Section of Environment, Energy, and Resources
Section Nanotechnology Project
Phase II
The American Bar Association Section of Environment, Energy, and Resources (SEER) Pesticides, Chemical Regulation, and Right-to-Know Committee is launching Phase II of its Nanotechnology Project. As discussed below, SEER recently completed successfully Phase I, which included the preparation of seven white papers and the completion of the Nano Quick Teleconference (“QT”) Track.
The Committee is now launching Phase II of the Nanotechnology Project. This phase is intended to address important legal topics not covered in Phase I. These include:
• The Food Quality Protection Act (“FQPA”)
• The Federal Food, Drug, and Cosmetic Act (“FFDCA”)
• The National Environmental Policy Act (“NEPA”)
• The Endangered Species Act (“ESA”).
Committee Chair Lynn Bergeson and Committee Vice Chairs Mark Duvall and James Chen serve as co-chairs of this project.
Phase II will analyze these statutes for three reasons. First, lawyers within EPA and the Food and Drug Administration (“FDA”) have inquired about whether SEER intends to prepare briefing documents on these laws and have noted a need for them. Second, SEER believes that briefing documents on these statutes are particularly important given the direction the legal debate has taken over the past year. This is particularly true of the many issues that FDA is now confronting. Third, we expect Congressional interest in these areas and believe the Section, through the Congressional Relations Task Force, could play an important role in identifying legal issues, contributing to the body of law in these areas.
As with Phase I, teams will prepare issue papers on these topics, which would also be provided to EPA’s Office of General Counsel and FDA’s Office of General Counsel. We will also arrange with those Offices to make presentations based on the issue papers. The teams are now forming.
Nanotechnology Teleconference Series
As a supplement to Phase II efforts, the Committee also plans to convene a Nano QT Track structured along lines similar to the first Nano QT Track. We propose initiating the series in the first or second quarter of 2008 to coincide with the issuance of the new briefing documents.
Next Steps
We have received permission from SEER to initiate Phase II, and we are now getting started. Accordingly, at this time we are soliciting interested attorneys to volunteer to work on one or more of the teams. There will be team for each statute: FQPA, FFDCA, NEPA, ESA.
We would be glad to discuss this with you further. Please contact Lynn Bergeson, Jim Chen, or Mark Duvall to volunteer to serve on or more teams:
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Phase I
The Section of Environment, Energy, and Resources (SEER) is pleased to make available the results of a comprehensive review of the core federal environmental statutes to assess the suitability of each to address issues pertinent to human health and the environment arising from applications of nanotechnology. In early 2007, the Section offered to brief representatives of the U.S. Environmental Protection Agency (EPA) Office of General Counsel (OGC) and pertinent other EPA representatives in EPA program offices on legal and regulatory issues arising in connection with the application of existing statutory and regulatory authorities to engineered nanoscale materials. Specifically, the Section offered to prepare detailed briefing documents on each of the six core environmental statutes, and a briefing document on innovative governance mechanisms, that identify key legal and regulatory issues EPA can be expected to encounter as it considers how best to address issues likely to arise in connection with nanotechnology.
SEER has been pleased to provide the benefit of its analyses to EPA’s OGC, and believes its contribution to the responsible development of nanotechnology is considerable. SEER hopes that its briefing documents will be distributed widely and reviewed by as many stakeholders as possible.
In March 2007, approximately 100 SEER lawyers organized into seven teams to prepare the briefing documents. Each team had a Team Leader and a Briefing Team.
Beginning in May, and concluding in mid-July, representatives from each of the seven teams presented their findings to EPA General Counsel Ann Klee and other EPA representatives in seven separate 90-minute meetings. The briefing documents themselves are linked below. These papers collectively provide the first comprehensive, scholarly review of the core federal environmental statutes with a view toward assessing the utility of each in addressing the legal and regulatory issues pertinent to EPA’s jurisdiction presented by nanotechnology. In general, the papers concluded that the core environmental statutes were found to provide EPA with sufficient legal authority to address adequately the challenges EPA is expected to encounter as it assesses the enormous benefits of and potential risks associated with nanotechnology. Please note these papers are solely the product of the ABA SEER, and do not purport to represent the opinions of EPA.
SEER’s efforts in undertaking and completing this ambitious project are extraordinary. The Section lawyers who devoted considerable time, energy, and scholarly attention to preparing the briefing documents have provided a unique and immensely useful service. The briefing documents are well written and comprehensive resources that the Section hopes lawyers, regulators, and stakeholders in the nanotechnology area will find useful and that will facilitate further discussion on the topics each considers.
CAA Nanotechnology Briefing Paper
The ABA SEER CAA Nanotechnology Subcommittee believes that EPA must: (1) distinguish between types of nanoparticles, identifying nanoparticles posing actionable risk, and determining appropriate regulatory approaches for each type of nanoparticle requiring regulatory control; (2) develop appropriate methods of sampling, analysis, and control sufficiently effective for nanoparticles; (3) recognize and adapt to a new form of “quantification” as number, rather than mass; and (4) to avoid creating unnecessary delay in developing strategies to address nanoparticle emissions, which could result in overregulation stifling this new industry, recognize that the current CAA program already contains sufficient authority to adequately address each of the issues discussed in this paper.
