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November 21, 2011

DTSC GRSP Meets to Review Revised “Informal Draft” Safer Consumer Products Regulations

The ACTA Group

On November 14-15, 2011, the California Department of Toxic Substances Control’s (DTSC) Green Ribbon Science Panel (GRSP) met to review DTSC’s “informal draft” Safer Consumer Products Regulations (SCPR) released on October 31, 2011. Memoranda providing background information are available online. Information about the meeting can be found online.

During the meeting, DTSC provided an explanation for how the regulations were developed and then set forth questions for discussion on three topics: (1) the Chemicals of Concern (COC) List; (2) the prioritization of products; and (3) the quality assurance of alternative assessments (AA).

  • The “Chemicals of Concern” List: DTSC discussed its approach to developing the COC List, which consists of establishing, within 30 days after the effective date of the regulations, a list of approximately 3,000 COCs that are included in 22 different lists of chemicals developed by a range of global authoritative bodies or identified by one or more of three sources of “reliable” information. DTSC provided several reasons for its approach, including (1) sending signals to the marketplace of those substances that have been flagged as potential concerns; (2) allowing DTSC to commence work immediately to identify priority products (PP) containing one or more COCs; and (3) using available information on chemicals to save costs and maximize benefits. DTSC also stated that an advantage of a larger list is that it will reduce the incentive for manufacturers immediately to deselect COCs to avoid these regulations but perhaps choose a substitute that is no better or even worse than the listed COC or would be listed later by DTSC.

    DTSC asked the GRSP to provide comments on whether the 22 lists were the “right” ones or if there should be fewer or more lists included. DTSC also asked if there were any potential unforeseen consequences to this approach.
    • Some GRSP members found the current approach to be “overreaching” and expressed concern that some of the lists from which the COC List would be derived did not qualify as authoritative bodies or reliable sources. One member noted that while there was an understanding that the COC List would include substances beyond those identified as Carcinogenic, Mutagenic or Toxic to Reproduction (CMR), the COC List will not be credible if DTSC does not use the correct lists developed by indisputable authoritative bodies. Another member suggested that DTSC only consider lists that were developed following public comments and data submissions. One list in particular that several GRSP members commented did not meet the standard of a source of “reliable” information was the Grandjean & Landrigan Identification of Neurotoxicants. Another source in dispute was the Oslo/Paris Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR) List of Chemicals for Priority Action.
    • Other GRSP members found that the sources selected by DTSC were not inclusive enough to capture all chemicals of potential concern. Some members stated, for example, that there were no lists identifying respiratory sensitizers, dermal sensitizers, ambient ozone contributors or ozone depletors, or asthmagens. Members suggested including the Registration, Evaluation, Authorization and Restriction of Chemical’s (REACH) substances of very high concern candidate list and substances that are monitored under California and the Centers for Disease Control and Prevention’s (CDC) biomonitoring program. Another GRSP member suggested that DTSC include not only those chemicals listed in the U.S. Environmental Protection Agency (EPA) Toxics Release Inventory (TRI) as “Persistent, Bioaccumulative, and Toxic Chemicals” but all TRI substances.
    • One GRSP member raised the question of whether nanomaterials, which are not specifically mentioned in these informal draft regulations, were meant to be excluded. The GRSP member thought that the regulation’s definition of “chemical” may be narrow and that nanomaterials may not fit within the definition.
  • “Priority Products” List: DTSC discussed its approach to developing its identification of the first PPs, which will occur after evaluating the potential adverse health and environmental impacts posed by the COCs in each product based on several factors: (1) the potential adverse impacts from the COCs; (2) potential exposures; (3) the “availability of reliable information to substantiate the potential adverse impacts and exposures”; (4) the extent to which other regulatory programs regulate the products; and (5) the existence, if any, of a known “readily available safer alternative, that is functionally acceptable and technologically and economically viable.” DTSC stated that it believed its approach to use this narrative standard was the best way it thought it could achieve its objectives to be forward thinking, take advantage of potential new technologies, and ensure that the standard was one that could grow over time. DTSC stated that it was advised that it would not be legally defensible to list specific products in the regulations. DTSC also stated that it expects the initial list to be quite small, with no more than five PPs, and it will operate as a type of pilot program.
    DTSC asked the GRSP to provide comments on what steps might be included to structure the prioritization process so that manufacturers are better able to predict the likelihood of their products being listed as PPs. Several comments addressed issues not directly requested by DTSC, particularly the scope of the notification process. GRSP members also sought clarifications or made suggestions to clarify the regulations so that PP alternatives were not limited to selecting alternative chemicals. GRSP members also expressed concern with the regulation requirement that a company demonstrate that the alternative has no greater significant adverse impacts than those associated with the PP, noting that there should be a higher standard than just exceeding the “floor” of impacts associated with the PP. DTSC noted that if a company performed an AA and did not evaluate or suggest an alternative with impacts that do not go above the “floor,” that company would likely expect a regulatory response from DTSC.
  • Quality Assurance for AAs: DTSC discussed the two stage process under which it will require non-exempt “Responsible Entities” to conduct AAs for its PPs. DTSC noted that the regulations include requirements to ensure quality for the AAs through DTSC audits, creating a certification program for assessors, and posting non-redacted portions of the AAs on DTSC’s website for public review. Specifically, after January 1, 2015, AAs must be performed, and reports must be completed by, or under the responsible charge of, an assessor certified by an accreditation body designated by DTSC. This is a significant difference from the initially proposed regulations, which had required third-party verifications of the AAs.

