|September 17, 2013|
On August 28, 2013, California's Office of Administrative Law (OAL) approved the California Department of Toxic Substances Control (DTSC or Department) Safer Consumer Products Regulations (Regulations). The Regulations will take effect on October 1, 2013.
The Regulations are the much anticipated regulatory implementation of California's Green Chemistry Initiative. DTSC's implementing regulations have gone through several iterations, including an initial draft released on June 23, 2010, a revised draft released on November 16, 2010, an "informal draft" released on October 31, 2011, proposed regulations released on July 27, 2012, revised proposed regulations released on January 29, 2013, another revised proposed regulations released on April, 10, 2013, and revisions proposed on August 23, 2013 (the 15-day comment period for these last comments are open until September 9, 2013, despite the issuance of final Regulations). Memoranda providing background information on past iterations are available online. The Regulations and Final Statement of Reasons are available online.
The scope of the Regulations, including the four core elements of Regulations -- Candidate Chemicals, Priority Products (PP), Alternatives Analysis (AA), and Regulatory Responses -- are discussed below. As noted below, considering the timeframes provided in the Regulations, it will be years to complete the process for one PP -- from the time the Candidate Chemicals List is first released, the Initial Priority Product List is released and then issued in final, the AA process is completed, and the regulatory responses are issued. While there are indications that these Regulations may be subject to litigation, a prudent initial step for any company doing business in California to consider is to review, when available from DTSC, the Initial Candidate Chemicals List and determine if any of its consumer products contain one of those substances. It will also be important for companies with products identified as PPs to identify other entities similarly affected and determine the ability to consolidate efforts (e.g., through a consortium) in conducting an AA.
Scope of Persons Subject to the Regulations
The Regulations apply to "responsible entities" -- including manufacturers, importers, assemblers, and retailers, defined as follows:
- Manufacturer: A manufacturer is defined as "any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or specifies the use of chemicals to be included in, the product." Section 69501.1(a)(44).
- Importer: An importer is defined as "a person who imports a product that is subject to the requirements of this chapter. 'Importer' does not include a person that imports a product solely for use in that person's workplace if that product is not sold or distributed by that person to others." Section 69501.1(a)(39).
- Retailer: Retailer is defined as "a person to whom a product that is subject to the requirements of this chapter is delivered or sold for purposes of sale or distribution by that person to a consumer." Section 69501.1(a)(61).
The requirements for responsible entities are tiered, such that primary responsibility will lie with the manufacturer. The importer will have responsibility if the manufacturer fails to comply. Retailers will be required to comply only if the manufacturer and importer (if any) fail to comply and this information is posted on the Failure to Comply List on DTSC's website. Section 69501.2.f
- Assembler: "Assembler" is defined as "any person who assembles a product containing a component that is a product subject to the requirements of this chapter." Section 69501.1(a)(16). Assemble and assembler thus are explicitly distinguished from manufacture and manufacturer. "Assemble" is defined as to "fit, join, put, or otherwise bring together components to create, repair, refurbish, maintain, or make non-material alterations to a consumer product." Section 69501.1(a)(15).
Scope of Products Subject to the Regulation
Under Section 69501.1(a)(24)(A), a consumer product is defined as it is defined in Health and Safety Code Section 25251: "a product or part of the product that is used, brought, or leased for use by a person for any purposes." The Regulations also state that a consumer product also means "[w]hen applicable, a component of an assembled 'consumer product.'"
DTSC defines "consumer product" to include components to provide the Department with flexibility to target materials within a product and "ensures that the weight of the Chemical of Concern in the product will not be diluted to include the entire product; which is critical because it allows DTSC to narrow the applicability of the AA Threshold concentration calculation to a component when it is a chemical in the component that is the basis for public health or environmental concern." Final Statement of Reasons at 62. As an example, DTSC states it could identify the insulation material (because of the flame retardant chemicals it contains) on a cable as the component that must undergo an AA. DTSC states in that case the identified component, and not the entire electronic product, would be subject to the AA requirement.
The Regulations apply only to consumer products placed into the stream of commerce in California. Section 69501(b)(1). "Placed into the stream of commerce" is defined as a consumer product that "has been sold, offered for sale, distributed, supplied, or manufactured in or for use in California as a finished product or as a component in an assembled product." Section 69501.1(a)(50)(A).
