[Federal Register Volume 88, Number 109 (Wednesday, June 7, 2023)]
[Rules and Regulations]
[Pages 37155-37174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12044]
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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-8223-02-OCSPP]
RIN 2070-AK68
Confidential Business Information Claims Under the Toxic
Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is finalizing 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 finalizes 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 rule also
addresses EPA procedures for reviewing and communicating with TSCA
submitters about confidentiality claims.
DATES: This final rule is effective on August 7, 2023.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2021-0419, is available online
at https://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC). Please review the visitor
instructions and additional information about the docket available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical 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: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be affected by this action if you 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:
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?
The statutory authority for this action is provided by section 14
of TSCA, as amended (15 U.S.C. 2601 et seq.). 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. Section 14 includes
provisions that explicitly contemplate promulgation of implementation
rules by the Administrator. For example, 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 such rules regarding a claim for protection from
disclosure as the Administrator has promulgated or may promulgate
pursuant to this title.'' In addition, TSCA section 14(c)(3) requires
that confidentiality claims be substantiated ``in accordance with such
rules as the Administrator has promulgated or may promulgate pursuant
to this section.'' Other provisions in TSCA section 14 further
recognize the role of the Administrator in specifying the form and
manner in which the requirements of TSCA section 14 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 additional 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 finalizing 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 (hereafter ``the Lautenberg amendments''),
made significant amendments to TSCA, including new provisions governing
the assertion and review of CBI claims that EPA is implementing in this
action.
In this document, EPA is finalizing specific 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 has authority to require under TSCA but was
originally submitted via other means; and (5) maintenance and
withdrawal of confidentiality claims.
EPA is also finalizing specific 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 finalizing new provisions, as well as amending and
reorganizing
[[Page 37156]]
existing provisions concerning assertion of confidentiality claims
under TSCA. Regulatory provisions concerning TSCA CBI claims are
currently spread over several 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 40 CFR
contain their own provisions regarding CBI, such as in 40 CFR part 711
(Chemical Data Reporting) and 40 CFR part 720 (Premanufacture
Notification).
In this final rule, most procedural requirements for asserting and
maintaining confidentiality claims are organized in a new part of 40
CFR, i.e., in part 703. The provisions in 40 CFR part 703 will apply to
any TSCA submission, except as modified elsewhere by more specific
provisions in 40 CFR part 2 or other TSCA-specific regulations in Title
40 of the CFR.
D. What are the estimated incremental economic impacts of this action?
EPA has evaluated the potential incremental impacts of this
rulemaking, including alternative options. The details are presented in
the economic analysis prepared for the rule (Ref. 2), which is
available in the docket and is briefly summarized here. The benefits of
the 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 rule is expected to
decrease the frequency of submitter error and increase efficiency in
the processes for asserting and maintaining CBI claims. Lastly, the
rule will 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
$272,804 in the first year after the rule is finalized and an annual,
ongoing burden of approximately 523 hours with an associated cost of
approximately $45,529 in each following year.
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 before the end of that 10-
year period.
Several new requirements also apply to EPA, including requirements
in TSCA section 14(g) to review and approve or deny all chemical
identity CBI claims asserted since the Lautenberg amendments were
enacted concerning substances that are or have been offered for
commercial distribution, as well as a subset of all other
confidentiality claims. Such reviews must be completed within 90 days
of assertion of the claim. Under TSCA sections 8 and 14, EPA must also
review all confidentiality claims for the chemical identity of
substances listed as active on the TSCA Inventory and assign and apply
unique identifiers (UIDs) to substances with approved confidentiality
claims for chemical identity. The amendments to TSCA section 14 also
expanded the categories of people who may now access TSCA CBI. These
new provisions have been discussed in previous documents published in
the Federal Register (see e.g., Refs. 3, 4, and 5).
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). The final rule includes
provisions intended to implement many of the new requirements in TSCA
section 14 for the remaining TSCA regulations, especially requirements
for asserting a CBI claim and procedures for EPA review of such claims.
Further background information and a detailed explanation of the
proposed rule is included in the preamble to the proposed rule (Ref.
6).
III. Summary of Response to Public Comments
In response to the proposed rule, EPA received eighteen public
comments. The commenters include trade associations, non-governmental
organizations, consultants, and individuals (two anonymous). Major
comments are discussed in the context of particular provisions in Unit
IV. A more detailed discussion is available in the Response to Comment
Document for this rule, which is available in the docket (Ref. 8).
IV. Summary of the Final Rule
A. Existing Regulations Governing Confidentiality Under TSCA
The final rule centralizes most CBI-related procedures in a new
part of the TSCA regulations, 40 CFR part 703. This new part also
largely replaces TSCA-specific CBI regulations in 40 CFR 2.306, though
a few provisions do remain regarding, e.g., the applicability of the
Agency's public information rules to TSCA CBI in general and procedures
for disclosure of information under special circumstances described in
TSCA sections 14(d)(2) through (7). Section 2.306 has been updated in
some provisions to conform to the timeframes specified for notice under
TSCA section 14(g).
In some cases, such as the regulations implementing TSCA section
14(d)(2) and (7), the final rule retains a notice requirement that is
not required by TSCA but which has historically been a feature of EPA's
40 CFR part 2, subpart B, regulations. EPA received some comments about
the proposal to retain these notice requirements in the rules, but
notes that TSCA does not prohibit providing such notice and that
especially in the case of rarely used disclosure provisions, providing
notice to the person who asserted the CBI claim does not tend to
significantly increase Agency burden or diminish the public
availability of information. Providing notice would also tend to reduce
confusion for the person who asserted the CBI claim and reduce the
possibility of unnecessary conflict over the handling of the
information.
B. Purpose and Applicability
EPA has somewhat revised 40 CFR 703.1 in response to public comment
but retains the proposed provisions concerning the scope of information
that is considered ``reported to or otherwise obtained by EPA pursuant
to TSCA or its implementing regulations,'' particularly that data need
not have been submitted pursuant to an exercise of TSCA authority in
order for it to be considered obtained under TSCA.
Some commenters criticized the scope provisions as greatly
expanding the range of information considered submitted under TSCA,
while others criticized the proposal as greatly narrowing this range.
EPA responds to both groups of commenters that the proposal was not
intended to modify the scope of TSCA jurisdiction, but rather to
clarify it. EPA also notes that the provision regarding what is
considered obtained under TSCA in the final rule works in tandem with
the retention of disclosure limits (for reasons other than
[[Page 37157]]
business confidentiality) in the statute under which the information
was originally provided to EPA.
