[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Rules and Regulations]
[Pages 13062-13069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03868]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 710
[EPA-HQ-OPPT-2018-0320; FRL-10005-48]
RIN 2070-AK21
Procedures for Review of CBI Claims for the Identity of Chemicals
on the TSCA Inventory
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is finalizing requirements for regulated entities to
substantiate certain confidential business information (CBI) claims
made under the Toxic Substances Control Act (TSCA) to protect the
specific chemical identities of chemical substances on the confidential
portion of the TSCA Inventory, and the Agency's plan for reviewing
certain CBI claims for specific chemical identities. The substantiation
requirements describe the applicable procedures and provide
instructions for regulated entities. The Agency's plan sets out the
review criteria and related procedures that EPA will use to complete
the reviews within the five-year timeframe set in TSCA.
DATES: This final rule is effective on May 5, 2020.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0320, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Scott M. Sherlock, Environmental
Assistance Division (Mail code 7408M), Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-8257; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This final rule establishes the CBI substantiation requirements for
manufacturers (which under TSCA includes importers) and processors who
claimed specific chemical identities as CBI in previously filed Notices
of Activity (NOAs) Form A (Ref. 1) in accordance with the 2017 TSCA
Inventory Notification (Active-Inactive) Requirements rule (hereinafter
``2017 Active-Inactive Rule,'' which is summarized in more detail in
Unit III and codified in 40 CFR part 710, subpart B) (Ref. 2). This
final rule also amends the existing CBI substantiation requirements for
manufacturers and processors who have filed or will file NOAs Form B
(Ref. 3) and claimed or claim specific chemical identities as CBI.
Manufacturers and processors who previously provided substantiations in
NOAs Form A or B for CBI claims for specific chemical identities
pursuant to the 2017 Active-Inactive Rule will be required to
supplement those substantiations to include responses to two new
questions related to a specific chemical identity's susceptibility to
reverse engineering. All substantiations must be submitted to the
Agency using EPA's Central Data Exchange (CDX), the Agency's electronic
reporting portal.
This final rule describes the Agency's plan to review the CBI
claims for specific chemical identities that were asserted in NOAs Form
A during the one-time retrospective reporting period under the 2017
Active-Inactive Rule, including procedures for the Agency's publication
of annual review goals and results. EPA will review each specific
chemical identity CBI claim and substantiation, and approve or deny
each claim consistent with the procedures and substantive criteria in
TSCA sections 8(b)(4) and 14 and 40 CFR part 2, subpart B.
EPA is amending the existing regulations in 40 CFR part 710,
subpart B, and is adding provisions about the NOA Form A substantiation
process and the Agency's review plan to a new subpart C.
B. What is the Agency's authority for taking this action?
EPA is issuing this rule pursuant to the authority in TSCA section
8(b), 15 U.S.C. 2607(b).
C. Why is the Agency taking this action?
TSCA section 8(b)(4)(C) requires EPA to promulgate a rule that
establishes the Agency's plan to review all CBI claims for the specific
chemical identities of chemical substances on the confidential portion
of the TSCA Inventory that were asserted in an NOA Form A pursuant to
the one-time retrospective reporting under the 2017 Active-Inactive
Rule. The 2017 Active-Inactive Rule required any reporter who sought to
maintain an existing CBI claim for a specific chemical identity to
assert that claim as part of the submission of an NOA Form A, but the
rule did not require substantiation of those claims at that time. This
final rule implements the statutory substantiation and review
requirements so as to ensure that only those specific chemical
identities that currently qualify for confidential treatment are
protected from disclosure by the Agency.
This final rule also addresses a Federal court remand of the 2017
Active-Inactive Rule by amending that rule to add two substantiation
questions which will be applicable to all NOA Form B reporters who seek
to maintain an existing CBI claim for a specific chemical identity, and
by including the same two questions in the newly finalized
substantiation requirements for NOA Form A reporters who seek to
maintain an existing CBI claim for a specific chemical identity. These
substantiation questions address whether a specific chemical identity
is readily discoverable through reverse engineering and will ensure the
submission of information that EPA will use to evaluate CBI claims for
specific chemical identities.
D. Who does this action apply to?
You may be affected by this action if you reported a confidential
chemical substance under the 2017 Active-Inactive Rule using an NOA
Form A or NOA Form B and sought to maintain an existing CBI claim for a
specific chemical identity. You may also be affected by this action if
you anticipate
[[Page 13063]]
reporting a confidential chemical substance under the 2017 Active-
Inactive Rule through an NOA Form B in the future and anticipate
seeking to maintain an existing CBI claim for a specific chemical
identity at that time. The following North American Industrial
Classification System (NAICS) codes are not intended to be exhaustive,
but rather provide a guide to help readers determine whether this
action may apply to them:
Chemical manufacturing or processing (NAICS code 325).