In addition to products not placed into the stream of commerce in California, the following products are exempt from the Regulations:
- Products exempt from the definition of "consumer product" as specified in California 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);
- Consumer products that DTSC determines are regulated by one or more federal and/or California State regulatory program(s), and/or applicable treaties or international agreements with the force of domestic law, that, in combination:
1. Address the same potential adverse impacts, potential exposure pathways, and potential adverse waste and end-of-life effects that could otherwise be the basis for the product being listed as a Priority Product; and
2. Provide a level of public health and environmental protection that is equivalent to or greater than the protection that would potentially be provided if the product were listed as a Priority Product;
- A product that ceased to be manufactured prior to the date the product is listed as a PP; and
- A product previously owned or leased by someone other than the manufacturer, importer, distributor, assembler, or retailer of the product.
Sections 69501.1(a)(24)(B)-(C), 69501(b)(2)-(3).
There are no upfront exemptions for consumer products manufactured or stored in, or transported through, California solely for use out-of-state or for products used in California solely for the manufacture of one or more of the products exempted from the definition of consumer product. These factors will be considered when DTSC is prioritizing product-chemical combinations for consideration as PPs. Section 69503.3(b)(4).
DTSC to Develop a "Candidate Chemicals" List
DTSC must establish, within 30 days after the effective date of the Regulations, a Candidate Chemicals List. Assuming the Regulations are effective October 1, 2013, the Candidate Chemicals List must be established by October 31, 2013. DTSC estimates the Candidate Chemicals List will contain approximately 1,200 Chemicals of Concern (COC). DTSC calls the list it will be releasing "informational."
Under Section 69502.2(a), the Candidate Chemicals List will include those substances that exhibit a hazard trait and/or an environmental or toxicological endpoint (identified through the Office of Environmental Health Hazard Assessment's (OEHHA) development of a Toxics Information Clearinghouse pursuant to Health and Safety Code Section 25256.1) and that meet one or more of the following criteria:
The chemical is included in one or more of 15 different lists already selected by other agencies and organizations:
- Substance "known" to cause cancer or reproductive toxicity under California's Proposition 65;
- Chemicals classified as carcinogens, mutagens, or reproductive toxicants under the European Commission's (EC) Regulation (EC) 1272/2008, Annex VI, Category 1A and 1B chemicals;
- Chemicals identified as Category 1 endocrine disruptors under the Regulation (EC) 1907/2006 Substances of Very High Concern;
- Chemicals for which a reference dose or reference concentration has been developed based on neurotoxicity under the U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS);
- Chemicals identified as Group A, B1, or B2 carcinogens under EPA's IRIS;
- Chemicals identified as "known to be" or "reasonably anticipated to be" a human carcinogen under the National Toxicology Program's (NTP) Report on Carcinogens;
- Chemicals included as persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative under Regulation (EC) 1907/2006 Substances of Very High Concern;
- Chemicals identified as persistent, bioaccumulative, and inherently toxic to the environment in Canada's Domestic Substances List;
- Chemicals classified as respiratory sensitizers under Regulation (EC) 1272/2008, Annex VI, Category 1 chemicals;
- Chemicals identified as Groups 1, 2A, and 2B Carcinogens by the International Agency for Research on Cancer;
- Chemicals identified as neurotoxicants by the Agency for Toxic Substances and Disease Registry's Toxic Substances Portal;
- Chemicals identified as persistent, bioaccumulative, and toxic priority chemicals under EPA's National Waste Minimization Program;
- Substances identified as reproductive or developmental toxicants in NTP Monographs;
- Substances reported under EPA's Toxics Release Inventory List of Persistent, Bioaccumulative, and Toxic Chemicals; or
- Substances identified as persistent, bioaccumulative, and toxic by the Washington Department of Ecology.
