California Green Chemistry Regulation Update
The California Green Ribbon Science Panel met May 5 and 6, 2011 to discuss the results of the subcommittee meetings that had been held in the previous weeks and to give Department of Toxic Substances Control (DTSC) advice on how they should write the regulation. The first half-day covered general issues around the subcommittee process and the de minimis exemption and unintentionally added material. The second day covered the selection of chemicals of concern and priority consumer products – whether there should be one or two lists and how they should be identified. As has been typical with the evolution of the implementing regulations, each step forward seems to be accompanied by another step backward. The result continues to be that the path forward remains somewhat unclear, a frustrating state of affairs for the business community.
The options under consideration looked a lot like the September draft regulation with a large number (>3000) of "Chemicals of Concern" (COC) and a smaller (<50 to start) number of "Priority Chemicals" (PC). The regulation could contain a "List of Lists" from authoritative bodies that would comprise the "Chemicals of Concern" or it could have a process for identifying COC. Nobody wants the to start over and ignore the work of authoritative bodies and do their own assessments of what chemicals might be of concern, but many commenters in earlier proceedings noted concerns with DTSC simply adopting lists of other organizations. Many business organizations also urged that the list be carefully circumscribed to avoid overbroad application.
Under SB509, OEHHA was tasked with determining hazard traits which could be used to determine which chemicals should be subject to this regulation. They have proposed ~300 hazard traits including water solubility which means that probably all chemicals could be subject to regulation since they would have at least one of these "hazard traits". It is a nice comprehensive list, but doesn't do anything to help with prioritization. Various criteria were discussed, including things like the Globally Harmonized System of Classification and Labeling (GHS) which is used by EPA's Design for the Environment (DfE). There still was no real determination about how PCs would be selected, although carcinogens, mutagens, and reproductive toxins (CMRs), persistent, bioaccumulative and toxic chemicals (PBTs) and endocrine disruptors were mentioned frequently. There was a lot of discussion about the need to pair selection of chemicals with selection of products since it doesn't do any good to select chemicals that aren't in consumer products. The fact that we don't know what chemicals are in what products lead to a discussion about whether DTSC has the authority to do a data call-in for PCs to find out what products they are used in and they thought they did have that authority.
The focus is on how to identify the chemical/product combinations of concern. There was general agreement that these products would be ones likely to be used by sensitive sub-populations (a requirement of AB1879). The lack of specific information about what chemicals are in what products, especially articles, hampers this approach. Also it is really not possible to pick products in isolation from priority chemicals. The suggestions were to have a data call-in to determine what products contain what chemicals or to make a start with "known" "bad" chemical/product combinations while other information was developed. For both chemical and product selection there has to be a transparent process and criteria because California's Administrative Procedures Act doesn't allow "underground regulation," There were suggestions that either the California Air Resources Board (CARB) process or EPA's DfE process could be models for chemical/product assessment. There was some support for a "tiered" alternatives assessment process where there would be different requirements for things like products with PCs below the de minimis level than for products with higher concentrations of PCs. This was to allow DTSC to take regulatory action on any product with any level of a PC from any source. Of course, that approach perpetuates a myth that the presence of a substance in a product leads to risk irrespective of pathways of exposure and the likely migration of the chemical under those exposure conditions, another key flaw in the approach.
One significant point of debate is whether any PC should be allowed at any level if it is 1) intentionally added or 2) unintentionally present because of small amounts of material in ingredients, un-reacted starting materials, etc. One previous proposal was to adopt a de facto de minimis level of 0.1%, but there is strong support for a de minimis value set for each priority chemical/product combination. Although the objective of AB1879 is ". . . to determine how best to limit exposure or to reduce the level of hazard posed by a chemical of concern . ." it was thought by many panel members that the regulation is trying to eliminate the use of chemicals of concern in priority consumer products so they shouldn't be intentionally added at any level.
There was particular concern by some GRSP members that CMRs, PBTs and endocrine disruptors should not have a de minimis level, even for unintentionally present chemicals. This is because they felt that there was no safe level. Some members felt that because there were only going to be a few chemicals and products to start with, and the presence of the chemical in the product would only trigger an alternatives assessment, not a particular regulatory response, that there should be no de minimis level for listed substances, whether intentionally added or unintentionally present, if the chemical is a CMR, PBT or endocrine disruptor. There was discussion about whether, if unintentionally present chemicals were below the de minimis level, a manufacturer would be required to file for an exemption with DTSC. Applying for an exemption seems to defeat the purpose of having a de minimis level, but some considered it an abbreviated alternatives assessment which would allow DTSC to take regulatory action if it was so inclined.
DTSC will take all of this away and presumably come up with suggested language for these parts of the regulation. There will almost certainly be additional subcommittee activity around the Alternatives Assessment and Regulatory Response sections, if not other areas of concern. Another GRSP meeting is proposed for July. Unfortunately, many of the suggestions from the GRSP appear to propose a regulation closer to the complex September version of the draft regulation rather than the latest November version. The business community will need to continue to weigh in with practical suggestions on moving forward. Keller and Heckman will continue to monitor all green chemistry developments and assist clients in understanding requirements and advocating their views.
For more information on green chemistry developments, contact Sheila A. Millar, firstname.lastname@example.org; Devon Wm. Hill, email@example.com; JC Walker, firstname.lastname@example.org; or Alisa A. Karlsons, email@example.com. For more information on Green Chemistry and other California requirements, contact Leslie T. Krasny, firstname.lastname@example.org or Diana G. Graham, email@example.com.