California Releases Revised Safer Consumer Product Alternatives Regulations for Comment
On November 16, 2010, the California Department of Toxic Substances Control (CDTSC) released revisions to its safer consumer product alternatives regulations for a 15-day comment period. The proposed regulations pertain to the identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and regulatory responses for selected alternatives. CDTSC held a public hearing on November 1, 2010, during which it accepted written and oral testimony. In addition, written comments were due November 1, 2010. CDTSC states that it has now made “post-hearing changes” to the proposed regulations. CDTSC has also added scientific external peer reviewer comments and the California Environmental Policy Council resolution to the rulemaking file. Of particular note, CDTSC has removed all references to nanotechnology and nanomaterials in the proposed regulations. Comments on the revised proposed regulations and documents added to the rulemaking file are due December 3, 2010. The revised regulations and documents added to the rulemaking file are available online.
CDTSC provides a partial summary of some of the “more significant modifications” to the proposed regulations:
Modifications to Section 69301: Purpose and Applicability Section 69301(b)
CDTSC states that, in response to comments regarding the scope of the proposed regulations, it made revisions to: eliminate the manufacturer having the burden of proof on the issue of whether a product is manufactured, stored in, or transported through California solely for use outside of California; eliminate the requirement that a manufacturer be unaware of an unintentionally added chemical or chemical ingredient to be outside the scope of the regulations (with one limited exception) and to eliminate the related due diligence requirements; move and expand the reach of the exclusion from these regulations if another specified regulatory program already regulates the chemical of concern or priority product in a manner that addresses the public health and environmental threats that would otherwise be the basis for the chemical of concern or priority product being subject to the regulations; move and expand the reach of the exclusion from these regulations for a chemical of concern that CDTSC determines has no exposure pathway that might pose a threat to public health or the environment during the product’s useful life or end-of-life management; and specify further the standards and burden of proof for establishing the standard set forth in the immediately preceding text.
CDTSC states that, in response to public comments regarding drafting and implementation concerns for proposed Section 69301(c), it has extensively rewritten and moved that provision. It moved the content of proposed Section 69301(c) to Section 69301(b)(4) for purposes of clarity, and it is now more integrated into the specification of consumer products that are, or are not, subject to these regulations. More importantly, according to CDTSC, it has significantly modified the proposed regulatory text in response to public comments that the requirement that a producer not know about an unintentionally added ingredient to be outside the scope of the regulations rendered the “unintentionally added” exception to the regulations virtually meaningless. CDTSC has “all but eliminated” the requirement that a producer be unaware of unintentionally added ingredients to be eligible for the unintentionally added ingredient exclusion from the regulations. The only residual requirement is that a producer be unaware of an unintentionally added ingredient to be outside the regulations concerns a recycled feedstock, component, or processing agent, which can contain a “toxic along for the ride.” In the case of these materials, according to CDTSC, “there is a greater ability to be aware of such unintentionally added ingredients and to ferret them out by taking reasonably feasible steps to obtain knowledge regarding the chemicals they may contain.”
Section 69301.2: Definitions Section 69301.2(a)(24)(A): “De Minimis Level”
CDTSC proposes to streamline significantly and clarify the applicability of a “de minimis level” presence of a chemical of concern in a priority product. CDTSC notes that it “remains of the opinion that a de minimis level exclusion from the substantive requirements of the regulations is necessary in order for the identification and prioritization of chemicals of concern in priority products to be workable and focused on the highest risks posed and on risks that can actually be addressed through the alternatives assessment and regulatory response processes.” CDTSC has retained a 0.1 percent concentration by weight as a necessary default value, below which a chemical of concern is not subject to the substantive requirements of the regulations, more specifically the Alternatives Assessment requirements. In response to public comments, CDTSC proposes to eliminate all other regulatory program references and their respective de minimis values as not useful or necessary to implement the regulations. CDTSC is proposing to add one additional alternative value for the controlling de minimis level: the applicable hazardous waste regulatory threshold under Health & Safety Code Section 25141. According to CDTSC, this change is necessary so that there is no inadvertent conflict between the hazardous waste requirements and these regulations as they may apply to the same product, particularly at the end of the useful life of a product.
