The U.S. Environmental Protection Agency’s (EPA) recent nanotechnology White Paper is the result of a 27-month review of the positive potential uses and the possible negative environmental, health, and safety (EHS) implications of nanotechnology. The goals of the paper are “to inform EPA management of the science needs associated with nanotechnology, to support related EPA program office needs, and to communicate these nanotechnology science issues to stakeholders and the public.” Although the 132-page paper does a good job of meeting these goals, it provides little new guidance for companies trying to “read the tea leaves” regarding how the EPA will ultimately treat nanomaterials for regulatory purposes.
The paper begins by explaining nanotechnology’s emerging importance: “[f]or EPA, nanotechnology has evolved from a futuristic idea to watch, to a current issue to address.” As the agency moves forward with its nanotechnology analysis, it attempts to balance research and development against safeguarding human health and the environment. Simply put, the agency’s quandary is that “[s]ome of the same properties that make nanomaterials useful are also properties that may cause some nanomaterials to pose hazards to humans and the environment, under specific conditions.” This same issue was identified in December 2004, when the EPA started the whole White Paper process. Nonetheless, the issue remains relevant and largely unresolved.
The paper then covers several potential environmental benefits posed by nanotechnology, including remediation of chemical and radiological contaminants; water purification; development of nanosensors to detect biological and chemical contaminants; reduction of energy demand through lighter and stronger materials; and energy-efficient fuel additives. The paper references a prior prediction that up to 14.5% annual energy savings may result from potential future uses of nanotechnology. These potential uses will indeed be dramatic “positives” when they come to fruition.
However, even though the paper spends a little more than six pages addressing potential nanotechnology benefits, it devotes 33 pages to countervailing potential EHS risks. In this regard, the paper presents perhaps the best summary of nano-related EHS information published in 2006 and could be quite useful as a quick reference guide; it should also be required reading for anyone involved in the nano-industry. This section covers, among other things, environmental, occupational, and general exposures; environmental fate of nanomaterials in air, soil, and water; detection and analysis of nanomaterials in the environment; human exposure routes, including inhalation, ingestion, dermal, and ocular; exposure mitigation techniques; and existing toxicological data, including whether analogies can be properly drawn from data in other areas such as ultra-fine particle studies.
Given the disparate treatment of the potential “pros” and “cons” of nanotechnology provided in the paper, the two topics might have been better addressed in separate documents. Certainly there should be a larger focus on nanotechnology’s potential benefits to better understand EPA’s current position on the use of nanomaterials pending comprehensive EHS testing. The potential-benefit section of the White Paper could use further, separate development. However, with all the recent attention given to nano-related EHS issues, one is hard-pressed to find serious fault with the EPA’s focus.
Moving forward, EPA identifies numerous research gaps that must be filled to progress with nanotechnology. The paper breaks down what might otherwise be an overwhelming list of research gap into two basic categories: environmental applications and risk assessment. Within the category of environmental applications, EPA’s primary research needs involve green manufacturing, green energy, environmental remediation and treatment, and sensors. Within the risk assessment category, the paper highlights the following research needs:
- Chemical identification and characterization;
- Environmental fate and treatment;
- Environmental detection and analysis;
- Human exposures measurement and control;
- Human health effects; and
- Ecological effects.
These are very large areas to cover: What else is there? Thus, current “unknowns” appear to be larger than the “knowns.” The paper was not intended to provide answers to the underlying EHS questions; instead, its purpose was to identify major issues for EPA management, which will later determine whether and how they should be tackled.
Similarly, regarding possible nanotechnology regulation, the paper takes the position that current environmental statutes provide the EPA with sufficient authority to regulate nano-materials. This statement is not new or surprising. Interestingly, however, the paper also notes that “[t]he statutes administered by EPA (identified as TSCA, FIFRA, CAA, PPA, CWA, SDWA, CERCLA, and TRI) are a starting point for evaluating and managing risks and benefits from nanomaterials. Some current EPA policies and regulations may require modifications to address this new technology.” The paper, however, does not provide any analysis regarding which statutes might need modification, nor does it suggest proposed modifications or even recommend a process for analyzing existing laws to determine whether they need such modification. Arguably, a thorough statutory analysis is the most compelling need currently facing EPA, and the paper misses an opportunity to make real progress on this issue.
For example, statutes such as the Clean Air Act and Resource Conservation Recovery Act contain measurable levels at which regulation begins, such as a specific concentration or weight emitted or discharged. Because nanomaterials may be a concern at vastly smaller measurements, many of these triggers that are measured in parts-per-million or pounds or tons emitted may not be applicable-a point EPA does not fully develop. However, it is likely that more detail will develop as the “data gap” begins to close and as more information concerning the behavior and interaction of nanomaterials at specific levels is learned.
A second example is that nanomaterials may require different treatment depending upon the environmental media (i.e., land, air, or water, which accepts the emission or discharge). While the paper briefly addresses this subject, there has always been a difference in how a material is regulated depending on the area to be protected. However, until more is learned about the interaction of nanomaterials in the natural environment, it is difficult to make definitive statements concerning specific data.
The paper concludes with seven research recommendations regarding the beneficial uses of nanotechnology and contains more than 35 general EHS research recommendations. While the creation of such lists is a valuable first step, the paper contains no budget suggestions, proposed research schedules, or division of assignments within the government to accomplish its goals. However, assuming EPA succeeds in implementing its own recommendations, the paper provides a good road map of future research needs.
Finally, the greatest practical environmental concerns facing nanotechnology companies remain, despite the paper’s long-awaited release. How will the public and industry react if EPA eventually regulates certain nanoparticles as potentially hazardous materials after they have been incorporated into consumer products for several years? Clearly, there is some level of risk of this occurring until the EPA makes a determination one way or the other. On the other hand, there are also business implications to sitting out the market and waiting to see what the EPA eventually does. It may take another several years for a clear picture to emerge while the rest of the nano-industry is rocketing along.
In addition, nano-businesses need to consider what ultimate protection will arise from a “positive” EPA determination regarding EHS issues. Absent embedding “preemption” provisions into any EPA nano-specific regulation, meeting the agency’s nano-standards-whatever their form-will not necessarily shield a company from potential liability. As a matter of law and also good business practices, no amount of government regulation can substitute for a company conducting its own analysis regarding the possible EHS implications of its new products.
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John C. Monica, Jr. (left) is a partner at Porter Wright Morris & Arthur LLP and is a specialist on nanotechnology product liability issues. Michael E. Heintz is an associate in the Environmental Practice Group at the law firm and focuses on traditional environmental issues, as well as nanotechnology and global climate change.