Jul. 31, 2012
On July 27, 2012, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products Regulations (Proposed Regulations). The Proposed Regulations, subject to a 45-day comment period, are the newest iteration of the much anticipated regulatory implementation of California's Green Chemistry Initiative. The Proposed Regulations have been through several iterations, including an 'informal draft' that was released in October 2011, and other drafts released on June 23, 2010, and November 16, 2010. DTSC describes the Proposed Regulations as a 'preemptive strategy that reduces the use of toxic substances in the design of products and industrial processes with the aim of creating safer and sustainable products that do not threaten human health or persist in the environment.' Memoranda providing background information are available online. The Proposed Regulations are available online.
DTSC will hold a public hearing on the proposed regulations on September 10, 2012. For written comments to be considered, they must be submitted no later than 5:00 p.m. on September 11, 2012. After the close of the comment period, if substantial changes are made, the modified full text will be made available for comment for at least 15 days prior to adoption.
Below is a summary of the core elements of the Proposed Regulations -- Chemicals of Concern (COC), Priority Products (PP), Alternative Assessments (AA), and Regulatory Responses -- and any significant changes from prior proposals.
DTSC to Develop a 'Chemicals of Concern' List
Of critical importance to most companies doing business in California is DTSC's directive to establish, within 30 days after the effective date of the regulations, a COC List. Under Section 69502.2(a), the COC List would include those substances that exhibit a hazard trait or an environmental or toxicological endpoint (identified by OEHHA pursuant to Health and Safety Code Section 25256.1):
Although it appears that some of the more controversial lists from which DTSC will derive its COC List have been removed in these Proposed Regulations, there are still a large number of sources of chemicals that other agencies or organizations have determined exhibit certain hazard traits (carcinogenicity, reproductive toxicity, mutagenicity, developmental toxicity, endocrine disruption, neurotoxicity, and/or persistent bioaccumulative toxicity) or list chemicals on exposure indicator lists for water quality, air quality, or biomonitoring.
While the regulations do not exempt any chemical per se, the following products are exempt from the Proposed Regulations pursuant to Section 69501(b): products exempt from the definition of 'consumer product' specified in Health and 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. Importantly, the Proposed Regulations apply to businesses placing consumer products into the stream of commerce in California, regardless of the place of manufacture of those products.
DTSC estimated in October 2011 that the list would include approximately 3,000 COCs. DTSC now plans to release a COC List with approximately 1,200 COCs, noting that the difference is based on the removal of chemicals covered by other regulations (e.g., pesticides) and other chemicals determined not to be relevant to consumer products. DTSC notes, however, that there are approximately 500 additional chemicals currently used only in pesticides and drugs that are currently excluded but could be added to the COC List in the future if they are used in products that are not excluded under Health and Safety Code Section 25251.
The Proposed Regulations have eliminated an exemption for products regulated by other laws that provide protections with respect to the same public health and environmental adverse impacts and exposure pathways that are addressed by these regulations. Instead, DTSC will 'consider' this factor during the product prioritization process. In addition, older versions of these regulations had contemplated an exemption for nanomaterials, however, that exemption (of nanomaterials generally) is not mentioned in the Proposed Regulations. To the extent that any nanomaterials have not yet been identified by regulatory agencies on the lists from which DTSC will derive the COC List, the nanomaterials will not, at least initially, be subject to these requirements.
The Proposed Regulations establish a process by which DTSC can identify additional chemicals as COCs after considering the potential chemical adverse impacts, potential exposures, availability of reliable information, and availability of safer alternatives. Section 69502.2(b). There also is a procedure for any person to petition DTSC to evaluate a claim that a chemical or product should be listed as a COC or PP. Interestingly, Section 69504 now adds that a person may petition to remove from (in addition to add to) the COC List, to 'add the entirety of an existing chemicals list,' to add to or remove a product from the PP List, or to establish or revise an AA threshold for a COC in a PP. Although the Proposed Regulations continue to require that DTSC must 'periodically update' the COC List 'to reflect changes to the underlying lists and sources from which it is drawn,' any specific timing requirements (e.g., every three years) under which DTSC must review and update the COC List has been eliminated.