Section 69301.2(a)(39): “Hazard Trait”
CDTSC has revised the proposed definition to include chemicals identified under Section 303(c) and Section 303(d) of the federal Clean Water Act (CWA), and chemicals included on the U.S. Environmental Protection Agency (EPA) Existing Chemicals Action Plan list. CDTSC states that this expansion of the term “hazard trait” responds to public comments indicating that the previously proposed definition was not reflective of all of the most significant threats to public health and the environment, particularly as to environmental endpoints. CDTSC states that it is “worth noting” that “it is virtually impossible at this point… to engage in any meaningful evaluation of the potential environmental impacts from the implementation of the regulations.” The list of hazard traits that may lead to a chemical being deemed a chemical of concern includes the Office of Environmental Health Hazard Assessment’s (OEHHA) yet-to-be promulgated list of hazard traits. Until OEHHA promulgates a regulation, CDTSC’s proposed regulations establish what hazard traits may lead to a chemical being evaluated for possible prioritization as a chemical of concern: (a) carcinogenicity or reproductive toxicity; (b) mutagenicity; (c) persistent bioaccumulative toxic chemicals; (d) priority toxic pollutants under CWA Section 303(c); (e) chemicals listed pursuant to CWA Section 303(d); and (f) chemicals included on the EPA Existing Chemicals Action Plan list. This results in a list of over 1,000 chemicals, and CDTSC states that “it is virtually impossible to know which of these 1,000-plus chemicals will be the subject of review under the regulations,” and that it “has made no commitment to act on any one of these potential pools of chemicals.” In addition, CDTSC notes, the proposed regulations call for further identification and prioritization of chemicals of concern in an unknown number of “priority products” — children’s products, personal care products, and household cleaning products. CDTSC states:
Evaluating the effects of potentially 1,000-plus chemicals that may be part of tens of thousands of products, and the possible environmental impact of alternative formulations, is both infeasible and unreasonably speculative. DTSC does not contemplate any physical changes to the environment resulting from the adoption of these regulations. It is important to note that there will be no physical change in the environment resulting from an action on the part of DTSC prior to the imposition of one or more Regulatory Responses, at the earliest, as the preceding activities being conducted by DTSC are intellectual evaluation and analysis only.
Section 69301.2(a)(53): “Place into the Stream of Commerce”
CDTSC has revised the definition to address concerns raised in public comments that the previous definition was difficult to understand and created the potential for applying the term to products that were not actually available for purchase in California. According to CDTSC, the revised definition “brings greater clarity to the term and allows for ease of implementation of the regulations.” CDTSC states that the revised definition is necessary for it to exercise regulatory authority over not just those products sold directly to California consumers, but also over products that reach California customers indirectly — through distributors, suppliers, and the like.
Modifications to Section 69301.6(c)(1): Chemical and Product Information
CDTSC is proposing to clarify and scale back the types and amount of information that parties are required to submit as part of the information-gathering process that feeds into the identification and prioritization processes for chemicals and products. According to CDTSC, it deleted the information requirements “identified as unnecessary and/or potentially damaging if handled in violation of trade secret protections.” The revised proposed regulations would require more general information about market presence, intended product use(s) and types of targeted customer base(s), as well as information about end-of-life management programs that may be in place.
Modifications to Section 69302.1 & 69303.1: Applicability and Duplication
CDTSC is proposing to modify the scope of the exclusion from the regulations for chemicals of concern and consumer products that are adequately regulated by another state program and/or federal regulatory program. Public comments questioned the scope of the authorizing legislation’s reach to qualify for exclusion from these regulations, claiming CDTSC was not satisfying the non-duplication provision in Health & Safety Code Section 25257.1 because the standard for qualifying for the exclusion was too stringent and not reasonably tailored.
