Document ID: EPA-HQ-OPPT-2021-0660-0010
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Toxic Substances Control Act (TSCA) Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances
Posted Date: 2022-06-29T04:00Z

[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Pages 38745-38746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13855]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0660; FRL-9980-01-OMS]

Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; TSCA Section 5 Premanufacture Review of New 
Chemical Substances and Significant New Use Rules for New and Existing 
Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an 
information collection request (ICR), TSCA Section 5 Premanufacture 
Review of New Chemical Substances and Significant New Use Rules for New 
and Existing Chemical Substances'' (EPA ICR Number 1188.13, OMB Control 
Number 2070-0038) to the Office of Management and Budget (OMB) for 
review and approval in accordance with the Paperwork Reduction Act. 
This is a request that will rename and consolidate two currently 
approved collections under OMB Control No. 2070-0038. Public comments 
were previously requested on a new consolidated ICR identified as EPA 
ICR No. 2702.01 via the Federal Register on December 27, 2021, during a 
60-day comment period. This notice allows for an additional 30 days for 
public comments. A fuller description of the ICR is given below, 
including its estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before July 29, 2022.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OPPT-2021-0660, online using https://www.regulations.gov (our 
preferred method) or by mail to: EPA Docket Center, Environmental 
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460. EPA's policy is that all comments received will 
be included in the public docket without change including any personal 
information provided, unless the comment includes profanity, threats, 
information claimed to be Confidential Business Information (CBI), or 
other information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed 
information collection within 30 days of publication of this notice to 
www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Katherine Sleasman, Regulatory Support 
Branch (7101M), Office of Chemical Safety and Pollution Prevention, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460; telephone number: (202) 566-1204; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in 
detail the information that the EPA will be collecting, are available 
in the docket for this ICR. The docket can be viewed online at https://www.regulations.gov or in person at the EPA Docket Center, WJC West, 
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone 
number for the Docket Center is 202-566-1744. For additional 
information about EPA's dockets, visit https://www.epa.gov/dockets.
    Abstract: This information collection request consolidates the 
reporting and recordkeeping requirements associated with the 
premanufacture review of new chemical substances and those associated 
with new and existing chemical substances that are subject to 
significant new use rules, which are programs administered by EPA under 
section 5 of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2604). 
Originally identified as a new ICR and assigned EPA ICR No. 2702.01 
(OMB Control No. 2070-NEW), this request consolidates two currently 
approved collections identified as EPA ICR No. 0574.18 (OMB Control No. 
2070-0012) and EPA ICR No. 1188.12 (OMB Control No. 2070-0038). Based 
on discussions with OMB, EPA subsequently determined that the 
consolidated ICR should be submitted as a revision to the existing ICR 
approved under OMB Control No. 2070-0038. The consolidation ICR is now 
identified as EPA ICR No. 1188.13 and includes a change in its title.
    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), a Microbial Commercial Activity Notice (MCAN) or an 
exemption application to EPA at least 90 days prior to commencing 
manufacture of that chemical and that EPA review such notice and take 
action as appropriate. In addition, if EPA determines that a non-
ongoing use of a new or existing chemical substance is a significant 
new use, EPA may promulgate a significant new use rule (SNUR) under 
TSCA section 5 to require any person who intends to manufacture 
(import) or process the chemical substance for that designated 
``significant new use'' must first submit a significant new use notice 
(SNUN) to EPA at least 90 days prior to commencing the manufacture or 
processing of that chemical for that use, which allows EPA to review 
such notice and take action as appropriate. TSCA section 5 also 
requires EPA to make determinations before the conclusion of its 90-day 
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.
    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

[[Page 38746]]

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.
    Form Numbers: 7710-23, 7710-25, 7710-56 and 6300-7.
    Respondents/affected entities: 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.
    Respondent's obligation to respond: Mandatory, 15 U.S.C 2604. 40 
CFR parts 720, 721, 723 and 725.
    Estimated number of respondents: 234 (total).
    Frequency of response: On occasion.
    Total estimated burden: 136,292 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $37,354,814 (per year), includes $0 
annualized capital or operation and maintenance costs.
    Changes in the estimates: The consolidation of the currently 
approved ICRs is expected to result in an overall decrease of 56,001 
burden hours and $17,188,154 burden costs when compared to the total 
combined burden and costs that is currently approved by OMB. Discussed 
in more detail in the ICR, this decrease is an adjustment.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-13855 Filed 6-28-22; 8:45 am]
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