Proposed Rule2022-09629
Confidential Business Information Claims Under the Toxic Substances Control Act (TSCA)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 12, 2022
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is proposing new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). Amendments to TSCA in 2016 included many new provisions concerning the assertion, Agency review, and treatment of confidentiality claims. This document proposes procedures for submitting such claims in TSCA submissions. It addresses issues such as substantiation requirements, exemptions, electronic reporting enhancements (including expanding electronic reporting requirements), maintenance or withdrawal of confidentiality claims, and provisions in current rules that are inconsistent with amended TSCA. The proposed rule also addresses EPA procedures for reviewing and communicating with TSCA submitters about confidentiality claims.
Full Text
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<title>Federal Register, Volume 87 Issue 92 (Thursday, May 12, 2022)</title>
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[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Proposed Rules]
[Pages 29078-29102]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09629]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 2, 702, 703, 704, 707, 716, 717, 720, 723, 725, and
790
[EPA-HQ-OPPT-2021-0419; FRL-8223-01-OCSPP]
RIN 2070-AK68
Confidential Business Information Claims Under the Toxic
Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing new and
amended requirements concerning the assertion and treatment of
confidential business information (CBI) claims for information reported
to or otherwise obtained by EPA under the Toxic Substances Control Act
(TSCA). Amendments to TSCA in 2016 included many new provisions
concerning the assertion, Agency review, and treatment of
confidentiality claims. This document proposes procedures for
submitting such claims in TSCA submissions. It addresses issues such as
substantiation requirements, exemptions, electronic reporting
enhancements (including expanding electronic reporting requirements),
maintenance or withdrawal of confidentiality claims, and provisions in
current rules that are inconsistent with amended TSCA. The proposed
rule also addresses EPA procedures for reviewing and communicating with
TSCA submitters about confidentiality claims.
DATES: Comments must be received on or before July 11, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0419, using the Federal eRulemaking Portal
at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and reading room is open by appointment only.
For the latest status information on EPA/DC services and in-person
docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Jessica Barkas, Project Management and
Operations Division (7401), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 250-8880; email address:
<a href="/cdn-cgi/l/email-protection#dfbdbeadb4beacf1b5baacacb6bcbe9fbaafbef1b8b0a9"><span class="__cf_email__" data-cfemail="9dfffceff6fceeb3f7f8eeeef4fefcddf8edfcb3faf2eb">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#b5e1e6f6f498fddac1d9dcdbd0f5d0c5d49bd2dac3"><span class="__cf_email__" data-cfemail="1c484f5f5d31547368707572795c796c7d327b736a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be affected by this action if you have submitted or expect
to submit information to EPA under TSCA and have made or expect to make
any confidentiality claims concerning that information. Persons who
seek information on such submissions may also be affected by this
action. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
<bullet> Manufacturers, importers, or processors of chemical
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical contact person
listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
TSCA section 14, 15 U.S.C. 2613, includes requirements for
asserting confidentiality claims and for EPA review of such claims to
determine whether the information is entitled to the requested
protections. Implementing
[[Page 29079]]
rules are explicitly contemplated for some provisions of TSCA section
14 (e.g., TSCA section 14(c)(1)(a) requires persons seeking to protect
information from disclosure to assert such a claim concurrent with
submission of the information, in accordance with existing or future
rules; TSCA section 14(c)(3) generally requires that confidentiality
claims be substantiated ``in accordance with such rules as the
Administrator has promulgated or may promulgate pursuant to this
section''). In addition, other TSCA section 14 requirements imply
authority to promulgate rules addressing the form and manner in which
those requirements should be fulfilled (e.g., manner of submitting
confidentiality claims, manner in which EPA will make required notices
under TSCA sections 14(g) or 14(e)).
Discussion of authority to require electronic reporting under TSCA
may be found in the preamble to the final rule entitled ``Electronic
Reporting under the Toxic Substances Control Act; Final Rule'' (Ref.
1). In addition, the Government Paperwork Elimination Act (GPEA), 44
U.S.C. 3504, provides that, when practicable, Federal organizations use
electronic forms, electronic filings, and electronic signatures to
conduct official business with the public.
C. What action is the Agency taking?
EPA is proposing new and amended requirements concerning the
assertion and treatment of CBI claims under TSCA, 15 U.S.C. 2601, et
seq. The Frank R. Lautenberg Chemical Safety for the 21st Century Act
of 2016, Public Law 114-182 (referred to in this Notice as ``the
Lautenberg amendments''), made significant amendments to TSCA,
including new provisions governing the assertion and review of CBI
claims that EPA is proposing to implement in this action.
In this document, EPA is proposing to specify procedures for
submitting and supporting CBI claims under TSCA, including among other
things: (1) Substantiation requirements applicable at the time of
submission; (2) Electronic reporting requirements; (3) Requirements to
provide certification statements and generic names when making
confidentiality claims; (4) Treatment of information used for TSCA
purposes that EPA could obtain under TSCA but was originally submitted
via other means; and (5) Maintenance or withdrawal of confidentiality
claims.
EPA is also proposing to specify procedures for reviewing and
communicating with TSCA submitters about confidentiality claims,
including requirements for submitters to maintain contact information,
and procedures for EPA to provide notices to submitters concerning
their claims.
EPA is proposing new provisions, as well as to amend and reorganize
existing provisions concerning assertion of confidentiality claims
under TSCA. Regulatory provisions concerning TSCA CBI claims are
currently spread over a large number of parts in the Code of Federal
Regulations (CFR). EPA has general provisions regarding confidentiality
claims at 40 CFR part 2, subpart B. Those general provisions are
accompanied by sections pertaining to confidentiality for many of the
statutes administered by the Agency. The TSCA-specific provisions of
the Agency's general business confidentiality regulations are at 40 CFR
2.306. In addition, many of the specific TSCA regulations in title 40
of the CFR contain their own provisions regarding CBI, such as in parts
711 (Chemical Data Reporting) and 720 (Premanufacture Notification).
In this proposed rule, most procedural requirements for asserting
and maintaining confidentiality claims would be organized into a
proposed new part of title 40 of the CFR, i.e., in part 703. The
provisions in proposed part 703 would apply to any TSCA submission,
except as modified elsewhere in part 2 or other TSCA-specific
regulations, as spelled out in this proposed rule. Further discussion
of the interactions between the various provisions regarding
confidentiality can be found in Unit II.B. of this document.
D. What are the incremental costs and benefits of this action?
EPA has evaluated the potential incremental impacts of this
proposed rulemaking, including alternative options. The details are
presented in the economic analysis prepared for the proposed rule (Ref.
2), which is available in the docket and is briefly summarized here.
The benefits of the proposed rule include improvements to EPA's
management of CBI, specifically in cases of deficient claims, and
improved communication and increased public transparency for chemical
information. The proposed rule is expected to decrease the frequency of
submitter error and increase efficiency in the processes for asserting
and maintaining CBI claims. Lastly, the proposed rule would bring TSCA
confidentiality regulations in line with the changes to TSCA section 14
brought about by the Lautenberg amendments.
EPA estimates that the public will incur a one-time burden and cost
of approximately 2,945 hours with an associated cost of approximately
$271,000 in the first year after the rule is finalized and an annual,
ongoing burden of approximately 525 hours with an associated cost of
approximately $45,000 in each following year.
E. Are there potentially disproportionate impacts for children health?
The proposed rule does not involve environmental health or safety
risks that the EPA has reason to believe may disproportionately affect
children. However, the Agency believes that the information collected
under this proposed rule, if finalized, will assist EPA and others in
evaluating potential hazards and risks associated with chemicals.
Although not directly impacting environmental health or safety risks,
this information will enable the Agency to better protect human health
and the environment, including the health of children.
F. What are the environmental justice impacts?
This proposed action does not address human health or environmental
risks or otherwise have disproportionately high and adverse human
health or environmental effects on minority populations, low-income
populations and/or indigenous peoples. Although not directly impacting
environmental justice-related concerns, the information collected under
this proposed rule will enable the Agency to better protect human
health and the environment, including in low-income and minority
communities.
II. Background
The Lautenberg amendments included several significant changes to
TSCA section 14. These include requirements that persons submitting
information under TSCA substantiate most confidentiality claims at the
time of submission, as well as additional statement, certification, and
generic name requirements. Under TSCA section 14(e), in order to
maintain most claims beyond a 10-year period, submitters are required
to reassert and resubstantiate those claims. Several new requirements
also apply to EPA, including requirements at TSCA section 14(g) to
review and approve or deny all chemical identity claims asserted since
the Lautenberg amendments were enacted concerning substances that are
offered for commercial distribution, as well as a subset of all other
confidentiality claims, within 90 days of assertion of the claim.
Further requirements that EPA review all confidentiality claims for the
chemical identity of substances listed as active on the TSCA Inventory,
a requirement to
[[Page 29080]]
assign and apply unique identifiers (UIDs) to substances with approved
confidentiality claims for chemical identity, as well as new provisions
providing expanded access to TSCA CBI, have been discussed in previous
documents that published in the Federal Register, see e.g., Refs. 3
(about the CBI review plan), 4 (about UIDs) and 5 (about expanded
access to CBI). Additionally, some TSCA regulations promulgated or
amended since the Lautenberg amendments have included confidentiality
provisions conforming to the amendments (e.g., Chemical Data Reporting
at 40 CFR 711.30 and Active/Inactive Inventory Reporting at 40 CFR
710.37).
A. Existing Regulations Governing Confidentiality Under TSCA
As proposed, this rulemaking would implement additional
requirements of the Lautenberg amendments concerning confidentiality
claims and would apply to all TSCA submissions. The proposal is
intended to clarify the TSCA section 14 requirements for submitters of
TSCA confidentiality claims. This would reduce the likelihood of claims
being denied because of procedural insufficiencies and facilitate the
public availability of information for which confidentiality is either
not requested or not allowed under TSCA. The proposed procedural rules
would aid efficient and timely EPA review of confidentiality claims and
reduce the likelihood of inadvertent disclosure of CBI.
Currently, CBI claims are asserted according to TSCA section 14 and
existing TSCA rule requirements that are specific to certain reporting
requirements (see Unit II.E. of this document). In some cases, further
claim assertion procedures are included in EPA's general CBI
regulations at 40 CFR part 2.
The procedures currently used by EPA to review TSCA CBI claims are
found in 40 CFR part 2, subpart B. These regulations were developed to,
among other things, apply Exemption 4 of the Freedom of Information Act
(FOIA), 5 U.S.C. 552, relating to business confidentiality, to review
CBI claims in response to a FOIA request. Some TSCA-specific provisions
in 40 CFR 2.306 add to or modify the general CBI regulations found in
40 CFR 2.201 through 2.215. 40 CFR 2.306 was last modified in 1993. In
the absence of revisions to accommodate the changes introduced by the
Lautenberg amendments, EPA has continued to use the 40 CFR part 2
regulations to complete the mandatory confidentiality determinations
required by the Lautenberg amendments.
The proposed rule would tailor all TSCA CBI claim assertion and
review procedures to the requirements of TSCA rules and consolidate
them in the TSCA rules--primarily in the proposed new part 703. 40 CFR
2.306 would be reduced in scope. It would clarify that most of the
general claim assertion and review rules found in the 40 CFR part 2 CBI
rules no longer apply to TSCA CBI claims and to elaborate on special
circumstances where CBI may be disclosed based on the provisions of
TSCA section 14(d) (disclosure to states, local governments and tribes
under TSCA section 14(d)(4); health or environmental professionals
under TSCA section 14(d)(5); or to certain emergency responders under
TSCA section 14(d)(6) or as relevant to a proceeding under TSCA section
14(d)(7)). EPA is proposing to retain certain notice requirements in 40
CFR part 2 that are not required by TSCA Section 14. Specifically,
under TSCA section 14(g)(2)(C)(iii), EPA is not required to provide
notice prior to disclosure of information pursuant to TSCA sections
14(d)(1), (2), (7), or (8), i.e., to Federal employees or officers, to
contractors, if relevant to a proceeding, or required to be made public
under other Federal law. EPA is proposing to retain certain existing
notice requirements in 40 CFR part 2 for disclosure to Federal
employees at 40 CFR 2.306(d), if relevant to a proceeding at 40 CFR
2.306(e), and for contractors and subcontractors at 40 CFR 2.306(f).
Additionally, the consolidation of TSCA CBI claim review procedures
into the proposed new part 703 includes the review procedures relating
to FOIA requests (i.e., CBI claim review required by TSCA section
14(f)(2)(A)). CBI claim review procedures in 40 CFR 2.306(d), (e), and
(g), and the procedures in 40 CFR 2.204 and 2.205 that are currently
cross-referenced in 40 CFR 2.306 are replaced with corresponding
provisions in the proposed new part 703.
B. Purpose and Applicability
EPA intends for the proposed requirements to apply broadly to any
information that is reported to, or otherwise obtained by, the Agency
under TSCA. 15 U.S.C. 2613(a)(1). This includes, for example,
information that is submitted pursuant to a requirement of TSCA or its
implementing regulations (e.g., a TSCA section 5 Premanufacture
Notification (PMN) or a TSCA section 8(e) notice of substantial risk),
information that is collected in the course of a TSCA inspection or
other TSCA enforcement-related activity, and materials that are
subpoenaed pursuant to TSCA. The proposed rule would also cover
information which is first obtained by EPA under an authority other
than TSCA but which meets the following criteria: (1) EPA has authority
to collect the information under TSCA; and (2) the information is
either used to satisfy the obligation of a person under TSCA or used by
EPA in the course of carrying out its responsibilities under TSCA. EPA
is proposing to interpret the phrase ``that is reported to, or
otherwise obtained by, the Administrator under TSCA'' to include
information that meets the two criteria identified above. The term
``under'' is not defined in TSCA section 14; therefore, EPA is
proposing to interpret this term as it is commonly used as well as from
its statutory context. See Kucana v. Holder, 558 U.S. 233, 245 (2010)
(quoting Ardestani v. INS, 502 U.S. 129, 135 (1991)) (``The word
`under' `has many dictionary definitions and must draw its meaning from
its context.' ''). Dictionary definitions can provide some insight into
how a reasonable or ordinary person would interpret the term. ``Under''
is defined as ``subject to the authority, control, guidance, or
instruction of,'' under, Merriam-Webster Online (2021), and ``subject
to'' is defined as ``affected by or possibly affected by (something).''
Subject to, Merriam-Webster Online (2021). In addition, the broad
inclusive language used--``reported to, or otherwise obtained by''--
suggests that Congress intended the provision to apply broadly. It
applies not only to information reported under TSCA but also to
information obtained under TSCA in manners other than reporting.
Language added to TSCA by the Lautenberg amendments also supports
the proposed interpretation that any information EPA has the authority
to collect under TSCA and is used for TSCA purposes should be
considered obtained ``under'' TSCA. First, TSCA section 4(h)(3)(A)
refers to the submission ``under this subchapter'' of voluntary
information, suggesting information need not be required by a rule or
order to be submitted ``under'' TSCA. Section 26(j) further provides
that subject to TSCA section 14, the Administrator shall make available
to the public ``a list of the studies considered by the Administrator
in carrying out each such risk evaluation, along with the results of
those studies.'' 15 U.S.C. 2625(j)(4). Moreover, TSCA section 26(k)
requires the Administrator to consider ``reasonably available''
information when conducting a risk evaluation. This language appears to
suggest that TSCA section 14 would govern confidentiality
determinations
[[Page 29081]]
for all studies considered by the Agency under TSCA section 6(b),
regardless of where the studies originated or how they were obtained.
However, there may be instances where information covered under
proposed new part 703 was originally submitted to EPA pursuant to a
statute with provisions regarding confidentiality, disclosure and
treatment of information that materially differ from those in TSCA. EPA
has addressed conflicts between regulatory provisions in 40 CFR
2.202(d), which states that the ``rule which provides greater or wider
availability to the public of the information shall govern,'' and more
specifically in the existing 40 CFR 2.306(b), which provides that under
the appropriate circumstances TSCA provisions would apply to certain
information originally submitted to EPA for some non-TSCA purpose. But
under the Lautenberg amendments to TSCA, EPA will be making use of
significant amounts of data originating from a variety of sources,
including existing studies submitted under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).
An example of a scenario in which such a situation may occur is
where a health and safety study is originally submitted to EPA under
FIFRA, but is subsequently used for TSCA purposes (e.g., in support of
a TSCA section 6 risk evaluation) and where the health and safety study
could have been collected under a TSCA authority (e.g., pursuant to
TSCA section 8(d)). Under FIFRA section 10(g), the disclosure of such a
study is limited to protect against disclosure to foreign or
multinational pesticide producers, but if the study were submitted
under TSCA, much of the information in the study would not be protected
from disclosure under TSCA section 14(b)(2).
