Green Chemistry Proposed Regulations

Transcription

1 Green Chemistry Proposed Regulations On September 14 the Department of Toxic Substances Control released its formal regulatory proposal for implementing the major part of California s green chemistry program (CEI September 15, 2010). The proposed regulations establish a process for identifying chemicals of concern that are found in consumer products in California, and require manufacturers of consumer products containing those chemicals to look at alternatives to using the suspect chemicals in their products. The regulations ultimately allow DTSC to order manufacturers to carry out alternatives to the continued use of the chemical in their products up to and including requiring the manufacturer to withdraw the product from the market in California. This is one of the most significant regulatory proposals in recent history, both in California and the United States. DTSC s adoption and implementation of the program established in these regulations is being watched throughout the country and could serve as a model for a similar program on the national level. Given its significance CEI will devote this Special Report to a detailed analysis of the DTSC proposal. Statutory Background The legislation that provides the authority for this proposal was signed into law in 2008 (AB 1879) and is codified along with other parts of the state s green chemistry program in Health and Safety Code sections through Among its other provisions the legislation requires DTSC to adopt regulations on or before January 1, 2011 that establish a process for identifying and evaluating chemicals of concern in consumer products and their potential alternatives. The regulations are also required to specify the range of regulatory responses that the department may take following the completion of the alternatives analysis. Development of the Regulations The Department has been working on these regulations for the last year-and-a-half. The Department first released a detailed straw proposal last October (CEI October 15, 2009). That proposal drew extensive criticism from the chemical industry and its business allies who complained that the straw proposal would require them to undertake detailed analysis of thousands of chemicals. In response DTSC withdrew the straw proposal and began a revision of it that concentrated on prioritizing both the chemicals and products covered prior to any required analysis by manufacturers. It released a framework of a new proposal in February and a detailed outline of how the program would work in April (CEI April 29, 2010). In June the Department released an initial draft of these regulations (CEI June 30, 2010). Once again it received extensive comments from interested parties, including criticisms from the regulated community, the environmental community, and from members of the panel established by the legislation to advise the panel on development of the program (Green Ribbon Panel) (CEI July 31, 2010). This final proposal accommodates many of the criticisms by these various parties; particularly the criticisms of the Green Ribbon Panel members. The Proposed Regulations DTSC s formal regulatory proposal is entitled Safer Consumer Product Alternatives. The draft proposal is 92 pages long; considerably longer than the 61 page initial draft in June. It is accompanied by a 141-page Initial Statement of Reasons that provides some explanation of the Department s reasoning in proposing various sections of the proposal. The draft establishes a step-by-step process from prioritizing chemicals for identification as chemicals of concern through the Department s regulatory response options for dealing with consumer products containing such chemicals. Guiding Principles The draft regulations contain a section, unusual in regulatory enactments, that states guiding principles that should be followed by the Department, manufacturers, and responsible entities in carrying out their respective obligations under the regulations. These include: Green chemistry principles (defined with reference to twelve principles identified in a particular publication) and life cycle thinking should be considered; Adverse impacts on public health and the environment that might result from the production or endof-life management of a consumer product should be considered; Adverse public health and environmental impacts of chemicals used in commerce should be significantly reduced by encouraging the redesign of the products and manufacturing processes while maintaining or enhancing product function and performance, and 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 exposure. Applicability The regulations are applicable to all consumer products placed into SEPTEMBER 30, 2010 California Environmental Insider

2 the stream of commerce in California. The term consumer product is broadly defined to include any product used, bought, or leased for any person by a person. The following categories of products are excluded, pursuant to the statute. - A dangerous drug or device as defined in section 4022 of the Business and Professions Code - Dental restorative material - Medical devices, as defined in section 4023 of the Business and Professions Code - Food - Packaging associated with any of the above items - Pesticides as defined under state law or FIFRA - Mercury containing lights, but only through December 31, Responsible Entities and Compliance An important concept in these regulations is that of the responsible entity. The responsible entity will be responsible for ensuring compliance with the following requirements: (1) providing the chemical and product information requested