The Congerssional Research Service recently issued a report on nanotechnology regulatory issues to Congress:
L. Schierow, Congressional Research Service Report for Congress, "Engineered Nanoscale Particles and Derivative Products: Regulatory Challenges," January 22, 2008.
CRS begins its reoprt by noting that "enthusiasm and investment in nanotechnology are somewhat restrained . . . by questions about the possible environmental, human health, and safety (EHS) risks associated with this new technology." CRS predicts that there may be great costs to the nanotechnology industry -- both monetarily and reputational -- if the public indiscriminately rejects nanotechnology as a whole because of an adverse incident involving a single nanoscale material.
CRS then notes several challenges facing any attempt by Congress to regulate nanotechnology: (i) lack of data characterizing nanomaterials; (ii) lack of standardization in nomenclature, metrics, and materials; (iii) proprietary nature of information; (iv) difficulty of communicating among academic disciplines; (v) limited resources; and (vi) possible inadequate statutory authority.
After briefly explaining the above difficulties, CRS identifies four possible approaches for Congress to use in controlling potential EHS risks posed by certain nanoscale materials:
1. Increase research and standardization funding. CRS takes the position that "[a]ccording to the Chairman of the House Subcommittee on Research and Science Education of the Committee on Science, 'the basic position of most outside observers from industry and non-governmental organizations is that the funding level should be on the order of 10% of the initiative's (NNI) total funding, rather than the current 4%.'" CRS does not breakdown how these new proposed research funds should be spent.
2. Reallocate existing federal research funding. CRS suggests reevaluating how nano-EHS research money is divided between federal agencies given priority research topics. CRS leaves it to NSF and NNI to determine whether and how such reallocation is appropriate.
3. Adopt a national or international research strategy. CRS notes this approach is difficult to implement without first conducting comprehensive EHS research. CRS further notes that when NNI/NEHI created their general nano-EHS-research framework in 2007, they identified five research categories and some specific needs, but they did not prioritize between these needs.
4. Enact legislation: information collection; restrictions on production, sale, use, and/or disposal. CRS notes existing EHS laws are probably adequate to govern the potential risks posed by nanotechnology, but they were not written with nanomaterials in mind. As a result, agencies may need to develop new policies, produce guidance documents, and possibly issue regulations to make existing statutes applicable to nanomaterials. CRS recognizes that any new regulations need to be implemented in phases. Further, CRS posits that to "reduce the burden imposed by a testing requirement, Congress might allow manufacturers to share test data (and costs of testing), grant exclusive production or marketing rights within the United States for a number of years to manufacturers who conduct testing (to compensate them for their expenditures), or exempt particular categories of products or manufacturers from requirements."
CRS concludes that "[i]t is noteworthy that Congress is considering its options at this early stage of technology development, when only a few nanomaterials are being manufactured on a large scale. Risk management decisions nonetheless are pressing, as the rate of nanotechnology development and commercialization is rapidly escalating."
