83 FR 27768 - Agency Information Collection Activities; Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances; Emergency Processing Request Submitted to OMB

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 115 (June 14, 2018)

Page Range		27768-27769
FR Document		2018-12811

EPA has submitted an amendment to the following information collection request (ICR) to the Office of Management and Budget (OMB) for emergency processing in accordance with the Paperwork Reduction Act (PRA): ``Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances'' and identified by EPA ICR No. 0574.17 and OMB Control No. 2070-0012. 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 summarized in this document.

Federal Register, Volume 83 Issue 115 (Thursday, June 14, 2018)

[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Pages 27768-27769]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12811]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0398; FRL-9979-26]


Agency Information Collection Activities; Pre-Manufacture Review 
Reporting and Exemption Requirements for New Chemical Substances and 
Significant New Use Reporting Requirements for Chemical Substances; 
Emergency Processing Request Submitted to OMB

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA has submitted an amendment to the following information 
collection request (ICR) to the Office of Management and Budget (OMB) 
for emergency processing in accordance with the Paperwork Reduction Act 
(PRA): ``Pre-Manufacture Review Reporting and Exemption Requirements 
for New Chemical Substances and Significant New Use Reporting 
Requirements for Chemical Substances'' and identified by EPA ICR No. 
0574.17 and OMB Control No. 2070-0012. 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 summarized in this document.

DATES: EPA requested that OMB approve the emergency processing request 
on or before June 11, 2018.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2018-0398, is available at 
http://www.regulations.gov. A public version of the docket is available 
for inspection and copying between 8:30 a.m. and 4:30 p.m., Monday 
through Friday, excluding federal holidays, at the U.S. Environmental 
Protection Agency, EPA Docket Center Reading Room, WJC West Building, 
Rm. 3334, 1301 Constitution Avenue NW, Washington, DC 20004. A 
reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT: Brandon Mullings, Environmental 
Assistance Division (MC 7408M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-4826 email 
address: [email protected].

SUPPLEMENTARY INFORMATION: 
    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: EPA is seeking emergency processing of amendments to an 
existing, approved ICR that is currently scheduled to expire on 
November 30, 2018.
    The Agency is issuing additional reporting guidance to help 
submitters better address the recently-amended requirements for new 
chemicals under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 
et seq.). Under the PRA, 44 U.S.C. 3501 et seq., an agency may ask OMB 
to authorize a collection of information if the agency has determined 
that the collection is needed prior to the expiration of time periods 
established under the PRA if the agency determines that the agency 
cannot reasonably comply with the

[[Page 27769]]

normal clearance procedures under the PRA, because either public harm 
is reasonably likely to result if normal clearance procedures are 
followed, an unanticipated event has occurred, or the use of normal 
clearance procedures is reasonably likely to prevent or disrupt the 
collection of information or is reasonably likely to cause a statutory 
or court ordered deadline to be missed.
    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: The Frank R. Lautenberg Chemical Safety for the 21st 
Century Act, immediately effective upon its enactment on June 22, 2016, 
made significant amendments to TSCA, including imposing a number of new 
responsibilities related to new chemical reviews. Specifically, TSCA 
section 5 requires that EPA now assess a new chemical under the 
``conditions of use,'' which is defined as the circumstances, as 
determined by the Administrator, under which the chemical is intended, 
known or reasonably foreseen to be manufactured, processed, distributed 
in commerce, used or disposed of. TSCA also now requires that EPA make 
one of five affirmative determinations on the new chemical within the 
statutory review period. The new determination requirement has resulted 
in a backlog of section 5 submissions awaiting final action.
    In an effort to avoid future delays and backlogs and to assist 
respondents in preparing a Premanufacture Notice (PMN), Significant New 
Use Notice (SNUN), or exemption notice (e.g., Low Volume Exemption or 
LVE) (hereinafter collectively referred to as ``notifications'') 
submissions in a manner that satisfies the amended TSCA section 5 
requirements, EPA developed a non-binding guidance document, entitled 
``Points to Consider When Preparing TSCA New Chemical Notifications''. 
To the extent that respondents are able to take information presented 
in the Points to Consider document into account prior to preparing and 
submitting a PMN, SNUN, or exemption notice, EPA also anticipates that 
more robust submissions will improve the factual bases for 
determinations on new chemical notices, speed review, and reduce the 
frequency of interactions with submitters in cases where EPA has 
questions about the submission. The Points to Consider document is 
urgently needed for a more timely and efficient new chemical review 
process. Complying with the normal clearance procedures for approval of 
the reporting guidance provided in the Points to Consider document 
could disrupt the collection of information by preventing companies 
from accessing applicable and helpful EPA guidance with respect to PMNs 
and SNUNs submitted prior to OMB approval of the ICR and cause harm due 
to the ensuing delays in marketing new chemical substances because 
companies do not have access to the guidance.
    Respondents/affected entities: Entities potentially affected by 
this ICR are manufacturers (including importers) and processors of new 
chemical substances.
    Respondent's obligation to respond: Mandatory (15 U.S.C. 2604).
    Estimated total number of potential respondents: 443.
    Frequency of response: On occasion.
    Estimated total burden: 117,176 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Estimated total costs: $34,389,692 (per year), includes no 
annualized capital investment or maintenance and operational costs.
    Changes in the estimates: There is an increase of 1,379 hours in 
the total estimated respondent burden compared with that identified in 
the ICR currently approved by OMB. This increase reflects the estimated 
additional time associated with reading the new guidance document 
before preparing and submitting a PMN, SNUN, or exemption notice (about 
1.4 hours per response). This burden increase is the result of a 
program change.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: June 7, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-12811 Filed 6-13-18; 8:45 am]
 BILLING CODE 6560-50-P

