By Drew Bergman:
The ABA Section of Environment, Energy, and Resources held a teleconference on January 16, 2007 on The Clean Air Act and Nanotechnology. The first presenter (Ann Klee of Crowell & Moring) discussed the National Nanotechnology Initiative, a federal research and development program comprising 25 federal agencies to coordinate multi-agency efforts in nanotechnology, including the U.S. Environmental Protection Agency. The Initiative has published a report entitled "Environmental, Health, and Safety Research Needs for Engineered Nanoscale Material" that summarizes ongoing nanotechnology research needs. The report can be found on the Initiative’s website at http://www.nano.gov/.
The next speaker (Jim Mason) spoke about the Oklahoma Nanotechnology Initiative, which can be found at www.oknano.com, to serve as a clearinghouse of information about the state of nanotechnology in Oklahoma. The position of business is (1) to develop an handle products in safe and environmentally responsible ways, (2) to continue development without uncertainty created by potential for misguided and overly zealous regulation resulting from fear and ignorance, (3) to initiate collaborative government and private industry research projects to explore the physical and chemical characteristics of engineered nanoparticles and to develop new test methods, protocols and standards to help move nanoscale manufacturing to commercialization, and (4) to develop an adequate data set allowing appropriate evaluation of the risks to human health and the environment from exposure to engineered nanostructures, byproducts, or materials incorporating them, or release of these materials into the environment. The current issues and concerns include (1) Where will the funds for toxicology studies come from? (2) If industry does the studies, how will the studies (and considerable expenditures) be perceived? (3) Over-regulation is inherently wasteful and will greatly reduce the potential for the U.S. to compete. (4) The U.S. is currently the world leader in nanotechnology research and applications, however, competition from China, Japan and the EU is rapidly overtaking the U.S. (5) Even before comprehensive toxicological data is developed, consider evaluating potential for risk by determining the point in the manufacturing process that the engineered nanostructure is introduced into a confining material matrix such that potential for exposure to workers and release to the environment is minimized during manufacture, and then evaluate subsequent use.
The next speaker (Robert J. Martineau, Jr.of Waller Lansden Dortch & Davis) spoke specifically about the Clean Air Act. The threshold question is does the CAA give EPA legal authority to regulate nanomaterials. The CAA gives EPA broad authority to regulate air pollutants. CAA section 108(a)(1) provides for EPA to "publish . . . a list which includes each air pollutant emissions of which . . . cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare the presence of which in the ambient air results from numerous diverse mobile or stationary sources." The questions presented are (1) Do we know enough to say that emissions may reasonably be anticipated to endanger public health or the environment? and (2) Are "nano" emission similar enough to say they result from numerous or diverse mobile or stationary sources? CAA section 111 provides for EPA to "publish . . . a list of categories of sources . . . [which] causes, or contributes significantly to, air pollution which may reasonably be anticipated to endanger public health or welfare. This section thus focuses on the category of sources and pollutant emitted, not on ambient air quality, and is better suited for nano materials given divergent source categories, but still must make showing that the "emissions from source may endanger public health or environment." CAA section 112 lists hazardous air pollutants and allows EPA to the HAP list those pollutants "which present, or may present . . . a threat of adverse human health effects . . . or adverse environmental effects. . . ." and allows EPA to issue "a list of all categories and subcategories of major sources [and certain area sources] of the air pollutants listed. . . ." This section is also pollutant/source category based rather than an ambient standard so more suitable to nano particles, but still have threshold question of showing harm and raises the question of whether new listing required for "nano pollutant’ or whether a nano particle can be regulated as a component of an already listed HAP. One other possible basis for nanomaterial regulation under the CAA is that both sections 111 and 112 authorize establishment of "work practice standards" where not feasible to prescribe an "emissions standard." This may be the best mechanism for regulation given the difficulties in measurement and monitoring.
The final speaker (Patrice Simms of NRDC) discussed the regulation of nano materials under the CAA’s mobile source provisions. The issue re mobile sources is in the potential uses of nanomaterials such as emission control equipment (e.g. catalyst material) or fuel additives. The sections of the CAA that regulate engines and equipment (sections 202(a) and (l) and 213) and fuels and additives (202(l) and 211(a), (b), (c) and (f)) are the pertinent provisions. The direct regulation of fuels is the more likely basis for regulating nanomaterials.
The ABA has issued a number of white papers on nanotechnology issues. One deals with the Clean Air Act and Nanotechnology and was edited by the moderator of the teleconference, Mary Ellen Ternes at McAfee & Taft. The white papers can be found at http://www.abanet.org/environ/nanotech/ .