The potential for conflict between statutory data protection
regimes, and the potential for disclosure of information originally
submitted under the expectation of specified information protection
requirements, has greatly increased from when the earlier regulations
were promulgated. EPA recognizes that there are several options for
dealing with these potential conflicts. As noted above, EPA is
proposing that in certain circumstances some information obtained under
authorities other than TSCA are information obtained under TSCA. EPA
also seeks to ensure that when information is submitted to EPA under a
statutory provision that provides an assurance of privacy, those
privacy protections continue to apply even when the information is used
for a different purpose. Cf Food Marketing Institute v. Argus Leader
Media, 139 S.Ct. 2356, 2366 (2019) (acknowledging the importance of
assurances of privacy to determinations regarding the confidentiality
of information). Thus, EPA is proposing that when there is a conflict
between statutory data protection regimes, the rules regarding the
treatment of information in that statute under which the information
was originally collected should continue to apply to the information,
regardless of how it is used by the Agency under TSCA. The proposed
regulations establishing this approach to potential conflicts appear in
proposed section 703.1. In addition, there are procedures in TSCA
section 14 that would be appropriate to apply to such data, such as the
limited disclosure authority, often under confidentiality agreements,
that is provided by TSCA section 14(d).
Other alternatives on which EPA requests comment include the
approach embodied in 40 CFR 2.202(d) that the statute which provides
for the greatest disclosure of the information governs, or the
opposite, that the most disclosure-restrictive statute governs. Either
approach could be implemented by applying the most (or least)
restrictive statute as a whole or by comparing specific statutory
provisions with TSCA section 14 and applying the least (or most)
restrictive provision on a provision-by provision basis. EPA believes
that the approach presented in proposed section 703.1 strikes an
appropriate balance and provides greater clarity, as well as being
consistent with the disclosure requirements applicable when the
submitter originally provided the information to EPA.
EPA requests comment broadly on these and any other options for
addressing, minimizing, or eliminating conflict between provisions
under different statutes regarding confidentiality, disclosure, and
treatment of information, including but not limited to alternative
statutory interpretations, principles that should govern the resolution
of conflicts, and options for resolving specific conflicts. EPA
specifically requests comment on whether the proposed approach
appropriately balances transparency under TSCA while also ensuring
appropriate protections for information obtained initially under
another statute consistent with the assurance of privacy implicitly or
explicitly provided by the government when such information is
obtained. See Food Marketing Institute v. Argus Leader Media, 139 S.Ct.
2356, 2366 (2019).
EPA also specifically seeks public comment on the proposed scope of
the rulemaking, particularly that information originally obtained
without the use of a TSCA authority is nevertheless obtained under TSCA
if the Agency has the authority to collect the information and it was
used for a TSCA purpose. EPA is also seeking comment on whether EPA
needs to exercise its TSCA authority or invoke its TSCA authority in
the original information collection in order for information to be
covered by TSCA section 14. EPA also seeks public comment on the
proposed treatment of information that was originally submitted under
another statute, as well as the alternatives identified. EPA is
particularly interested in comments on how studies that were originally
submitted under FIFRA should be treated under the TSCA regulations.
Finally, EPA is interested in comments on whether and, if so, how
the term ``TSCA submission'' should be defined in proposed section
703.3.
C. Requirements for Asserting a Confidentiality Claim
TSCA section 14(c) governs assertion of confidentiality claims for
TSCA submissions. This provision requires that persons submitting
information under TSCA substantiate most confidentiality claims at the
time of submission. It also includes additional certification and
generic name requirements. These and related requirements are
elaborated upon in Unit III.C.
1. Assertion of Confidentiality Claim Upon Submission of Information to
EPA
TSCA section 14(c)(1)(a) requires an affected business to assert a
claim for protection from disclosure concurrent with submission of the
information. Consistent with this provision, proposed section 703.5
would require that confidentiality claims be asserted at the time of
submission. If no such claim is made, the information may be made
available to the public without prior notice to the person who
submitted the information. While similar language appears in some of
the existing regulations that implement TSCA (e.g., 40 CFR 711.30(e)),
this proposal would clarify that the up-front assertion requirement is
applicable to all non-exempt TSCA CBI claims, in accordance with TSCA
section 14(c)(1)(A).
Proposed section 703.5 would further clarify and reiterate that
where a TSCA submission identifies a chemical substance listed on the
confidential portion of the TSCA Inventory but does not assert a
confidentiality claim for the
[[Page 29082]]
chemical identity as required by TSCA section 14 or in the manner
required by the applicable rule (see, e.g., 40 CFR 711.30), the
specific chemical identity would no longer be eligible for confidential
treatment on the TSCA Inventory. This would not apply where the
submission does not pertain to manufacture or processing for commercial
purposes, e.g., research and development.
The TSCA Inventory is a list of chemical substances manufactured or
processed for a commercial purpose. A substance may be afforded
confidential Inventory treatment (e.g., listing by generic name and
accession number) so long as the fact that anyone manufactures or
processes that substance for commercial purposes in the United States
has not been disclosed to the public. By making a non-confidential
report of having manufactured or processed a particular substance, the
reporter in effect discloses their activities concerning the substance
to the public and renders the substance ineligible for continued
confidential Inventory treatment. EPA would update the TSCA Inventory
to publicly list the specific chemical name and Chemical Abstracts
Service Registry Number (CASRN), if available, without further notice
(to any person who may have made a CBI claim for this substance).
(Updates to individual submissions that contain a prior claim for what
appears to be the same information would occur only after that claim is
withdrawn or as result of a review and final determination in
accordance with TSCA section 14 denying the claim in that submission.)
Under some existing rules, once the chemical identity is listed on the
public portion of the TSCA Inventory, claims can no longer be asserted
for such information (see, e.g., 40 CFR 711.30(a)(2)(i)). This is also
intended to clarify that the Agency will not provide notice to
submitters with previously approved or pending claims for the same
chemical identity prior to such disclosure on the TSCA Inventory. 40
CFR 711.30(a)(2)(i)). In addition, other chemical identity CBI claims
for the substance would likely be denied upon review. However, claims
for information related to the chemical identity, e.g., the identity of
the submitter, would not be precluded.
2. Substantiation and Exemptions
EPA previously published an interpretation concerning the
requirement to substantiate CBI claims in TSCA section 14(c)(3), see
(Ref. 6). In that document, EPA stated that the statute requires
persons asserting CBI claims to substantiate those claims at the time
the affected business submits the claimed information to EPA. This
proposed rule, in proposed section 703.5(b)(1), would make EPA's TSCA
confidentiality regulations consistent with TSCA section 14(c)(3).
Subsequent to the interpretation that published in the Federal
Register of January 19, 2017 (Ref. 6), some TSCA rules were updated to
include a set of required substantiation questions and apply the
substantiation exemptions in TSCA section 14(c)(2). See, e.g., Chemical
Data Reporting at 40 CFR 711.30. This proposed rule includes a standard
set of substantiation questions in proposed sections 703.5(b)(3) and
(4) that would be applicable to any confidentiality claim in any TSCA
submission for which substantiation is required and includes additional
substantiation questions specific to chemical identity claims. However,
proposed section 703.4(b)(3) would provide that individual TSCA rules
may modify the questions (by, for example, not requiring answers to
substantiation questions that are not applicable in a particular TSCA
submission type).
The substantiation questions in proposed sections 703.5(b)(3) and
(4) have been designed to elicit information to allow EPA to determine
whether the submitter's claim for confidentiality meets the substantive
review criteria set forth in proposed section 703.7(f). EPA is
interested in public comment concerning the proposed question set,
including whether some questions might be consolidated or revised to
minimize burden while also assuring responses are adequate to support a
confidentiality determination (i.e., according to the criteria in
proposed section 703.7(f)). The questions proposed here are similar to
those included in the 2020 amendments to the Chemical Data Reporting
(CDR) rule (see 40 CFR part 711) which the Agency believes are adequate
to support its review of confidentiality claims in those submissions.
a. Patents
EPA is proposing a question on patents in proposed section
703.5(b)(3)(iii)(C) and is seeking comment on alternatives to the
proposed question language, or whether a standalone patent question is
necessary at all. The Agency requests comment on whether a standalone
patent question is necessary or if it can be reasonably added to the
publications question found in proposed section 703.5(b)(3)(iii)(B). In
the Agency's experience, patents related to information claimed as CBI
under TSCA rarely if ever disclose information in the same context or
with the same level of detail as in the related TSCA submission. The
Agency notes that asking whether information appears in a patent is not
the same thing as asking whether the information is covered by a
patent. For the purposes of TSCA confidentiality claims, the Agency is
interested in both whether the same information claimed to be
confidential in the TSCA submission appears in a patent and whether it
is covered by a patent. More specifically, if the exact same
information appears in both a published patent and in the TSCA
submission, then the information should not be entitled to confidential
treatment. Also, if the information is covered (i.e., legally
protected) by a patent in such a way that no substantial harm to the
competitive position of the business would result from the release of
the information, then the information is not subject to confidential
treatment on that ground as well. If the question of whether TSCA
information claimed as CBI can both appear in and be covered by a
patent without destroying the CBI claim can always be answered with a
yes or no response with no additional explanation, then a standalone
patent question may not be necessary. The Agency seeks comment from
submitters explaining why they believe existence of a patent that
contains and covers the information claimed CBI should not affect the
ability of the submitter to the claim the same information as CBI under
TSCA.
Alternatively, the Agency requests comment on whether the
standalone patent question used in the 2020 CDR rule (40 CFR 711.30)
and proposed section 703.5(b)(3)(iii)(C) is adequate, or whether can be
improved to elicit more pertinent responses from submitters regarding
the potential public disclosure in a patent of the information claimed
confidential in the TSCA submission. The existing question is as
follows: Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
Particularly, the Agency would like to know how a company would be
reasonably likely to suffer substantial competitive harm if the
information is released under TSCA if the company already enjoys legal
protections against competitors for patent infringement. Further,
should the patent question elicit substantiation to explain why the
information claimed to be confidential in the TSCA submission is not
actually
[[Page 29083]]
revealed in the particular patent? The Agency proposes the following as
an alternative substantiation question: Has a patent been published for
the chemical identity you claim confidential? What chemical identity
information is not revealed by the patent? How is release of that
specific information likely to cause substantial competitive harm?
Failure to explain this harm may lead to denial of your confidentiality
claim.
The Agency requests comment on whether the proposed alternative
question is more likely to elicit pertinent responses on the relevance
of a patent and invites suggestions that may help improve how the
Agency considers patents in its CBI reviews.
b. Trade Secrets
EPA has observed that the question concerning trade secrets found
in several existing TSCA rules, e.g., at 40 CFR 711.30(b)(4), tends to
elicit answers that are either redundant with the answers to other
substantiation questions, or otherwise do not tend to include
information that is useful for the agency to consider whether the
information meets the specific legal standard for trade secrets. This
is rooted in confusion about trade secrets and CBI, which are distinct
but related concepts.
TSCA section 14(a) invokes FOIA Exemption 4 as a ceiling for
protecting business information. Exemption 4 protects ``trade secrets
and commercial or financial information obtained from a person and
privileged or confidential.'' 5 U.S.C. 552(b)(4). Trade secrecy has
long been held as grounds for Exemption 4 protection distinct from that
for ``commercial or financial information obtained from a person and
privileged or confidential.'' See, e.g., Public Citizen Health Research
Group v. FDA, 704 F.2d 1280, 1286 (D.C. Cir. 1983).
A trade secret has been defined by the D.C. Circuit as ``a secret,
commercially valuable plan, formula, process, or device that is used
for the making, preparing, compounding, or processing of trade
commodities and that can be said to be the end product of either
innovation or substantial effort.'' Public Citizen at 1288. This
definition also incorporates a requirement that there be a ``direct
relationship'' between the trade secret and the productive process.
CBI is defined by 5 U.S.C. 552(b)(4) as information that is (a)
commercial or financial, (b) obtained from a person, and (c) privileged
or confidential. The U.S. Supreme Court has addressed the meaning of
the word ``confidential'' in 5 U.S.C. 552(b)(4) stating that
``confidential'' must be given its ``ordinary'' meaning, which is
information that is ``private'' or ``secret.'' Food Marketing Institute
v. Argus Leader Media, 139 S. Ct. 2356, 2363 (2019). The Court held
that at 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 FOIA Exemption 4. Food Marketing
at 2366. In addition, TSCA section 14 requires the submitter to
demonstrate that it has a reasonable basis to conclude that disclosure
of the information is likely to cause substantial harm to the
competitive position of the business.
While the trade secret standard and CBI standard could
theoretically provide two avenues to protect information from
disclosure, EPA is not aware of any situation where information
submitted under TSCA was determined to be entitled to trade secret
protection but not CBI protection. EPA does not believe that asking a
specific trade secret question for TSCA confidentiality substantiations
will generate useful information because of the considerable overlap
between the two standards. EPA seeks comment on whether the trade
secret question still has value in the context of TSCA confidentiality
claims.
c. Specificity of Competitive Harm
In order to properly evaluate the various CBI claims in a single
submission, EPA needs a separate explanation from the submitter for
each type of information claimed as confidential to explain why
disclosure of that information would be likely to cause substantial
competitive harm. To that end, EPA proposes two versions of the
substantiation question concerning substantial competitive harm in this
rulemaking. The first version of the question comes directly from the
CDR rule, which states: ``will disclosure of the information claimed as
confidential likely cause substantial harm to your business's
competitive position? If you answered yes, describe the substantial
harmful effects that would likely result to your competitive position
if the information is disclosed, including but not limited to how a
competitor could use such information, and the causal relationship
between the disclosure and the harmful effects.'' 40 CFR 711.30(b).
The second version for consideration is in proposed section
703.5(b)(3)(i): Please specifically explain what harm to the
competitive position of your business would be likely to result from
the release of the information claimed as confidential. How would that
harm be substantial? Why is the substantial harm to your competitive
position likely (i.e., probable) to be caused by release of the
information rather than just possible? If you claimed multiple types of
information to be confidential (e.g., site information, exposure
information, environmental release information, etc.), explain how
disclosure of each type of information would be likely to cause
substantial harm to the competitive position of your business.
The version of the question in proposed section 703.5(b)(3)(i) may
enable EPA to better determine whether disclosure of the information is
likely to cause substantial harm to the competitive position of the
submitter. For purposes of this question, the term ``substantial''
means ``of considerable importance.'' Oxford English Dictionary (2021).
``Likely'' means ``probable.'' Oxford English Dictionary (2021). The
last portion of the question is intended to help submitters explain how
each type of information claimed confidential could harm the business
if released. For instance, the harm to the business that could result
from release of a confidential chemical identity may be different from
the harm that could result from release of information concerning the
number of workers exposed to the chemical during processing.
EPA requests comment from submitters and the public on which of the
two proposed versions of the question would be most likely to elicit
information from submitters that will best allow EPA to determine that
the submitter has demonstrated a reasonable basis to conclude that
disclosure of the information is likely to cause substantial harm to
the competitive position of its business. EPA is also seeking comment
on how ``substantial'' and ``likelihood'' should be defined.
d. Exemptions
The proposed section 703.5(b)(5) addresses the TSCA section
14(c)(2) exemptions from the substantiation requirement. This proposed
provision includes criteria for the exemption in TSCA section
14(c)(2)(G) pertaining to substances that have not been offered for
commercial distribution. The other proposed exemptions include:
<bullet> Specific information describing the processes used to
manufacture or process a chemical (e.g., information reported under 40
CFR 720.45(g)(2));
<bullet> Marketing and sales information (note that submitting
company identifiers are not generally themselves
[[Page 29084]]
considered marketing and sales information);
<bullet> Information identifying a supplier or customer (such as
the identities of some joint submitters reporting information under 40
CFR720.40(e) or 711.15);
<bullet> Details on mixture composition and percentage (such as
might be included in a TSCA section 8(e) notice of substantial risk
that concerns a mixture);
<bullet> Specific chemical substance use information (such as is
required to be reported under 40 CFR 720.45(f) and 725.155(g)); and
<bullet> Specific production or import volumes (such as are
required to be reported under 40 CFR 711.15 and 720.45(e).
EPA expects to update the reporting forms and applications for most
TSCA submissions to prompt the submitter for substantiation where
required, but not to prompt the submitter for types of data the Agency
has concluded are always covered by a substantiation exemption.
3. Public Copies of Submissions
In proposed section 703.5(c), EPA proposes to require public copies
of submissions that include confidentiality claims. The proposed rule
would not require preparation of a separate public copy where the
reporting form or electronic reporting application contains a specific
CBI designation identifying specifically what is claimed as CBI.
However, where the submission is made without the use of such a TSCA
reporting form (e.g., subpoena responses), or includes attachments or
other ``non-fielded'' data, the submitter would be required to produce
and submit a public (sanitized) copy of the submission and/or
attachments. Some existing TSCA rules already include such a
requirement. See, e.g., 40 CFR 720.40(d)(2) and 716.55(b). This
proposed rule would consolidate existing requirements in proposed new
part 703 and extend them generally.
The proposed provision would also provide that the sanitized
version would have to redact only that information that is claimed as
confidential. Any information not included in the sanitized version, or
redacted from the sanitized version, must be subject to a
confidentiality claim and as such must be substantiated as described in
this unit. It further states that a public copy that redacts all or
substantially all of the original submission would most likely not meet
the requirements of the rule because it is unlikely that all of the
information in a form or attachment can be appropriately claimed CBI.
Additionally, any information not included in or redacted from a public
copy is subject to the supporting statement in TSCA section 14(c)(1)(B)
and the certification requirement in TSCA section 14(c)(5). False
statements may give rise to criminal liability under 18 U.S.C. 1001.