    DTSC asked the GRSP whether, given DTSC’s limited resources, this approach is sufficient to provide meaningful quality assurance. DTSC also asked if there were any steps that could be taken to restructure or supplement this approach.
    • Several members expressed concerns that the third-party certifications were a weakness in the program that might provide too much variability in how companies have their AAs certified. GRSP members made several suggestions to restructure the regulations with regard to certified assessors, including: (1) limiting the number of accredited bodies (perhaps to 3-4) and allowing companies to compete to be accredited; (2) establishing a common examination for certification so that everyone is tested the same way; (3) asking for some portion of any fees collected by the certified assessors to be passed back to DTSC; (4) scheduling an annual conference for DTSC and assessors to discuss the accreditation process, how assessors are conducting their reviews, etc.; and (5) requiring assessors to carry professional liability insurance.
    • While one GRSP member asked DTSC to reconsider the provision prohibiting an entity from seeking accreditation if it has “any economic interest” and instead ensure that organizations do not have significant conflicts of interest which may go beyond financial interests, other members stated that accredited assessors need to be trusted by all parties involved from all different viewpoints.

With regard to other measures in the regulations to ensure quality, GRSP members commented that while DTSC audits were a good idea, DTSC was confronted with significant budget issues and the actual audits that DTSC conducts may be much less than that which would occur under a well-funded agency. One member suggested that the regulations provide or clarify that DTSC has the authority when conducting audits to require changes or to come to a different conclusion. Regarding the posting of AAs on the Internet with some information redacted, some members commented that this was a necessary step to assist with transparency, although it was noted that knowledge of public disclosure may create incentives for companies to create AAs with very limited information. One member stated that the regulations should specify that the process by which AAs are conducted cannot be claimed as trade secret.

Next Steps

Based on the comments from the GRSP, it appears that most members approved of the general scope and framework of the informal draft regulations and offered comments and suggestions regarding the details of how this framework would be implemented. DTSC does not expect to hold another face-to-face GRSP meeting before the regulations are promulgated. The GRSP may schedule a teleconference sometime during the process. DTSC is holding a workshop on December 5, 2011, to “welcome comments and suggestions from the public to enhance the informal draft regulations to make them more meaningful, practical, technically sound, and legally defensible.” Details regarding the workshop can be found online. DTSC also is accepting comments on the regulations, which are due by December 30, 2011. DTSC emphasized that it would be helpful if those that were submitting comments offered solutions to any problems identified.