Source: https://www.martenlaw.com/newsletter/20120913-california-chemicals-regulation
Timestamp: 2019-09-16 16:38:01
Document Index: 523657418

Matched Legal Cases: ['§ 2601', '§ 69502', '§ 69502', '§ 69503', '§ 69503', '§ 69505', '§ 69506', '§ 69507', '§ 69508', '§ 69509', '§ 69510']

California Pursuing New Approach to Chemicals Regulation | Marten Law
California Pursuing New Approach to Chemicals Regulation
California has once again gone its own way on the environment – this time, with new regulations governing chemical exposure. On July 23, 2012, the California Environmental Protection Agency – Department of Toxic Substances Control (DTSC) proposed its “Safer Consumer Product Alternatives Regulation,”[1] as part of the California “Green Chemistry Initiative,” which was launched in 2007 by then-Governor Arnold Schwarzenegger. The proposed regulation aims at reducing the use of toxic chemicals in products and industrial processes and is being promoted as a potential model for policy reform at the national-level.
There is widespread agreement that existing mechanisms for regulating chemical safety in the United States are woefully out of date. The principal federal legislation in this area, the Toxic Substances Control Act of 1976 (TSCA),[2] has been on the books now for over three and a half decades without substantive revision.[3] Jurisdictions outside the United States have enacted regulations that shift the burden of demonstrating chemical safety away from government agencies (as is the case with TSCA) to chemical manufacturers. The best known of these new approaches is embodied in the European Community’s regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemical Substances, or REACH.[4] The management strategies employed in the REACH program have been used increasingly in chemical regulations adopted elsewhere in the world, including China.[5]
Efforts by Congress to modernize TSCA along similar lines generally have made little progress. Sen. Frank Lautenberg has introduced proposed legislation every year since 2005, most recently in the form of the Safe Chemicals Act of 2011, S. 847, 112th Cong. (introduced April 4, 2011).[6] S. 847 would substantially revamp TSCA by requiring manufacturers to develop and submit safety data for each chemical they produce, prioritizing chemicals based on risk, and placing the burden of proof on chemical manufacturers to demonstrate the safety of their chemicals. The bill was reported out of the Senate Committee on Environment and Public Works on July 25, 2012; however, it is unlikely to garner sufficient support in the full Senate and almost certainly will not be taken up at all in the House of Representatives.[7]
In 2008, DTSC issued a report (the “Final Report”) [8] outlining the elements of California’s Green Chemistry Initiative and describing six specific policy recommendations for a new chemicals management strategy: (1) expand pollution prevention and product stewardship programs to more business sectors; (2) develop green chemistry workforce education and training, research and development and technology transfers; (3) create an online product ingredient network to disclose chemical ingredients for products sold in California; (4) create an online toxics clearinghouse, an online database providing data on chemical, toxicity and hazard traits; (5) create a systematic, science-based process to evaluate chemicals of concern and identify safer alternatives to ensure product safety; and (6) establish a California green products registry to develop green metrics and tools for a range of consumer products.[9]
The fourth and fifth of these recommendations (creation of a toxics clearinghouse and a new system for evaluating chemicals of concern and safer alternatives, presumptively along lines similar to the European REACH program) can be considered the core of the overall initiative. In order to carry out these recommendations, the state legislature passed two bills (Assembly Bill 1879 – Chapter 559, Feuer) and Senate Bill 509 (Chapter 560, Simitian), adding to the California Health and Safety Code. These sections specifically require DTSC to adopt regulations establishing a process to identify and evaluate chemicals of concern in consumer products, to identify safer alternatives to those chemicals, and to specify regulatory responses that may be imposed upon completion of the alternatives analysis process.[10]
The proposed Safer Consumer Product Alternatives Regulation, which would add a new chapter 55 to division 4.5 of Title 22, California Code of Regulations (“CCR”), is the result of DTSC’s effort to fulfill its statutory mandate under Health & Safety Code sections 25252-25253 and specifically to implement recommendation number five of the California Green Chemistry Initiative Final Report.
