[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Proposed Rules]
[Pages 16826-16833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07920]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 710

[EPA-HQ-OPPT-2018-0320; FRL-9992-05]
RIN 2070-AK21


Procedures for Review of CBI Claims for the Identity of Chemicals 
on the TSCA Inventory

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The 2016 amendments to the Toxic Substances Control Act (TSCA) 
require EPA to establish a plan to review all confidential business 
information (CBI) claims for specific chemical identity asserted in a 
Notice of Activity (NOA) Form A. EPA is proposing a rule to establish 
the plan, including the procedures for substantiating and reviewing 
these claims.

DATES: Comments must be received on or before June 24, 2019.

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

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Scott M. Sherlock, Environmental Assistance Division (Mail code 7408M), 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-8257; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you reported a confidential 
chemical substance under the TSCA Inventory Notification (Active-
Inactive) Requirements rule (hereinafter ``Active-Inactive rule'') 
(Ref. 1) (40 CFR part 710, subpart B) through a Notice of Activity 
(NOA) Form A (Ref. 2) and sought to maintain an existing CBI claim for 
a specific chemical identity. The following North American Industrial 
Classification System (NAICS) codes are not intended to be exhaustive, 
but rather provides a guide to help readers determine whether this 
action may apply to them:
     Chemical manufacturing or processing (NAICS code 325).
     Petroleum and Coal Products Manufacturing (NAICS code 
324).
    The discussion in Unit III.A. and the proposed regulatory text 
describe in more detail the circumstances in which entities might be 
subject to this proposed action. If you have any questions regarding 
the applicability of this action to a particular entity, consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.
    Note that TSCA's statutory definition of ``manufacture'' includes 
importing. Accordingly, the regulatory definition of ``manufacture'' 
for this rule includes importation. Since ``manufacture'' is itself 
defined at 40 CFR 710.3(d) and at TSCA section 3(9) (15 U.S.C. 2602(9)) 
to include ``import,'' it is clear that importers are a subset of 
manufacturers. All references to manufacturing in this document should 
be understood to also encompass importing. Where EPA's intent is to 
specifically refer to domestic manufacturing or importing (both 
activities constitute ``manufacture''), this rule will do so expressly.

B. What is the agency's authority for taking this action?

    EPA is proposing this rule pursuant to the authority in TSCA 
section 8(b), 15 U.S.C. 2607(b). See also the discussion in Unit II.B.
    In addition, the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., requires Federal agencies to manage information resources to 
reduce information collection burdens on the public (including through 
the use of automated collection techniques or other forms of 
information technology);

[[Page 16827]]

increase program efficiency and effectiveness; and improve the 
integrity, quality, and utility of information to all users within and 
outside an agency, including capabilities for ensuring dissemination of 
public information, public access to Federal Government information, 
and protections for privacy and security (44 U.S.C. 3506).
    TSCA section 2 expresses the intent of Congress that EPA carry out 
TSCA in a reasonable and prudent manner and in consideration of the 
impacts that any action taken under TSCA may have on the environment, 
the economy, and society. EPA is proposing to manage and leverage its 
information resources, including information technology, to require the 
use of electronic reporting to implement this proposed rulemaking in a 
reasonable and prudent manner.

C. What action is the agency taking?

    Pursuant to TSCA sections 8(b)(4)(C) through (E), EPA is proposing 
to amend 40 CFR part 710 to establish a new subpart C that sets forth 
the Agency's plan to review certain CBI claims to protect the specific 
chemical identities of substances on the confidential portion of the 
TSCA Inventory. The CBI claims that would be reviewed under this plan 
are those that were asserted on NOA Form A's filed in accordance with 
the requirements in the Active-Inactive rule (40 CFR part 710, subpart 
B).
    In accordance with TSCA section 8(b)(4)(D), EPA is proposing 
substantiation requirements for manufacturers (including importers) and 
processors who filed NOA Form A's with assertions that they seek to 
maintain CBI claims to protect the specific chemical identities of 
chemical substances on the confidential portion of the TSCA Inventory. 
Manufacturers and processors who provided substantiations pursuant to 
the voluntary substantiation process in the Active-Inactive rule NOA 
collection, or who identify a previous substantiation for the claim 
made to EPA during the 5-year period ending on the substantiation 
deadline specified by EPA, would be exempt from this requirement. EPA 
would 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. Also included in this proposed rule are 
provisions clarifying the duration of protection for approved CBI 
claims, and providing for the publication of annual review goals and 
results.
    As described in Unit III.D., EPA is proposing to apply the 
electronic reporting requirement at 40 CFR 710.39 to the substantiation 
requirements of the CBI review plan. The Agency is proposing to require 
submitters to use EPA's Central Data Exchange (CDX), the Agency's 
electronic reporting portal, for reporting information.

