On February 15, 2007 the United States Environmental Protection Agency (“EPA”) released the final draft of its Nanotechnology White Paper (“White Paper”), which contains the most current statement of EPA policy regarding nanotechnology. Borrowing from the National Nanotechnology Initiative (“NNI”), EPA has defined nanotechnology as: “[R]esearch and technology development at the atomic, molecular, or macromolecular levels using a length scale of approximately one to one hundred nanometers in any dimension; the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and the ability to control or manipulate matter on an atomic scale.”
EPA has also recognized that nanotechnology is “nearing the end of basic research,” and that we have begun to enter the second generation, which involves, among other things, targeted drug delivery systems and adaptive structures and actuators.
The White Paper contains recommendations to ensure that EPA is in the vanguard in addressing potential societal risks and rewards of nanotechnology given the current pace of nanotechnology and its convergent counterparts in other disciplines. Specifically, EPA intends to perform its own research and to foster the research of other entities to develop a better understanding as to nanoscale materials and environmental applications (including fate and treatment methods, as well as detection and analysis); chemical identification and characterization; measurement and control of human exposures; human health effects assessment; and ecological effects assessment.
Additionally, EPA intends to take a conclusive approach to nanotechnology through the following:
• Engage resources and expertise to “encourage, develop and support nanomaterial pollution prevention,” and to support “second generation” applications that promote greater environmental stewardship (such as “green energy and green manufacturing”);
• Encourage collaborations with EPA regarding nanomaterial applications and potential human and environmental health implications;
• Create an intra-Agency group which would share information regarding nanotechnology risk assessment or regulatory activities; and
• Continue training EPA scientists and managers as to potential environmental applications and environmental implications of nanotechnology.
Consistent with its approach since 2005, when the first draft of the White Paper was published, EPA has not indicated any strong need or desire to regulate the nano industry. Instead, its recommendations appear to be directed at creating a “partnership approach,” whereby science, industry and government would share information about the potential benefits and drawbacks of nanoscale materials. EPA’s proposed methods appear to be reasonably well suited toward creating a consensus as to the potential costs and benefits of nanotechnology. Whether this approach can function in light of the proprietary nature of some nanoscale materials is uncertain, as is the duration of EPA’s implicit “partnerships.” However, it appears that, at least in the short run, EPA is content to work with industry and science rather than single-handedly create new regulations unique to nanotechnology.
In contrast to EPA’s approach is that of Berkeley, California which, on January 11, 2007 revised the hazardous materials and waste management chapter of its Municipal Code (“Code”). Under the Code’s revised Chapter 15, §12.040(I), “[a]ll facilities that manufacture or use manufactured nanoparticles shall submit a separate written disclosure of the current toxicology of the materials reported, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.” Berkeley, CA, Code §15.12.040(I). The quantity of nanoscale materials that trigger the disclosure requirement is set forth in Chapter 15, §12.050(7), which states that, “[a]ll manufactured nanoparticles, defined as a particle with one axis less than 100 nanometers in length, shall be reported in the disclosure plan.” Berkeley, CA, Code §15.12.050(7).
When §§ 15.12.040(I) and 15.12.050(7) are read in conjunction, the revised Code appears to require any company that intentionally manufactures nanoscale particles to submit a written disclosure of the known toxicology of nanoscale materials as well as plans for safely dealing with the particles while the particles are located within Berkeley, and the parts of Oakland for which Berkeley has regulatory and enforcement authority. Berkeley, CA, Code §15.12.010(E).
A major weakness in the statutory scheme is that the word “safely” remains undefined, which creates a great deal of uncertainty as to what a company must do to be compliant with the Code. It also opens itself to allegations of selective and subjective enforcement. Companies with locations in the Bay Area or considering locating to the Bay Area must be aware that the Code presents an unknown regulatory variable.
Whether Berkeley’s approach is a bellwether remains to be seen, and is dependent upon the manner in which it is enforced in the future. At this time EPA’s regulatory “scheme,” which offers certainty in the present and lacks the potential subjective pitfalls of the Berkeley Code, appears to be better suited to addressing the needs not only of the regulatory body and the people, but also of science and the nascent industry that is arising as a result of the first generation of nanotechnology research.