EPA Says Chemical Ingredients No Longer Confidential
- Starting August 25th, Environmental Protection Agency (EPA) will likely reject all confidentiality claims for chemical identity in health and safety studies.
This is tremendous news for anyone interested in chemical information disclosure. Please feel free to contact us for more information.
Blog-Advisor Kal Kawar, PE, CIH
The Big Picture
- EPA announced last week that companies making confidentiality claims should expect a letter from EPA denying such claims. EPA expects to begin reviews of confidentiality claims — both newly submitted and existing claims — in accordance with this guidance 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.
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).
Supply Chain Engagement
- Professional Chemical Engineer and Certified Industrial Hygienist Kal Kawar says, “Supplier engagement in material disclosure for chemical ingredient accounting can be elevated by having functional groups other than Environmental Health and Safety or EHS involved.”
How can it actually work? Kawar says, “Purchasing, supply chain, and product stewardship must work together. With the right software, the inter-departmental work-flow can be automated and monitored from any computer or mobile device with a browser and the right network security clearance.”
Regulatory Loopholes?
- 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. 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.
This builds on similar efforts regarding confidentiality of chemical identities listed on the public version of the TSCA Chemical Substances Inventory (TSCA Inventory) and submitted in notifications pursuant to TSCA section8(e), discussed in the Federal Register of January 21, 2010.
Comments?
Though EPA is not required to solicit comment for this action, comments received before this date will inform these reviews. ADDRESSES: Submit your comments, identified by docket identification (ID)number EPA–HQ–OPPT–2010–0446, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov website is an ‘‘anonymous access’’ system. This means EPA will not know your identity or contact information unless you provide it in the body of your comment. Direct your comments to docket ID number EPA–HQ–OPPT–2010–0446. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov. The complete story on how to submit comments is here, in the Federal Register.
More Info
- Many companies are already implementing tools to manage chemical and material disclosure / regulatory information. Try a Google search on “Material Disclosure.” This will get you started finding related tools to manage materials information at the substance – or granular – level.
For technical information, contact: Scott M. Sherlock, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 564–8257; e-mail address:sherlock.scott@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422South Clinton Ave., Rochester, NY14620; telephone number: (202) 554–1404; e-mail address: TSCAHotline@epa.gov.
Background
What is “Confidential Business Information” (CBI)? According to the EPA web site, as it stands now, 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.
On January 21, 2010, as part of EPA Administrator Lisa P. Jackson’s commitment to strengthen and reform chemical management, EPA announced a new policy to increase the public’s access to information on chemicals. Starting in January, EPA put forth its intention to reject a certain type of confidentiality claim, known as Confidential Business Information (CBI), on the identity of chemicals. Read the backstory. (The ACC responded here.)
Summary: Starting August 25th, EPA will review all confidentiality claims for chemical identity in health and safety studies. EPA announces to companies making confidentiality claims that they should expect to get a letter from EPA denying such claims.
Further reading: Richard Denison, a Scientist at EDF.org, wrote a sufficient piece about this if you get a chance. For more information, inquire here with the materials management experts at Actio Corp.
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