
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6522-6525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01235]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0026; FRL-9958-34]


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: In June 2016, the Frank R. Lautenberg Chemical Safety for the 
21st Century Act amended the Toxic Substances Control Act (TSCA). EPA 
is announcing an interpretation of TSCA section 14 concerning 
confidential business information (CBI) claims for information 
submitted to EPA. EPA interprets the revised TSCA section 14(c)(3) as 
requiring substantiation of non-exempt CBI claims at the time the 
information claimed as CBI is submitted to EPA.

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 March 20, 2017.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This announcement 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.). 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 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-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 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 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?

    The amended TSCA provides new requirements relating to the 
assertion, substantiation and review of CBI claims. EPA is interpreting 
the revised TSCA section 14(c)(3) as requiring substantiation of all 
CBI claims at the time the information claimed as CBI is submitted to 
EPA, except for claims for information subject to TSCA section 
14(c)(2).
    This action facilitates the Agency's implementation of TSCA section 
14(g) to review all CBI claims for chemical identity, with limited 
exceptions, as well as to review a representative sample of at least 
25% of other non-exempt claims.

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

    EPA has determined that TSCA section 14(c)(3), 15 U.S.C. 
2613(c)(3), requires an affected business to substantiate all TSCA CBI 
claims, except for information subject to TSCA section 14(c)(2), at the 
time the affected business submits the claimed information to EPA.
    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 rules. TSCA section 
14(c)(3) in turn requires an affected business submitting a claim to 
protect information from disclosure to substantiate the claim, also in 
accordance with existing or future rules. The language of TSCA section 
14(c)(3) is as follows:

    ``(3) Substantiation requirements. Except as provided in 
paragraph (2), a person asserting a claim to protect information 
from disclosure under this section shall substantiate the claim, in 
accordance with such rules as the Administrator has promulgated or 
may promulgate pursuant to this section.''

    EPA interprets TSCA section 14(c)(3) to require substantiation for 
all TSCA CBI claims, except for information

[[Page 6523]]

