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IEET > Security > SciTech > Fellows > Randall Mayes

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Is Nanotechnology Regulatable? Reporting from the Nano Summit


Randall Mayes
By Randall Mayes
Ethical Technology

Posted: Oct 15, 2009

On October 8-9, roughly 150 invited guests—graduate students, researchers, government officials, and consultants gathered in North Carolina to discuss priorities and provide recommendations to businesses and policy makers to ensure the safe development of nanotechnology.

The Research Triangle Environmental Health Collaborative hosted the event at the North Carolina Biotechnology Center. Created in 1981, the center is the first state sponsored initiative to develop biotechnology. Its mission is to strengthen academic and industrial research institutions, educate the public, and develop partnerships to move research to commercialization. Currently, the RTP area is one of the nation’s hotspots in nanotechnology.

Asilomar provided several lessons for managing biotechnology. The nanotech community is attempting to follow the successful paradigm of the 1975 Asilomar Conference when the risks of recombinant DNA technology were unknown.

1. Public engagement

In the early stages of genetic engineering, the city of Cambridge, MA banned recombinant DNA research. Following a period without the determination of any real risks, Senator Edward Kennedy said, public hysteria cannot be maintained indefinitely in the absence of a credible villain of recombinant DNA technology. 

To prevent negative backlash, it is important to determine the stakeholders concerns and address them through education. Arizona State, University of Wisconsin, and North Carolina State University have secured millions of dollars in NSF grants to study the public’s perception.

The NC State researchers revealed in general the public is not up on the technology enough to be concerned about health and environmental risks. The ETC Group with an office in Chapel Hill is a different story having called for a moratorium and the precautionary principle until further testing is done. Todd Kuiken of the Woodrow Wilson Center’s Project for Emerging Technologies noted we are past precautionary, nanomaterials are already out there.


2. What is unique?

At Asilomar, we learned genetic engineering is a process and recombinant DNA is a product. We understand that the unique properties of nanosize particles also have unknown risks. Their really small size enables them to bypass the immune system and cross the blood brain barrier.


3. Determining real versus perceived risks

Genetic engineering is harmless, but recombinant DNA such as GM foods can have unintended consequences to ecosystems. Businesses loss billions of dollars and governments of third world countries prevented starving people from taking advantage of GM crops.

This lesson has turned out to be a more difficult task for nanotechnology. The workgroup acknowledged researchers and businesses want to know what information is needed and where to get it to determine how to minimize risks. The workgroup recommends this is best accomplished through training and toxicological data. So, information sharing through databases is a priority, and nanotech companies should take the lead for providing it.

Charles Holliday former CEO of DuPont teamed up with Fred Krupp of the Environmental Defense Fund and wrote the Wall Street Journal op-ed Let’s Get Nanotech Right in 2005. The two later developed a partnership, and Holliday spoke about his experiences on developing an industrial model for providing toxicological data. DuPont’s process involves choosing a nanomaterial, studying its life cycle exposure, evaluating the risks, developing risk management, and finally putting a plan into action. This method resulted in the document Nano Risk Framework.


4. How to regulate?

Scientists at Asilomar had a temporary moratorium until the risks were better understood and later developed a recombinant DNA committee to provide guidelines. So, for genetic engineering the scientists were self-regulated.

In a publication produced by the Woodrow Wilson International Center for Scholars Where Does the Nano Go?, a number of federal regulations are discussed that could possibly regulate nanotechnology. Policymakers could potentially use several existing federal laws to regulate the handling of nanomaterials; RRCA for hazardous waste, CERCLA for Superfund, TSCA for chemicals, but changes are necessary.

Even if a specific scenario is determined hazardous, for a risk there must be an exposure. The Holliday-Krupp document provides a life cycle analysis framework for nanomaterials. However, regulations are different than guidelines since regulations need quantification of specific materials and determining thresholds.

But, which nanomaterials are toxic? Nigel Walker, a toxicologist with the National Institute of Environmental Health Sciences located in RTP, discussed the difficulty of determining toxicity. Many types of nanomaterials exist with different shapes and reactivity. They are also used in many scenarios, can change forms, and are part of a product that eventually decomposes.

If a business or researcher is not sure if a nanomaterial is hazardous, what guidelines should currently be followed? In order to receive the economic benefits of nanotechnology and environmental and health protection, a method offered by consultant Jo Anne Shatkin of CLF Ventures is to treat it as if it is hazardous.

Links

Nano Summit
http://environmentalhealthcollaborative.org/summit/summit-2009

Nano Risk Framework
http://www.nanoriskframework.com/page.cfm?tagID=1095

Where Does the Nano Go?
http://www.nanotechproject.org/publications/archive/pen_10_-_where_does


Randall Mayes served as a 2009 IEET Fellow. He is a science writer and policy analyst with a focus on enhancement and emerging biotechnologies.
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