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, 60845-60846 [2018-25778]

Download as PDF Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices The Environmental Protection Agency (EPA) has submitted the 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): ‘‘PCBs, Consolidated Reporting and Record Keeping Requirements’’ and identified by EPA ICR Number 1446.12 and OMB Control Number 2070–0112. The ICR, which is available in the docket along with other related materials provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. This is a request to renew the approval of an existing ICR, which is currently approved through November 30, 2018. EPA previously provided a 60day public review opportunity via the Federal Register on August 27, 2018. With this submission, EPA is providing an additional 30-days for public review. DATES: Comments must be received on or before December 27, 2018. ADDRESSES: Submit your comments, identified by docket identification (ID) number [EPA–HQ–OPP–2017–0647, to both EPA and OMB as follows: 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) OMB via email to oira_ submission@omb.eop.gov. 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: Peter Gimlin, National Program Chemicals Division (7404T), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 566–0515; email address: Gimlin.Peter@ epa.gov. For general information contact: TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 Docket: 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. ICR status: This is a request to renew the approval of an existing ICR, which is currently approved through November 30, 2018. EPA did not receive any comments in response to the previously provided 60-day public review opportunity (83 FR 43675, August 27, 2018) (FRL–9982–52). Under the PRA, 44 U.S.C. 3501 et seq., 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. Abstract: This ICR covers the information collection activities that implement the statutory mandates in section 6(e) of the Toxic Substances Control Act (TSCA) related to polychlorinated biphenyls (PCBs), 15 U.S.C. 2605(e). Specifically, TSCA section 6(e)(1) directs EPA to regulate the marking and disposal of PCBs. Section 6(e)(2) bans the manufacturing, processing, distribution in commerce, and use of PCBs in other than a totally enclosed manner. Section 6(e)(3) establishes a process for obtaining exemptions from the prohibitions on the manufacture, processing, and distribution in commerce of PCBs. Implementing regulations have been codified in 40 CFR part 761, and include approximately 100 specific reporting, third-party reporting, and recordkeeping requirements. The regulations are intended to prevent the improper handling and disposal of PCBs and to minimize the exposure of human beings or the environment to PCBs. Responses to the collection of information are mandatory (see 40 CFR part 761). 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 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 60845 with, the procedures in TSCA section 14 and 40 CFR part 2. Form numbers: 7720–12 and 7710–53. Respondents/affected entities: Entities potentially affected by this ICR are persons who currently possess PCB items, PCB-contaminated equipment or other PCB waste. Respondent’s obligation to respond: Mandatory. Estimated number of respondents: 87,190 (total). Frequency of response: On occasion. Total estimated burden: 681,407 hours (per year). Burden is defined at 5 CFR 1320.3(b). Total estimated cost: $30,374,118 (per year), includes $0 annualized capital or operation & maintenance costs. Changes in the estimates: This request reflects a decrease of 64,519 hours in the total estimated respondent burden from that currently in the OMB inventory. The changes in the total annual respondent reporting and recordkeeping burdens and costs are due to updates to the most current wage rate data and to revisions to the total number of respondents. The revisions to total number of respondents are the result of new data gathered for this ICR effort, updated Agency data regarding total numbers of regulated entities, and the overlapping coverage of the recently revised Universal Hazardous Waste Manifest ICR (OMB Control No. 2050– 0039). The ICR supporting statement provides a detailed analysis of the change in burden estimate. This change is an adjustment. Dated: November 16, 2018. Courtney Kerwin, Director, Collection Strategies Division. [FR Doc. 2018–25775 Filed 11–26–18; 8:45 am] BILLING CODE 6560–50–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) has submitted the SUMMARY: E:\FR\FM\27NON1.SGM 27NON1 amozie on DSK3GDR082PROD with NOTICES1 60846 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices 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 oira_ submission@omb.eop.gov. 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: ross.adam@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone: (202) 554–1404; email address: TSCA-Hotline@epa.gov. SUPPLEMENTARY INFORMATION: Supporting documents, including the VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 9990 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 E:\FR\FM\27NON1.SGM 27NON1

Agencies

[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