Document ID: EPA-HQ-OPPT-2018-0320-0034
Agency: epa
Document Type: Proposed Rule
Title: Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory: Revisions to the CBI Substantiation Requirements
Posted Date: 2019-11-08T05:00Z

[Federal Register Volume 84, Number 217 (Friday, November 8, 2019)]
[Proposed Rules]
[Pages 60363-60370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23714]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 710

[EPA-HQ-OPPT-2018-0320; FRL-10001-44]
RIN 2070-AK21

Procedures for Review of CBI Claims for the Identity of Chemicals 
on the TSCA Inventory; Revisions to the CBI Substantiation Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: In response to a recent federal circuit court decision, EPA is 
proposing revisions to existing and proposed substantiation 
requirements for certain confidential business information (CBI) claims 
made under the Toxic Substances Control Act (TSCA). Specifically, EPA 
is proposing two additional questions that manufacturers and processors 
would be required to answer to substantiate certain CBI claims for 
specific chemical identities; and is proposing procedures for 
manufacturers and processors to use in amending certain previously-
submitted substantiations to include responses to the additional 
questions. These proposed revisions supplement the proposed rule issued 
in the Federal Register of April 23, 2019, and would amend the TSCA 
Inventory Notification (Active-Inactive) Requirements rule promulgated 
in the Federal Register of August 11, 2017.

DATES: Comments must be received on or before December 9, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0320, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket,

[[Page 60364]]

along with more information about dockets generally, is available at 
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Scott M. Sherlock, Environmental 
Assistance Division (Mail code 7408M), 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.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you reported a confidential 
chemical substance under the TSCA Inventory Notification (Active-
Inactive) Requirements rule (hereinafter ``Active-Inactive Rule'') 
(Ref. 1) (40 CFR part 710, subpart B) through a Notice of Activity 
(NOA) Form A (Ref. 2) or NOA Form B (Ref. 3) and sought to maintain an 
existing CBI claim for a specific chemical identity. You may also be 
affected by this action if you anticipate reporting a confidential 
chemical substance under the Active-Inactive Rule through an NOA Form B 
in the future, and anticipate seeking to maintain an existing CBI claim 
for a specific chemical identity at that time. The following North 
American Industrial Classification System (NAICS) codes are not 
intended to be exhaustive, but rather provides a guide to help readers 
determine whether this action may apply to them:
     Chemical manufacturing or processing (NAICS code 325).
     Petroleum and Coal Products Manufacturing (NAICS code 
324).
    ``Manufacture'' is defined by TSCA section 3(9) (15 U.S.C. 2602(9)) 
and 40 CFR 710.3(d) to include ``import.'' Accordingly, all references 
to manufacturers in this document should be understood to include 
importers.
    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. What is the Agency's authority for taking this action?

    EPA is proposing this rule pursuant to the authority in TSCA 
section 8(b), 15 U.S.C. 2607(b). See also Units I.B and II.B in EPA's 
proposed rule entitled ``Procedures for Review of CBI Claims for the 
Identity of Chemicals on the TSCA Inventory,'' issued in the Federal 
Register of April 23, 2019 (hereinafter ``2019 Proposed Rule'') (Ref. 
4), which proposed provisions to be codified in 40 CFR 710, subpart C.

C. What action is the Agency taking?

    EPA is supplementing the 2019 Proposed Rule (Ref. 4), which 
proposed to use the same CBI substantiation questions that were 
promulgated in the Active-Inactive Rule (Ref. 1) and codified in 40 CFR 
710, subpart B. EPA is now proposing to revise the substantiation 
questions promulgated in the Active-Inactive Rule. See the discussions 
in Unit II.
    As discussed in more detail in Unit III., this supplemental 
proposed rule presents two additional questions that EPA is proposing 
manufacturers and processors would be required to answer to 
substantiate CBI claims for specific chemical identities asserted in an 
NOA Form A or B. To ensure that EPA receives sufficient information to 
review and approve or deny all specific chemical identity CBI claims 
asserted in an NOA Form A or B, EPA is also proposing procedures for 
manufacturers and processors to use in supplementing previously-
submitted substantiations to include responses to the additional 
questions.