Petroleum and coal products manufacturing (NAICS code
324).
``Manufacture'' is defined in TSCA section 3(9) (15 U.S.C. 2602(9))
and 40 CFR 710.3(d) to include ``import.'' Accordingly, all references
to manufacture in this document should be understood to include import.
If you have any questions regarding the applicability of this
action to a particular entity after reading the regulatory text,
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential incremental impacts of this
rulemaking in an economic analysis (EA), titled ``Economic Analysis for
the Final Rule: Procedures for Review of CBI Claims for the Identity of
Chemicals on the TSCA Inventory'' (Ref. 4), which is available in the
docket, discussed in Unit IV., and briefly summarized here.
1. Benefits. The benefits of the rule include improvements in the
management of CBI claims for specific chemical identities, including a
decrease in the number of unsupported claims of confidentiality. There
would also be a corresponding increase in transparency for the public
with regard to specific chemical identity information. Overall, the
rule results in a more efficient means of enacting the various
requirements and duties prescribed to EPA in TSCA, while also providing
the potential for a greater level of transparency with regard to the
specific chemical identities of chemical substances on the TSCA
Inventory.
2. Costs. Over the course of the first ten years after the
effective date of the final rule, EPA estimates a one-time total burden
and cost for regulated entities of 5,259 hours and approximately
$407,000, respectively and an ongoing, annual burden and cost of
approximately 0.38 hours and $29, respectively.
II. Background
A. How were CBI claims for specific chemical identities addressed in
the 2017 Active-Inactive Rule?
Pursuant to TSCA section 8(b), the 2017 Active-Inactive Rule
(codified in 40 CFR part 710, subpart B) required manufacturers, and
allowed processors, to report those chemical substances on the TSCA
Inventory that were manufactured or processed for a nonexempt
commercial purpose during the 10-year time period ending on June 21,
2016. EPA used these retrospective notifications--filed on an NOA Form
A--to designate chemical substances as ``active'' or ``inactive,'' and
EPA now includes those active and inactive designations on the TSCA
Inventory. Going forward, the 2017 Active-Inactive Rule requires
notification if manufacturing or processing of an inactive chemical
substance for a nonexempt commercial purpose is expected to resume. On
receiving such a forward-looking notification--filed on an NOA Form B--
EPA will change the designation of the pertinent chemical substance on
the TSCA Inventory from inactive to active. The one-time submission
period for NOA Form A ended on October 5, 2018, while the NOA Form B is
submitted on an ongoing basis.
Consistent with TSCA sections 8(b)(4)(B)(ii) and (5)(B)(ii), the
2017 Active-Inactive Rule provided that manufacturers and processors
filing an NOA Form A or B could seek to maintain an existing CBI claim
for a specific chemical identity by including such a request on their
NOA Form A or B, through the process established in 40 CFR 710.37(a).
NOA Form A submitters were permitted to voluntarily substantiate their
CBI claims for specific chemical identities at the time of filing their
NOA Form A by answering the substantiation questions set forth in 40
CFR 710.37(c). NOA Form B submitters were (and are, subject to the
amendments effectuated through this rule) required to substantiate
their CBI claims not later than 30 days after submitting their NOA Form
B by answering the same substantiation questions.
On April 26, 2019, the U.S. Court of Appeals for the District of
Columbia Circuit entered a judgment in Environmental Defense Fund v.
EPA, 922 F.3d 446 (D.C. Cir. 2019), granting in part and denying in
part a petition for review of the 2017 Active-Inactive Rule (Ref. 5).
The court decision impacted the CBI substantiation provisions set forth
in 40 CFR 710.37 as discussed in more detail in the supplemental
proposed rule (Ref. 6).
B. What did EPA propose?
On April 23, 2019, EPA proposed to establish a plan to review all
CBI claims for specific chemical identities asserted in an NOA Form A,
including the procedures for submitter substantiation and EPA review of
those claims (Ref. 7).
In response to the court decision of April 26, 2019, EPA issued a
supplemental proposed rule on November 8, 2019 that included revisions
to the existing substantiation requirements in the 2017 Active-Inactive
Rule at 40 CFR 710.37 and supplemented the proposed rule issued in
April 2019. Specifically, EPA proposed two additional questions
addressing a specific chemical identity's susceptibility to reverse
engineering that manufacturers and processors would be required to
answer to substantiate CBI claims for specific chemical identities
asserted in an NOA Form A or B; and proposed procedures for
manufacturers and processors to use in supplementing substantiations
that had already been submitted under the 2017 Active-Inactive Rule to
include responses to the two additional questions.
