There is a clear push underway to tighten regulation of chemical substances in the United States. This push is in reaction to the headline-grabbing report 10 of the President’s Cancer Panel, which suggested that “traces of nearly 300 pollutants” have been found in the blood of newborn babies. While US EPA intends to use its current regulatory structure to make changes, Congress is instead considering a major overhaul to the Toxic Substances Control Act (TSCA). 11 It appears only a matter of time before more-stringent regulation becomes a reality, so understanding the direction of the movement is critical.
The Safe Chemicals Act of 2010, which, if enacted, would amend TSCA to require (1) chemicals to meet risk-based safety standards; (2) chemical manufacturers to provide enhanced “health and environmental information” on chemical substances and (3) expanded access to information on chemical safety and use.12
The most fundamental change to TSCA would be a shift in who has the burden of proving that a chemical is safe. Currently, TSCA requires US EPA to explicitly find that a chemical substance or mixture either presents or will present an “unreasonable risk of injury to health or the environment” before it takes action to protect against the risk. 13 However, under S. 3209, the burden would be imposed on chemical manufacturers and processors to demonstrate that a substance meets safety standards.14 The result of the change is that US EPA, instead of being an investigator as it is under the current scheme, would now sit in judgment over safety standard data. This is particularly alarming since S. 3209 also provides that US EPA decisions “shall not be subject to judicial review.”15 This places manufacturers and processors at the mercy of agency personnel reviewing the data with no recourse to the courts.
S. 3209 would also require US EPA to establish rules defining the minimum information necessary to support a safety standard determination on a chemical substance or mixture.16 Yet, the legislation fails to include guidelines or notice to the regulated community on what this might entail leaving it solely to agency discretion. This may have significant repercussions as S. 3209 would also have US EPA develop a priority list17 of chemical substances that would need to have the minimum data set submitted within 18 months after placement on the priority list.18
While there is a general lack of guidance on what information will be necessary, S. 3209 is clear that US EPA would have broad authority to order tests on a chemical substance “as necessary” to make a safety standard determination. 19 Thus, it could require a chemical manufacturer to perform a battery of tests to evaluate a substance’s toxicity or its carcinogenic or bioaccumulation properties prior to making a safety standard determination.20 This suggests that significant information development will likely be required under this new approach. Further, to keep the public informed, S. 3209 would require US EPA to publish in the Federal Register all test data it receives within 15 days of receipt.
In addition, S. 3209 seeks to limit manufacturers’ and processors’ claims for confidential business information protections under TSCA. Administrator Jackson contends that US EPA is unable to publicly identify 17,000 of the 83,000 substances listed on the TSCA Inventory due to claims of confidentiality.21 S. 3209 would impose specific limits on the information that can remain confidential. The identity of a chemical substance would no longer be protected nor would safety standard determinations or health and safety studies. Instead, US EPA would be required to develop standards that cannot be more restrictive than the Freedom of Information Act.22 Further, even if a request for confidentiality is approved, S. 3209 would provide that it can be kept confidential for no more than five years.23 This is particularly concerning given the amount and type of proprietary information that is generally submitted under TSCA.
Separately, but certainly related, US EPA has made a determination that TSCA does not extend confidential status to health and safety studies that do not disclose process or chemical make-up information.24 Thus, US EPA has given notice that it will begin reviewing confidentiality claims this month and issuing determination letters. 25 Parties can seek judicial review of a determination, but the flood gates will be open and disclosure may be permitted if a stay or injunction is not otherwise granted.
Thus, changes are certainly on the horizon - it is simply a question of when. On July 22, 2010 Representatives Rush and Waxman introduced legislation in the House – H. 5280, the Toxic Chemical Safety Act of 2010 - that largely mirrors S. 3209. These two pieces will likely form the benchmarks for the debate concerning TSCA Reform that is sure to proceed and provide a clear indication of where this debate is headed. Obviously, if enacted in its current form, S. 3209 (or H. 5280) would place significant additional burdens on chemical manufacturers and processors and yet decrease proprietary protections at the same time. Chemical manufacturers and processors need to be vigilant as both the Senate and House bills proceed in evaluating how they will be impacted.