Four Step Regulatory Process
The proposed regulations provide for an iterative four-step process to identify consumer product alternatives:
First, DTSC must establish a list of approximately 1,200 existing “Chemicals of Concern,” or “COCs”, based on the work already done by other authoritative organizations.[11] The regulations also specify a process for DTSC to identify additional COCs[12]
Second, DTSC must evaluate and prioritize product/COC combinations to develop a list of “Priority Products” for which an alternatives analysis must be conducted.[13]
Third, responsible entities (manufacturers, importers, and retailers) must notify DTSC when their products are listed as Priority Products.[14] Manufacturers or other responsible entities for a product listed as a Priority Product must perform an alternatives analysis for the product and the COCs in the product to determine how best to limit exposures to, or public health and environmental impacts from COCs in the product. [15]
Finally, DTSC is required to identify and take regulatory actions to prevent or limit adverse public health and/or environmental impacts, if any, posed by the Priority Products (if the manufacturer decides to continue to make and sell them), or by alternatives selected to replace those products.[16]
In addition to requirements governing the chemical assessment process, the proposed regulations include provisions for the resolution of disputes with DTSC over the conduct of the process,[17] for certifying third-parties as qualified to perform alternatives analyses,[18] for auditing regulatory compliance,[19] and for trade secret protection.[20]
Identification and Listing of COCs
In the short term, the aspect of the proposed regulation of greatest potential interest to industry is the process for identifying and listing COCs. Under proposed section 69502.3(a), DTSC must issue a list within thirty days of the effective date of the regulation. The list will include substances already identified as exhibiting a hazard trait or an environmental or toxicological endpoint on one or more of 14 different lists developed by other agencies and organizations.[21]
The regulation does not provide any exemptions for individual chemicals, al-though certain types of products that may contain COCs are exempt from regulation under proposed section 69501(b), including: products exempt from the definition of “consumer product” under Health & Safety Code section 25251 (e.g., dangerous prescription drugs and devices; dental restorative materials; medical devices; pesticides; food; and packaging associated with dangerous prescription drugs and devices, dental restorative materials, and medical devices); and consumer products manufactured or stored in, or transported through, California solely for use out-of-state. An earlier version of the proposed regulations also contained an exemption for products regulated by other laws that are intended to protect against the same against public health and environmental impacts; however, under the current proposal, the existence of such protections are simply to be considered by DTSC during the product prioritization process.
The “Priority Products” List
To develop its list of Priority Products, DTSC is required to evaluate potential adverse health and environmental impacts posed by the COCs in each product based on several factors: (1) potential adverse impacts from and potential exposures to COCs present in the product; (2) the extent of information available to substantiate adverse impacts and exposures; and (3) the extent to which other programs regulate product use. Under section 69503.2(b), DTSC must give priority to products that: (1) contain a COC with a significant ability to contribute to or cause adverse public health and environmental impacts; and (2) have a significant ability for the public and/or aquatic, avian, or terrestrial animal or plant organisms to be exposed to the COC in quantities that would contribute to or cause adverse public health or environmental impacts.
Under section 69503.3(f), DTSC has until January 1, 2014, to develop a Priority Product Work Plan that identifies and describes the product categories in which new products will be added during the next three years. Subsequent work plans will be issued no later than one year before the expiration date of the current work plan.
Preparation of Alternative Analyses by “Responsible Entities”
Once DTSC has listed a product as a Priority Product, the burden falls to the manufacturer to notify DTSC within 60 days that a product is a Priority Product or is exempt from regulation. Importers and retailers (as appropriate) are responsible if the manufacturer fails to provide a notice.
Responsible entities will have to perform alternatives analyses to determine how best to limit potential exposures or potential health and environmental impacts. Pursuant to section 69505.3, the responsible entity initially must: (1) use available quantitative information and analyses, supplemented by available qualitative information and analyses, to evaluate and compare the Priority Product and each of the alternatives under consideration with respect to various specific relevant factors [22] and associated exposure pathways and life cycle segments; (2) select the alternative that will replace or modify the Priority Product, unless the decision is to retain the existing product; (3) consider other relevant information and data; and (4) prepare a final report that contains an implementation schedule for implementing the selected alternative, if any, and/or proposed regulatory responses, if any.
A preliminary alternatives analysis report must be submitted no later than 180 days after the date the product is listed unless DTSC specifies a different date. Pursuant to section 69505.5, the preliminary report must include an executive summary, information about the preparer, responsible entity and product suppliers, COC and product information, an evaluation and comparison of the product with its alternatives, an identification of the factors determined to be relevant for comparison of the product and its alternatives, a description of methodology used to conduct the analysis, supporting information and an identification of information gaps, a description of the selected alternative and the implementation plan for the selective alternative, and sufficient information for DTSC to determine the appropriate due date for submission of the final report.
Under section 69505.1(c), final reports generally must be submitted no later than 12 months after the date DTSC issues a notice of compliance for the preliminary report. The final report must include the same information as the preliminary report plus additional information regarding the evaluation and comparison of the product and its alternatives, an explanation of any differences from the information and analyses presented in the preliminary report, and sufficient information for DTSC to determine the appropriate regulatory response(s), if any.
DTSC is allowing a final public review and comment process for its proposed regulation that is quite limited given the rule’s magnitude and scope. A number of potential difficulties already have been identified, not the least of which involves what appears to be a cursory analysis of the economic costs and benefits of the new rules (covering only a few pages out of a regulatory package that literally is hundreds of pages in length).[23] It is hard to see how such a modest analysis could be sustained. There also may be questions about the viability of the rule given the existence of a corresponding (albeit outdated) federal scheme that could be viewed as pre-empting the regulatory field.
DTSC is poised to begin implementing what could be the most extensive and complex chemicals management regime yet adopted in the United States. Affected manufacturers, importers and retailers will need to become familiar with the rules and follow the litigation likely to follow their publication.