4. Supporting Statement and Certification
TSCA section 14(c)(1)(B) requires that each claim of
confidentiality be accompanied by a standard supporting statement
regarding the eligibility of the information for confidential
treatment. TSCA section 14(c)(5) also requires a certification that the
TSCA section 14(c)(1)(B) statement and information required to
substantiate the claim under TSCA section 14(c)(3) are true and
correct. (See explanation in Unit III.A.2. of the preamble to the CDR
rule (Ref. 7)). This supporting statement and certification language
has already been incorporated in most TSCA reporting forms (example
available at <a href="https://www.epa.gov/tsca-cbi/making-cbi-claims-tsca-submissions#howto">https://www.epa.gov/tsca-cbi/making-cbi-claims-tsca-submissions#howto</a>). To the extent that the submission is not being made
on such a reporting form (e.g., a subpoena response), proposed section
703.5(a) provides language that may be included in a cover letter or
other attachment to a submission.
5. Generic Names
TSCA section 14(c)(1)(C) requires the submission of a generic name
any time a specific chemical identity is claimed as confidential. This
provision further requires that the generic name be ``structurally
descriptive'' and that it ``describe the chemical structure [. . .] as
specifically as practicable'' while also protecting the features of the
chemical substance that are claimed confidential or where disclosure
would likely cause substantial harm. 15 U.S.C. 2613(c)(1)(C)(ii). The
generic name must also be consistent with the generic name guidance
developed in accordance with TSCA section 14(c)(4)(A), 15 U.S.C.
2613(c)(1)(C)(i). See Refs. 8, 9 and 10. The generic name guidance
document provides information to assist companies in creating
structurally descriptive generic names for chemical substances whose
specific chemical identities are claimed confidential, for the purposes
of protecting the specific chemical identities from disclosure while
describing the chemical substance as specifically as practicable, and
for listing substances on the TSCA Chemical Substance Inventory. The
proposed rule acknowledges that the TSCA Inventory already includes
generic names for confidential substances, and that in most cases, such
generic names are expected to be acceptable for the purposes of
compliance with TSCA section 14(c)(1)(C) (possible exceptions may
include generic names for some substances added to the TSCA Inventory
prior to June 22, 2016, which would be addressed under proposed section
703.5(d)(2)).
For substances that are not on the TSCA Inventory (e.g., new
chemical submissions under TSCA sections 5 or 8(e) submissions
concerning pre-market chemical substances), the proposed rule includes
a few basic criteria, drawn mainly from the TSCA section 14(c)(4)(A)
guidance (e.g., the generic name should mask only the confidential
portions of the specific chemical name, generally only one structural
element of a specific chemical name may be masked to protect a
confidential chemical identity), and would require that where the
submitter believes those criteria are in some way inappropriate or
inapplicable to a particular substance or generic name, the submission
must also include an explanation for why more extensive masking of the
specific chemical identity is necessary in the particular case.
In proposed section 703.5(d)(3), EPA is also proposing that where a
generic name submitted for a substance that is not on the TSCA
Inventory is acceptable for the purposes of meeting the requirements of
TSCA section 14(c)(1)(C), the generic name might nonetheless be later
subject to additional review and potential change when commercial
manufacture of the substance is commenced (e.g., when a Notice of
Commencement (NOC) is submitted). Further procedures and requirements
for review and acceptance of generic names submitted with an NOC are
elaborated in proposed revisions to 40 CFR 720.102 and 725.190, As
discussed in Unit II.E.5.
Finally, in proposed section 703.5(d)(4), EPA is proposing to
provide an opportunity to revise proposed generic names that EPA
concludes are not in compliance with 15 U.S.C. 2613(c)(1)(C). EPA would
provide an electronic notice of the deficiency to the submitting
company, who would then be afforded ten days to propose a revised
generic name. If the submitter does not submit a compliant generic
name, EPA would reject the underlying submission and may ultimately
deny the CBI claim. (See discussion in Unit III.C.4. and proposed
section 703.5(e) on deficient submissions.)
6. Deficient Submissions
In proposed section 703.5(e), EPA is proposing to specify that
confidentiality
[[Page 29085]]
claims, identified for review pursuant to proposed section 703.7(a),
that are missing the certification, substantiation, or generic name
(where applicable) required by TSCA section 14(c) will be considered
deficient. Submissions that are missing a public copy or where the
public copy does not meet the requirements of proposed section
703.5(b)(6) would also be considered deficient-EPA has observed many
instances where the attachments to TSCA submissions appear over-
redacted (e.g., public copies of health and safety studies or the
Safety Data Sheets (SDSs) that are often provided with TSCA section 5
PMN submissions might be entirely or largely blank). This level of
redaction is rarely if ever consistent with the limitations that TSCA
section 14(b) places on CBI protections for health and safety
information. Submissions that include a generic name that does not meet
the requirements of proposed section 703.5(d) or rely on inappropriate
substantiation exemption assertions would also be considered deficient.
EPA anticipates that electronic reporting requirements, coupled
with modifications to new and existing reporting forms to incorporate
the certification statements and prompt for substantiation and generic
names, will eliminate most such deficiencies. However, to the extent
TSCA submissions are occasionally still made on paper or are not made
using a TSCA form for which entries can be automatically validated
(e.g., unformatted information in attachments to TSCA forms, such as
health and safety study reports or SDSs), such deficiencies may still
occur. EPA is proposing that when such deficiencies are identified, EPA
would initially place a hold on the submission.
In such an instance, EPA would provide notice of the deficiency to
the submitter and provide them with a ten (10) business day opportunity
to fix the deficiency. Meanwhile, any applicable review periods for the
underlying submission and for the confidentiality claim would be
suspended while the hold is in place. For example, if EPA held a PMN
for an inadequate public copy, both the CBI review period and the 90-
day review period for the PMN would be suspended until either (1) the
deficiency in the CBI claim is remedied, or (2) ten (10) business days
pass without the deficiency being remedied.
If the deficiency is not remedied within ten (10) business days of
EPA providing the notice of deficiency, EPA will resume the review of
the submission and will likely deny the CBI claim(s).
EPA is interested in public comment on this approach to claim
deficiencies, and on alternative approaches, such as strictly
interpreting the requirements of TSCA section 14(c) as necessary to
making a valid confidentiality claim (i.e., claims that don't meet the
requirements of TSCA section 14(c) would not be recognized, and could
thereby be released to the public without prior notice to the
submitter). Additionally, EPA is not proposing a time window in which
the Agency may identify deficiencies, which potentially leaves open the
possibility that a deficiency is identified, for example, on day 45 of
the review period for the underlying submission. EPA is particularly
interested in public comment on whether a time period for identifying
deficiencies, e.g., between 10 to 15 business days from the date of
submission, would be appropriate.
7. Electronic Reporting
Most TSCA submissions must now be made electronically, using
various reporting tools built into CISS (Chemical Information
Submission System, EPA's web-based reporting tool for preparing and
submitting TSCA submissions) and submitted via EPA's CDX system
(Central Data Exchange, EPA's centralized electronic document reporting
portal). The proposed section 703.5(f) would fill most of the current
gaps in electronic reporting requirements by requiring that nearly all
TSCA confidentiality claims be asserted electronically. For example,
while current TSCA section 8(e) notices of substantial risk may be made
either on paper or via an optional electronic reporting form, EPA is
proposing that all TSCA section 8(e) notices that include a
confidentiality claim would be required to be submitted electronically,
using an EPA-provided reporting tool. Similarly, electronic reporting
applications would be developed or updated for TSCA section 12(b)
notices of export and TSCA section 5 polymer exemption notifications.
Means of providing information via CDX relating to TSCA section 6
prioritization, risk evaluation, and risk management have already been
made available. These new and updated reporting applications would be
available by the time the new electronic reporting provisions become
effective. This proposal would expand the electronic reporting
requirement to all TSCA section 12(b) notices of export and TSCA
section 5 polymer exemption notifications (whether or not they include
confidentiality claims), thereby closing most remaining gaps in
electronic reporting requirements under TSCA. A discussion on the
benefits of electronic reporting under TSCA relevant to the expansion
described in this proposed rule was provided in a previous document
(Ref. 1). Some exceptions to the general requirement to report CBI-
containing materials electronically will remain, such as for materials
that EPA has subpoenaed or requested or collected in the course of a
TSCA inspection, which may be collected in person, and/or in a format
or volume that makes electronic submission impractical.
Closing these gaps in electronic reporting is intended to reduce
the likelihood of submitter error when asserting a confidentiality
claim, facilitate EPA's ability to review confidentiality claims in a
timely manner, reduce resources required to process, handle, and store
TSCA submissions, reduce the opportunity for errors related to the
handling of CBI, facilitate public access to information not claimed as
CBI, and enable or enhance EPA and TSCA submitters' ability to promptly
communicate about the status of confidentiality claims in the
submission in the future. EPA will enhance its current practice of
assigning a document or ``case'' number to each TSCA submission (e.g.,
P-20-0XXX or 8EHQ-2020-0XXXX) by assigning and making that submission
identifier available to the submitter within the submitter's CDX
account.
As stated above, EPA is proposing to require any information or
materials not obtained under TSCA section 11 to be submitted through
CDX if they contain a TSCA CBI claim. The Agency is requesting public
comment broadly on this approach, and on whether there are scenarios
the Agency should consider where a person providing TSCA CBI to EPA via
an irregular means (e.g., a letter) would not be able to or would face
substantial difficulties in using CDX to submit information claimed
CBI.
8. Requirement To Report Health and Safety Information Using Harmonized
Templates
In proposed section 703.5(g), EPA is proposing a requirement to
provide health and safety studies and information from health and
safety studies in a templated format, using Organisation for Economic
Co-operation and Development (OECD) Harmonized Templates, where an
applicable template is available. See <a href="https://www.oecd.org/ehs/templates/harmonised-templates.htm">https://www.oecd.org/ehs/templates/harmonised-templates.htm</a>. EPA is interested in comment on
this proposed requirement. Many TSCA submitters may be familiar with
and already have created templated versions of health and safety study
reports they may be
[[Page 29086]]
required to submit under TSCA, owing to reporting requirements in other
countries. For these submitters, the burden associated with this
requirement to submit templated data is expected to be minimal. EPA
anticipates that data that has been put into one of these standardized
templates will be more readily used and shared within the Agency, and
(where permitted by confidentiality restrictions and other agreements)
across jurisdictions. In addition, CBI clams may be more clearly
indicated if asserted via a templated format (e.g., CBI claims could be
indicated by checking a box for each discrete data element, rather than
by redacting sections of text piecemeal from a study report line by
line). It should be noted, however, that the proposed requirement to
provide data in a templated format does not supersede existing
regulatory requirements to also submit a full study report, such as the
present requirement for TSCA section 4 test reports.
EPA is soliciting public comment on the proposed requirement that
information obtained from a study, in addition to whole study
submissions, be provided in templated form to the Agency. EPA is also
interested in public comments on the requirement that submitters
identify the ``appropriate'' OECD template for a particular submission.
9. Maintenance of Company Contact Information and Communications
Concerning Claims
From time to time, EPA needs to contact a company about CBI claims
made in a TSCA submission. These contacts may be made relatively soon
after submission, in order to clarify something about a claim or
provide an opportunity to correct a deficiency with the claim (see
proposed section 703.5(e)), or they may be required notifications made
months or years later, such as a notice concerning a denied
confidentiality claim, or a notice concerning a pending confidentiality
review under TSCA section 14(f). In the future, EPA will also need to
contact or notify companies about expiring confidentiality claims,
pursuant to TSCA section 14(e). For all of these reasons, it is
important for EPA to have current contact information for the submitter
of each TSCA submission and an efficient means for satisfying the
notice requirements under the statute. EPA is proposing to require
companies to maintain current contact information for all individuals
associated with a submission (which reinforces and complements existing
CDX terms and conditions concerning maintenance of CDX accounts,
particularly the requirement to notify EPA when individual account
access is no longer needed so that the account can be deactivated; see
<a href="https://cdx.epa.gov/Terms">https://cdx.epa.gov/Terms</a>), enhance the means by which companies update
contact information, and require the submission of notices of transfer
of ownership via CDX.
In light of the significant resources and document tracking
concerns related to continuing to largely rely on paper correspondence
for such communication and notifications, the rulemaking proposes that
most such correspondence would be electronic, via CDX. See proposed
section 703.5(h). ``Two-way'' communication via CDX provides a secure
means for EPA and companies to correspond about a TSCA submission or
confidentiality claims. EPA can more readily assure that a
communication is available to a company or specific submitter by using
CDX to communicate, rather than certified mail or a courier. In CDX,
EPA is able to verify that a particular communication is available to
the submitter of a particular submission and is able to track the date
the communication was sent. EPA believes that these facts satisfy the
requirement in TSCA section 14(g)(2)(A) that notification, including
for the denial of a confidentiality claim, be sent by means that
``allows verification of the fact and date of receipt.'' This would be
the case even if EPA does not receive a ``read receipt'' or cannot
otherwise verify that the submitter opened the electronic notice, much
as EPA cannot verify whether or when a recipient of certified mail
opens the envelope and reads the contents.
The proposed rule describes how EPA expects to furnish the required
notices concerning expiration of confidentiality claims under TSCA
section 14(e). The first expirations will occur in 2026, for claims
that were asserted in 2016 and that were not exempt from substantiation
and review according to TSCA sections 14(c)(2) and 14(g). As proposed,
EPA would periodically publish a list of TSCA case numbers that are
approaching claim expiration on the EPA website, or other appropriate
platform. In addition, EPA intends to send individual notices of
upcoming claim expiration and other individual notices concerning CBI
claims to the company via CDX.
The proposed rule includes similar notice and communication
provisions for when review of claims is initiated under TSCA section
14(f) (e.g., in response to a FOIA request for information that has
been claimed as confidential). EPA would provide any necessary notice
of review and/or opportunity to substantiate or resubstantiate to the
Authorized Official or Technical Contact listed on the most recent
version of the submission (or as listed in a more recent notice of
transfer of ownership relating to that submission), along with
instructions for response. Alternatively, if the submission with the
relevant CBI claim is not associated with a CDX account, EPA would send
the notice via CDX to the company contact provided in the most recent
TSCA submission made by that company.
For TSCA submissions that were not originally made via CDX, EPA is
proposing to send the notice by certified mail or courier to the
address provided in the most recent TSCA submission from that company,
or via other means that allows verification of the fact and date of
receipt. For example, EPA is also considering further development of
two-way CDX communication to permit EPA to also send these notices,
likely using the contact information in the most recent CDX submission
from the same company.
10. Withdrawing Claims
TSCA confidentiality claims may be voluntarily withdrawn by the
submitter at any time. See 15 U.S.C. 2613(e)(1)(A)(i) and (B)(ii)(I).
Proposed section 703.5(i) includes instructions for voluntarily
withdrawing confidentiality claims prior to automatic expiration or
denial. The preferred approach is for the company to amend the
submission electronically, via CDX, to withdraw the claims (i.e.,
``uncheck'' the CBI boxes or unredact the submission and resubmit it).
When this is not possible (for example, when the submission was not
originally submitted via CDX, or because the company does not have
access to the electronic submission), claims may be withdrawn by CDX
submission as well, using a new correspondence tool that enables
efficient linking of the withdrawal letter with the related submission,
and permits EPA to communicate with the company about the withdrawal
(e.g., if clarification is needed).
11. Amending a Public Copy Following Claim Denial or Expiration
Following the denial or expiration of a confidentiality claim, the
public copy of the submission must be revised to provide public access
to the newly non-CBI information. For some electronic submissions this
may be a more or less straightforward process of un-checking some boxes
and generating a new public copy of the submission, but for other TSCA
submissions, the denied or
[[Page 29087]]
expired claims may be intermingled with still-valid or approved claims,
or the claims may have been indicated by numerous redactions throughout
a voluminous text. The proposed rule (see proposed section 703.5(j))
would encourage companies to prepare this updated public copy
themselves. EPA believes that submitters are in the best position to
assert and indicate their remaining claims accurately. However, in the
case that the submitter is unavailable or otherwise unable to update
the public copy, the proposed rule makes clear that EPA will undertake
this function, as needed.
EPA invites comment on the option of requiring TSCA submitters to
update their original submission to reflect CBI claims that have been
withdrawn or denied.
D. EPA Review of Confidentiality Claims
1. Representative Subset
TSCA section 14(g)(1)(A) requires that EPA approve or deny
confidentiality claims, except for claims exempt from review under TSCA
section 14(c)(2). TSCA section 14(g)(1)(C) further specifies that EPA
review all confidentiality claims for chemical identity (except those
exempt under TSCA section 14(c)(2)(G)) and a ``representative subset''
comprising at least 25% of all other claims, with the exception (as
provided in TSCA section 14(g)(1)(A)) of information exempted from
substantiation under TSCA section 14(c)(2).
Proposed section 703.7 would codify EPA's current practice of
reviewing all claims (except those exempt from substantiation
requirements under TSCA section 14(c)(2)) in every fourth submission
received via CDX that contains CBI claims besides those pertaining to
chemical identity.
Consistent with current practice, submissions with CBI claims not
submitted through CDX would be excluded from the representative subset.
