA, August 12, 2007.

Oversight of Nanomaterials in Consumer Products
February 8, 2007

CTA Staff Attorney George Kimbrell spoke on nanotechnology oversight issues at Intertech Pira’s Regulation of Nanotechnology in Consumer Products Conference in Washington, D.C., February 8-9, 2007.

Nanotechnology and Toxic Torts
December 11, 2006

CTA Staff Attorney George Kimbrell addressed plaintiff and defense toxic tort attorneys from around the country at the 2006 HarrisMartin Publishing’s Cutting Edge Toxic Tort conference in Scottsdale, AZ on the human health and environmental hazards of nanomaterials and the possibility of future nano-based toxic torts.

Nanomaterials in Consumer Products:It’s a Small (and Unregulated) World After All
December 1, 2006

CTA Staff Attorney George Kimbrell provided this commentary to the University of Chicago-Kent School of Law’s Center on Nanotechnology and Society on Nanomaterials in Consumer Products and FDA’s first Public Meeting on Nanotechnology.

Nanomaterials in the Waste Stream
October 6, 2006

Nanomaterials are being integrated into consumer products at an alarming rate, where they are traveling through the household waste stream and into the environment.  Their impacts are largely unknown, but existing studies raise red flags concerning some manufactured nanoparticles’ mobility and interactions with microorganisms.  CTA Staff Attorney George Kimbrell spoke at the 2006 National Association of Clean Water Agencies (NACWA) conference about these concerns.

Carpe Diem: Now is the Time to Consider Nanotechnology’s Impact on the Human Condition
October 1, 2006

CTA Human Genetics Director Jaydee Hanson provided this commentary to the University of Chicago-Kent School of Law’s Center on Nanotechnology and Society discussing nanotechnology’s impacts on the human condition.

Nanomaterials in Sunscreens and Cosmetics
September 13, 2006

CTA Staff Attorney George Kimbrell spoke at the 2006 Health and Beauty America (HBA) Expo’s Regulatory Summit on the regulation of nanomaterials used in personal care products.  Held at the Jacob K. Javits Center in New York City, the HBA Expo is the largest personal care product conference in the world.  Mr. Kimbrell was the only non-industry speaker invited to the Summit (webcast available here).

Nanomaterials in Consumer Products and FDA Regulation: Regulatory Challenges and Necessary Amendments
September 1, 2006

Nanotechnology Law and Business, the leading peer reviewed journal devoted to the legal, business, and policy aspects of small scale technologies, publishes an article on CTA’s FDA petition and related regulatory issues written by CTA Staff Attorney George Kimbrell, 3 Nanotech L. & Bus. 328 (Fall 2006).

Nanotechnology and Biotechnology in Society (NABIS) 2006 Conference
August 10, 2006

The 2006 Nano and Bio In Society conference brought together leading scientists, academics, industry representatives, government officials, and non-profit organizations to discuss the various impacts these technologies are having on our planet and society.  CTA Staff Attorney George Kimbrell spoke on U.S. regulation of nanomaterials in consumer products.

Friends of the Earth publishes report on use of nanotechnology in cosmetics
May 16, 2006

Some of the biggest names in cosmetics, including L’Oreal, Revlon and Estee Lauder, continue to sell products containing nano-scale ingredients despite growing evidence that nanomaterials can be toxic to humans, according to a report released today by Friends of the Earth.

The report, titled “Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks”, details the extensive use of newly developed and poorly understood substances called nanomaterials in more than 116 sunscreens, cosmetics and personal care products currently on the market, despite a lack of independent safety assessment and regulation. The report also surveys a growing body of scientific research showing that many types of nanoparticles pose risks to consumers, workers and the environment. CTA staffers contributed to the report, which was released in conjunction with CTA’s legal petition to FDA, the first-ever legal action on the risks of nanotechnology.

Lessons for Nanotechnology from Agricultural Biotechnology
November 23, 2005

CTA Human Genetic Director Jaydee Hanson crafted this commentary for the University of Chicago-Kent School of Law’s Center on Nanotechnology and Society on the Lessons for Nanotechnology from Biotechnology and discussing a Fall 2005 Conference held on that topic at Michigan State University.