Under California’s Green Chemistry Initiative, the Department of Toxic Substances Control (DTSC) will begin identifying and prioritizing chemicals in consumer products for regulation by January 1, 2011. The currently proposed “Safer Consumer Product Alternatives” Regulation (SCPA) not only contemplates the regulation of nanomaterial-containing consumer products “placed into the stream of commerce in California,” but also purports to govern any sale or transfer of such products outside the state “without maintaining sufficient control” over the product to prevent eventual use by California consumers.1 Consequently, nanotechnology-related companies throughout the state and beyond may quickly find themselves facing onerous requirements under the SCPA, including:
- providing extensive (and potentially proprietary) chemical and product data to DTSC (e.g., identity of chemical ingredients in products, market and sales data, specific sales locations and intended product uses);
- generating new chemical and product data and other information at DTSC’s request;
- conducting mandatory chemical alternatives assessments;
- preparing reports, work plans and other documents for DTSC; and
- legally certifying that they have employed “life cycle thinking and green chemistry principles” in connection with their products.2
Given the growing presence of nanomaterials in mainstream consumer products, DTSC characterizes nanotechnology as the “new plastic” and has been actively exploring potential nanomaterial health and environmental risks for several years.3 DTSC began evaluating potential health and environmental effects at least as early as 2004, and in January 2009, issued “Chemical Call-In” information requests to California businesses manufacturing or importing carbon nanotubes. DTSC has subsequently asked manufacturers of reactive nanometal oxides, including aluminum oxide, silicon dioxide, titanium dioxide, zinc oxide, nano silver, nano zerovalent iron and cerium oxide to submit information on analytical test methods, environmental fate and transport, and other critical information.4
Nanomaterials under the SCPA
The SCPA, however, sets the stage for state involvement in nanomaterial issues to take a quantum leap beyond mere information gathering. Under the proposed regulation, DTSC will identify and prioritize “Chemicals of Concern” in consumer products in a stepwise fashion.5 Specifically, DTSC will create a “Chemicals under Consideration” list, which will in turn lead to a “Priority Chemicals” listing of substances deemed the “highest priority” for public health and/or the environment.6 In addition to being listed on DTSC’s website for public review, consumer products containing these so-called Priority Chemicals may be placed on a “Products under Consideration” list and, ultimately, a list of “Priority Products” subject to prohibition.7
Critically, the term “chemical” as used throughout the SCPA expressly includes any “nanomaterial,” which is broadly defined as an “intentionally engineered chemical, substance, or material” (i) with at least one dimension between 1 and 100 nanometers in size, or (ii) that is less than 1000 nanometers in one dimension but exhibits one or more nanoscale phenomena.8 Further, the prioritization factors for the Chemicals under Consideration list include “chemical and physical properties” such as “other physical, chemical, or quantum properties specific to nanomaterials.”9 DTSC’s plain attention to nanomaterials in the proposed SCPA undeniably underscores that nanomaterials—and nanomaterialcontaining consumer products—will almost certainly make these target lists.
Although landing on the SCPA’s “Priority Chemicals List” will eventually yield the most onerous requirements, even substances merely listed as Chemicals under Consideration will be subject to burdensome regulation. If, for example, any product containing a chemical on the Chemicals under Consideration list is “reformulated or redesigned to remove or reduce the concentration of that chemical or the original product has been replaced with an alternative product,” all manufacturers, importers, distributors and retailers (among others) must provide AA Notifications to DTSC before placing the product into California’s stream of commerce.10
Such AA Notifications must include:
- the submitting party’s name and contact information;
- information identifying and describing the original product and the reformulated, redesigned or substituted product, including the brand name(s) and labeling information for both products;
- the intended uses, and targeted customer base(s), for the product;
- the Chemical under Consideration or Priority Chemical removed from, or reduced in, the product; and
- a Tier 1 AA Report comparing the two products.11
The Tier I AA Report is especially noteworthy because it requires a detailed chemical alternatives analysis consistent with Clean Production Action’s “Green Screen for Safer Chemicals,” a chemical hazard assessment method.12 A chemical’s hazard is defined by (i) its potential to cause adverse effects in humans or wildlife, (ii) its fate in the environment and (iii) any physical/chemical properties of concern to human health. Thus, Tier I AA Reporting essentially requires companies to assess the potential hazards posed by the chemical in both the original product and the reformulated, redesigned or alternative product.
DTSC, in turn, may then use these Tier I AA Reports as the basis for subsequent regulation, such as expanding the Priority Chemicals and Priority Products lists. Priority Products require even more detailed Tier II AA Reporting, which includes chemical hazard and exposure potential assessments, as well as a multimedia life cycle evaluation. DTSC even has the authority to impose product bans on Priority Products and Priority Chemicals if it determines that a “safer alternative” exists that does not contain a Priority Chemical.13
While the SCPA’s implications for all consumer products cannot be overlooked, the potential impact on nanomaterial innovation is especially severe. As legal advocacy groups increasingly focus on the potential risks associated with nanomaterials, it seems inevitable that mandatory product “alternatives assessments” could generate reports and information subject to misuse by plaintiffs in future lawsuits. Indeed, allegations that nanotechnology companies used materials somehow deemed “less safe” than other alternatives by a state agency may present significant challenges.