As explained above, all submissions other than those submitted pursuant
to TSCA section 11 will be required to be submitted through CDX (see
proposed section 703.5(f)), so the Agency believes that only a small
number of infrequent TSCA submissions would not be included in the
total number of claims received for purposes of determining the
representative subset. Moreover, these materials are not representative
of TSCA submissions because they are collected irregularly, from widely
spread geographic locations, may be voluminous, provided in multiple
batches, be of assorted media type (photos, large maps, etc.) or exist
only on paper or other physical media at the time of collection. EPA is
also proposing that amendments to submissions would not be counted as
new submissions for purposes of selecting the representative subset--
rather, the confidentiality claim review will include amendments
available at the time of review. EPA is interested in public comment
concerning its selection of the representative subset, including
possible alternative representative selection methods.
EPA is proposing that two additional types of submissions not be
included in the representative subset as they are not representative of
TSCA submissions as a whole. These include: (1) Bona fide inquiries
under 40 CFR 720.25, and 721.11 and (2) TSCA section 5 prenotice
communications (correspondence submitted prior to a prospective TSCA
section 5 submission asking questions or requesting a meeting to
discuss whether and how a prospective TSCA submission should be made).
These document types are not representative of TSCA submissions as a
whole. These submission types help submitters ascertain whether a TSCA
submission is required in a particular situation and/or what type or
format should be used to make a particular submission. Moreover, in
each case in which EPA confirms that a specific TSCA submission is
required, these pre-notice or bona fide submissions would be followed
by the corresponding TSCA submission, which itself would be subject to
selection as part of the representative subset (e.g., a PMN or
Significant New Use Notice). Conversely, where no TSCA submission is
deemed necessary, the information in these documents does not relate to
EPA's regulation of chemical substances under TSCA.
EPA is interested in public comment concerning the universe of
claims that contribute to the representative subset and its
identification of, and exclusions from, the representative subset,
including possible alternatives.
2. EPA Review of Claims
a. Procedures
EPA is proposing to revise EPA's procedures for reviewing
confidentiality claims. As noted in previous EPA statements (e.g., Ref.
6), EPA reviews confidentiality claims in accordance with the
requirements in TSCA section 14 and has relied to date on the review
procedures set out in 40 CFR part 2 for all TSCA CBI reviews. However,
the review procedures described in 40 CFR part 2 (including TSCA-
specific provisions at section 2.306), which were promulgated prior to
the Lautenberg amendments, do not fully accommodate or account for the
requirements in TSCA section 14, particularly the demands of the TSCA
section 14(g)(1) mandatory review program. Rather than extensively
update the EPA review procedures for TSCA CBI in 40 CFR part 2 to
reflect the amendments to TSCA section 14, this rulemaking proposes to
consolidate most of them in the proposed new part 703, consistent with
the broader effort to centralize regulations on TSCA CBI.
In many respects, the procedures and substantive review criteria in
proposed new part 703 mirror those in 40 CFR part 2 but include
adaptations to reflect the requirements of TSCA section 14, and to
facilitate the high volume, time-limited review process required to
meet the requirements of TSCA sections 14(e) and 14(g). For example,
the substantive criteria in 40 CFR 2.208, as referenced and modified by
40 CFR 2.306(g), would be retained, but would be somewhat modified to
align with the substantial competitive harm language in TSCA section
14. (The other criteria include that the CBI claim has not expired,
been waived, or withdrawn; that the business protects the
confidentiality of the information; and that no statute prohibits
confidential protection.)
The criteria would also be revised to clarify that whether a
substance may be readily reverse engineered is among the factors EPA
considers as part of the criterion on whether the CBI-claimed
information is legitimately and reasonably obtainable without the
business's consent. Alternatively, the Agency could consider whether a
substance may be readily reverse engineered as a stand-alone criterion.
The Agency requests comment on how this reverse engineering component
should be incorporated into the Agency's substantive review criteria in
proposed section 703.7(f), either as a stand-alone review criterion or
as part of the existing criterion. The substantive review criteria in
proposed section 703.7(f) will establish the Agency's standard of
review for all TSCA CBI claims. For each claim to be approved,
submitters' substantiations would be required to adequately address all
of the criteria set forth in proposed section 703.7(f). Accordingly,
the Agency would then be able to deny TSCA CBI claims for failure to
address any one of the proposed criteria in the substantiation.
The requirement in 40 CFR 2.306(e)(1) that EPA's Office of General
Counsel (OGC) make most final confidentiality determinations would no
longer be required by regulation under the proposed new part 703;
rather, final determinations may be made by OGC or
[[Page 29088]]
other EPA offices (e.g., the EPA Office of Pollution Prevention and
Toxics), as designated by the General Counsel. Regardless of which
office within EPA issues a given final determination, EPA expects to
continue to publish final CBI determinations on its website.
EPA also proposes, in proposed section 703.7(g), to add a means to
request reconsideration by OGC of determinations denying confidential
treatment. Reconsideration would be available during the 30-day notice
and appeal period prior to disclosure of the information. This
mechanism is intended to permit parties to identify any EPA errors in
the determination prior to the point that the information is disclosed,
and without immediately proceeding to judicial review of the decision.
If a request for reconsideration is timely received, EPA will suspend
the 30-day notice period described in proposed section 703.7(e) while
OGC reconsiders the Agency's determination. OGC will review the
submission de novo and will only consider the submission record as it
existed for the final determination. EPA requests comment on this
reconsideration approach and the suspension of the 30-day notice
period.
The proposed rule sets forth review procedures to apply to CBI
reviews initiated under TSCA section 14(g)(1) (including reviewing
requests for extension under TSCA section 14(e)) as well as some
additional procedures to implement CBI reviews initiated under TSCA
section 14(f). In proposed section 703.7(b)(2), EPA proposes to permit
submitters requesting extension of confidentiality protections under
TSCA section 14(e) to either submit new substantiation or rely on
substantiation that was provided with the initial submission,
certifying that the substantiation remains true and correct.
In proposed section 703.8, EPA proposes similar procedures for
reviews initiated under TSCA section 14(f) as for those under TSCA
section 14(g), though the notice and resubstantiation provisions
necessarily vary to reflect the fact that the review of different
claims may be triggered by TSCA section 14(f) versus TSCA section
14(g). The proposed rule also clarifies that EPA is not required to
review claims as designated in TSCA section 14(f)(1) (claims concerning
active or TSCA section 6(b) high-priority substances or where
disclosure would assist EPA in conducting a risk evaluation under TSCA
section 6); rather, reviews of such claims are discretionary.
The proposed rule also elaborates on the timing and scope of review
in proposed section 703.7(c). For the purposes of TSCA section 14(g),
the proposed rule specifies that the 90-day review period begins on the
day EPA accepts a new TSCA submission that includes confidentiality
claims (TSCA submissions under TSCA section 5 must clear a brief ``pre-
screen'' review for basic completeness to ensure consistency with
requirements in 40 CFR part 720, which is usually complete within a few
days of submission; following that review, the submission is considered
``accepted''), and that amendments to non-chemical identity information
in the submission will be considered in the confidentiality review for
that submission up to 60 days after the original submission date. (New
confidentiality claims concerning chemical identity would be reviewed
within 90 days of EPA accepting the submission or amendment including
the new chemical identity claim.) The date that the submission is
considered ``accepted'' will be used to calculate the 10-year sunset
period for purposes of TSCA section 14(e). ``Accepted'' is defined in
the proposed section 703.3.
EPA notes that some submission types are often amended one or more
times after submission (e.g., new chemical-related submissions under
TSCA section 5) as new information is developed, or as requested by
EPA. In order to meet the 90-day statutory review deadline, EPA
believes it is important that submissions be complete, at least
procedurally, prior to starting review, and notes that there is a point
in the 90-day period past which significant amendments to the
submission and related claims would be difficult or impossible to
consider while still meeting the statutory review deadline.
EPA has considered some alternatives in developing this proposed
rule, including either resetting the 90-day clock every time an
amendment is received, or not commencing confidentiality claim review
at all until some period of time after initial submission, to allow for
a majority of amendments to be made prior to beginning the
confidentiality review. In the first case, EPA identified that
resetting the 90-day clock with each amendment would likely require a
lot of duplicative effort. EPA also anticipates that either of these
options would often delay confidentiality determinations considerably,
especially for new chemical submissions, in which public interest has
been heightened in recent years. EPA invites public comment on the
proposed approach described in proposed section 703.7(c), as well as
these and other alternatives.
b. Substantial Competitive Harm
In the preamble of the 2020 final rule on CDR (Ref. 7), EPA noted
that the Agency did not view the Supreme Court's decision in Food
Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2363 (2019)
as necessitating the Agency to remove the ``substantial competitive
harm'' substantiation question for TSCA CBI claims. See also Ref. 11.
Congress amended TSCA section 14 in 2016 to, among other things,
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) and (c)(5); see also TSCA section
14(c)(1)(C)(ii)(II) (referencing substantial competitive harm). For
each claim, the Agency's review will determine whether the business has
made a satisfactory showing that it has a reasonable basis to conclude
that disclosure of the information is likely to cause substantial harm
to the competitive position of the business.
The proposed rule clarifies that the Agency requires the
certification statement on substantial competitive harm and considers
substantial competitive harm as part of its substantive review criteria
for TSCA CBI claims.
c. Information From Health and Safety Studies
The proposed rule also elaborates on the limitations on
confidentiality protections for health and safety information described
in TSCA section 14(b). TSCA section 14(b)(2), which denies
confidentiality protection to health and safety studies and information
from health and safety studies, excludes from its coverage certain
categories of information in health and safety studies, such as
formulas. In addition, existing regulations allow withholding of
specified information beyond that provided in TSCA section 14(b)(2).
See, e.g., 40 CFR 720.90(3) (allowing withholding of ``[i]nformation
which is not in any way related to the effects of a substance on human
health or the environment, such as the name of the submitting company,
cost or other financial data, product development or marketing plans,
and advertising plans''). However, the applicable regulations are not
uniform in this respect; nor has the statutory basis for these
provisions (which itself has changed under the Lautenberg
[[Page 29089]]
amendments) been previously enunciated by EPA. The Agency is proposing
here to systematize these provisions, generally allowing CBI claims for
very limited categories of information contained within a health and
safety study.
While such ancillary information may be contained in a study
document submitted under TSCA, EPA does not consider such information
to be part of a ``health and safety study'' as defined in TSCA section
3(8). That definition states that the term `health and safety study'
means any study of any effect of a chemical substance or mixture on
health or the environment or on both, including underlying information
and epidemiological studies, studies of occupational exposure to a
chemical substance or mixture, toxicological, clinical, and ecological
studies of a chemical substance or mixture, and any test performed
pursuant to this chapter. This definition does not seek to provide an
exclusive list of what is or is not ``included'' in the health and
safety study but instead clarifies that all ``underlying'' information
must be considered part of the study. The term ``underlying'' is an
adjective ``used to describe something on which something else is
based.'' Cambridge Dictionary (Online). A study report may contain
information beyond that which is the basis for the study. Information
such as the names of lab technicians neither form the basis for the
study nor are relevant to the study results.
Additionally, TSCA section 14(b)(1) provides that information that
is protected from disclosure under this section, and which is mixed
with information that is not protected from disclosure under this
section, does not lose its protection from disclosure notwithstanding
that it is mixed with information that is not protected from
disclosure. TSCA section 14(b)(1) is consistent with the interpretation
that a study report can contain information not included within the
definition of a ``health and safety study'' under TSCA section 3(8) and
adopting such an interpretation gives effect to TSCA section 14(b)(1).
EPA is therefore proposing a definition of ``health and safety
study'' (for purposes of this proposed rule) in proposed section 703.3
that specifies types of information that are not within the scope of
TSCA section 3(8):
<bullet> Name of the submitting company;
<bullet> Name of the laboratory;
<bullet> Internal product codes;
<bullet> Names of laboratory personnel;
<bullet> Names and other private information included in study data
or reports;
<bullet> Cost or other financial data; and
<bullet> Product development, advertising, or marketing plans.
The Agency is requesting comment on the underlying interpretation
and this list.
This proposed rule would clarify these existing provisions and make
them uniform for all TSCA submissions. EPA invites comment on the
proposed examples of information that might be in a study, but
nonetheless permissible to withhold as confidential, should the
information otherwise meet the confidentiality criteria in TSCA section
14.
E. Related or Corresponding Revisions to Other TSCA Rules
In addition to proposing a new confidentiality claim section of the
TSCA rules, the proposed rule would revise confidentiality provisions
in existing rules. In some cases, the proposed revisions would replace
existing provisions with a cross reference to the proposed new part
703. In others, more specific and extensive revision is proposed.
1. Proposed Revisions to 40 CFR Parts 702, 704, 707, 716, 717, 723, and
790
EPA is proposing to revise the following provisions to reference
the general CBI provisions in the proposed new part 703:
<bullet> 40 CFR 702.37(d), the confidentiality provisions for
manufacturer requests for risk evaluations;
<bullet> 40 CFR 704.7, the confidentiality provision for TSCA
section 8(a) rules;
<bullet> 40 CFR 707.75(d), the confidentiality provision of rules
concerning TSCA section 12(b) notices of export;
<bullet> 40 CFR 716.55, the confidentiality provisions for TSCA
section 8(d) reporting rules;
<bullet> 40 CFR 717.19, the confidentiality provision for TSCA
section 8(c) recordkeeping and reporting rules;
<bullet> 40 CFR 723.50(l) and 723.250 (f), the confidentiality
provision for certain exemption requests under TSCA section 5 (low
volume exemption and low releases and low exposures exemption); and
<bullet> 40 CFR part 790, the confidentiality provision of rules
concerning TSCA section 4 test rules, orders, and agreements.
2. Further Clarification Proposed for 40 CFR Part 707
EPA is proposing to revise the provision concerning the contents of
TSCA section 12(b) notices of export, 40 CFR 707.67(a), by adding a
sentence to provide that in most cases, a confidential specific
chemical identity need not be included in the notice (the primary
exception would be in the case where the substance to be reported under
TSCA section 12(b) is claimed as confidential but does not have a TSCA
accession number). Instead, the TSCA section 12(b) notice of export may
identify the substance by the generic name and accession number that
appeared in the TSCA section 4, 5, 6, or 7 action that triggered the
TSCA section 12(b) reporting requirement. EPA anticipates that with
this change, TSCA section 12(b) submitters would submit fewer
confidentiality claims for specific chemical identity, which in almost
all cases is unnecessary to report under the existing TSCA section
12(b) rules.
3. Proposed Revision in 40 CFR 717.17 and 723.250 To Reflect Electronic
Reporting
EPA proposes to modify 40 CFR 717.17 and 723.250(f) to reflect the
proposed new electronic reporting requirement discussed in Unit II.C.5.
4. Proposed Revisions to Confidentiality Provisions in the PMN Rules
EPA is proposing to simplify and replace many of the
confidentiality provisions in 40 CFR part 720, subpart E with a cross
reference to the general confidentiality provisions in proposed new
part 703. The general provisions on confidentiality in PMNs, 40 CFR
720.80, is proposed to be replaced with this cross reference.
Requirements in 40 CFR 720.85 and 720.90 are proposed to be deleted,
with portions moved to 40 CFR part 720, subpart F, the provisions
concerning NOCs.
The existing provisions concerning chemical identity claims in PMNs
and in health and safety studies would be covered in the proposed new
part 703. In addition, TSCA section 14(c)(2)(G) created an exemption
from the substantiation requirement for confidentiality claims for
chemical identity when identity information is submitted before
substance is offered for commercial distribution. The CBI claim review
provisions of TSCA section 14(g) exclude these exempt claims from
routine EPA review requirements, diminishing the need to elaborate on
requirements for asserting and maintaining such claims in the PMN
rules.
Relatedly, a confidentiality claim review process in existing 40
CFR 720.90, whereby claims that were made in health and safety studies
in the PMN are revisited at the NOC stage, is a poor fit with new TSCA
section 14(g) requirements that confidentiality claims
[[Page 29090]]
be reviewed within 90 days of receipt, or in accordance with the
discretionary or mandatory provisions of TSCA section 14(f). In
practice, PMNs and NOCs (the latter of which may be submitted many
months or years after the corresponding PMN, if at all) are treated by
EPA as separate submissions for the purposes of routine CBI review. At
the PMN stage, chemical identity claims, including claims made in
health and safety studies, are generally exempt from review, per the
exemptions from substantiation and review set out in TSCA sections
14(c) and (g). NOCs, on the other hand, do not include health and
safety information. With the proposed deletion of 40 CFR 720.90, the
review of confidentiality claims in NOC submissions would be limited to
the information included in the NOC submission--principally chemical
identity and submitting company information. Claims that were made in
the PMN submission may be revisited at a later time, in accordance with
either mandatory or discretionary review provisions in TSCA section
14(f).
5. PMN NOC Provisions
The proposed rule leaves much of 40 CFR part 720, subpart F,
intact, but reorganizes some provisions that concern specific chemical
identity claims in or following submission of an NOC. These provisions
are presently in subpart E and would move to subpart F. Additionally,
the proposed revisions would update and clarify NOC reporting
instructions in 40 CFR 720.102(c)(2), concerning the assertion and
substantiation of confidentiality claims throughout the NOC reporting
form. The existing rule only reflects the substantiation requirements
that pre-dated the Lautenberg amendments, which were limited to
specific chemical identity confidentiality claims, and do not reflect
the newer generic name and certification requirements in TSCA section
14(c).
