Professor Albert C. Lin at the University of California at Davis law school, recently published "Size Matters: Regulating Nanotechnology" in the Harvard Environmental Law Review. 31 Harv. Envtl. L. Rev. 349 (2007).
Lin begins with broad overviews of (i) the potential benefits of nanotechnology, (ii) the theoretical environmental, health, and safety (“EHS”) concerns accompanying the use of some nanoscale materials in certain settings, and (iii) how he believes existing federal laws are insufficient to address this latter risk. Most of this has been said before in a myriad of very articulate papers published by the Woodrow Wilson International Center for Scholars (“WWI”). Although Lin gives WWI plenty of credit, his summaries are not as well-balanced as one might hope. At the very least, Lin should have addressed the set of American Bar Association papers which provide an excellent counterpoint. Lin also spends a fair amount of time (i) recounting lessons he believes industry should have learned from the dispute over genetically modified organisms, (ii) debating whether the “precautionary principle” should be adopted by EPA, and (iii) providing regulators a host of reasons why they should specifically regulate nanotechnology sooner rather than later. While interesting, these topics distract from the core of his paper.
The real “meat” of Lin’s paper is his proposal for new all-encompassing nano-specific federal regulation. Under Lin’s proposal, all products containing nanoscale materials would be subject to mandatory EPA premanufacturing notification and labeling requirements. Additionally, products containing “free nanomaterials” would also be subject to an additional screening process, post market monitoring, and bonding requirements.
Regarding mandatory EPA premanufacturing notification, Lin envisions such notice would include a description of the specific nanoscale material being used, the manufacturing process employed, any resulting by-products from that process, all available information on health and environmental effects, and an estimate of number of people who might be exposed. Lin acknowledges most of this information is already required for any nanoscale material deemed to be a “new chemical substance” or a “significant new use” of an existing chemical substance under TSCA. He argues, however, that incorporating these same requirements into an entirely new nano-specific law is preferable because it would be less subject to legal challenges and could be structured much broader than TSCA to cover consumer and FDA regulated products all under a single unified nano-regulation.
Regarding nano-labeling, Lin proposes new labels for all products containing nanoscale materials. Such labels would identify the specific nanomaterials in use and also, "[p]rovide a brief comparison of the nanomaterial with the bulk version of the material." Lin acknowledges these notice and labeling requirements will depend on development of standard terminology and nomenclature for nanotechnology. Lin does nothing, however, to explain what type of comparative information he would actually require in labels.
More problematic is Lin’s proposal regarding “free nanomaterials.” Lin argues that because “free nanomaterials” pose increased health risks, they should be subject to the additional requirements of screening, bonding, and workplace and waste stream monitoring. Lin should spend more time developing his concept of “free nanomaterials,” and providing his readers with some idea regarding their actual prevalence (or lack thereof).
Nevertheless, Lin proposes that screening tests would be used to curtail the use of certain “free nanomaterials” that appear most likely to be toxic. “A substance that fails to pass the screening would not be completely excluded from commercial use, however. For such substances, the burden would shift to the manufacturer to demonstrate through more extensive research that the substance can be sued in a safe manner.” Lin recognizes that new in vitro tests will need to be developed to accomplish this result, and they must be periodically reevaluated for effectiveness.
Regarding post-manufacturing monitoring, Lin proposes manufacturers using “free nanomaterials” would be required to gather toxicity data, track fate and transport of their nanomaterials in the environment, and to monitor any adverse exposure effects in the environment and workplace. This data would then be submitted to EPA and used to evaluate the effectiveness of its existing regulation of nanoscale materials. Again, Lin provides few specifics regarding what type of information would actually be required under this part of his proposal.
Regarding financial responsibility for any potential personal injury or environmental damage caused by “free nanomaterials,” Lin argues typical commercial insurance coverage will not work because insurance companies may decline to cover nano-related EHS risks, leaving no pool of recovery funds to possible plaintiffs. Additionally, Lin argues a liability cap fund partially funded by the government (like Price-Anderson Act for nuclear power) is also unacceptable because it shifts costs and risks to the government and/or "potential victims" and does not adequately compensate for all potential losses. He argues these costs should be borne by the nanotechnology industry.
To address these purported deficiencies, Lin advocates environmental bonding, calling it the most important component of his proposal: "Under this requirement, any manufacturer or distributor introducing into commerce a product containing free nanomaterials would be required to post a dated assurance bond that would cover damages that may arise as a result of the company’s operations for each year. EPA would set the value of the bond at an amount adequate to cover the most damaging scenario deemed plausible under a worst-case analysis. Such an analysis, which would be assigned to an independent scientific advisory board, would consider factors such as possible routes and levels of exposure, and similarities between the material in question and substances with known toxicology. The term of the bond would be fifteen years, or a period long enough to generate a reasonable amount of short term and long-term toxicity information, and its value could be revised upward or downward periodically to reflect new information. The bond would be refundable in whole or part, with interest, at the end of the term if the company could demonstrate lower damages, or lower expected damages, than those estimated by EPA in setting the bond. The unrefunded portion of the bond, intended to cover expected damages that have not yet occurred, would be deposited in a trust fund that the proposal would establish.”
Anticipating reaction to his bonding proposal, Lin admits it is likely to slow down innovation and commercialization, will have and administrative cost, and that the bonds themselves may be insufficient to cover potential nano-related EHS losses. More importantly, to more fully develop his bonding proposal, Lin should explain whether and how he believes the Comprehensive Environmental Response, Compensation, and Liability Act is insufficient to assess and recover potential nano-environmental remediation costs. The paper could also benefit from additional explanation regarding why Lin believes traditional toxic tort, product liability, and personal injury laws are insufficient to compensate those potentially injured from exposure to nanomaterials.