As part of EPA’s initiative to increase transparency under the Toxic Substances Control Act (TSCA), on February 10, 2011, the Agency sent a letter to five companies informing them that the identities of 14 chemicals contained in certain health and safety studies were ineligible for protection from public disclosure. The studies are “substantial risk” reports that the companies submitted to EPA to fulfill their obligations under section 8(e) of TSCA (15 U.S.C. § 2607(e)). Readers will recall that substantial risk reports disclose information that reasonably supports the conclusion that a chemical substance or mixture (collectively “chemicals”) presents a substantial risk of injury to health or the environment. EPA reasons that the public has a right to know the identities of chemicals posing such risks. In contrast, industry frequently contends that disclosure of identities could reveal commercially valuable information about formulations or manufacturing processes. To stop the disclosure of the identities of its chemicals, a company would need to initiate a legal challenge within 30 days of receiving the Agency’s February letter.
The letters comprise the Agency’s first serious attempt to implement a new transparency policy announced on January 21, 2010. (The scope of the policy was subsequently expanded in May 2010.) As announced in January, EPA will deny Confidential Business Information (CBI) protection for the identities of chemicals included in section 8(e) reports when those chemicals are listed on the public version of the TSCA Inventory. EPA contends that substantial risk reports are a type of health and safety study, as defined under section 3(6) of TSCA (15 U.S.C. § 2602(6)) and the regulations at 40 C.F.R. § 2.306(a)(3). The Agency also asserts that a chemical’s identity is either part of a health and safety study or the data included within such study, as explained in various TSCA regulations such as those at 40 C.F.R. § 716.3; § 720.3(k). And because section 14(b)(1) of TSCA (15 U.S.C. § 2613(b)(1)) “does not prohibit disclosure of” health and safety studies (and their data) concerning chemicals offered for commercial distribution, EPA concludes that a chemical’s identity would be eligible for disclosure when it is listed on the public version of the TSCA Inventory and it is the subject of a substantial risk report.
According to EPA’s letter, the chemicals fit squarely within the Agency’s policy. Each of the chemicals is currently listed on the public version of the TSCA Inventory of “existing” substances. (The Inventory is EPA’s official list of chemicals that can be lawfully imported or manufactured for commercial distribution without first submitting a premanufacture notice under section 5 of TSCA – the public version lists those chemicals whose identities are not confidential.) And each of them supposedly was the subject of a substantial risk report.
However, section 14(b)(1) prohibits disclosure of data from health and safety studies when such disclosure would reveal “processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release [would disclose] the portion of the mixture comprised by any of the chemical substances in the mixture.” These exceptions are designed to prevent the disclosure of trade secrets and other sensitive business information. EPA’s letter seems to anticipate this objection from the companies, noting “that the [chemical] identity itself, as well as any information that might be derived from it about processes or portions, has already been disclosed” and therefore neither exception applies.
Whether the companies will seek judicial review remains to be seen. Many challenged CBI claims are withdrawn, and judicial review is expensive. If the companies seek judicial review, they may challenge EPA’s statutory interpretion or its conclusion that neither disclosure exception applies. (If a challenge(s) is brought, look for a future blog post discussing the various arguments.)
Regardless of whether there’s a challenge, the Agency’s decision is somewhat controversial – applauded by some and criticized by others. Unless there’s a successful legal challenge or some other restraint imposed, look for EPA’s continued release of unredacted substantial risk reports and possibly other health and safety studies. The Agency has clearly signalled its intention to increase the amount of publicly-available information concerning chemical risks. When balancing commercial interests against environmental and health interests, EPA’s current administration plans to favor the latter at the expense of the former, raising the question: “Could a better balance be achieved?” Perhaps – EPA could release the reports with a descriptive generic name in lieu of the chemical’s specific name, a practice the Agency’s used elsewhere under TSCA.