- The chemical is identified as belonging to one or more specified types of chemicals:
- Chemicals for which notification levels have been established by the California Department of Public Health;
- Chemicals for which primary maximum contaminant levels have been established in California;
- Chemicals identified as toxic air contaminants in California;
- Chemicals identified as priority pollutants in California Water Quality Control Plans;
- Chemicals identified with non-cancer endpoints and listed with an inhalation or oral reference exposure level by OEHHA;
- Priority chemicals that are identified under the California Environmental Contaminant Biomonitoring Program;
- Chemicals identified by the Centers for Disease Control and Prevention in the Fourth National report on Human Exposure to Environmental Chemicals and Updated Tables; or
- Chemicals identified on Part A of the list of chemicals for priority action by the Oslo and Paris Conventions for the Protection of the Marine Environment of the North-East Atlantic.
When identifying Candidate Chemicals, DTSC is authorized to request existing information or request the generation of new information from one or more chemical manufacturer, importer, assembler, and/or retailer. Sections 69502, 69501.4.
Initial Candidate Chemicals List
Prior to January 1, 2016, DTSC will consider a limited scope of Candidate Chemicals when reviewing product-chemical combinations. Specifically, DTSC will consider Candidate Chemicals that meet both of the listing criteria (i.e., a chemical listed on one or more of the authoritative organizations' hazard trait based chemical lists specified in Section 69502.2(a)(1), and that also appear on a chemical list developed based on potential exposure concerns and specified in Section 69502.2(a)(2)) even though the Regulations state that either criterion can be met to be listed as a Candidate Chemical. Section 69503.6(a). This initial Candidate Chemicals List will thus be significantly smaller (reportedly less than 250) than the 1,200 expected to be listed in the full Candidate Chemicals List. DTSC states this Initial List is necessary "to send more predictable signals to responsible entities and other interested parties as to which Candidate Chemicals may be identified as Chemicals of Concern in Priority Products during the early years of program implementation." Final Statement of Reasons at 196.
Additions and Deletions to Candidate Chemicals List
The Regulations establish a process by which DTSC can identify additional chemicals as Candidate Chemicals after considering the potential chemical adverse impacts, potential exposures, and availability of reliable information. Section 69502.2(b). The Regulations allow persons to petition DTSC to add or remove one or more chemicals from the Candidate Chemicals List or to add or remove an entire list source from which the Candidate Chemicals List is derived. Section 69504.
The Regulations provide that DTSC must "periodically update" the Candidate Chemicals List to reflect changes to the sources from which the list is drawn. Section 69502.3(a). There is no specific timing requirement under which DTSC would have to review and update the Candidate Chemicals List (e.g., every three years).
DTSC to Identify "Priority Products"
DTSC will evaluate and prioritize products that contain Candidate Chemicals to develop a list of PPs for which AAs must be conducted. Specifically, DTSC will be identifying and prioritizing product-chemical combinations when listing PPs:
The Department may identify and list as a Priority Product one or more product-chemical combinations that it determines to be of high priority. The Department's decision to identify and list a product-chemical combination as a Priority Product shall be based on an evaluation of the product-chemical combination to determine its associated potential adverse impacts, potential exposures, and potential adverse waste and end-of-life effects by considering the factors described in paragraphs (1) and (2) [Adverse Impacts and Exposures and Other Regulatory Programs] for which information is reasonably available.
The Regulations further state:
Any product-chemical combination identified and listed as a Priority Product must meet both of the following criteria:
(1) There must be potential public and/or aquatic, avian, or terrestrial animal or plant organism exposure to the Candidate Chemical(s) in the product; and
(2) There must be the potential for one or more exposures to contribute to or cause significant or widespread adverse impacts.
To determine products of high priority, DTSC will evaluate the potential adverse health and environmental impacts posed by the Candidate Chemical(s) in each product based on several factors:
- The potential adverse impacts posed by the Candidate Chemicals (e.g., hazard traits, environmental fate properties, adverse impacts for sensitive subpopulations or endangered or threatened species) and potential exposures (e.g., market presence, types of uses, frequency and duration of exposure) during the life-cycle of the product;
- "[P]roduct uses, or discharges or disposals, in any manner that have the potential to contribute to or cause adverse waste and end-of-life effects associated with the Candidate Chemical(s) in the product";
- The "extent and quality of information that is available to substantiate the existence or absence of potential adverse impacts, potential exposures, and potential adverse waste and end-of-life effects";
- The extent to which other regulatory programs regulate the product; and
Sections 69503.2, 69502.3.
- "[W]hether there is a readily available safer alternative that is functionally acceptable, technically feasible, and economically feasible."
