Document ID: EPA-HQ-OPPT-2017-0026-0010
Agency: epa
Document Type: Notice
Title: Statutory Requirements for Substantiation of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA)
Posted Date: 2019-07-16T04:00Z

[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33939-33941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15005]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0026; FRL 9993-96]

Statutory Requirements for Substantiation of Confidential 
Business Information (CBI) Claims Under the Toxic Substances Control 
Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On January 19, 2017, EPA announced an interpretation of 
section 14 of the Toxic Substances Control Act (TSCA). Under this 
interpretation, non-exempt confidential business information (CBI) 
claims must be substantiated at the time the information claimed as CBI 
is submitted to EPA, and non-exempt CBI claims submitted without a 
substantiation are considered deficient. To facilitate compliance with 
the change in interpretation, EPA announced it would undertake a non-
statutorily required

[[Page 33940]]

practice of sending a notice of deficiency to an affected business that 
submitted a non-exempt CBI claim without a substantiation, providing an 
opportunity to correct the deficiency. The Agency also sent out notices 
of deficiency in instances where there were other procedural flaws in 
the submission, namely where the required CBI certification statement 
was not provided, or no generic name was provided when specific 
chemical identity was claimed as CBI. EPA's extensive outreach on this 
interpretation over the past two years has been effective. As such, EPA 
is announcing it is revising its policy and that it will cease sending 
these non-statutorily required notices of deficiency to businesses who 
submit procedurally flawed CBI claims. This action makes more efficient 
EPA's implementation of the TSCA section 14(g) requirement to review 
within 90 days of receipt all CBI claims for chemical identity, with 
limited exceptions, as well as to review a representative subset of at 
least 25% of other non-exempt claims.

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; email address: TSCA-Hotline@epa.gov.
    For technical information contact: Scott M. Sherlock, Attorney 
Advisor, 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; email address: sherlock.scott@epa.gov.

DATES: This action is effective on August 15, 2019.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This announcement is directed to the public in general. It may be 
of particular interest to businesses that manufacture (defined by 
statute to include import) and/or process chemicals covered by TSCA (15 
U.S.C. 2601 et seq.). This may include businesses identified by the 
North American Industrial Classification System (NAICS) codes 325 and 
32411. Because this action is directed to the general public and other 
entities also may be interested, the Agency has not attempted to 
describe all of 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 number EPA-HQ-OPPT-2017-0026. 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 available publicly only in hard copy. Publicly 
available docket materials may be found 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 and 
the amended TSCA, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.

II. What action is the Agency taking?

    On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 
21st Century Act, which amended TSCA, was signed into law. The amended 
TSCA provides new requirements relating to the assertion, 
substantiation, and review of CBI claims. On January 19, 2017, EPA 
published an interpretation of TSCA section 14(c)(3), indicating that 
the provision requires substantiation of all TSCA CBI claims at the 
time the information claimed as CBI is submitted to EPA, except for 
claims for information that are exempt from substantiation requirements 
by virtue of TSCA section 14(c)(2), (82 FR 6522, FRL-9958-34). This 
statutory interpretation was announced as effective within two months.
    To give time for submitters to adjust to the new requirements, EPA 
announced that it would send a notice of deficiency to an affected 
business that submitted non-exempt CBI claims without substantiation on 
or after March 20, 2017, providing 30 days to submit the required 
substantiation. EPA also indicated on its website that it would send 
out notices of deficiency when there were other procedural flaws 
related to the CBI claims in a submission, including a failure to 
provide either a certification statement as required under TSCA section 
14(c)(1)(B) and (c)(5), or a generic name required under TSCA section 
14(c)(1)(C) when specific chemical identity is claimed as confidential. 
If the procedural flaws were not addressed within 30 days of receipt of 
the notice, then the CBI claims would be considered withdrawn and the 
information could be made public with no further notice.
    Since the publication of the announcement the EPA has engaged in a 
variety of communications and outreach activities to educate the 
interested public on the interpretation. The EPA has facilitated or 
participated in webinars, and meetings with members of the public. EPA 
has also engaged via telephone with TSCA submitters, trade groups, and 
others on the requirements of TSCA section 14. EPA has also updated its 
web pages on CBI, to provide detailed guidance to facilitate compliance 
with the new requirements of TSCA. EPA has notified interested persons 
of the web page updates via listserv communications. The communications 
and outreach have been effective: Since the March 21, 2017 effective 
date of the interpretation, EPA has sent out 984 notices of deficiency, 
the vast majority which relate to submissions received before March 21, 
2017. Only 97 notices have been generated, to date, that related to 
filings directed to EPA after March 21, 2017.
    Over two years have passed since the announcement of the section 
14(c)(3) interpretation, so the interpretation is no longer new, and 
companies have had ample notice of the requirements. Therefore, EPA is 
phasing out the practice of sending notices of deficiency. This action 
makes more efficient EPA's implementation of the TSCA section 14(g) 
requirement to review within 90 days of receipt all CBI claims for 
chemical identity, with limited exceptions, as well as to review

[[Page 33941]]

a representative subset of at least 25% of other non-exempt claims.

III. What is the Agency's authority for taking this action?

    TSCA section 14(c)(3), 15 U.S.C. 2613(c)(3), requires an affected 
business to substantiate all TSCA CBI claims at the time the affected 
business asserts the claim to EPA, except for information subject to 
TSCA section 14(c)(2).
    TSCA section 14(c)(1)(a) requires an affected business to assert a 
claim for protection from disclosure concurrent with submission of the 
information in accordance with existing or future EPA rules.
    TSCA imposes no requirement to provide notices of deficiency to 
affected businesses. EPA chose to do so to facilitate compliance with 
the statutory requirement.

IV. Implementation

    Beginning on August 15, 2019, EPA will no longer send out notices 
of deficiency in instances where submissions containing non-exempt 
information claimed as CBI do not include substantiation for all such 
claims, and where the CBI claims have other procedural flaws such as a 
missing certification statement or, in the case of specific chemical 
identity CBI claims, a missing generic name. Instead, the Agency will 
provide written notice to affected business submitters that those CBI 
claims are invalid, and the underlying information is treated as not 
subject to a confidentiality claim, and therefore subject to disclosure 
without further notice.
    This action is consistent with the Agency's overall efforts to be 
more efficient in the implementation of TSCA section 14 requirements. 
EPA will continue to assist submitters with compliance with TSCA 
section 14(c)(3) and has revised its web pages at https://www.epa.gov/tsca-cbi to include additional information on this policy, the 
substantiation questions from 40 CFR 2.204(e), suggested substantiation 
templates, substantiation exemptions and how the substantiations should 
be directed to the Agency.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: July 10, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2019-15005 Filed 7-15-19; 8:45 am]
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