D. Why is the agency taking this action?

    TSCA section 8(b)(4)(C) requires EPA to promulgate a rule that 
establishes a plan to review all CBI claims to protect 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 Active-Inactive rule. This proposed rule is a follow-on regulation 
to the Active-Inactive rule that would require substantiation of CBI 
claims for specific chemical identity from any reporters who asserted 
such a claim as part of the NOA Form A submission, but did not provide 
(voluntary) upfront substantiation at that time. TSCA section 
8(b)(4)(C) further requires EPA to promulgate this rule not later than 
one year after the date that the Agency published the first TSCA 
Inventory containing all ``active'' substance designations. EPA 
announced the release of the updated TSCA Inventory on February 19, 
2019. To download the public version of the TSCA Inventory, get more 
information about the TSCA Inventory Notification (Active-Inactive) 
Requirements rule, or requirements to notify EPA going forward, go to 
https://www.epa.gov/tsca-inventory.

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

    EPA has evaluated the potential costs of establishing the proposed 
reporting requirements for manufacturers and processors. An economic 
analysis titled ``Economic Analysis for the Proposed Rule: Procedures 
for Review of CBI Claims for the Identity of Chemicals on the TSCA 
Inventory'' has been prepared for the proposed rule, is available in 
the docket, and is briefly summarized here (Ref. 3). The proposed rule 
requirements involve a one-time reporting effort with activities that 
are the same, or similar to those in the Active-Inactive rule. All 
respondents would already have submitted at least one NOA under the 
Active-Inactive rule, and therefore should know whether any actions are 
necessary under this proposed rule. Moreover, an exemption included in 
this proposed rule would allow certain submitters to reference a 
previously submitted chemical identity CBI substantiation (in the last 
five years), in lieu of providing a full CBI substantiation for the NOA 
Form A chemical identity information.
    Companies potentially affected by this proposed rule fall into 
three groups of potential NOA Form A reporters who made a CBI claim for 
a specific chemical identity. The first group (Group (1)) consists of 
those reporters who already voluntarily submitted upfront CBI 
substantiation as part of the NOA submission process, who therefore do 
not need to take further action. The second group (Group (2)) consists 
of those reporters who will be able to use the exemption offered under 
this proposed rule by referencing a previous substantiation, such as 
one submitted through the 2016 Chemical Data Reporting (CDR) rule (40 
CFR part 711). The third group (Group (3)) consists of the remaining 
reporters who did not submit prior chemical identity CBI 
substantiations and would be required to provide full substantiation as 
proposed in this rule. The average incremental burden and cost 
estimates include rule familiarization, recordkeeping and submission of 
applicable CBI substantiations (i.e., one-time form completion). For 
Group (1), the burden and costs for this group are minimal and were not 
calculated because the reporters have already voluntarily submitted 
upfront CBI substantiation as part of the NOA submission process for 
the Active-Inactive rule and would not need to take further action. For 
Group (2), the average burden and costs per company are estimated at 
5.1 hours and $390, respectively per submission (involving on average 
four chemicals per company), for rule familiarization and 
substantiation using a previous reference. For Group (3), the average 
burden and costs per company are estimated at 34.1 hours, and $2,641 
respectively per submission (involving on average 27 chemicals per 
company), for rule familiarization and full substantiation. An 
estimated 126 companies would be expected to report, with an estimated 
23 companies in Group (2), and 103 companies in Group (3), resulting in 
an estimated total incremental burden and costs expected over 60 days 
of 3,629 hours and $280,981 for this proposed rule (Ref. 3).

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI in a CD-ROM or other 
electronic media that you mail to EPA, mark the outside of the media as 
CBI and then identify electronically within the media the specific 
information that is claimed as

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CBI. In addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2, subpart B.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.