DTSC to Develop a 'Priority Products' List
DTSC will evaluate and prioritize products that contain COCs to develop a list of PPs for which AAs must be conducted. To determine products of high priority, DTSC will evaluate the potential adverse health and environmental impacts posed by the COCs in each product based on several factors listed in the Proposed Regulations that are somewhat similar to that previously proposed: (1) the potential adverse impacts from the COCs (e.g., hazard traits, environmental fate properties) and potential exposures (e.g., market presence, types of uses, frequency and duration of exposure); (2) the 'extent of information that is available to substantiate adverse impacts and exposures,' recognizing that '[a]ll other factors being equal, a product for which there is a greater amount of information to substantiate adverse impacts and exposures, relative to other products being evaluated, shall be given a higher priority'; and (3) the extent to which other regulatory programs regulate the product. Section 69503.2. DTSC removed as a factor the existence, if any, of a known 'readily available safer alternative, that is functionally acceptable and technologically and economically viable.' The Proposed Regulations also provide that DTSC is to give priority to products that have: (1) a COC in the product with a significant ability to contribute to or cause adverse public health and environmental impacts; and (2) 'a significant ability for the public and/or aquatic, avian, or terrestrial animal or plant organisms to be exposed to the [COC] in the product in quantities that would contribute to or cause adverse public health or environmental impacts, which may include consideration of how widely the product is distributed in commerce and how widely the product is used by consumers.' Section 69503.2(b).
In any proposed or final PP List, DTSC must list: (1) the COC and the hazard trait(s) that is/are the basis for the product being listed as a PP; (2) '[i]f applicable, the component(s) and/or homogeneous material(s) within a component, to which the alternatives analysis threshold applies, and which is/are the required minimum focus of the AA' (with additional requirements for each PP that is a 'highly durable product'); and (3) the due date for submission of the Preliminary AA Report, which shall be 180 days after the date the product is listed on the final PP List unless otherwise specified. The Proposed Regulations no longer distinguish between 'assembled' and 'formulated' products. DTSC defines 'consumer product' to include, in part, 'component' and 'homogeneous material' to provide it 'flexibility to name any identifiable constituent or part or a homogeneous layer of material in the finished product or that makes up the finished product as a Priority Product.'
As an example, DTSC states that a motor vehicle may be made of thousands of parts, but the COC may be used in only one component of this product. By defining component, 'DTSC may name a uniquely identifiable component as being subject to the requirement for an alternatives analysis, such as a tire or DTSC could name only the outer homogeneous layer of a tire as the Priority Product.' Thus, if DTSC names only the homogenous material, 'the concentration of the [COC] will not be diluted with the weight of the entire assembly or subassembly.'
Also significant, DTSC has changed the term 'de minimis level' with regard to the presence of the COC in the PP to an 'Alternatives Analysis Threshold,' defined as a concentration by weight specified by DTSC. DTSC has thus removed any specific default thresholds (e.g., 0.01 percent by weight). Sections 69503.5 and 69503.6 set forth the criteria by which DTSC will set the AA Threshold for each COC in a PP, and the procedure by which a responsible entity can submit an AA Threshold Exemption Notification to seek an exemption from the requirement to conduct an AA.
DTSC previously stated that it expected its initial list of PPs would include only two to five products; this is now explicitly stated in the Proposed Regulations. Section 69503.4(e). In addition, prior to January 1, 2016, DTSC may list a product as a PP only if the product is being listed on the basis of one or more COCs in the product that meet both of the criteria noted above, even though the Proposed Regulations state that either criterion can be met. DTSC also must review the PP List at least once every three years.
