Responding to an EPA Office of Inspector General recommendation, EPA has committed to publishing a comprehensive rule on confidential business information (CBI) claims under the Toxic Substances Control Act by September 30, 2014.
The scope of CBI protection under TSCA has been a controversial issue for years, and is one of the key stumbling points for TSCA reform. In 2009, former EPA Administrator Lisa Jackson announced the agency’s commitment to increase access to and transparency in chemical information submitted to EPA by businesses. Since then, EPA has tightened its approach for CBI protection. As part of that commitment, EPA has reviewed TSCA submissions and rejected numerous CBI claims. In 2010, EPA issued a CBI Declassification Challenge, asking industry to voluntarily withdraw CBI claims made in their TSCA submissions; this effort resulted in the declassification of almost 1000 documents. Also in 2010, EPA notified the regulated community that it would scrutinize CBI claims for chemical identities in health and safety studies. As EPA stated, “Where a chemical identity does not explicitly contain process information or reveal portions of a mixture, EPA expects to find that the information would clearly not be entitled to confidential treatment.” (Emphasis added.)
This recent evolution in the agency’s approach has resulted from mounting public pressure to open access to chemical information. The pressure on EPA continues from its own Office of Inspector General. That Office evaluates and audits EPA and its contractors to ensure that the agency is working effectively and efficiently, with the overall goal of supporting EPA’s programs protecting human health and the environment. In its latest Compendium of Unimplemented Recommendations, the OIG identifies significant recommendations that it has made in prior evaluations, which EPA has not been implemented. In this instance, the OIG issued a report in 2010, “EPA Needs A Coordinated Plan To Oversee Its Toxic Substances Control Act Responsibilities.” One of the OIG’s 2010 recommendations was for EPA to develop a more detailed CBI guide that would establish criteria for approving a CBI claim and a time limit for all CBI request to eventually provide public access to health and safety data.
Protection of CBI is critical for ensuring that US industry remains innovative and competitive. At the same time, the public has a legitimate need for access to information about chemicals to which they may be exposed or which may enter the environment. This tension has long been target of delicate balancing of interests in every regulatory program. Here, the OIG’s most recent 2014 report states, “[T]he EPA’s procedures for handling confidential business information requests are predisposed to protect industry information rather than to provide public access to health and safety studies.” In response to this OIG report, EPA has committed to establishing sunsetting provisions for CBI claims, and a more comprehensive rule covering CBI protection.
Stay tuned. Companies subject to TSCA’s requirements should be playing close attention to this development, not only because of direct impacts under the TSCA program, but also because whatever rule EPA promulgates could form the template for a CBI provision in any TSCA reform legislation and for CBI provisions in state regulatory programs.