27768 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices

may cause unreasonable adverse effects personal information provided, unless 2070–0012. The ICR, which is available
or may not be effective at controlling the the comment includes profanity, threats, in the docket along with other related
target pests. Accordingly, EPA still information claimed to be Confidential materials, provides a detailed
welcomes comments on this request and Business Information (CBI) or other explanation of the collection activities
will review all comments received in information whose disclosure is and the burden estimate that is
response to this Notice, and consider restricted by statute. summarized in this document.
whether any such comments identify a FOR FURTHER INFORMATION CONTACT: DATES: EPA requested that OMB
need for modification or revocation of Karen VanSickle, Clean Air Markets approve the emergency processing
the specific exemption. Division, Office of Air and Radiation, request on or before June 11, 2018.
Authority: 7 U.S.C. 136 et seq. (6204M), Environmental Protection ADDRESSES: The docket for this action,
Agency, 1200 Pennsylvania Ave. NW, identified by docket identification (ID)
Dated: June 6, 2018.
Washington, DC 20460; telephone number EPA–HQ–OPPT–2018–0398, is
Michael L. Goodis, number: 202–343–9220; fax number: available at http://www.regulations.gov.
Director, Registration Division, Office of 202–343–2361; email address: A public version of the docket is
Pesticide Programs.
vansickle.karen@epa.gov. available for inspection and copying
[FR Doc. 2018–12803 Filed 6–13–18; 8:45 am]
SUPPLEMENTARY INFORMATION: This between 8:30 a.m. and 4:30 p.m.,
BILLING CODE 6560–50–P Monday through Friday, excluding
document extends the public comment
period established in the Federal federal holidays, at the U.S.
Register document of April 16, 2018 (83 Environmental Protection Agency, EPA
ENVIRONMENTAL PROTECTION Docket Center Reading Room, WJC West
FR 16357) from June 15, 2018, to July
AGENCY Building, Rm. 3334, 1301 Constitution
14, 2018. In that document, EPA opened
[EPA–HQ–OAR–2018–0209; FRL–9979–03– a 60-day comment period for the Avenue NW, Washington, DC 20004. A
OEI] proposed renewal of the ICR, Cross- reasonable fee may be charged for
State Air Pollution Rule and Texas SO2 copying.
Proposed Information Collection Trading Programs (Renewal)’’ (EPA ICR FOR FURTHER INFORMATION CONTACT:
Request; Extension of Comment No. 2391.05, OMB Control No. 2060–
Period; Cross-State Air Pollution Rule Brandon Mullings, Environmental
0667). The docket for this action was Assistance Division (MC 7408M), Office
and Texas SO2 Trading Programs not made available on https://
(Renewal) of Pollution Prevention and Toxics,
www.regulations.gov until May 15, Environmental Protection Agency, 1200
AGENCY: Environmental Protection 2018. As a result, EPA is extending the Pennsylvania Ave. NW, Washington, DC
Agency (EPA). comment period for 29 days until July 20460–0001; telephone number: (202)
ACTION: Extension of comment period. 14, 2018. 564–4826 email address:
Courtney Kerwin, mullings.brandon@epa.gov.
SUMMARY: The Environmental Protection SUPPLEMENTARY INFORMATION:
Agency (EPA) issued a notice in the Director, Regulatory Support Division.
Docket: Supporting documents,
Federal Register of April 16, 2018, [FR Doc. 2018–12770 Filed 6–13–18; 8:45 am]
including the ICR that explains in detail
opening a 60-day comment period for an BILLING CODE 6560–50–P
the information collection activities and
information collection request (ICR), the related burden and cost estimates
Cross-State Air Pollution Rule and that are summarized in this document,
Texas SO2 Trading Programs (Renewal), ENVIRONMENTAL PROTECTION
AGENCY are available in the docket for this ICR.
that EPA is planning to submit to the The docket can be viewed online at
Office of Management and Budget [EPA–HQ–OPPT–2018–0398; FRL–9979–26] http://www.regulations.gov or in person
(OMB) for review and approval in at the EPA Docket Center, West William
accordance with the Paperwork Agency Information Collection Jefferson Clinton Bldg., Rm. 3334, 1301
Reduction Act (PRA). Although the Activities; Pre-Manufacture Review Constitution Ave. NW, Washington, DC.
notice published in the Federal Register Reporting and Exemption The telephone number for the Docket
on April 16, 2018, EPA did not make Requirements for New Chemical Center is (202) 566–1744. For additional
publicly available on https:// Substances and Significant New Use information about EPA’s public docket,
www.regulations.gov the docket for this Reporting Requirements for Chemical visit http://www.epa.gov/dockets.
action until May 15, 2018. EPA is Substances; Emergency Processing ICR status: EPA is seeking emergency
extending the comment period until Request Submitted to OMB processing of amendments to an
July 14, 2018, to allow for the full 60- AGENCY: Environmental Protection existing, approved ICR that is currently
day comment period. Agency (EPA). scheduled to expire on November 30,
DATES: Comments must be received on 2018.
ACTION: Notice.
or before July 14, 2018. The Agency is issuing additional
ADDRESSES: Submit your comments, SUMMARY: EPA has submitted an reporting guidance to help submitters
identified by Docket ID No. EPA–HQ– amendment to the following better address the recently-amended
OAR–2018–0209, online using https:// information collection request (ICR) to requirements for new chemicals under
www.regulations.gov (our preferred the Office of Management and Budget the Toxic Substances Control Act
method), by email to a-and-r-Docket@ (OMB) for emergency processing in (TSCA) (15 U.S.C. 2601 et seq.). Under
epa.gov, or by mail to: EPA Docket accordance with the Paperwork the PRA, 44 U.S.C. 3501 et seq., an
daltland on DSKBBV9HB2PROD with NOTICES