II. Background

A. The TSCA Inventory and Active-Inactive Rule

    EPA is required under TSCA section 8(b) to compile and keep current 
a list of chemical substances manufactured or processed in the United 
States. This list, the TSCA Chemical Substance Inventory (TSCA 
Inventory), is EPA's comprehensive list of confidential and non-
confidential substances manufactured or processed in the United States 
for nonexempt commercial purposes (Ref. 4). EPA promulgated the Active-
Inactive rule to obtain the information necessary for EPA to designate 
as ``active'' chemical substances that had been manufactured or 
processed for a nonexempt commercial purpose during the 10-year time 
period ending on June 21, 2016. Respondents (manufacturers and 
processors) reported these chemical substances through the process set 
forth in 40 CFR part 710, subpart B, by filing an NOA Form A with EPA. 
Consistent with TSCA section 8(b)(4)(B)(ii), respondents who 
manufactured or processed an active chemical substance listed on the 
confidential portion of the TSCA Inventory prior to June 22, 2016, 
could seek to maintain an existing claim for protection against 
disclosure of the specific chemical identity of the substance as 
confidential by voluntarily filing an NOA Form A that included such 
request. Through this process established in 40 CFR 710.37(a), 
manufacturers and processors secured an opportunity to maintain the 
confidential status of a specific chemical identity on the confidential 
portion of the TSCA Inventory.

B. Statutory Requirements for the CBI Review Plan

    TSCA section 8(b)(4)(C) requires EPA to promulgate a rule 
establishing a plan to review all CBI claims to protect the specific 
chemical identities of chemical substances on the confidential portion 
of the TSCA Inventory that were asserted in an NOA Form A. TSCA 
requires that EPA promulgate this rule not later than one year after 
the publication of the first TSCA Inventory containing all ``active'' 
substance designations (TSCA section 8(b)(4)(C)). TSCA also requires 
the Agency to implement the CBI review plan so as to complete all CBI 
claim reviews not later than five years after such TSCA Inventory 
publication, with the possibility of a two-year extension (TSCA section 
8(b)(4)(E)). Since the updated TSCA Inventory was released on February 
19, 2019, the deadline for issuing a final rule is February 19, 2020, 
and the deadline for completing all the CBI claim reviews is February 
19, 2024. If EPA determines in the future to invoke the 2-year 
extension under TSCA, the deadline for completing all the CBI claim 
reviews would then become February 19, 2026.
    Other types of CBI claims are outside the scope of the review plan 
under TSCA section 8(b)(4)(C) through (E), and hence are outside the 
scope of this proposed rule. Those claims are governed by other 
statutory and regulatory provisions. Substantiation and review of CBI 
claims for other data elements in an NOA Form A are governed by TSCA 
section 14(g) and 40 CFR 710.37(b) and (c)(1). Substantiation and 
review of CBI claims for specific chemical identity in an NOA Form B--a 
forward-looking reporting form required when reintroducing an 
``inactive'' chemical substance into U.S. commerce for a nonexempt 
commercial purpose--are governed by TSCA section 8(b)(5) and 40 CFR 
710.37(a)(2).
    TSCA section 8(b)(4)(D) provides the parameters of the review plan 
for specific chemical identity CBI claims asserted in NOA Form A's.
    1. Requirement to provide substantiations. TSCA section 
8(b)(4)(D)(i) provides that in establishing the review plan, EPA must 
require all manufacturers and processors to substantiate their CBI 
claims for specific chemical identities in accordance with TSCA section 
14 and at a time specified by EPA, unless the manufacturer or processor 
has previously substantiated the claim in a submission made to EPA 
during the 5-year period ending on the substantiation deadline 
specified by EPA.
    2. EPA review of confidentiality claims and substantiations. TSCA 
section 8(b)(4)(D)(ii) requires that EPA review each CBI claim and 
substantiation for a specific chemical identity to determine if such 
claim qualifies for protection from disclosure. The Agency must then 
approve or deny each claim. TSCA section 8(b)(4)(D)(ii)(III) further 
provides that if the information is approved for CBI status, then, 
except as otherwise provided in TSCA sections 8 and 14, EPA must 
protect such information from disclosure for a period of 10 years, 
unless the claim is withdrawn, or EPA becomes aware that the 
information does not qualify for protection from disclosure, in which 
latter case EPA must take the actions described in TSCA section 
14(g)(2) (i.e., to notify the claimant of EPA's intent to disclose the 
information).
    3. Completion of reviews. TSCA section 8(b)(4)(E) provides that the 
Agency must implement the review plan so as to complete all of the 
reviews not later than five years after the date on which the Agency 
has compiled the initial list of active substances. With adequate 
public justification, the Agency may extend the deadline for completion 
of reviews for not more than two years.
    4. Posting of annual goals and numbers of reviews completed. TSCA 
section 8(b)(4)(E) further requires that at the beginning of each year, 
EPA publish an annual goal for reviews and the number of reviews 
completed in the prior year.
    5. Record retention requirement. TSCA section 8(b)(9)(B) provides 
that records relevant to compliance with this rule must be retained for 
a period of 5 years beginning on the last day of the submission period.