C. Public Comments
EPA received seven comments during the public comment period for
the proposed rule, and an additional five comments during the comment
period for the supplemental proposed rule. Submitted comments generally
focused on the Agency's proposed substantiation and review processes as
well as the duration of protection of CBI from disclosure. A number of
commenters requested clarification or provided suggestions that EPA
considered in preparing this final rule. EPA has summarized the
comments and provided detailed responses in a Response to Comments
document that is available in the docket (Ref. 8).
III. Final Rule
After careful consideration of the public comments received, EPA is
finalizing the substantiation requirements and the Agency's review plan
as discussed in this unit.
A. CBI Claims for Specific Chemical Identities Asserted in NOAs Form A
1. Substantiation Requirements
a. Scope. This final rule establishes the substantiation
requirements for manufacturers and processors who previously filed NOAs
Form A seeking to maintain existing CBI claims to protect the specific
chemical identities of active chemical substances on the
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confidential portion of the TSCA Inventory.
b. Persons subject to substantiation requirements. This final rule
provides that any person who filed an NOA Form A requesting to maintain
an existing CBI claim for a specific chemical identity must
substantiate that confidentiality claim by addressing the
substantiation questions in this rule, unless the person is eligible
for an exemption. There are two exemptions in this rule which set forth
reduced requirements for certain persons who have previously
substantiated their CBI claims. These exemptions are substantively
unchanged from the supplemental proposed rule.
The first exemption applies to those persons who previously
completed the voluntary substantiation process set forth in the 2017
Active-Inactive Rule at 40 CFR 710.37(a)(1). These persons may rely on
their previously submitted substantiation in lieu of answering the
first six substantiation questions in this rule, and are only required
to submit answers to the two questions relevant to reverse engineering
that are being finalized in 40 CFR 710.45(b)(7) and (8), signed and
dated by an authorized official, and to complete the certification
statement in 40 CFR 710.37(e).
The second exemption applies to those persons who previously
substantiated their CBI claims for specific chemical identities in
different submissions made to EPA less than five years before the
substantiation deadline set forth in this rule. So long as that prior
substantiation contains information that is responsive to all
substantiation questions set forth in this rule at 40 CFR 710.45, these
persons may rely on their prior substantiation in lieu of answering the
substantiation questions in this rule. To establish eligibility for
this exemption and to ensure that EPA can locate and match the prior
substantiation with the proper NOA Form A filer, persons who seek to
rely on this exemption must report to EPA the submission date;
submission type; and case number, transaction ID, or equivalent
identifier for the previous submission that contained the
substantiation, not later than the deadline specified in this rule. For
example, substantiations for CBI claims for specific chemical
identities submitted with 2016 or 2020 Chemical Data Reporting (CDR)
submissions in accordance with the substantiation procedures at 40 CFR
711.30(b)(1), or with Notices of Commencement (NOCs) in accordance with
the substantiation procedures at 40 CFR 720.85(b)(3)(iv), serve as a
basis for this exemption.
A person who is eligible for an exemption may choose whether to
take advantage of the reduced reporting under this rule afforded by the
exemption or submit a new full substantiation in accordance with all
requirements of this rule. Persons who have previously submitted a
substantiation may prefer to complete a new substantiation under this
rule if, for example, they wish to provide updated or additional
information to support their CBI claim for a specific chemical
identity.
c. Contents of substantiation. The final rule provides that a
person substantiating a CBI claim for a specific chemical identity must
submit written answers to the questions set forth in the rule at 40 CFR
710.45, signed and dated by an authorized official, and complete a
certification statement. If information submitted in response to the
substantiation questions is itself claimed as CBI, the submitter must
clearly indicate such by marking that information as CBI.
In response to public comments, EPA has revised several of the
proposed substantiation questions to improve clarity and reduce any
unnecessary burden. First, EPA has chosen not to finalize one proposed
question that asked whether the information claimed as confidential is
exempt from substantiation pursuant to TSCA section 14(c)(2). EPA
agrees with several commenters who noted that the question was neither
necessary nor appropriate because no TSCA section 14(c)(2) exemption
would ever apply to the CBI claims for specific chemical identities at
issue in this rule. Second, in response to comments, EPA has clarified
several of the substantiation questions proposed. While these questions
remain substantively the same as those proposed (which, with the
exception of the two reverse engineering questions addressed in the
supplemental proposal, were identical to the questions in the 2017
Active-Inactive Rule at 40 CFR 710.37(c)), they have been re-written
for clarity and to more clearly solicit answers potentially more
responsive to the substantive criteria the Agency employs in making CBI
determinations. Relevant public comments and the resulting changes to
the substantiation questions are discussed in greater detail in the
Response to Comments document (Ref. 8).