Functionally acceptable, technically feasible, and economically feasible are important concepts to the Regulations, defined as follows:
- Functionally Acceptable: Functionally acceptable means "an alternative product meets both of the following requirements: (A) The product complies with all applicable legal requirements; and (B) The product performs the functions of the original product sufficiently well that consumers can be reasonably anticipated to accept the product in the marketplace." Section 69501.1(a)(35). DTSC provides the following example:
[L]ead-free house paint is not functionally identical to lead-containing house paint, and in some respects may be functionally inferior ¿ for example, it may not adhere to walls as strongly and, therefore, reapplication is required at more frequent intervals. However, lead-free house paint does last for many years, is suitable for the same applications formerly filled by lead containing house paint, and has been widely accepted in the consumer marketplace.
Final Statement of Reasons at 71.
- Technically Feasible: Technically feasible means "that the technical knowledge, equipment, materials, and other resources available in the marketplace are expected to be sufficient to develop and implement an alternative product or replacement chemical." Section 69501.1(a)(65).
- Economically Feasible: Economically feasible means "an alternative product or replacement chemical does not significantly reduce the manufacturer's operating margin." Section 69501.1(a)(29). DTSC states: "The purpose of this program is not to put companies out of business, but to ensure a fair and reasonable search for safer alternatives that may actually be used." Final Statement of Reasons at 67.
When identifying product-chemical combinations, DTSC is authorized to request existing information or request the generation of new information from one or more product manufacturer, importer, assembler, and/or retailer. Sections 69503, 69501.4. The Regulations also include a process under which a person can petition to add or remove a product-chemical combination from the PP List. Section 69504.
When listing chemical-product combinations in PPs, the Regulations provide that PPs will be established and updated through rulemaking pursuant to the Administrative Procedure Act (commencing with Government Code Section 11340) in addition to provisions already in place that DTSC will hold one or more public workshops. Section 69503.5(a)(2).
In any proposed or final PP List, DTSC must include the following information for each PP:
- "A description of the product-chemical combination that is sufficient for a responsible entity to determine whether one or more of its products is a Priority Product";
- "If the product-chemical combination is a component of one or more assembled products, a description of the known assembled product(s) in which the component is used shall be included";
- The Candidate Chemical(s) that is/are the basis for the product being listed and the hazard trait and/or an environmental or toxicological endpoint known to be associated with that chemical(s); and
- The due date for submission of a preliminary AA report, which will be 180 days after the date the product is listed on the final PP List, unless otherwise specified.
For a "complex durable product," DTSC will not list as PPs, in a three-year period, more than ten components contained in that product.
Once a Candidate Chemical becomes the basis for a product being listed as a PP, DTSC will designate that chemical as a COC for that product (i.e., it changes from being identified as a Candidate Chemical to being identified as a COC). Section 69503.5(b)(1)(B).
Alternatives Analysis Threshold (AAT)
When listing a PP, DTSC also may specify an alternative analysis threshold (AAT) for any COC that is an intentionally added ingredient. The Regulations also outline the procedure by which a responsible entity can submit an AAT exemption notification to seek an exemption from the requirement to conduct an AA. Section 69505.3. DTSC defines the AAT as the "Practical Quantitation Limit for a Chemical of Concern that is present in a Priority Product solely as a contaminant" or a concentration by weight as specified by DTSC. Section 69501.1(a)(12). This means there is no default threshold (e.g., 0.01 percent by weight). DTSC states that its definition of AAT is intended to clarify that an AAT concentration can be determined for a COC that is an intentionally added ingredient, as well as an AAT concentration greater than the applicable Practical Quantitation Limit (PQL) for any COC that is a contaminant. DTSC states:
If DTSC becomes aware (either prior to issuing the proposed Priority Product listing or upon receipt of public comments) of the existence of products containing the Chemical of Concern at relatively small concentrations compared to most other products covered by the same Priority Product listing, the regulations (at section 69503.5(c)) give DTSC the latitude to establish an AA Threshold for that particular Priority Product listing that would allow such products (with lower concentration Chemicals of Concern) to be exempted under section 69505.3 from the AA requirements - the AA requirements would still apply to the other products covered by the same Priority Product listing that contain the Chemical of Concern at higher concentration levels.