Revisions include adding a new paragraph (e) in 40 CFR 720.102, the
substance of which is currently in 40 CFR 720.85(b)(3), concerning
requirements that apply when asserting a confidentiality claim for
chemical identity in the period after commencing commercial
manufacture. Additionally, there is a cross-reference to the
requirements of proposed new part 703, which, among other things, would
replace the list of substantiation questions currently in 40 CFR 720.85
(which under existing rules, only apply to chemical identity claims in
NOCs).
Finally, the proposed revisions to 40 CFR 720.102 would include a
new paragraph (f), concerning generic names. These provisions are
intended to be consistent with generic name provisions in proposed new
part 703, but include some additional provisions specific to the
submission and review of generic names for the purposes of listing on
the TSCA Inventory, including additional procedures intended to aid the
prompt negotiation by the submitter and EPA of more difficult generic
names (which are themselves based in part on procedures presently in 40
CFR 720.85), and a provision that NOCs will be temporarily held in
situations where the submitter has not provided an acceptable generic
name despite the negotiation. If the submission is not corrected, EPA
would proceed with review of the CBI claim for chemical identity and
would likely deny the claim. EPA invites comments on these and other
possible approaches to efficiently developing an acceptable generic
name for purposes of listing on the TSCA Inventory.
6. Microorganisms
EPA is proposing to replace much of the confidentiality provisions
currently in 40 CFR part 725, subpart C, with a new, simplified subpart
C, which largely relies on a cross-reference to the proposed new
general confidentiality provisions to be placed in proposed new part
703. The proposed amendments would remove current provisions that are
inconsistent with the Lautenberg amendments, such as existing
requirements to provide upfront substantiation of organism identity
confidentiality claims prior to the commencement of commercial
manufacture. The proposed rule also proposes some adjustments to the
general confidentiality provisions in proposed new part 703 when they
are applied to genetically modified microorganisms and other products
of biotechnology covered by 40 CFR part 725. These include some
adjustments to the substantiation questions to reflect some practical
differences between these products and other types of TSCA chemical
substances.
The proposed rule also includes proposed revisions to 40 CFR
725.190, concerning NOCs, that are similar to the proposed revisions to
the parallel conventional chemical NOC provisions in 40 CFR 720.102,
including some elaboration on what must be included in a generic name.
As in the case with NOCs relating to PMNs, EPA proposes to update 40
CFR 725.190 to be generally consistent with generic name provisions in
proposed new part 703, but with some additional provisions specific to
the review of generic names for the purposes of listing on the TSCA
Inventory, including additional procedures intended to aid the prompt
negotiation of more difficult generic names, and a provision that NOCs
will be held in situations where the submitter has not provided an
acceptable generic name despite the negotiation (and that such
deficiencies, if not promptly corrected, may result in denial of the
claim). EPA invites comments on these and other possible approaches to
efficiently developing an acceptable generic name for purposes of
listing on the TSCA Inventory.
7. Changes in Proposed Regulations
This action proposes a significant number of new and revised CBI
provisions to be included in proposed new part 703 and proposes to
revise confidentiality provisions in other existing regulatory
provisions to cross reference the proposed new part 703. EPA recognizes
that during the pendency of this rulemaking process, EPA is developing
other rulemakings that may address confidentiality provisions. For
example, EPA is developing a proposed rule regarding asbestos reporting
under TSCA section 8(a). Until this CBI rule is finalized, however,
additional regulations proposed or finalized need to refer to the
existing CBI regulations, rather than to the new and revised CBI
provisions addressed in this rulemaking. EPA requests comment on
options for harmonizing such provisions. Specifically, EPA requests
comment on using this action to make any needed conforming amendments,
e.g., adding cross references to the new and revised CBI provisions
proposed here to any CBI provisions finalized during the pendency of
this action including any CBI provisions finalized in the asbestos TSCA
section 8(a) rule.
III. Request for Comments
EPA is seeking public comment on all aspects of this proposed rule
and the Economic Analysis prepared in support of this proposed rule
(Ref. 2). In addition to specific requests for comment included
throughout this document, EPA is interested in comments pertaining to
specific issues discussed in this unit. EPA encourages all interested
persons to submit comments on the issues identified in this proposed
rule and to identify any other relevant issues as well. This input will
assist the Agency in developing a final rule that successfully
addresses information needs while minimizing potential reporting
burdens associated with the rulemaking. EPA requests that commenters
making specific recommendations include supporting
[[Page 29091]]
documentation where appropriate. EPA invites specific comment on:
<bullet> EPA's interpretation of the coverage of TSCA section 14(a)
(proposed section 703.1), and how this may impact submitters of
information to the Agency under other statutes, such as FIFRA. EPA is
particularly interested in comments on the treatment of FIFRA studies
on inert ingredients under TSCA section 14(b)(2).
<bullet> The applicability of the proposed new or revised
requirements to submissions received before the effective date of the
subsequent final rule. Specifically, EPA requests comment on whether
each proposed new or revised requirement should apply only to
submissions received on or after the effective date of the final rule;
to all submissions received on or after the effective date of the
Lautenberg amendments; or to all submissions regardless of submission
date.
<bullet> The proposed substantiation questions (proposed section
703.5(b)), especially the proposal to omit a trade secrets-specific
question; on how the patents question might be modified to elicit more
pertinent information; and comment on the alternative substantial
competitive harm question.
<bullet> The proposed list of information that might be included
with health and safety information, but that might be permissible to
withhold as confidential (proposed section 703.5(b)(6)). EPA is also
interested in comment on alternatives to the proposal that might better
assure that health and safety information is not inappropriately
treated as confidential.
<bullet> The proposed approach to CBI claim deficiencies (proposed
section 703.5(e)) and on alternative approaches.
<bullet> Whether submitting templated data should be required
(proposed section 703.5(g)).
<bullet> The option of requiring TSCA submitters to update their
original submission to reflect CBI claims that have been withdrawn or
denied (proposed section 703.5(j)).
<bullet> Selection of the representative subset, including possible
alternative representative selection methods (proposed section 703.7).
<bullet> Whether bona fide or pre-notice inquiries or
correspondence should be considered part of a representative subset of
TSCA submissions (proposed section 703.7).
<bullet> On the proposed approach to determining when a TSCA
section 14(g) CBI review period begins and how amendments to the
submission are included in the review (proposed section 703.7).
<bullet> The proposed and alternative possible approaches to
efficiently developing an acceptable generic name for purposes of
listing on the TSCA Inventory, as described in proposed sections
720.102 and 725.190.
<bullet> On how to incorporate whether a substance may be readily
reverse engineered into the Agency's substantive review criteria in
proposed section 703.7(f).
IV. References
The following is a list of the documents that are specifically
referenced in this document. The docket includes these documents 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 person listed under FOR FURTHER INFORMATION CONTACT.
1. U.S. EPA. Electronic Reporting under the Toxic Substances Control
Act; Final Rule. Federal Register. 78 FR 72818, December 4, 2013
(FRL-9394-6).
2. U.S. EPA. Economic Impact Analysis for the Procedures for
Submitting Information Subject to Business Confidentiality Claims
under the Toxic Substances Control Act (TSCA); Proposed Rule. April
4, 2022.
3. U.S. EPA. Procedures for Review of CBI Claims for the Identity of
Chemicals on the TSCA Inventory; Final Rule. Federal Register. 85 FR
13062, March 6, 2020 (FRL-10005-48).
4. U.S. EPA. TSCA Chemical Substances; Unique Identifier Assignment
and Application Policy; Notice of Availability. Federal Register. 83
FR 30168, June 27, 2018 (FRL-9979-59).
5. U.S. EPA. Guidance on Expanded Access to TSCA Confidential
Business Information; Notice of Availability. Federal Register. 83
FR 30171, June 27, 2018 (FRL-9979-75).
6. U.S. EPA. Statutory Requirements for Substantiation of
Confidential Business Information (CBI) Claims Under the Toxic
Substances Control Act (TSCA); Notice. Federal Register. 82 FR 6522,
January 19, 2017 (FRL-9958-34).
7. U.S. EPA. TSCA Chemical Data Reporting Revisions Under TSCA
Section 8(a); Final Rule. Federal Register. 85 FR 20122, April 9,
2020 (FRL-10005-56).
8. U.S. EPA. Guidance for Creating Generic Names for Confidential
Chemical Substance Identity Reporting Under the Toxic Substances
Control Act; Notice of Availability. Federal Register. 83 FR 30173,
June 27, 2018 (FRL-9979-02).
9. U.S. EPA. Guidance for Creating Generic Names for Confidential
Chemical Substance Identity Reporting under TSCA. Publication ID No.
EPA 743B18001. June 2018. Available at: <a href="https://www.epa.gov/sites/production/files/2018-06/documents/san6814_guidance_for_creating_tsca_generic_names_2018-06-13_final.pdf">https://www.epa.gov/sites/production/files/2018-06/documents/san6814_guidance_for_creating_tsca_generic_names_2018-06-13_final.pdf</a>.
10. U.S. EPA, Office of Pollution Prevention and Toxics. Points to
Consider in the Preparation of TSCA Biotechnology Submissions for
Microorganisms. June 2, 1997. Available at: <a href="https://www.epa.gov/sites/production/files/2015-08/documents/biotech_points_to_consider.pdf">https://www.epa.gov/sites/production/files/2015-08/documents/biotech_points_to_consider.pdf</a>.
11. U.S. EPA. Response to Public Comments, TSCA Chemical Data
Reporting Revisions for Reporting and Recordkeeping Requirements
under TSCA Section 8(a) (RIN 2070-AK33). Document ID No. EPA-HQ-
OPPT-2018-0321-0140. March 2020. Available at: <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0321-0140">https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0321-0140</a>.
12. U.S. EPA. Information Collection Request (ICR) entitled:
Confidential Business Information Claims under the Toxic Substances
Control Act (TSCA)--Proposed Rule (RIN 2070-AK68). EPA ICR No.:
2706.01; OMB Control No.: 2070-NEW. April 4, 2022.
V. Statutory and Executive Orders Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="http://www2.epa.gov/laws-regulations/laws-and-executive-orders">http://www2.epa.gov/laws-regulations/laws-and-executive-orders</a>.
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). EPA prepared an analysis of the estimated costs and
benefits associated with this action (Ref. 2), which is available in
the docket and is summarized in Unit I.D. 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. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et
seq. The Information Collection Request (ICR) document that EPA
prepared has been assigned EPA ICR No. 2706.01 (Ref. 12). You can find
a copy of the ICR in the docket for this action, and it is briefly
summarized here.
The reporting requirements identified in this proposed rule
implement statutory requirements in TSCA section 14, including new
requirements that persons submitting information under
[[Page 29092]]
TSCA must substantiate most confidentiality claims at the time of
submission, as well as additional certification and generic name
requirements. In order to maintain most claims beyond a 10-year period,
submitters will also be required to reassert and substantiate those
claims. Several new requirements also apply to EPA, including
requirements to review and approve or deny all chemical identity claims
asserted concerning substances that are offered for commercial
distribution, as well a subset of all other confidentiality claims,
within 90 days of the claim being asserted. Further requirements that
EPA review all confidentiality claims concerning substances listed as
active on the TSCA Inventory, a requirement to assign and apply unique
identifiers (UIDs) to substances with approved confidentiality claims
for chemical identity, as well as new provisions providing expanded
access to TSCA Confidential Business Information (CBI), have been
discussed in previous Federal Register documents. Additionally, TSCA
rules promulgated since the Lautenberg amendments have included
confidentiality provisions conforming to the amendments (e.g., 40 CFR
parts 710 and 711).
Respondents/affected entities: Firms asserting claims for
confidentiality in submissions to EPA under TSCA.
Respondent's obligation to respond: Required to obtain or retain a
benefit. TSCA section 14; 15 U.S.C. 2613.
Estimated number of respondents: 1,100 firms with an estimated
additional 55 new firms each year.
Frequency of response: On occasion.
Total estimated burden: 2,945 hours paperwork burden in the first
year and 523 hours in each following year. Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $ 270,783 in the first year and $ 44,605 in
each following year (2020$), and an estimated cost of $ 0 for non-
burden hour paperwork costs, e.g., capital investment or maintenance
and operational costs.
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 for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and displayed on the information
collection instruments (e.g., forms, instructions).
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 proposed rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs using
the interface at <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this
particular ICR by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. 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 June 13, 2022. The EPA
will respond to ICR-related comments in the final rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are chemical manufacturers (including importers). EPA
estimates that 1,096 small firms would be affected by the proposed
requirements. Of those small firms, 100% would have cost impacts of
less than 1% of annual revenues, which EPA has determined does not
qualify as a significant impact. Details of this analysis are presented
in the Economic Analysis of the proposed rule (Ref. 2), which is
available in the docket.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local or tribal governments or the
private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 4, 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.
F. 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 does not have
substantial direct effects on tribal government because asbestos is not
manufactured (including imported) or processed by tribes and would not
impose substantial direct compliance costs on tribal governments.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying only to those regulatory actions that concern
environmental health or safety risks that the EPA has reason to believe
may disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy and has not otherwise been designated by the Administrator of
OMB's Office of Information and Regulatory Affairs as a ``significant
energy action.'' The action is predicted to reduce energy use and is
not expected to reduce energy supply or increase energy prices.
I. National Technology Transfer and Advancement Act (NTTAA)
This proposed action does not involve any technical standards as
specified in NTTAA section 12(d), 15 U.S.C. 272 note.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
List of Subjects
40 CFR Part 2
Administrative practice and procedure, Confidential business
information, Courts, Environmental protection, Freedom of information,
Government employees.
[[Page 29093]]
40 CFR Part 702
Administrative practice and procedure, Chemicals, Environmental
protection, Hazardous substances.
40 CFR Part 703
Administrative practice and procedure, Chemicals, Confidential
business information, Environmental protection, Exports, Hazardous
substances, Imports, Reporting and recordkeeping requirements.
40 CFR Part 704
Chemicals, Environmental protection, Exports, Hazardous substances,
Imports, Reporting and recordkeeping requirements.
40 CFR Part 707
Chemicals, Environmental protection, Exports, Hazardous substances,
Imports, Reporting and recordkeeping requirements.
40 CFR Part 716
Chemicals, Confidential business information, Environmental
protection, Hazardous substances, Health, Reporting and recordkeeping
requirements, Safety.
40 CFR Part 717
Chemicals, Environmental protection, Hazardous substances,
Reporting and recordkeeping requirements.
40 CFR Part 720
Chemicals, Environmental protection, Hazardous substances, Imports,
Reporting and recordkeeping requirements.
40 CFR Part 723
Chemicals, Environmental protection, Hazardous substances,
Phosphate, Reporting and recordkeeping requirements.
40 CFR Part 725
Administrative practice and procedure, Biologics, Chemicals,
Environmental protection, Hazardous substances, Imports, Labeling,
Microorganisms, Occupational safety and health, Reporting and
recordkeeping requirements.
40 CFR Part 790
Administrative practice and procedure, Biologics, Chemicals,
Environmental protection, Hazardous substances, Imports, Labeling,
Microorganisms, Occupational safety and health, Reporting and
recordkeeping requirements.
Authority: 15 U.S.C. 2603, 2604, 2605, 2607, 2613, 2619, and
2625 et seq.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, it is proposed
that 40 CFR chapter I be amended as follows:
PART 2--PUBLIC INFORMATION
0
1. The authority citation for part 2 continues to read as follows:
Authority: 5 U.S.C. 552, 552a, 553; 28 U.S.C. 509, 510, 534; 31
U.S.C. 3717.
0
2. Revise Sec. 2.306 to read as follows:
Sec. 2.306 Special rules governing certain information obtained
under the Toxic Substances Control Act.
(a) Definitions. For the purposes of this section:
(1) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et
seq.
(2) Chemical substance has the meaning given it in section 3(2) of
the Act, 15 U.S.C. 2602(2).
(3) EPA Legal Office means the EPA Office of General Counsel and
any EPA office over which the EPA General Counsel exercises supervisory
authority.
(4) Proceeding means any rulemaking, adjudication, or licensing
conducted by EPA under the Act or under regulations which implement the
Act, except for determinations under this subpart.
(b) Applicability. This section applies as set forth in 40 CFR
703.1.
(c) Basic rules that apply without change. Sections 2.210, 2.211,
2.212, 2.214, and 2.215 apply without change to information to which
this section applies. Unless otherwise specified in Sec. 2.306, the
provisions in Sec. Sec. 2.201 through 2.205 and 2.208 do not apply to
information subject to this section. Instead, the provisions of 40 CFR
part 703 provide the requirements and procedures relevant to
confidentiality determinations for information submitted to EPA under
the Act.
(d) Disclosure in special circumstances. Disclosures of information
claimed as confidential under TSCA section 14(d)(4), (5), and (6) may
be made in accordance with the provisions of the Act, Sec. 2.306 and
any applicable EPA guidance required by section 14(c)(4)(B) of the Act.
Section 2.209 applies to information to which this section applies,
except that:
(1) The following two additional provisions apply to Sec.
