Document ID: EPA-HQ-OPPT-2017-0645-0014
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances
Posted Date: 2018-11-27T05:00Z

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60845-60846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25778]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0645; FRL-9986-96-OEI]

Agency Information Collection Activities; Renewal Request 
Submitted to OMB for Review and Approval; Comment Request; 
Premanufacture Review Reporting and Exemption Requirements for New 
Chemical Substances and Significant New Use Reporting Requirements for 
Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted the

[[Page 60846]]

following information collection request (ICR) to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act (PRA): Premanufacture Review Reporting and 
Exemption Requirements for New Chemical Substances and Significant New 
Use Reporting Requirements for Chemical Substances (EPA ICR No. 
0574.18, OMB Control No. 2070-0012). The ICR, which is available in the 
docket, is only briefly summarized in this document. This is a request 
to renew the approval of an existing ICR, currently approved through 
November 30, 2018. EPA previously provided a 60-day public review 
opportunity via the Federal Register on July 25, 2018. With this 
submission, EPA is providing an additional 30-days for public review. 
Under the 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.

DATES: Comments must be received on or before December 27, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number [EPA-HQ-OPP-2017-0645, to: (1) EPA online using http://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 and (2) via email to 
[email protected]. Address comments to OMB Desk Officer for 
EPA. EPA's policy is that all comments received will be included in the 
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. Do not submit electronically any 
information you consider to be CBI or other information whose 
disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Adam Ross, Chemical Control 
Division (7404M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone: (202) 564-1625; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone: (202) 554-1404; 
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, including the ICR that 
explains in detail the information collection activities and the 
related burden and cost estimates that are summarized in this document, 
are available in the docket for this ICR. The docket can be viewed 
online at http://www.regulations.gov or in person at the EPA Docket 
Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC. The telephone number for the 
Docket Center is (202) 566-1744. For additional information about EPA's 
public docket, visit http://www.epa.gov/dockets.
    Abstract: This ICR covers the information collection activities 
that implement the statutory mandates in section 5 of the Toxic 
Substances Control Act (TSCA), as amended by the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act of 2016, related to new 
chemical substances, 15 U.S.C. 2604, and the implementing regulations 
codified in 40 CFR parts 700, 720, 721, 723, and 725. Specifically, 
TSCA section 5 requires that any person who proposes to manufacture 
(which includes import) a new chemical substance (i.e., a chemical 
substance not listed on the TSCA section 8(b) Inventory) or a 
significant new use of a chemical substance (as identified by EPA rule) 
must provide a notice to EPA at least 90 days prior to commencing the 
manufacture of that chemical substance. EPA must review the section 5 
notice, make an affirmative determination on the safety of the new 
chemical substance or significant new use, and, if appropriate, 
regulate the chemical substance to address any unreasonable risks 
identified before it can proceed to the marketplace. TSCA section 5 
authorizes EPA to determine by rule that a use of a chemical substance 
is a significant new use requiring notice to and review and 
determination by the Agency through a significant new use rule (SNUR) 
that requires any person who proposes to manufacture or process a 
chemical substance for a designated new use to submit a Significant New 
Use Notice (SNUN) to the Agency. EPA must review the SNUN, make a 
determination on the chemical substance, and take appropriate action 
pursuant to TSCA section 5. The submitter of a premanufacture notice 
(PMN), significant new use notice (SNUN), or microbial commercial 
activity notice (MCAN) is also required to inform EPA when non-exempt 
commercial manufacture of the substance in question actually begins by 
submitting a Notice of Commencement (NOC). Under TSCA section 5, EPA 
must make one of five possible regulatory determinations with respect 
to the new chemical substance or significant new use and take action, 
as appropriate, to ensure adequate protection of human health and the 
environment. If EPA takes no action within the 90-day review period for 
PMNs (or 30 or 45 days for PMN exemption applications), TSCA section 5 
states that the PMN submitter is entitled to receive a refund of fees 
paid. Respondents may claim all or part of a response confidential. EPA 
will disclose information that is covered by a claim of confidentiality 
only to the extent permitted by, and in accordance with, the procedures 
in TSCA section 14 and 40 CFR part 2.
    Form numbers: Premanufacture Notice (EPA Form No. 7710-25) and 
Notice of Commencement of Manufacture or Import (EPA Form No. 7710-56).
    Respondents/affected entities: Companies that manufacture, process 
or import chemical substances.
    Respondent's obligation to respond: Mandatory.
    Frequency of response: On occasion.
    Estimated total number of respondents: 234.
    Estimated total burden: 135,230 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Estimated total cost: $49,979,150 (per year), includes $0 
annualized capital or operation and maintenance costs.
    Changes in the estimates: There is an increase of 18,054 hours in 
the total estimated respondent burden compared with that currently 
approved by OMB. This increase reflects an adjustment in EPA's 
estimated number of each type of notice; the estimated number of annual 
CDX registrants; and EPA corrected some discrepancies in estimating 
burden from the previous ICR. This increase also reflects a program 
change from incorporating burden associated with new CBI substantiation 
requirements resulting from the 2016 amendment to TSCA and the 
inclusion of burden associated with the ``Points to Consider When 
Preparing TSCA New Chemical Notifications'' guidance document.

    Dated: November 19, 2018.
Courtney Kerwin,
Director, Collection Strategies Division.
[FR Doc. 2018-25778 Filed 11-26-18; 8:45 am]
 BILLING CODE 6560-50-P