Every day, the United States produces or imports 42 billion pounds of chemicals for commercial and industrial use. Green Chemistry: Cornerstone to a Sustainable California, 2008, University of California, available at http://coeh.berkeley.edu/docs/news/green_chem_brief.pdf. Ninety percent of these chemicals rely on fossil fuel feedstocks, which are nonrenewable, and an additional 1,000 new chemicals are introduced into commerce each year. Moreover, global chemical production is doubling every 25 years, a remarkable pace that exceeds the rate of population growth. These chemicals are used in countless industrial processes and consumer products and as such, the toxicity and ecotoxicity of these chemicals are of great concern.
The European Union has taken the lead in implementing sweeping new regulations that favor cleaner technologies including green chemistry. For example, the EU has implemented the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) directive that prohibits the use of lead, cadmium, mercury, certain flame-retardant chemicals, and other toxic materials in electronic and electrical equipment sold in the EU. And most recently, in 2007, the EU adopted the European Community Regulation on Chemicals or “REACH” (Registration, Evaluation, Authorization and Restriction of Chemical Substances), which requires chemical manufacturers and importers to gather information on the properties of their chemical substances and to register most chemicals that are widely used in a central database run by the European Chemicals Agency (ECHA). REACH further requires in-depth evaluation of suspicious chemicals and calls for the substitution of the most dangerous chemicals when suitable alternatives have been identified.
Like REACH, the goal of California’s Green Chemistry Initiative (GCI) is to improve the protection of human health and the environment by forcing manufacturers, importers, and retailers of chemicals to identify and manage risks linked to the substances they manufacture and market. The GCI results from two bills passed in 2008, SB 509 and AB 1879. SB 509 requires the Department of Toxic Substances Control (DTSC) to establish a Toxics Information Clearinghouse for the collection, maintenance, and distribution of specific chemical hazard traits and environmental and toxicological endpoint data, and by January 2, 2011, the Office of Environmental Health Hard Assessment (OEHHA) was to evaluate and specify this data to be included in the clearinghouse. This system was to be web-based and publicly accessible.
AB 1879 required DTSC to adopt regulations by January 1, 2011, to (1) establish a process by which chemicals or chemical ingredients in products may be identified or prioritized for consideration as being “chemicals of concern” (COC); and (2) establish a process by which COCs in products are evaluated to determine how best to limit exposure or to reduce the level of hazard posed by a COC.
GCI was developed to bridge the chemical data gap, safety gap, and technology gap surrounding chemicals used in commerce. Numerous studies had shown that the federal Toxic Substances Control Act of 1976 (TSCA) did not serve as an effective vehicle for the public, industry, or government to assess the hazards of chemicals in commerce or control those of greatest concern. Without comprehensive information on the toxicity and ecotoxicity for most chemicals, it is difficult to identify hazardous chemicals in supply chains or to identify safer chemical products. This presents a data gap. Moreover, because government agencies do not have the information they need to systematically identify and prioritize chemical hazards or the legal tools to efficiently mitigate known hazards, this presents a safety gap. Finally, the lack of market and regulatory drivers has dampened motivation to develop and invest in new green chemistry technology, and this presents a technology gap.
DTSC’s development of the mandated regulations has been a protracted process. In January 2009, when GCI went into effect, DTSC began a series of meetings with stakeholders to identify regulatory concepts. These meetings were followed by public workshops and a legislatively mandated Green Ribbon Science Panel (the Panel) was formed to provide DTSC advice on scientific matters, chemical policy recommendations, and implementation strategies. California Department of Toxic Substances Control, Green Chemistry Regulations for Safer Products Frequently Asked Questions (FAQs), June 23, 2010. A “straw” proposal for the rules was released in late 2009, and after additional input was received, DTSC released a draft conceptual flowchart and a detailed outline for the draft regulation. On June 23, 2010, DTSC issued the draft Regulation for Safer Consumer Products. After additional input, on November 16, 2010, DTSC finally issued the Proposed Regulation for Safer Consumer Products (Proposed Regulation). However, these proposed regulations were extensively criticized.
Indeed, even the author of AB 1879, Assembly Member Mike Feuer (D-LA), as well as several members of the Panel withdrew their support of the regulations. Many of these individuals asserted that DTSC had gutted its initially proposed regulations. The Proposed Regulation prioritized the application of GCI to children’s products, personal care products, and household cleaning products through the end of 2015, and only thereafter, would the GCI apply to all consumer products. Moreover, the Proposed Regulation would have also required DTSC to demonstrate that a chemical was harmful before regulating it pursuant to the GCI.
Other stakeholders raised concerns about the number of products and companies affected by the GCI and the costs of complying with the GCI. They also pointed out the lack of any quantitative assessment of the benefits to be derived from implementation of the GCI.