Most notably, EPA divided into three sub-questions the proposed
substantiation question asking whether the confidential information
appears in any public documents. Though the question as originally
worded was intended to capture information in patents and patent
applications, state, local, or Federal agency files, and any document
required to be publicly disclosed under any other Federal law, EPA
rewrote the question to make this more explicit. In addition, EPA
clarified the proposed reverse engineering question asking whether the
chemical substance can be identified by analysis of the product. The
finalized question asks more directly whether the specific chemical
identity can be readily discovered by analysis of the substance (e.g.,
product, effluent, or emission), in light of existing technologies and
any associated costs, difficulties, or limitations. Finally, EPA
clarified the proposed substantiation question pertaining to
substantial competitive harm to make clearer that responses should
include an explanation of how a competitor could use such information
and the causal relationship between the disclosure and the harmful
effects.
d. When to submit substantiation or information on previous
substantiation. The final rule provides at 40 CFR 710.47 that
manufacturers and processors seeking to maintain CBI claims for
specific chemical identities asserted in an NOA Form A will have 180
days from the effective date of the rule to submit substantiations,
including responses to the two new substantiation questions, or, in the
case of one of the exemptions, information identifying a previously
submitted substantiation. This deadline applies to all persons who
asserted CBI claims for specific chemical identities in an NOA Form A,
including (1) persons newly substantiating their claims; (2) persons
who voluntarily substantiated under the 2017 Active-Inactive Rule and
need only submit responses to two substantiation questions under this
rule; and (3) persons who substantiated their claims in some other
submission within the last five years and need only submit information
identifying that prior substantiation. EPA is finalizing a 180-day
deadline in response to several comments from industry groups
expressing concerns about meeting the proposed 90-day deadline.
e. Failure to report. In the proposed rule, EPA addressed the
situation where a person filed an NOA Form A and asserted a CBI claim
for a specific chemical identity, but never, either as a voluntary
submission or per this rule, provided a substantiation or notice of
prior substantiation. EPA had proposed to treat the CBI claim for a
specific chemical identity as deficient because no substantiation was
provided or referenced and proposed that the Agency may release the
specific
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chemical identity to the public without further notice to the NOA Form
A submitter. In response to comments, the final rule provides that when
a person who asserted a CBI claim for a specific chemical identity in
an NOA Form A failed to timely submit a substantiation or notice of
prior substantiation, the CBI claim will be denied, and the submitter
will be provided notice and an opportunity to seek judicial review of
the final confidentiality determination in accordance with TSCA section
14(g)(2) and 40 CFR 2.306(e).
f. Electronic filing. The final rule provides that information must
be submitted electronically via CDX in accordance with the existing
regulation at 40 CFR 710.39. Prior to submission, this information must
be generated and completed using the e-NOA software module. This is
unchanged from what was proposed.
g. Record-keeping requirements. The final rule provides that
persons subject to this rule must retain records for a period of five
years beginning on the last day of the submission period. This is
unchanged from what was proposed.
2. EPA's Review Plan
This final rule also addresses the CBI claim review process, the
duration of protection from disclosure, TSCA Inventory updates, the
posting of annual review goals and results, and the timeframe for
completion of Agency reviews. These provisions are substantively
unchanged from the proposal.
a. Review criteria and procedures. The final rule provides that CBI
claims for specific chemical identities asserted in NOAs Form A will be
reviewed and approved or denied in accordance with the criteria and
procedures in TSCA section 14 and 40 CFR part 2, subpart B. The final
rule differs from the proposal in that a TSCA section 14 reference is
added to the regulatory text to make explicit that the Agency's review
criteria and procedures will follow the statutory requirements of TSCA.
To the extent that there is any conflict between TSCA section 14 and 40
CFR part 2, subpart B, the statutory provision controls.
b. Duration of protection from disclosure. The final rule provides
that a specific chemical identity whose CBI claim was approved by EPA
will generally be protected from disclosure for a period of 10 years
from the date on which the confidentiality claim was first asserted by
any submitter after June 22, 2016. The main exceptions to this period
of protection from disclosure are (1) that if prior to the expiration
of the period, the claimant notifies EPA that the person is withdrawing
the confidentiality claim, EPA will not protect the information from
disclosure from that date forward; or (2) if EPA otherwise becomes
aware that the information does not qualify for protection from
disclosure, the Agency will take the actions described in TSCA section
14(g)(2) to notify the claimant of EPA's intent to disclose the
information. The period of protection is also subject to the exceptions
and extensions to protection from disclosure enumerated in TSCA section
14. This is unchanged from what was proposed.
c. Updating the TSCA Inventory. The final rule provides that EPA
will periodically update the TSCA Inventory based on the results of the
reviews of the confidentiality claims for a specific chemical identity.