2.209(c):
(i) The official purpose for which the information is needed must
be in connection with the agency's duties under any law for protection
of health or the environment or for specific law enforcement purposes;
and
(ii) EPA notifies the other agency that the information was
acquired under authority of the Act and that any knowing disclosure of
the information may subject the officers and employees of the other
agency to the penalties in section 14(h) of the Act (15 U.S.C.
2613(h)).
(2) The 10 business day period for notification specified in Sec.
2.209(b)(2) is instead 15 business days.
(3) The timeline for notification in Sec. 2.209(d) is replaced by
the timeline for notification in 15 U.S.C. 2613(g)(2)(B).
(e) Disclosure of information relevant in a proceeding. (1) Under
section 14(d)(7) of the Act (15 U.S.C. 2613(d)(7)), any information to
which this section applies may be disclosed by EPA when the information
is relevant in a proceeding under the Act, notwithstanding the fact
that the information otherwise might be entitled to confidential
treatment under this subpart. However, any such disclosure shall be
made in a manner that preserves the confidentiality of the information
to the extent practicable without impairing the proceeding. Disclosure
of information to which this section applies because of its relevance
in a proceeding shall be made only in accordance with this paragraph
(e).
(2) The provisions of Sec. 2.301(g)(2) through (4) apply to
disclosures under this paragraph (e).
(f) Disclosure of information to contractors and subcontractors.
(1) Under section 14(d)(2) of the Act (15 U.S.C. 2613(d)(2)), any
information to which this section applies may be disclosed by EPA to a
contractor or subcontractor of the United States that is necessary for
the satisfactory performance of their work in connection with the Act,
notwithstanding the fact that the information otherwise might be
entitled to confidential treatment under this subpart. Subject to the
limitations in this paragraph (f), information to which this section
applies may be disclosed:
(i) To a contractor or subcontractor with EPA, if the EPA program
office managing the contract first determines in writing that such
disclosure is necessary for the satisfactory performance by the
contractor or subcontractor of the contract or subcontract; or
(ii) To a contractor or subcontractor with an agency other than
EPA, if the EPA program office which provides the information to that
agency, contractor, or subcontractor first determines in writing, in
consultation with the General Counsel, that such disclosure is
necessary for the satisfactory performance by the contractor or
[[Page 29094]]
subcontractor of the contract or subcontract.
(2) The provisions of Sec. 2.301(h)(2)(ii) through (iv) apply to
disclosures under this paragraph (f).
(3) At the time any information is furnished to a contractor or
subcontractor under this paragraph (f), the EPA office furnishing the
information to the contractor or subcontractor shall notify the
contractor or subcontractor that the information was acquired under
authority of the Act and that any knowing disclosure of the information
may subject the contractor or subcontractor and its employees to the
penalties in section 14(d) of the Act (15 U.S.C. 2613(d)).
(g) Disclosure of information when necessary to protect health or
the environment against an unreasonable risk of injury. (1) Under
section 14(d)(3) of the Act (15 U.S.C 2613(d)(3)), any information to
which this section applies may be disclosed by EPA when disclosure is
necessary to protect health or the environment against an unreasonable
risk of injury to health or the environment, without consideration of
costs, or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation as relevant by EPA
under conditions of use. However, any disclosure shall be made in a
manner that preserves the confidentiality of the information to the
extent not inconsistent with protecting health or the environment
against the unreasonable risk of injury. Disclosure of information to
which this section applies because of the need to protect health or the
environment against an unreasonable risk of injury shall be made only
in accordance with this paragraph (g).
(2) If any EPA office determines that there is an unreasonable risk
of injury to health or the environment and that to protect health or
the environment against the unreasonable risk of injury it is necessary
to disclose information to which this section applies that otherwise
might be entitled to confidential treatment under this subpart, the EPA
office shall notify the EPA Legal Office in writing of the nature of
the unreasonable risk of injury, the extent of the disclosure proposed,
how the proposed disclosure will serve to protect health or the
environment against the unreasonable risk of injury, and the proposed
date of disclosure. Such notification shall be made as soon as
practicable after discovery of the unreasonable risk of injury. If the
EPA office determines that the risk of injury is so imminent that it is
impracticable to furnish written notification to the EPA Legal Office,
the EPA office shall notify the EPA Legal Office orally.
(3) Upon receipt of notification under paragraph (g)(2) of this
section, the EPA Legal Office shall make a determination in writing
whether disclosure of information to which this section applies that
otherwise might be entitled to confidential treatment is necessary to
protect health or the environment against an unreasonable risk of
injury. The EPA Legal Office shall also determine the extent of
disclosure necessary to protect against the unreasonable risk of injury
as well as when the disclosure must be made to protect against the
unreasonable risk of injury.
(4) If the EPA Legal Office determines that disclosure of
information to which this section applies that otherwise might be
entitled to confidential treatment is necessary to protect health or
the environment against an unreasonable risk of injury, the EPA Legal
Office shall furnish notice to each affected business of the
contemplated disclosure and of the Legal Office's determination. Such
notice shall be made in writing, via either electronic notice as
described in 40 CFR 703.5(h) or by certified mail, return receipt
requested, at least 15 business days before the disclosure is to be
made. The notice shall state the date upon which disclosure will be
made. However, if the EPA Legal Office determines that disclosure of
the information is necessary to protect against an imminent and
substantial harm to health or the environment, no prior notification is
necessary.
PART 702--GENERAL PRACTICES AND PROCEDURES
0
3. The authority citation for part 702 continues to read as follows:
Authority: 15 U.S.C. 2605 and 2619.
0
4. Revise Sec. 702.37(d) to read as follows:
Sec. 702.37 Submission of manufacturer requests for risk
evaluations.
* * * * *
(d) Confidential business information. Claims of confidentiality
must be made in accordance with the procedures described in 40 CFR part
703.
* * * * *
0
5. Add part 703 to read as follows:
PART 703--CONFIDENTIALITY CLAIMS
Sec.
703.1 Purpose and applicability.
703.3 Definitions.
703.5 Requirements for asserting and maintaining confidentiality
claims.
703.7 EPA review of confidentiality claims under TSCA Section 14(g).
703.8 EPA review of confidentiality claims under TSCA Section 14(f).
Authority: 15 U.S.C. 2613.
Sec. 703.1 Purpose and applicability.
(a) The purpose of this part is to describe procedures for
asserting and maintaining confidentiality claims in accordance with
TSCA section 14, and for EPA review of such claims. The procedures
described in this part are generally applicable to the submission and
EPA review of any TSCA submission, except to the extent that
application of the requirements would be inconsistent with TSCA section
14(i). The procedures include requirements concerning the form and
manner in which TSCA submissions must be made to meet the requirements
in TSCA section 14(b) and (c), to facilitate EPA review of such claims
in accordance with TSCA section 14(f) and (g), and to facilitate
disclosure of non-confidential information to the public in accordance
with TSCA, FOIA, and their implementing regulations.
(b) This part applies to all information that is reported to or
otherwise obtained by EPA pursuant to TSCA or its implementing
regulations. Unless otherwise specified in 40 CFR 2.306, the provisions
of 40 CFR 2.201 through 2.205 and 40 CFR 2.208 do not apply to
information subject to this part. This part also applies to information
that satisfies all three of the following criteria:
(1) The information was first obtained by EPA other than pursuant
to the authority of TSCA or its implementing regulations;
(2) EPA has authority to collect the information under TSCA; and
(3) Either:
(i) Subsequent to its submission the information is being used to
satisfy the obligation of a person under TSCA or its implementing
regulations; or
(ii) EPA makes use of the information in the course of carrying out
its responsibilities under TSCA.
(c)(1) This part applies regardless of:
(i) Whether the information is intended by its submitter to be used
by EPA in implementing TSCA;
(ii) Whether TSCA or an implementing regulation was cited as
authority for the request or submission of the information; or
(iii) Whether the information was provided directly to EPA or
through some third person.
(2) In the event the information satisfies the requirements of
Sec. 703.1, and such information was originally submitted to or
obtained by EPA under
[[Page 29095]]
another statute, and the other statute or its implementing regulations
prescribe conflicting rules for the treatment of the information, the
statute or rule under which the information was provided to EPA shall
govern, except that the provisions in 40 CFR 2.306(d) through (f)
apply, where relevant, to how EPA may share such information.
Sec. 703.3 Definitions.
The definitions in this section and the definitions in TSCA section
3 apply to this part. In addition, the definition in Sec. 720.3(ff)
for test data also applies in this part.
Accepted in the context of asserting a TSCA CBI claim means the
date that EPA first approved the submission in CISS, or its successor
system.
CDX or Central Data Exchange means EPA's centralized electronic
document receiving system, or its successor system.
CISS or Chemical Information Submission System means EPA's web-
based reporting tool for preparing and submitting TSCA submissions, or
its successor system.
Confidentiality claim means a claim or allegation that business
information is entitled to confidential treatment.
Health and safety study has the same meaning as that provided in
Sec. 720.3(k), except that for purposes of this part 703 the following
information is not part of a health and safety study:
(1) The name of the submitting company;
(2) The name of the laboratory conducting the study;
(3) Internal product codes;
(4) The names of laboratory personnel;
(5) Names of individual study subjects and other private
information included in study data or reports;
(6) Cost and other financial data; and
(7) Product development, advertising, and marketing plans.
Sec. 703.5 Requirements for asserting and maintaining
confidentiality claims.
Any person who submits information under TSCA or these implementing
regulations may assert a business confidentiality claim to information
included in such submission. Such claim must be made concurrent with
submission of the information. If no such claim accompanies the
submission, EPA will not recognize a confidentiality claim, and the
information in or referred to in that submission may be made available
to the public (e.g., by publication of specific chemical name and CASRN
on the public portion of the TSCA Inventory) without further notice.
(a) Supporting statement and certification. A person asserting a
confidentiality claim must submit a statement that the person has:
(1) Taken reasonable measures to protect the confidentiality of the
information;
(2) Determined that the information is not required to be disclosed
or otherwise made available to the public under any other Federal law;
(3) A reasonable basis to conclude that disclosure of the
information is likely to cause substantial harm to the competitive
position of the person; and
(4) A reasonable basis to believe that the information is not
readily discoverable through reverse engineering.
(5) The person must also certify that these four statements and any
information required to substantiate the confidentiality claim in
accordance with paragraph (b) of this section are true and correct.
(b) Substantiation. (1) Timing of substantiation. Confidentiality
claims must be substantiated at the time of submission to EPA, unless
exempt under paragraph (b)(5) of this section. In the case of
information collected by EPA or on behalf of EPA in person at the site
of a TSCA inspection under section 11 of the Act, the affected company
must assert its confidentiality claim(s) in writing at the time the
information is collected, and then must provide substantiation of its
confidentiality claims and the supporting statement and certification
described in paragraph (a) of this section within ten working days
after the inspection ends.
(2) Confidentiality claims in substantiation. Information in
substantiations may be claimed as confidential. Such claims must be
accompanied by the certification described in paragraph (a) of this
section, but need not be themselves substantiated.
(3) Substantiation questions for all claims. Unless otherwise
specified elsewhere in 40 CFR 700 et seq (e.g., 40 CFR part 711),
answers to the following questions must be provided for each
confidentiality claim in a TSCA submission:
(i) Please specifically explain what harm to the competitive
position of your business would be likely to result from the release of
the information claimed as confidential. How would that harm be
substantial? Why is the substantial harm to your competitive position
likely (i.e., probable) to be caused by release of the information
rather than just possible? If you claimed multiple types of information
to be confidential (e.g., site information, exposure information,
environmental release information, etc.), explain how disclosure of
each type of information would be likely to cause substantial harm to
the competitive position of your business.
(ii) Has your business taken precautions to protect the
confidentiality of the disclosed information? If yes, please explain
and identify the specific measures, including but not limited to
internal controls, that your business has taken to protect the
information claimed as confidential. If the same or similar information
was previously reported to EPA as non-confidential (such as in an
earlier version of this submission), please explain the circumstances
of that prior submission and reasons for believing the information is
nonetheless still confidential.
(iii)(A) Is any of the information claimed as confidential required
to be publicly disclosed under any other Federal law? If yes, please
explain.
(B) Does any of the information claimed as confidential otherwise
appear in any public documents, including (but not limited to) safety
data sheets; advertising or promotional material; professional or trade
publications; state, local, or Federal agency files; or any other media
or publications available to the general public? If yes, please explain
why the information should be treated as confidential.
(C) Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
(iv) Is the claim of confidentiality intended to last less than 10
years (see TSCA section 14(e)(1)(B))? If yes, please indicate the
number of years (between 1 and 10 years) or the specific date after
which the claim is withdrawn.
(v) Has EPA, another Federal agency, or court made any
confidentiality determination regarding information associated with
this chemical substance? If yes, please provide the circumstances
associated with the prior determination, whether the information was
found to be entitled to confidential treatment, the entity that made
the decision, and the date of the determination.
(4) Additional substantiation questions for chemical identity-
related claims only. Unless otherwise specified in the relevant
electronic reporting form, answers to the following questions must be
provided for each chemical
[[Page 29096]]
identity-related confidentiality claim in a TSCA submission:
(i) Is this chemical substance publicly known (including by your
competitors) to be in U.S. commerce? If yes, please explain why the
specific chemical identity should still be afforded confidential status
(e.g., the chemical substance is publicly known only as being
distributed in commerce for research and development purposes, but no
other information about the current commercial distribution of the
chemical substance in the United States is publicly available). If no,
please complete the certification statement:
I certify that on the date referenced I searched the internet
for the chemical substance identity (i.e., by both chemical
substance name and CASRN). I did not find a reference to this
chemical substance and have no knowledge of public information that
would indicate that the chemical is being manufactured or imported
by anyone for a commercial purpose in the United States. [provide
date].
(ii) Does this specific chemical substance leave the site of
manufacture (including import) in any form, e.g., as a product,
effluent, emission? If yes, please explain what measures have been
taken to guard against the discovery of its identity.
(iii) If the chemical substance leaves the site in a form that is
available to the public or your competitors, can the chemical identity
be readily discovered by analysis of the substance (e.g., product,
effluent, emission), in light of existing technologies and any costs,
difficulties, or limitations associated with such technologies? Please
explain why or why not.
(iv) Would disclosure of the specific chemical identity release
confidential process information? If yes, please explain.
(5) Exemptions from the substantiation requirement. Information
described in paragraphs (b)(5)(i) and (b)(5)(ii) of this section is
exempt from the requirement to substantiate the claim at the time of
submission. EPA may identify on a reporting form certain information as
exempt from substantiation. Additional assertions of exemption from
substantiation may be asserted by the submitter. Each such assertion
must include a detailed explanation for why the information falls
within the claimed exemption. If the explanation is missing or
inadequate, and the claim is not otherwise substantiated, EPA will
place a hold on the submission, as described in paragraph (d) of this
section.
(i) The following information types are exempt from the
substantiation requirement at the time of information submission:
(A) Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture, or article;
(B) Marketing and sales information;
(C) Information identifying a supplier or customer;
(D) Details of the full composition of a mixture and the respective
percentages of constituents;
(E) Specific information regarding the use, function, or
application of a chemical substance or mixture in a process, mixture,
or article; and
(F) Specific production or import volumes.
(ii) Exemption for chemical substances not yet offered for
commercial distribution.
(A) A confidentiality claim for specific identity of a chemical
substance, where the submission is made prior to the date on which the
chemical substance whose identity is claimed as confidential is first
offered for commercial distribution, is exempt from the requirement to
substantiate confidentiality claims at the time of submission.
(B) A specific chemical identity claim includes specific chemical
names, CAS numbers, molecular formulas, reactants (if required to be
reported as part of the identification of the chemical, such as for
Class 2 substances in Sec. 720.45(a)), and structural diagrams; or in
the case of microorganisms, genus and species name and genetic
construct.
(C) This exemption applies where the submitter lacks information to
reasonably conclude that the chemical substance has been offered for
commercial distribution, where both:
(1) The chemical substance is not on the TSCA Inventory, and
(2) The substance is otherwise not publicly known to have been
offered for commercial distribution.
(c) Public copies. All TSCA submissions and their accompanying
attachments that include a confidentiality claim must be accompanied,
at the time of submission, by a public version of the submission and
any attachments, with all information that is claimed as confidential
removed. In the case of documents collected by EPA or on behalf of EPA
in person at the site of a TSCA inspection under section 11 of the Act,
the affected company must provide such public copies at the same time
as it provides substantiation of its confidentiality claims in
accordance with paragraph (b)(1) of this section, within ten working
days after the inspection ends. Only information that is claimed as
confidential may be redacted or removed. Generally, a public copy that
removes all or substantially all of the information would not meet the
requirements of this paragraph (c) of this section and the submission
may be temporarily put on hold as deficient.
(1) Where the applicable reporting form or electronic reporting
tool contains a checkbox or other means of designating with specificity
what information is claimed as confidential, no further action by the
submitter is required to satisfy this requirement.
(2) For all other information claimed as confidential, including
but not limited to information in attachments and in substantiations
required under paragraph (b) of this section, the submitter must
prepare and attach a public copy. EPA may hold as deficient submissions
with public or sanitized copies that are entirely blank or that are
substantially reduced in length as compared to the CBI version (see
paragraph (e) of this section).