Final Statement of Reasons at 232.
Response to a PP Listing
Within 60 days after a product-chemical combination is placed on the PP List, responsible entities will be required to provide a PP Notification to DTSC stating that they will conduct an AA unless they submit "alternative notifications." As noted above, responsible entities will include, on a tiered basis, manufacturers, importers, assemblers, and retailers who sell products in California. Sections 69501.1(a)(60), 69501.2(a). A PP Notification must include contact information for the responsible entity; an indication whether the responsible entity is a manufacturer, importer, assembler, or retailer; the type, brand name(s), and product name(s) of the PP; if the product is a component of one or more assembled products, a description of the known product(s) in which the component is used; if applicable, the contact information for the person that will comply with AA requirements instead of the responsible entity; and if applicable, an indication that an alternative notification will be submitted. Section 69503.7.
Alternative notifications to the PP Notification include:
- AAT Exemption Notification (where the COC is present only as a contaminant and the concentration does not exceed the PQL, or does not exceed the AAT established by DTSC);
- Chemical Removal Notification (where the only change is the removal of the COC from the PP without use of a replacement chemical or otherwise adding other chemicals to the product);
- Product Removal Notification (if the PP will cease to be sold or distributed in California); and
Sections 69505.2, 69505.3. Alternate notifications can be submitted concurrently with a PP Notification, although these notifications can be submitted later in the process -- but no later than the due date for submitting the Preliminary AA Report -- in lieu of conducting an AA. Sections 60503.5(f), 69505.2, 69505.3.
- Product-Chemical Replacement Notification (where the COC is removed from the PP and any replacement chemical meets certain criteria).
Initial PP List
Under Section 69503.6, the Initial PP List is limited to no more than five products. The Regulations provide that DTSC may identify more than one COC for each PP. DTSC must release the Initial PP List for public comment and review no later than 180 days after the effective date of the Regulations, or by March 30, 2014. DTSC also must review the PP List at least once every three years.
The Regulations require that DTSC develop, within one year of the effective date of the Regulations, an Initial Priority Product Work Plan that "identifies and describes the product categories that the Department will evaluate to identify product-chemical combinations to be added to the Priority Products list during the three (3) years following the issuance of the work plan." Section 69503.4(a). 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. The Regulations allow DTSC to revise a work plan if it is legally required to take action on a particular chemical or product prior to the expiration of the work plan or if DTSC grants a petition.
Companies to Prepare Alternative Analysis
Responsible entities (generally, manufacturers) must perform an AA for the listed COC-PP combination 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. Before the Initial PP List is issued in final, DTSC will make available on its website guidance materials to assist persons performing AAs. Section 69505.
Under the Regulations, AAs must be conducted in two stages. In the first stage, the responsible entity must:
- Identify the PP's Requirements: First, the responsible entity must identify the PP's functional, performance, and legal requirements that must be met for any potential alternative; the role of the COC in meeting the PP's function, performance, and legal requirements; and if the COC or any alternative replacement chemical is "necessary" to meet the PP's identified requirements. If the COC or any alternative replacement chemical is not "necessary," the responsible entity should evaluate removal of the COC from the PP or possibly submit a Chemical Removal Notification.
- Identify Alternatives: The responsible entity must identify alternative(s), defined to include removal of a COC from a PP with or without use of one or more replacement chemicals, reformulation or redesign of a PP and/or manufacturing process to eliminate or reduce the concentration of a COC in a PP, redesign of a PP and/or manufacturing process to reduce or restrict potential exposures to COC(s) in a PP, or "[a]ny other change" to a PP or manufacturing process that reduces the potential adverse impacts and/or potential exposures associated with a COC in the PP. Section 69501.1(a)(10). A responsible entity shall "consider any identified alternative in the AA, or explain in the AA Report why such an alternative is not viable for consideration."
- Identify Factors Relevant for Comparison of Alternatives: The responsible entity must identify "relevant" factors (e.g., those that make a "material contribution" to one or more adverse public health impacts, adverse environmental impacts, adverse waste and end-of-life effects, and/or materials and resource consumption impacts) and use available quantitative information and analytical tools, supplemented by available qualitative information and analytical tools, to identify certain factors that are relevant for the comparison of the PP and the alternatives under consideration.
