Date: Apr 30, 2010
Partners from Keller and Heckman LLP's Chemical Control Practice group convened today to discuss ramifications for the chemical industry if Senator Frank Lautenberg's (D-N.J.) "Safe Chemicals Act of 2010" were to be enacted in its current, unworkable form. Part summary, part roundtable discussion, and part question and answer session, the webinar concluded that the Bill required too much, too soon, and without sufficient justification for an overhaul of existing chemical control requirements in the United States.
The Bill would significantly amend the 1976 Toxic Substances Control Act (TSCA), 15 U.S.C. § 2601, et seq., and would establish a comprehensive system of regulation for new chemicals, existing chemicals, and new uses of existing chemicals. Shifting the burden of proof to manufacturers and processors of chemicals, mixtures, and "articles" containing those chemicals/mixtures, the Bill requires a showing of "reasonable certainty of no harm" – namely, that the substance or mixture poses a negligible risk to human health or the environment. All marketed chemicals would be required to meet this safety threshold, and the Bill would provide the U.S. Environmental Protection Agency (EPA) with broad authority to require the submission of any data helpful to establishing the safety of the chemical. Under the Bill, through a "minimum" dataset EPA can require extensive information in the name of its safety determination process, i.e., information on substance characteristics, hazard information, exposure data, use data, chemical identity, etc. Moreover, the majority of information submitted to EPA – including chemical identity – can no longer be claimed as "confidential business information" due to the Bill's significant rewriting of TSCA's section 14 confidentiality provisions.
While replete with lofty, idealistic ambitions, the resounding conclusion was that the Bill lacks practicality and well-rounded solutions. For example, although it includes a mechanism for prioritization of chemicals, the prioritization is not conducted in any meaningful way. The Bill provides no explanation of prioritization, no specific listing of chemicals of concern, and no information exchange to measure the cost-benefit of chemical listing before a listing is made by EPA. The Bill also ignores the dramatic impact on product development, as it allows EPA to control the pace of innovation, rather than allow innovation to be controlled by scientific development or the economy. Moreover, the Bill attempts to make overly broad delegations of authority to EPA – it prohibits judicial review of many final Agency decisions – decisions that can and will bear on the rights of the persons involved.
Keller and Heckman recognizes and supports the informed, thoughtful development of chemical control law in the U.S. The Safe Chemicals Act is not, however, a supportable final product. We urge members of the industry to contact Congressional representatives and to communicate that the Safe Chemicals Act of 2010, in its current form, is not a feasible or pragmatic TSCA reform measure.
The Senate's Safe Chemicals Act 2010 can be located at http://lautenberg.senate.gov/assets/SCA2010.pdf.
The House's almost identical TSCA reform measure can be located at http://energycommerce.house.gov/Press_111/20100415/TCSA.Discussion.Draft.pdf.