(d) Generic name. Each confidentiality claim for specific chemical
identity must be accompanied by a structurally descriptive generic name
for that substance. This generic name must be consistent with guidance
on the determination of structurally descriptive generic names
developed in accordance with TSCA section 14(c)(4)(A) (e.g., Guidance
for Creating Generic Names for Confidential Chemical Substance Identity
Reporting under TSCA; available at <a href="https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting">https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting</a>), and 15 U.S.C. 2613(c)(1)(C)(ii).
(1) At a minimum, the generic name must either:
(i) Be identical to the generic name for the same substance
included on the non-confidential portion of the TSCA Inventory (if the
substance is listed on the TSCA Inventory), or
(ii) For substances that are not listed on the TSCA Inventory, mask
only the confidential portions of the specific chemical name. In most
cases, only one structural element of a specific chemical name may be
masked to protect a confidential chemical identity--if the submitter of
a proposed generic name wishes to mask more than one such element, the
submission must include an explanation of why masking only one element
is insufficient to protect the confidential identity.
(2) Notwithstanding paragraph (d)(1) of this section, EPA may
conclude that a generic name provided with the submission and listed on
the current non-confidential version of the TSCA
[[Page 29097]]
Inventory does not comply with 15 U.S.C. 2613(c)(1)(C). In such cases,
EPA will notify the submitting company and proceed as described in
paragraph (c)(4) of this section.
(3) A generic name that meets the requirements of section
14(c)(1)(C) of the Act prior to the date on which the chemical
substance is first offered for commercial distribution for the purposes
of a pre-market submission (e.g., a PMN) may not be sufficient for the
purposes of subsequent listing on the TSCA Inventory, as identified
upon review under section 14(g)(1)(C)(i) of the Act of a
confidentiality claim for specific chemical identity made in a Notice
of Commencement required under Sec. 720.102 or Sec. 725.190(f). In
such cases, EPA will notify the submitting company and proceed as
described in Sec. 720.102(f) or Sec. 725.190(f).
(4) If EPA concludes that the proposed generic name does not comply
with 15 U.S.C. 2613(c)(1)(C), EPA will notify the submitter, and
provide 10 business days for the submitter to provide a revised generic
name. If EPA concludes that the revised generic name is still not
acceptable, EPA will hold the submission for an additional period of up
to 10 business days, and proceed as set out in paragraph (e) of this
section.
(e) Deficient confidentiality claims. (1) A confidentiality claim
under TSCA is deficient if it meets one or more of the following
criteria:
(i) The confidentiality claim is not accompanied by the supporting
statement and certification required by paragraph (a) of this section.
(ii) The confidentiality claim is not accompanied by the
substantiation required by paragraph (b) of this section. If the
submitter claims an exemption from substantiation under paragraph
(b)(5) of this section and the exemption does not apply or an
explanation is not provided for the exemption pursuant to paragraph
(b)(5) of this section, the confidentiality claim is deficient.
(iii) The confidentiality claim is not accompanied by a public copy
that meets the requirements of paragraph (c) of this section.
(iv) The confidentiality claim is for a specific chemical identity
and is not accompanied by a generic name that meets the requirements of
paragraph (d) of this section.
(2) A submission that is identified as deficient under paragraph
(e)(1) of this section will be held for a period of up to 10 business
days, and the submitter will be notified via CDX as described in
paragraph (h) of this section. During the hold, which commences on the
day the CDX notice is sent, any applicable review period for the
underlying submission will be suspended until either the deficiency is
corrected or the 10 business days elapse without such correction. Upon
the occurrence of the first of either of these events, the applicable
review period for the underlying submission commences or comes out of
suspension. If the deficiency is not remedied during the suspension,
EPA will proceed with review of the submission and may deny the CBI
claim(s).
(f) Electronic reporting required. (1) Except in the case of
information subpoenaed under TSCA section 11(c) or materials collected
or requested by EPA as part of an inspection under TSCA section 11(a),
TSCA submissions bearing confidentiality claims must be submitted via
CDX.
(2) You must use CISS to complete and submit TSCA submissions via
CDX. To access CISS go to <a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a> and follow the
appropriate links.
(3) On receipt by EPA, each electronic TSCA submission will be
assigned a case number or document identifier, which will be available
to the submitter in their CDX account. This identifier may be used as a
reference in future communications that concern the substance, and may
be used by EPA in public communications (e.g., Federal Register
notices) that concern the submission, such as notices of receipt, final
confidentiality determination, pending confidentiality claim
expiration, or in other regulatory actions that concern the TSCA
submission.
(g) Requirement to report health and safety studies using
templates. Submitters of health and safety studies or information from
such studies must provide such data in templated form, using an
appropriate OECD harmonized template, if such template is available for
the data type (<a href="https://www.oecd.org/ehs/templates/">https://www.oecd.org/ehs/templates/</a>). Individual test or
data submission rules or orders may specify an appropriate template or
templates. Submission of templated data is not a substitute for
submitting a full study report where a specific TSCA rule or order
requires submission of the full study report (e.g., Sec. 720.50(a), or
according to the terms of a specific order under TSCA section 5(e)).
(h) Requirement to maintain company contact information; electronic
notices concerning confidentiality claims. (1) To facilitate ongoing or
future communication concerning TSCA submissions, current contact
information for all of the individuals associated with a particular
TSCA submission must be maintained. Contact information for all the
individuals associated with a particular TSCA submission must be
updated by amending the submission via CDX, except that submissions
that are either no longer accessible to the submitting company or that
were not submitted via CDX (e.g., submissions that were originally
provided on paper or other physical media), updated company contact
must be provided via CDX using the appropriate EPA-provided electronic
reporting application in CISS. In circumstances where ownership of the
company or unit of a company has changed, such that contact information
for one or more prior TSCA submissions that include confidentiality
claims is affected, a notice of transfer of ownership must be directed
to EPA via CDX. Instructions for providing this notice and for
requesting access to copies of a prior TSCA submission are available at
<a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a>.
(2) When EPA contacts a TSCA submitter concerning confidentiality
claims (e.g., related to a pending or concluded confidentiality claim
review, a deficient submission, or in relation to the 10-year
expiration of a confidentiality claim (described in TSCA section
14(e)), EPA may provide notices and other correspondence to the
submitter via CDX, using the contact information provided in the most
recent version of the submission, or using the contact information
provided in a more recent notice of transfer of ownership relating to
that submission. The fact and date of delivery of such notice is
verified automatically by CDX.
(3) In addition to individual notice described in paragraph (h)(2)
of this section, EPA will publish on its website, or other appropriate
platform, a list of TSCA submissions with confidentiality claims that
are approaching the end of the ten-year period of protection described
in TSCA section 14(e). Such TSCA submissions will be referred to by the
TSCA case or document identifier (as described in paragraph (f)(3) of
this section) that was assigned to the submission by EPA when it was
originally submitted. TSCA submissions will be added to this list at
least 60 days prior to the end of the ten-year period of protection,
along with instructions for reasserting and substantiating expiring
claims.
(4) When a confidentiality claim is being reviewed pursuant to TSCA
section 14(f), EPA will provide, when necessary, notice of such review
and an opportunity to substantiate or resubstantiate the affected
confidentiality claim to the submitter using the contact information
for the authorized official or technical contact provided in the most
recent version of the submission or in a more recent
[[Page 29098]]
notice of transfer of ownership relating to that submission.
(5) Where the submission with the relevant CBI claim was not
originally made via CDX, EPA will send the notice via courier or US
Mail to the company address provided in the most recent TSCA submission
made by that company, or via other means that allows verification of
the fact and date of receipt. The notice will provide instructions for
substantiating claims that were exempt from substantiation when the
confidentiality claim was asserted or for which the submitter was
otherwise not required to provide substantiation at the time of initial
submission, and for updating or re-substantiating as necessary any
claims that were previously substantiated.
(i) Withdrawing confidentiality claims. TSCA confidentiality claims
may be voluntarily withdrawn by the submitter at any time.
(1) Confidentiality claims in TSCA submissions that were originally
made via electronic submission may be withdrawn by reopening the
submission in CDX, removing confidentiality markings (e.g.,
confidential checkmarks or bracketing), revising sanitized attachments
or copies as appropriate, and then resubmitting the submission.
(2) For submissions that were not originally made via CDX, or that
are no longer accessible to the submitting company via CDX,
confidentiality claims may also be withdrawn via CDX using the ``TSCA
Communications'' application or successor system. The withdrawal
correspondence must indicate the case or document number (or other
applicable document identifier or document identifying details) from
which CBI claims are being withdrawn, identify the submitting company,
and include a list or description of the information for which CBI
claims are being withdrawn, including page numbers where relevant.
Current contact information for the person withdrawing the claim must
also be provided, in the event EPA needs clarification concerning which
claim or claims are being withdrawn.
(j) Amending public copy following confidentiality claim denial or
expiration. (1) Following the expiration or EPA's denial of a TSCA
confidentiality claim, the person who asserted the denied or expired
claim should prepare and submit a revised public copy of the submission
to EPA, following the procedures for voluntarily withdrawing claims
described in Sec. 703.5(i).
(2) If the person who asserted the denied or expired claim declines
or fails to provide within 30 days a revised public copy of the
submission that includes the information for which the confidentiality
claim(s) were denied or expired, EPA may prepare an addendum to the
original public copy, as needed, in order to provide the newly
available information to the public.
Sec. 703.7 EPA review of confidentiality claims under TSCA Section
14(g)
(a) Representative subset. (1) Definition. A representative subset
consists of at least 25% of confidentiality claims asserted under TSCA,
not including claims for specific chemical identity or for the
categories of information listed in section 14(c)(2) of TSCA. Excluded
from the representative subset are
(i) Inquiries with respect to potential submission to EPA of a
notification under 40 CFR part 720, 721, 723 or 725 by a person who has
not submitted the notification at the time of the inquiry, including
inquiries under Sec. 720.25(b) or 721.11;
(ii) Submissions or other communication not submitted to EPA via
CDX; and
(iii) Amendments to previous TSCA submissions.
(2) Selection of submissions for review. To satisfy its
confidentiality claim review obligations under section 14(g)(1)(C)(ii)
of TSCA, EPA may review all claims (except those exempt from
substantiation under TSCA section 14(c)(2)) in every fourth TSCA
submission submitted via CDX that is part of the representative subset,
in chronological order of receipt by EPA. For each submission selected
for review as part of the representative subset, EPA reviews and
approves or denies every individual confidentiality claim in that
submission (except claims that are exempt under TSCA sections 14(c)(2)
and 14(g)), including claims made in attachments and amendments
available to EPA at the time of the review.
(b) Review of new and expiring confidentiality claims under TSCA
Section 14(g). (1) Under TSCA Section 14(g), EPA will review:
(i) All chemical identity claims asserted in TSCA submissions
except those that are exempt from substantiation according to TSCA
Section 14(c)(2)(G), and
(ii) A representative subset of other confidentiality claims as
provided in paragraph (a) of this section.
(2) EPA will review all timely requests for extension of claims
under section 14(e) of TSCA within 30 days of receipt.
(3) EPA will also review or re-review confidentiality claims under
certain other circumstances, as set out in TSCA section 14(f). TSCA
section 14(f) reviews are conducted in accordance with procedures set
out in Sec. 703.8.
(c) Commencement of the review period and effect of amendments.
Subject to Sec. 703.5(e), the 90-day review period described in TSCA
section 14(g) begins on the day that EPA accepts a new TSCA submission
that includes confidentiality claims. For new information, other than
specific chemical identity, added to a submission after EPA first
accepts the submission, the review will take into account such
amendments to that submission that are made either up to 60 days from
the original submission date, or until the Agency issues a final
confidentiality determination for the submission, whichever comes
first. If a submission is amended to report an additional or different
chemical substance that includes a new specific chemical identity
claim, the TSCA section 14(g) review period for the added chemical
identity begins on the day EPA accepts the amendment including the new
claim.
(d) Publication of final determinations. Final confidentiality
determinations will be published on EPA's website, or other platform,
periodically, in accordance with the requirements of TSCA section
26(j).
(e) Claim denials and notice period. Final determinations will be
issued by the General Counsel or their designee, which may include
personnel outside of the Office of General Counsel. In the case that
EPA determines that a claim or part of a claim is not entitled to
confidential treatment, EPA will provide notice of the denial to the
person who made the claim and provide reasons for the denial or denial
in part. The notice will be provided electronically, as described in
Sec. 703.5(h)(2). The 30-day notice period described in TSCA section
14(g)(2)(B) begins on the next business day following the date the
notice is made available to the submitter in their CDX account.
(f) Substantive criteria for use in confidentiality determinations.
Information claimed as confidential under TSCA section 14 will be
approved if:
(1) The business has asserted a business confidentiality claim
which has not expired by its terms, nor been waived nor withdrawn;
(2) The business has satisfactorily shown that it has taken
reasonable measures to protect the confidentiality of the information,
and that it intends to continue to take such measures for as long as
the claim is maintained;
[[Page 29099]]
(3) The 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; e.g., the business has demonstrated a reasonable basis to
believe the information is not readily discoverable through reverse
engineering);
(4) The business has demonstrated a reasonable basis to conclude
that disclosure of the information is likely to cause substantial harm
to the competitive position of the business; and
(5) No statute denies confidential protection to the information.
Information from health and safety studies is not entitled to
confidential treatment, except that the following information may be
entitled to confidential treatment if it otherwise meets the remainder
of criteria in this paragraph (f):
(i) Any information, including formulas (including molecular
structures) of a chemical substance or mixture, that discloses
processes used in the manufacturing or processing of a chemical
substance or mixture; or
(ii) In the case of a mixture, the portion of the mixture comprised
by any of the chemical substances in the mixture.
(g) Request for Reconsideration. Persons who received a denial or
partial denial notification under paragraph (e) of this section may
request reconsideration by the Office of General Counsel prior to the
end of the 30-day period specified in the notice and described under
paragraph (e) of this section. The business must make its request for
reconsideration electronically via CDX, following the instructions in
the notice. If a request for reconsideration is timely received, EPA
will suspend the 30-day notice period described in paragraph (e) of
this section while the Office of General Counsel reconsiders the
Agency's determination. Once the Office of General Counsel's
reconsideration is complete, the Agency will provide notification,
pursuant to Sec. 703.5(h), to the person of EPA's decision on the
request for reconsideration. If upon reconsideration the Agency upholds
the confidentiality determination, the 30-day notice period will
resume. The Office of General Counsel will perform its review de novo
and will only reconsider determinations based on the information
included with the original submission and amendments made up until the
time the final determination was issued.
(h) Criteria to use in consideration of requests for extension
under TSCA section 14(e). Requests to extend the period of
confidentiality protection under TSCA section 14(e) use the same
criteria as described under Sec. 703.7(f). Requests for extension may
rely on a substantiation previously provided to EPA, but the submitter
must recertify that the substantiation is still true and correct.
Sec. 703.8 EPA Review of Confidentiality Claims Under TSCA Section
14(f).
(a) Review of confidentiality claims initiated under TSCA Section
14(f). In accordance with the procedures described in this section, EPA
may review confidentiality claims that are subject to TSCA section
14(f)(1), and will review confidentiality claims subject to TSCA
section 14(f)(2) in the following situations:
(1) In response to a request under the Freedom of Information Act
(5 U.S.C. 552) for TSCA information claimed confidential;
(2) If EPA has reason to believe that information claimed
confidential does not qualify for protection from disclosure; or
(3) For any chemical substance EPA determines under TSCA section
6(b)(4)(A) presents an unreasonable risk of injury to health or the
environment.
(b) Substantiation exemptions not applicable. All confidentiality
claims asserted in submissions described by paragraph (a) of this
section are subject to the substantiation requirements, including those
that were initially exempt from substantiation according to section
14(c)(2) of TSCA.
(c) Additional substantiation. If necessary, such as in the case
that substantiation has not previously been provided for
confidentiality claims under review, or in the case that EPA has reason
to believe the substantiation is incomplete or out of date, EPA will
request additional substantiation from the person(s) that claimed the
information as confidential.
(d) Additional substantiation notice. If additional substantiation
is necessary, EPA will provide notice to the person that claimed the
information as confidential in the manner specified in Sec.
703.5(h)(4). The notice will provide the time allowed for additional
substantiation from the business and the method for requesting a time
extension if necessary. If the person does not make a timely response
or extension request, EPA will consider any existing substantiations in
its review of the claims or, in the case of any unsubstantiated claim,
EPA will construe this as a waiver of the claim and may make the
information public without any further notice to the submitter.
(e) Substantive criteria for use in confidentiality determinations.
The criteria in Sec. 703.7(f) apply to confidentiality determinations
initiated under TSCA section 14(f). For determinations required to
respond to a FOIA request, the criteria in Sec. 703.7(f) are
supplemented with one additional criterion that must be satisfied: The
business adequately demonstrates that the information is commercial or
financial information obtained from a person and is confidential within
the meaning of FOIA Exemption 4 (5 U.S.C. 552(b)(4)).
(f) Adverse determinations and notice period. Final determinations
will be issued by the General Counsel or their designee, including
personnel outside of the Office of General Counsel. Except for
instances where claims were waived, if EPA determines that information
claimed confidential does not qualify for protection from disclosure,
EPA will provide written notice to the person who asserted the claim.