D. Why is the Agency taking this action?

    In response to the federal circuit court decision that is discussed 
in more detail in Unit II.C., EPA is reconsidering the inclusion of 
substantiation questions directly related to a chemical identity's 
susceptibility to reverse engineering. Because the 2019 Proposed Rule 
specifically references the substantiation questions promulgated in the 
Active-Inactive Rule that were subsequently subject to the federal 
court decision, EPA believes it is most efficient and straightforward 
to address the substantiation questions for both rules in this 
supplemental proposed rule. This will allow stakeholders to submit a 
single set of comments pertaining to EPA's inclusion of substantiation 
questions regarding reverse engineering in light of the federal court's 
decision and supports EPA's efforts to maintain consistency in the 
manner by which these two closely related rules address the issue. EPA 
intends to consider comments received and finalize amendments to the 
existing substantiation questions in 40 CFR 710, subpart B as part of 
the final rule promulgating 40 CFR 710, subpart C.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of adding two additional 
questions related to substantiation of CBI claims for specific chemical 
identity to the 2019 Proposed Rule and the previous Active-Inactive 
Rule. A memorandum outlining the estimated costs, entitled ``Burden and 
Cost Estimates for the Supplemental Notice of Proposed Rulemaking: 
Procedures for Review of CBI Claims for the Identity of Chemicals on 
the TSCA Inventory'' (Ref. 5), has been prepared for this supplemental 
proposed rule, is available in the docket, and is briefly summarized 
here. The incremental change to requirements involves the reporting 
activity of addressing two additional CBI substantiation questions, 
which is an activity similar to those already included in the Active-
Inactive Rule and in the 2019 Proposed Rule.
    1. Procedures for Review of CBI Claims for the Identity of 
Chemicals on the TSCA Inventory (proposed subpart C of 40 CFR part 710, 
as proposed to be amended by this supplemental proposed rule). As 
explained in Unit I.E of the 2019 Proposed Rule, companies potentially 
affected by the 2019 Proposed Rule fall into three groups of reporters 
who made a CBI claim for a specific chemical identity in their NOA Form 
A. Group (1) consists of those reporters who already voluntarily 
submitted substantiation as part of the NOA Form A submission process 
and who will now need to supplement their substantiations. Group (2) 
consists of those reporters who would be eligible to reference some 
other previous substantiation made to EPA within the last five years, 
exempting them from the requirement to submit new substantiation. Group 
(3) consists of those reporters who would be required to submit a full 
substantiation as they did not previously substantiate the claim, 
either as part of the NOA Form A voluntary substantiation process, or 
as part of some other submission within the last five years. Under this 
supplemental proposed rule, Groups (1) and (3) would be required to 
submit responses to the two proposed additional substantiation 
questions. There would be no additional requirements for Group (2).
    2. Active-Inactive Rule (subpart B of 40 CFR part 710, as proposed 
to be amended by this supplemental proposed rule). Under the 
requirements of the Active-Inactive Rule, as proposed to be amended by 
this supplemental proposed rule, all reporters who assert a CBI claim 
for specific chemical

[[Page 60365]]

identity in their NOA Form B would be required to address the two 
proposed additional substantiation questions. As detailed in the 
Active-Inactive rule at 40 CFR 710.25(c) and 710.27, reporters 
submitting an NOA Form B are those who intend to manufacture or process 
for nonexempt purposes a chemical substance designated as inactive on 
the TSCA Inventory. Note that Form B reporting is ongoing, compared to 
the one-time reporting associated with Form A.
    3. Total estimated incremental impacts. Table 1 summarizes the 
incremental impacts of the supplemental proposed rule for each group 
according to Form/rule/ICR. The incremental increase in unit burden for 
the two additional substantiation questions is estimated at 0.19 hours 
per affected chemical-specific submission. Total incremental burden for 
one-time reporting on NOA Form A is 1,123 hours with associated cost of 
approximately $87,000 per year; total incremental burden for reporting 
on NOA Form B is 0.4 hours per year with associated cost at about $29 
per year.

                           Table 1--Incremental Impacts of Supplemental Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                                     Responses
                                                                    (chemical-
          Rule/form                Frequency        Respondents      specific     Burden (hours)   Cost (2018$)
                                                                   submissions)
----------------------------------------------------------------------------------------------------------------
             Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory
----------------------------------------------------------------------------------------------------------------
Form A Group (1)--            One-time..........             149           3,137             595         $46,090
 Submissions Supplementing
 Voluntary Upfront CBI
 Substantiation.
Form A Group (2)--            One-time..........              23              98               0               0
 Submissions with CBI
 Substantiation Using
 Reference.
Form A Group (3)--            One-time..........             103           2,751             528          40,964
 Submissions with Full CBI
 Substantiation.
                             -----------------------------------------------------------------------------------
    Total, Form A...........  ..................             275  ..............           1,123          87,054
----------------------------------------------------------------------------------------------------------------
                                              Active-Inactive Rule
----------------------------------------------------------------------------------------------------------------
Form B--Submissions with      Annual............               1               2             0.4              29
 Full CBI Substantiation.
----------------------------------------------------------------------------------------------------------------

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI in a CD-ROM or other 
electronic media that you mail to EPA, mark the outside of the media as 
CBI and then identify electronically within the media the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2, subpart B.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.