This is unchanged from what was proposed.
d. Posting annual goals and numbers of reviews completed. The final
rule provides that at the beginning of each calendar year until all
reviews are completed, EPA will publish an annual goal for reviews and
the number of reviews completed in the prior year on the Agency
website. This activity will begin in 2021, because substantiations are
not required to be submitted to EPA until late 2020. The setting of
annual review goals will take into consideration the number of claims
needing review, available resources, and the statutory target
completion date for all reviews to be completed not later than February
19, 2024. The final rule reflects a minor modification from the
proposal to clarify that the posting of annual goals and number of
reviews completed will cease upon completion of all reviews.
e. Extension. The final rule provides, consistent with the statute,
that in the event that EPA determines that the target completion date
cannot be met based on the number of claims needing review and the
available resources, then EPA will publish a notice in the Federal
Register announcing an extension of the deadline to complete its review
of all confidentiality claims. The extension may not be for more than
two additional years. EPA will provide an explanation of the reasons
for the extension in the Federal Register. This is unchanged from what
was proposed.
B. CBI Claims for Specific Chemical Identities Asserted in NOAs Form B
This final rule amends existing substantiation requirements set
forth in 40 CFR 710.37(a)(2) and (c)(2) for CBI claims for specific
chemical identities asserted in an NOA Form B. These amendments add two
substantiation questions relevant to a specific chemical identity's
susceptibility to reverse engineering, which claimants will be required
to answer when substantiating such CBI claims in the future. The
amendments also require any person who has already submitted an NOA
Form B and substantiation on that form before the effective date of
this final rule to supplement that substantiation within 30 days of the
effective date of the final rule by adding responses to the two new
questions. All other existing regulatory provisions in 40 CFR 710.37
applicable to the assertion, substantiation, certification, and review
of CBI claims remain unchanged.
IV. Economic Analysis
The estimated incremental impacts of this rulemaking are briefly
summarized in this unit and the complete Economic Analysis is available
in the docket (Ref. 4). The rule requirements involve an incremental
reporting effort for respondents who asserted CBI claims for one or
more specific chemical identities in NOAs Form A during the one-time
reporting period in 40 CFR part 710, subpart B. The rule requirements
also involve an incremental reporting effort for respondents who
assert(ed) CBI claims for one or more specific chemical identities in
NOAs Form B. These reporting efforts consist of activities that are the
same as or similar to those in the 2017 Active-Inactive Rule.
Respondents who submitted an NOA Form A and would potentially be
subject to an incremental reporting effort fall into three groups based
on the information provided in their submission. The first group (Group
(1)) consists of those respondents who voluntarily submitted upfront
CBI substantiation as part of the NOA submission process. The second
group (Group (2)) consists of those respondents who did not voluntarily
submit upfront CBI substantiation, but will be able to use the
exemption offered under this rule by referencing a previous
substantiation, such as one submitted under the 2016 or 2020 Chemical
Data Reporting (CDR) rule (40 CFR part 711) or with a Notice of
Commencement. The third group (Group (3)) consists of the remaining
respondents who did not voluntarily submit upfront CBI substantiation
in their NOA Form A submissions and would be required to provide full
substantiation under this rule.
In addition to the three NOA Form A reporting groups, respondents
who assert(ed) CBI claims for one or more specific chemical identities
in NOAs Form B are subject to an incremental reporting effort. This
includes respondents who will submit an NOA Form B as part of ongoing
reporting, as
[[Page 13066]]
well as a set of 54 companies who asserted CBI claims for one or more
specific chemical identities in NOAs Form B that was submitted during a
one-time transitional reporting period.
Under this rule, the 275 companies who asserted CBI claims for one
or more specific chemical identities in NOAs Form A incur a one-time
burden and cost. For Group (1), the average one-time burden and costs
per company are estimated at approximately 7 hours and $543,
respectively (involving an average of 21 chemicals per company) for
rule familiarization, providing answers for two substantiation
questions relating to reverse engineering, and recordkeeping. For Group
(2), the average one-time burden and costs per company are estimated at
5 hours and $390, respectively (involving an average of four chemicals
per company), for rule familiarization, identification of a previous
substantiation, and recordkeeping. For Group (3), the average one-time
burden and costs per company are estimated at 39 hours, and $3,039,
respectively (involving an average of 27 chemicals per company), for
rule familiarization, full substantiation, and recordkeeping.
Respondents who have filed or will file an NOA Form B that asserts
a CBI claim for a specific chemical identity would be required to
provide answers for two additional substantiation questions relating to
reverse engineering. For NOA Form B submissions occurring on an annual
basis, the average incremental burden and costs per company are
estimated at approximately 0.38 hours and $29, respectively (involving
an average of two chemicals per company). For the 265 NOA Form B
submissions from a total of 54 companies that were received during a
one-time transitional reporting period, the total one-time burden and
cost across all companies are estimated at approximately 50 hours and
$3,903, respectively.
