[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53478-53481]
[FR Doc No: 2018-23056]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0386]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments and Listing of
Ingredients in Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on ``Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products.''

DATES: Submit either electronic or written comments on the collection
of information by December 24, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 24, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0386 for ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments and Listing of
Ingredients in Tobacco Products.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the

Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments and Listing of Ingredients in Tobacco
Products

OMB Control Number 0910-0650--Extension

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by adding, among other things, a chapter
granting FDA important authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect the public
health generally and to reduce tobacco use by minors. The Tobacco
Control Act created new requirements for the tobacco industry. Section
101 of the Tobacco Control Act amended the FD&C Act by adding sections
905 and 904 (21 U.S.C. 387e and 387d).
    Section 905 of the FD&C Act requires the annual registration of any
``establishment in any State engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products.''
Section 905 requires this registration be completed by December 31 of
each year. The Secretary of Health and Human Services (Secretary) has
delegated to the Commissioner of Food and Drugs the responsibility for
administering the FD&C Act, including section 905. Section 905 of the
FD&C Act requires owners or operators of each establishment to
register: (1) Their name; (2) places of business; (3) a list of all
tobacco products which are manufactured by that person; (4) a copy of
all labeling and a reference to the authority for the marketing of any
tobacco product subject to a tobacco product standard under section 907
of the FD&C Act (21 U.S.C. 387g) or to premarket review under section
910 of the FD&C Act (21 U.S.C. 387j); (5) a copy of all consumer
information and other labeling; (6) a representative sampling of
advertisements; (7) upon request made by the Secretary for good cause,
a copy of all advertisements for a particular tobacco product; and (8)
upon request made by the Secretary, if the registrant has determined
that a tobacco product contained in the product list is not subject to
a tobacco product standard established under section 907 of the FD&C
Act, a brief statement of the basis upon which the registrant made such
determination.
    FDA collects the information submitted pursuant to section 905 of
the FD&C Act through an electronic portal, and through paper forms
(Forms FDA 3741 and FDA 3741a) for those individuals who choose not to
use the electronic portal.
    FDA has also published a guidance for industry entitled
``Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments'' (https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf). This
guidance is intended to assist persons making tobacco product
establishment registration and product listing submissions to FDA.
    Section 904(a)(1) of the FD&C Act requires that each tobacco
product manufacturer or importer submit ``a listing of all ingredients,
including tobacco, substances, compounds, and additives that are, as of
such date, added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in each
brand and subbrand'' by December 22, 2009. This section applies only to
those tobacco products manufactured and distributed before June 22,
2009, and which are still manufactured as of the date of the ingredient
listing submission.
    Section 904(c) of the FD&C Act requires that a tobacco product

manufacturer: (1) Provide all information required under section 904(a)
of the FD&C Act to FDA ``at least 90 days prior to the delivery for
introduction into interstate commerce of a tobacco product not on the
market on the date of enactment'' of the Tobacco Control Act; (2)
advise FDA in writing at least 90 days prior to adding any new tobacco
additive or increasing in quantity an existing tobacco additive, except
for those additives that have been designated by FDA through regulation
as not a human or animal carcinogen, or otherwise harmful to health
under intended conditions of use; and (3) advise FDA in writing at
least 60 days prior to eliminating or decreasing an existing additive,
or adding or increasing an additive that has been designated by FDA
through regulation as not a human or animal carcinogen, or otherwise
harmful to health under intended conditions of use.
    FDA collects the information submitted pursuant to sections
904(a)(1) and 904(c) of the FD&C Act through an electronic portal, and
through a paper form (Form FDA 3742) for those individuals who choose
not to use the electronic portal.
    In addition to the development of the electronic portal and paper
form, FDA published a guidance entitled ``Listing of Ingredients in
Tobacco Products.'' This guidance is intended to assist persons making
tobacco product ingredient listing submissions. FDA also provides a
technical guide, embedded hints, and a web tutorial to the electronic
portal.
    The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to Chapter 9 of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah, pipe tobacco,
nicotine gels, dissolvables that were not already subject to the FD&C
Act, and other tobacco products that may be developed in the future (81
FR 28974 at 28976) (``the final deeming rule'')).
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
        FDA form/activity/TCA section            Number of     responses per   Total annual               Hours per response                Total hours
                                                respondents     respondent       responses
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Tobacco Product Establishment Initial                    100               1             100  1.6.......................................             160
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions);
 Sections 905(b), 905(c), 905(d), 905(h), or
 905(i).
Tobacco Product Establishment Renewal                  3,578               1           3,578  .16 (10 minutes)..........................             572
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions);
 Sections 905(b), 905(c), 905(d), 905(h), or
 905(i).
Tobacco Product Listing; Form FDA 3742                    10               1              10  2.........................................              20
 Listing of Ingredients (Electronic and
 Paper submissions); Section 904(a)(1).
Tobacco Product Listing; Form FDA 3742                    35               2              70  0.40 (24 minutes).........................              28
 Listing of Ingredients (Electronic and
 Paper submissions); Section 904(c).
Obtaining a Dun and Bradstreet D-U-N-S                   100               1             100  0.5 (30 minutes)..........................              50
 Number.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             830
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The PRA burden estimates have been updated to fully incorporate the
use of an electronic system known as FURLS for submitting registration
and product listing information to FDA. With the FURLS, manufacturers
can enter information quickly and easily. For example, product label
pictures can be uploaded directly. We anticipate that most, if not all
companies, already have electronic versions of their labels for
printing, sales, or marketing purposes.
    Product listing information is provided at the time of
registration. Currently, registration and listing requirements only
apply to domestic establishments engaged in the manufacture,
preparation, compounding, or processing of a tobacco product. This
includes importers to the extent that they engage in the manufacture,
preparation, compounding, or processing of a tobacco product, including
repackaging or otherwise changing the container, wrapper, or labeling
of any tobacco product package. Foreign establishments are not required
to register and list until FDA issues regulations establishing such
requirements in accordance with section 905(h) of the FD&C Act. To
account for the foregoing, we include both domestic manufacturing
establishments and importers in our estimates.
    As the deadline for initial establishment registration and product
listing for both statutorily regulated and deemed products has passed,
FDA estimates that few (up to 100) new establishments will submit one
initial establishment registration and product listing report each
year. Such new establishments potentially include new vape shop
locations that mix or assemble products on the market as of the final
deeming rule effective date. The Agency estimates that up to 100
tobacco establishments will each submit 1 initial establishment
registration and product listing report each year, which is expected to
take 1.6 hours, for a total 160 burden hours.