III. Summary of Proposed Rule

    The TSCA section 8(b)(4)(D) and (E) provisions regarding the Review 
Plan are prescriptive and the proposed rule closely follows the 
statutory text.

A. What confidentiality claims for specific chemical identities would 
be substantiated under this rule?

    1. CBI claims subject to substantiation. Subject to the exemptions 
described in this unit, the substantiation requirement in this proposed 
rule would apply to all CBI claims for specific chemical identities 
that manufacturers or processors requested to maintain in NOA Form A's 
filed in accordance with the Active-Inactive rule.
    2. Exemptions from substantiation requirement. Pursuant to TSCA 
section 8(b)(4)(D), EPA is proposing exemptions from the requirement to 
submit new substantiation in certain cases where the CBI claims have 
already been substantiated in a recent submission to EPA. The proposed 
exemptions would be available to manufacturers or processors who 
provided substantiations for specific chemical

[[Page 16829]]

identity CBI claims either: (1) Pursuant to the voluntary 
substantiation process associated with the Active-Inactive rule, or (2) 
in another submission made to EPA less than five years before the 
substantiation deadline that will be set in the final rule.
    For those manufacturers or processors who filed voluntary 
substantiations with their NOA Form A's pursuant to the process set 
forth in the Active-Inactive rule, codified at 40 CFR 710.37(a)(1), no 
further action would be required. Those persons would automatically be 
deemed exempt from the substantiation requirement under this proposed 
rule.
    EPA is proposing to require manufacturers and processors who wish 
to establish eligibility for an exemption based upon any other 
recently-submitted substantiation to report and identify for EPA the 
following about that recently-submitted substantiation: Submission 
date; submission type; and case number, transaction ID, or equivalent 
identifier that uniquely identifies the previous submission that 
includes the substantiation upon which the manufacturer or processor is 
relying.
    Previously submitted substantiations might include, for example, 
those submitted pursuant to a regulatory up-front substantiation 
requirement (such as 40 CFR 711.30(b)(1) or 40 CFR 720.85(b)(3)(iv)), 
the statutory substantiation requirement at TSCA section 14(c)(3) (see 
82 FR 6522, January 19, 2017), or the comment process described in 40 
CFR 2.204(e).

B. When would substantiation be required?

    EPA is proposing to require that all substantiations be filed not 
later than 90 days after the effective date of the final rule. EPA is 
proposing the same filing deadline for submissions identifying a 
previously submitted substantiation for purposes of establishing 
eligibility for an exemption. If a substantiation or notice of prior 
CBI substantiation was not filed within the 90-day filing period in 
accordance with all requirements of this proposed rule or voluntarily 
filed in accordance with all requirements of 40 CFR 710.37(a)(1), EPA 
is proposing to consider the confidentiality claim to be deficient and 
would treat the specific chemical identity as not subject to a 
confidentiality claim, such that EPA may make the information public 
without further notice. This treatment of unsubstantiated 
confidentiality claims as deficient would be consistent with how EPA 
has handled unsubstantiated confidentiality claims in other 
regulations, e.g., 40 CFR 710.37(a)(2) and (b) (Active-Inactive rule) 
and 40 CFR 711.30(e) (Chemical Data Reporting rule). EPA nevertheless 
requests comment on the validity of making this information public 
without further notice, particularly where a claimant may have 
previously submitted a substantiation to EPA less than five years 
before the substantiation deadline that will be set in the final rule, 
but failed to report and identify that previously-submitted 
substantiation to EPA within the 90-day filing period.

C. How would CBI claims be substantiated?

    EPA is proposing to require that non-exempt manufacturers and 
processors substantiate any CBI claim for a specific chemical identity 
that they requested to maintain in an NOA Form A by submitting answers 
to the questions identified in Unit III.C.1, by providing the 
certification statement identified in Unit III.C.2, and by requiring 
that the submission be signed and dated by an authorized official.
    1. Substantiation questions. a. Do you believe that the information 
is exempt from substantiation pursuant to TSCA section 14(c)(2)? If you 
answered yes, you must individually identify the specific information 
claimed as confidential and specify the applicable exemption(s).
    b. Will disclosure of the information likely result in substantial 
harm to your business's competitive position? If you answered yes, 
describe with specificity the substantial harmful effects that would 
likely result to your competitive position if the information is made 
available to the public.
    c. To the extent your business has disclosed the information to 
others (both internally and externally), what precautions has your 
business taken? Identify the measures or internal controls your 
business has taken to protect the information claimed as confidential: 
Non-disclosure agreement required prior to access; access is limited to 
individuals with a need-to-know; information is physically secured; 
other internal control measure(s). If yes, explain.
    d. Does the information appear in any public documents, including 
(but not limited to) safety data sheets, advertising or promotional 
material, professional or trade publication, or any other media or 
publications available to the general public? If you answered yes, 
explain why the information should be treated as confidential.
    e. Is the claim of confidentiality intended to last less than 10 
years? If so, indicate the number of years (between 1-10 years) or the 
specific date/occurrence after which the claim is withdrawn.
    f. Has EPA, another federal agency, or court made any 
confidentiality determination regarding information associated with 
this chemical substance? If you answered yes, explain the outcome of 
that determination and provide a copy of the previous confidentiality 
determination or any other information that will assist in identifying 
the prior determination.
    g. 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.
    2. Certification Statement. An authorized official of a 
manufacturer or processor substantiating a request to maintain an 
existing claim of confidentiality for specific chemical identity would 
be required to certify that the submission complies with the 
requirements of the rule by signing and dating the following 
certification statement:

