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EPA’s Stewardship Program: A First Step in Responsible Nanotechnology Growth

October 13th, 2009

Originally published by The Triple Helix.

Alysia Bone, Claire Comfort, Julie Devine, and Michelle Lorica
Georgetown University

Opinions expressed in the Op-Ed articles are solely those of the author and do not represent those of the Triple Helix. However, submission of varying and divergent opinions on controversial and current issues is encouraged.

Nanotechnology, or the use of particles at the 1-100 nanometer scale, is a fast-growing and exciting area of science. Nanoproducts have the potential for many new applications in daily life. Some nanoproducts already on the market are stain-resistant pants, more effective sunscreens and sunglasses, and alternative fuel additives. Despite nanotech’s undeniable potential benefits, some health risks have been associated with their use. For instance, nanoparticles have been shown to be small enough to become embed in the lungs, causing respiratory problems. [1] Because of their scale, nanoparticles could incorporate into DNA, potentially causing carcinogenic mutations. [2] Some of these potential hazards could also provide great health or technological benefits. For example, nanoparticles are able to cross the blood-brain barrier. This could be lifesaving in terms of drug delivery to the brain, since larger particles are not able to cross this barrier. On the other hand, if nanoparticles become prevalent in the environment, they could indiscriminately cross this blood-brain barrier, potentially leading to brain damage. In fact, studies on a specific nanoparticle called the buckyball have already shown that exposure to even a small concentration of nanoparticles can lead to brain damage in fish. [3]

Nanoparticles can be designed
to perform various functions.
Courtesy of proteomics.cancer.gov

To date, the federal government has done little to regulate or establish guidelines for the nanotech industry. The Woodrow Wilson International Center for Scholars published a report on nanotechnology, which made clear that there is currently no tailored regulation on the nanotech market. “Nanotechnology is difficult to address using existing regulations. There are a number of existing laws … that provide some legal basis for reviewing and regulating NT materials. However, all of these laws either suffer from major shortcomings of legal authority, or from a gross lack of resources, or both.” [4]

The Environmental Protection Agency has released a White Paper on nanotechnology which recognized both the benefits and the risks, but has not yet placed any special regulations on nanomaterials [5], even though they display unique and potentially toxic properties. [6]

To determine whether the potential risks of nanotechnology should be more aggressively assessed, we began directly contacting government officials.

We met first with a nanotech expert from the Environmental Protection Agency to determine the EPA’s stance on the safety of the technology. He informed us of the many obstacles to regulation that the industry faces, among them: the difficulty of establishing a regulatory definition of “nanoparticle,” what little is known about their properties, the current lack of funding, and the fine line between new and existing materials. For instance, the ability of the EPA to swiftly approve a product to be put on the market is determined by whether or not the components of the product are in their database of “existing” elements. The characteristics of these elements are observed at the elements’ bulk, or macro, scale. If the components are all in this database, the EPA can then enforce the predetermined regulations and certify the product. If the components, however, are “new,” or not in the database, the EPA must further research the novel materials and then determine how to proceed. Nanotechnology complicates this procedure as a product may contain an element that is “existing” according to the EPA, but demonstrate very different characteristics at this nanoscale, posing the question of whether the nanoparticle is new or existing.

nano2A nanopore array used
to make nanowires.
Courtesy of http://www.anl.gov

The EPA official mentioned that a Nanoscale Materials Stewardship Program, which was proposed in November 2005, would begin the process of gathering information about nanoparticles. The program would tackle such issues as risk assessment and proper regulation procedures. This proposal may seem like an appealing start, but we were disappointed to learn that the Stewardship Program will probably not be enacted for at least a year.

Our chief concern is that a lack of understanding about the potential health risks of nanoparticles could result in a tragedy akin to the asbestos disaster in which the risks were discovered only after the material became widespread. With more than 200 nanotech products already on the market, it will become increasingly difficult to get ahead of any potential public health risk. [7]

Following our meeting with the EPA, we decided to appeal to Congress to advance the Stewardship Program. We met with a professional staffer for the House Science Committee, who was enthusiastic about our goal, but informed us that there is not currently enough concern on the Hill to get Congress to actively support the Stewardship Program. This needs to change.

We have met with staff in the offices of Members of Congress responsible for overseeing nanotech regulation including Senator Robert Menendez (D-NJ, Member of the Energy and Natural Resources Committee), Congressmen Jim Saxton (R-NJ, Member of the Resources Committee) and Norm Dicks (D-WA, Ranking Member of the Environment Appropriations Subcommittee). Increased Congressional attention can ensure the timely implementation of the Stewardship Program.

Nanotechnology is a promising and exciting new field, but the responsible growth of the industry requires a careful examination of potential risks. It is in the government’s – and public’s – best interest to act now.


[1] Weiss, Rick. “Nanotech Raises Worker-Safety Questions”. The Washington Post, 8 Apr 2006, A01.

[2] Hoet, P.H.M., Bruske-Hohlfeld, I., and Salata, O.V. 2004. “Nanoparticles – known and unknown health risks”. Journal of Nanobiotechnology. 2: 12.

[3] Oberdorster, E. 2004. Toxicity of nC60 fullerenes to two aquatic species: Daphnia and largemouth bass. Abstract IEC21. 227th ACS National Meeting. March 28-Aril 1. Anaheim, CA.

[4] Davies, J. Clarence. “Managing the Effects of Nanotechnology.” Woodrow Wilson International Center for Scholars.

[5] Nanotechnology White Paper (External Review Draft). U.S. Environmental Protection Agency, Washington, D.C.: 2 Dec 2005.

[6] Nel, A., T. Xia, L. Madler, and N. Li. 2006. Toxic Potential of Materials at the Nanolevel. Science: 311: 622-627.

[7] Nanotechnology Consumer Products Inventory. Woodrow Wilson International Center for Scholars.

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