by DTSC as part of the prioritization process (see below), (2) notifying DTSC that the product for which it is responsible is a Priority Product, (3) performing an alternatives assessment and submitting a work plan for such an assessment and a report to the Department based on the assessment, and (4) complying with any regulatory response demanded by DTSC. Responsible entities are defined as including (1) the owner of the product, (2) California importers of the product, (3) California distributors of the product, (4) retailers of the product, and (5) anyone else with a contractual agreement with one of these entities concerning the product. The Department recognizes that there will be multiple responsible entities for each covered product. The above requirements will be considered satisfied, so long as at least one responsible entity fulfills the requirements for the product. The Department anticipates that the above requirements will usually be fulfilled on behalf of the responsible entity by a manufacturer, trade association, or a public-private partnership. When the Department determines that a requirement has not been fulfilled for a particular product all responsible entities will be issued a notice of non-compliance. The responsible entity may fulfill the requirement or cease placing the product in the stream of commerce in California. If the non-compliance is not remedied, that fact will be noted on a website to be maintained by the Department, and if the product is not withdrawn the Department may impose fines and penalties on the responsible entities. Information Needed for Prioritization The regulations allow DTSC to request data concerning particular chemicals and products from responsible entities for the purpose of prioritization of chemicals and products. The Department is required to attempt to first attempt to obtain needed information from data in the public domain. If it cannot do so, it can request the information from responsible entities. If the information isn t currently available, the Department can require the responsible entity to generate new information according to a schedule specified by the Department. The regulations specify how the Department is required to obtain the information and require the Department to ensure that to the extent possible it doesn t seek the information from more than one source. The types of information in question includes product content data, intended uses of a product, targeted customers, volume of sales in California, description of end-of-life management programs, analytical chemistry protocols used for chemical detection, and numerous other categories of information. Availability of Information on the Department s Website The regulations require the Department to post 16 categories of information on its website including the aforementioned failure to comply list, a list of requests for information, proposed and final chemical and product lists (see below), the schedule by which individual responsible parties are required to produce their alternatives assessments, a list of de minimis exemption requests (see below), and miscellaneous other information. All information submitted to the Department as part of the process established under these regulations will be made public, unless it is subject to withholding pursuant to the confidential information provisions (see below). Chemical Prioritization Process This is the first step in the process leading ultimately to the required alternative assessments and regulatory responses. Chemicals will be included in the prioritization process only if they exhibit one of the hazard traits separately identified by OEHHA. OEHHA has begun the process of developing the list of covered hazard traits by releasing a pre-regulatory draft of regulations listing covered traits (CEI August 31, 2010). OEHHA is supposed to have the hazard trait list in place by this January. However, until OEHHA finalizes the list, the DTSC regulations provide that the Department will only consider prioritizing chemicals that are: (1) carcinogens or reproductive toxicants listed under Proposition 65 or listed as possible human carcinogens by the National Toxicology Project, U.S. EPA, the International Agency for Research on Cancer, or the European Union; mutagenic chemicals as identified by the European Union; or persistent bioaccumulative toxic chemicals as identified by U.S. EPA. DTSC will develop an initial list continued on next page 2 California Environmental Insider SEPTEMBER 30, 2010

3 Green Chemistry continued from previous page of Chemicals Under Consideration that include one or more of the above traits using the following prioritization factors: - Chemical and physical properties; - Adverse public health impacts; - Adverse ecological impacts; - Adverse environmental impacts; - Volume of the chemical in the stream of commerce in California; - Potential for public or environmental exposure to the chemical during the useful life and end-of-life management of consumer products containing it; - Existence of data relating to actual and potential public or environmental exposure to the chemical; and - The degree to which other federal or state regulatory programs address the public health and environmental threats posed by the chemical throughout the life cycle of the chemical and consumer products containing the chemical. The regulations contain a long list of chemical and physical properties, and adverse public health, ecological, and environmental attributes that must be included when each of the first four of the prioritization factors listed above is considered. The Department will then create a second list of