nanotechnology oversight - Project on Emerging Nanotechnologies

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Nanotechnology Oversight: An Agenda for the New Administration 11 EPA is by far the largest of the four agencies. Its budget is larger than that of FDA, OSHA and CPSC combined. EPA also has the broadest mandate of any of the four agencies, but even more relevant is that EPA, unlike the other regulatory agencies, has major functions in addition to its regulatory activities. EPA has a large science component that does both applied and basic research. It provides funding and technical assistance for construction of waste-treatment facilities and for the operation of state pollution control agencies. It has 10 regional offices. Although EPA’s responsibilities have expanded, its budget, as illustrated in Table 1, has shrunk. In constant dollars, EPA’s budget is significantly less than it was in the early 1970s, before it was given such major responsibilities as TSCA, the Superfund program and implementation of the 1990 Clean Air Act amendments. FDA’s budget, unlike the budgets of the other three agencies, has increased in recent decades. However, most of that increase is attributable to user fees, which are dedicated to pre-market reviews of drugs and other products. As Michael Taylor, a former FDA official and now a professor at George Washington University, has observed, “FDA lacks the resources it needs to build its own <strong>nanotechnology</strong> expertise, to develop the safety testing protocols and detection methods needed to evaluate new <strong>nanotechnology</strong> products, to conduct its own risk research, to gather the necessary pre-market data required to get ahead of commercialization and to oversee products after they have entered the market” (Taylor 2006, p. 7). Taylor notes that for FDA to be able to do what it was doing in 1996 and to continue the new activities mandated for it since then, the agency’s 2007 budget would have to be more than 50 percent greater than it is (ibid.). OSHA’s problems are largely due to politics. Protecting workplace safety is essential, but OSHA has been largely beholden to one constituency—labor unions—a constituency tied to one of the country’s two major political parties, the Democrats. In recent decades, neither the unions nor the Democrats have fared particularly well, and neither has OSHA. If OSHA is to take on the task of protecting workers from excess exposure to nanomaterials, it will need more resources, regardless of which party wins in 2008. CPSC does not have the money, expertise or regulatory tools to deal with <strong>nanotechnology</strong>. At present, its main function is to serve as an excuse for not regulating consumer products. Legislation now moving through Congress would help CPSC and may include funding earmarked to deal with <strong>nanotechnology</strong>. But the legislation is only a band-aid on a gaping wound. The new administration and Congress will have to decide whether they are serious about the safety of consumer products. If they are, they must enact legislation that gives the agency greater authority to prevent the marketing of dangerous products rather than to recall them after they are in people’s homes. The commission form of agency rule is a prescription for cumbersome decision making and muddled responsibility. CPSC will also require greatly increased resources. It is beyond the scope of this paper to suggest what the budgets of the regulatory agencies should be. It is important to point out, however, that the actual dollars consumed by the agencies are a very small part of the federal budget. The combined total FY 2009 proposed budgets for the four agencies are about 10 percent of the budget of the Department of Agriculture. The total of the budgets of all four agencies equals 3 percent of the cost over-
12 run of DOD weapons procurement (see GAO 2008). Nanotechnology is a very small portion of the EPA and FDA budgets, and OSHA and CPSC are currently spending almost no money on nano. There are many needs beyond resources. There are specific actions that should be taken by each of the regulatory agencies. These are described below, starting with EPA. ENVIRONMENTAL PROTECTION AGENCY EPA is central to <strong>nanotechnology</strong> <strong>oversight</strong> in part because it administers TSCA, the only law that, at least potentially, could provide <strong>oversight</strong> for <strong>nanotechnology</strong> in general . TSCA is intended to oversee all chemical substances, and nanomaterials are chemical substances. However, the act has a number of serious defects and badly needs to be amended (see Section III). It has been characterized as “toothless” and “gutless,” but it still has some functioning parts that can be usefully applied to nano. *1. Define nanomaterials as “new” chemical substances under TSCA. One of the notable weaknesses of TSCA is that most of its authority to regulate existing chemical substances (as contrasted with new chemical substances) has been rendered inoperative by court decisions and by the language of the act. If nanomaterials are not defined as new chemical substances, they are not, in practical terms, subject to most of the TSCA regulatory authorities. In 2007, EPA issued a policy paper announcing that the agency would not take size into account when deciding what substances were new chemicals. Since size is the factor that defines a nanomaterial, and it is size that makes nanomaterials behave differently, and perhaps more dangerously, than normal-size substances, the EPA announcement amounted to saying that there would not be a TSCA <strong>nanotechnology</strong> program. Two points should be noted, however. First, the agency’s interpretation of how TSCA defines a new chemical may be legally correct: the act’s definition talks only about molecular structure and not about any other defining characteristics. Second, because the molecular structure of some nanomaterials is unique, some of them will be included in the new chemicals category. However, the majority of nanomaterials will not be included because they have the same chemical composition and structure as some larger material (e.g., silver, titanium dioxide, carbon). Nanomaterials must be defined as new chemical substances if TSCA is to serve as the vehicle for dealing with their potential adverse effects. There are two ways in which this could be done. First, the new administration could submit to Congress legislation amending TSCA’s definition of “chemical substance.” There would probably be some industry opposition to this, but how much is not clear. If, for political or other reasons, legislation seems undesirable, an alternative would be for the administration to promulgate a “significant new use rule” (SNUR) under TSCA. The act gives broad authority to cover categories of chemicals under such a rule and, once covered, the chemicals are essentially considered to be new chemicals. The disadvantage of such a rule is that it would almost certainly be tested in the courts, which might cause a lengthy delay in implementing the rule. Neither the legislative amendment nor the SNUR option is a perfect solution, but the central importance of TSCA for nanotechnol-
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Page 3 and 4: ACKNOWLEDGEMENTS The author thanks
Page 5 and 6: ABOUT THE AUTHOR J. CLARENCE (TERRY
Page 7 and 8: urgently need to be strengthened. F
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