within TSCA section 14(c)(2). That is the clear import of the language, 
``a person asserting a claim to protect information from disclosure 
under this section shall substantiate the claim . . .'' While the final 
clause requires that submissions be in accordance with EPA rules, EPA 
interprets this provision as addressing the form and manner of a 
submission, not as making the substantiation requirement conditional 
upon a future EPA rulemaking. In the future, EPA may promulgate 
regulations governing the form and manner of substantiating CBI claims 
for those submissions addressed by this action. Nonetheless, EPA 
considers the statutory substantiation requirement to be in place as of 
the effective date of this action.
    EPA's interpretation is supported by legislative history for the 
recent amendments to TSCA. Both the Senate and House intended to 
require substantiation of CBI claims. See S. Rpt. 114-67 (observing, on 
page 5, that ``section 14 [of pre-amendment TSCA] and EPA's 
implementation of it has been criticized for failing to require . . . . 
up-front substantiation of confidentiality claims,'' and, on page 22, 
stating that, under the Senate bill, ``all new claims for protection of 
information not presumed to be protected from disclosure must be 
substantiated by the claimant''); H. Rpt. 114-176 at 29 (a 
confidentiality claim must ``include . . . . a justification for each 
claim of confidentiality''); Senate Environment and Public Works 
Committee summary: ``Reforming the Toxic Substances Control Act'' at 3 
(http://www.epw.senate.gov/public/_cache/files/aa2ac4d1-15bb-4e71-9588-909d49bdcff2/tsca-reform-marketing-packet-5.19-final.pdf). (``The 
legislation promotes additional transparency by requiring up-front 
substantiation of claims to protect confidential commercial 
information. . . .'') EPA's interpretation also is supported by TSCA 
section 14(i)(2), which provides that, ``nothing in this chapter'' 
prevents EPA from requiring substantiation before the effective date of 
rules that may be promulgated after June 22, 2016, the date on which 
the amendments to TSCA were enacted.
    It might be maintained that TSCA section 14(c)(3) does not impose a 
substantiation requirement, but merely authorizes EPA to promulgate 
rules requiring substantiation. Alternatively, it might be maintained 
that the section does impose a substantiation requirement, but that the 
requirement must be effectuated through EPA rulemaking.
    The first reading does not effectuate the legislative intent to 
require substantiation. In addition, the provision is not worded as a 
mere grant of authority. Numerous other provisions of TSCA--both of the 
pre-amended statute and of the Lautenberg amendments--demonstrate that 
Congress used more straightforward language when it intended simply to 
grant EPA rulemaking or other authority (e.g., TSCA section 14(f)(1) 
(``The Administrator may require any person . . . to reassert and 
substantiate or re-substantiate'' an existing claim under certain 
circumstances); TSCA section 4(a)(2) (``The Administrator may, by rule, 
order, or consent agreement . . . . require the development of new 
information''). Finally, TSCA section 14(c)(1) already authorizes EPA 
to promulgate rules governing the assertion of CBI claims. This 
paragraph provides authority for EPA to promulgate rules requiring 
substantiation, and EPA in fact promulgated a number of rules requiring 
substantiation under similarly worded authority in pre-amendment TSCA 
section 14(c)(1). See, e.g., 40 CFR 711.30(b)(1), requiring up-front 
substantiation for chemical identity claims for Chemical Data Reporting 
under part 711. To interpret TSCA section 14(c)(3) as merely providing 
authority to require substantiation, where that authority already 
exists in TSCA section 14(c)(1), would arguably give TSCA section 
14(c)(3) no effect at all.
    The second reading amounts to a revision of the legislative text. 
TSCA section 14(c)(3) does not require EPA to undertake rulemaking; it 
merely acknowledges that EPA ``may'' do so. Unless this ``may'' were 
read as ``shall'', EPA would be under no obligation to promulgate the 
rules required to carry out the objective of requiring substantiation. 
Here again, numerous other provisions of TSCA demonstrate that Congress 
used clear language--and included deadlines--when it intended to 
require EPA to promulgate regulations (e.g., TSCA section 
6(b)(1)(A)(``Not later than 1 year after June 22, 2016, the 
Administrator shall establish, by rule, a risk-based screening process. 
. . .'').
    Having determined that TSCA section 14(c)(3) requires 
substantiation of all non-exempt TSCA CBI claims, EPA believes the 
provision is best interpreted as requiring substantiation concurrent 
with the submission. This is the natural reading of the requirement 
that ``a person asserting a claim . . . . shall substantiate the 
claim.'' By analogy, TSCA section 14(c)(5)--another requirement newly 
added by the Lautenberg amendments--provides that a claimant ``shall 
certify that the statement required to assert a [confidentiality] claim 
. . . . and any information required to substantiate a claim . . . . 
are true and correct.'' While this provision does not explicitly state 
that the certification must accompany the submission, it is reasonable 
to conclude that Congress intended that result. Moreover, a requirement 
to substantiate CBI claims at some unspecified time would not create 
any meaningful self-executing requirement, because there would be no 
point in time at which an affected business could be found not to have 
complied.
    Reading the law as requiring substantiation concurrent with the CBI 
claim also comports with the legislative history. In addition to the 
history cited earlier in this document, the Senate Report, on p. 5, 
noted stakeholder concerns that, under pre-amendment TSCA, the lack of 
a requirement for up-front substantiation resulted in ``an over-
abundance of CBI claims, some of which may not be legitimate.'' 
Interpreting TSCA section 14(c)(3) as requiring substantiation of a CBI 
claim concurrent with the claim's submission best effectuates the 
expressed intent of Congress.
    This interpretation is consistent with the requirement in TSCA 
section 14(g)(1) that EPA review most confidentiality claims for 
chemical identity and at least 25% of claims for other types of non-
exempt information within 90 days after the receipt of the claim. An 
approach under which substantiations were submitted at some point after 
assertion of CBI claims would significantly reduce (and has already 
significantly reduced) the short period for such CBI reviews. To date, 
for each review, the Agency must contact each affected business, 
request the submission of a substantiation, and allow a period of time 
for the affected business to submit the substantiation. Since timely 
substantiation provides critical information for completing CBI 
reviews, it is reasonable to conclude that Congress intended for claims 
to be substantiated at the time the CBI claim is asserted.
    When the amendments to TSCA became law on June 22, 2016, EPA 
published initial Questions and Answers (Q and A's) in an effort to 
respond to the inquiries and requests concerning EPA's views on the new 
law. EPA needed to issue guidance to the public as quickly as possible 
on a broad range of matters under the amendments, since the amendments 
became effective

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upon signature. In the Q and A's on TSCA section 14, EPA stated that 
the Agency was using existing authorities to obtain CBI substantiations 
and that the Agency may revise CBI substantiation requirements for 
specific types of information submissions by subsequent rulemaking. 
Since the time the Q and A's were developed, EPA has heard the views of 
a number of stakeholders and has had the opportunity to more fully 
review the statute and legislative history and to evaluate the 
operational considerations associated with the interpretation of TSCA 
section 14(c)(3).
    Operationally, given the large volume of CBI claims, including 
those that the Agency has already received and those that the Agency 
expects to receive in the future, it is administratively efficient to 
interpret the statute as requiring up-front substantiation, which 
necessarily saves the Agency the time and resources that would 
otherwise be spent in attempting to contact the affected business. Up-
front substantiation will also significantly enhance EPA's ability to 
meet the review deadlines in TSCA section 14(g). Further, requiring 
substantiation concurrent with submission will mitigate any need for an 
affected business to request an extension to substantiate a CBI claim. 
Additionally, requiring the affected business to provide justification 
at the time of submission may help limit unwarranted claims of CBI. 
Based on this further review, for the reasons stated above, EPA has 
concluded that the provision is best read as creating a requirement to 
substantiate non-exempt TSCA CBI claims concurrent with their 
submission.