EPA has modified the proposed regulation text in response to some
of these comments. The final rule clarifies and reconciles the
applicable provisions of TSCA and the other laws by which EPA may have
received data that is later used for TSCA purposes. Even where TSCA
excludes certain data from eligibility for business confidentiality
protection, there are very limited circumstances where the statute
requires affirmative disclosure of that same data by EPA. Instead, data
used under TSCA might have originally been submitted under and remain
protected or restricted from disclosure for reasons other than business
confidentiality under another statute. An example is FIFRA section
10(g), which limits disclosure of certain pesticide data to persons who
can certify they are not acting on behalf of an entity engaged in the
production, sale, or distribution of pesticides in countries other than
the United States. Where certain data is not entitled to business
confidentiality protections under TSCA but does enjoy disclosure
protections under another statute for other reasons (e.g., FIFRA
section 10(g)), EPA does not believe there is a conflict between the
two statutory provisions. It therefore does not violate TSCA for EPA to
withhold or restrict disclosure of such data pursuant to the
requirements of the other law. EPA has therefore replaced the proposed
language concerning resolution of conflicts with language clarifying
that information that was originally submitted under a statute other
than TSCA may be protected from disclosure under the provisions of the
other statute for reasons other than claims of business
confidentiality, even if the information is subsequently used under
TSCA and would not be eligible for business confidentiality protections
under TSCA.
Related to these provisions, some commenters were concerned that
data originally obtained under other statutes would be used and
potentially disclosed to the public by EPA without any notice to the
original submitter. Particularly with respect to disclosure, this is
not the case. Such data, once it is considered as being submitted or
obtained under TSCA, will be treated and disclosed consistent with
today's final rule, TSCA, and any other pertinent laws. For example, if
the information were claimed as business confidential and became
subject to a Freedom of Information Act (FOIA) request or EPA otherwise
believed that the information might not be entitled to confidential
treatment, the Agency would review and make a final confidentiality
determination under TSCA section 14(f), which would involve notice and
opportunity for affected persons to substantiate confidentiality
claims--if EPA denies the confidentiality claim, the affected persons
would be provided notice according to today's final rule and TSCA
section 14(g).
C. Definitions
EPA received several comments concerning the proposed definition of
``health and safety study'' at 40 CFR 703.3, particularly the proposed
excluded categories of information. Some commenters proposed additional
exclusions, while others argued that there should be fewer or no
exclusions because having any exclusions is inconsistent with TSCA and/
or that the proposed categories are information underlying and relevant
to the studies.
In this final rule, EPA is declining to add exclusions beyond those
originally proposed but is making modifications to the original
proposal to combine similar exclusions and to clarify the intended
scope of the exclusions. As EPA explained in the preamble to the
proposed rule (Ref. 6), EPA considers some types of information that
may be included in or with a study document as not part of the ``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 is it relevant to
the study results.
EPA notes that most of the exclusions have long been part of the
existing TSCA rules in one form or other, such as in 40 CFR parts 720
and 716, so the final rule will in most respects maintain the status
quo. EPA also considered TSCA section 14(b)(1) (``[i]nformation 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'') in
finalizing the list, reasoning that the excluded types of information
may be protected from disclosure under TSCA section 14 although
included in a document that also contains information that is not
protected from disclosure. EPA notes that study reports can and often
are provided in a number of formats, with variable detail, and with
varying levels and types of information that are ancillary to the study
report.
EPA is declining to add additional exclusions, as many of the
suggestions made were either redundant with the proposed list (e.g.,
laboratory address is redundant with the name of the laboratory), or do
not constitute information that EPA can categorically determine as
unnecessary to interpret the study, and therefore cannot be
categorically excluded from the definition of a health and safety study
under TSCA section 3(8).
The final rule is modified from the proposal to combine similar
exclusions and to clarify the intended scope of the exclusion. The
exclusion for name of the submitting company (previously included in 40
CFR parts 716 and 720) is combined with the exclusion for name of
laboratory. This exclusion is intended to permit confidentiality claims
for submitting company identity and other information that would
disclose company identity, such as addresses and laboratory name in the
case that the laboratory that conducted the study was part of or
closely related to the submitting company. The exclusion for ``internal
product codes'' is clarified with a parenthetical that explains that
this refers to the code names for a test substance that is used
internally by the submitting company or is used to identify the test
substance by the test laboratory. The exclusions for names of
laboratory personnel and for names and other private information of
study subjects are also combined in the final rule. Finally, the
proposed exceptions for costs and other financial data and for product
development, advertising, and marketing plans are combined. These types
of information do not often appear in study reports themselves but may
be included with a larger submission that includes a study report or
other health and safety data or included in materials relating to cost
[[Page 37158]]
sharing for chemical testing (e.g., in relation to a test order).
D. 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. The final rule retains most of the proposed
provisions, with some modifications to clarify the regulatory
provisions, or in response to public comment.
1. Assertion of Confidentiality Claim Upon Submission of Information to
EPA
The final rule requires that confidentiality claims be asserted
(and substantiated as necessary) at the time of submission (limited
exceptions may apply in the case that such information is collected
during an in-person TSCA enforcement inspection). See 40 CFR 703.5.
This includes confidentiality claims for specific chemical identity,
which must be asserted as specified in existing reporting rules (e.g.,
CDR, 40 CFR part 711). Several commenters expressed concern regarding
language in the preamble to the proposed rule clarifying that failing
to assert a CBI claim for a specific chemical identity submitted under
those existing regulations would lead to the specific chemical identity
being moved from the confidential to the public portion of the
Inventory. (Refs. 6 and 8.) The commenters' concern pertains to those
instances where the chemical identity is reported by accession number
(a non-confidential identifier) and no chemical identity CBI claim is
asserted, with the result that the specific chemical identity is moved
to the public Inventory. Existing rules require that the reporter
assert and substantiate confidentiality claims for the specific
identity if they wish for that substance to remain on the confidential
portion of the TSCA Inventory. See, e.g., 40 CFR 711.20(e). Commenters
expressed concerns that downstream customers or processors of a
specific chemical would report under TSCA by accession number and,
ignorant of specific chemical identity, could accidentally or
intentionally waive the confidentiality claim and cause the substance
to lose confidential status.
EPA has consistently maintained and provided public notice of its
position that if any submitting entity chooses not to assert and/or
substantiate a confidentiality claim for a chemical identity as
required by TSCA section 14, the chemical identity is no longer
entitled to confidential treatment and may be published on the public
portion of the TSCA Inventory. For example, the Agency noted in the
2009 updates of the TSCA Inventory that ``some manufacturers of these
530 chemical substances did not include any claim of confidentiality
for the chemical identity of the chemical substance with the IUR
submission.'' (74 FR 37224 (July 28, 2009) (FRL-8392-4)) (emphasis
added). See also TSCA Inventory Update Reporting Modifications;
Chemical Reporting, (76 FR 50815 and 50825 (Sept. 15, 2011) (FRL 8872-
9)) (stating that failure to identify the chemical identity as CBI and
complete upfront substantiation will waive any CBI claim to the
chemical identity). This position was further reinforced recently in
the 2020 Procedures for Review of Confidential Business Information
Claims for the Identity of Chemicals on TSCA Inventory's Response to
Comments (RTC) where EPA stated ``[i]f another person reveals to the
public that a confidential chemical substance is manufactured or
processed for nonexempt commercial purposes in the United States, then
the specific chemical identity would no longer be eligible for
confidential protection, and CBI claims for that specific chemical
identity would be denied upon review'' (Ref. 10, at 17.)
