Do you know if the ingredients in the products you are selling in California pose hazards such as epigenicity, ototoxicity, phytotoxicity, genotoxicity, or any of the other 40+ hazard traits currently identified in proposed regulations under California's new green chemistry laws?
California's Office of Environmental Health Hazard Protection (OEHHA) is proposing that a whole suite of new hazard traits and toxic endpoints be included in the Toxic Information Clearinghouse for use in the new green chemistry regulatory program (pdf). The regulations are nearly done, as the last of three comment periods on these draft regulations closed on October 24, 2011, and the regulations are expected to be finalized before December 17, 2011.
The purported goal of these regulations is to identify the basic sets of scientific information that regulators, government scientists, and the public will want to know when they evaluate chemicals in consumer products. But how they will obtain this information, how a product manufacturer will be required to supply this information, and how the regulators will use this information once they get it is anybody’s guess. More disconcertingly, these regulations have the potential to create a veritable playground for plaintiff’s attorneys under toxic tort and product liability schemes and theories.
One fundamental problem with these regulations is that . . . oops . . . the statute does not actually authorize OEHHA to promulgate regulations. Rather, the statute vests that authority with another public agency, the California Department of Toxic Substances Control (“DTSC”). The statute limits OEHHA’s role to that of an advisor to DTSC, to recommend the hazard traits that should be included in the green chemistry program.
The green chemistry law establishes a single regulatory agency, DTSC, and establishes an interagency consultation role for OEHHA so that DTSC is informed by OEHHA’s expertise. While the statute envisioned the creation of an online toxics clearinghouse as a key step in gathering the world’s knowledge on toxicity data in order to create a science-based prioritization scheme to stimulate green chemistry research and rapid innovation toward safer alternatives, DTSC has skipped this critical step in its first few years of its implementation and has spent nearly three years wandering in a swamp of mish-mashed regulatory schemes. In fact, DTSC has not even commenced draft regulations to establish a toxics clearinghouse. Rather, OEHHA appears to be preempting the Department’s statutory role by binding its interagency advice and consultation into a regulation.
In addition to this fundamental flaw, OEHHA’s proposed regulation to establish a set of 40+ hazard traits is not integrated or coordinated with DTSC’s proposed regulations to develop the green chemistry program which will require product manufacturers to perform an alternatives analysis across a product’s lifecycle (and perhaps for the 40+ hazard traits.) {On October 31, 2011, DTSC release its third draft proposed regulation which for the first time identified the OEHHA hazard traits in its prioritization of chemicals and hint at how DTSC will factor those traits in its regulatory scheme.} Effective public participation is denied when you do not know how the list of hazard traits they have come up with, will be used, relied upon or what requirements will be imposed on industry related to them.
The OEHHA regulations create an entirely new hazard trait system that is unique and not linked to global consensus-based standards. One wonders why California would want to isolate its market this way? The impact on cutting-edge industries is particularly worrisome. Take nanomaterials as an example. For many nano-scale substances, which exhibit qualities entirely distinct from a macro-scale sample of the same material, there exist no tests with which to assess many of the newly-identified hazard traits. While to date the DTCS has relied upon information call-ins and input from the nanomaterial industry to guide its evaluation of toxicity issues, OEHHA’s intervention could very quickly thrust an unmanageable array of new burdens on a developing industry.
What plaintiffs’ attorneys will do with this new field of regulatory standards is another wild card that should concern manufacturers. History suggests that as soon as standards are created, they will be used by litigators as the claimed threshold for liability. Even if specific standards are not finally adopted for particular substances, the mere promulgation of 40+ hazard traits itself creates new avenues for enterprising plaintiffs’ attorneys to develop novel theories of causation, harm and liability.
Given the enormity of problems created by these proposed regulations, it is likely that someone will initiate an action to enjoin it as a claim exists against OEHHA to require that it cease and desist from any further attempts at rule-making, and confine itself to its statutorily-defined role as DTSC’s consultant and advisor. An agency can only regulate what the Legislature allows it to, and the Legislature has not given OEHHA any authority to enact hazard trait regulations.
Maureen Gorsen is a partner in Alston & Bird’s environmental and land development group where she provides strategic public policy, litigation and regulatory advocacy and counsel to a wide range of product manufacturers, brand owners, industrial facilities and landowners. Prior to joining the firm, she was the general counsel of the California Environmental Protection Agency, and most recently, the director of the California Department of Toxic Substances Control, where she spearheaded the Green Chemistry Initiative. Peter Masaitis is a partner in the Los Angeles office of Alston & Bird where his practice is focused on complex litigation matters, particularly products liability claims and toxic torts.
