Innovative Regulatory Approaches

Posted on July 17, 2007 by John C. Monica, Jr.

It has been a little over a year since the American Bar Association published its "Innovative Regulatory Approaches” to Nanotechnology discussion paper in June 2006.  During the intervening  period, EPA published its White Paper and its TSCA voluntary framework.  Both provide some general idea of where EPA is heading with environmental regulation, and in this context it is useful to take a glimpse back at the ABA paper.

 

The authors explained that the history of environmental regulation in the US has produced a regulatory system focused on controlling workplace exposures and end-of-pipe/fence line emissions, enacting management standards for hazardous wastes, and requiring increased information disclosure and risk assessment for new chemicals and pesticides. The authors also provided some insight into why they believe nanotechnology may require a different approach: the speed at which it is developing; competitive pressures; limited resources available to government regulators; difficulty in enacting new federal environmental legislation; level of scientific uncertainty and the complex risks involved in nanotechnology; difficulty in monitoring nanoscale releases; and the importance to the industry in maintaining public confidence.

The authors propose a new integrated approach to nanotechnology regulation to address these issues . Under this multifaceted approach, “[t]he goal would be to avoid the rote application of existing regulatory approaches to these 21st century technologies if a better way exists.”

In order to accomplish this goal, the ABA authors suggest several environmental accountability, mechanisms: traditional regulation and enforcement; new approaches to regulations including flexible standards; enhanced monitoring and public reporting; well-defined liability standards, voluntary industry programs, improved public education, corporate social responsibility programs, and relevant stakeholders dialogues.

Looking back, with EPA's recent White Paper and TSCA voluntary stewardship papers published within the past 6 months, the latter mechanisms suggested by the ABA authors will undoubtedly take on renewed importance and deserve further development.

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ABA Teleconference Report: The Clean Air Act and Nanotechnology

Posted on February 1, 2007 by Michael E. Heintz

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/ .
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Review: Nanotechnology: What You Need to Know on the Law, Regulation, and Science Policy Front

Posted on November 17, 2006 by Michael E. Heintz
On November 16, 2006, the American Bar Association held their second of eight teleconferences concerning the regulation of nanomaterials.  The teleconference, moderated by Lynn L. Bergeson, entitled Nanotechnology: What You Need to Know on the Law, Regulation, and Science Policy Front , consisted of a three member panel, representing three different regulatory perspectives.  The panel members were: Jennifer Sass, Ph.D., Natural Resources Defense Council, Jim Alwood, U.S. Environmental Protection Agency, and William P. Gulledge, American Chemistry Council.

The three panelists discussed their views on regulation of nanomaterials.  All agreed that more information is needed before firm policy can be developed and that additional funding, especially in the area of health and safety research, is also needed.  Of particular note, Mr. Alwood noted that the EPA is focusing nanomaterials regulation under the Toxic Substances Control Act (TSCA) when those materials exhibit "unique properties" from those chemicals already appearing on the TSCA Chemical Inventory.  Mr. Alwood explained that a difference in the sizes of chemicals is not new to TSCA, and that to track with the National Nanotechnology Initiative definition of "nanotechnology," nanomaterials will likely have to display unique behavioral characteristics to warrant a repeated entry on the TSCA Chemical Inventory.  Mr. Alwood also referenced the Stewardship Program that EPA is developing, and referred listeners to the letter that was released by EPA on October 18, 2006 requesting the voluntary submission of nanotechnology research data to supplement EPA's research efforts concerning TSCA regulation.  That letter is available at http://epa.gov/oppt/nano/nano-letter.pdf

Next, Dr. Sass addressed the health and safety concerns raised by the manufacture of nanomaterials.  She was particularly concerned with the toxicological impacts nanomaterials may have when introduced into biological systems.  She believes more information is needed to properly address the risks posed by nanomaterials, and that research budgets should be increased accordingly.  She is particularly concerned over the inhalation dangers posed by nanomaterials, and cited to several laboratory experiments providing epidemiological data on health impacts.

Finally, Mr. Gulledge presented the manufacturer's perspective on nanotechnology, and tended to agree with the other panelists concerning data gathering and funding issues.  Of note, Mr. Gulledge pointed to recently released survey results presented by the International Council of Nanotechnology at Rice University.  Those survey results, available at, icon.rice.edu/projects.cfm, outline the findings from an international survey conducted to determine current environmental, health, and safety, and stewardship efforts being made by manufacturers.  Mr. Gulledge also provided a brief overview of the international efforts being made by the Organisation for Economic Co-operation and Development (OECD, www.oecd.org/department/0,2688,en_2649_37015404_1_1_1_1_1,00.html).  That organization, in which the United States is an active participant, is taking an international approach to stewardship, environmental, and health concerns posed by manufactured nanomaterials.