EPA has considered the commenters' concerns that an entity lacking
knowledge of a specific chemical identity may nonetheless waive
confidentiality for that chemical identity. Such a situation might
arise when TSCA reporting rules implicate a universe of reporters from
sectors that typically have little knowledge of the identities of
specific chemical substances in their products, one example being
importers of articles containing the chemical substance in question.
The Agency recognizes that this issue might arise in specific contexts.
However, this final rule addresses a wide variety of situations where
the knowledge issue is not presented. EPA believes that the best way to
address commenters' concerns is to include measures in specific TSCA
reporting rules that take into account the reporting entity's potential
lack of knowledge, where such measures are necessary. Addressing the
issue in the context of specific reporting rules will allow EPA to take
into consideration the unique reporting context for the rule, such as
the attributes of specific reporters. For example, a specific reporting
rule might except all or a category of reporters from requirements to
reassert chemical identity claims to maintain confidential Inventory
status.
Outside this final rule, the Agency has already begun exploring
options for addressing the knowledge concerns raised by the commenters.
For example, in the proposed rule TSCA section 8(a)(7) Reporting and
Recordkeeping Requirements for the Perfluoroalkyl and Polyfluoralkyl
(PFAS) Substances; Notice of Data Availability and Request for Comment,
the Agency sought to clarify and add language to the PFAS proposed rule
based in part on comments received during the public comment period for
today's final rule and concerning an entity's knowledge of a specific
chemical identity (Ref. 11).
2. Substantiation and Exemptions
The final rule includes substantiation questions in 40 CFR 703.5(b)
largely as set out in the proposed rule. As suggested in the proposed
rule, the final rule omits a patent-specific question in favor of
including the issue of patents in another question. The provisions
concerning substantiation exemptions are as proposed.
a. Patents. The final rule omits a substantiation question
exclusively concerned with patents, for the reasons discussed in the
proposed rule and supported by public comment. Instead, where
information claimed as confidential appears in some form in a patent or
patent application, persons submitting those claims must address this
public disclosure in their answer to the question on public disclosures
more generally, 40 CFR 703.5(b)(3)(iii). Failure to address such a
patent disclosure in the substantiation increases the risk that EPA
will determine the information not entitled to confidential treatment.
Further discussion of comments concerning CBI and patents is included
in the Response to Comments for this rule (Ref. 8).
b. Trade secrets. Consistent with the proposed rule, the final rule
omits a substantiation question specifically concerning trade secrets.
See discussion in the preamble to the proposed rule (Ref. 6).
c. Specificity of competitive harm. EPA received several comments
on the substantiation question concerning substantial competitive harm
(40 CFR 703.5(b)(3)(i)), several supporting the proposed question, some
advocating instead for a version of the question currently used for CDR
submissions (40 CFR 711.30; ``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
[[Page 37159]]
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''), or clarification,
elaboration, or other changes from the proposed question. The final
rule uses the proposed version of the question. Submitters may continue
to use existing guidance describing EPA's expectations for
substantiation and may contact EPA regarding case-specific
substantiation questions. Guidance and current staff contact
information is available at https://www.epa.gov/tsca-cbi.
d. Exemptions. The final rule provisions at 40 CFR 703.5(b)(5)
concerning substantiation exemptions in TSCA section 14(c)(2) are the
same as proposed. EPA received limited comment concerning the exemption
at TSCA section 14(c)(2)(G), for the specific identity of chemicals
that have not yet been introduced into commerce, arguing that because
the exemption may only be applied to claims made up until the substance
is introduced into commerce, EPA has an obligation to revisit those
pre-commerce claims once the substance has been introduced into
commerce. While EPA agrees that new claims for the same information
would no longer be exempt from the substantiation requirement once the
chemical is introduced into commerce, there is nothing in the statute
to suggest that EPA is required to revisit those prior claims. Indeed,
CBI claims are generally only reviewed as required by TSCA section
14(g) (within 90 days of submission) or as permitted or required
pursuant to one of the provisions of TSCA section 14(f). The filing of
a Notice of Commencement (NOC), for example, does not trigger a
mandatory review of prior CBI claims for the subject chemical substance
by the same submitter.
3. Public Copies of Submissions
40 CFR 703.5(c) of the final rule includes a requirement that TSCA
submitters include a public copy (sometimes referred to as a
``sanitized copy'') of their submission, though 40 CFR 703.5(c)(1)
limits this requirement to unfielded data, such as study reports and
other documents that might be submitted as attachments to a reporting
form. Most TSCA submissions that are made on a standard reporting form
include individual data fields that each have a checkbox-type indicator
for confidentiality claims. In the case of these forms, a public copy
is either already generated automatically, or the reporting tool could
be updated to perform this function in future enhancements of CDX.
Commenters generally supported this provision in the proposal, though
some argued that EPA should further elaborate in the rule on how and
when public copies would be made available, or that EPA should reject
entire submissions or disregard CBI claims in submissions with
incomplete or possibly incomplete public copies. The Response to
Comments document (Ref. 8) elaborates on EPA's current and planned
practices for making public copies of TSCA submissions available, while
noting that committing many of these practices to a rule is beyond the
intended scope of this rulemaking activity except to the extent EPA
finds the public copy to be deficient. The final rule provisions
concerning treatment of deficiencies including missing or incomplete
public copies are elaborated in Unit IV.D.6.
4. Supporting Statement and Certification
The final rule at 40 CFR 703.5(a) includes certification and
supporting statements as set out in TSCA section 14, which are
consolidated into one certification that is automatically incorporated
into most TSCA reporting forms. TSCA submitters who for unusual and
case-specific reasons are not able to provide their submission via CDX
must assure that the consolidated statement is included in their
submission. This provision is unchanged from the proposal.
5. Generic Names
The final rule includes provisions specifying requirements for
generic chemical names, which are used in place of specific chemical
names in public documents mentioning substances with confidential
specific chemical identities. 40 CFR 703.5(d). The requirements cover
when and how such generic names must be submitted, some basic
requirements, and procedures for resolving disagreements about the
adequacy of a given generic name. 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) (Ref. 7).
The generic name provisions in the final rule are the same as were
proposed. EPA received a few public comments on these provisions,
questioning incorporation of elements of EPA's generic name guidance
into the rule, urging that EPA should undertake a CBI review of every
generic name submitted under TSCA section 14, and suggesting that
procedures permitting negotiation of generic names or permitting
correction of deficiencies that EPA identifies with a generic name are
too complex or are unnecessary, among other comments.