The burden and cost estimates associated with the rule include a
one-time burden associated with NOA Form A submissions, as well as an
ongoing burden and one-time burden associated with NOA Form B
submissions. A total of 275 companies are subject to a one-time burden
associated with substantiating CBI claims for specific chemical
identities asserted in NOAs Form A, including: Group (1), consisting of
149 companies, Group (2), consisting of 23 companies, and Group (3),
consisting of 103 companies. The ongoing burden associated with NOA
Form B submissions is based on the expectation that each year one
company will submit an NOA Form B that includes CBI claims for two
specific chemical identities and, therefore, incur a burden associated
with ongoing reporting. Additionally, the one-time burden and cost
estimates associated with this rule take into account a set of 265 NOA
Form B submissions from a total of 54 companies that were received
during a one-time transitional reporting period.
The total burden and costs associated with this rule consist of a
one-time burden and cost for regulated entities estimated at 5,259
hours and $406,852 and an ongoing annual burden and cost estimated at
approximately 0.38 hours and $29 for each year of a ten-year period.
The equivalent annualized costs are expected to be $47,729 at a three
percent discount rate and $57,968 at a seven percent discount rate
(Ref. 4).
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
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Notice of Activity Form A; Final, 2017.
2. EPA. TSCA Inventory Notification (Active-Inactive) Requirements;
Final Rule. Federal Register, 82 FR 37520, August. 11, 2017 (FRL-
9964-22).
3. EPA. Notice of Activity Form B; Final, 2017.
4. EPA. Economic Analysis for the Final Rule: Procedures for Review
of CBI Claims for the Identity of Chemicals on the TSCA Inventory
(RIN 2070-AK21). February 4, 2020.
5. U.S. Court of Appeals for the District of Columbia Circuit
entered a judgment in Environmental Defense Fund v. EPA, 922 F.3d
446 (DC Cir. 2019).
6. EPA. Procedures for Review of CBI Claims for the Identity of
Chemicals on the TSCA Inventory; Revisions to the CBI Substantiation
Requirements; Supplemental notice of proposed rulemaking. Federal
Register, 84 FR 60363, November 8, 2019 (FRL-10001-44).
7. EPA. Procedures for Review of CBI Claims for the Identity of
Chemicals on the TSCA Inventory; Proposed Rule. Federal Register, 84
FR 16826, April 23, 2019 (FRL-9992-05).
8. 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.
9. EPA. Information Collection Request (ICR) Supporting Statement.
Procedures for Review of CBI Claims for the Identity of Chemicals on
the TSCA Inventory (Notice of Activity Form As). EPA ICR No.:
2594.03, OMB Control No.: 2070-0210. February 4, 2020.
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.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review under Executive Orders 12866 (58 FR 51735, October 4, 1993)
and 13563 (76 FR 3821, January 21, 2011).
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not a regulatory action under Executive Order 13771
(82 FR 9339, February 3, 2017) because this action is not significant
under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
The information collection activities in this action have been
submitted for approval to the Office of Management and Budget (OMB)
under the PRA, 44 U.S.C. 3501 et seq. The Information Collection
Requests (ICR) are assigned EPA ICR number ICR No. 2594.03 and OMB
Control No. 2070-0210 (Ref. 9). You can find a copy of the ICR in the
docket and it is briefly summarized here.
The reporting requirements identified in this action will provide
EPA with information necessary to evaluate confidentiality claims and
determine whether the claims qualify for protection from disclosure.
EPA will review each CBI claim for specific chemical identity and
related substantiation, and approve or deny each claim consistent with
the procedures and substantive criteria in TSCA sections 8(b)(4) and 14
and 40 CFR part 2, subpart B.
Respondent's obligation to respond: Mandatory under TSCA section 8
and 40 CFR part 710.
Estimated total number of potential respondents: 329 companies (one
time) and 1 company annually (ongoing).
Frequency of response: Once per chemical substance.
[[Page 13067]]
Estimated total burden: 5,259 hours (one time) and 0.38 hours
annually (ongoing). Burden is defined at 5 CFR 1320.3(b).
Estimated total costs: $406,852 (one time) and $29 annually
(ongoing), includes no annualized capital investment or maintenance and
operational costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are
displayed on the related collection instrument or form. 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.
D. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
certify that this final rule will not have a significant economic
impact on a substantial number of small entities. The small entities
subject to the requirements of this action are manufacturers (including
importers) and processors of chemical substances. The estimated
economic impacts on small entities are presented in the Economic
Analysis, (Ref. 4), which is available in the docket and briefly
summarized here.
As a conservative approach, this small entity analysis applies the
highest unit cost to all small entities. When considering the highest
estimated average cost per company, the rule is not anticipated to have
cost impacts greater than 1% on any small entities. Details of this
analysis are included in the accompanying Economic Analysis for this
final rule (Ref. 4).