II. Background

A. What is the Active-Inactive Rule?

    TSCA section 8(b) requires EPA to designate chemical substances on 
the TSCA Chemical Substance Inventory as either ``active'' or 
``inactive'' in U.S. commerce. To accomplish that, the 2017 Active-
Inactive Rule (Ref. 1), codified in 40 CFR part 710, subpart B, 
established a retrospective electronic notification of chemical 
substances on the TSCA Inventory that were manufactured (including 
imported) for nonexempt commercial purposes during the 10-year time 
period ending on June 21, 2016, with provision to also allow 
notification by processors. EPA used these notifications--filed on an 
NOA Form A--to distinguish active substances from inactive substances, 
and now includes the active and inactive designations on the TSCA 
Inventory. The Active-Inactive Rule also established procedures for 
forward-looking electronic notification of chemical substances on the 
TSCA Inventory that are designated as inactive, if and when the 
manufacturing or processing of such chemical substances for nonexempt 
commercial purposes is expected to resume. On receiving forward-looking 
notification, which is filed on an NOA Form B, EPA will change the 
designation of the pertinent chemical substance on the TSCA Inventory 
from inactive to active. The one-time submission period for NOA Form A 
ended on October 5, 2018, while the NOA Form B will be submitted on an 
ongoing basis.
    Consistent with TSCA sections 8(b)(4)(B)(ii) and (5)(B)(ii), the 
Active-Inactive Rule provided that manufacturers and processors filing 
an NOA Form A or B could seek to maintain an existing claim for 
protection against disclosure of the specific chemical identity of a 
chemical substance as confidential by including such a request on their 
NOA Form A or B. Through this process established in 40 CFR 710.37(a), 
manufacturers and processors secured an opportunity to maintain the CBI 
status of a specific chemical identity on the confidential portion of 
the TSCA Inventory. The Active-Inactive Rule required NOA Form B 
submitters to substantiate these CBI claims not later than 30 days 
after submitting their NOA Form B by answering substantiation questions 
set forth in the Rule and codified at 40 CFR 710.37(c). The Rule also 
permitted NOA Form A submitters to voluntarily substantiate their CBI 
claims for specific chemical identities at the time of filing their NOA 
Form A by answering the same substantiation questions. The Active-
Inactive Rule did not require NOA Form A submitters to substantiate 
these CBI claims because TSCA section 8(b)(4)(C) directed EPA to 
promulgate another rule addressing the substantiation and review of 
those claims.

B. What is the 2019 Proposed Rule?

    On April 23, 2019, EPA proposed to establish a plan to review all 
CBI claims for specific chemical identities asserted in an NOA Form A, 
including the procedures for substantiating and

[[Page 60366]]

reviewing those claims (Ref. 4). The 2019 Proposed Rule was presented 
as a follow-on rulemaking to the 2017 Active-Inactive Rule. See 
detailed background in Unit II. of the 2019 Proposed Rule (Ref. 4). As 
such, it specifically referenced the substantiation questions for 
specific chemical identity CBI claims that had been promulgated in the 
Active-Inactive Rule and codified at 40 CFR 710.37(c), i.e., proposing 
to require manufacturers and processors who had submitted an NOA Form A 
requesting to maintain an existing CBI claim for a specific chemical 
identity to substantiate that CBI claim by submitting answers to the 
substantiation questions in 40 CFR 710.37(c). Manufacturers and 
processors who had already submitted answers to those substantiation 
questions pursuant to the voluntary process established in the Active-
Inactive Rule would have been exempt from any further substantiation 
requirements under the 2019 Proposed Rule. Manufacturers and processors 
who had provided substantiations for specific chemical identity CBI 
claims in another submission made to EPA less than five years before 
the substantiation deadline that would be set in the final rule, would 
also have been exempt from further substantiation requirements under 
the 2019 Proposed Rule, provided that they reported to EPA certain 
identifying information about the previously submitted substantiation 
(submission date; submission type; and case number, transaction ID, or 
equivalent identifier that would uniquely identify the previous 
submission that contained the substantiation).

C. What is the Federal Circuit Court decision?

    On April 26, 2019, the U.S. Court of Appeals for the District of 
Columbia Circuit entered a judgment in Environmental Defense Fund v. 
EPA, 922 F.3d 446 (D.C. Cir. 2019), granting in part and denying in 
part a petition for review of the Active-Inactive Rule. The court 
ordered a limited remand of the Active-Inactive Rule, without vacatur, 
for EPA ``to address its arbitrary elimination of substantiation 
questions regarding reverse engineering.'' 922 F.3d at 459. Citing the 
statutory requirements at TSCA section 14(c)(1)(B)(iv) and (c)(3) that 
a person asserting a CBI claim must include a statement that the person 
has ``a reasonable basis to believe that the information is not readily 
discoverable through reverse engineering,'' and must ``substantiate the 
claim,'' the court found that EPA's ``omission of any inquiry into a 
chemical identity's susceptibility to reverse engineering effectively 
excised a statutorily required criterion from the substantiation 
process.'' Id. at 454. Because the Active-Inactive Rule did not explain 
the gap in substantiation or acknowledge the consequence of the 
omission, the court found the Active-Inactive Rule to be arbitrary and 
capricious to the extent that it omitted any substantiation requirement 
pertaining to reverse engineering. Id. The court remanded the Active-
Inactive Rule to EPA without vacatur, leaving all provisions of the 
Active-Inactive Rule in effect while EPA conducts further proceedings 
on remand. A copy of the court's opinion is available in the docket for 
this action.

