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Claims of Confidentiality of Certain Chemical Identities Submitted under Section 8(e) of the Toxic Substances Control Act

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Environmental Protection Agency (EPA).




EPA is announcing a new general practice of reviewing submissions under section 8(e) of the Toxic Substances Control Act (TSCA) for confidential business information (CBI) claims of chemical identities listed on the public portion of the TSCA Chemical Substances Inventory. Where a health and safety study submitted under section 8(e) of TSCA involves a chemical identity that is already listed on the public portion of the TSCA Chemical Substances Inventory, EPA expects to find that the chemical identity clearly is not entitled to confidential treatment. EPA believes this new general practice will make more health and safety information available to the public and support an important part of the Agency's mission: To promote public understanding of the potential risks posed by chemicals in commerce.

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For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail address:

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:

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I. General Information

A. Does this Action Apply to Me?

This notice is directed to the public in general. It may, however, be of particular interest to you if you manufacture (defined by statute to include import) and/or process chemicals covered by TSCA (15 U.S.C. 2601 et seq.). You may be identified by the North American Industrial Classification System (NAICS) codes 325 and 32411. Because this notice is directed to the general public and other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2009-1013. All documents in the docket are listed in the docket index available at Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

2. Other related information. For information about EPA's programs to evaluate new and existing chemicals and their potential risks, go to​oppt/​index.htm. For more information about reporting under TSCA section 8(e), go to​opptintr/​tsca8e/​index.htm.

II. What Action is the Agency Taking?

The Agency expects to respond to certain CBI claims regarding chemical identities with a determination letter under 40 CFR 2.306(d) and 40 CFR 2.204(d)(2). This Federal Register document only serves to announce this new general practice and is not itself a final Agency action; rather, any determination letter issued by EPA will constitute the Agency's final determination that the chemical identity at issue clearly is not entitled to confidential treatment under TSCA section 14 (15 U.S.C. 2613).

At this time, EPA expects to issue these letters only when the chemical identity claimed as CBI: (1) Is already publicly available on the TSCA Chemical Substances Inventory, and (2) is submitted under TSCA section 8(e) as part of—or data from—a health and safety study.

Each letter will provide a contact person within the Agency whom the recipient of the letter can contact with any questions or concerns about the determination related to their submission.

This action is part of a broader effort to increase transparency and provide more valuable information to the public by identifying programs where non-CBI may have been claimed and treated as CBI in the past. For such information, EPA is considering what actions might be appropriate in accordance with its regulations at 40 CFR part 2, subpart B. Start Printed Page 3463

III. What is the Agency's Authority for Taking this Action?

As a general rule, TSCA section 14(b)(1) provides that health and safety studies and data from health and safety studies are not entitled to treatment as CBI, with an exception for information that “discloses processes used in the manufacturing or processing of a chemical substance or mixture,” or, in the case of a mixture, where release of the data discloses the portion of a mixture comprised by a particular substance. 15 U.S.C. 2613(b)(1).

EPA considers information contained in a notice of substantial risk under TSCA section 8(e) to be health and safety information and, therefore, covered by the term “health and safety study,” as defined in section 3(6) of TSCA. See “TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance,” 68 FR 33129 at 33136, June 3, 2003 (FRL-7287-4). Chemical identity is part of a health and safety study. See e.g., 40 CFR 716.3 and 40 CFR 720.3(k). As such, chemical identity associated with a health and safety study in a TSCA section 8(e) submission is not entitled to confidential treatment unless it falls into the exemption under TSCA section 14(b)(1). Where the identity of a chemical substance is already contained on the public portion of the TSCA Chemical Substances Inventory, which is publicly available from the National Technical Information Service and other sources, EPA believes that the identity itself, even assuming it might otherwise be CBI, as well as any information that might be derived from it about processes or portions, has already been disclosed.

EPA's regulations regarding CBI at 40 CFR part 2, subpart B provide for a process where the relevant office determines that certain information clearly is not entitled to confidential treatment. See 40 CFR 2.306(d); 40 CFR 2.204(d)(2); and 40 CFR 2.205(f). As provided in the regulations, the letters will serve as the final EPA determinations concerning the subject confidentiality claims, and recipients of the letters may seek judicial review under 5 U.S.C. 701 et seq.

IV. Why is EPA Taking this Action?

Part of the Agency's mission is to promote public understanding of potential risks by providing understandable, accessible and complete information on potential chemical risks to the broadest audience possible. In support of this mission, EPA posts useful information about chemicals regulated under TSCA for the public on its website (​oppt/​index.htm). One important source of this information is submissions to the Agency under TSCA section 8(e). TSCA section 8(e) requires that:

Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.

15 U.S.C. 2607(e).

When EPA receives submissions under TSCA section 8(e), it makes this information available on its website. Previously, EPA's general practice had been to redact chemical identity from TSCA section 8(e) postings where the identity was claimed as CBI even when the chemical identity was listed on the public portion of the TSCA Chemical Substances Inventory. EPA believes that the posting of the TSCA section 8(e) information received is incomplete and far less informative where the public is not able to view the chemical identity associated with the new health and safety information posted. Where the identity of the chemical is already publicly available on the TSCA Chemical Substances Inventory, the new general practice will allow the public to link the TSCA section 8(e) information with the relevant chemical and will support the Agency's mission of promoting public understanding of potential risks.

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Dated: January 14, 2010.

Steve A. Owens,

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

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[FR Doc. 2010-1105 Filed 1-20-10; 8:45 am]