July 15, 2010 Maziar Movassaghi Acting Director California Department of Toxic Substances Control P.O.

Box 806 Sacramento, CA 95812-0806 Submitted via Electronic Mail

RE: Comments on draft regulations from members of the Green Ribbon Science Panel
Dear Director Movassaghi: As members of the Green Ribbon Science Panel, appointed to advise the Department on the development of regulations for the implementation of SB 509 and AB 1879, we are writing to provide comment on the Safer Alternatives Draft Regulations that were issued on June 23, 2010. We applaud DTSC staff for the enormous effort and progress that has been made in the development of these regulations over the last several months. We are providing the comments below to highlight several key issues that we believe are serious enough to preclude the successful implementation of this ground-breaking legislation. We have previously discussed many of these pOints in detail at meetings of the Green Ribbon Science Panel and were very disappointed to see that these concerns and recommendations were not reflected in the regulations. Other issues we would like to call your attention to have come to light with the publishing of the complete draft regulatory language.

Concern #1: Section 69302.4 (b) and (c): Identification of Chemicals of Concern: a) Section 69302.4 (b) Ongoing Restriction: Permanent elimination from
designation as chemicals of concern all chemicals with no hazard traits other than carcinogenicity or reproductive toxicity unless they are listed pursuant to Health and Safety Code section 25249.8 is unacceptable and counterproductive to the stated goal of the California Green Chemistry Initiative.

Solution: Remove this language from the draft regulations. b) Section 69302.4 (c) Limitations on Initial List: Limiting sources for the
generation of the initial list of Chemicals of Concern (CoC) to only Prop 65, the US EPA's PBT list and EU Category 1A or 1B mutagens is similarly inadequate and counterproductive. For example, the US EPA's list of PBTs has only 12 chemicals listed and most of them are not relevant to consumer

Green Ribbon Science Panel Comments to DTSC

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products. Furthermore, this list is not actively updated by US EPA and reflects out of date thinking on the subject. Solution: Remove these restrictions from the process of generating the initial list of Chemicals of Concern. California should have the ability to take action on high priority chemicals immediately and without restriction. If, however, existing lists are to be used for an initial CoC list, these lists should at a minimum include all of the EU's chemical lists, not just the EU mutagen lists. c) Timelines: No timeline is specified for the generation of subsequent lists of Chemicals of Concern. While Section 69302.2(e) requires DTSC to "review and revise" the Chemicals under Consideration and Chemicals of Concern lists at least every three years, it is not clear whether this section applies to the generation of new versions of these lists. Solution: Clarify the applicability of Section 69302.2(e) to provide a reasonable timeline for the periodic generation of subsequent lists of Chemicals under Consideration and Chemicals of Concern. d) No minimum data requirement: The process for identifying Chemicals of Concern as currently described prioritizes data-rich chemicals; with no mechanism for requiring a minimum data set the regulatory process would virtually exempt chemicals for which little information exists. DTSC has the authority to require data to be provided under the draft regulations, but this is not sufficient. Many chemicals in commerce that are not recognized as chemicals of concern because of missing data will simply remain in commerce. AB 1879 requires DTSC to identify chemicals of concern, which it cannot do without closing data gaps. Solution: DTSC should require a minimum data set for chemicals in consumer products that pose a potential threat to public health and the environment (e.g., are in use in high volume or have a high exposure potential), for which there is insufficient data to determine whether they have hazard traits that fall under the regulation. Since design of such a data set is not trivial, DTSC should establish a process for developing a required data set in a set time period of one to two years. Concern #2: Section 69301.2. Definition of de minimis: The definition of de minimis set at 0.1 % does not reflect growing scientific literature on the effects of low dose chemical exposures, aggregate sources of exposure, or the potential impacts of contaminants in consumer products. Solution: Do not permit exemption for Chemicals of Concern simply because their concentration in a product is below 0.1 %. At the very minimum, change the definition of de minimis so as not to apply to classes of chemicals that are linked to adverse effects on human health and the environment at low levels, including,

Green Ribbon Science Panel Comments to DTSC but not limited to, persistent, bioaccumulative, and toxic chemicals (PBTs), carcinogenic, mutagenic, or reproductive toxins (CMRs), and endocrine disrupting compounds.

