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. 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.
OEHHA's regulations fit into a broader regulatory scheme under California's new green chemistry law. This law envisions 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. Yet, to date, there has been little communication on the status of the development of this online toxics clearinghouse.
Rather, OEHHA's proposed regulation establish a set of 40+ hazard traits have been created in a vacuum relative to the other moving parts in the regulatory scheme. The OEHHA hazard traits are not integrated or coordinated with the Department of Toxic Substances Control's (DTSC) proposed regulations to develop the overall green chemistry program.
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 hinted at how DTSC will factor those traits in its regulatory scheme. The DTSC draft regulations will require product manufacturers to perform an alternatives analysis across a product's lifecycle (including perhaps for OEHHA's 40+ hazard traits). It is possible that the new set of regulations could require product manufacturers to generate toxicity data for these new sets of hazard traits if insufficient data is found during the alternatives analysis process.
The OEHHA regulations create an entirely new hazard trait system that is unique and not linked to global consensus-based standards. 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. Another concern is the potential mischief that plaintiffs' attorneys could create with this new field of regulatory standards. 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.
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.
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 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.
OEHHA regulations and clist of hazard traits
DTSC Safer Consumer Product Regulations