EPA concluded that incorporation of elements of the generic name
guidance into the rule provides helpful clarification concerning
minimum generic name requirements. Despite that clarification, however,
EPA's experience is that, in some instances, disagreement regarding the
sufficiency of a generic name may be unavoidable. Therefore, the final
rule sets forth a streamlined process for negotiating generic names in
TSCA section 5 Notices of Commencement (40 CFR 720.102) and introduces
a provision for EPA to provide an opportunity to correct deficient
generic names in any TSCA submission (40 CFR 703.5(e)). The
substantiation exemption for certain specific chemical identities
contained in section 14(c)(2)(G) and corresponding exclusions from
routine CBI review under TSCA section 14(g) indicate that substantive
review of the sufficiency of every generic name at the time of
submission is both in excess of TSCA requirements and impractical
(especially where the substantiation necessary to complete such a
review is neither required nor provided). The Response to Comments
document provides more detailed discussion of these comments. (Ref. 8.)
6. Deficient Submissions
The clear requirements in the final rule regarding assertion of CBI
claims, combined with recent improvements to TSCA reporting tools
including near-universal electronic reporting, should significantly
reduce the incidence of procedural deficiencies. Nonetheless, EPA does
not expect that these will prevent all such problems. EPA is therefore
retaining the proposed deficiency provisions in the final rule at 40
CFR 703.5(e).
Some public commenters advocated that the short correction period
provided in the rule should be longer, and/or that EPA should give one
or more additional notices, using both electronic and paper means of
[[Page 37160]]
communication. Others criticized providing any such opportunity to
correct deficiencies, arguing that it would deprive the public of
information that should be treated as non-confidential and that EPA
should instead either reject such submissions outright, or immediately
disclose the information subject to the deficient claim. As elaborated
in the Response to Comments Document, the time period for correction of
deficiencies is necessarily quite short, given statutory constraints on
the time for CBI review and reviews under other parts of TSCA, such as
TSCA section 5 (Ref. 8). As is also elaborated in the Response to
Comments Document (Ref. 8) and in Unit IV.D.7. of this document, it is
now a practical necessity that EPA and TSCA submitters rely primarily
on electronic communications and notices made through CDX. Id.
By relying on electronic communications and keeping the period for
correcting deficiencies short, EPA believes information not entitled to
confidential treatment will be available to the public more quickly
using the approach in the final rule (which also briefly pauses other
statutory review periods, such as under TSCA section 5, such that the
public is not deprived of the materials for any longer than it takes to
identify the deficiency) than if EPA instead rejected the whole
submission or proceeded to immediately release the information
(actions, especially in the latter case, that could be expected to
precipitate protracted litigation over an Agency action that could be
seen as unduly punitive, arbitrary, and beyond statutory authority).
7. Electronic Reporting
The final rule requires, with very limited exceptions, that all
TSCA submissions that include CBI claims must be submitted
electronically. 40 CFR 703.5(f). This requirement most notably affects
reporting under TSCA section 8(e), export notifications under TSCA
section 12(b), and polymer exemption notices under TSCA section 5, for
which electronic reporting is required for the first time in today's
final rule. Voluntary e-reporting was already available for TSCA
sections 8(e) and 12(b) notices, so those existing reporting tools will
be updated in accordance with the final rule and will become mandatory
to use for reporting. A new reporting tool will be available for
submitting annual polymer exemption notices. A few commenters expressed
concern over reliance on electronic reporting, citing past incidences
of technical difficulties with providing electronic submissions via
CDX, especially related to 2020 CDR reporting (Ref. 8). EPA notes that
in the case of 2020 CDR reporting, EPA moved quickly to correct the
technical problems and extended the reporting deadline to accommodate
reporters who had issues. Similar problems, many of which were related
to both the large size of individual submissions and the peak volume of
submissions being made around the same time, are fairly unique to the
CDR rule reporting and would not be expected with TSCA section 8(e),
TSCA section 12(b), or polymer exemption reporting, as the former two
submission types are submitted throughout the year (not all at once)
and for all three submission types, most submissions are fairly small.
EPA expects that in the case technical reporting issues such as
occasionally encountered in the 2020 CDR reporting period do recur in
the future, the Agency would continue its practice of promptly
addressing the problem and making appropriate accommodations (such as
extending reporting deadlines). Also, noting one comment concerned with
potential legal barriers to electronic reporting, such as when a
submission might include classified information or otherwise include
handling restrictions distinct from CBI claims, EPA expects to continue
to handle these unusual and rare situations on a case-by-case basis, in
accordance with their special legal and technical needs.
8. Requirement To Report Health and Safety Information Using OECD
Harmonized Templates
EPA is finalizing the requirement to provide health and safety
information using the appropriate OECD harmonized template (OHT), when
such a template is available. 40 CFR 703.5(g). As explained in the
preamble to the proposed rule, this requirement would be in addition to
existing requirements to provide a full study report. EPA received some
non-specific comments suggesting that the reporting burden associated
with filling in such templates would be more substantial than EPA
estimated, but these comments provided no alternative estimate. Use of
the templates is already required for submitting data to regulatory
authorities in other countries (e.g., to the European Chemicals Agency
(ECHA)) and international programs with strong U.S. participation and
support encourage and facilitate reciprocal acceptance and use of data
and non-duplication of chemical safety testing (see, e.g., the OECD
Mutual Acceptance of Data (MAD) system, https://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm). Thus, in many if not most cases,
companies or groups of companies conducting and/or submitting such
chemical safety testing in the U.S will have already or would otherwise
be required to fill out such templates anyway when providing the same
information to regulatory authorities in other countries. Templated
data will make CBI review of the submission more efficient (by aiding
in identification of CBI claims) and aid in data sharing and
dissemination within EPA and in public databases. EPA intends to
elaborate on instructions for including OHT files (e.g., currently
acceptable file types and IUCLID software versions) as appropriate in
individual reporting rules or orders, and/or in the applicable
reporting tool instruction documents.
9. Maintenance of Company Contact Information and Communications
Concerning Claims
The final rule provisions concerning maintenance of company contact
information and reliance on electronic notices concerning CBI claims
are as proposed. 40 CFR 703.5(h). EPA received several comments in
favor of EPA providing redundant multi-media notices (electronic, paper
mail, email, etc.) and concerned with the burden of maintaining contact
information for each submission over time. As explained in the preamble
to the proposed rule, it is EPA's experience that providing notice by
other permissible means, such as via certified mail, does not
necessarily better assure prompt delivery and access by its intended
recipient than would EPA's proposed and preferred shift to reliance on
electronic notices. For those commenters who advocated an email in
addition to a CDX-delivered electronic notice, EPA notes that this is
already occuring--each CDX notice coincides with a more generic email
notice to the email address provided by the company contact.
Maintaining contact information for individual submissions is an
inescapable consequence of the Lautenberg amendments, particularly
since most CBI claims now expire after ten years unless reasserted by
the submitter. The TSCA section 14(f) CBI review provisions also call
for submission-specific company contact maintenance, in that those
types of CBI review almost always require some notice to the company,
both that the review is taking place and for the purpose of permitting
submission of substantiation. Such reviews can take place at any time
after a submission is made. EPA has created new reporting
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tools that permit a company to request copies of record it may have
lost access to by turnover in personnel or to provide updated contact
information for one or more company submissions. More broadly, EPA
strongly suggests that companies develop internal practices to assure
that a current company contact is maintained for each of their
submissions including CBI. This might include, for example, use of
email addresses that more than one person can access to receive CBI
notices, a limited-access internal list of submission passphrases, or
other procedures to better assure that passphrases and TSCA submission-
specific information is known to or available to more than one person
and isn't lost to the company when any one of its personnel are
suddenly unavailable.
