[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Notices]
[Pages 35269-35271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15920]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0645; FRL-9978-03]


Agency Information Collection Activities; Proposed Renewal of an 
Existing Collection (EPA ICR No. 0574.18); Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit an Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
The ICR, entitled: ``Premanufacture Review Reporting and Exemption 
Requirements for New Chemical Substances and Significant New Use 
Reporting Requirements for Chemical Substances'' and identified by EPA 
ICR No. 0574.18 and OMB Control No. 2070-0012, represents the renewal 
of an existing ICR that is scheduled to expire on November 30, 2018. 
Before submitting the ICR to OMB for review and approval, EPA is 
soliciting comments on specific aspects of the proposed information 
collection that is summarized in this document. The ICR and 
accompanying material are available in the docket for public review and 
comment.

DATES: Comments must be received on or before September 24, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0645, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental

[[Page 35270]]

Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Adam Ross, Chemical Control 
Division (7101M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-1625; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), 
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply 
to?

    Title: Premanufacture Review Reporting and Exemption Requirements 
for New Chemical Substances and Significant New Use Reporting 
Requirements for Chemical Substances.
    ICR number: EPA ICR No. 0574.18.
    OMB control number: OMB Control No. 2070-0012.
    ICR status: This ICR is currently scheduled to expire on November 
30, 2018. 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 for EPA's 
regulations in title 40 of the Code of Federal Regulations (CFR), after 
appearing in the Federal Register when approved, are listed in 40 CFR 
part 9, 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: Section 5 of the Toxic Substances Control Act (TSCA), as 
amended by the Frank R. Lautenberg Chemical Safety for the 21st Century 
Act requires that any person who proposes to manufacture (which 
includes import) a ``new chemical'' (i.e., a chemical not listed on the 
TSCA section 8(b) Inventory) must provide a notice to EPA at least 90 
days prior to commencing manufacture of that chemical. EPA must review 
a section 5 notice, make an affirmative determination on the safety of 
the new chemical substance, and, if appropriate, regulate the chemical 
to address any unreasonable risks identified before it can proceed to 
the marketplace.
    EPA is authorized to determine that a use of a chemical substance 
is a significant new use and promulgate a significant new use rule 
(SNUR). In certain instances, persons may opt to pursue that use, in 
which case they must submit a notice and undergo a review. For such 
circumstances, TSCA section 5 requires a significant new use notice 
(SNUN) from any person who proposes to manufacture or process a 
chemical for a use that is determined by EPA to be a ``significant new 
use.''
    Furthermore, TSCA section 5 requires EPA to make determinations 
regarding the manufacture, processing, distribution in commerce, use 
and/or disposal of new chemical substances or significant new uses. To 
assist in the evaluation, EPA encourages notice submitters to contact 
an EPA specialist through a pre-submission consultation to ensure that 
the submitter understands EPA's review process and information needed 
to make a determination regarding the chemical. On June 20, 2018, EPA 
issued guidance entitled ``Points to Consider When Preparing TSCA New 
Chemical Notifications'' to inform and assist submitters planning to 
prepare notices, and exemption applications for Agency review (see 
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca). Using the notice 
submitted to the Agency, EPA evaluates the health and environmental 
effects of new chemical substances. On the basis of its review, 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), the Lautenberg 
amendments state that the PMN submitter is entitled to receive a refund 
of fees. EPA requires that the submitter of a PMN or MCAN inform EPA 
when non-exempt commercial manufacture of the substance in question 
actually begins by submitting a Notice of Commencement.
    This information collection addresses the reporting and 
recordkeeping requirements associated with TSCA section 5.
    Responses to the collection of information are mandatory (see 40 
CFR parts 700, 720, 721, 723 and 725). Respondents may claim all or 
part of a document 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.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to range between 
approximately 17 and 524 hours per response. Burden is defined in 5 CFR 
1320.3(b).
    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 here:
    Respondents/affected entities: Entities potentially affected by 
this ICR are companies that manufacture, process or import chemical 
substances.
    Estimated total number of potential respondents: 234.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent: 
1,795.
    Estimated total annual respondent burden hours: 148,312 hours.

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    Estimated total annual respondent costs: $46,765,6135. This 
includes an estimated burden cost of $138,093 and an estimated cost of 
$0.00 for capital investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

    There is an increase of 146,312 hours in the total estimated 
respondent burden compared with that identified in the ICR currently 
approved by OMB. This increase reflects a change in the mix of EPA's 
estimated number of each type of notice. Similarly, the estimated 
number of annual CDX registrants also increased. Lastly, there was an 
increase in burden associated with new CBI substantiation requirements 
resulting from the 2016 amendment to TSCA. The change in burden is 
explained more fully in the ICR Supporting Statement. This change is an 
adjustment and a program change.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to 
announce the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the technical person listed under 
FOR FURTHER INFORMATION CONTACT.

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

    Dated: July 13, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-15920 Filed 7-24-18; 8:45 am]
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