This paper is extracted from the report “Managing The Effects of Nanotechnology” and has two purposes. The first is to describe the menu of possibilities for government action to deal with the adverse effects of nanotechnology. If there are important alternatives that are not described here it is because of inadvertence or ignorance.
The second purpose is to provide evidence relevant for determining what needs to be done to manage nanotechnology. When I began this work, my initial assumption was that there was no need for new statutory authority. As I learned more about the unique aspects of nanotechnology and thought more about the weaknesses of existing statutes, I was increasingly led to the conclusion that a new law is needed. This paper, however, is not an advocacy piece for a new law. It would have been written quite differently if that were its purpose. Rather, it is a policy analysis, intended to give the reader the information relevant for thinking about a course of action.
In short, the paper is intended to inform, not persuade.
A New Law
Given all the difficulties of using existing laws to address the potential adverse effects of nanotechnology, there is much to be said for considering a completely new law. New legislation could be tailored specifically to take account of the current characteristics of nanotechnology as well as characteristics we expect to emerge in the next decade or two. A new law also could take advantage of what we have learned about regulation in the past four decades.
The wide spectrum of products and materials included in nanotechnology means that the law would have to be broad enough to cover all of these products and materials. At the same time, the law would have to allow for broad categories of exemptions - perhaps up to 80 or 90 percent of nanotechnology products - if resource demands were not to become prohibitive. The rapid development of nanotechnology would require a regulatory structure that is flexible and that does not unduly impede development of the technology. The lack of data about the adverse effects of nanotechnology means that the law would have to be structured to provide incentives for developing effects data and making it available.
The near impossibility of passing new regulatory legislation (including strengthening of existing laws) in the current political climate could change. The political climate could shift because of changes in the nation or the global competitive climate. A dramatic event or crisis affecting some aspect of the environment – or involving nanotechnology directly - could create an opportunity or a demand for new legislation. A broad consensus, perhaps fed by disparate state and local regulatory action, could emerge to favor nanotechnology legislation.
The insurance companies, concerned about the liability of their industry customers, and the European Union, which has been more active about regulation than the United States, are constantly pressing for action on nanotechnology. The nanotechnology industry might endorse legislation as a way of assuring the public about the safety of nanotechnology.
Because of these possibilities, and because thinking about nanotechnology legislation is itself a mechanism for reaching agreement about what should be done, this section of the paper outlines what a new nanotechnology legislative initiative might look like.
I begin with the assumption that a new law would focus on products, not on the environment, because once nanotechnology materials get into the environment, it is probably too late to take remedial measures. The law should focus on prevention, not cleanup, for the same reason. Thus, the general framework looks something like TSCA or FIFRA, or the drug part of FDCA.
Given the lack of nanotechnology effects data, it would be necessary to place the burden on the manufacturer to show that the proposed product is safe. As more is learned about classes of nanotechnology products, it may be possible to carve out categories of exemptions, or types of products that require less information. The process that the law would prescribe can be envisioned in four stages: ground rules, sustainability plan, review and follow-up.
In the first stage, EPA (assuming EPA is the lead agency) would have to define the law’s coverage. Providing a workable definition of nanotechnology products will not be easy. It does seem clear that all products containing nanotechnology materials will have to be covered, not just the basic nanotechnology materials. The reason is that both exposure and toxicity are not predictable from the nanotechnology material alone. The exposure and toxicity of a carbon nanotube or a titanium nanoparticle, for example, will depend on what structure it is shaped in, what other materials it is used with, and how it is used. Regulations probably should require labels on nanotechnology materials stating that any product using the material must be registered with and reviewed by EPA.
There are at least two further definitional issues. The first is: Should the coverage exclude products covered by other laws? I think the answer is yes, provided that the coverage of the law is really adequate to protect the public. Thus, drugs, biologics, medical devices, food additives, pesticides and nuclear materials all would be excluded. However, cosmetics, for example, would not be excluded because there is no regulatory review of cosmetic products. The second issue is: What do we do about nanotechnology products already on the market? Should the law be applied retroactively? I think probably not, because the resource burden on both the regulating agency and the manufacturers would be unmanageable. However, the law should contain provisions for restricting products already on the market if it is discovered that they are having an adverse effect.
EPA also would have to establish testing and reporting requirements. The requirements should be coordinated internationally and, ideally, would be the same in all nations. This would benefit manufacturers as well as governments. The International Life Sciences Institute (ILSI) has developed the elements of a detailed screening strategy for human health effects of nanomaterials.