Priority Chemicals selected from the list of Chemicals Under Consideration based on the following three factors: - The relative degree of threat posed by each chemical to public health or the environment based on the above factors; - Availability of reliable information to substantiate the threat; and - Availability of Department resources. In establishing this second list the Department will give priority to those chemicals that pose the greatest threat to public health or the environment considering potential exposure and potential harm. The regulations specify the types of public data that the Department is supposed to use in making this determination (e.g. harm to children and other sensitive subpopulations). All products that the Department has determined through various information sources contain a priority chemical will be listed on the Department s website, including the name of the chemical(s). Product Prioritization Using a list of consumer products that contain a Priority Chemical, the Department will next develop a list of Products Under Consideration based on the following factors. Volume of the product in the stream of commerce in California, and the product s contribution to the volume of the Priority Chemical in the stream of commerce; Potential for public or environmental exposure to the Priority Chemical in the product during the useful life and end-of-life management of the product; Types and extent of consumer uses that could result in public exposure to the Priority Chemical in the product; Product uses or management or disposal practices that could result in releases to the environmental of the Priority Chemical; Existence of data and other information related to actual and potential public or environmental exposures to the Priority Chemical in the product; Whether the Priority Chemical is required to be used in or contained in the product pursuant to federal or California state law; and The degree to which federal or state regulatory programs already address the public health and environmental threats posed by the Priority Chemical in the product. From the list of Products Under Consideration the Department will select a list of Priority Products based on the following factors: The relative degree of threat posed by each product to public health and the environment, due to the Priority Chemical which it contains; The availability of reliable information to substantiate the threat posed by the product; and Availability of DTSC resources. Posting of Lists and Timelines Prior to finalizing each of the four chemical and product lists the Department will post the proposed lists on its website for public review and comment. The lists will be posted according to the following schedule. Proposed initial list of Chemicals Under Consideration June 1, 2011 Final initial list of Chemicals Under Consideration March 1, 2012 Proposed initial list of Priority Chemicals July 1, 2012 Proposed initial list of Products Under Consideration March 1, 2013 Proposed initial list of Priority Products September 1, 2013 Final initial list of Priority Products December 1, 2013 As is obvious from the above dates, the four initial lists will be developed separately and sequentially. However, the Department notes that subsequent lists may be issued simultaneously. Petition Process Any person may petition DTSC to evaluate a chemical or product using the chemical prioritization or product prioritization process described above. DTSC has 60 days to review the petition to determine whether it is complete. The Department will undertake a technical review of each petition to determine whether to grant it based on the comprehensiveness of the data it provides, its quality, and the availability of data beyond that supplied by the petitioner. SEPTEMBER 30, 2010 California Environmental Insider 3

4 After the technical review DTSC will either grant or deny the petition. If it does the former it will evaluate and, if applicable, prioritize the chemical or product in accordance with the above described processes. Alternatives Assessment The Alternatives Assessment (AA) is the main driver of the Department s draft regulation. It will force manufacturers or other entities responsible for placing Priority Products in the marketplace to look at safer alternatives to the use of suspect chemicals in those products. The AA will also form the basis for any regulatory response by the Department. Tier I Assessment The most significant change between this final draft regulation and the June draft is the addition of a simplified assessment process designed to encourage responsible entities to introduce safer products as soon as possible. This follows the suggestion of both environmental and business groups, as well as the Green Ribbon Panel. The draft regulation authorizes a responsible entity with a product that contains a Chemical Under Consideration to begin product reformulation or substitution well before the chemical is listed as a Priority Chemical and its product is listed as a Priority Product. Any such entity that decides to take advantage of this process must provide the Department with an AA Notification, which must be accompanied by either (1) a Tier I AA report; or (2) other information describing the rationale for the reformulation and an identification of the hazard traits (if any) of the substitute chemical used in the reformulation. The Tier 1 AA must be based on what is known as the Green Screen for Safer Chemicals prepared by Clean Production Action, a non-profit organization that collaborates with industry and government to design environmentally preferable products. The Green Screen requires entities going