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action is not expected to impose enforceable
duty on any state, local or tribal governments, and the requirements
imposed on the private sector are not expected to result in annual
expenditures of $100 million or more for the private sector. As such,
EPA has determined that the requirements of UMRA sections 202, 203,
204, or 205 do not apply to this action.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the states, on the relationship between
the National Government and the states, or on the distribution of power
and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes. Thus, E.O. 13175 does not apply to this
action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
Executive Order 13045 has the potential to influence the regulation.
This action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate health or
safety risks.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on energy supply,
distribution, or use.
J. National Technology Transfer and Advancement Act (NTTAA)
Since this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994), because it does not establish an
environmental health or safety standard. This action establishes an
information requirement and does not affect the level of protection
provided to human health or the environment.
VII. 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 in 40 CFR Part 710
Environmental protection, Chemicals, Confidential business
information, Hazardous substances, Reporting and recordkeeping
requirements.
Dated: February 19, 2020.
Andrew R. Wheeler,
Administrator.
Therefore, 40 CFR chapter I, subchapter R, is amended as follows:
PART 710--[AMENDED]
0
1. The authority citation for part 710 continues to read as follows:
Authority: 15 U.S.C. 2607(a) and (b).
Subpart B--Commercial Activity Notification
0
2. Amend Sec. 710.37 by adding paragraph (a)(2)(i) and reserved
paragraph (a)(2)(ii) and revising paragraph (c)(2) to read as follows:
Sec. 710.37 Confidentiality claims.
(a) * * *
(2) * * *
(i) Persons who submitted the information described in paragraph
(a)(2) of this section before May 5, 2020 must submit answers to the
questions in paragraphs (c)(2)(ii) and (iii) of this section not later
than June 4, 2020.
(ii) [Reserved]
* * * * *
(c) * * *
(2) Substantiation for confidentiality claims for specific chemical
identity. (i) Is the confidential chemical substance publicly known to
have ever been offered for commercial distribution in the United
States? If you answered yes, explain why the information should be
treated as confidential.
(ii) Does this particular chemical substance leave the site of
manufacture (including import) or processing in any form, e.g., as a
product, effluent, or emission? If yes, please explain what measures
have been taken, if any, to guard against the discovery of its
identity.
[[Page 13068]]
(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, or emission), in light of existing technologies and any
costs, difficulties, or limitations associated with such technologies?
Please explain why or why not.
* * * * *
0
3. Add subpart C to read as follows:
Subpart C--Review Plan
Sec.
710.41 Scope.
710.43 Persons subject to substantiation requirement.
710.45 Contents of substantiation.
710.47 When to submit substantiation or information on previous
substantiation.
710.49 Failure to report.
710.51 Electronic filing.
710.53 Recordkeeping requirements.
710.55 Claim review, duration of protection, TSCA Inventory
maintenance, posting results, and extension.
Sec. 710.41 Scope.
This subpart applies to the substantiation and review of claims of
confidentiality asserted in Notices of Activity Form A to protect the
specific chemical identities of chemical substances.
Sec. 710.43 Persons subject to substantiation requirement.
(a) Who must substantiate. Any person who filed a Notice of
Activity Form A requesting to maintain an existing confidentiality
claim for a specific chemical identity must substantiate that
confidentiality claim as specified in Sec. Sec. 710.45 and 710.47
unless eligible for an exemption in paragraph (b) of this section.
(b) Exemptions. (1) Any person who completed the voluntary
substantiation process set forth in Sec. 710.37(a)(1) is exempt from
the substantiation requirement of this subpart pertaining to the
submission of answers to the questions in Sec. 710.45(b)(1) through
(6). All remaining requirements of Sec. 710.45 must be met in
accordance with the deadline specified in Sec. 710.47(a), including
the requirement to submit answers to the questions in Sec.
710.45(b)(7) and (8), signed and dated by an authorized official, and
to complete the certification statement in Sec. 710.37(e).
(2) A person who has previously substantiated the confidentiality
claim for a specific chemical identity that the person requested to
maintain in a Notice of Activity Form A, by submitting information that
is responsive to all questions in Sec. 710.45, is exempt from the
substantiation requirement of this subpart if both of the following
conditions are met:
(i) The previous substantiation was submitted to EPA on or after
November 1, 2015; and
(ii) The person reports to EPA the submission date, submission
type, and case number, transaction ID, or equivalent identifier for the
previous submission that contained the substantiation, not later than
the deadline specified in Sec. 710.47.
Sec. 710.45 Contents of substantiation.
(a) The submission. A person substantiating a confidentiality claim
for a specific chemical identity must submit written answers to the
questions in paragraph (b) of this section, signed and dated by an
authorized official, and complete the certification statement in Sec.