    ``I certify that all claims for confidentiality made or sought 
to be maintained with this submission are true and correct, and all 
information submitted herein to substantiate such claims is true and 
correct. Any knowing and willful misrepresentation is subject to 
criminal penalty pursuant to 18 U.S.C. 1001. I further certify that 
it is true and correct that:
     My company has taken reasonable measures to protect the 
confidentiality of the information;
     I have determined that the information is not required 
to be disclosed or otherwise made available to the public under any 
other Federal law;
     I have a reasonable basis to conclude that disclosure 
of the information is likely to cause substantial harm to the 
competitive position of my company; and
     I have a reasonable basis to believe that the 
information is not readily discoverable through reverse 
engineering.''

D. How would information be submitted to EPA?

    The proposed rule would require persons submitting substantiations 
or information on previously submitted substantiations to follow the 
electronic reporting procedures set forth in the Active-Inactive rule 
at 40 CFR 710.39. Any person submitting a substantiation under this 
proposed rule could claim any part or all of the substantiation as 
confidential business information. Submitters would be required to use 
EPA's electronic reporting portal, Central Data Exchange (CDX), and 
EPA's web-based reporting tool, Chemical Information Submission System 
(CISS). Because all submitters under this proposed rule would have 
previously

[[Page 16830]]

filed NOA Form A's under the Active-Inactive rule using these 
electronic reporting procedures, EPA expects that all submitters are 
already registered with CDX and familiar with the electronic reporting 
procedures. EPA is proposing mandatory electronic reporting because it 
is expected to allow for more efficient data transmittal, support 
improved data quality, and minimize respondent burden and reduce EPA 
administrative costs associated with information submission and 
recordkeeping.

E. How would EPA review claims of confidentiality for specific chemical 
identities?

    Consistent with how EPA handles the review of other TSCA 
confidentiality claims, EPA would carefully consider the facts provided 
in the substantiations, any pertinent previously issued confidentiality 
determinations, and other reasonably available information that EPA 
finds appropriate to determine the information's entitlement to 
confidential treatment. See 40 CFR 2.204(f), 2.205(d)(2) and 2.306. EPA 
would apply the substantive criteria for confidentiality determinations 
set forth in 40 CFR 2.208 and 2.306(g), which provide in relevant part 
that information is entitled to confidential treatment for the benefit 
of a particular business if: (a) The business has asserted a 
confidentiality claim which has not expired by its terms, nor been 
waived nor withdrawn; (b) 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; (c) 
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 need in a judicial or quasi-judicial proceeding); (d) no 
statute specifically requires disclosure of the information; and (e) 
the business has satisfactorily shown that disclosure of the 
information is likely to cause substantial harm to the business's 
competitive position.
    In instances where there are multiple NOA Form A's asserting the 
confidentiality of the same chemical identity, the Agency may choose to 
review these NOA Form A's together as a matter of efficiency.
    In instances where a CBI claim is denied, the Agency would notify 
the submitter, in writing, of EPA's intent to disclose the specific 
chemical identity and of EPA's reasons for denying the claim. The 
notice would be furnished by certified mail (return receipt requested), 
by personal delivery, or by other means that allows verification of the 
fact and date of receipt. EPA would not disclose the specific chemical 
identity until the date that is 30 days after the date on which the 
submitter receives the denial notice. Submitters can challenge EPA's 
denial of a CBI claim by commencing an action to prevent disclosure in 
an appropriate Federal district court. See generally TSCA section 14(g) 
and 40 CFR 2.306(e). In instances where a CBI claim is approved, EPA 
would so inform the submitter, and the chemical substance will be 
identified in subsequent publications of the TSCA Inventory by a unique 
identifier assigned under TSCA section 14(g)(4), in addition to the 
accession number, generic name, and, if applicable, premanufacture 
notice case number. Further information about the assignment and 
application of unique identifiers for confidential chemical substances 
may be found in the Federal Register of June 27, 2018 (83 FR 30168).