For more information on California’s new chemical product regulations, please contact Kevin Haroff in Marten Law’s San Francisco office.
[1] Title 22, California Code of Regulations, 45-Day Public Notice and Comment Period, “Safer Consumer Product Alternatives,” DTSC Reference No. R-2011-02, OAL Notice File No. Z-2012-0717-04 (July 23, 2012), available at http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Public-Notice-7-23-2012.pdf.
[2] 15 U.S.C. §§ 2601-2692.
[3] Over the years, Congress has never modified the core provisions of TSCA (Subchapter 1), but has simply added separate new provisions regarding specific issues, including asbestos hazard emergency response (Subchapter II), indoor radon abatement (Subchapter III), and lead exposure reduction (Subchapter IV). The need for a comprehensive update to TSCA has been acknowledged by both industry and environmental groups. See, e.g., Assessing the Effectiveness of U.S. Chemical Safety Laws: Hearing before the Subcommittee on Superfund, Toxics and Environmental Health of the Senate Committee on Environment and Public Works, 112th Cong. (February 3, 2011) (Statements of Kelly Semrau, Sen. V.P., S.C. Johnson & Son, Inc.; Steve Goldberg, V.P., BASF Corporation; Frances Beinecke, Pres., Natural Resources Defense Council; and Cal Dooley, Pres., American Chemistry Council), available at http://epw.senate.gov/public/.
[4] Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, available athttp://www.eur-lex.europa.eu.
[5] See Alissa Sasso, China’s strengthened chemicals program looks increasingly like REACH (August 3, 2012), Environmental Defense Fund Chemicals and Nanomaterials Blog, http://blogs.edf.org/nanotechnology/2012/08/03/.
[6] Available at http://lautenberg.senate.gov/assets/SCA2010.pdf.
[7] Zack Colman, Senate committee moves chemicals bill without GOP support, The Hill Energy & Environment Blog (July 25, 2012, 12:08 PM ET), http://thehill.com/blogs/e2-wire/e2-wire/239981.
[8] California Green Chemistry Initiative – Final Report (December, 2008), available at http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/.
[9] Final Report, p. 3.
[10] Under Health & Safety Code section 25253(a)(2), the evaluation of potential alternatives must include “life cycle assessment tools” that take into consideration (without limitation) product function or performance; useful life; materials and resource consumption; water conservation; water quality impacts; air emissions; production, use, and transportation energy inputs; energy efficiency; greenhouse gas emissions; waste and end-of-life disposal; public health impacts, including potential impacts to sensitive subpopulations, including infants and children; environmental impacts; and economic impacts.
[11] 42 CCR § 69502.2.
[12] 42 CCR § 69502.3(b)-(c).
[13] 42 CCR §§ 69503-69503.6.
[14] 42 CCR § 69503.7.
[15] 42 CCR § 69505.
[16] 42 CCR §§ 69506-69506.12.
[17] 42 CCR § 69507.
[18] 42 CCR § 69508.
[19] 42 CCR § 69509.
[20] 42 CCR § 69510.
[21] Existing lists referenced under proposed section 69502.2(a) include the list of known carcinogens and reproductive toxicants developed for purposes of California’s Proposition 65 toxics exposure law; the list of Category 1A and 1B chemicals identified in the European Commission 1272/2008 Annex VI due to carcinogenicity, reproductive toxicity, and/or mutagenicity; the International Agency for Research on Cancer (IARC)’s list of Group 1, 2A, and 2B carcinogens; the Toxics Release Inventory of Persistent, Bioaccumulative, and Toxic Chemicals; the list of chemicals for which a reference dose or reference concentration has been developed based on neurotoxicity in EPA’s Integrated Risk Information System; the list of chemicals that are identified as High Production Volume Persistent Bioaccumulating Toxins by the European Union; the list of chemicals for which Notification Levels have been established by the California Department of Public Health; the list of chemicals for which primary Maximum Contaminant Levels have been established in California; and the list of priority chemicals that are identified under the California Environmental Contaminant Biomonitoring Program).
[22] These factors include: (1) multimedia life cycle impacts and chemical hazards; (2) product function and performance; (3) economic impacts; and (4) exposure pathways (chemical quantity information and exposure factors). As part of the alternatives analysis, the responsible entity also must identify factors that make (i) a “demonstrable contribution to one or more adverse public health, environmental, waste and end-of-life, and/or materials and resource consumption impacts of the [PP] and/or one or more of the alternatives under consideration” and (ii) a “demonstrable difference in the factor’s contribution to such impact(s) between two or more of the alternatives being considered.”
[23] The Preliminary Economic and Fiscal Impact Statement form provided with the proposed regulations states that the estimated costs and benefits are “unknown” and the entry on the form for “cost-effectiveness ratio” is “N/A.” See DTSC, Preliminary Economic and Fiscal Impact Statement – Safer Consumer Products, Dept. of Finance Notice File Number Z 2012-0717 (July 10, 2012, approved July 17, 2012), available at http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-399-7-17-2012.pdf.