Starting August 25th, Environmental Protection Agency (EPA) will likely reject all confidentiality claims for chemical identity in health and safety studies.
As it stands now, on July 30, 2010, submitters may claim confidentiality for proprietary information within a Toxic Substances Control Act (TSCA) submission -- but should submit a detailed written explanation to substantiate all confidential business information (CBI) claims. Also, submitters must submit a sanitized or "cleaned-up" (think crossed-out sections of CIA docs) copy of the submission (with confidential information deleted) for placement in the TSCA Public Docket.
Back in January 21, 2010, EPA announced a new policy to increase the public’s access to information on chemicals. EPA stated its intention to reject a certain type of confidentiality claim, known as Confidential Business Information (CBI), on the identity of chemicals. Read the full backstory. (The ACC responded here.)
Chemical ingredients and chemical cocktails
EPA says that companies making confidentiality claims should expect a letter from EPA denying such claims. And very notably: EPA expects to begin reviews of confidentiality claims — both newly submitted and existing claims — on August 25, 2010.
This newsflash is of particular interest for those who manufacture (defined by statute to include import) and/or process chemical substances and mixtures subject to TSCA (15 U.S.C. 2601 et seq.) Also, companies identified by the North American Industrial Classification System (NAICS) codes 325 and 32411 are likely to be affected. However, EPA has not attempted to describe all the specific entities that may be interested in this action.
“New governmental initiatives in the U.S. -- including EPA, TSCA and California Green Chemistry initiatives -- push product stewardship to a new level," said Russell McCann, President and CEO of Actio Corp. "The key to compliance is collecting granular data on all chemical substances in all ingredients in each product, then screening standardized measurements of each against chemical classifications and regulatory threshold limits."
EPA will begin a general practice of reviewing confidentiality claims for chemical identities in health and safety studies, and in data from health and safety studies, submitted under the Toxic Substances Control Act (TSCA). Under TSCA, companies may claim a range of sensitive, proprietary information as CBI. Under Section 8(e) of TSCA, companies that manufacture, process, or distribute chemicals are required to immediately provide notice to EPA if they learn that a chemical presents a substantial risk of injury to health or the environment. However, until this announcement, companies would routinely claim confidentiality for the actual identity of the chemical covered by the Section 8(e) submission, thus public posting of the information would not include the name of the chemical. The new EPA policy ends this practice for chemicals on the public portion of the TSCA Inventory. This new policy grants the public access to the chemical identification information submitted, along with other health and safety data under Section 8(e).
This is tremendous news for anyone interested in chemical information disclosure.
- Here are the Instructions for Claiming Confidentiality as it stands.
- Here is EPA's page about CBI, including relevant change information.
- For more on chemical information management systems, inquire here with the materials management experts at Actio Corp.