Nanotechnology, the study of the controlling of matter on an atomic and molecular scale, promises a number of benefits to society. If current trends in manufacturing are any indication, this emerging technology is here to stay. The August 21, 2008 Project on Emerging Nanotechnologies estimated that over 800 manufacturer-identified nanotechnology products are publicly available, with 3 to 4 new products arriving in the market place per week.
Early research has established that while some types of nanomaterials are seemingly inert, others may be highly toxic. Thus, the field of nanotechnology is ripe for regulatory intervention. Policy makers in several jurisdictions are already establishing legal frameworks for the management of nanotechnology. For example, the federal Toxic Substances Control Act (“TSCA”) already includes nanoscale materials within its definition of “chemical substances.” And if recent legislative proposals to overhaul TSCA become law, the level of federal regulatory scrutiny of nanotechnology will expand, subjecting manufacturers and processors to additional notification, reporting and review procedures.
Recently, the California Department of Toxic Substances Control (“DTSC”) submitted the Green Chemistry Proposed Regulation for Safer Consumer Products to California’s Office of Administrative Law to begin the formal rule making process that will regulate nanomaterials as chemicals.
The proposed regulation establishes a process for identifying and prioritizing “chemicals of concern” and “priority products” containing such chemicals. Once a nanomaterial is identified as a chemical of concern, its manufacturers must perform an alternatives assessment of relevant consumer products. After the alternatives assessment is performed, DTSC determines the appropriate regulatory response, which may include chemical substitution, labeling requirements, or use restrictions, among other actions.
One unique aspect of this regulatory scheme is that it defines a “chemical” to mean any of the following: (A) a chemical substance; (B) a chemical mixture; (C) nanomaterial. A “nanomaterial” is defined as “any form of an intentionally engineered chemical, substance or material that is intended to be composed of a discrete nanostructure that meets either of the following criteria: 1. at least one spatial dimension of the nanostructure is at the nanoscale, or 2. the nanostructure is larger than nanoscale in any spatial dimension, but is 1000 nanometers or less in at least one spatial dimension, and the nanostructure exhibits one or more nanoscale phenomena.” The proposed regulation goes on to define the terms “Nanoscale”, “Nanoscale phenomena” and “Nanostructure.”
In addition to incorporating nanomaterials into the definition of a chemical, the proposed regulation excludes nanomaterials from the de minimis exemption available to other chemicals, thus implying a heightened, more inclusive level of regulation of these materials.
As the California regulatory landscape expands to cover nanomaterials in a new and more comprehensive way, stakeholders should note several possible areas of concern including the possible preemption of state law and overlap with federal authority. In light of the proposed changes to TCSA, preemptory challenges to California’s Green Chemistry regulation may prove futile. Section 2617 of TCSA, as it currently exists, grants the EPA broad authority to preempt state and local regulations of chemicals covered under the Act. (15 U.S.C. 2617) However, the proposed revision of TSCA amends the preemption section to include language suggesting that a federal preemption argument may no longer be valid. (H.R. 5820).
While it is too early to know the impact nanomaterials regulation will have on the fledgling industry, as manufacturers increasingly make use of nanomaterials in consumer products, California’s proposed Green Chemistry regulation, set to be finalized in January 2011, is likely to have a significant impact and bears close watching.