10. Withdrawing Claims
The final rule adopts the proposed provisions on withdrawing
claims, which provide instructions for withdrawing claims originally
made in an electronic submission, and for withdrawing claims originally
made on paper or in an electronic submission no longer accessible to
the company. 40 CFR 703.5(i).
11. Amending a Public Copy Following Claim Denial or Expiration
Public commentary was divided on who should be responsible for
updating public copies of submissions to make newly non-CBI information
available (the submitting company or EPA); other commenters suggested
that making this information available need not be a priority unless a
specific request for it was pending (e.g., a FOIA request). Based on
its experience, EPA has concluded that companies submitting CBI claims
should retain primary responsibility for updating public copies.
Because the company best understands the intended scope and purpose of
its original CBI claim(s), that company is in the best position to
determine with precision which of its claims remain and assure these
are indicated in the public copy accurately prior to release of the
data. If EPA must occasionally dispute the scope of the remaining
claims indicated by the submitter, EPA and the submitter could resolve
this issue prior to release of the data, which is not possible when EPA
prepares and releases the updated public copy without the involvement
of the submitter. The final rule does include some minor amendments to
clarify how EPA will append public copies to make newly non-CBI
information available, in cases where EPA must perform this function.
40 CFR 703.5(j).
E. EPA Review of Confidentiality Claims
1. Representative Subset
EPA received several comments on selection of the representative
subset (40 CFR 703.7(a)), especially on the submissions it proposed to
exclude from the subset as not being especially representative of TSCA
submissions more generally. The final rule maintains the proposed case
selection methodology (one in four TSCA submissions with non-exempt CBI
claims for information other than chemical identity) but clarifies that
this is the method EPA will use in general. EPA believes that some
flexibility is appropriate here in case it might occasionally be
necessary to issue additional confidentiality determinations to ensure
that the Agency is meeting the minimum 25% required by TSCA section
14(g)(1)(C)(ii). The final rule also maintains the proposed exclusions
from the representative subset, including certain pre-submission types
of correspondence intended mainly to ascertain subsequent TSCA
reporting obligations (e.g., bona fide notices under 40 CFR 720.25),
occasional submissions that may be excluded from the otherwise nearly
universal electronic reporting requirement, and amendments. In general,
EPA believes that excluding these submissions is appropriate and will
not significantly affect the total number of claims reviewed because
these submissions may not contain many claims in the first place, the
claims they do include are or will be duplicated in other submissions,
and/or the submission type is relatively rare.
2. Substantive Criteria
TSCA itself does not specify the criteria that must be used in
making a confidentiality determination, so EPA proposed and will retain
in this final rule (40 CFR 703.7(f)) elements drawn from TSCA section
14(b) limitations of confidentiality protections, TSCA section 14(c)
requirements to assert confidentiality claims, as well as EPA's long
pre-existing criteria for evaluation of confidentiality claims as set
out in 40 CFR 2.208.
Some commenters suggested a longer list of criteria or somewhat
different wording to more strongly emphasize some parts of some
criteria over others. EPA has declined most of these suggestions as EPA
believes them to be unnecessary and unlikely to influence the outcome
of a CBI determination. In response to one comment noting that a FOIA-
specific criterion was missing from the proposed 14(g) substantive
criteria in 703.7 (it was proposed in 703.8 only for FOIA-prompted
reviews under TSCA section 14(f)), EPA has made the substantive
criteria uniform for any CBI determination. Though introducing some
redundancy with the other criteria, EPA believes that one set of
criteria for all reviews improves clarity and consistency between
reviews.
EPA has declined the suggestion of one commenter that the criterion
mentioning the limited confidentiality protections for health and
safety study data (40 CFR 703.7(f)(5)) should be expanded to permit
generic name to stand in for specific identity in any health and safety
study for which the submitter wishes to assert a CBI claim. Instead,
the study report would refer only to the generic name of the substance.
The commenter supposed that simply not including the specific chemical
identity in the study report could avoid the section 14(b) limitations
on CBI protections in health and safety data. However, taking the
commenter's suggestion would be contrary to longstanding EPA policy and
rules stating that chemical identity is always considered part of a
study (e.g., 40 CFR 720.3(k)); ignore the fact that health and safety
studies are usually submitted as part of (attachments to) various TSCA
reporting forms that also specifically identify the chemical; and not
reflect the fact that chemical identity may be protected as CBI, need
not be substantiated, and will not be routinely reviewed (under TSCA
section 14(g)) until the chemical substance is introduced into U.S.
commerce. However, the criterion has been clarified in the final rule
to reflect that the limitations on confidentiality protections don't
apply to all health and safety information that might be submitted
under TSCA (e.g., data on R&D substances, prior to premanufacture
notification).
3. Reconsideration Process
After considering comment on the proposal, EPA has decided to omit
the reconsideration process (for denied CBI claims) from the final rule
(Ref. 6). While some commenters supported the proposal, others did not,
describing it as biased, open-ended, and lacking in transparency. EPA
now believes that codifying a reconsideration process is unnecessary.
If a person believes that a determination was incorrect or has
questions about the determination, they may contact EPA (using the
contact information in the final CBI determination letter) about their
[[Page 37162]]
concerns prior to filing a judicial appeal.
F. Related or Corresponding Revisions to Other TSCA Rules
1. Revisions to 40 CFR Parts 702, 704, 707, 716, 717, 723, and 790
The final rule replaces the CBI provisions of several TSCA rules
with a cross reference to 40 CFR part 703 to centralize the CBI rules
and make them more consistent among submission types. EPA received some
comment advocating for retaining some of the existing CBI provisions,
but EPA believes this is unnecessary, redundant, and/or needlessly
inconsistent with the final CBI rules centralized in 40 CFR part 703.
For further discussion, see the Response to Comments (Ref. 8).
2. Clarification of TSCA Section 12(b) Rules
The language in 40 CFR part 707 is revised in the final rule to
cross reference 40 CFR part 703 for CBI reporting requirements, to
require electronic reporting, and to clarify that it is generally not
necessary to list confidential specific chemical identities in a TSCA
section 12(b) report. EPA received some public comment criticizing this
provision, misunderstanding the clarification as rescinding a previous
requirement to provide specific chemical identities in TSCA section
12(b) notices. Part 707 regulations never included such a requirement,
though some submitters unnecessarily provided such information anyway.
The Response to Comments Document provides further clarification of the
pre-existing rule and elaborates on how EPA processes TSCA section
12(b) notices without need for a confidential specific chemical
identity in the report (Ref. 8).
3. Revision in 40 CFR 717.17 and 723.250 To Reflect Electronic
Reporting
The final rule revises 40 CFR parts 717 and 723 to reflect that
TSCA section 8(c) incident reports and TSCA section 5 polymer exemption
notices must be submitted electronically.
