On April 14, 2011, Senator Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011 (S. 847) to modernize the Toxic Substances Control Act (TSCA). Lautenberg initiated similar legislation, S. 3209, in the 111th Congress. Below is a summary of key differences between Lautenberg's S. 847 and S. 3209.
Section 3 of TSCA has been revised as follows:
• "Aggregate exposure" is defined to include all sources of exposure, including those from non-TSCA uses (subject to the Federal Food, Drug and Cosmetic Act).
• "Chemical identity" no longer includes provisions concerning mixtures, but Section 26(c)(3) grants the U.S. Environmental Protection Agency (EPA) the right to extend authorities to mixtures if the administrator determines "such extension is reasonable and efficient."
• "Cumulative exposure" now refers to aggregate exposures from multiple chemicals that "are known or suspected to contribute appreciably to the same or similar adverse effect."
• "Environment" includes "ambient and indoor air."
• A "new chemical substance" is considered one "for which the manufacturer or processor of the chemical substance has not submitted a declaration."
• "Reasonable certainty of no harm," which appeared in S. 3209 is no longer included, although the term is still used in the Section 6 safety standard.
• "Special substance characteristic" has been retained, including considerations for size or size distribution; shape and surface structure; reactivity; and any other properties that may significantly affect the risks posed (this is of key significance to the nano community).
Minimum Data Sets and Testing of Chemical Substances. TSCA Section 4 would require the EPA to modify Minimum Data Sets to include the minimum amount of information necessary for the administrator to conduct a "screening level" risk assessment of the chemical substance or category of chemical substances. This includes information on the characteristics, toxicological properties, exposure and use of a chemical substance. EPA would encourage alternative testing methods and strategies to generate information quickly, at low cost, and without the use of animal-based testing.
Prioritization Safety Standard Determination, and Risk Management. Section 6 revisions require EPA to develop and publish a list containing names of chemical substances/categories of chemicals that the administrator determines warrant placement within one of three "priority classes." Consistent with S. 3209, S. 847 would prohibit judicial review of: the assignment of a particular chemical substance; EPA's determination of whether an assignment is warranted; a response to a petition to include a chemical substance on the list; and the recommendation to list a substance. Manufacturers and processors of a chemical substance are to provide "sufficient information" for EPA to determine whether the chemical substance meets the applicable safety standard.
Preemption. This provision has been revised under S. 847. Nothing affects the "right of a State or a political subdivision of a State to adopt or enforce any regulation, requirement, or standard of performance that is different from, or in addition to, a regulation, requirement, liability, or standard of performance established pursuant to this Act unless compliance with both this Act and the State or political subdivision of a State regulation, requirement, or standard of performance is impossible, in which case the applicable provisions of this Act shall control."
S. 847 seeks to respond to industry's criticism of S. 3209. Examples include clarifying and limiting the purposes of Section 4 Minimum Data Sets to "screening level information," and separating out categories of Section 6 priorities and actions in lieu of blanket and encompassing data generation, assessment, and safety standard determination requirements that S. 3209 applied to all chemicals. The Section 6 "hit list" of chemicals has been removed and the identification of substances left to the EPA to evaluate data and take action. The treatment of mixtures is facilitated conceptually, but remains open-ended depending on the EPA definition of "reasonable and efficient."
The proposal introduces significant new requirements and expansions in others, including: the treatment of "mixtures;" requirements that each manufacturer or processor of a chemical must submit a Minimum Data Set; that all chemicals would be subject to export notification; and that substances in imported articles must meet all statutory requirements unless the requirements have been excluded by rule.
At this stage, it is too early to assess whether S. 847 will provide a basis to revise TSCA, or if stakeholders will let another year pass without much-needed TSCA reform.
Lynn L. Bergeson is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected].
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.