83 FR 60845 - 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

Federal Register Volume 83, Issue 228 (November 27, 2018)

Page Range		60845-60846
FR Document		2018-25778

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): 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.

Federal Register, Volume 83 Issue 228 (Tuesday, November 27, 2018)

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60845-60846]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices 60845

SUMMARY: The Environmental Protection Docket: Supporting documents, with, the procedures in TSCA section 14
Agency (EPA) has submitted the including the ICR that explains in detail and 40 CFR part 2.
following information collection request the information collection activities and Form numbers: 7720–12 and 7710–53.
(ICR) to the Office of Management and the related burden and cost estimates Respondents/affected entities: Entities
Budget (OMB) for review and approval that are summarized in this document, potentially affected by this ICR are
in accordance with the Paperwork are available in the docket for this ICR. persons who currently possess PCB
Reduction Act (PRA): ‘‘PCBs, The docket can be viewed online at items, PCB-contaminated equipment or
Consolidated Reporting and Record http://www.regulations.gov or in person other PCB waste.
Keeping Requirements’’ and identified at the EPA Docket Center, West William Respondent’s obligation to respond:
by EPA ICR Number 1446.12 and OMB Jefferson Clinton Bldg., Rm. 3334, 1301 Mandatory.
Control Number 2070–0112. The ICR, Constitution Ave. NW, Washington, DC. Estimated number of respondents:
which is available in the docket along The telephone number for the Docket 87,190 (total).
with other related materials provides a Center is (202) 566–1744. For additional Frequency of response: On occasion.
detailed explanation of the collection information about EPA’s public docket, Total estimated burden: 681,407
activities and the burden estimate that visit http://www.epa.gov/dockets. hours (per year). Burden is defined at 5
is only briefly summarized in this ICR status: This is a request to renew CFR 1320.3(b).
document. This is a request to renew the the approval of an existing ICR, which Total estimated cost: $30,374,118 (per
approval of an existing ICR, which is is currently approved through year), includes $0 annualized capital or
currently approved through November November 30, 2018. EPA did not receive operation & maintenance costs.
30, 2018. EPA previously provided a 60- any comments in response to the Changes in the estimates: This request
day public review opportunity via the previously provided 60-day public reflects a decrease of 64,519 hours in the
Federal Register on August 27, 2018. review opportunity (83 FR 43675, total estimated respondent burden from
With this submission, EPA is providing August 27, 2018) (FRL–9982–52). Under that currently in the OMB inventory.
an additional 30-days for public review. the PRA, 44 U.S.C. 3501 et seq., an The changes in the total annual
DATES: Comments must be received on agency may not conduct or sponsor, and respondent reporting and recordkeeping
or before December 27, 2018. a person is not required to respond to, burdens and costs are due to updates to
ADDRESSES: Submit your comments, a collection of information, unless it the most current wage rate data and to
identified by docket identification (ID) displays a currently valid OMB control revisions to the total number of
number [EPA–HQ–OPP–2017–0647, to number. The OMB control numbers are respondents. The revisions to total
both EPA and OMB as follows: To (1) displayed either by publication in the number of respondents are the result of
EPA online using http:// Federal Register or by other appropriate new data gathered for this ICR effort,
www.regulations.gov (our preferred means, such as on the related collection updated Agency data regarding total
method) or by mail to: EPA Docket instrument or form, if applicable. The numbers of regulated entities, and the
Center, Environmental Protection display of OMB control numbers for overlapping coverage of the recently
Agency, Mail Code 28221T, 1200 certain EPA regulations is consolidated revised Universal Hazardous Waste
Pennsylvania Ave. NW, Washington, DC in 40 CFR part 9. Manifest ICR (OMB Control No. 2050–
Abstract: This ICR covers the
20460 and (2) OMB via email to oira_ 0039). The ICR supporting statement
information collection activities that
submission@omb.eop.gov. Address provides a detailed analysis of the
implement the statutory mandates in
comments to OMB Desk Officer for EPA. change in burden estimate. This change
EPA’s policy is that all comments section 6(e) of the Toxic Substances
is an adjustment.
Control Act (TSCA) related to
received will be included in the docket Dated: November 16, 2018.
polychlorinated biphenyls (PCBs), 15
without change, including any personal
U.S.C. 2605(e). Specifically, TSCA Courtney Kerwin,
information provided, unless the
section 6(e)(1) directs EPA to regulate Director, Collection Strategies Division.
comment includes profanity, threats,
the marking and disposal of PCBs. [FR Doc. 2018–25775 Filed 11–26–18; 8:45 am]
information claimed to be Confidential
Section 6(e)(2) bans the manufacturing,
Business Information (CBI), or other BILLING CODE 6560–50–P
processing, distribution in commerce,
information whose disclosure is
and use of PCBs in other than a totally
restricted by statute. Do not submit
enclosed manner. Section 6(e)(3) ENVIRONMENTAL PROTECTION
electronically any information you
establishes a process for obtaining AGENCY
consider to be CBI or other information exemptions from the prohibitions on the
whose disclosure is restricted by statute. manufacture, processing, and [EPA–HQ–OPPT–2017–0645; FRL–9986–96–
FOR FURTHER INFORMATION CONTACT: OEI]
distribution in commerce of PCBs.
For technical information contact: Implementing regulations have been
Peter Gimlin, National Program Agency Information Collection
codified in 40 CFR part 761, and Activities; Renewal Request Submitted
Chemicals Division (7404T), Office of include approximately 100 specific
Pollution Prevention and Toxics, to OMB for Review and Approval;
reporting, third-party reporting, and Comment Request; Premanufacture
Environmental Protection Agency, 1200 recordkeeping requirements. The
Pennsylvania Ave. NW, Washington, DC Review Reporting and Exemption
regulations are intended to prevent the Requirements for New Chemical
20460–0001; telephone number: (202) improper handling and disposal of PCBs
566–0515; email address: Gimlin.Peter@ Substances and Significant New Use
and to minimize the exposure of human Reporting Requirements for Chemical
epa.gov. beings or the environment to PCBs.
amozie on DSK3GDR082PROD with NOTICES1