III. Summary of Proposed Revisions

    In response to the court's remand and discussed in detail in this 
unit, EPA is proposing to amend 40 CFR 710.37(c) to include two 
additional substantiation questions related to a specific chemical 
identity's susceptibility to reverse engineering. These substantiation 
questions would apply to manufacturers and processors who request(ed) 
to maintain a CBI claim for a specific chemical identity in either an 
NOA Form A or an NOA Form B. EPA is also proposing to require any 
manufacturer or processor who has already submitted answers to the 
substantiation questions currently listed in the Active-Inactive Rule 
at 40 CFR 710.37(c) to supplement their submission by adding answers to 
the newly proposed questions relating to reverse engineering. Finally, 
EPA is proposing to revise the proposed substantiation exemption for 
NOA Form A submitters who have previously submitted a substantiation 
outside of the Active-Inactive Rule process, to clarify that this 
proposed exemption would apply only where the previously submitted 
substantiation is responsive to all substantiation questions in 40 CFR 
710.37(c) as amended by the final rule to the 2019 Proposed Rule.

A. What additional substantiation questions is EPA proposing?

    To solicit additional information about a specific chemical 
identity's susceptibility to reverse engineering, EPA is proposing to 
add the following two questions to 40 CFR 710.37(c)(2):
    1. Does this particular chemical substance leave the site of 
manufacture or processing in any form, e.g., as product, effluent, 
emission? If so, what measures have been taken to guard against the 
discovery of its identity?
    2. If the chemical substance leaves the site in a product that is 
available to the public or your competitors, can the chemical substance 
be identified by analysis of the product?
    These two questions are intended to assist EPA in gathering the 
information it uses to evaluate confidentiality claims. They are 
modeled after substantiation questions that appear in EPA's existing 
regulations governing CBI claims for specific chemical identities that 
are asserted in Notices of Commencement (NOCs) (40 CFR 
720.85(b)(3)(iv)(H)-(I)) and Chemical Data Reporting (CDR) submissions 
(40 CFR 711.30(b)(1)(viii)-(ix)). EPA proposed nearly identical 
questions in the January 13, 2017 Active-Inactive proposed rule (Ref. 
9) and in the April 25, 2019 CDR revisions proposed rule (Ref. 10). The 
first question has been modified from the version that appeared in the 
earlier proposed and existing rules to add ``or processing,'' to the 
first sentence, in recognition of the fact that unlike NOCs and CDR 
submissions, which are only filed by manufacturers, NOA forms may be 
filed (and hence CBI claims may be asserted and substantiated) by both 
manufacturers and processors. The second question is unchanged from the 
version that appeared in the Active-Inactive proposed rule and in the 
existing and proposed CDR rules. (Both questions are phrased slightly 
differently in the NOC regulation than in the other existing and 
proposed regulations.)
    As indicated previously, EPA's 2019 Proposed Rule, ``Procedures for 
Review of CBI Claims for the Identity of Chemicals on the TSCA 
Inventory,'' cross-referenced the substantiation questions for chemical 
identity CBI claims at 40 CFR 710.37(c). Under this supplemental 
proposed rule that cross-reference would remain unchanged, because it 
would include the two additional substantiation questions that EPA 
proposes to add to 40 CFR 710.37(c).
    The proposed substantiation questions are intended to solicit 
information that is known to or reasonably ascertainable by the 
respondent (the manufacturer or processor making the CBI claim). 
``Known to or reasonably ascertainable by'' is defined in 40 CFR 710.23 
to mean ``all information in a person's possession or control, plus all 
information that a reasonable person similarly situated might be 
expected to possess, control, or know.'' EPA intends that the inquiry 
into whether a chemical substance can be identified by analysis of the 
product would be answered based on information that is known to or 
reasonably ascertainable by the respondent, about reasonably available 
analytical capabilities currently in use

[[Page 60367]]

by the chemical industry. EPA does not intend to require respondents to 
initiate a special research program to answer the inquiry, or to 
speculate about hypothetical analytical capabilities.

B. Who would have to answer these substantiation questions?

    The additional substantiation questions in this supplemental 
proposed rule would apply to manufacturers and processors who requested 
to maintain a CBI claim for a specific chemical identity in either of 
two commercial activity notices submitted to EPA pursuant to the 
Active-Inactive Rule (40 CFR part 710, subpart B): An NOA Form A 
(retrospective commercial activity reporting) or an NOA Form B 
(forward-looking commercial activity reporting). The additional 
substantiation questions would also apply to manufacturers and 
processors who submit an NOA Form B in the future that requests to 
maintain a CBI claim for a specific chemical identity.