710.37(e). If any of the information contained in the answers to the
questions listed in paragraph (b) of this section is itself claimed as
confidential, the submitter must clearly indicate such by marking that
information as confidential business information.
(b) Substantiation questions. (1) Will disclosure of the
information claimed as confidential likely cause substantial harm to
your business's competitive position? If you answered yes, describe the
substantial harmful effects that would likely result to your
competitive position if the information is disclosed, including but not
limited to how a competitor could use such information and the causal
relationship between the disclosure and the harmful effects.
(2) To the extent your business has disclosed the information to
others (both internally and externally), 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.
(3)(i) Is any of the information claimed as confidential required
to be publicly disclosed under any other Federal law? If yes, please
explain.
(ii) 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.
(iii) Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
(4) Is the claim of confidentiality intended to last less than 10
years? If yes, please indicate the number of years (between 1-10 years)
or the specific date/occurrence after which the claim is withdrawn.
(5) Has EPA, another Federal agency, or court made any
confidentiality determination regarding information associated with
this chemical substance? If yes, please provide the circumstances
associated with the prior determination, whether the information was
found to be entitled to confidential treatment, the entity that made
the decision, and the date of the determination.
(6) Is the confidential chemical substance publicly known
(including by your competitors) to have ever been offered for
commercial distribution in the United States? 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).
(7) Does this particular chemical substance leave the site of
manufacture (including import) or processing in any form, e.g., as a
product, effluent, or emission? If yes, please explain what measures
have been taken, if any, to guard against the discovery of its
identity.
(8) 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, or emission), in light of existing technologies and any
costs, difficulties, or limitations associated with such technologies?
Please explain why or why not.
Sec. 710.47 When to submit substantiation or information on previous
substantiation.
(a) All persons required to substantiate a confidentiality claim
pursuant to Sec. 710.43(a) or (b)(1) must submit their substantiation
not later than November 1, 2020.
(b) All persons who seek an exemption under Sec. 710.43(b)(2) must
submit the information specified in
[[Page 13069]]
Sec. 710.43(b)(2)(ii) not later than November 1, 2020.
Sec. 710.49 Failure to report.
If neither the substantiation required under Sec. 710.43(a) or
(b)(1), nor the information specified in Sec. 710.43(b)(2)(ii), is
submitted to EPA in accordance with the provisions of this subpart,
then EPA will deny the confidentiality claim in accordance with the
procedures set forth in TSCA section 14(g)(2) and 40 CFR part 2,
subpart B.
Sec. 710.51 Electronic filing.
EPA will accept information submitted under this subpart only if
submitted in accordance with Sec. 710.39.
Sec. 710.53 Recordkeeping requirements.
Each person who is subject to this part must retain records that
document any information reported to EPA. Records must be retained for
a period of 5 years beginning on the last day of the submission period.
Sec. 710.55 Claim review, duration of protection, TSCA Inventory
maintenance, posting results, and extension.
(a) Review criteria and procedures. Except as set forth in this
subpart, confidentiality claims for specific chemical identities
asserted in Notices of Activity Form A will be reviewed and approved or
denied in accordance with the criteria and procedures in TSCA section
14 and 40 CFR part 2, subpart B.
(b) Duration of protection from disclosure. Except as provided in
40 CFR part 2, subpart B, and section 14 of TSCA, a specific chemical
identity that is the subject of an approved confidentiality claim under
this subpart will be protected from disclosure for a period of 10 years
from the date on which the confidentiality claim was first asserted by
any submitter after June 22, 2016, unless, prior to the expiration of
the period, the claimant notifies EPA that the person is withdrawing
the confidentiality claim, in which case EPA will not protect the
information from disclosure; or EPA otherwise becomes aware that the
information does not qualify for protection from disclosure, in which
case EPA will take the actions described in TSCA section 14(g)(2) to
notify the claimant of EPA's intent to disclose the information.
(c) Updating the TSCA Inventory. EPA will periodically update the
TSCA Inventory based on the results of the reviews of the
confidentiality claims asserted in Notices of Activity Form A.
(d) Posting of annual goals and numbers of reviews completed. At
the beginning of each calendar year until all reviews are completed,
EPA will publish an annual goal for reviews and the number of reviews
completed in the prior year on the Agency website. Determination of
annual review goals will take into consideration the number of claims
needing review, available resources, and a target completion date for
all reviews under this subpart not later than February 19, 2024.
(e) Extension. If EPA determines that the target completion date in
paragraph (d) of this section cannot be met based on the number of
claims needing review and the available resources, then EPA will
publish a document in the Federal Register announcing the extension of
the deadline to complete its review of all confidentiality claims under
this subpart for not more than two additional years, together with an
explanation of the reasons for the extension.
[FR Doc. 2020-03868 Filed 3-5-20; 8:45 am]
BILLING CODE 6560-50-P