For general information contact: Substances
Responses to the collection of
TSCA-Hotline, ABVI-Goodwill, 422 information are mandatory (see 40 CFR AGENCY: Environmental Protection
South Clinton Ave., Rochester, NY part 761). Respondents may claim all or Agency (EPA).
14620; telephone number: (202) 554– part of a response confidential. EPA will ACTION: Notice.
1404; email address: TSCA-Hotline@ disclose information that is covered by
epa.gov. a claim of confidentiality only to the SUMMARY: The Environmental Protection
SUPPLEMENTARY INFORMATION: extent permitted by, and in accordance Agency (EPA) has submitted the

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60846 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices

following information collection request ICR that explains in detail the to the new chemical substance or
(ICR) to the Office of Management and information collection activities and the significant new use and take action, as
Budget (OMB) for review and approval related burden and cost estimates that appropriate, to ensure adequate
in accordance with the Paperwork are summarized in this document, are protection of human health and the
Reduction Act (PRA): Premanufacture available in the docket for this ICR. The environment. If EPA takes no action
Review Reporting and Exemption docket can be viewed online at http:// within the 90-day review period for
Requirements for New Chemical www.regulations.gov or in person at the PMNs (or 30 or 45 days for PMN
Substances and Significant New Use EPA Docket Center, West William exemption applications), TSCA section
Reporting Requirements for Chemical Jefferson Clinton Bldg., Rm. 3334, 1301 5 states that the PMN submitter is
Substances (EPA ICR No. 0574.18, OMB Constitution Ave. NW, Washington, DC. entitled to receive a refund of fees paid.
Control No. 2070–0012). The ICR, which The telephone number for the Docket Respondents may claim all or part of a
is available in the docket, is only briefly Center is (202) 566–1744. For additional
summarized in this document. This is a response confidential. EPA will disclose
information about EPA’s public docket,
request to renew the approval of an information that is covered by a claim
visit http://www.epa.gov/dockets.
existing ICR, currently approved of confidentiality only to the extent
Abstract: This ICR covers the permitted by, and in accordance with,
through November 30, 2018. EPA information collection activities that
previously provided a 60-day public the procedures in TSCA section 14 and
implement the statutory mandates in 40 CFR part 2.
review opportunity via the Federal section 5 of the Toxic Substances
Register on July 25, 2018. With this Control Act (TSCA), as amended by the Form numbers: Premanufacture
submission, EPA is providing an Frank R. Lautenberg Chemical Safety for Notice (EPA Form No. 7710–25) and
additional 30-days for public review. the 21st Century Act of 2016, related to Notice of Commencement of
Under the PRA, an agency may not new chemical substances, 15 U.S.C. Manufacture or Import (EPA Form No.
conduct or sponsor, and a person is not 2604, and the implementing regulations 7710–56).
required to respond to, a collection of codified in 40 CFR parts 700, 720, 721,
information, unless it displays a Respondents/affected entities:
723, and 725. Specifically, TSCA Companies that manufacture, process or
currently valid OMB control number. section 5 requires that any person who import chemical substances.
DATES: Comments must be received on proposes to manufacture (which
or before December 27, 2018. includes import) a new chemical Respondent’s obligation to respond:
ADDRESSES: Submit your comments, substance (i.e., a chemical substance not Mandatory.
identified by docket identification (ID) listed on the TSCA section 8(b) Frequency of response: On occasion.
number [EPA–HQ–OPP–2017–0645, to: Inventory) or a significant new use of a Estimated total number of
