FDA recommends nanotechnology research, but not labeling
report that recommends the agency takes steps to assess the
benefits and risks of nanotechnology.
The recommendation, by FDA's Nanotechnology Task Force, follows mounting calls from the scientific community and public concern organizations that the potential risks to the health of humans and the environment should be investigated. Andrew von Eschenbach, commissioner of food and drugs said he endorsed the tast force and that nanotechnology holds enormous potential for use in a vast array of products. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials," he said. The task force reported that nanotechnology could potentially be used in most product types regulated by FDA and that those materials present challenges similar to those posed by products using other emerging technologies. Nanotechnology is the manipulation of materials at near atomic scales to create new processes, materials and devices. Food, packaging and a host of other products can benefit from the technology, which can be used to increase shelf life, strengthen products and improve nutritional content. Due to the emerging, yet uncertain nature of the technology, the report also said that there was a need for ensuring transparent, consistent, and predictable regulatory pathways to oversee nanotechnology. However, FDA fell short of recommending that products that use nanotechnology should be labeled as such and that additional regulatory authority was required. "We believe we do not have scientific evidence about nano-sized materials posing safety questions that merit being mentioned on the label," said Randall Lutter, FDA's associate commissioner for policy and planning, during a briefing with reporters, according to Reuters. The International Center for Technology Assessment (ICTA), a nonprofit policy group that is suing the FDA calling for more oversight over the technology, said the task force failed to propose strong protections against the risks. George A. Kimbrell, staff attorney at ICTA, said that the report recognizes the fundamentally different challenges and uncertainty that nanomaterials present but then dismisses potential oversight actions or requiring labeling for another day. "The result is that FDA will at least for now continue to treat the radical new products of nanotechnology as nothing more than 'business as usual,'" he said. "Nanotech presents an opportunity for FDA to 'get it right the first time,' but time is of the essence. FDA's unfortunate decision to delay meaningful action makes it more likely that nanotech will join its long and growing list of regulatory failures, to the determent of human health and the environment." The Woodrow Wilson Centre for Scholars - one of the most unremitting of those calling for research into the risks - welcomed the recommendations as a step in the right direction. Coinciding with the official recommendations for a scientific assessment is a publication by Woodrow Wilson, which raises questions about how nanoproduct waste will be dealt with. The report, published this month, is an analysis of the two key Environmental Protection Agency (EPA) laws that regulate the end-of-life strategies for materials and products. The Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation Liability Act (CERCLA) are examined to determine whether they are suitable for regulating nanotechnology. RCRA regulates the handling, reuse, recycling, storage, treatment, and disposal of solid wastes, including hazardous materials. CERCLA deals hazardous substance contamination that other legislation has fails to address. In respect of the RCRA, the study poses the question as to whether specific nanowastes, or categories of nanowastes, should be listed and treated as hazardous wastes. The study also said that research should be conducted to determine whether existing practices for handling, treating, storing, and disposing of bulk solid waste is suitable for dealing with the same chemicals at nanoscale dimensions. For the CERCLA, the study questions whether the law that governs hazardous materials covers nanotechnology and whether actions that affect nanomaterials under other statutes could indirectly result in its addition to the list of hazardous substances. Last year sales of nanotechnology-related products reached almost $1bn (€744m), jumping from $150m (€112m) in 2002. Three years ago less than 40 nanopackaging products were on the market, compared to over 500 available at present. Consultant Helmut Kaiser estimates this month that nanotechnology will change 25 per cent of the food packaging market, currently worth $100bn (€74bn).
