[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: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
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 $29
per year.
Table 1--Incremental Impacts of Supplemental Proposed Rule
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Responses
(chemical-
Rule/form Frequency Respondents specific Burden (hours) Cost (2018$)
submissions)
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Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory
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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.
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Total, Form A........... .................. 275 .............. 1,123 87,054
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Active-Inactive Rule
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Form B--Submissions with Annual............ 1 2 0.4 29
Full CBI Substantiation.
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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 [email protected], 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