4. Revisions to Confidentiality Provisions in the Premanufacture Notice
(PMN) and Microbial Commercial Activity Notice (MCAN) Rules
The final rule revises 40 CFR parts 720 and 725 as proposed. Some
public commenters also favored retaining more of the CBI provisions in
40 CFR part 720. A commenter asserted that the proposed revisions to 40
CFR 720.85 omitted necessary existing statements that are not
sufficiently duplicated in the final rule--EPA disagrees and notes that
the commenter in some areas misunderstands 40 CFR 720.85. The language
in 40 CFR part 720.85(a) is mostly redundant with TSCA section 14,
other provisions of the final rule, or both. Under the final rule,
persons may assert CBI claims for chemical identity in a PMN, but they
must also submit a generic name consistent with TSCA section 14(c).
Persons who would like to consult EPA concerning an appropriate generic
name may continue to do so through the pre-notice consultation process.
See: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/filing-pre-manufacture-notice-epa#pre-notice.
Much of 40 CFR 720.85(b) is retained in the final rule, but has
been moved to 40 CFR 720.102, while the substantiation provisions are
replaced with the substantiation provisions in 40 CFR part 703. The
provision in section 720.85(b)(1), providing that a CBI claim for
chemical identity may not be asserted in an NOC unless that CBI claim
has been asserted for the underlying PMN, is not necessary. If the
chemical identity is not claimed as CBI in the PMN, the chemical
identity is published in the public notice required by TSCA section
5(d)(2). PMNs and NOCs are identified by the same case number,
providing a public link between the NOC and the PMN. Upon required TSCA
section 14(g) review of the chemical identity claim in the NOC, EPA
would not uphold a confidentiality claim that was not made in the PMN.
Further discussion is available in the Response to Comments document
(Ref. 8).
One commenter advocated retaining most of 40 CFR 720.90 (except
(a)(3), (b)(2)(iii), and (c)(3)), arguing that chemical identity claims
should not be permitted in health and safety studies at the PMN stage,
but that if EPA continues to permit such claims in the PMN, the PMN
claim should be re-reviewed when an NOC is filed and chemical identity
should be disclosed. EPA disagrees. Chemical identity claims are
permitted in the PMN submission including attachments, and such claims
are exempt from upfront substantiation requirements under TSCA section
14(c)(2)(G) and from routine review under TSCA section 14(g). TSCA
section 14(g) requires that EPA review certain CBI claims within 90
days of submission. In nearly all circumstances, an NOC is filed well
more than 90 days after the PMN, usually months or sometimes years
later (or not at all). The NOC is also, while linked to the PMN
submission, a different TSCA submission--one that does not include
health and safety studies. NOCs are subject to review under TSCA
section 14(g), as are PMNs, but the filing of an NOC does not open or
reopen the TSCA section 14(g) review of the PMN filed previously.
Instead, the PMN may be reviewed or re-reviewed pursuant to TSCA
section 14(f), under one of the mandatory or discretionary provisions,
where applicable. Even following TSCA section 14(f) review, many
chemical identity claims in health and safety studies will still be
valid, as TSCA section 14(b) includes exceptions from information that
is not protected from disclosure, including information that discloses
processes used in the manufacture of a substance or portion of mixture
information.
V. References
The following is a listing 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 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); Final Rule (RIN 2070-
AK68). April 2023.
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. Confidential Business Information Claims under the
Toxic Substances Control Act (TSCA); Proposed Rule. Federal
Register. 87 FR. 29078, May 12, 2022 (FRL-8223-01-OCSPP).
7. U.S. EPA. Guidance for Creating Generic Names for Confidential
Chemical Identity Reporting under TSCA. Publication ID No. EPA
743B18001. June 2018. Available at: https://www.epa.gov/sites/production/files/2018-06/documents/san6814_guidance_for_creating_tsca_generic_names_2018-06-13_final.pdf.
[[Page 37163]]
8. U.S. EPA. Confidential Business Information Claims under the
Toxic Substances Control Act (TSCA); Final Rule (RIN 2070-AK68).
Response to Comments Document. April 2023.
9. U.S. EPA. Information Collection Request (ICR) entitled:
Confidential Business Information Claims under the Toxic Substances
Control Act (TSCA)--Final Rule (RIN 2070-AK68). EPA ICR No.:
2706.02; OMB Control No.: 2070-0223. February 2023.
10. U.S. EPA. Response to Comments on the Proposed Rule, Procedures
for Review of CBI Claims for the Identity of Chemicals on the TSCA
Inventory. February 4, 2020, available at https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0320-0061.
11. U.S. EPA. TSCA section 8(a)(7) Reporting and Recordkeeping
Requirements for the Perfluoroalkyl and Polyfluoralkyl (PFAS)
Substances; Notice of Data Availability and Request for Comment.
Federal Register. 87 FR 72439, Nov. 25, 2022 (FRL-7902-4)
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders#influence.
A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is not a significant regulatory action as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore
not subject to Executive Order 12866 review.
B. Paperwork Reduction Act (PRA)
The information collection activities in this final rule have been
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared is
assigned EPA ICR No. 2706.02 and OMB Control No. 2070-0223 (Ref. 9).
You can find a copy of the ICR in the docket for this action, and it is
briefly summarized here. The information collection requirements are
not enforceable until OMB approves them.
The reporting requirements identified in this final rule implement
statutory requirements in TSCA section 14, including the new
requirements that persons submitting information under 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 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 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. See also Unit I.A.
Respondent's obligation to respond: Mandatory (TSCA section 14; 15
U.S.C. 2613).
Frequency of response: On occasion.
Total estimated number of respondents: 1,100 firms with an
estimated additional 55 new firms each year.
Total estimated number of responses: 1,100.
Total estimated burden: 2,945 hours in the first year and 523 hours
every subsequent year. Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $ 272,804 in the first year and $ 45,592
every subsequent year, which includes $ 0 annualized capital or
operation and maintenance 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 the EPA
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves
this ICR, the Agency will announce that approval in the Federal
Register and publish a technical amendment to 40 CFR part 9 to display
the OMB control number for the approved information collection
activities contained in this 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 1,001 small firms would be affected by the proposed
requirements. Of those small firms, 100% would have cost impacts of
less than 1 percent of annual revenues, which EPA has determined does
not qualify as a significant impact. Details of this analysis are
presented in the Economic Analysis (Ref. 2), which is available in the
docket. We have therefore concluded that this action will have not have
a significant adverse economic impact on all directly regulated small
entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action 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) because 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) because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian Tribes. It does not have substantial direct
effects on Tribal government because EPA does not anticipate that
Tribal governments will often make TSCA submissions, let alone those
for which they would assert a CBI claim necessitating substantiation
and other requirements under TSCA and this rule, so this rulemaking is
not expected to impose substantial direct compliance costs on Tribal
governments. Thus, Executive Order 13175 does not apply to this action.