Chemical and Product Prioritization
Some commenters expressed concern that the regulations did not provide an understanding as to how CDTSC would use the list of prioritization factors in Sections 69302.3 and 69303.3 to prioritize Chemicals Under Consideration and Products Under Consideration. According to CDTSC, many of these same commenters expressed support for the prioritization decision-making factors proposed in Sections 69302.4(b)(1) and 69303.4(b)(1) for identifying Priority Chemicals and Priority Products. These commenters urged CDTSC to set priorities to apply these factors “rigorously and through quantifiable methods” to compare hazards and potential exposures to these chemicals when contained in products. CDTSC states that, while it will still consider many of the factors previously listed in Sections 69302.3 and 69303.3, “ultimately the choice of chemicals and products to be placed on the lists will be based on the decision-making factors specified in Sections 69302.4 and 69303.4 (now in newly proposed Sections 69302.3 and 69303.3), which will be applied using the quantifiable data specified in these sections.” CDTSC has added language to clarify the order in which CDTSC will consider the factors specified to “screen” sequentially the chemicals and products being evaluated to select the proposed lists of Chemicals of Concern and Priority Products.
Modifications to Section 69302.3: Chemical Prioritization Modifications to Section 69303.3: Product Prioritization
CDTSC is proposing to eliminate the Chemical Under Consideration and Product Under Consideration lists. Some commenters questioned the need for two separate chemicals lists and two separate products lists. After considering these comments, CDTSC states that it has determined that having two sets of chemicals and products lists is not necessary to the process and achievement toward developing safer alternatives to consumer products that contain chemicals of concern. Additionally, according to CDTSC, it and interested party resources can be more efficiently used by focusing on a single list of Chemicals of Concern and a single list of Priority Products using the prioritization process set forth in revised Sections 69302.3 and 69303.3. While the factors that CDTSC will use to develop the lists of Chemicals of Concern and Priority Products remain largely the same, CDTSC has made the proposed regulations more specific as to the process CDTSC will use to evaluate chemicals and products based on the factors specified in newly proposed Sections 69302.3 and 69303.3.
Modifications to Alternatives Assessments (AA)
In response to public comments, CDTSC revised the proposed regulations to recognize more explicitly that AAs may range from relatively simple to highly complex assessments depending on the product that is the subject of the assessment. According to CDTSC, the proposed revisions create greater flexibility and tailor the chemical hazard/potential for exposure assessments and multimedia life cycle evaluations to the specific Priority Product being evaluated. Additionally, the evaluation factors relating to product function and performance and economic impacts would be separated out from the multimedia life cycle evaluation, as suggested by several commenters.
Section 69305.1: Tier I AA Notifications
CDTSC proposes to eliminate the Tier I AA Notification in Section 69305.1. According to CDTSC, numerous public comments expressed concerns that the Tier I AA Notification may inadvertently stifle innovation, impose stigma on a “safe” product, and be otherwise counterproductive. In response to these public comments, CDTSC is proposing to eliminate this requirement altogether. CDTSC would require an AA only for products identified as Priority Products.
Other Changes to the AA Process
CDTSC proposes to reduce the previously proposed two types of AA Reports into a single AA Report. According to CDTSC, the requirement of a single AA Report is “the bare essential type of written assessment that DTSC must see in order for the regulated community and DTSC to perform their respective duties under the regulatory regime.”
Modifications to Confidentiality of Information Section 69310: Confidentiality of Information
CDTSC intended this provision to clarify the applicable statutory authorities, but in response to comments arguing that it essentially restates existing law, CDTSC has removed this provision as duplicative. CDTSC has moved the definition of “confidential information,” which CDTSC states is necessary to distinguish between requirements for trade secret claims and all other confidentiality claims.