IV. Implementation

    Existing EPA confidentiality rules at 40 CFR part 2, section 
2.204(e), provide substantiation questions that the Agency may 
specifically request answers to, pursuant to the procedures in those 
regulations. While those specific questions are not dictated by the 
self-executing substantiation requirement in TSCA section 14(c)(3), EPA 
suggests that companies look to those questions for guidance as to how 
to fulfill the TSCA section 14(c)(3) substantiation requirement for 
information that is not currently subject to an existing regulatory up-
front substantiation requirement. The answers to those questions 
typically form the basis of EPA final confidentiality determinations, 
and substantiations that do not address those questions might not 
provide sufficient information to uphold a determination, pursuant to 
TSCA section 14(g)(1), that information claimed as CBI is eligible for 
confidential protection. For information that is currently subject to a 
regulatory up-front substantiation requirement (for example, chemical 
identity CBI claims in the Chemical Data Reporting rule, under 40 CFR 
711.30), the terms of that requirement, including the substantiation 
questions required, will continue to govern the substantiation.
    EPA has revised its Web pages on CBI to assist compliance with this 
interpretation of TSCA section 14. The Web pages list the 
substantiation questions from 40 CFR 2.204(e) and provide information 
on substantiation exemptions and on how the substantiations should be 
directed to the Agency.
    Because EPA is providing this interpretation of TSCA section 
14(c)(3) for the first time in this document, the Agency is setting 
different procedures for those who have submitted or will submit 
information claimed as CBI under TSCA before the effective date of this 
action, i.e., March 20, 2017, and those who submit information claimed 
as CBI afterwards.

A. TSCA Submissions Filed on or After March 20, 2017

    Those submissions containing information claimed as CBI filed on or 
after the effective-date of this action (i.e., March 20, 2017) must 
provide a substantiation for all information claimed as confidential, 
other than information exempt from substantiation pursuant to TSCA 
section 14(c)(2). Any non-exempt CBI claim that is submitted without a 
substantiation will be considered deficient, and EPA will send a notice 
of deficiency to the affected business. The notice will inform the 
affected business that it must submit its substantiation within 30 
calendar days in order to remedy its deficient CBI claim. The notice 
letter will also inform the affected business that if a timely 
substantiation has not been received by EPA within 30 days of receipt 
of the letter, then any CBI claims not substantiated will be considered 
withdrawn, and the information may be made public with no further 
notice to the affected business.

B. TSCA Submissions Filed Between June 22, 2016 and March 20, 2017

    Those submissions containing information claimed as CBI filed 
between June 22, 2016 and March 20, 2017, must provide a substantiation 
for all information claimed as confidential, other than information 
exempt from substantiation pursuant to TSCA section 14(c)(2). The 
Agency is giving submitters until September 18, 2017 to provide 
substantiations and direct them to the Agency. If a substantiation has 
already been provided to EPA with the submission or in response to a 
substantiation request, no additional substantiation need be filed for 
the same information. Be aware, however, that if some non-exempt 
information claimed as confidential in a particular submission has 
already been substantiated and some has not, the unsubstantiated 
information claimed as CBI in the submission must still be 
substantiated by September 18, 2017. The CBI claims, and the 
substantiations, may then be reviewed consistent with the provisions of 
TSCA, its implementing regulations and in accordance with the Agency 
procedures set forth in 40 CFR part 2. Once September 18, 2017 has 
passed, if no substantiation has been received for a claim, then EPA 
will provide the affected business 30 days' notice and a final 
opportunity to substantiate. The notice will inform the affected 
business that any CBI claims not substantiated at the end of the 30 
days will be considered withdrawn, and the information may be made 
public with no further notice to the affected business.
    EPA's electronic reporting systems for TSCA submissions have been 
modified to require substantiations for non-exempt CBI claims in 
submissions filed on or after March 20, 2017. Any new paper TSCA 
submissions that are directed to the Agency after that date must 
include substantiations for all non-exempt CBI claims at the time of 
submission.
    For electronic submissions made using EPA's Central Data Exchange 
(CDX) during the period from June 22, 2016 to March 20, 2017 that were 
not substantiated, affected businesses must provide substantiation for 
CBI claims using the amendment processes for the particular submission 
type. Information on electronic reporting, including how to make 
amendments, can be found at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reporting-requirements-certain-information.
    For any paper TSCA submissions that were submitted to the Agency 
during the period from June 22, 2016 to March 20, 2017, the affected 
business must submit substantiations for any non-exempt CBI claims that 
have not yet been substantiated. Submit these substantiations to: TSCA 
Confidential Business Information Center (7407M), WJC East; Room 6428; 
Attn: TSCA CBI Substantiations. U.S. Environmental Protection Agency, 
1200 Pennsylvania Avenue NW., Washington, DC 20460-0001.

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    Courier Deliveries should be directed to:
    U.S. EPA, Office of Pollution Prevention and Toxics, Confidential 
Business Information Center (CBIC), Attn: TSCA CBI Substantiations. 
1201 Constitution Avenue NW., WJC East; Room 6428 Washington, DC 20004-
3302, (202) 564-8930.
    More information on how to substantiate CBI claims for paper 
submissions can be found at https://www.epa.gov/tsca-cbi/.

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

    Dated: January 13, 2017.
James J. Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2017-01235 Filed 1-18-17; 8:45 am]
 BILLING CODE 6560-50-P