[[Page 37164]]
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern 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 Executive Order 13045. This
action is not subject to Executive Order 13045 because it does not
concern environmental health risk or safety risk.
Although this action does not concern human health or safety risk,
it does set clear procedures for confidentiality claims made by
reporting entities under TSCA, this action is expected to improve the
quality of such claims, reduce unnecessary and unsupported claims, and
is anticipated to result in more information being available to the
public. This action does not address any human health or environmental
risks and does not affect the level of protection provided to human
health or the environment. Information submitted under TSCA can also be
used by government agencies and others to identify potential problems,
set priorities, and take appropriate steps to reduce any potential
risks to human health and the environment and as noted in this
paragraph, may make more of this information available to the public.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This action is not a subject to Executive Order 13211 (66 FR 28355,
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866 and has not otherwise been designated as a
significant energy action by the Administrator of the Office of
Information and Regulatory Affairs.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or indigenous
peoples) and low-income populations.
EPA believes that this action does not directly concern human
health or environmental conditions and therefore cannot reasonably be
evaluated with respect to potentially disproportionate and adverse
effects on people of color, low-income populations and/or indigenous
peoples. This action does not directly address any human health or
environmental risks and does not directly affect the level of
protection provided to human health or the environment. However,
although this action does not directly concern human health or
environmental conditions, in setting clear procedures for
confidentiality claims made by reporting entities under TSCA, this
action is expected to improve the quality of such claims, reduce
unnecessary and unsupported claims, and is anticipated to result in
more information being available to the public. By ensuring uniform
substantiation of CBI claims, electronic reporting requirements,
certification statements, clarifying how EPA treats certain information
initially obtained in a context other than TSCA, and the process for
maintenance or withdrawal of confidentiality claims, EPA is improving
communications and transparency to the public and promoting consistency
for the regulated community. Improved communication and transparency
has inherent informational benefits including increasing understanding
and awareness of potential issues related to chemical information.
Information submitted under TSCA can also be used by government
agencies and others to identify potential problems, set priorities, and
take appropriate steps to reduce any potential risks to human health
and the environment and as noted in this paragraph, may make more of
this information available to the public. Therefore, the informational
benefits of the action are likely to have a positive impact on the
human health and environmental impacts of all populations, including
minority populations, low-income populations, and indigenous peoples.
L. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 2
Administrative practice and procedure, Confidential business
information, Courts, Environmental protection, Freedom of information,
Government employees.
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.
[[Page 37165]]
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, 40 CFR chapter I
is amended as follows:
PART 2--PUBLIC INFORMATION
0
1. The authority citation for part 2 continues to read as follows:
Authority: 15 U.S.C 2613.
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:
Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
Chemical substance has the meaning given it in section 3(2) of the
Act, 15 U.S.C. 2602(2).
EPA Legal Office means the EPA Office of General Counsel and any
EPA office over which the EPA General Counsel exercises supervisory
authority.
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 of this part apply without change to
information to which this section applies. Unless otherwise specified
in this section, 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. (1) EPA intends to make
disclosures pursuant to a request under section 14(d)(4), (5), or (6)
of the Act for information to which this section applies in accordance
with the requirements of the Act and any applicable EPA guidance
required by section 14(c)(4)(B) of the Act.
(2) Section 2.209 applies to information to which this section
applies, except that:
(i) The notification specified in Sec. 2.209(b)(2) is 15 business
days.
(ii) The following two additional provisions apply to Sec.
2.209(c):
(A) 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
(B) 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)).
(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 shall be disclosed by EPA to
a contractor or subcontractor of the United States if, in the opinion
of the Administrator, the disclosure 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
subcontractor of the contract or subcontract.
(2) The provisions of Sec. 2.301(h)(2)(ii) through (iv) apply to
disclosures under paragraph this (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(h) of the Act (15 U.S.C. 2613(h)).
(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 shall be disclosed by EPA if the
Administrator determines that 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 identified as relevant by the Administrator
under the 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
[[Page 37166]]
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. Amend Sec. 702.37 by revising paragraph (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 requirements in
TSCA sections 14(b) and (c), to facilitate EPA review of such claims in
accordance with TSCA sections 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. This includes information that was first obtained by EPA
other than pursuant to the authority of TSCA or its implementing
regulations, provided that the following two criteria have been met:
(1) EPA has authority to collect the information under TSCA; and
(2) 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 (e.g., EPA considered such information
in its actions under TSCA sections 4, 5, or 6).
(c)(1) This part applies regardless of the following:
(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) However, where such information is not protected from
disclosure under TSCA Section 14, but the statute under which the
information was originally provided to EPA limits disclosure for
reasons other than business confidentiality (for example, limited
disclosure of pesticide data to multinational pesticide producers under
7 U.S.C. 136h(g)), the disclosure limitation in the statute under which
the information was obtained by EPA continues to apply, except where
TSCA expressly requires disclosure of that information.
(d) The provisions of 40 CFR part 2, subpart B, apply to this
section, as modified by 40 CFR 2.306.
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) of
this subchapter for test data also applies in this part.
Accept in the context of asserting a TSCA CBI claim means EPA's
first approval of the submission containing the CBI claim in CISS, or
its successor system.
Act, or TSCA, means the Toxic Substances Control Act, 15 U.S.C.
2601 et seq.
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.
FOIA means the Freedom of Information Act, 5 U.S.C. 552, et seq.
Health and safety study has the same meaning as that provided in
Sec. 720.3(k) of this subchapter, except that for purposes of this
part 703 the following information is not part of a health and safety
study:
(1) The name, address, or other identifying information for the
submitting company, including identification of the laboratory that
conducted the study in cases where the laboratory is part of or closely
affiliated with the submitting company.
(2) Internal product codes (i.e., code names for the test substance
used internally by the submitting company or to identify the test
substance to the test laboratory).
[[Page 37167]]
(3) Names and contact details for testing laboratory personnel and
names and other private information for health and safety study
participants or persons involved in chemical incidents such as would
typically be withheld under 5 U.S.C. 552(b)(6) or under other privacy
laws.
(4) Information pertaining to test substance product development,
advertising, or marketing plans, or to cost and other financial data.
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 except where such a claim is disallowed by
applicable regulation under this subchapter. 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. (1) A person asserting
a confidentiality claim must submit a statement that the person has:
(i) Taken reasonable measures to protect the confidentiality of the
information;
(ii) Determined that the information is not required to be
disclosed or otherwise made available to the public under any other
Federal law;
(iii) A reasonable basis to conclude that disclosure of the
information is likely to cause substantial harm to the competitive
position of the person; and
(iv) A reasonable basis to believe that the information is not
readily discoverable through reverse engineering.
(2) 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) 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 business days after the
inspection ends. Confidentiality claims lacking required substantiation
after ten business days will be treated as deficient under paragraph
(e) of this section. Unless otherwise directed by EPA, such information
or materials must be submitted via CDX. In the case of an unusually
voluminous document collection under section 11 of the Act, the
affected company may request additional time to assert claims and
provide substantiation, which EPA may grant at its discretion. The
inspection is considered to have ended when the inspector physically
exits the regulated facility on the last day of the inspection.
