[Federal Register Volume 75, Number 13 (Thursday, January 21, 2010)]
[Pages 3462-3463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1105]



[EPA-HQ-OPPT-2009-1013; FRL-8807-9]

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

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.


SUMMARY:  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.

FOR FURTHER INFORMATION CONTACT:  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: [email protected].
    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: [email protected].


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 

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 http://www.regulations.gov. 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 http://www.regulations.gov, 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 
http://www.epa.gov/oppt/index.htm. For more information about reporting 
under TSCA section 8(e), go to http://www.epa.gov/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.

[[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 
(http://www.epa.gov/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.

List of Subjects

    Environmental protection, Chemicals, Confidential business 
information, Reporting and recordkeeping.

    Dated: January 14, 2010.
Steve A. Owens,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 

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