Section 69310.1: Assertion of a Claim of Confidential Information
CDTSC revised subsections (a)(1) and (a)(2) to delete the mention of the claims index, which CDTSC also deleted, and to make clear that the legal authority for a privilege claim must be communicated via separate correspondence at the time the submission is made. CDTSC revised subsection (b)(2) to delete superfluous language and to emphasize its discretionary power in proactively disclosing the redacted copy to the public. CDTSC states that the requirement for conspicuous marking in the newly proposed Section 69309(c) of confidential information is necessary for appropriate handling of submitted information because it better informs CDTSC staff as to how to handle the document in question, and reduces the chances of inadvertent disclosure. According to CDTSC, the creation of a special definition of “confidential information” is necessary to ensure that certain provisions for the handling of trade secrets are consistent with those for handling other confidential information (such as the marking and submission of complete and redacted copies).
Section 69310.2: Marking and Indexing of Documents
CDTSC moved the requirement to mark confidential information and trade secret information as part of a larger consolidation of sections. CDTSC deleted the requirement that persons submit a claims index at the time of submission as unnecessary and in response to comments that it was potentially in conflict with the statutory requirement for claim justification only upon request.
Section 69310.3: Safeguarding of Confidential Information
CDTSC deleted the prohibition on misuse of confidential information by employees as duplicative of existing law and Departmental practice. CDTSC also deleted the requirement that employees take appropriate measures to safeguard confidential information as duplicative of existing law and Departmental practice.
Section 69310.4: Support of a Claim of Trade Secret Protection
CDTSC revised Section 69310(a) regarding the timing of a justification submission to reflect more clearly the “upon request” nature of the authorizing statute, while giving it flexibility to negotiate a longer period so that responsible entities may have a reasonable period of time to submit their justification documentation as individual circumstances may require. CDTSC states that it removed certain content requirements for justification documentation in subparagraphs (a)(1) through (11) to delete superfluous requests and to harmonize with the information categories already used in California case law and current CDTSC guidelines. The modifications to the previous Section 69310.4 are now found in the newly proposed Section 69309.1. According to CDTSC, Section 69309.1(a) is necessary to operationalize the requirement that persons making a trade secret claim provide justification upon request, while providing a default ten-day response time for planning purposes for submitters to supply trade secret claim justification when so requested. The explicit authority to negotiate a longer deadline is also necessary and appropriate to ensure that submitters are provided with a reasonable period of time to supply the justification requested in cases where substantial numbers of claims are made. Subparagraph (a)(1) through (7) contains seven specified categories of information and is necessary to inform the submitter in advance of what kinds of information CDTSC generally finds appropriate and useful when reviewing a Public Records Act (PRA) request for information claimed as a trade secret.
Section 69310.5: Departmental Review of Trade Secrets
CDTSC deleted this section, which contained provisions for independent review of trade secret claims, in conformance with the provisions of Health & Safety Code Section 25257(a), which requires that information claimed as a trade secret be released only according to the provisions of that section. This section also contained clarifying procedures for the review of trade secret claims after a request for release, which CDTSC deleted as essentially duplicative of existing law.
Section 69310.6: Hazard Trait Submissions
CDTSC modified this section to remove certain provisions that further define the term “hazardous trait submissions” as unnecessary and in response to comments that it was potentially unwarranted. According to CDTSC, the provision in revised Section 69309.2(a) is necessary to avoid potential confusion by reconciling an inadvertent terminological difference between the statute and the regulations, and to clarify that the language of Health & Safety Code Section 25257(f) operates to prohibit trade secret protection for such submissions, “to avoid a too literal reading that might suggest silence on the question, which could leave open the alternative of seeking trade secret protection under the PRA, thereby contravening the clear intent of the section.” CDTSC revised Section 69309.2(b) to clarify that the term properly pertains to all submissions — including those related to alternatives. The relevant statute denies trade secret protection to submissions made “pursuant to this article ” and CDTSC interprets those submissions to include information about alternatives because “that article explicitly calls for ‘… a process that includes an evaluation of the availability of potential alternatives and potential hazards posed by those alternatives.'”