Regulatory interest in evaluating nanotechnology’s potential health and environmental risks has grown, at multiple levels, in parallel with the expanding commercialization of nanotechnology-related products and processes in recent years. In 2008, for example, EPA’s Office of Pollution Prevention and Toxics launched its well-publicized Nanoscale Materials Stewardship Program (“NMSP”) seeking voluntary data submissions relating to nanomaterial risks, including information on health hazards, potential human exposures, environmental releases, and corporate risk management procedures. EPA also frequently issues consent orders requiring nanomaterial manufacturers to implement worker and environmental protection measures. At the state level, the California Department of Toxic Substances Control issued a 2009 “chemical information call-in” requiring carbon nanotube manufacturers to submit data on analytical test methods, fate and transport in the environment, and other relevant information, and reportedly plans to request similar information from other companies on a range of different nanomaterials.
Skip Lockard, co-chair of Alston & Bird’s Nanotechnology practice, tackles emerging issues with three of the nation’s leading thinkers on emerging nanotechnology regulation: Dr. Jeff Wong, Chief Scientist at the California Department of Toxic Substances Control (DTSC); Bill Gulledge, Managing Director of the American Chemistry Counsel (ACC)’s Chemical Products & Technology Division and Chair of the ACC Nanotechnology Panel; and Tom Jacob, former DuPont Manager of Government Affairs for the Western Region and currently of T.R. Jacobs & Associates, LLP.
Question: Thanks to each of you for taking the time to discuss these important issues. As a general proposition, is nano-specific regulation necessarily incompatible with business goals?
Skip Lockard, co-chair of Alston & Bird’s Nanotechnology practice.
Tom Jacob: No. In fact, I think industry recognizes potential benefits from nano-regulation. That’s why several major stakeholders have already approached EPA with the intent of collaborating on development of responsible industry practices. Regulations based on sound science and the best collective understanding of environmental, health, and safety (“EH&S”) issues is unquestionably beneficial to the reasonable, appropriately-controlled development of nanoproducts.
Bill Gulledge: I agree. The ACC welcomes reasonable regulation, as opposed to uncertainty about how nanomaterials should be regulated.
Dr. Jeff Wong: At DTSC, for example, we are trying to evaluate nanotechnology issues rationally and based on facts. We are looking at data and trying to reach meaningful, factual, “boots on the ground” conclusions that will help companies make good decisions. In a sense, our goal is simply for these conclusions to help companies incorporate environmental protection principles through rational product design at the front end, rather than dealing with problems on the back end.
Q: There is an ongoing debate as to whether nanomaterials should be regulated under existing laws, or addressed through a completely new regulatory scheme. What do you think?
BG: ACC advocates the use of existing regulatory frameworks for the responsible development of nanotechnology. In particular, we’d like to see a modernization or revision of the Toxic Substances Control Act (“TSCA”) to address all chemical management issues including nano, although, to date, EPA has probably not even fully used its existing regulatory authority under TSCA. We’d also like to see a uniform national approach to nanomaterial regulation, rather than something piecemeal on a state-to-state basis. And we urge international cooperation on nanosafety. Having consistent approaches to nanomaterial regulation in the U.S., EU, Canada, and elsewhere would be very desirable.
TJ: In terms of future regulation, I also think it’s important to keep in mind that different nanomaterials clearly have different properties. As a result, different materials have different environmental or health implications. One broadly shared concern within the chemical industry is whether future regulations properly take these differences into account.
Q: Where have regulatory efforts focused to date?
TJ: The general approach thus far has been to try to make information about the safety, health, and environmental aspects of nanomaterials accessible to the public and in the marketplace. When downstream users or consumers have questions about nanomaterials or wish to deal with companies that can actually provide meaningful answers to these kinds of questions, consumers can discriminate among manufacturers based on demonstrated knowledge of health and safety parameters.
JW: That’s certainly been one of our primary objectives: to spur the disclosure of information. DTSC is trying to stimulate interest in the health and safety of nanomaterials because there is long-term value to society in having an open dialogue as materials are increasingly deployed into the environment. Rather than thinking “regulate” first, we want health and safety information about nanomaterials to be publicly available as the industry continues to evolve so that industry can become good stewards from the beginning of product design, rather than waiting to be regulated at the back end. This information also must eventually reach the marketplace so that consumers can make truly informed decisions on their own.