C. When would the additional substantiation be required?

    Manufacturers and processors who have not yet submitted any 
substantiation to EPA would be required to submit answers to the two 
newly proposed substantiation questions at the same time as they submit 
the rest of their required substantiation. The substantiation deadline 
for those entities would depend on whether the chemical identity CBI 
claim was asserted in an NOA Form A or B. For persons substantiating a 
chemical identity CBI claim asserted in an NOA Form A, if finalized as 
proposed, EPA's 2019 Proposed Rule would require that all 
substantiations be filed not later than 90 days after the effective 
date of the final rule. EPA is not altering or otherwise revisiting 
that proposed requirement in this supplemental proposed rule. For 
persons substantiating a chemical identity CBI claim asserted in an NOA 
Form B, the Active-Inactive Rule requires that all substantiations be 
submitted within 30 days of submitting the NOA Form B. See 40 CFR 
710.37(a)(2). That provision is currently in effect, and EPA is not 
proposing to amend or otherwise revisit that requirement in this 
supplemental proposed rule.
    Manufacturers and processors who have already voluntarily submitted 
substantiation to EPA with an NOA Form A, or who will have submitted 
substantiation for a chemical identity CBI claim asserted in an NOA 
Form B before the revisions to 40 CFR 710.37(c) are finalized and go 
into effect, would be required to supplement their earlier submission 
with answers to the two new substantiation questions. For persons 
substantiating a chemical identity CBI claim asserted in an NOA Form A, 
EPA is proposing to require submission of the supplemental 
substantiation by not later than 90 days after the effective date of 
the final rule, consistent with the other substantiation deadlines in 
the 2019 Proposed Rule. For persons substantiating a chemical identity 
CBI claim asserted in an NOA Form B, EPA is proposing to require 
submission of the supplemental substantiation by not later than 30 days 
after the effective date of the final rule. The 30-day deadline would 
facilitate EPA's ability to meet the statutory requirement to 
``promptly'' review chemical identity CBI claims asserted in an NOA 
Form B, see TSCA 8(b)(5)(B)(iii)(II), and would be consistent with the 
existing 30-day deadline for substantiation of such claims pursuant to 
40 CFR 710.37(a)(2).

D. Would this impact the proposed exemption for other previously 
submitted substantiations?

    In the 2019 Proposed Rule, EPA recognized that some persons may 
have recently substantiated their specific chemical identity CBI claims 
in other submissions to the Agency outside of the voluntary 
substantiation process for NOA Form A that was set forth in the Active-
Inactive Rule. EPA proposed to exempt those persons from the 
substantiation requirement in the 2019 Proposed Rule so long as the 
previous substantiation was submitted less than five years before the 
substantiation deadline that will be set in the final rule, and the 
person reports to EPA certain identifying information for the previous 
substantiation (i.e., submission date and type, and case number, 
transaction ID, or equivalent identifier).
    In this supplemental proposed rule, EPA is also revising the 
proposed exemption in the 2019 Proposed Rule to clarify that a 
previously submitted substantiation must contain information that is 
responsive to all substantiation questions in the final rule to relieve 
the submitter of the requirement to submit a new substantiation. In 
other words, to serve as a substitute for a new substantiation, EPA is 
proposing to require that a previously submitted substantiation must 
provide information that is substantively equivalent to that sought in 
the substantiation questions that are ultimately finalized. 
Substantiations of specific chemical identity CBI claims that were 
submitted with CDR submissions in accordance with the substantiation 
procedures at 40 CFR 711.30(b)(1), or with NOCs in accordance with the 
substantiation procedures at 40 CFR 720.85(b)(3)(iv), would be deemed 
by EPA as responsive to all substantiation questions in the amended 40 
CFR 710.37(c), and could therefore serve as a basis for the proposed 
exemption. EPA expects that the vast majority of recent substantiations 
for specific chemical identity CBI claims submitted outside of the 
voluntary Active-Inactive Rule process would have been submitted 
pursuant to one of those two regulatory substantiation provisions. 
Substantiations that were not submitted pursuant to one of those two 
regulatory provisions (for example, substantiations for CBI claims 
asserted in submissions under TSCA section 8(e)) may also be responsive 
to all substantiation questions in the amended 40 CFR 710.37(c), but 
would need to be evaluated on a case-by-case basis.

E. How would EPA review CBI claims for specific chemical identity?

    In the 2019 Proposed Rule, EPA explained that when reviewing CBI 
claims, EPA would apply the substantive criteria for confidentiality 
determinations set forth in 40 CFR 2.306(g) and 2.208. See Ref. 4 at 
16830. The Active-Inactive Rule likewise incorporated these substantive 
criteria for confidentiality determinations. See 40 CFR 710.37(a) 
(referencing the 40 CFR part 2, subpart B procedures for treatment and 
disclosure of information claimed as confidential). EPA is not 
proposing to change either the 2019 Proposed Rule or the Active-
Inactive Rule (40 CFR 710.37(a)) in this regard. EPA interprets the 
substantive criteria described in 40 CFR 2.208 and cross-referenced in 
40 CFR 2.306(g) to already encompass consideration of a specific 
chemical identity's susceptibility to reverse engineering.
    Specifically, 40 CFR 2.208(c) provides that one of the required 
criteria for approval of a confidentiality claim is that ``[t]he 
information is not, and has not been, reasonably obtainable without the 
business's consent by other persons (other than governmental bodies) by 
use of legitimate means (other than discovery based on a showing of 
special need in a judicial or quasi-judicial proceeding).'' If a 
specific chemical identity is readily discoverable through reverse 
engineering, then that chemical identity is reasonably obtainable 
without the business's consent by other persons by use of legitimate 
means, and the specific chemical identity would not be entitled to 
confidential treatment.
    EPA notes that on June 24, 2019, the U.S. Supreme Court issued a 
decision

