The Toxic Substance Control Act of 1976 (“TSCA”) imposes various data reporting obligations on manufacturers and importers of chemical substances. Under TSCA Section 4, for example, EPA may require manufacturers of existing chemicals to conduct tests “to develop data with respect to the health and environmental effects” of existing chemicals. Similarly, TSCA Section 8 may obligate manufacturers to notify EPA of new data suggesting that a chemical poses risks to human health or the environment. Thus, in many cases, TSCA submissions to EPA include health and safety data.
Companies have long been permitted to designate sensitive and proprietary information in such EPA submissions as confidential business information (“CBI”). CBI designations have generally prevented disclosure of the specific identities of chemicals in such reports. Among other legitimate considerations, disclosure of precise chemical names can potentially help competitors “reverse engineer” the submitting company’s manufacturing processes and/or product compositions.
According to a February 10 press release, however, EPA has rejected CBI designations as to the chemical identities of 14 substances described in numerous TSCA submissions. While implicating only a relatively small number of substances, this development is the latest in a series of EPA actions aimed at increasing “transparency” in the context of health and environmental data submissions.
In 2010, for example, EPA announced a general policy of reviewing CBI designations as to chemical identities in new health and safety studies. EPA has also asked companies to declassify information previously submitted under CBI designations, and to reduce the number of CBI claims going forward. Critically, the agency’s review of CBI designations is not just “proactive” in scope; EPA has also launched a review of approximately 16,000 CBI-designated chemical identities in past submissions.
Setting aside the policy arguments offered in support of EPA’s ongoing shift toward greater “transparency,” increased scrutiny of CBI designations seemingly ratchets up the already-substantial toxic tort and environmental litigation risks for companies complying with TSCA and other federal reporting requirements. Put simply, publicly linking human health and environmental data in TSCA submissions to particular chemicals can only help Plaintiffs’ counsel looking for the new litigation targets.