California’s Green Chemistry Regulations; A Lot of R&R (Requirements and Responsibilities) for Regulated IndustrySeptember 28, 2010
In September 2008, California Governor Arnold Schwarzenegger signed landmark green chemistry legislation authorizing the Department of Toxic Substance Control (“DTSC”) to: (1) identify and prioritize chemicals of concern, evaluate alternatives as well as to specify regulatory responses (Assembly Bill 1879); and (2) establish an online Toxics Information Clearinghouse to provide public access to information on the toxicity of chemicals (Senate Bill 509).
According to the DTSC, the objective of this legislation is:
that chemical and consumer product prioritization processes should seek to identify and give priority to those chemicals, and the consumer products that contain them, that pose the greatest public health and environmental threats, are most prevalently distributed in commerce and used by consumers, and for which there is the greatest potential for consumers or environmental receptors to be exposed to the chemical in quantities that can result in public health or environmental harm.
In carrying out the law, the DTSC is the designated entity responsible for drafting regulations to implement the law by December 31, 2010. After 18 months of workshops and various draft proposals, the DTSC has recently released the formal proposed regulations. Here’s a summary of the proposal . . . .
The definition of a consumer product is very broad but does exempt dangerous drugs or devices; dental restorative materials; foods; pesticides; and mercury- containing lights. (Mercury-containing devices are only exempted from these regulations until December 31, 2011.)
Additionally, the list of authoritative entities that could be consulted in creating the priority chemicals list is expansive. As defined by the regulation the DTSC may review a chemical listed as a carcinogen or a reproductive toxin, or both, pursuant to one or more of the following:
- California Health and Safety Code section 25249.8 (Proposition 65);
- The National Toxicology Program Report on Carcinogens that lists chemicals known and reasonably anticipated to be human carcinogens;
- United States Environmental Protection Agency chemicals classified as Known or Likely (Group A, B1 or B2), as maintained on its Integrated Risk Information System, or equivalent weight-of-evidence classifications that result from subsequent revisions to its “Guidelines for Carcinogen Risk Assessment”;
- The International Agency for Research on Cancer Group I and 2A chemicals; (E) The International Agency for Research on Cancer Group 2B chemicals where there exists sufficient evidence of carcinogenicity in animals, even if evidence of carcinogenicity in humans is inadequate; and
- The European Union Classification and Labeling (Globally Harmonized System) Category 1A and 1B chemicals.
After a chemical has been listed as a Chemical under Consideration or Priority Chemical, manufacturers (which has a broad definition) must submit an Alternatives Assessment Notification if they reformulate or redesign products to remove or reduce the concentration of that chemical, or replace the original product with an alternative product. The Alternatives Assessments must be done by an accredited “Lead Assessor” (i.e., accredited by DTSC or an Accrediting Body designated by DTSC).
When a Priority Chemical is listed in a Priority Product, an alternative analysis report shall provide sufficient detail to support the selection of an alternative, or a decision to retain the existing Priority Product in lieu of an alternative and selection of appropriate regulatory response. The regulations also specify that DTSC may require any of the following as regulatory responses that it determines are necessary to limit exposure to, and reduce the level of public health or environmental hazards posed by, a selected alternative, or a Priority Product for which an alternative is not selected:
- Product information for consumers;
- End-of-life product stewardship program;
- Product sales prohibition;
- Engineered safety measures to control access or limit exposure to the Priority Chemical in a product; and
- Restrictions on the use of the Priority Chemical.
Additionally, the proposed regulations include requirements for “responsible entities” to generate toxicity and ingredient data for product components developed in a complex global supply chain. This requirement will be expanded exponentially once California’s Department of the Office of Health Hazard Assessment (“OEHHA”) issues its regulation expanding the types of hazard traits for which data could be requested. OEHHA is currently considering public comments on its rulemaking. The hazard traits currently being considered as part of the proposed regulation would extend beyond just carcinogenity and reproductive toxicity – i.e., Proposition 65 hazard traits – to also include neurotoxicity, endocrine toxicity, epigenetic toxicity, totoxicity, phytotoxicity and others.
There will be a public hearing on the green chemistry regulations on November 1, 2010.
* Mr. Pollack is a guest author and is an attorney with Randy Pollack Law Office in Sacramento, CA.
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