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Concern #3: Section 69305. Alternatives Assessments: The proposed requirements for alternatives assessments are extensive and, while warranted in cases where there are complex trade offs among potential alternatives, are unnecessarily burdensome to manufacturers where there are appropriate alternatives available and needlessly obstructive where a fast track to regulatory response is prudent. Given the large number of widely diverse assessments that will be required by the regulation, it is critical that the DTSC have a broader discretion of types of alternatives assessments as envisioned in the tiered approach proposed by members of the GRSP. Solution: Implement a tiered approach to alternatives assessments such as that proposed. Concern #4: DTSC Resources: The availability of DTSC resources will impact the implementation of these regulations at a number of points (e.g., designation of chemicals of concern, determination of products of concern, review of alternatives assessments, evaluation of petition submissions, dispute resolution, etc.); the issue of providing for adequate resources for implementation must be addressed. Solution: Provide for the assessment of fees for DTSC review of the data and alternatives assessment submittals required by the draft regulations. If DTSC believes that they do not have the statutory authority to assess fees for the implementation under AB 1879, this concern should be conveyed to the California legislature. Concern #5: Section 69306.5. Product Sales Prohibition: In the Regulatory Response section, the criteria for a Product Sales Prohibition imply a cost-benefit analysis that does not include externalities and societal burden. Solution: Change the language of this section to clearly include externalized human health and environmental health costs in the cost-benefit calculation. Concern #6: Public Participation: There is no provision for public input or review in the processes detailed in the regulations beyond the determination of chemicals or products of concern. Without public oversight of the conduct of alternatives analyses and implementation of regulatory responses, government and industry will not be accountable to the public, providing little reason for confidence in the decisions being made. Solution: Provide mechanisms for public input and review at appropriate stages of the alternatives assessments, granting of exemptions from the need to perform

Green Ribbon Science Panel Comments to DTSC

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alternatives assessments for any priority product containing a chemical of concern, and determinations of whether to require or enforce a regulatory response.

Ann Blake, Ph.D. Principal, Environmental & Public Health Consulting Debbie Raphael Department of the Environment City and County of San Francisco Kelly D. Moran, Ph.D. TDC Environmental, LLC Lauren Heine, Ph.D. Science Director, Clean Production Action Richard Denison, Ph.D. Senior Scientist Environmental Defense Fund Julia Quint, Ph.D. California Department of Public Health (Retired) Michael Wilson, Ph.D., MPH Center for Occupational and Environmental Health School of Public Health, University of California, Berkeley Megan Schwarzman, MD, MPH Center for Occupational and Environmental Health School of Public Health, University of California, Berkeley Ken Geiser, Ph.D. Professor of Work Environment Co-Director, Lowell Center for Sustainable Production University of Massachusetts Lowell Joseph H. Guth, Ph.D., J.D. Legal Director, Science & Environmental Health Network Associate Researcher, U.C. Berkeley Center for Green Chemistry Cc: John Moffatt, Deputy Legislative Secretary Office of Governor Arnold Schwarzenegger

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Linda S. Adams Secretary for Environmental Protection California Environmental Protection Agency Odette Madriago Chief Deputy Director Department of Toxic Substances Control Jeff Wong Ch ief Scientist Department of Toxic Substances Control Trina Gonzalez Deputy Director for the Office of Pollution Prevention and Green Technology Department of Toxic Substances Control Karl Palmer Pollution Prevention Performance Manager Department of Toxic Substances Control Kathy Barwick Office of Pollution Prevention and Green Technology