(1) EPA online using http:// chemical substance (as identified by respondents: 234.
www.regulations.gov (our preferred EPA rule) must provide a notice to EPA
method) or by mail to: EPA Docket at least 90 days prior to commencing the Estimated total burden: 135,230 hours
Center, Environmental Protection manufacture of that chemical substance. (per year). Burden is defined at 5 CFR
Agency, Mail Code 28221T, 1200 EPA must review the section 5 notice, 1320.3(b).
Pennsylvania Ave. NW, Washington, DC make an affirmative determination on Estimated total cost: $49,979,150 (per
20460 and (2) via email to oira_ the safety of the new chemical year), includes $0 annualized capital or
submission@omb.eop.gov. Address substance or significant new use, and, if operation and maintenance costs.
comments to OMB Desk Officer for EPA. appropriate, regulate the chemical
EPA’s policy is that all comments Changes in the estimates: There is an
substance to address any unreasonable
received will be included in the docket increase of 18,054 hours in the total
risks identified before it can proceed to
without change, including any personal the marketplace. TSCA section 5 estimated respondent burden compared
information provided, unless the authorizes EPA to determine by rule with that currently approved by OMB.
comment includes profanity, threats, that a use of a chemical substance is a This increase reflects an adjustment in
information claimed to be Confidential significant new use requiring notice to EPA’s estimated number of each type of
Business Information (CBI), or other and review and determination by the notice; the estimated number of annual
information whose disclosure is Agency through a significant new use CDX registrants; and EPA corrected
restricted by statute. Do not submit rule (SNUR) that requires any person some discrepancies in estimating
electronically any information you who proposes to manufacture or process burden from the previous ICR. This
consider to be CBI or other information a chemical substance for a designated increase also reflects a program change
whose disclosure is restricted by statute. new use to submit a Significant New from incorporating burden associated
FOR FURTHER INFORMATION CONTACT: Use Notice (SNUN) to the Agency. EPA with new CBI substantiation
For technical information contact: must review the SNUN, make a requirements resulting from the 2016
Adam Ross, Chemical Control Division determination on the chemical amendment to TSCA and the inclusion
(7404M), Office of Pollution Prevention substance, and take appropriate action of burden associated with the ‘‘Points to
and Toxics, Environmental Protection pursuant to TSCA section 5. The Consider When Preparing TSCA New
Agency, 1200 Pennsylvania Ave. NW, submitter of a premanufacture notice Chemical Notifications’’ guidance
Washington, DC 20460–0001; telephone: (PMN), significant new use notice document.
(202) 564–1625; email address: (SNUN), or microbial commercial
ross.adam@epa.gov. Dated: November 19, 2018.
activity notice (MCAN) is also required
amozie on DSK3GDR082PROD with NOTICES1

For general information contact: The to inform EPA when non-exempt Courtney Kerwin,
TSCA-Hotline, ABVI-Goodwill, 422 commercial manufacture of the Director, Collection Strategies Division.
South Clinton Ave., Rochester, NY substance in question actually begins by [FR Doc. 2018–25778 Filed 11–26–18; 8:45 am]
14620; telephone: (202) 554–1404; email submitting a Notice of Commencement BILLING CODE 6560–50–P
address: TSCA-Hotline@epa.gov. (NOC). Under TSCA section 5, EPA
SUPPLEMENTARY INFORMATION: must make one of five possible
Supporting documents, including the regulatory determinations with respect

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Document Created: 2018-11-27 01:24:14
Document Modified: 2018-11-27 01:24:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments must be received on or before December 27, 2018.
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,
FR Citation		83 FR 60845