More than 1,300 products now on the market claim to incorporate Engineered Nanomaterials (ENMs), whose very tiny size yields novel properties, such as making products, lighter, stronger, and better able to retain moisture and deliver pesticides. None of these products have undergone a pre-market safety assessment. To prevent harm to public health and the environment, ENMs must be regulated and tested prior to commercial release, according to a report issued today by the Institute for Agriculture and Trade Policy (IATP).

The report, “Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation,” takes into account a June 9 draft, voluntary guidance issued to industry regarding nanotechnology by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA)—released the same day as a White House–issued executive memorandum on principles of regulation and oversight of nanomaterials. The draft EPA guidance, if finalized, will take the first step towards requiring companies to submit ENM data for regulatory review.

Specifically addressing food and agriculture applications of nanotechnology—e.g., coating fruits and vegetables to preserve shelf life—the report details possible hazards to human health and the environment if they are marketed without pre-market safety assessment and post-market surveillance.

“While the guidance from these agencies is an encouraging first step, there is little motivation for companies using agri-nanotechnology to self-regulate,” said IATP’s Steve Suppan, senior policy analyst. “Many nanomaterial applications are classified as confidential business information, and those that are known have had little to no publicly available testing by regulatory authorities for human health, safety or environmental effects. We know from academic studies that ENMs present hazards that merit regulatory review.”

Several steps are needed to design and implement a nano-specific regulatory structure, including agreeing on a definition of what constitutes an ENM and developing a comprehensive inventory of which products are already in the market and which are in development.

Applications of ENMs include making toxins more bio-available in pesticides, targeting nutrients in smaller doses, improving the texture of ice cream and detecting bacteria in packaged foods. Under current rules, companies have the discretion to determine whether a substance already considered safe in its usual (macro-scale) form (and hence not reportable to the FDA) is also safe in its nano-scale form.

“As nanomaterials in internationally traded goods increases, administrative, technical and budgetary constraints are keeping U.S. and international agencies well behind the pace and variety of product commercialization,” author Steve Suppan said, “ Non-regulation and austerity budgets for regulators cannot comply with the White House memo order to protect human health, worker safety and the environment from ENM hazards.”

 

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New developments in the US

Notre Dame Leads in Discussion of the Ethical and Societal Impacts of Nanotechnology

The world of nanotechnology, which involves science and engineering down at billionths-of-a-meter scales, might seem remote.
 
But like most new advances, the application of that technology to everyday experience has implications that can affect people in real ways.
 
If not anticipated, discussed or planned for, some of those implications might even be harmful.
 
In a recent paper, Kathleen Eggleson, a research scientist in the Center for Nano Science and Technology (NDnano) at the University of Notre Dame, provided an example of a nanotechnology-related safety and ethics problem that is unfolding right now.
 
The problem: Hospital-acquired infections are a persistent, costly, and sometimes fatal issue. A patient goes in for one condition, say an injury, but ends up being infected by a microorganism picked up in the hospital itself. That microorganism might even have developed a resistance to conventional drug treatments.
 
The solution: Engineers are developing new and innovative ways of coating medical materials with nano-sized particles of silver, an element that has long been known for its antimicrobial properties. These particles are being applied to hard surfaces, like bedrails and doorknobs, and to fabrics, such as sheets, gowns, and curtains, by a growing number of medical supply companies. And these new materials are proving effective.
 
“Nanosilver coatings have made life-saving differences to the properties of typical hospital items,” says Eggleson. “Just this last December, a textile made by a Swiss company was the first nano-scale material approved as a pesticide by the EPA.”
 
The possible new danger: The vast majority of bacteria and other microorganisms are actually neutral, or even beneficial, to human life and a healthy environment. For example, some bacteria are needed to maintain appropriate levels of nitrogen in the air, and others, living inside the human body, are critical to both vitamin synthesis and digestion.
 
So overuse of nanosilver products, especially outside of clinical environments, could pose a danger to needed microorganisms, and enable resistant strains to flourish.
 
“Under most conditions, the preservation of microbial biodiversity is a benefit,” explains Eggleson.
 
“In fact, those who would use these potent new antimicrobial technologies for frivolous uses, such as for odor control, work directly against the U.S. National Nanotechnology Initiative’s goal of responsible nanotechnology development.”
 
An ongoing, community-wide conversation about nanotechnology
 
Eggleson came to the Center for Nano Science and Technology last year to study and prompt discussion of problems like these.
 
“NDnano is expanding its scope into studies of the societal impact of nanotechnology,” explains Wolfgang Porod, the Frank M. Freimann Professor of Electrical Engineering at Notre Dame and director of the center. “This is the background for bringing Kathy on board.”
 
To facilitate such discussion, Eggleson initiated a monthly meeting group, called the Nano Impacts Intellectual Community, which brings together Notre Dame researchers from across campus, visiting scholars and authors from outside the university, and leaders from the local area to probe nanotechnology topics in depth.
 
  The group has tackled such issues as the ethics of nanomedicine, the commercialization of nanotechnology products, and the interdisciplinary nature of nanotechnology research.
 
“I appreciate being a part of this on-going conversation,” says Glenn Killoren, an attorney at Barnes & Thornburg LLP and a regular Nano Impacts attendee. “Nanotechnology isn’t just something that happens in research labs anymore. It’s a small but growing part of our lives, and both scientists and non-scientists need to think about its effects.”
 
Eggleson and NDnano faculty have also met with a number of local middle school and high school teachers who feature nanotechnology in their lesson plans. Moreover, the center supports Ivy Tech Community College-North Central’s program to train aspiring nanotechnology technicians.
 
“We try to do as much as we can to engage the community this exciting area,” says Eggleson.
 
 The University of Notre Dame Center for Nano Science and Technology (NDnano) is one of the leading nanotechnology centers in the world. Its mission is to study and manipulate the properties of materials and devices, as well as their interfaces with living systems, at the nano-scale.
 
The center’s expanding work on the societal impacts of nanotechnology has been made possible, in part, by one of the university’s Strategic Research Investments (SRIs), which represent a commitment of internal funds and other resources, supplementing funding from external grants and gifts, to advance excellence in research.
 
In addition, Nano Impacts is supported by the Office of the Provost’s Initiative on Building Intellectual Community.