The notice will be provided electronically, as described in Sec.
703.5(h)(2). The 30-day notice period described in TSCA section
14(g)(2)(B) begins on the next business day following the date the
notice is made available to the submitter in their CDX account.
(g) Disclosure of Information. After a final determination has been
made by EPA to release some or all of the information claimed as
confidential, the Agency shall make the information available to the
public (in the absence of a court order prohibiting disclosure)
whenever:
(1) The period provided for commencement by a business of an action
to obtain judicial review of the determination has expired without
notice to EPA of commencement of such an action; or
(2) The court, in a timely-commenced action, has denied the
person's motion for a preliminary injunction, or has otherwise upheld
the EPA determination.
(h) Notice relating to public requests for records. Any person
whose request for release of the information under 5 U.S.C. 552 is
pending at the time notice is given under paragraph (f) of this section
shall be furnished notice under 5 U.S.C. 552 either stating the
circumstances under which the some or all of the information will be
released or denying the request if all requested information was found
to be entitled to confidential treatment.
[[Page 29100]]
PART 704--REPORTING AND RECORDKEEPING REQUIREMENTS
0
6. The authority citation for part 704 continues to read as follows:
Authority: 15 U.S.C 2607(a).
0
7. Revise Sec. 704.7 to read as follows:
Sec. 704.7 Confidential business information claims.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
PART 707--CHEMICAL IMPORTS AND EXPORTS
0
8. The authority citation for part 707 continues to read as follows:
Authority: 15 U.S.C 2611(b) and 2612.
0
9. Amend Sec. 707.63 by redesignating paragraphs (a) through (d) as
paragraphs (b) through (e) and adding a new paragraph (a) to read as
follows:
Sec. 707.63 Definitions.
(a) CDX or Central Data Exchange means EPA's centralized electronic
document receiving system, or its successor system.
0
10. Amend Sec. 707.65 by revising paragraphs (a)(1) and (2), removing
paragraph (a)(3), and revising paragraph (c) to read as follows:
Sec. 707.65 Submission to the Agency.
(a) * * *
(1)(i) The notice must be for the first export or intended export
by an exporter to a particular country in a calendar year when the
chemical substance or mixture is the subject of an order issued, an
action that is pending, or relief that has been granted under TSCA
section 5(f), a rule that has been proposed or promulgated under TSCA
section 6, or an action that is pending or relief that has been granted
under TSCA section 7.
(ii) The notice must only be for the first export or intended
export by an exporter to a particular country when the chemical
substance or mixture is the subject of an order issued, an action that
is pending, or relief that has been granted under TSCA section 5(e), a
rule that has been proposed or promulgated under TSCA section 5(a)(2),
or when the submission of data is required under TSCA section 4 or
5(b). Under this paragraph (a)(1)(ii), notice of export to a particular
country is not required if an exporter previously submitted to EPA a
notice of export to that country prior to January 16, 2007.
(2) The notice must be submitted to EPA within seven days of
forming the intent to export or on the date of export, whichever is
earlier. A notice of intent to export must be based on a definite
contractual obligation, or an equivalent intra-company agreement, to
export the regulated chemical.
* * * * *
(c) Notices must be submitted via CDX, using the TSCA section 12(b)
Export Notification Application or its successor.
0
11. Amend Sec. 707.67 by revising paragraph (a) to read as follows:
Sec. 707.67 Contents of notice.
* * * * *
(a) The name of the regulated chemical as it appears in the TSCA
section 4, 5, 6, and/or 7 action. For substances on the confidential
portion of the TSCA Inventory, this means that the substance must be
identified by generic name and accession number, or by any other non-
confidential identifier under which it is listed on the TSCA section
12(b) reporting list maintained by EPA and available in the TSCA
section 12(b) Export Notification Application described in Sec.
707.65(c). If a category is regulated, the name of the individual
regulated chemical within that category, as well as the category, must
be given. The name must be that which appears in the TSCA Inventory, if
the chemical appears there.
* * * * *
0
12. Amend Sec. 707.75 by revising paragraph (d) to read as follows:
Sec. 707.75 Confidentiality
* * * * *
(d) Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
PART 716--HEALTH AND SAFETY DATA REPORTING
0
12. The authority citation for part 716 continues to read as follows:
Authority: 15 U.S.C 2607(d).
0
13. Revise Sec. 716.55 to read as follows:
Sec. 716.55 Confidentiality claims.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
PART 717--RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMCIAL
SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE
ENVIRONMENT
0
14. The authority citation for part 717 continues to read as follows:
Authority: 15 U.S.C 2607(c).
0
15. Amend Sec. 717.17 by revising paragraph (c) to read as follows:
Sec. 717.17 Inspection and reporting requirements.
* * * * *
(c) How to Report. When required to report, firms must submit
copies of records via CDX <a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a> using the EPA provided
electronic reporting application.
0
16. Revise Sec. 717.19 to read as follows:
Sec. 717.19 Confidentiality.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
PART 720--PREMANUFACTURE NOTIFICATION
0
17. The authority citation for part 720 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2613.
0
18. Revise Sec. 720.80 to read as follows:
Sec. 720.80 General provisions.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
* * * * *
Sec. 720.85 [Removed]
0
19. Remove Sec. 720.85.
Sec. 720.90 [Removed]
0
20. Remove Sec. 720.90.
0
21. Revise Sec. 720.95 to read as follows:
Sec. 720.95 Public file.
All information submitted with a notice, including any health and
safety study and other supporting documentation, will become part of
the public file for that notice, unless such materials are claimed
confidential in accordance with procedures in 40 CFR 703.5. In
addition, EPA may add materials to the public file, subject to subpart
E of this part. Publicly available materials are available at the
docket addresses in Sec. 700.17(b)(1) and (2) of this chapter and on
EPA's website.
0
22. Amend Sec. 720.102 by revising paragraph (c)(2) and adding
paragraphs (e) and (f) to read as follows:
Sec. 720.102 Notice of commencement of manufacture or import.
* * * * *
(c) * * *
(2) If the submitter claims any information on the form as
confidential, the claim must be asserted and substantiated in
accordance with the requirements described in 40 CFR part 703 and must
be submitted via EPA Form 7710-56. If the submitter wants the chemical
identity to be listed on the confidential portion of the TSCA
Inventory, the chemical identity must be claimed as confidential and
the submitter must also follow the
[[Page 29101]]
certification, substantiation, and generic name requirements described
part 703 and paragraphs (e) and (f) of this section. Otherwise, EPA
will list the specific chemical identity on the public TSCA Inventory.
Submitters who did not claim the chemical identity, submitter identity,
or other information to be confidential in the PMN cannot claim this
information as confidential in the notice of commencement.
* * * * *
(e) Confidentiality. (1) Any person who asserts a confidentiality
claim for chemical identity in a Notice of Commencement submitted under
Sec. 720.102 must:
(i) Comply with generic name requirements described in part 703 and
as specified in paragraph (f) of this section.
(ii) Agree that EPA may disclose to a person with a bona fide
intent to manufacture or import the chemical substance the fact that
the particular chemical substance is included on the confidential TSCA
Inventory for purposes of notification under section 5(a)(1)(A) of the
Act.
(iii) Have available for the particular chemical substance, and
agree to furnish to EPA upon request:
(A) An elemental analysis.
(B) Either an X-ray diffraction pattern (for inorganic substances),
a mass spectrum (for most other substances), or an infrared spectrum of
the particular chemical substance, or if such data do not resolve
uncertainties with respect to the identity of the chemical substance,
additional or alternative spectra or other data to identify the
chemical substance.
(2) Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
(f) Generic Name. If a submitter asserts a claim of confidentiality
for chemical identity in a notice of commencement, they must provide a
structurally descriptive generic name.
(1) Generic names must:
(i) Be structurally descriptive (e.g., not a trade name);
(ii) Describe the chemical structure of the chemical substance as
specifically as practicable while protecting only those features of the
chemical structure that are claimed as confidential and disclosure of
which would likely cause substantial harm to the competitive position
of the person--the generic name should generally only obscure one
structural feature, but in any case, should conceal only the feature(s)
necessary to avoid a likelihood of substantial competitive harm to the
submitter; and
(iii) Be consistent with guidance on the determination of
structurally descriptive generic names, developed in accordance with
TSCA section 14(c)(4)(A) (e.g., Guidance for Creating Generic Names for
Confidential Chemical Substance Identity Reporting under TSCA;
available at <a href="https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting">https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting</a>).
(2) Generic names will be reviewed by EPA at the time of
submission. (i) If EPA concludes that a proposed generic name meets the
criteria in paragraph (f)(1) of this section, EPA will include that
generic name in the public TSCA Inventory listing for that substance.
(ii) If the proposed generic name does not meet the criteria in
paragraph (f)(1) of this section, EPA will notify the submitter
concerning the deficiency via CDX, as described in 40 CFR 703.5(f). EPA
will provide 10 business days to correct the deficiency and provide an
alternative generic name that would be acceptable to EPA. If the
alternative generic name proposed by EPA is acceptable to the submitter
(or if the submitter does not respond within the 10-day period), EPA
will place that alternative generic name on the public TSCA Inventory.
If the alternative generic name proposed by EPA is not acceptable to
the submitter, the submitter must submit a revised generic name that
meets the criteria in paragraph (f)(1) of this section and an
explanation of how EPA's proposed generic name reveals confidential
information. If EPA concludes that the submitter's revised generic name
also does not meet the criteria in paragraph (f)(1) of this section,
EPA will hold the notice of commencement for a period of up to 10
business days. Reporting requirements will not be considered to have
been met and the substance will not be added to the TSCA Inventory
during this period. If the submission remains deficient after this 10-
day period, EPA will proceed with CBI review of the chemical identity
claim and will likely deny the claim.
PART 723--PREMANUFACTURE NOTICE EXEMPTIONS
0
23. The authority citation for part 723 continues to read as follows:
Authority: 15 U.S.C. 2604.
0
24. Amend Sec. 723.50, by revising paragraph (l) to read as follows:
Sec. 723.50 Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low
environmental releases and human exposures.
* * * * *
(l) Confidentiality. Claims of confidentiality must be made in
accordance with the procedures described in 40 CFR part 703.
* * * * *
0
25. In Sec. 723.250, revise the introductory text of paragraphs (f)
and (n) to read as follows:
Sec. 723.250 Polymers.
* * * * *
(f) Exemption report for polymers manufactured under the terms of
this section. For substances exempt under paragraphs (e)(1), (e)(2),
and (e)(3) of this section a report of manufacture or import must be
submitted by January 31 of the year subsequent to initial manufacture.
The report and accompanying claims must be submitted via CDX (<a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a>), using the TSCA Section 5 Notices and Supports--ePMN
application. See Sec. 720.40(a)(2)(ii) for information on how to
access e-PMN software. The notice must include:
* * * * *
(n) Confidentiality. Claims of confidentiality must be made in
accordance with the procedures described in 40 CFR part 703.
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
26. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
27. Revise Sec. 725.80 to read as follows:
Sec. 725.80 General provisions.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703, except as modified in this
paragraph. In general, references to ``chemical'' or ``chemical
identity'' in part 703 are equivalent to ``microorganism'' or
``microorganism identity'' for the purposes of this part.
(a) In place of Sec. 703.5(b)(3)(v), the following question
applies: Has EPA, another Federal agency, or court made any
confidentiality determination regarding information associated with
this microorganism? If yes, please provide the circumstances associated
with the prior determination, whether the information was found to be
entitled to confidential treatment, the entity that made the decision,
and the date of the determination.
(b) In place of Sec. 703.5(b)(4), the following questions apply:
(1) Has the identity of the microorganism been kept confidential to
the extent that competitors do not know it is being manufactured or
imported
[[Page 29102]]
into US commerce? If not, explain why the microorganism identity should
still be afforded confidential status (e.g., the microorganism is
publicly known only as being distributed in commerce for research and
development purposes, but no other information about the current
commercial distribution of the microorganism in the United States is
publicly available).
(2) Does the microorganism leave the site of production or testing
in a form which is accessible to the public or to competitors? If yes,
please explain what measures have been taken to guard against the
discovery of its identity. Further, what is the cost to a competitor,
in time and money, to develop appropriate use conditions? What factors
facilitate or impede product analysis?
Sec. 725.85 [Removed]
0
28. Remove Sec. 725.85.
Sec. 725.92 [Removed]
0
29. Remove Sec. 725.92.
Sec. 725.94 [Removed]
0
30. Remove Sec. 725.94.
0
31. Revise Sec. 725.95 to read as follows:
Sec. 725.95 Public file.
All information submitted, including any health and safety study of
a microorganism and other supporting documentation, will become part of
the public file for that submission, unless such materials are claimed
as confidential in accordance with this section. In addition, EPA may
add materials to the public file, subject to subpart C of this part.
Publicly available materials are available at the docket addresses in
Sec. 700.17(b)(1) and (2) of this chapter and on EPA's website.
0
32. Amend Sec. 725.190 by revising paragraph (c) and adding paragraphs
(e) and (f) to read as follows:
Sec. 725.190 Notice of Commencement of manufacture or import.
* * * * *
(c) Information to be reported. The NOC must contain the following
information: Specific microorganism identity, MCAN number, and the date
when manufacture or import commences. If the person claims any
information on the form as confidential, the claim must be asserted and
substantiated in accordance with the requirements described in part 703
and Sec. 725.80, as indicated in EPA Form 7710-56. If the submitter
wants the microorganism identity to be listed on the confidential
portion of the TSCA Inventory, the microorganism identity must be
claimed as confidential and also follow the certification,
substantiation, and generic name requirements described in part 703 and
paragraph (e) and (f) of this section.
* * * * *
(e) Requirements for assertion. Any person who asserts a
confidentiality claim for microorganism identity must:
(i) Comply with the requirements of paragraph (f) of this section
regarding submission of a generic name.
(ii) Agree that EPA may disclose to a person with a bona fide
intent to manufacture or import the microorganism the fact that the
particular microorganism is included on the confidential TSCA Inventory
for purposes of notification under section 5(a)(1)(A) of the Act.
(iii) Have available and agree to furnish to EPA upon request the
taxonomic designations and supplemental information required by Sec.
725.12.
(iv) Make claims of confidentiality in accordance with the
procedures described in 40 CFR part 703.
(f) Generic Name. If a submitter asserts a claim of confidentiality
for microorganism identity in a notice of commencement, they must
provide a generic name.
(1) Generic names must:
(i) Be structurally descriptive (e.g., not a trade name); and
(ii) Be consistent with guidance on the determination of
structurally descriptive generic names, developed in accordance with
TSCA section 14(c)(4)(A) (e.g., Guidance for Creating Generic Names for
Confidential Chemical Substance Identity Reporting under TSCA). Generic
names for microorganisms may only mask the portion of microorganism
identity that the submitter believes is proprietary (considering that
the identity of a microorganism to be listed on the TSCA Inventory must
include taxonomic designations (genus, species, and strain), key
phenotypic traits, key genotypic traits and modifications, genetic
material that has been introduced or modified, any vector constructs
used, cellular location of introduced or modified genes, number and
type of genes introduced or modified, and method of construction or
modification). Taxonomic designation (in most cases down to strain)
must be included in the generic name except where the submitter claims
the taxonomic designation confidential, in which case the person making
such claim must provide an explanation of why such masking is necessary
to protect proprietary information. Additionally, the generic
microorganism identity must include a statement regarding the function
and stability of the genetic construct. This includes an indication of
whether the introduced or modified genes are present on the chromosome
or extrachromosomal.
(2) Generic names will be reviewed by EPA at the time of
submission.
(i) If EPA concludes that a proposed generic name meets the
criteria in paragraph (f)(1) of this section, EPA will include that
generic name in the public TSCA Inventory listing for that substance.
(ii) If the proposed generic name does not meet the criteria in
paragraph (f)(1) of this section, EPA will notify the submitter
concerning the deficiency via CDX, as described in Sec. 703.5(h). EPA
will provide ten business days to correct the deficiency and provide an
alternative generic name that would be acceptable to EPA. If the
alternative generic name proposed by EPA is acceptable to the submitter
(or if the submitter does not respond within the ten-day period), EPA
will place that alternative generic name on the public TSCA Inventory.
If the alternative generic name proposed by EPA is not acceptable to
the submitter, the submitter must submit a revised generic name that
meets the criteria in paragraph (f)(1) of this section and an
explanation of how EPA's proposed generic name reveals confidential
information. If EPA concludes that the revised generic name also does
not meet the criteria in paragraph (f)(1) of this section, EPA will
hold the notice of commencement for a period of up to 10 business days.
Reporting requirements will not be considered to have been met and the
microorganism will not be added to the TSCA Inventory during this
period. If the submission remains deficient after this 10-day period,
EPA will proceed with CBI review of the microorganism identity claim
and will likely deny the claim.
PART 790--PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST
RULES
0
33. The authority citation for part 790 continues to read as follows:
Authority: 15 U.S.C. 2603.
0
32. Revise Sec. 790.7 to read as follows:
Sec. 790.7 Confidentiality.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
[FR Doc. 2022-09629 Filed 5-11-22; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on May 12, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.