[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73277-73278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28066]



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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0660; FRL-9156-01-OCSPP-01]


Agency Information Collection Activities; Proposed Renewal and 
Consolidation of Two Currently Approved Collections Under Section 5 of 
the Toxics Substances Control Act; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit a request to renew 
and consolidate two existing approved Information Collection Requests 
(ICRs) to the Office of Management and Budget (OMB). Before submitting 
the consolidated ICR to OMB for review and approval, EPA is soliciting 
comments on specific aspects of the proposed information collection 
that is summarized in this document. The consolidated ICR is entitled: 
``TSCA Section 5 Reporting and Recordkeeping for Premanufacture Review 
of New Chemical Substances and Significant New Use Rules for New and 
Existing Chemical Substances'' and identified by EPA ICR No. 2702.01 
and OMB Control No. 2070-NEW. EPA is consolidating these two existing 
approved ICRs because the information required to be collected and 
maintained is similar for both collection activities. The ICR and 
accompanying material are available in the docket for public review and 
comment.

DATES: Comments must be received on or before February 25, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0660, using the Federal eRulemaking Portal 
at http://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. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) is open to the public by appointment only. For 
the latest status information on EPA/DC and docket access, visit 
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Katherine Sleasman, Mission Support 
Division, (7101M), Office of Program Support, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 566-1204; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A), 44 U.S.C. 3506(c)(2)(A), EPA 
specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.

II. What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    [ssquf] Explain your views as clearly as possible, include specific 
examples and describe any assumptions that you used.
    [ssquf] Provide copies of any technical information and/or data you 
used that support your views.
    [ssquf] If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    [ssquf] Submit your comments by the deadline identified under 
DATES, and be sure to identify the docket ID number assigned to the ICR 
in the subject line on the first page of your response. You may also 
provide the ICR title and related EPA and OMB numbers.

III. What do I need to know about PRA?

    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information subject to PRA approval 
unless it displays a currently valid OMB control number. The OMB 
control numbers for the EPA regulations in title 40 of the Code of 
Federal Regulations (CFR), after appearing in the preamble of the final 
rule, are further displayed either by publication in the Federal 
Register or by other appropriate means, such as on the related 
collection instruments or form, if applicable. The display of OMB 
control numbers for certain EPA regulations is consolidated in a list 
at 40 CFR 9.1.
    As used in the PRA context, burden is defined in 5 CFR 1320.3(b).

IV. What information collection activity or ICR does this action apply 
to?

    Title: TSCA Section 5 Reporting and Recordkeeping for 
Premanufacture Review of New Chemical Substances and Significant New 
Use Rules for New and Existing Chemical Substances.
    ICR number: EPA ICR No. 2702.01.
    OMB control number: OMB Control No. 2070-NEW.
    ICR status: This is a new ICR that reflects the consolidation of 
the following two currently approved ICRs:
    1. ``TSCA Section 5(a)(2) Significant New Use Rules for Existing 
Chemicals'' (identified by EPA ICR No. 1188.12 and OMB Control No. 
2070-0038), which is currently approved through July 31, 2022; and
    2. ``Premanufacture Review Reporting and Exemption Requirements for 
New Chemical Substances and Significant New Use Reporting Requirements 
for Chemical Substances'' (identified by EPA ICR No.0574.18 and OMB 
Control No. 2070-0012), which is currently approved through December 
31, 2022.
    Abstract: The information collection activities in the consolidated 
ICR addresses the reporting and recordkeeping requirements associated 
with the new chemical substances review and regulatory program and the 
existing chemicals program administered by EPA under section 5 of the 
Toxic Substances Control Act (TSCA), as amended by the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act (the ``Lautenberg 
Act'') (15 U.S.C. 2604).
    TSCA section 5 requires that any person who proposes to manufacture 
(which includes import) a ``new chemical'' (i.e., a chemical not listed 
on the TSCA section 8(b) Inventory) must provide a premanufacture 
notice (PMN) or an exemption application to EPA at

