National leaders sound off on emerging nanotechnology regulation

Skip Lockard tackles emerging issues with three of the nation's leading thinkers on nanotechnology regulation.

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.
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.

Q:  What message has the chemical industry taken from actions by DTSC, as well as the U.S. Environmental Protection Agency, to require submission of nanomaterial health and safety data?

TJ:  I think data collection signals a growing regulatory expectation that “industry” will actively observe appropriate stewardship. That, in turn, implies a certain level of internal understanding about the materials companies are using.

Q:  Do large and small companies face different dynamics in dealing with emerging nano-regulatory issues?

TJ:  There are just some inescapable practical realities. Large companies often have very sophisticated [EH&S] departments, with personnel trained in understanding toxicological and material handlings issues. Small operations, in contrast, don’t always have that luxury.

JW:  DTSC recognizes that small companies and large companies are differently situated. For example, we are aware of studies indicating that carbon nanotubes exposures under experimental conditions could lead to outcomes that might be indicative of cancer. We considered sending out requests for data on this issue, but realized that some bioassays would be multi-million dollar propositions, and a lot of the California nanotech companies are smaller companies, or VC-funded companies. So we decided to not pursue this with individual companies and instead think about an approach that might involve a consortium of companies, academia and the federal government. The idea is not to bankrupt anyone or chase businesses out of California.

TJ:  The sheer costs associated with developing health and environmental data, are why, to a significant degree, control over nanomaterial safety is currently in the hands of big players in private sector. Not only do the major players have sophisticated EH&S capabilities doing leading-edge science on nano safety issues, but industry is also very involved in collaborative research efforts with major academic institutions, as well as government agencies, to indentify and prioritize emerging questions around nanomaterials. Such questions include the most appropriate protective equipment when working with nanomaterials and issues about nanotoxicity. I think that industry is very interested in working “arm in arm” with the government on getting the right answers to these questions.

Q:  From a regulator’s perspective, should companies be worried about future nano-regulation?

JW:  The main idea behind all of DTSC’s nanotechnology initiatives has really been to return information to the marketplace. Our immediate goal is not to find ways to regulate nanomaterials for the sake of regulating something. Regulation could of course eventually happen down the road if the data ultimately warrants it, but we’re not there yet. Right now, we just want companies to share what they know so that businesses can have the information they need to be good stewards.

Q:  How does the regulatory community try to bolster trust with industry?

JW:  Well, DTSC is committed to transparency. We see industry as a key stakeholder in the nano-debate. We’ve gone to great lengths to let everyone know where we are coming from, and provided a great deal of opportunity to interact informally with DTSC prior to issuing the call-in letter. We traveled around the state and visited various California companies, we hosted stakeholder meetings, and announced the call-in in advance. We have been very open and are interested in corporate input on how questions about nanomaterials should be prioritized. And believe it or not, we even read articles and commentaries that attorneys write abut our programs, and try to think about how we can do things better!

Q: Some observers have suggested that the disclosure of nanomaterial safety information in response to EPA’s Nanoscale Materials Stewardship Program and DTSC data call-ins has been modest. What are the reasons?

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.

JW:  I would say that the response to DTSC’s call-in has been varied. I’m not sure there is a valid way to determine whether there is any real “trend” in the responses. But smaller companies generally provided lower-quality responses than larger entities, and my sense is that some of the smaller VC-based companies may not have resources to respond fully to questions. They have other responsibilities and demands from investors, and are also not always sure how detailed their responses should be or exactly how to answer. But, DTSC views this first effort at gaining this valuable information as tremendously successful because it brought us from “zero” understanding as to what companies know to having what we have today.

TJ:  Another factor in the low response rate to information call-ins is probably lingering uncertainty about how agencies will use submitted data from a regulatory standpoint. And, there is also concern about the disclosure of confidential business information (“CBI”), which is a very active issue across the entire chemical frontier, not just for nanomaterials specifically.

BG:  As far as EPA’s voluntary stewardship program is concerned, I think a lot of smaller companies were unaware of the program until fairly late in the game. Moreover, a lot of smaller companies don’t have any experience working collaboratively with EPA, and were worried about the implications of voluntary EH&S disclosures. Some people that considered participating didn’t like the perceived “open-ended” nature of EPA’s in-depth program and the possibility that participants might be required to do additional testing. And CBI is definitely an issue when it comes to voluntary sharing of information – big and small companies alike have a lot invested in proprietary nanotechnologies, and data confidentiality is of course a major concern.