through a reformulation or product substitution to evaluate selected alternatives using a progressively more stringent benchmark system. The first benchmark requires the entity to avoid chemicals of high concern. The remaining benchmarks require a look at progressively safer chemicals ending up with the safest possible alternative. The draft regulation provides that an entity doing a Tier 1 AA may utilize some equivalent analytical technique to the Green Screen. The rationale behind the Tier 1 process is to encourage more rapid replacement of chemicals of concern in products, while at the same time ensuring that any reformulation or product substitution is actually safer. Tier II Assessment Those responsible entities that elect not to utilize the Tier 1 process will be required to undertake the considerably more rigorous Tier II process for each Priority Product. The process begins with the submission of a work plan for developing the AA. This must be submitted by a responsible entity within 180 days of the listing of the entity s product as a Priority Product. The AA itself is made up of three parts: A Chemical Hazard Assessment that includes information about the chemical, its public health and ecological impacts and chemical traits related to its environmental impacts. This assessment must be performed for the Priority Product itself and any alternative initially identified. An Exposure Potential Assessment that discusses exposure limitations, chemical quantity information, and chemical traits related to environmental impacts. The Exposure Assessment must be performed for all alternatives being considered that exhibit one or more hazard traits. If no alternative exhibits such a trait, the Exposure Assessment is not required. These two assessment together are referred to as a Tier II-A AA. There are detailed requirements for what must be considered during each of the assessments. The third part of the AA is known as the Multimedia Life Cycle Evaluation; referred to as Tier II B AA. This assessment looks at such factors as product function and performance, materials and resource consumption impacts, environmental impacts (including end-of-life impacts), and economic impacts. It is performed for both the Priority Product itself and any alternative being considered. The Department suspects that some alternatives initially considered will be eliminated by this stage through the first two steps in the process; the Chemical Hazard and Exposure Potential Assessments. The regulations describing these three steps in the process are quite detailed. De Minimis Exemption The June draft regulation contained a flat de minimis exemption from the AA requirement for any product containing less than 0.1% of a Priority Chemical by weight. Environmental groups and Green Ribbon panelists complained that this flat exemption could allow the continued use of chemicals considered hazardous at low concentrations. In response the current draft provides that the 0.1% concentration is now a default de minimis standard. In the Priority Products list DTSC will have the option of specifying that the exemption is not available for any specific product/chemical combination if: (1) the chemical has been shown to be harmful in concentrations below the 0.1% level, or (2) the chemical is found below the de minimis level in numerous consumer products that are commonly used on a frequent basis and those cumulative exposures to de minimis concentrations are shown to be harmful. If it concludes that the default level should not apply, the Department may specify an alternative de-minimis level. continued on next page California Environmental Insider SEPTEMBER 30, 2010

5 Green Chemistry continued from previous page The de minimis exemption will not be allowed in any situation for chemicals, materials, or substances manufactured or engineered at the nanoscale, which include nanostructures, or are considered to be a nanomaterial. A request for a de minimis exemption must be submitted to DTSC within 60 days after the listing of a product as a Priority Product. Qualified Assesssors The AA workplan and the AA itself must be prepared by a third-party assessor or an in-house assessor that has been certified by the Department as meeting specified qualifications. It must be signed off on by a lead assessor who must meet a separate set of qualifications. Confidentiality of Information The statute itself governs how the Department will treat claims of trade secrets [Health and Safety Code section 25257]. To claim trade secret protection the entity submitting the information must make the claim at the time the information is submitted, pursuant to the standard California trade secret provisions contained in Government Code section and Section 1060 of the Evidence Code. In addition to trade secret claims, a person submitting information can claim it is exempt from disclosure pursuant to the California Public Records Act. The regulations prescribe how the information must be designated as confidential when it is submitted. Any information not claimed to be confidential or which doesn t qualify as confidential will be subject to public disclosure, including the posting of the information on the Department s website. These disclosure provisions apply to any information submitted during the regulatory process, whether it is submitted as part of a Department request for information for purposes of the chemical and product priority processes or is submitted as part of an alternatives assessment. Regulatory Responses This final section of the draft regulation will apply to the following three categories of products: (1) a product manufactured as an alternative