In another of what the U.S. Environmental Protection Agency (“EPA”) refers to as a series of “unprecedented actions,” EPA announced it has made public the names of more than 150 chemicals identified in over 100 health and safety studies that had been claimed confidential by submitting companies pursuant to the Toxic Substances Control Act (“TSCA”). TSCA requires chemical manufacturers, importers, processors and distributors to submit reports to EPA after obtaining information that a chemical presents a substantial risk of injury to health or the environment.
According to EPA’s press release, the named chemicals are used in “dispersant formulations and consumer products such as air fresheners, non-stick and stain resistant materials, fire resistant materials, nonylphenol compounds, perfluorinated compounds, and lead.”
In 2010, EPA challenged industry to voluntarily declassify unwarranted claims of confidential business information (“CBI”) and issued new guidance outlining the agency’s plan to deny confidentiality claims for the identity of chemicals in health and safety studies under TSCA. The agency’s May 2010 notice informed industry that Section 14(b) of TSCA “does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” Fed. Reg., Vol. 75, No. 102, May 27, 2010. Therefore, where a chemical identity does not explicitly contain process information or reveal portions of a mixture, EPA expects the information would not be entitled to confidential treatment.
As a follow-up to its May 2010 notice, in February 2011, EPA informed a number of companies that their CBI claims were not eligible for confidential treatment under TSCA and the chemical names would be made public.
EPA’s recent efforts to make chemical information more readily available has included free online access to a consolidated TSCA inventory of chemicals and a new chemical data access tool that provides an electronic database platform to search over 10,000 health and safety documents. Now, EPA has announced that it will be regularly posting new TSCA declassified materials on its website.
Chemical manufacturers, importers, processors and distributors may still claim confidentiality under TSCA for proprietary reasons but must submit more detailed explanations to substantiate all CBI claims. EPA has provided a list of questions that a submitting company should answer to substantiate a CBI claim, available here.© MICHAEL BEST & FRIEDRICH LLP