A new element of the Proposed Regulations is the requirement that DTSC develop, no later than January 1, 2014, a Priority Product Work Plan that 'identifies and describes the product categories that the Department will evaluate to identify products to be added to the Priority Products list during the next three (3) years.' Section 69503.3(f). The work plan 'must include a general explanation of the decision to select the identified product categories for evaluation during the life of the work plan.' Subsequent work plans will be issued no later than one year before the three-year expiration date of the current work plan.
Companies to Prepare Alternative Analysis
DTSC will require 'responsible entities' -- including manufacturers, importers, and retailers who sell products in California -- to notify DTSC within 60 days of a PP's listing that its product is a PP or satisfies an exemption. The types of notifications are:
As with prior versions of the regulations, the responsibilities for responsible entities are tiered, such that primary responsibility will lie with the manufacturer (the person that makes the product or the person who controls the specifications and design of, or use of materials in, the products), the importer will have responsibility if the manufacturer fails to comply, and retailers will be required to comply only if the manufacturer and importer (if any) fail to comply and such information is posted on a 'Failure to Comply' list on DTSC's website. Section 69501.2(a)(1).
Thus, responsible entities (generally, manufacturers) must perform an AA for the listed COC and PP to determine how best to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the COC in the PP. Under the Proposed Regulations (and prior versions), AAs must be conducted in two stages (Sections 69505.3 and 69505.4):
The Preliminary AA Report must include an executive summary, information about the preparer, responsible entity and supply chain information, COC and PP information, evaluation and comparison of the PP and its alternatives, identification of the factors determined to be relevant for comparison of the PP and its alternatives, methodology used to conduct the AA, supporting information (this can be cited in the reports and made available to DTSC upon request) and information gaps, the selected alternative, the implementation plan for the selective alternative, and sufficient information for DTSC to determine the appropriate due date for submission of the Final AA Report. Section 69505.5. The Final AA Report must include the same information as the Preliminary AA Report plus additional information regarding the evaluation and comparison of the PP and its alternatives, an explanation of any differences from the information and analyses presented in the Preliminary AA Report, and sufficient information for DTSC to determine the appropriate regulatory response(s), if any.
The Final AA Report must be submitted no later than 12 months after the date DTSC issues a notice of compliance for the Preliminary AA Report, unless the responsible entity requests, and DTSC approves, a longer period of time not to exceed 24 months (or up to 36 months if regulatory safety and/or performance testing is required for the alternatives being considered). Section 69505.1(c).
Other issues of note include:
Trade secret protection may be claimed for the chemical identity of a chemical that is the subject of a hazard trait submission only if the subject of claim is a proposed alternative to a Chemical of Concern in a Priority Product, and the claimant does all of the following: (1) Demonstrates to the Department's satisfaction that the chemical that is the subject of the claim is a new chemical or a new use of an existing chemical; (2) Provides the Department with sufficient health, safety, and environmental data on the chemical subject to the claim to demonstrate, to the Department's satisfaction, that it is substantially safer than the existing Chemical of Concern in the Priority Product; and (3) Complies with the substantiation requirements.
DTSC to Identify and Impose Regulatory Responses on Priority Products/Chemicals of Concern
Once a Final AA Report is submitted and DTSC determines it is compliant (i.e., not deficient), DTSC will specify a proposed due date for implementation of the regulatory response after considering the complexity of implementing the regulatory response. Section 69505.6(c)(2).
DTSC will require implementation of regulatory responses 'designed to protect public health and the environment, and maximize the use of alternatives of least concern, where such alternatives are technically and economically feasible.' Section 69506(a). The definition of 'technically and economically feasible alternative' has been revised in the Proposed Regulations to mean 'an alternative product or chemical for which: (A) The technical knowledge, equipment, materials, and other resources available in the marketplace are expected to be sufficient to develop and implement the alternative, and to meet consumer demand after an appropriate phase-in period; and (B) The manufacturer's operating margin is not significantly reduced.' Section 69501.1(59). This definition removes consideration of externalized costs, takes into account consumer acceptance after a phase-in period, and attempts to ensure that manufacturer's operating margins are not significantly reduced. This means that DTSC will have an opportunity effectively to override a responsible entity's decision to retain an existing PP, or to select an alternative that is still a COC based on a determination that a safer alternative exists that does not contain a COC and is technologically and economically feasible.