F. Annual Review Goals and Results, Extension

    EPA is proposing to use the Agency's website to publish its annual 
goal for reviews completed under this review plan at the beginning of 
each calendar year, starting with its goals for 2020, which the Agency 
anticipates would be posted in February 2020 on the Agency web page. 
EPA is also proposing to track the number of CBI reviews completed 
under this review plan each year and is proposing to use the Agency's 
website to publish that number at the beginning of the following year, 
starting with the number of reviews completed in 2020, which the Agency 
anticipates would be posted on the Agency web page in February 2021. 
These activities will address the requirements of TSCA section 
8(b)(4)(E)(ii)(II).
    EPA intends to implement the CBI review plan described in this 
proposed rule to complete reviews of all CBI claims for specific 
chemical identities not later than five years after the publication of 
the first TSCA Inventory containing all ``active'' substance 
designations based on NOA Form A's, as required under TSCA section 
8(b)(4)(E)(i). Since the initial list of active substances published on 
February 19, 2019, EPA intends to complete all reviews by February 19, 
2024. EPA intends the annual review goals to take into consideration 
this target completion date, the number of claims needing review, and 
available resources. Before the effective date of this rule's 
finalization, EPA may begin reviewing and deciding claims that were 
voluntarily substantiated under the Active-Inactive rule (subject to 
the outcome of pending litigation involving that rule), or that appear 
to be clearly not entitled to protection from disclosure based upon 
other information available to the Agency. TSCA section 14(i)(2) 
expressly permits EPA to review, require (re)substantiation of, and 
decide TSCA CBI claims before the effective date of such rules 
applicable to those claims as EPA may promulgate after June 22, 2016. 
EPA believes that TSCA section 14(i)(2) clearly authorizes the Agency 
to begin its reviews under TSCA section 8(b)(4) prior to publication of 
this final rule, and that doing so is appropriate in light of the 
Congressionally-mandated timeline for the completion of reviews.
    TSCA section 8(b)(4)(E)(ii)(I) provides that after an adequate 
public justification, the Agency may extend the five-year deadline for 
completion of reviews for not more than two additional years. While the 
Agency does not currently anticipate a need for an extension, possible 
justifications for an extension might include, among other things, 
competing TSCA obligations which prevent the Agency from completing the 
reviews within five years, intervening events that divert the Agency's 
resources from completing the required reviews, or litigation involving 
the claim substantiation and review process that may delay EPA's 
commencement of CBI claim reviews. Should an extension become 
necessary, EPA is proposing to announce the extension and its 
justification to the public via a notice in the Federal Register.

G. Duration of Protection From Disclosure

    TSCA section 8(b)(4)(D)(ii)(III) provides that specific chemical 
identities for which EPA has approved a CBI claim under TSCA section 
8(b)(4)(D) must be protected from disclosure for a period of 10 years, 
unless, prior to the expiration of that period, the claimant notifies 
EPA that they are withdrawing the confidentiality claim, in which case 
the Agency cannot protect the information from disclosure; or the 
Agency otherwise becomes aware that the information does not qualify 
for protection from disclosure, in which case the Agency must take the 
actions described in TSCA section 14(g)(2) (i.e., to notify the 
claimant of EPA's intent to disclose the information). TSCA section 
8(b)(4)(D)(ii)(III) does not explicitly state when the 10-year period 
of protection begins, but TSCA section 8(b)(4)(D)(ii) provides as a 
general matter that EPA's

[[Page 16831]]