Center, Environmental Protection Reduction Act (PRA): ‘‘Pre-Manufacture agency may ask OMB to authorize a
Agency, Mail Code 28221T, 1200 Review Reporting and Exemption collection of information if the agency
Pennsylvania Ave. NW, Washington, DC Requirements for New Chemical has determined that the collection is
20460. Substances and Significant New Use needed prior to the expiration of time
EPA’s policy is that all comments Reporting Requirements for Chemical periods established under the PRA if the
received will be included in the public Substances’’ and identified by EPA ICR agency determines that the agency
docket without change including any No. 0574.17 and OMB Control No. cannot reasonably comply with the

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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 27769

normal clearance procedures under the reduce the frequency of interactions ENVIRONMENTAL PROTECTION
PRA, because either public harm is with submitters in cases where EPA has AGENCY
reasonably likely to result if normal questions about the submission. The
clearance procedures are followed, an Points to Consider document is urgently [FRL–9979–12—Region 10]
unanticipated event has occurred, or the needed for a more timely and efficient
use of normal clearance procedures is new chemical review process. Approval of the Application by the
reasonably likely to prevent or disrupt Complying with the normal clearance State of Idaho To Administer the
the collection of information or is procedures for approval of the reporting National Pollutant Discharge
reasonably likely to cause a statutory or guidance provided in the Points to Elimination System (NPDES) and
court ordered deadline to be missed. Electronic Reporting
Consider document could disrupt the
An agency may not conduct or
sponsor, and a person is not required to collection of information by preventing AGENCY: Environmental Protection
respond to, a collection of information, companies from accessing applicable Agency (EPA).
unless it displays a currently valid OMB and helpful EPA guidance with respect
ACTION: Notice.
control number. The OMB control to PMNs and SNUNs submitted prior to
numbers are displayed either by OMB approval of the ICR and cause SUMMARY: On June 5, 2018, the
publication in the Federal Register or harm due to the ensuing delays in Administrator for the Environmental
by other appropriate means, such as on marketing new chemical substances Protection Agency approved the
the related collection instrument or because companies do not have access application by the State of Idaho to
form, if applicable. The display of OMB to the guidance. administer and enforce the Idaho
control numbers for certain EPA Respondents/affected entities: Entities Pollutant Discharge Elimination System
regulations is consolidated in 40 CFR potentially affected by this ICR are (IPDES) program pursuant to the Clean
part 9. manufacturers (including importers) Water Act. Concurrent with this
Abstract: The Frank R. Lautenberg approval, EPA is also approving IPDES
and processors of new chemical
Chemical Safety for the 21st Century program for electronic reporting. The
Act, immediately effective upon its substances.
Idaho Department of Environmental
enactment on June 22, 2016, made Respondent’s obligation to respond: Quality (IDEQ) will administer the
significant amendments to TSCA, Mandatory (15 U.S.C. 2604). approved IPDES program regulating
including imposing a number of new Estimated total number of potential discharges of pollutants into waters of
responsibilities related to new chemical respondents: 443. the United States under its jurisdiction
reviews. Specifically, TSCA section 5 as described in the state’s program
requires that EPA now assess a new Frequency of response: On occasion.
application. EPA has approved the