[[Page 60368]]

addressing the test for determining whether commercial information 
qualifies as ``confidential'' for purposes of Exemption 4 of the 
Freedom of Information Act (FOIA), 5 U.S.C. 552(b)(4). See Food 
Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356 (2019). The 
Court found that, ``[a]t least where commercial or financial 
information is both customarily and actually treated as private by its 
owner and provided to the government under an assurance of privacy, the 
information is `confidential' within the meaning of Exemption 4.'' 139 
S. Ct. at 2366. The Court rejected the ``substantial competitive harm'' 
test that had long been applied by many courts of appeals, under which 
certain commercial information could not be deemed ``confidential'' 
unless disclosure was likely to cause substantial harm to the 
competitive position of the person from whom the information was 
obtained. Id. at 2361, 2364-66. A copy of the Court's opinion is 
available in the docket for this action.
    Because TSCA section 14(a) incorporates FOIA Exemption 4 as the 
basic framework for determining whether information is eligible for 
protection from disclosure under TSCA, the substantive criteria for 
TSCA confidentiality determinations include the ``substantial 
competitive harm'' test that courts of appeals had formerly applied 
under FOIA Exemption 4. See 15 U.S.C. 2613(a), 40 CFR 2.306(g), and 40 
CFR 2.208(e)(1). In light of the recent Court decision, EPA is 
considering whether revisions are warranted to EPA's substantive review 
criteria for CBI claims not submitted under TSCA. However, EPA is not 
proposing to remove the ``substantial competitive harm'' review 
criterion or any related substantiation question for the TSCA CBI 
claims addressed in this rulemaking, because Congress amended TSCA 
section 14 in 2016 to specifically require any person asserting a CBI 
claim under TSCA to include a certified statement that the person has 
``a reasonable basis to conclude that disclosure of the information is 
likely to cause substantial harm to the competitive position of the 
person.'' TSCA section 14(c)(1)(B)(iii), (c)(5); see also TSCA section 
14(c)(1)(C)(ii)(II) (referencing substantial competitive harm).

IV. Request for Comments

    EPA is seeking public comment on all aspects of this supplemental 
proposed rule, including the proposed two additional substantiation 
questions, the proposed revisions to the proposed exemptions from 
substantiation requirements, the proposed procedures for supplementing 
previously-submitted substantiations, and whether EPA has appropriately 
addressed the federal circuit court decision. EPA is seeking comment 
only on the issues discussed in this supplemental proposed rule and is 
not reopening comment on any other aspects of the 2019 Proposed Rule or 
the Active-Inactive Rule. Public comments on the 2019 Proposed Rule 
that were submitted to the docket by the end of the comment period for 
that proposed rule (i.e., June 24, 2019) will be considered by EPA and 
addressed in the final rule.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these references and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical contact listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. TSCA Inventory Notification (Active-Inactive) Requirements; 
Final Rule. Federal Register, 82 FR 37520, August. 11, 2017 (FRL-
9964-22).
2. EPA. Notice of Activity Form A; Final, 2017.
3. EPA. Notice of Activity Form B; Final, 2017.
4. EPA. Procedures for Review of CBI Claims for the Identity of 
Chemicals on the TSCA Inventory; Proposed Rule. Federal Register, 84 
FR 16826, April 23, 2019 (FRL-9992-05).
5. EPA. Memorandum from Laura Nielsen to Scott Sherlock, Burden and 
Cost Estimates for the Supplemental Notice of Proposed Rulemaking: 
Procedures for Review of CBI Claims for the Identity of Chemicals on 
the TSCA Inventory (Docket #EPA-HQ-OPPT-2018-0320), 2019.
6. EPA. ICR No. 2594.01 Information Collection Request Proposed 
Addendum to TSCA Review Plan CBI Substantiation Supporting Statement 
for a Request for OMB Review under the Paperwork Reduction Act. 
2019.
7. EPA. ICR No. 2565.03 Information Collection Request Proposed 
Addendum to TSCA Section 8(b) Reporting Requirements for TSCA 
Inventory Supporting Statement for a Request for OMB Review under 
the Paperwork Reduction Act. 2019.
8. EPA. Economic Analysis for the Proposed Rule: Procedures for 
Review of CBI Claims for the Identity of Chemicals on the TSCA 
Inventory, 2019.
9. TSCA Inventory Notification (Active-Inactive) Requirements; 
Proposed Rule. Federal Register, 82 FR 4255, January 13, 2017 (FRL-
9956-28).
10. TSCA Chemical Data Reporting Revisions and Small Manufacturer 
Definition Update for Reporting and Recordkeeping Requirements Under 
TSCA Section 8(a); Proposed Rule. Federal Register, 84 FR 17692, 
April 25, 2019 (FRL-9982-16).
11. EPA. Small Entity Analysis Report for the Final Rule: TSCA 
Inventory Notification Requirements, 2017.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review under Executive 
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, 
January 21, 2011). Any changes made in response to OMB recommendations 
have been documented in the docket for this action as required by 
section 6(a)(3)(E) of Executive Order 12866.

