TSCA, TSCA Reform:
Confidential Business Information (CBI) continues to be a focal point of the debates over improving implementation of the current version of TSCA, as well as amending the statute. Here’s a short update on where those debates currently stand.
EPA Adopts New Practices under TSCA
On May 27, 2009, EPA announced in a Federal Register notice that the Agency will begin a “general practice” of reviewing CBI claims for chemical identities in health and safety studies and related data, submitted under TSCA in accordance with EPA regulations at 40 C.F.R. Part 2, Subpart B. According to the notice, “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.” If the chemical identity does not clearly reveal mixture portions or process information, EPA is unlikely to find the information eligible for confidential treatment. EPA will apply its new practice to both newly submitted and existing claims, beginning August 25, 2010.
Stakeholders supporting or opposing this new practice are likely to submit comments to the Agency in advance of the August implementation.
Congressional Debate over the Bills to Modernize TSCA
Both the Senate and House bills would revise and narrow the protections for CBI. The bills would require all CBI claims to be justified up front. EPA would have to review the claims within a prescribed time period. Only those that withstood the review – applying standards that EPA would adopt within one year of enactment of the legislation – would be eligible for protection. Approved claims would receive protection for up to five years.
Similar to the current version of Section 14, the bills would not allow “the release of any data which discloses 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.” Nonetheless, the chemical industry remains concerned about the negative impact the new CBI provisions would have on innovation, jobs, and the U.S. industry’s general competitiveness. ICIS reports that the CEOs from 30 different chemical companies planned to meet this past Wednesday with 50 different members of Congress or their staff to discuss the bills, and the CBI provisions concerning chemical identities were on the top of their list of concerns.
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Watch for future postings as the debates over CBI evolve.