Q:  Are agencies sensitive to CBI concerns, especially since we’re often dealing with novel, cutting-edge technologies when we talk about “nanomaterials”?

JW:  I can’t speak for EPA, but from DTSC’s perspective, we are very willing to work with companies on CBI issues. Of course, companies sometimes do request CBI protection over information that doesn’t really seem like CBI. But in general, we do take confidentiality seriously and will vigorously protect truly confidential information to the extent allowed by law.

Q:  The DuPont Nano Risk Framework is the best-known program for promoting responsible development of nanomaterials. Why did DuPont invest so heavily in developing the Framework?

TJ:  DuPont operates at the cutting edge of science, and we recognized that a number of business units were already involved with nanomaterials. We were also very conscious of the fact that there was somewhat of a regulatory void for nanomaterials, and wanted to make sure our businesses don’t move forward with the development and application of nanomaterials in ways that pose risks to the public or, from a business perspective, to DuPont. We got together with the Environmental Defense Fund and worked very closely with EDF to identify some of the most critical emerging issues associated with nanomaterials. The resulting Framework is intended to guide business decisions regarding nanomaterial development in ways that are consistent with responsible product stewardship.

BG:  The DuPont-EDF Framework is probably the best example of a voluntary program available right now. A lot of companies have clearly taken the framework and customized it to fit their own particular business and issues.

Q:  Have you seen much evidence that the typical consumer really cares about nanomaterial safety?

BG:  In some ways, nanotechnology awareness is a localized issue. Populations around centers of excellence tend to be familiar with nanotechnology just because the local economy is tied to research and development programs. But overall, the American public’s level of awareness about nanotechnology and its potential benefits, as well as potential risks, is probably still low.

TJ:  I agree. It’s hard to say just how much the “average” consumer or downstream user of nanotechnology is aware of health and safety issues right now. The data on nanotechnology awareness is pretty mixed.

Q:  How important is developing and maintaining public awareness and acceptance of nanotechnology?

BG:  We’ve already seen nanomaterials yield some tremendous advances in some applications such as paints and coatings, and we’ve only just begun to scratch the surface. The next generation of nanomaterials will offer amazing promise, particularly in the medical field. So we want to make sure that the public dialogue about nanomaterials is as fair and balanced as we can possibly make it. EPA has thus far been sensitive to this concern, as reflected by EPA’s focus on specific types of nanomaterials rather than broad-brushing all nanomaterials into one hazard category or another.

TJ:  I think there is a common understanding among regulators and majory industry players that nanomaterials carry enormous promise, enormous potential to benefit society. No one wants to choke that off. And I think both sides are aware that if questions about nanomaterials safety are not answered in a timely, transparent, and responsible way, there is a potential for “reactionary” responses that could unnecessarily constrain careful and appropriate uses of nanomaterials.

Q:  What’s next for nanomaterial regulation?

BG:  I predict that EPA will continue data call-ins and other TSCA regulatory efforts for nanomaterials. I think EPA feels like it still needs basic information on various nanomaterials, nanoclays being one prime example, and it is also interested in metal oxides and applications using carbon nanotubes. On the legislative front, I do think it’s just a matter of time before TSCA is amended and generally updated. There could be a significant debate about how nanomaterials should be treated under a revised version of TSCA.

JW:  At DTSC, we don’t have a strict prioritization mechanism. We look at the literature, reported toxicities, and trends in the deployment of nanomaterials in the marketplace. We are certainly interested in titanium dioxide and zinc oxide because they seem to be deployed in a lot of personal care and cosmetic products, so there is potentially a high exposure opportunity. Zero-valent iron, on the other hand, is not widely incorporated into consumer products but does seem increasingly common in groundwater remediation technologies. So DTSC is interested in what people know about environmental fate and transport, and nobody seems to know what happens when the treatment is over. How widely a given material is deployed is definitely a factor in our thinking.

TJ:  In addition to expanding the list of specific materials agencies are interested in, I generally perceive that they are starting to look further down the product value chain and ask questions not just about raw nanomaterials themselves, but what the implications might be for workers and product end-users. Looking at the entire product chain may become increasingly important.

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