After extensive deliberation, Congress has crafted a carefully worded overhaul of the Toxic Substances Control Act (TSCA), the primary federal statute that regulates the chemicals ultimately used to manufacture most products. Some of the framework and concepts are old, including provisions relating to "existing chemicals," which are already on the Environmental Protection Agency's (EPA) official list or inventory. Existing chemicals may still be used in commerce unless EPA finds (based on a balancing of specified factors) that continued use warrants regulatory risk reduction.
New chemicals are those not on the EPA inventory; they cannot be utilized until EPA has conducted a review under the new statutory scheme. The TSCA amendments fundamentally transform the current framework by, among other things: (a) setting deadlines for re-evaluating the risks, costs, and other factors for at least 20 existing chemicals within the next year; (b) granting EPA authority to require companies to perform testing to fill data gaps; (c) requiring EPA to provide an affirmative approval of the "safety" of each use of a chemical (rather than approving by silence); (d) allowing companies to prioritize chemicals for an EPA "safety" review (if the company pays EPA's costs for reviewing the data); (e) limiting business confidentiality of industry submissions; and (f) adding a complex provision that partially pre-empts some state chemical regulations.
Most significantly, the criteria for determining whether chemical risk reduction measures (including prohibition of the sale of products) are warranted is now a two-stage process. Unlike the current approach, which is based on a determination of unreasonable risk that includes cost considerations, the new assessment relies on risk factors alone. This new unreasonable risk calculation includes special consideration for protecting vulnerable populations like children and pregnant women, but must be based on the "best available science" and the weight of the evidence. After this determination, the level of risk reduction from alternatives, costs, benefits, and other factors are considered in concluding what, if any, risk reduction measures are warranted.
Unfortunately, neither the amendments, the prior statute, nor even EPA's past practice define how to determine what daily or lifetime exposure presents an unreasonable risk not considering cost. Nor is there any clear direction concerning what weight to place on the available factors in selecting among potential risk reduction actions, if any, that should be applied to chemicals that have been found to present an unreasonable risk (without considering costs). All that is known for certain is that EPA is no longer required to choose the least burdensome requirement.
Chemical manufacturers, importers of chemicals and products, and the companies that use these chemicals in their manufacturing processes and/or in products, are likely to be significantly affected by the new law, which will create pressure on manufacturers to search for sustainable substitute chemicals to replace those likely to be judged high risk. EPA is planning to develop implementing regulations, and companies that may be caught up in the new requirements should review and comment on EPA's forthcoming proposals. Even more urgently, businesses should conduct strategic assessments of key products' vulnerabilities - or competitive opportunities - under this major change in the law.
