Document ID: EPA-HQ-OPPT-2018-0398-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances
Posted Date: 2018-06-14T04:00Z

[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Pages 27768-27769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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]
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