The teleconference provided a good opportunity to hear basic information concerning current and potential research and regulatory activities being pursued by different organizations.  The panelists largely agreed on several topics including the need for additional research funding and the authority given to EPA to regulate nanomaterials within current statutory framework.  As these teleconferences continue, further updates will be posted here.
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Summary -- ABA Nanotechnology Seminar

Posted on October 27, 2006 by John C. Monica, Jr.

AUTHORED BY ANDREW BERGMAN

On October 27, 2006, the ABA Section on Environment, Energy and Resources sponsored a teleconference on the science of nanotechnology.  The speakers were Kristen Kulinowski, Ph.D., from Rice University, and John Balbus, M.D., from Environmental Defense, and the moderator was Sunil Garg, Ph.D., Esq., from the Ecoshelf Group.

Kulinowski described nanotechnology as understanding and controlling of matter between the molecular and particulate levels, where the properties of materials change and new properties emerge. For example, gold at nanoscale is red or blue and has a much higher chemical reactivity.  Major changes can be made to a material's magnetism, friction and electrical conductivity. There are already 200-300 products on the market today that are touted as nanomaterials, and success is predicted for nanomaterials with regard to solar panels, replacing copper wires, defense applications, medicine and environmental technology. However, nanomaterials cause come concern. Some materials appear to be fairly cytotoxic, and larger cell organisms show the effects of nanomaterials in hazard studies (inject in lab).

 Exposure studies lag being hazard studies. Evaluating nanomaterials is difficult because they are extremely diverse; a limitless capacity to create such materials leads to no overarching framework of potential hazards. So far analytical tools are poorly developed for understanding risk so beware of over generalizing nanomaterial behavior, either good or bad. Current barriers to understanding risk include (1) lack of strategic research, (2) lack of standards, (3) uncertain regulatory environment, (4) transparency and responsiveness of public concerns, and (5) lack of sufficient funding. However, the International Council on Nanotechnology is developing a database of technical material and is releasing a survey of how firms handle nanomaterials on Nov. 13 (will be available on their website). Predictions for 2007: increased pressure on regulatory agencies to understand how nanotechnology fits into existing statutes and regs, increased call for labeling of consumer products, development of the research framework for evaluating risk, new standards for workplace handling, and better evaluation of potential risks.

Balbus agreed with much of what Kulinowski's comments. Nanomaterials hold great promise as solutions to energy and health issues so the challenge is to achieve the benefits without repeating past mistakes re risk. For the discussion of potential risks, analogize to combustion particles, fine and ultra fine, because we know about their serious health effects. Particles can get through physiological barriers so enter the blood system and be taken up into cells by different mechanisms. They also can pick up unwanted other toxic materials and so deliver secondary particles. We are at early stages in understanding risk; the approach so far has been to analogize to larger particles, hypothesize using computer models, and conduct actual studies. Some studies have been reassuring but others had surprising results such as the evidence of direct stimulatory effect on cells and increased water solubility. We also have gaps in our understanding of bioaccumulation: do these materials accumulate in the body or are they secreted? Are they mobile in the environment or do they breakdown? How interact with critical cells and molecules? What are their structural activity relationships (i.e. how surface characteristics relate to toxicity? What about chronic toxicity? Difficult to make strong conclusions about toxicity of nanoparticles at this time. Reasons for a gaps in understanding: (1) infinite variation, (2) expensive to get enough material for long-term studies, (3) need instruments to detect and measure, and (4) materials tend to clump together so hard to recreate actual exposure situations. Need to develop a risk management framework. Existing regulatory coverage uncertain so companies are doing more to avoid liability than to meet existing regs; a document will be released in 2007 on Dupont's attempts to manage risk. Need more investment to research risk, need transparency in research, and need proactive stance by regulatory agencies.

Points made during question and answer. Concerns over lack of standards or guidelines for labeling consumer products. Concerns over the harmonization of international efforts over terminology and nomenclature, and standards for handling. Not sure how the REACH regime in Europe will apply to nanotechnology. Two efforts at voluntary standards: ASTM document out soon (protocol for minimizing exposure) and ISO document out later. Top research priorities: instrumentation and monitoring equipment, bioaccumulation and transport, and exposure to consumers and the environment.

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