B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is expected to be subject to the requirements for 
regulatory actions specified in Executive Order 13771 (82 FR 9339, 
February 3, 2017). EPA prepared an analysis of the estimated costs and 
benefits associated with this action (Ref. 5), which is available in 
the docket and is summarized in Unit I.E.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this supplemental proposed 
rule have been submitted for approval to OMB under the PRA, 44 U.S.C. 
3501 et seq. EPA prepared a supplement to the Information Collection 
Request (ICR) document that was submitted for the 2019 Proposed Rule, 
which has been assigned EPA ICR No. 2594.02 and OMB Control No. 2070-
[New] (Ref. 6). The information collection activities contained in the 
Active-Inactive Rule are approved by OMB under EPA ICR No. 2565.01 and 
OMB Control No. 2070-0201 (Ref. 7). You can find a copy of the ICRs in 
the docket for this rule, and the incremental paperwork burden is 
briefly summarized here.
    The incremental reporting requirements identified in this 
supplemental proposed rule involve the addition of two substantiation 
questions that would provide EPA with

[[Page 60369]]

information necessary to evaluate confidentiality claims and determine 
whether the claims qualify for protection from disclosure. Since the 
incremental burden impacts both ICRs, the summary is presented in Table 
2.

             Table 2--Incremental Paperwork Burden Estimates
------------------------------------------------------------------------
 
------------------------------------------------------------------------
EPA ICR No..................  2565.01.............  2594.02.
OMB Control No..............  2070-0201...........  2070-[new].
Rulemaking..................  Active-Inactive Rule  2019 Proposed Rule.
ICR Activities..............  Ongoing annual        One-time burden/
                               burden/cost           cost.
                               (forward looking).
Respondents/affected          Persons who           Persons who
 entities.                     manufacture or        manufacture or
                               process chemical      process chemical
                               substances and        substances and
                               submit a Form B       submit a Form A
                               with chemical         with chemical
                               identity              identity
                               substantiation        substantiation
                               requirements.         requirements.
Respondent's obligation to    Mandatory...........  Mandatory.
 respond.
Frequency of response.......  On-occasion.........  Once per chemical.
Estimated total number of     1...................  275.
 respondents.
Estimated burden per          0.4 hours per year..  4 hours.
 respondents.
Estimated total burden......  0.4 hours...........  1,123 hours (one
                                                     time).
Estimated costs per           $29.................  $317.
 respondent.
Estimated total costs.......  $29 per year........  $87,054.
------------------------------------------------------------------------

    Under the PRA, an agency may not conduct or sponsor, and a person 
is not required to respond to, a collection of information unless it 
displays a currently valid OMB control number. The OMB control numbers 
are displayed either by publication in the Federal Register or by other 
appropriate means, such as on the related collection instrument or 
form, if applicable. The display of OMB control numbers for certain EPA 
regulations in 40 CFR is consolidated in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to EPA using the docket identified at the 
beginning of this supplemental proposed rule. You may also send your 
ICR-related comments to OMB's Office of Information and Regulatory 
Affairs via email to OIRA_submission@omb.eop.gov, Attention: Desk 
Officer for EPA. Since OMB is required to make a decision concerning 
the ICR between 30 and 60 days after receipt, OMB must receive comments 
no later than December 9, 2019. EPA will respond to any ICR-related 
comments in the final rule.

D. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I certify 
that this action will not have a significant economic impact on a 
substantial number of small entities. The small entities subject to the 
requirements of this supplemental proposed rule are manufacturers 
(including importers) and processors of chemical substances. In this 
supplemental proposed rule, impacts on these small entities are 
evaluated qualitatively and with respect to the two rules in which 
small entity impacts are assessed in the small entity analyses (SEAs) 
prepared for the Active-Inactive Rule (Ref. 11) and for the 2019 
Proposed Rule (Ref. 8). The estimated incremental impact on small 
entities associated with this supplemental proposed rule are presented 
in the Cost Memo (Ref. 5), which is in the public docket for this 
action. In that analysis, EPA explains how each component of this 
supplemental proposed rule does not have a significant economic impact 
on a substantial number of small entities, and moreover how the 
combination of the components does not have a significant economic 
impact on a substantial number of small entities.
    In the small entity analysis (SEA) for the NPRM for this proposed 
rule, EPA found that no small entities from Groups (2) and (3) would 
experience an impact of greater than 1% of revenues. The same 
respondents are considered for Groups (2) and (3) for this component of 
this SNPRM, but at a much lower average incremental cost per 
respondent. Therefore, the same conclusion from that SEA applies to the 
corresponding small entities in Groups (2) and (3) potentially affected 
by this SNPRM.
    In the SEA for the Active-Inactive rule, the most burdensome 
average unit compliance cost selected for assessment was associated 
with manufacturers (including importers) submitting Form As in the 
start-up reporting period. The small entities in Group (1) for this 
SNPRM are drawn from Form A submitters identified in the Active-
Inactive rule. Using that reporting group as a basis, EPA found in that 
SEA that no small entities would experience an impact of greater than 
1% of revenues. The Group (1) small entities for this component of the 
SNPRM represent a subset, and therefore lower number of small entities 
than evaluated in the most affected group in that SEA. Moreover, EPA 
reasonably assumes for purposes of this SNPRM SEA that the small entity 
impacts for this component of this SNPRM associated with Group (1) 
respondents involve a similar impacts distribution as for the Active-
Inactive Form A start-up reporters. Given these considerations and 
additionally the much lower average incremental cost per respondent in 
this SNPRM compared to the Active-Inactive rule Form A start-up 
reporters, the conclusion from the Active-Inactive rule SEA applies to 
the corresponding small entities in Group (1) potentially affected by 
this SNPRM.
    Similarly, small entities submitting a Form B under the Active-
Inactive rule would incur a much lower average incremental cost per 
respondent than in the Active-Inactive rule's SEA, and therefore the 
conclusion from the Active-Inactive rule SEA applies to the 
corresponding small entities potentially affected by this SNPRM.
    Considering impacts on small businesses from the components 
presented in this unit, the information from each component is combined 
to support the conclusion that the overall impact of this action is 
minimal and would have no significant economic impact on a substantial 
number of small entities.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action is not expected to impose enforceable 
duty on any state, local or tribal governments, and the requirements 
imposed on the private sector are not expected to result in annual 
expenditures of $100 million or