chemical under the ‘‘conditions of use,’’ Estimated total burden: 117,176 hours State’s implementation plan that
which is defined as the circumstances, (per year). Burden is defined at 5 CFR transfers the administration of specific
as determined by the Administrator, 1320.3(b). program components from EPA to the
under which the chemical is intended, State over a four-year period in
Estimated total costs: $34,389,692
known or reasonably foreseen to be accordance with the Memorandum of
(per year), includes no annualized
manufactured, processed, distributed in Agreement between IDEQ and EPA R10
commerce, used or disposed of. TSCA capital investment or maintenance and
operational costs. (MOA) and subject to EPA oversight and
also now requires that EPA make one of enforcement. EPA will suspend
five affirmative determinations on the Changes in the estimates: There is an issuance of NPDES permits in Idaho in
new chemical within the statutory increase of 1,379 hours in the total accordance with the State’s approved
review period. The new determination estimated respondent burden compared schedule to transfer NPDES program
requirement has resulted in a backlog of with that identified in the ICR currently authority. EPA will retain the authority
section 5 submissions awaiting final approved by OMB. This increase reflects to issue NPDES permits for facilities
action. the estimated additional time associated located on tribal lands and/or
In an effort to avoid future delays and with reading the new guidance discharging to tribal waters.
backlogs and to assist respondents in document before preparing and
preparing a Premanufacture Notice DATES: On June 5, 2018, the
submitting a PMN, SNUN, or exemption Administrator approved Idaho’s IPDES
(PMN), Significant New Use Notice
notice (about 1.4 hours per response). program including electronic reporting.
(SNUN), or exemption notice (e.g., Low
This burden increase is the result of a FOR FURTHER INFORMATION CONTACT: Visit
Volume Exemption or LVE) (hereinafter
collectively referred to as program change. EPA’s web page at https://www.epa.gov/
‘‘notifications’’) submissions in a Authority: 44 U.S.C. 3501 et seq. npdes-permits/idaho-npdes-program-
manner that satisfies the amended Dated: June 7, 2018.
authorization or contact Karen Burgess,
TSCA section 5 requirements, EPA NPDES Permits Unit, EPA Region 10;
Charlotte Bertrand,
developed a non-binding guidance (206) 553–1644; burgess.karen@epa.gov.
document, entitled ‘‘Points to Consider Acting Principal Deputy Assistant The State’s application, supporting
When Preparing TSCA New Chemical Administrator, Office of Chemical Safety and documentation and EPA’s response to
Notifications’’. To the extent that Pollution Prevention. comments received during the public
respondents are able to take information [FR Doc. 2018–12811 Filed 6–13–18; 8:45 am] comment period and hearings may be
presented in the Points to Consider BILLING CODE 6560–50–P viewed or downloaded from EPA’s web
daltland on DSKBBV9HB2PROD with NOTICES

document into account prior to page. The IDEQ contact is Mary Anne
preparing and submitting a PMN, Nelson, IPDES Program Manager;
SNUN, or exemption notice, EPA also mary.anne.nelson@deq.idaho.gov; (208)
anticipates that more robust 373–0291. IDEQ’s application, related
submissions will improve the factual documents and program development
bases for determinations on new documents may be viewed or
chemical notices, speed review, and downloaded from the IDEQ website

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Document Created: 2018-06-14 01:39:18
Document Modified: 2018-06-14 01:39:18

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		EPA requested that OMB approve the emergency processing request on or before June 11, 2018.
Contact		Brandon Mullings, Environmental Assistance Division (MC 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4826 email
FR Citation		83 FR 27768