actions under the review plan must be ``in accordance with section 
14.'' Under TSCA section 14(e)(1)(B)(i), as amended on June 22, 2016, 
the duration of protection from disclosure lasts ``for a period of 10 
years from the date on which the person asserts the claim with respect 
to the information submitted to the Administrator.''
    Notably, all specific chemical identity CBI claims subject to 
review under TSCA section 8(b)(4) and this proposed rule had already 
been asserted by one or more persons prior to June 22, 2016, resulting 
in the placement of the chemical substance on the confidential portion 
of the TSCA Inventory. Pursuant to TSCA section 8(b)(4)(B)(ii) and the 
Active-Inactive rule, manufacturers and processors submitting NOA Form 
A's were only permitted to indicate that they seek to maintain an 
existing claim for protection against disclosure of the specific 
chemical identity of the chemical substance. TSCA section 8(b)(4)(C) 
describes these requests to maintain existing claims as ``claims . . . 
asserted pursuant to [TSCA section 8(b)(4)(B)],'' and TSCA section 
8(b)(4)(D)(i) refers to ``manufacturers or processors asserting claims 
under [TSCA section 8(b)(4)(B)]'' (emphasis added). Thus, EPA believes 
Congress intended that the filing date of the request seeking to 
maintain the CBI claim (i.e., the filing date of the NOA Form A) may 
function as the date of claim assertion for purposes of determining the 
period of protection from disclosure. However, in cases where the same 
specific chemical identity was subject to a CBI claim in another 
submission filed on or after June 22, 2016, EPA believes it would be 
incongruous to effectively re-start the 10-year period of protection 
from disclosure based upon the subsequent submission of a request 
(i.e., an NOA Form A) seeking to maintain that claim. Accordingly, EPA 
proposes to interpret the date of assertion for purposes of calculating 
the duration of protection under TSCA section 8(b)(4)(D)(ii)(III) as 
the date of submission of the first filing in which the specific 
chemical identity was claimed as CBI after June 22, 2016. This 
interpretation would impact the calculation of the period of protection 
from disclosure where there are multiple submitters of the NOA Form A 
that are asserting confidentiality claims on the same specific chemical 
identity, as well as where one or more submitters of information to EPA 
outside the context of the NOA Form A has asserted a specific chemical 
identity confidentiality claim after June 22, 2016. Companies will be 
notified of the date from which the 10-year period of protection will 
be calculated.
    For example, if on July 1, 2016, a company addressing a CDR rule 
reporting requirement filed a report for a subject chemical substance 
and asserted a CBI claim for the specific chemical identity, and if EPA 
subsequently approved the company's confidentiality claim, then the 10-
year time period of protection from disclosure would begin on July 1, 
2016. If that company subsequently filed an NOA Form A on January 1, 
2018 and sought to maintain the confidentiality claim for that specific 
chemical identity, and if EPA subsequently approved that claim, the 10-
year period of protection from disclosure would continue to run from 
July 1, 2016, and would not restart on the date of NOA filing. If a 
second company then filed an NOA Form A on February 1, 2018 seeking to 
maintain a CBI claim for that same specific chemical identity, and the 
second company's claim were approved, the 10-year period of protection 
from disclosure would still run from July 1, 2016. In cases where an 
NOA Form A was the first submission to assert the CBI claim for a 
specific chemical identity after June 22, 2016, the 10-year period of 
protection for an approved claim would begin on the date of that NOA 
filing.

H. What are the record retention requirements?

    EPA is proposing to require that persons subject to the finalized 
rule retain records that document any information reported to EPA. The 
proposed rule would require such records to be retained for a period of 
5 years beginning on the last day of the submission period, which is 
consistent with the statutory mandate in TSCA section 8(b)(9)(B).

IV. Request for Comments

    EPA is seeking public comment on all aspects of this proposed rule, 
including filing requirements, the exemptions process, annual goal 
setting, duration of protection from disclosure, Agency reviews, 
economic burden, and the scope of the substantiation questions 
described in Unit III.C and referenced in the proposed regulatory text 
at section 710.45, as well as other issues discussed in this document.

V. References

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

    1. EPA. TSCA Inventory Notification (Active-Inactive) 
Requirements Rule. Federal Register, 82 FR 37520, August 11, 2017 
(FRL-9964-22).
    2. EPA. Notice of Activity Form A; Final, 2017.
    3. EPA. Economic Analysis for the Proposed Rule: Procedures for 
Review of CBI Claims for the Identity of Chemicals on the TSCA 
Inventory--RIN 2070-AK21--Office of Pollution Protection and Toxics. 
Washington, DC, February 2019.
    4. EPA. TSCA Chemical Substance Inventory. 2018. https://www.epa.gov/tsca-inventory/how-access-tsca-inventory.
    5. EPA. ICR No. 2594.01 Information Collection Request for TSCA 
Review Plan CBI Substantiation Supporting Statement for a Request 
for OMB Review under the Paperwork Reduction Act. February 2019.