CAA Nanotechnology Briefing Paper
Team Leader: Mary Ellen Ternes
Briefing Team: Ken Meade, David Friedland, and Lynn L. Bergeson
CERCLA Nanotechnology Issues
The current state of knowledge concerning the environmental and health effects of nanomaterials poses practical difficulties in applying CERCLA. It is probably correct to say that most of the scientific and technical predicates for applying the statute to nanomaterials do not yet exist. This knowledge gap is not as problematic under CERCLA as it is for environmental statutes that focus on current activities. Indeed, CERCLA was purpose-built to cope with the unanticipated adverse consequences of previously accepted practices. It expanded existing law by creating a totally new concept -- liability for conditions that exist today, no matter when the conduct giving rise to them occurred. This concept fits the paradigm of adverse consequences that may arise in the future from as-yet unknown properties of nanomaterials. Only technical input is needed to apply the statutory authorities to nanomaterials. When we can answer the questions of whether nanomaterials are hazardous, and if so, in what ways and in what amounts, the CERCLA machinery will be available to address adverse consequences.
CERCLA Nanotechnology Issues
Team Leader: Chris McCormack
Briefing Team: Richard Fil, and Lynn L. Bergeson
CWA Nanotechnology Briefing Paper
Although EPA likely has the authority to regulate nanoparticles, it would also likely be necessary for EPA to demonstrate that certain nanoparticles (e.g., specific compounds or a class or category of nanoparticles) have a potential adverse effect on human health or the environment, thus making regulation of the nanoparticle necessary and appropriate under the CWA. To this end, further research and study would likely be necessary. In addition, before any meaningful regulation could be implemented, the technology must be developed that would allow nanoparticles to be accurately monitored, measured, and controlled.
CWA Nanotechnology Briefing Paper
Team Leader: Pamela E. Barker
Briefing Team: Steven Ziesmann, Jim Wedeking, and Lynn L. Bergeson
EMS/Innovative Regulatory Approaches
We believe that the issues surrounding nanotechnology provide an interesting and unique opportunity for EPA to imagine and implement a 21st century approach to environmental management. Consideration of the issues and options presented here would allow the systematic development and use of a wide range of tools to encourage desirable environmental behavior that will protect human health and the environment while allowing the nanotechnology industry to grow and compete globally.
EMS/Innovative Regulatory Approaches
Team Leader: Richard M. Fil
Briefing Team: Lee Paddock, Greg Mandel, and Lynn L. Bergeson
The Adequacy of FIFRA to Regulate Nanotechnology-Based Pesticides
EPA can regulate nanopesticides adequately through its existing statutory authority, although it may want to revisit its current regulations and guidance to address the unique characteristics of nanopesticides. Congress did provide additional statutory authority to regulate antimicrobials under the Food Quality Protection Act (FQPA), but that authority mostly addressed procedure rather than substantive criteria for registration. The FQPA does not establish a precedent for EPA needing legislative action to address particular classes of pesticides presenting different characteristics than the pesticides traditionally addressed by FIFRA. The better precedent is genetically engineered microorganisms used as pesticides. In 1986, EPA determined that it could regulate the pesticidal products of biotechnology through FIFRA, despite the Agency’s recognition that at least some of those products were likely to exhibit new traits. EPA addressed such factors as EUP exemptions, data requirements for registration, and post-registration reporting of adverse effects information for bioengineered microbial pesticides under FIFRA without the need for new legislative authority. More recently, in 2001 EPA promulgated regulations to address a particular class of bioengineered pesticides, plant-incorporated protectants, again without additional legislative authority. These examples suggest that EPA can regulate nanopesticides effectively under FIFRA.
The Adequacy of FIFRA to Regulate Nanotechnology-Based Pesticides
Team Leader: Mark N. Duvall
Briefing Team: James Chen, Warren Lehrenbaum, and Lynn L. Bergeson
RCRA Regulation of Wastes from the Production, Use, and Disposal of Nanomaterials
We conclude that EPA already has expansive authority under RCRA to regulate discarded wastes that might include nanoscale materials. EPA’s current regulations governing the management of hazardous wastes will also likely apply broadly to solid and hazardous wastes containing nanoscale constituents. Despite EPA’s sweeping powers to regulate hazardous waste management and its comprehensive regulatory framework, we also identify several areas of potential interest where EPA may wish to determine whether its current regulations will have unintended consequences when applied to nanoscale waste materials.
RCRA Regulation of Wastes from the Production, Use, and Disposal of Nanomaterials
Team Leader: Tracy Hester
Briefing Team: Joseph Guida, Christopher Bell, and Lynn L. Bergeson
Regulation of Nanoscale Materials under the Toxic Substances Control Act
The following conclusions can be made regarding the ability of TSCA to regulate nanotechnology: (1) nanomaterials include chemical substances and mixtures that EPA can regulate pursuant to TSCA; (2) if a “new” chemical substance is manufactured at the nanoscale, it is subject to the same PMN review requirements under TSCA Section 5(a)(1) that are applicable to any new chemical; and (3) as an alternative to its Section 5(a)(1) PMN authority over “new” chemical substances, EPA may regulate nanomaterials as existing chemical substances under its Section 5(a)(2) authority to promulgate SNURs. In addition, EPA has other authorities under TSCA to regulate nanomaterials, including the authority to require health and environmental testing; collect production, health, and environmental information about nanomaterials; and promulgate rules regulating, and even prohibiting, the manufacture, processing, distribution, and use of nanomaterials.
Regulation of Nanoscale Materials under the Toxic Substances Control Act
Team Leader: Christopher Bell
Briefing Team: Mark N. Duvall, James Chen, and Lynn L. Bergeson