[[Page 60370]]

more for the private sector. As such, EPA has determined that the 
requirements of UMRA sections 202, 203, 204, or 205 do not apply to 
this action.

F. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes. Thus, E.O. 13175 does not apply to this 
action.

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), 
as applying only to those regulatory actions that concern health or 
safety risks, such that the analysis required under section 5-501 of 
Executive Order 13045 has the potential to influence the regulation. 
This action is not subject to Executive Order 13045 because it does not 
establish an environmental standard intended to mitigate health or 
safety risks.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on energy supply, 
distribution, or use.

J. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA 
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994), because it does not establish an 
environmental health or safety standard. This action establishes an 
information requirement and does not affect the level of protection 
provided to human health or the environment.

List of Subjects in 40 CFR Part 710

    Environmental Protection, Chemicals, Confidential Business 
Information, Hazardous substances, Reporting and Recordkeeping 
Requirements.

    Dated: October 24, 2019.
Andrew R. Wheeler,
Administrator.

    Therefore, it is proposed that 40 CFR chapter I, part 710, subpart 
B be amended and 40 CFR chapter I, part 710, subpart C, as proposed to 
be added at 84 FR 16833 (April 23, 2019), be amended as follows:

PART 710--COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY

0
1. The authority citation for part 710 continues to read as follows:

    Authority: 15 U.S.C. 2607(a) and (b).

Subpart B--Commercial Activity Notification

0
2. Amend Sec.  710.37 by adding paragraph (a)(2)(i), and revising 
paragraph (c)(2) to read as follows:

Sec.  710.37  Confidentiality claims.

    (a) * * *
    (2) * * *
    (i) Persons who submitted the information described in paragraph 
(a)(2) of this section before [EFFECTIVE DATE OF THE FINAL RULE] must 
submit answers to the questions in paragraphs (c)(2)(ii) and (iii) of 
this section not later than [DATE 30 CALENDAR DAYS AFTER EFFECTIVE DATE 
OF THE FINAL RULE].
    (ii) [Reserved].
* * * * *
    (c) * * *
    (2) Substantiation for confidentiality claims for chemical 
identity. (i) Is the confidential chemical substance publicly known to 
have ever been offered for commercial distribution in the United 
States? If you answered yes, explain why the information should be 
treated as confidential.
    (ii) Does this particular chemical substance leave the site of 
manufacture or processing in any form, e.g., as product, effluent, 
emission? If so, what measures have been taken to guard against the 
discovery of its identity?
    (iii) If the chemical substance leaves the site in a product that 
is available to the public or your competitors, can the chemical 
substance be identified by analysis of the product?
* * * * *

Subpart C--Review Plan

0
3. Amend Sec.  710.43(b), as proposed to be added at 84 FR 16833 (April 
23, 2019), by revising paragraph (b)(1) and paragraph (b)(2) 
introductory text to read as follows:

Sec.  710.43  Persons subject to substantiation requirement.

* * * * *
    (b) Exemptions. (1) Any person who completed the voluntary 
substantiation process set forth in Sec.  710.37(a)(1) is exempt from 
the substantiation requirement of this subpart pertaining to the 
submission of answers to the questions in Sec.  710.37(c)(1) and 
(2)(i). All remaining requirements of Sec.  710.45 must be met in 
accordance with the deadline specified in Sec.  710.47(a), including 
the requirement to submit answers to the questions in 710.37(c)(2)(ii) 
and (iii), signed and dated by an authorized official, and to complete 
the certification statement in Sec.  710.37(e).
    (2) A person who has previously substantiated the confidentiality 
claim for a specific chemical identity that the person requested to 
maintain in a Notice of Activity Form A, by submitting information that 
is responsive to all questions in Sec.  710.37(c)(1) and (2), is exempt 
from the substantiation requirement of this subpart if both of the 
following conditions are met:
* * * * *
0
4. Revise Sec.  710.47(a), as proposed to be added at 84 FR 16833 
(April 23, 2019), to read as follows:

Sec.  710.47  When to submit substantiation or information on previous 
substantiation.

    (a) All persons required to substantiate a confidentiality claim 
pursuant to Sec.  710.43(a) or (b)(1) must submit their substantiation 
not later than [DATE 90 CALENDAR DAYS AFTER THE EFFECTIVE DATE OF THE 
FINAL RULE].
* * * * *
[FR Doc. 2019-23714 Filed 11-7-19; 8:45 am]
 BILLING CODE 6560-50-P