to a Priority Product after completion of the AA; (2) the Priority Product itself if the responsible entity elects not to select an alternative; and (3) a Priority Product that remains in commerce pending replacement by an alternative. Regulatory responses will not be required for the selected alternative, (1) if it contains no Priority Chemical above applicable de-minimis levels; (2) the selected alternative does not pose a public health or environmental threat; or (3) the Priority Product is being phased out in three years and replaced with an acceptable alternative. Where a regulatory response is required the draft regulation contemplates two categories of such responses. Self-Implementing Regulatory Responses The regulations establish specific responses that the responsible entity must implement without any further prompt by the Department. Product Information for Consumers. Product information must be provided to consumers within 12 months, if the alternative contains a Priority Product, or if the responsible entity chooses to retain the existing Priority Product. The regulation specifies that the required information can be provided through various methods, including package inserts and product manuals. End-of-Life Stewardship Program. The responsible entity must establish and fund within 2 years an endof-life stewardship program that provides for the collection and ultimate disposal of the product. The regulations specify the details of the program, including allowing several manufacturers to band together to establish a single program. There are no precise goals that must be met by any such program, although the regulations require participants to take a number of specific steps to ensure that the program is likely to succeed. Regulatory Responses Triggered by Specific DTSC Findings Information Requested by DTSC. The responsible entity must provide the DTSC with any information it needs to determine the effectiveness of a regulatory response. Product Information for Consumers. In addition to the self-implementing consumer information requirement discussed above, a responsible entity at DTSC s request must provide information on how a consumer might safely use a product, information on product stewardship and end-of-life reclamation efforts being taken for the product. End-of-Life Stewardship Program. In addition to the self-regulating end-of-life requirements, the Department can require additional steps, if it determines that there is significant potential for end-of-life mismanagement, that end-of-life reclamation is needed to conserve resources, or without a product stewardship program there would be significant waste management costs borne by taxpayers or local governments. Product Sales Prohibition. If the selected alternative contains a Priority Chemical or the Priority Product continues to be marketed, and DTSC determines that there is a safer alternative without a Priority Chemical that is functionally equivalent to the Priority Product and technologically and economically feasible, the responsible entity must do one of the following: - Ensure that the Priority Product is removed from the stream of commerce in California within one year, and ensure than an inventory recall program for the product is implemented and completed within two years; or - Submit to DTSC, within one SEPTEMBER 30, 2010 California Environmental Insider

6 year, an AA report that selects an alternative that does not contain a Priority Chemical. A responsible entity choosing this latter option must notify DTSC within 60 days of its intent. Other Regulatory Responses In addition to the above mandatory responses, DTSC may require any of the following as responses that it determines are necessary to limit exposure or reduce public health and safety from any alternative product or the Priority Product, if it remains in the market. Product information for consumers End-of-life product stewardship program Product sales prohibition Engineered safety measures to control access to or limit exposure to the Priority Chemical in a product; Restrictions on the use of the Priority Chemical; Green Chemistry R&D project or Green Chemistry challenge grant; New AA (but no sooner than 3 years after original AA) (1) if the prior AA did not identify or select an alternative, or (2) DTSC becomes aware of a safer alternative that is technologically and economically feasible. Regulatory Response Exemptions A responsible entity can request an exemption from an otherwise applicable regulatory response requirement in the following circumstances. - The required regulatory response would be in conflict with a requirement of another California or federal program, or an international trade agreement in such a way that the responsible entity or manufacturer cannot reasonably be expected to comply with both requirements. - The required regulatory response substantially duplicates a requirement of another state or federal regulatory program or an international trade agreement. What s Next? Comment on the draft regulations is due by November 1. The Department will hold a hearing on the draft proposal on November 1 at Cal/EPA Headquarters, 1001 I Street in Sacramento, beginning at 1 p.m. In theory after this hearing the Department could simply adopt the regulations as proposed. A more likely outcome will be some further changes that will be the subject of a shorter comment period. A copy of the draft regulations, meeting notice, accompanying staff report, and other informational documents can be found at: www. dtsc.ca.gov/pollutionprevention/ GreenChemistryInitiative/Proposed-Regulation.cfm. California Environmental Insider SEPTEMBER 30, 2010