As such, Linda Adams, Secretary for the California Environmental Protection Agency, requested that DTSC reconsider the Proposed Regulations, and in an open letter dated December 23, 2010, to Assembly Member Feuer (available at http://www.dtsc.ca.gov/upload/GRSP-12-23-2010.pdf), Secretary Adams wrote: “At my request, DTSC has agreed to take additional time to be responsive to the concerns raised and revisit the proposed regulations. I believe this extra time will allow us to create a workable program and address critical policy issues, such as third-party verification and prioritization.”
She further directed DTSC to reconvene the Panel to “further vet the programmatic issues that have been brought to our attention via the public comment process” to “help ensure that the vision behind this component of the Green Chemistry Initiative and implementing statute AB 1879, is fully realized.”
Almost 11 months after the statutory deadline of January 1, 2011, on Oct. 31, 2011, DTSC issued a new “informal” draft of the regulations, titled the “Safer Consumer Products Regulation” (Informal Draft). After receiving so much criticism on its prior Proposed Regulation, DTSC has apparently decided to test the waters prior to releasing a formal draft in the Spring of 2012.
This iteration of the regulations is substantially different from the prior versions and has the following features:
- Many timeframes have been shortened and/or made more specific.
- It establishes an immediate robust (~3,000) list of COCs (Chemicals of Concern) which will be effective as of the date of the regulations.
- The list of hazard traits has been expanded to include all hazard traits and environmental and toxicological endpoints specified by the OEHHA.
- Product categories for consideration when listing Priority Products during the first five years are not limited to children’s products, personal care products, and household cleaning products.
- There is no requirement to provide chemical and product information during the prioritization process unless requested by DTSC.
- The Alternatives Analysis (AA) process is more specific and structured and expands the primary responsibility for compliance beyond the manufacturer to the person who controls the product design and importers.
- There is no requirement to fill information gaps during the AA, but DTSC has the option to require this as a regulatory response.
- The third-party verification requirement for AAs has been replaced by the requirement that AAs be conducted by a certified assessor, and DTSC will play a greater role in auditing AAs.
- The default de minimis level has been redefined, and DTSC has the discretion to set a lower or higher level.
- There is no exemption for unintentionally added chemicals, but these chemicals may be considered for setting a higher de minimis level.
- There is no exemption for “no exposure pathway.” However, exposure potential will still be considered during the chemical/product prioritization process.
- A manufacturer can no longer avoid doing an AA by simply removing the COC once the product is listed as a Priority Product—the manufacturer must provide notice to DTSC of the removal or introduction of a similar product containing a COC.
Summary of the Informal Draft
The Informal Draft specifies the process for identifying COCs, prioritizing consumer products containing COCs (Priority Products), identifying potential alternatives for Priority Products to limit potential exposures and impacts posed by the COCs in the product, and imposing regulatory responses following completion of an alternatives analysis. Each of these points is further summarized below.
Chemicals of Concern. Within 30 days after the effective date of the regulations, DTSC must post on its website a list of COCs. A chemical is identified as a COC if it exhibits a hazard trait or an environmental endpoint (as specified by OEHHA pursuant to Health and Safety Code section 25256.1), and meets one or more of the following criteria: (1) the chemical is identified as exhibiting a hazard trait on 15 different lists (e.g., Prop. 65, International Agency for Research on Cancer carcinogens, etc.), (2) the chemical is identified based on exposures or environmental or toxicological endpoints on four different lists (e.g., OSPAR lists, etc.), or (3) the chemical is identified by three sources of “reliable information” (e.g., U.S. EPA Integrated Risk Information System carcinogens, etc.).
In addition to the initial list of COCs, DTSC may identify chemicals that exhibit one or more hazard traits or environmental or toxicological endpoints as COCs by considering the potential chemical adverse impacts and potential exposures as set forth in the Informal Draft. As discussed above, DTSC anticipates that the initial list of COCs will include about 3,000 chemicals.
Prioritizing Products Containing COCs. Pursuant to the Informal Draft, DTSC will evaluate products to determine the potential adverse impacts and exposures posed by COCs in a product due to the potential exposures during the manufacture, useful life, and end-of-life disposal or management of the product. DTSC shall give priority to products meeting one or more of the following key prioritization criteria: (1) The COC(s) in the product have a significant potential to cause adverse public health and environmental impacts; (2) The product is widely distributed in commerce and widely used by consumers; (3) There is a significant potential for public and environmental exposures to the COC(s) in the product in quantities that can result in adverse public health or environmental impacts; (4) For assembled products, the products contain one or more COC(s) that may present potential exposures through inhalation or dermal contact; and/or (5) For formulated products, the product is intended to be applied directly to the body, dispersed as an aerosol or a vapor, or applied to hard surfaces with the likelihood of runoff or volatilization.
After considering the potential adverse impacts and potential exposures for the product and its COC(s), DTSC must then determine whether and to what extent these potential adverse impacts and exposures are addressed by other federal and/or California State regulatory programs and any applicable international trade agreements ratified by the U.S. Senate. If these potential adverse impacts and exposures are addressed, DTSC should adjust the prioritization accordingly.
