Client Alert: California Broadens, Then Narrows, Scope of Proposed Green Chemistry Initiative Regulations
California's Department of Toxic Substances Control (DTSC) recently released its third draft of proposed regulations to implement the Green Chemistry Initiative (GCI), entitled "Safer Consumer Product Alternatives." The initial concept of the GCI was to create a list of "priority chemicals," and then to focus on replacing these chemicals with safer alternatives in certain "priority consumer products." The second draft of proposed implementing regulations, which significantly broadened the scope of the initiative and would have imposed burdensome reporting requirements on manufacturers, generated substantial oral and written comments in opposition. A review of these comments resulted in DTSC's release of Draft #3 on November 16, 2010. The DTSC is accepting comments on the revised regulations through December 3, 2010.
Draft #3 includes useful changes that reduce the scope and burden of the GCI, but a broad array of products remains covered. Key revisions contained in Draft #3 include the following:
Chemicals of Concern: The DTSC now proposes to establish a list of "Chemicals of Concern," by December 31, 2011, based on specific hazard traits, including:
- Physical chemical hazards;
- Adverse public health impacts;
- Adverse ecological impacts;
- Adverse air quality impacts;
- Adverse water quality impacts;
- Adverse soil quality impacts; and
- Potential for exposure to children, pregnant women, other sensitive subpopulations and environmental receptors.
These chemicals must be one of the following:
- Carcinogens or reproductive toxins or both;
- Category 1A or 1B mutagens in Annex VI of the European Union's Regulation (EC) No. 1272/2008; or
- Persistent bioaccumulative toxic chemicals as determined by the U.S. Environmental Protection Agency.
The latest draft removes nanomaterials from the definition of Chemicals of Concern and it appears that DTSC will not attempt to regulate them through the GCI at this time. Importantly, recognizing the validity of the many comments that suggested that the DTSC's resources were wholly inadequate to respond to the very broad requirements laid out in Draft #2, Draft #3 states: ". . .the list [of Chemicals of Concern] shall be limited in number based upon the availability of Department resources to evaluate consumer products containing these chemicals."
Clarification of Initial Focus on Priority Products: Responding to concerns that Draft #2 lost the required focus on specific "Priority Products," Draft #3 clarifies that within the first five years of implementation, initial Priority Products will come exclusively from three primary categories: (1) children's products, (2) personal care products, and (3) household cleaning products. Recognizing budgetary limits, Draft #3 states: ". . .the list shall be limited in number based upon the availability of Department resources to review AA Work Plans and AA Reports and make regulatory response determinations for these products." All three categories are broadly defined, however, and the effect of the GCI is thus likely to be widely felt.
Alternative Assessments (AAs): The core concept of the GCI is the requirement that industry members conduct an Alternatives Assessment designed to eliminate use of hazardous chemicals in identified products of concern without substituting another chemical that is worse from an environmental and health perspective. Draft #2 called for a two-tiered process (Tier I and Tier II) for AAs. Significantly, that draft would have imposed notification and AA requirements for any consumer product (even non-priority products) containing Chemicals under Consideration or Priority Chemicals, a point that generated significant opposition because it appeared to go beyond the mandates of the statute. In response, DTSC now proposes to require an AA only for products identified as Priority Products or certain components of Priority Products. Each AA must be reviewed and verified by a third-party with no economic interest in the manufacturer or product. However, DTSC removed the requirements that the verifying assessor must apply for certification through the Department.
An AA Work Plan will be required from each "responsible entity" within 180 days of listing of a Priority Product that specifies the Chemical(s) of Concern in the product and how the AA will be conducted. An AA Report will document the results of the analysis and whether an alternative was selected or the Priority Product retained. The AA Report must include, among other things:
- Manufacturer's name and supply chain information, including location of retail outlets or names of distributors;
- Location of the facility where the Priority Product was produced and its proximity to raw materials containing the Chemical of Concern;
- Product's brand name;
- List of the Chemicals of Concern in the Priority Product;
- Approach and methodology;
- Assessment and comparison of alternatives;
- Differences in the chemical composition of the alternative from the Priority Product if an alternative is selected; and
- Any suggested regulatory responses that the entity submitting the AA believes will help limit exposure to the Chemical of Concern contained in the product.
While the obligation to conduct an AA remains burdensome, these changes at least circumscribe to some extent the scope of an AA.
De minimis exemption: A new section was added in Draft #2 to permit manufacturers to apply for a de minimis exemption for certain Chemicals of Concern present in consumer products. Draft #3 clarifies the de minimis cut off level as 0.1%, or if applicable, the hazardous waste regulatory threshold specified for the chemical pursuant to Health and Safety Code section 25141. Draft #3 reduces the paperwork burden, requiring that a manufacturer of a product containing a de minimis amount of a Chemical of Concern in a Priority Product only has to notify DTSC of the de minimis chemical rather than apply for the exemption.
Confidential Information: Understandably, there has been concern among manufacturers that AA Reports would require exposing trade secrets and other confidential information. Although still required to submit certain confidential information, manufacturers may also submit a redacted version clearly marked "Confidential" or "Trade Secret." In addition to conspicuously marked documents, the manufacturer will also be required to assert a claim of confidentiality through separate correspondence detailing the legal authority for the claims. However, DTSC has discretion on how much information will be released to the public and the Department can request additional support for claims of a trade secret.
Although less onerous than the previous draft, the regulations will still impose substantial reporting requirements on many retailers and manufacturers of consumer products in California. Even after the revisions, there are thousands of chemicals that will be potentially reviewed under the regulations. The practical result of the burdens imposed by the draft regulations is likely to be the withdrawal of a substantial number of products from the California market. Affected stakeholders should submit comments by December 3, addressing both aspects of Draft 3 which they support as well as additional points requiring further revision. Avoiding duplication of regulatory effort in light of budgetary constraints is likely to remain a key point in further comments.
It is also important not to lose sight that California is only one of several states advancing green chemistry initiatives that involve potentially burdensome reporting requirements likely to yield limited, if any, public health benefits. The landscape will continue to become increasingly complex for the entire supply chain as the focus on chemicals in products, rather than potential risk of exposure to chemicals in products using well-defined and time-tested methodologies, continues to be at the core of these initiatives.
For more information on Green Chemistry and product safety, contact Sheila A. Millar, email@example.com, J.C. Walker, firstname.lastname@example.org, or Alisa A. Karlsons, email@example.com. For more information on Green Chemistry and other California requirements, contact Leslie T. Krasny, firstname.lastname@example.org or Diana G. Graham, email@example.com.
 For a comparison of the second and third drafts, see: http://www.dtsc.ca.gov/LawsRegsPolicies/upload/SCPA_Regs_15Day_Revisions_11162010.pdf.