- Evaluate and Screen Alternative Replacement Chemicals: The responsible entity must use "available quantitative information and analytical tools, supplemented by available qualitative information and analytical tools, to evaluate and compare each of the alternative replacement chemicals under consideration with the Chemical(s) of Concern in the Priority Product." This step is not required if there are no alternatives identified that use one or more replacement chemicals or otherwise adding chemicals to the product. DTSC states this step "is necessary to make specific that for the alternatives that include replacement of a Chemical of Concern with another chemical, the AA must include an assessment of the adverse public health and environmental impacts associated with each alternative replacement chemical being considered as compared to the Chemical of Concern and any other alternative replacement chemical being considered. This, in turn, is necessary so that regrettable substitutes can be avoided." Final Statement of Reasons at 256.
- Consider Additional Information: The responsible entity may consider other relevant information and data not specifically identified above. A responsible entity "may eliminate an alternative from further consideration based on the additional factors and information as long as the reason for its elimination is explained in the Preliminary AA Report and there are alternatives remaining to be evaluated in the second AA stage."
- Prepare Preliminary AA Report: The responsible entity must prepare the Preliminary AA Report and develop a work plan and implementation schedule for completion of the second AA stage and preparation and submission of the Final AA Report.
A Preliminary AA Report must be submitted no later than 180 days after the date the product is listed on the final PP List unless DTSC specifies a different date.
In the second stage, the responsible entity must:
- Identify Factors Relevant for Comparison of Alternatives: The responsible entity can reevaluate the identification of factors and the associated exposure pathways and life cycle segments identified in stage one for the comparison of the PP and the alternatives still under consideration after completion of the first AA stage. Additional factors for consideration include product function and performance and economic impacts. If the responsible entity's alternative selection is to retain the PP "based in whole or in part on internal cost impacts, this decision must be explained in the Final AA Report." The Final AA Report "must include a quantified comparison of the internal cost impacts of the Priority Product and the alternatives, including manufacturing, marketing, materials and equipment acquisition, and resource consumption costs."
- Compare the PP and Alternative(s): The responsible entity must then "use available quantitative information and analytical tools, supplemented by available qualitative information and analytical tools, to evaluate and compare the Priority Product and each of the alternatives under consideration with respect to each relevant factor and associated exposure pathways and life cycle segments, if applicable, identified."
- Select Alternative: The responsible entity must select the alternative(s) that will replace the PP, unless the decision is to retain the PP.
- Prepare Final AA Report: The responsible entity must prepare a Final AA report.
A 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). Sections 69505.1(b)-(c), 69505.7(k).
There are three alternatives to conducting an AA according to the two stage procedure set forth in the Regulations. First, a responsible entity meeting specified requirements can prepare an "Abridged AA Report" if it determines, after completing the first stage, that a functionally acceptable and technically feasible alternative is not available. Section 69505.4(b). DTSC allows for an Alternate Process AA to the two stage process set forth in the Regulations provided certain criteria are satisfied (e.g., the process provides the same information needed to prepare a Final AA Report, the responsible entity compares the PP and alternatives using, at a minimum, the same relevant factors specified in the first stage). A responsible entity planning to submit an Alternate Process AA must first submit to DTSC an Alternate Process AA Work Plan demonstrating how the necessary requirements will be met. Section 69505.4(c). In addition, a responsible entity can also submit a previously completed AA (i.e., one prepared by the responsible entity, obtained by the responsible entity, or publicly available) that meets certain criteria. Section 69505.4(d).
Preliminary and Final AA Reports
The Preliminary AA Report must include an executive summary, information about the preparer, responsible entity and supply chain information, PP information, scope of relevant comparison factors, scope and comparison of alternatives (including a matrix or other summary format to provide a clear visual comparison), methodology used to conduct the AA, supporting information (this can be cited in the reports and made available to DTSC upon request), the alternatives selected for further evaluation, and the work plan. Section 69505.7. The Final AA Report must include the same information as the Preliminary AA Report plus additional information regarding the comparison of the PP with alternative(s), information on the selected alternative(s) and any alternative replacement chemicals, if any, and an explanation of any differences from the information and analyses presented in the Preliminary AA Report.