DTSC also states that it will give preference to regulatory responses providing 'the greatest level of inherent protection,' where 'inherent protection' refers to 'avoidance or reduction of adverse impact or exposure that is achieved through the redesign of a product or process, rather than through administrative or engineering controls designed to limit exposure to, or the release of, a Chemical of Concern in a product.' Section 69506(b). In selecting regulatory responses, DTSC may consider any or all of the following factors: (1) the likely actual effectiveness of the regulatory response, including the capacity of responsible entities to comply, and the ability of end-users to understand and act upon any information and directions provided with respect to the product; (2) the relative cost-effectiveness of the regulatory response as compared to other possible responses; (3) the administrative and other burdens that would be placed upon DTSC, the responsible entities, the product end-users, and the public; (4) any unique or additional burdens that would be imposed by the regulatory response upon sensitive subpopulations; and/or (5) the ease and efficacy of enforcement of the regulatory response. Section 69506(c).
No regulatory response is required if DTSC determines for the selected alternative, after review of the Final AA Report, that no regulatory response is necessary to prevent or limit adverse public health or environmental impacts. Section 69506.3. If DTSC determines that it needs additional information to select and ensure implementation of one or more regulatory responses, it can require a responsible entity to provide such supplementary information. It can also require a responsible entity to 'obtain or develop' information to fill one or more 'information gaps' if DTSC determines such information is needed to reevaluate the initial regulatory response(s) imposed for a selected alternative or a PP that remains in commerce. Section 69506.2
Other regulatory responses discussed in the Proposed Regulations are similar to those previously proposed. DTSC states that the changes it made to the Proposed Regulations with regard to regulatory responses is intended to 'provide more guideposts for the circumstances under which specified regulatory responses (e.g., use restrictions, sales prohibitions, engineering or administrative controls, and research and development projects) will be required, as well as principles and factors for DTSC to consider in selecting regulatory responses.'
Companies with consumer products in the stream of commerce in California will need to notify DTSC that its product is a PP (or cease to enter the product in the stream of commerce in California) or satisfy another exemption (e.g., AA threshold exemption); perform an AA and prepare a Preliminary AA Report and Final AA Report; and comply with any regulatory responses applicable to its product or that DTSC determines are necessary. Companies also may need to respond to information requests from DTSC, substantiate claims when information is submitted as trade secret, and potentially utilize the dispute resolution procedures to dispute certain actions taken by DTSC (Section 69507). DTSC provides that these responsibilities may be fulfilled by a consortium, trade association, or other entity, but does not provide in the regulations any conditions or criteria for how issues (e.g., formation, compensation) will be resolved.
DTSC has made some revisions in the Proposed Regulations in response to concerns identified in earlier versions. Certain controversial lists upon which the COC List could be derived have been eliminated, the prior de minimis exemption has been revised so that there is no default concentration, the time for responsible entities to remedy non-compliance notices regarding an AA or regulatory response is extended from 60 to 90 days, and inventory recalls have been eliminated as a regulatory response. The procedure that runs from developing a COC List to determining appropriate regulatory responses remains complicated, with a large variety of factors to be applied and evaluated at every turn.
Although recognizing that the Proposed Regulations will have an economic impact on businesses, DTSC states that generally, it 'does not expect the regulations to result in cost increases, given the wide variety of comparable safer products readily available at competitive prices.' While it is true that many companies already conduct these types of assessments as part of their product stewardship efforts, it remains to be seen whether compliance with these particular regulations will increase costs. The cost to the State of California to administer the program also remains unclear. Companies that conduct thorough and useful assessments of this kind may find it difficult to fit their models into that now required by DTSC. Fortunately, DTSC will only subject a small number of PPs to these regulations initially, a fact that may provide interested parties with an opportunity to see how these regulations will be implemented, what AA Reports will look like, and what changes or refinements may be needed.