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least 90 days prior to commencing manufacture of that chemical and that 
EPA review such notice and take action as appropriate. EPA considers 
certain genetically engineered microorganisms to be chemical substances 
for purposes of the notification requirements found in TSCA section 5; 
the 90-day notice for microorganisms is a Microbial Commercial Activity 
Notice (MCAN).
    Under TSCA section 5, EPA is authorized to determine that a non-
ongoing use of a new or existing chemical substance is a significant 
new use and promulgate a significant new use rule (SNUR). When someone 
opts to pursue the manufacture (import) or processing of the chemical 
substance for that use, they must first submit a significant new use 
notice (SNUN) to EPA
    from any person who proposes to manufacture or process a chemical 
for a use that is determined by EPA to be a ``significant new use.'' 
Note that the scope of this ICR only includes reporting of estimates 
for respondent activities associated with SNURs in instances where a 
SNUN is submitted. For more information on new and existing chemical 
SNURs, see a recent EPA Economic Analysis for new chemical SNURs issued 
under 40 CFR 721 Subpart D--Expedited Process, and the Supporting 
Statement for ``TSCA section 5(a)(2) Significant New Use Rules for 
Existing Chemicals Information Collection Request.''
    TSCA section 5 requires EPA to make determinations before the 
conclusion of its review of the submitted notices regarding whether the 
manufacture, processing, distribution in commerce, use and/or disposal 
of the new chemical substances or the significant new use of the 
existing chemical substances may present unreasonable risk to health or 
the environment. EPA's determination on a chemical substance or new use 
will dictate how and to what extent the chemical's manufacture, use, 
processing and/or disposal may be restricted. If EPA fails to make a 
timely determination, fees may be refunded; however, nothing relieves 
EPA of its obligation to make a determination. EPA requires that the 
submitter of a PMN or MCAN inform EPA when non-exempt commercial 
manufacture of the substance in question actually begins by submitting 
a Notice of Commencement; EPA would then add the new chemical substance 
to the TSCA section 8(b) Inventory.
    Persons who intend to export a substance identified in a proposed 
or final SNUR are subject to the export notification provisions of TSCA 
section 12(b), and regulations that interpret TSCA section 12(b) appear 
at 40 CFR part 707 and the associated paperwork activities and burdens 
are approved under OMB Control No. 2070-0030, ICR entitled 
``Notification of Chemical Exports--TSCA Section 12(b),'' identified by 
EPA ICR No. 0795.16.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to be between 17 
to 526 hours per response. The consolidated ICR, a copy of which is 
available in the docket, provides a detailed explanation of this 
estimate, which is only briefly summarized here:
    Respondents/Affected entities: Entities potentially affected by 
this ICR are chemical manufacturers (defined by statute to include 
importers) and processors, e.g., entities identified by the North 
American Industrial Classification System (NAICS) codes 325, Chemicals 
and Allied Products Manufacturers, and 324, Petroleum Refining.
    Estimated total number of potential respondents: 234.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 
5.74.
    Estimated total annual burden hours: 136,292 hours.
    Estimated total annual costs: $ 37,354,814. This includes an 
estimated burden cost of $ 37,354,814 and an estimated cost of $ 0 for 
non-burden hour paperwork costs, e.g., capital investment or 
maintenance and operational costs.

V. Are there changes in the estimates from the last approvals?

    The consolidation of the currently approved ICRs is expected to 
result in an overall decrease of 55,863 burden hours and $ 17,188,154 
burden costs when compared to the total combined burden and costs that 
is currently approved by OMB. This decrease in the total estimated 
burden and costs is primarily due to the declining number of TSCA 
section 5 submissions for new chemicals, and other adjustments made in 
EPA's estimates of the number of respondents, as well as the related 
burden and costs estimates. This change is an adjustment.
    In addition, OMB has requested that EPA move towards using the 18-
question format for ICR Supporting Statements used by other federal 
agencies and departments and that is based on the submission 
instructions established by OMB in 1995, replacing the alternate format 
developed by EPA and OMB prior to 1995. The Agency does not expect this 
change in format to result in substantive changes to the information 
collection activities or related estimated burden and costs.

VI. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the consolidated 
ICR as appropriate. The final ICR package will then be submitted to OMB 
for review and approval pursuant to 5 CFR 1320.12. EPA will issue 
another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to 
announce the submission of the ICR to OMB and the opportunity for the 
public to submit additional comments for OMB consideration. If you have 
any questions about this ICR or the approval process, please contact 
the person listed under FOR FURTHER INFORMATION CONTACT.
    Authority: 44 U.S.C. 3501 et seq.

    Dated: December 21, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-28066 Filed 12-23-21; 8:45 am]
BILLING CODE 6560-50-P