DTSC and Public Review of AA Reports
Within 60 days of receiving a Preliminary AA Report, Final AA Report, or alternative reports (e.g., Alternate Process AA Work Plan), DTSC shall review the report for compliance and issue a notice of compliance, notice of deficiency, notice of disapproval, or notice of ongoing review. Section 69505.9. If deficiencies are identified, the Regulations set forth a procedure for responsible entities to correct those deficiencies, including the requirement that the information be submitted within 60 days of the notice of deficiency (with a potential 90-day extension for revisions to a Final AA Report or Abridged AA Report). If the revisions are not submitted or do not address the deficiencies, DTSC will issue a notice of disapproval.
To provide a quality assurance mechanism for the AAs, DTSC will provide a public comment period for the Final AA Report and Abridged AA Report, review those comments, and then identify, no later than 30 days after the close of the public comment period, any issues that it determines need to be addressed by the responsible entity in an AA Report Addendum. Section 69505.8. The due date for the AA Report Addendum will be provided by DTSC, taking into consideration "the scope and complexity of the issues the Department is requiring the person to address."
With respect to any documents or information submitted to DTSC, a person may assert a claim of trade secret protection. Section 69509. These claims will need to be substantiated by providing certain information to DTSC specified in the Regulations and by providing a redacted copy of the documentation being submitted with the trade secret information removed.
The Regulations provide that trade secret protection may not be claimed for any hazard trait submission or for any chemical identity information associated with a hazard trait submission. Section 69509(f). A limited exception will allow a responsible entity to mask temporarily the precise identity of a chemical that is the subject of a hazard trait submission "if that chemical is an alternative considered or proposed in an Alternatives Analysis, and a patent application is pending for the chemical or its contemplated use in the product." DTSC will allow the masking of chemical identity only until the information is made public through any means, and requires the person claiming the trade secret to notify DTSC within 30 days of the information being made public. Section 69509(g)(1). DTSC states the following regarding the limited scope of this exemption: "Notwithstanding may commenters' request that DTSC additionally extend chemical identity protection to those chemicals whose nature is held as a trade secret, DTSC believes the unlimited nature of a trade secret claim too greatly undermines the public disclosure aspects of the green chemistry legislation." Final Statement of Reasons at 341.
There is no timeframe provided within which DTSC must review a trade secret claim. If the Department finds the claim insufficient, it will notify the submitter of the insufficiency, identify the additional information needed, and set a date by which the requested information must be submitted. Section 69509.1. If additional information is not provided, DTSC will provide notice that the information will be subject to disclosure but will also wait 30 days for the submitter to seek judicial review.
DTSC to Identify and Impose Regulatory Responses on PP/COC Combinations
After evaluating the Final AA Report, DTSC is required to consider the appropriate regulatory response. In selecting regulatory responses, DTSC shall seek to "maximize the use of alternatives of least concern when such alternatives are functionally acceptable, technically feasible, and economically feasible." Section 69506(a). 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 impacts, exposures, and/or waste and end-of-life effects 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 or replacement Candidate Chemical in a product." Section 69506(b). In selecting regulatory responses, DTSC may consider several factors related to public health and environmental protection and the private economic interests of responsible entities. Section 69506(c).
Possible regulatory responses triggered by DTSC's findings and determinations include:
- Product Information: In general, product information must be provided to consumers for: (1) PPs for which an alternative was not selected; (2) PPs that continue to be introduced into commerce in California pending development and distribution of an alternative product for longer than 12 months after DTSC issues a notice of compliance or notice of disapproval for an AA Report; and (3) selected alternative products that retain CODs and/or contain any replacement Candidate Chemical(s).
The information required includes the manufacturer's or importer's name, the brand name/product name, the COCs (including common names) in the product, safe handling procedures, end-of-life management programs or requirements, and a website address to obtain additional information about the product, the adverse impacts associated with the product as identified in the AA Report, and proper end-of-life disposal or management of the product. Section 69506.3(b). To satisfy the responsible entity's obligation to make this information available to consumers in "easily seen, legible, and understandable formats," the entity must post the information on its website and use one or both of the following means of informing consumers at the point of sale of the information: (1) providing the required information on the product packaging or in accompanying written material that is accessible without breaking the product seal; and/or (2) posting the information in a prominent place at the point of retail display. Section 69506.3(c).