(2) 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 separately
substantiated.
(3) Substantiation questions for all claims. Unless otherwise
specified elsewhere in this subchapter (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. If this chemical
is patented and the patent reveals the information you are claiming
confidential, please explain your reasons for believing the information
is nonetheless still 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 or not 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 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].
[[Page 37168]]
(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) Information described in paragraphs (b)(5)(i) and (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 (e)
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) of this subchapter), 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
and in the same manner 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) so
will likely be treated as deficient under paragraph (e) of this
section.
(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 treat as deficient
submissions with public 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, and made binding by, section 14(c)(4)(A)
of the Act (e.g., Guidance for Creating Generic Names for Confidential
Chemical Substance Identity Reporting under TSCA; available at https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting), 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 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) of
this subchapter. In such cases, EPA will notify the submitting company
and proceed as described in Sec. 720.102(f) or Sec. 725.190(f) of
this subchapter.
(4) If EPA concludes that the proposed generic name does not comply
with 15 U.S.C. 2613(c)(1)(C), EPA will
[[Page 37169]]
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, proceeding 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) TSCA submissions bearing
confidentiality claims must be submitted via CDX, except where EPA
directs that information subpoenaed under section 11(c) of the Act or
materials collected or requested by EPA as part of an inspection under
section 11(a) of the Act, not be submitted via CDX. Any required TSCA
submission asserting a CBI claim that does not meet the requirements of
this paragraph will be deemed incomplete. EPA reserves the ability to
waive the requirements of this paragraph, at its discretion, where
compliance is infeasible.
(2) You must use CISS to complete and submit TSCA submissions via
CDX. To access CISS go to https://cdx.epa.gov/ 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 (https://www.oecd.org/ehs/templates/). 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) of
this subchapter, or according to the terms of a specific order under
section 5(e) of the Act).
(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
https://cdx.epa.gov/.
(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 section 14(e) of
the Act)), 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 section 14(e) of the Act. 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
section 14(f) of the Act, 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 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
[[Page 37170]]
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. To withdraw a claim, a
person must reopen the submission in CDX, remove confidentiality
markings (e.g., confidential checkmarks or bracketing), revise public
copies including any attachments to unredact the information no longer
claimed confidential, and then resubmit 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 paragraph (i) of this section.
(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, disclosing the information to the
public.
Sec. 703.7 EPA review of confidentiality claims under TSCA section
14(g)
(a) Representative subset and selection of submissions for review.
(1) A representative subset consists of at least 25 percent 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 the Act. 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 Sec. 721.11 of this
subchapter;
(ii) Submissions or other communication not submitted to EPA via
CDX; and
(iii) Amendments to previous TSCA submissions.
(2) To satisfy its confidentiality claim review obligations under
section 14(g)(1)(C)(ii) of the Act, EPA will generally review all
claims (except those exempt from substantiation under section 14(c)(2)
of the Act) 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 sections 14(c)(2) and 14(g) of the Act), 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)(i) Under section 14(g) of the Act, EPA will review:
(A) All chemical identity claims asserted in TSCA submissions
except those that are exempt from substantiation according to section
14(c)(2)(G) of the Act; and
(B) a representative subset of other confidentiality claims as
provided in paragraph (a) of this section.
(ii) Final determinations will be issued by the General Counsel or
their designee, which may include personnel outside of the Office of
General Counsel.
(2) EPA will review all timely requests for extension of claims
under section 14(e) of the Act within 30 days of receipt.
(3) EPA will also review or re-review confidentiality claims under
certain other circumstances, as set out in section 14(f) of the Act.
Review under section 14(f) of the Act 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
section 14(g) of the Act 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 section 26(j) of
the Act.
(e) Claim denials and notice period. 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, as described in Sec. 703.5(h).
The 30-day notice period described in section 14(g)(2)(B) of the Act
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 section 14 of the Act will be
approved if all of the following apply:
(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;
(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);
[[Page 37171]]
(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 respecting any chemical that
has been offered for commercial distribution or for which testing is
required under section 4 of the Act or notice is required under section
5 of the Act 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.
(6) 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)).
(g) 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) will be evaluated
using the same criteria as described in paragraph (f) of this section.
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 where authorized by 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 which 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. The exemptions from
substantiation requirements contained in section 14(c)(2) of TSCA do
not apply to confidentiality claims reviewed under this section 703.8,
even if such exemptions applied when the information was originally
submitted to EPA.
(c) Additional substantiation. If necessary, such as where
substantiation has not previously been provided for confidentiality
claims under review, or where 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).
(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.
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:
0
a. Removing the paragraph designations (a) through (d) and listing the
existing definitions in alphabetical order; and
0
b. Adding in alphabetical order a definition for ``CDX''.
The addition reads as follows:
Sec. 707.63 Definitions.
* * * * *
CDX or Central Data Exchange means EPA's centralized electronic
document receiving system, or its successor system.
* * * * *
0
10. Revise Sec. 707.65 to read as follows:
Sec. 707.65 Submission to the agency.
(a) For each action under TSCA triggering export notification,
exporters must notify EPA of their export or intended export of each
subject
[[Page 37172]]
chemical substance or mixture for which export notice is required under
Sec. 707.60 in accordance with the following:
(1)(i) The export 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 export 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, 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 export 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.
(b) If the EPA action that prompts the notice is a proposed rule,
the requirement to submit export notices to EPA shall begin thirty days
after publication of the action in the Federal Register.
(c) Export 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, 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 https://cdx.epa.gov/ 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 subchapter 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 certification, substantiation, and
generic name requirements described 40 CFR 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
this section must:
(i) Comply with generic name requirements described in 40 CFR 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
[[Page 37173]]
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 https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting).
(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. Amend Sec. 723.250 by revising paragraphs (f) introductory text
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) through (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 (https://cdx.epa.gov/ gov/), using the TSCA Section 5 Notices and Supports--ePMN application.
See Sec. 720.40(a)(2)(ii) of this subchapter 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 for confidentiality claims.
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) of this subchapter, the
following question must be answered: 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) of this subchapter, 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 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.
[[Page 37174]]
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 subchapter and on EPA's website.
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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
of this subchapter 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 of
this subchapter and paragraphs (e) and (f) of this section.
* * * * *
(e) Requirements for assertion. Any person who asserts a
confidentiality claim for microorganism identity must:
(1) Comply with the requirements of paragraph (f) of this section
regarding submission of a generic name.
(2) 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.
(3) Have available and agree to furnish to EPA upon request the
taxonomic designations and supplemental information required by Sec.
725.12.
(4) 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
section 14(c)(4)(A) of the Act (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) of
this subchapter. 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
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34. The authority citation for part 790 continues to read as follows:
Authority: 15 U.S.C. 2603.
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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. 2023-12044 Filed 6-6-23; 8:45 am]
BILLING CODE 6560-50-P