Products determined to be of high priority after this process may be listed as Priority Products. However, certain Priority Products may be exempt from the Alternatives Assessment (AA) requirements if they contain de minimis levels of the COC. De minimis levels are defined as: (A) 0.01 percent by weight for chemicals exhibiting one of nine specified hazard traits (carcinogenicity, developmental toxicity, reproductive toxicity, endocrine toxicity, genotoxicity, immunotoxicity, neurotoxicity, bioaccumulation, or environmental persistence); (B) 0.1 percent by weight for chemicals that do not exhibit any of the nine specified hazard traits and environmental and toxicological endpoints; or (C) the de minimis concentration specified by DTSC for a COC in the Priority Product.
DTSC must issue an initial proposed list of Priority Products within 180 days after the effective date of the regulations. DTSC must further make the proposed Priority Products list and supporting documentation available on its website and publish the notice of availability in the California Regulatory Notice Register (CRNR). The public comment period is 45 days after publication of the notice of availability, and during this period, DTSC must hold one or more public workshops. Once DTSC finalizes the Priority Product List, it must post the list on its website.
Within 60 days after a product is listed as a Priority Product, each responsible entity (manufacturer, importer, or retailer of a consumer product) for such a Priority Product is required to notify DTSC of its Priority Product unless the responsible entity has submitted a De Minimis Exemption Notification.
Alternatives Assessment. For manufacturers, importers, and retailers of Priority Products, the AA requirement is the crux of the GCI. Pursuant to the Informal Draft, the assessment of Priority Products and alternatives must be conducted in two stages. The first stage results in the submittal of a Preliminary AA Report within 180 days after the final Priority Products list is posted, and the second stage results in the submittal of a Final AA Report within 12 months after the date DTSC issues a notice of compliance for the Preliminary AA Report. Extensions may be granted for both reports.
The first stage involves the following steps:
- Identification of product criteria (by function, performance, technical feasibility, and legal requirements) and determination of whether the COC or substitute chemical is necessary to meet the product criteria;
- Identification of alternatives that eliminate or reduce the concentration of the COC in the Priority Product and/or reduce the potential for public and/or environmental exposures to the COC;
- Initial screening of alternative chemicals to be substituted for the COC; and
- Develop workplan and proposed implementation schedule for second AA stage.
The second stage of the AA involves the following steps:
- Identification of factors relevant for comparison of alternatives (e.g., multimedia life cycle impacts and chemical hazards, product function and performance, and economic impacts);
- Comparison of the Priority Product and alternatives to each relevant factor, associated exposure pathways, and life cycle segments; and
- Selection of the alternative that will replace or modify the Priority Product (unless the decision is to retain the existing Priority Product).
The Informal Draft provides detailed instructions on the contents of each AA Report.
Within 60 days of receiving a Final AA Report, the DTSC shall review the AA Report for compliance and issue a notice of its findings along with a notice of compliance or deficiency. DTSC will also indicate whether a regulatory response is required. Unless the selected alternative does not contain a COC in a concentration exceeding the de minimis level, it is likely that DTSC will require some regulatory response(s). DTSC’s potential regulatory responses include any of the following: (a) requiring additional information to be provided to DTSC; (b) requiring responsible entities to inform consumers of the COCs contained in the selected alternative or Priority Product (where the alternative is not selected), any end-of-life management programs and safe handling procedures prior to any exposure to the COCs; (c) requiring responsible entities to cease selling a selected alternative or Priority Product (where the alternative is not selected) and implement an inventory recall program when DTSC determines there is a safer alternative that is functionally acceptable and technologically and economically feasible; (d) requiring engineered safety measures to control access or limit exposure to the COC in a product; (e) restricting the use of COCs in a product; (f) requiring the responsible entity to initiate research and development projects or fund a challenge grant (pertinent to the product and uses green chemistry principles); and (g) requiring a new AA to be performed.
Retailers should be aware of their obligations under the Informal Draft and consider participating in DTSC’s rulemaking process, given the potential burden that they may be subjected to. For example, the Informal Draft requires that a responsible entity (including the retailer) for a selected alternative, or a Priority Product (where an alternative is not selected) that presumably contains a COC, must ensure that the product is managed as a hazardous waste in California at the end of its useful life. This provision could potentially obligate the retailer to “fund, establish, and maintain an end-of-life management program for the product.” This is one of many potential pitfalls that retailers could unwittingly fall into without proper guidance.
Judging by the sheer volume and diversity of comments received by DTSC on the Informal Draft, the Informal Draft will undoubtedly see additional revisions before a final draft is issued by the agency. DTSC will likely continue to forge ahead with extreme caution, which is appropriate given the lofty goals of the GCI and the complex task of harmonizing the regulations with existing state, federal, and international law.