- Use Restrictions: DTSC can impose use restrictions on one or more COCs or replacement Candidate Chemicals in a selected alternative, or COCs in a PP for which an alternative is not selected, or restrictions on the product itself that the Department determines necessary. Use restrictions may include one or more of the following: (1) restrictions on the amount or concentration of the COC or replacement Candidate Chemical permitted in a product; (2) restrictions on the settings in which a product may be sold or used; (3) restrictions regarding the form in which a product is sold; (4) restrictions on who may purchase and/or use a product; (5) requirements for training of product purchasers and/or users; and/or (6) any other use restriction that reduces the amount of any COC(s) or replacement Candidate Chemical(s) in the product, or reduces the potential for the product to contribute to or cause an exposure to the COC(s) or replacement Candidate Chemical(s) in the product. Section 69506.4.
- Sales Prohibitions: DTSC can ensure that the PP is no longer sold in California by prohibiting its sale where DTSC determines there is a safer alternative that does not contain the COC(s) or replacement Candidate Chemical(s) and that is functionally acceptable, technologically feasible, and economically feasible. If a responsible entity decides in a Final AA Report to retain an existing PP or select an alternative that still contains a COC or replacement Candidate Chemical, this provision provides DTSC the opportunity effectively to override a responsible entity's decision to retain an existing PP, or to select an alternative that is still a COC or replacement Candidate Chemical based on a determination that a safer alternative exists that does not contain a COC or replacement Candidate Chemical of concern and is functionally acceptable, technologically feasible, and economically feasible. Section 69506.5. DTSC states this provision is necessary so it is "able to impose a product sales ban when a known safer viable alternative exists, but the responsible entity chooses not to use this safer alternative." Final Statement of Reasons at 305. Responsible entities are provided an option to submit a revised Final AA Report instead of implement such a ban.
- Engineered Safety Measures or Administrative Controls: The Department "may require a manufacturer to engineer safety measures that integrally contain or control access to, and/or implement administrative controls that limit exposure to, the Chemical(s) of Concern or replacement Candidate Chemical(s) in a selected alternative, or the Chemical(s) of Concern in a Priority Product for which an alternative is not selected, to reduce the potential for adverse impacts." Section 69506.6.
- End-Of-Life Management: A responsible entity must establish, maintain, and fund (within one year) an end-of-life product stewardship program, and provide product information to consumers, if the alternative product (or the PP, if the manufacturer chooses to retain the PP) is required to be managed as a hazardous waste in California at end-of-life. Section 69506.7.
- R&D: DTSC also can require manufacturers to initiate research and development products or fund challenge grants to design a safer alternative, improve the performance of a safer alternative, decrease the cost of the safer alternative, or increase the market penetration of a safer alternative. This option is available only "[w]hen a manufacturer concludes that no safer alternative to its Priority Product is functionally acceptable, technically feasible, and economically feasible, or a manufacturer selects an alternative that reduces but does not eliminate the use of Candidate Chemicals in the product." Section 69506.8.
And so it begins. Once the Regulations are effective on October 1, 2013, the clock will begin running for DTSC to release the Candidate Chemicals List (30 days from the Regulations' effective date) and identify the first set of proposed PPs (180 days from the Regulations' effective date). Companies with consumer products in the stream of commerce in California that are identified as PPs will need to notify DTSC that its product is a PP; perform an AA and prepare a Preliminary AA Report and Final AA Report (or use an approved alternative); and comply with any regulatory responses DTSC applies to its product. Considering the timeframes provided, it will be years from the time the Candidate Chemicals List is first released, the Initial Priority Product List is released and then issued in final, the AA process is completed, and the regulatory responses are issued. Companies also may need to respond to information requests from DTSC, submit notifications to avoid AA responsibilities, 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).
While there are indications that these Regulations may be subject to litigation, a prudent initial step for any company doing business in California to consider is to review, when available from DTSC, the Initial Candidate Chemicals List and determine if any of its consumer products contain one of those substances. It will also be important for companies with products identified as PPs to identify other entities similarly affected and determine the ability to consolidate efforts (e.g., through a consortium) in conducting an AA.