Notice2021-28066
Agency Information Collection Activities; Proposed Renewal and Consolidation of Two Currently Approved Collections Under Section 5 of the Toxics Substances Control Act; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 27, 2021
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 245 (Monday, December 27, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73277-73278]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28066]
[[Page 73277]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
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
<a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#8bf8e7eeeaf8e6eae5a5e0eaffe3eef9e2e5eecbeefbeaa5ece4fd"><span class="__cf_email__" data-cfemail="dfacb3babeacb2beb1f1b4beabb7baadb6b1ba9fbaafbef1b8b0a9">[email protected]</span></a>.
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
[[Page 73278]]
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 27, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.