The testing requirements would build on a set of protocols that describe how each type of test should be done. What tests are required would be based on the type of product and the results of previous tests (a decision tree). The testing requirements also could be tiered over time, although it is not clear what the basis of the tiers would be. Current EU chemicals law requires more testing as the volume of the chemical produced increases. However, this is probably not a good basis for tiering the testing of nanotechnology materials.
The reporting requirements, which also could be coordinated with other nations, should place as small a burden as possible on the manufacturer, but provide enough continuing information to alert the government if a problem arises. At a minimum, the manufacturer should be required to report results of any tests conducted on adverse effects, as well as any information received about adverse effects occurring. Less information could be required of companies with good health and environmental records.
In the second stage, the manufacturer would submit a sustainability plan (SP) to EPA, preferably in electronic format. The SP would have six components: 1) a life cycle analysis of the material or product; 2) testing results; 3) proposed future reporting requirements; 4) proposed labeling of the product; 5) proposed restrictions, if any, on the product; and 6) an explanation of why the product risk, if any, is acceptable. The burden of proof for showing that the product does not pose unacceptable risks belongs to the manufacturer.
In the third stage, the government would initiate a review process, the endpoint of which is to approve the SP, approve it with changes, or disapprove it. The criterion for approval is that the product will not create any “unacceptable risks,” a term which the law would have to define with great care.
There are several, not necessarily mutually exclusive, approaches that could be taken to defining unacceptable risk. First, and most obvious, the manufacturer might have to anticipate likely risks from the product and show either that they would not occur if reasonable steps were taken to prevent them, or that, if they occurred, the actual damage would be very small. A second possibility is to take a rough cost-benefit approach. That is, some risks would be deemed acceptable if the benefits of the product clearly outweighed the risks. If the product cured cancer, for example, some risk of death in unusual cases would be acceptable. A third approach is based on comparative risk. A product’s risk might be acceptable if it could be shown clearly that it would substitute for a material that had greater risks. Some combination of these approaches, as well as other possibilities, needs to be considered.
A review stage should strike a balance between allowing a sufficient amount of consultation with interested parties and minimizing the time taken to approve or disapprove the SP. The general public needs to have an opportunity to comment, and administrative law usually requires that the public be given at least 60 or 90 days to make comments. If a public hearing is requested or required, however, the time consumed by public review will be considerably greater. And while other nations also should be consulted, this could be very time consuming, even when aided by electronic communications.
At present, there is no institutional structure to formulate or facilitate international regulation. The amount of time and degree of detail necessary for international consultation will depend on how much agreement there is on the basic regulatory framework. Ideally, there would be complete consistency among major nations, so that approval of a product in one country constituted approval globally.
However, if this were the case, other countries might have to be given enough time to review the SP themselves. Protection of confidential business information is another important consideration that must be incorporated into the review process.
There is a need for coordination among U.S. agencies for all decisions regarding a particular material or product, as well as for general policies on matters such as risk assessment and labeling. Any new statute should mandate coordinated policies and decisions and should establish an interagency group to implement the mandate.
The review stage may provide companies additional incentives for developing environmentally beneficial product. If there were tax incentives for developing such products, EPA could decide whether the product qualified for a tax benefit, or could provide input for such a determination by the Treasury Department.
Also, the approval process could be speeded up in various ways for products that had major health or environmental benefits. The follow-up stage would have to include provisions for dealing with new uses of a product, and for requiring further testing if new evidence comes to light. Again, the law would need to be balanced between giving the government the information it would like but not imposing on manufacturers burdens that would stifle entrepreneurship. Another trade off involves enforcement and judicial review. TSCA has been rendered almost inoperative because of the difficulties of enforcing the law and defending against attacks in the courts. However, the rights of the regulated parties and the general public also need protection.
A balance should be struck. Any new law would have to deal with a variety of other issues such as imports, exports, national defense and citizen lawsuits.
EPA proposed a voluntary program for nanotechnology in September 2005.The program would ask producers of engineered nanoscale materials to submit to EPA, for materials chosen by the producer, information on: 1) material characterization; 2) hazard information; 3) use and exposure potential; and 4) risk management practices. If basic information on material characterization (such as surface area, solubility or chemical composition) were missing, the voluntary program participant would be expected to generate the information, but there is no expectation that any other information would be generated for the program. A separate “in-depth” program would focus on a more limited number of materials, and would ask participants to generate and report risk information specified by EPA. That information is intended to allow the agency to conduct a full risk assessment of the identified materials and associated uses. Both programs are designed to help EPA develop a permanent (and, presumably, non-voluntary) regulatory program for nanotechnology.