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

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

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

C. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule 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 
Request (ICR)

[[Page 16832]]

document that the EPA prepared has been assigned EPA ICR number ICR No. 
2594.01 and OMB Control No. 2070-NEW (Ref. 5). You can find a copy of 
the ICR in the docket for this rule, and it is briefly summarized here.
    The reporting requirements identified in the proposed rule would 
provide EPA with information necessary to evaluate confidentiality 
claims and determine whether the claims qualify for protection from 
disclosure. Manufacturers and processors who provided substantiations 
pursuant to the voluntary substantiation process in the Active-Inactive 
rule NOA collection would be exempt from the proposed substantiation 
requirements. EPA would 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.
    Respondent's obligation to respond: Mandatory.
    Frequency of response: Once per chemical.
    Estimated total number of potential respondents: 126.
    Estimated total burden: 3,629 hours (one time). Burden is defined 
at 5 CFR 1320.3(b).
    Estimated total costs: $ 280,981 (one time), includes no annualized 
capital investment or maintenance and operational costs.
    Under PRA, an agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it 
displays a currently valid OMB control number. The OMB control numbers 
are displayed either by publication in the Federal Register or by other 
appropriate means, such as on the related collection instrument or 
form, if applicable. The display of OMB control numbers for certain EPA 
regulations is consolidated in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to EPA using the docket identified at the 
beginning of this proposed rule. You may also send your ICR-related 
comments to OMB's Office of Information and Regulatory Affairs via 
email to [email protected], Attention: Desk Officer for EPA. 
Since OMB is required to make a decision concerning the ICR between 30 
and 60 days after receipt, OMB must receive comments no later than May 
23, 2019. EPA will respond to any ICR-related comments in the 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 action 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. EPA estimates that a total of 
126 companies are expected to be impacted by this proposed rule, of 
which 121 are identified as small entities. Given the estimated per 
submission burden and costs range from 5.1 hours and $390 (for Group 
(2)) to 34.1 hours and $ 2,640 (for Group (3)), as presented in Unit 
1.E. EPA has determined that all 121 of the identified small entities 
considered in this analysis will experience an impact of less than 1% 
of revenues.
    In the affected universe of small entities, there are two groups of 
entities affected by this proposed rule (Groups (2) and (3)), based on 
the extent of substantiation information involved in the submission. 
Entities of Group (3) are expected to incur the highest burden under 
this proposed rule, as they are required to submit full confidentiality 
substantiations (each submission involving an average of 27 chemicals 
per entity) in response to the regulatory requirements. As a 
conservative approach, in this small entity analysis the higher unit 
cost from Group (3), as the most affected group, is applied to all 
small entities. Details of this analysis are included in the 
accompanying Economic Analysis for this proposed rule (Ref. 3).

E. Unfunded Mandates Reform Act (UMRA)

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

[[Page 16833]]

List of Subjects in 40 CFR Part 710

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

    Dated: April 10, 2019.
Andrew R. Wheeler,
Administrator.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 710--COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY

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

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

0
2. 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 No confidentiality claim.
710.51 Electronic filing.
710.53 Record-keeping requirements.
710.55 Claim review, duration of protection, TSCA Inventory 
maintenance, posting results, and extension.


Sec.  710.41  Scope.

    This part 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) 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.
    (b) Exemptions. (1) Any person who completed the voluntary 
substantiation process set forth in Sec.  710.37(a)(1) by submitting 
with the Notice of Activity Form A answers to the questions in Sec.  
710.37(c)(1) and (2), signed and dated by an authorized official, and 
completing the certification statement for claims specified in Sec.  
710.37(e), is exempt from the substantiation requirement of this 
subpart.
    (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 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 
[insert date five years before the date that is 90 days after effective 
date of final rule]; 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 person substantiating a confidentiality claim for a specific 
chemical identity must submit answers to the questions in Sec.  
710.37(c)(1) and (2), 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 Sec.  
710.37(c)(1) or (2) is claimed as confidential, the submitter must 
clearly indicate such by marking the substantiation as confidential 
business information.


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) must submit their substantiation not later 
than [insert date that is 90 days after effective date of final rule].
    (b) All persons who seek an exemption under Sec.  710.43(b)(2) must 
submit the information specified in Sec.  710.43(b)(2)(iii) not later 
than [date that is 90 days after effective date of final rule].


Sec.  710.49  No confidentiality claim.

    If substantiation required under Sec.  710.43(a) is not submitted 
to EPA in accordance with the provisions of this subpart, and no 
exemption under Sec.  710.43(b) applies, EPA will consider the 
confidentiality claim as deficient, so that the specific chemical 
identity is not subject to a confidentiality claim, and EPA may make 
the information public without further notice to the Notice of Activity 
Form A submitter.


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  Record-keeping 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 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, 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. 2019-07920 Filed 4-22-19; 8:45 am]
BILLING CODE 6560-50-P