A key question to ask about any voluntary program is: What incentives are there for people to join the program and comply with its requirements? For example, the 33–50 program, one of the first major voluntary efforts initiated by EPA, asked companies to volunteer to make major reductions in toxic air emissions. Many companies voluntarily made the reductions, but they were encouraged to do so by the fact that in a few years they almost certainly would be forced to do so by enforcement of the Clean Air Act.
The primary incentives for joining the voluntary EPA nanotechnology program are that it would provide companies “a concrete means to demonstrate their individual and collective commitment to responsible nanotechnology development,” and that it would give participants “an opportunity to help determine the best ways to evaluate and address the potential risks” of nanotechnology (US EPA 2005).Many companies involved in nanotechnology fear a public reaction against nanotechnology, which might be fed by a lack of regulation. They also fear the possibility of over-regulation by EPA and other regulatory agencies. Thus, the incentives offered by the EPA program have some appeal, and may be sufficient to motivate companies to participate. Because the demands of the proposed program are fairly modest, non-compliance from those who do participate should not be a problem. An exception may be the withholding of existing negative risk information.
A major disadvantage of voluntary programs is that they may leave out the people who most need to be included. In the case of nanotechnology, small firms making risky products and large firms with small consciences are not likely to volunteer to do health testing or to give EPA information that might indicate a significant risk.
The other major option to new legislation is a ban either on commercialization of nanotechnology products or on nanotechnology research. ETC, the Action Group on Erosion, Technology, and Concentration, a Canadian-based organization, has stated: “Given the concerns raised over nanoparticle contamination in living organisms, Heads of State … should declare an immediate moratorium on commercial production of new nanomaterials and launch a transparent global process for evaluating the socio-economic, health and environmental implications of the technology.
This is, as far as I know, the only organization that has called for a ban on nanotechnology. Focus groups convened by the Project on Emerging Nanotechnologies indicate that only a small minority of the general public support a ban. The British Royal Society did recommend that: “Until more is known about environmental impacts … the releases of manufactured nanoparticles and nanotubes into the environment should be avoided as far as possible.” It also recommended prohibiting “the use of free (that is, not fixed in a matrix) manufactured nanoparticles in environmental applications such as remediation” until more is known about the risks and benefits of such use.
A ban is consistent with the “precautionary principle” which, in one of its simplest forms, says you will not undertake any action unless you know that it will not have any unacceptable consequences. The wisdom of a ban depends on weighing the potential benefits of continued development of nanotechnology against the severity and likelihood of any adverse consequences resulting from the technology. Most knowledgeable observers believe that the benefits of nanotechnology will outweigh the adverse consequences, especially if steps are taken to minimize adverse effects.
Another option is labeling. Some have argued that consumers are entitled to know if products contain nanomaterials. Labeling also can benefit manufacturers by allowing them to determine the contents of supplied goods and/or the supplier’s conformance with good practices. While labeling is a supplement, rather than a substitute, for the broader programs outlined above, it could be important.
For example, if nanotechnology product review were not made retroactive, products already on the market might be labeled to indicate that they had not been reviewed by the government. There is not a lot of empirical evidence about the effectiveness of labeling, although the available evidence indicates that labels often do not have much impact on consumer behaviour.
State pilot programs are yet another option. nanotechnology development is concentrated in fewer than a dozen states, and, in theory, a state could initiate a program at least to collect data on nanotechnology uses and effects. Given the intense interstate competition to attract high-tech industry, it seems doubtful that any state would have much incentive to take such an initiative. Several states have initiated programs to encourage nanotechnology as part of their economic development efforts. Washington State has called the competition to attract nano companies “one of the most intensely competitive technological races in history”.
Some would say that the most likely option always is to do nothing, taking no initiatives to deal with nanotechnology’s adverse effects. But that would serve no one’s interest. The public would be left unprotected, the government would struggle to apply existing law to a technology for which it was not designed, and industry would be exposed to the possibility of public fear and outrage over a powerful, mysterious, and potentially dangerous new technology.
This article has been broken into parts due to its original length. The parts can be found as follows:
· Part 1
· Part 2
· Part 3
· Part 4
· Part 5
The original document is Managing The Effects of Nanotechnology