    FDA estimates that the confirmation or updating of establishment
registration and product listing information as required by section 905
of the FD&C Act will take 10 minutes annually per confirmation or
update per establishment. Based on FDA's experience with current
establishment registration and product listings submitted to the
Agency, the Agency estimates that on average 3,578 establishments will
each submit one confirmation or updated report each year, which is
expected to take 0.16 hour (10 minutes) for a total 572 burden hours.
    FDA estimates that we have received most tobacco product ingredient
submissions for large manufacturers of deemed products. Small
manufacturers' deadline for ingredient submissions is November 2018.
This is based on the counts we have to date (July 2018), including
statutorily regulated products (based on information in our tracking
system).
    FDA estimates that the submission of ingredient listings required
by section 904(a)(1) of the FD&C Act for each establishment will take 2
hours initially. Because this burden estimate covers a timeframe of 3
years, we anticipate almost all section 904(a)(1) tobacco ingredient
submissions to have been received before the expiration of the current
approval (prior to 11/8/2018 for small manufacturers and large
manufacturers, 5/8/18). We are estimating approximately 30
manufacturers may miss their deadline. This is based on estimates of
how many large manufacturers we are aware of that have missed their
deadline. Because this burden estimate covers 3 years, we are dividing
by 3, to yield 10 respondents as a yearly average for this estimate.
Therefore, FDA estimates that 10 establishments will initially submit
one report annually at 2 hours per report, for a total of 20 hours.
    Submissions under 904(c) of the FD&C Act are for any new product
that is not yet on the market (e.g., if on the market due to deeming
compliance period), newly deemed product manufacturers should have
submitted under section 904(a)(1) of the FD&C Act. This includes any
statutorily regulated product that would receive a marketing
authorization and any new deemed product not subject to the deeming
compliance period. For deemed product categories, while we anticipate
receiving a large number of premarket applications, there is a portion
of these applicants who will have reported their ingredients under
section 904(a)(1) as most of these submissions are expected to be for
products subject to the deeming compliance period.
    Based on FDA's experience and the actual number of product
ingredient listings submitted over the past 3 years, FDA estimates that
35 establishments will each submit two reports (one every 6 months).
FDA also estimates that the confirmation or updating of product
(ingredient) listing information required by section 904(c) of the FD&C
Act is expected to take 0.40 hour (24 minutes) and will take 48 minutes
annually for two confirmations or updates per establishment, for a
total 28 burden hours. FDA estimates that obtaining a DUNS (data
universal numbering system) number will take 30 minutes. FDA assumes
that all new establishment facilities that will be required to
initially register under section 905 of the FD&C Act would obtain a
DUNS number. FDA estimates that up to 100 establishments that would
need to obtain this number each year. The total industry burden to
obtain a DUNS number is 50 hours.
    FDA estimates the total burden for this collection to be 830 hours.
We have adjusted our burden estimate, which has resulted in a decrease
of 93,086 hours to the currently approved burden. Based on data we
reviewed from the past 3 years and projecting the number of remaining
establishments that have not registered and submitted product
ingredient listings, we revised the number of respondents and burden
hours in this information collection.

    Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23056 Filed 10-22-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Page 14421]
[FR Doc No: 2021-05381]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14863-001]

BM Energy Park, LLC; Notice of Surrender of Preliminary Permit

    Take notice that BM Energy Park LLC, permittee for the proposed
Banner Mountain Pumped Storage Hydro Project, has requested that its
preliminary permit be terminated. The permit was issued on May 8, 2018
and would have expired on April 30, 2021.\1\ The project would have
been located in Converse County, Wyoming.
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    \1\ 163 FERC ] 62,080 (2018).
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    The preliminary permit for Project No. 14863 will remain in effect
until the close of business, April 9, 2021. But, if the Commission is
closed on this day, then the permit remains in effect until the close
of business on the next day in which the Commission is open.\2\ New
applications for this site may not be submitted until after the permit
surrender is effective.
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    \2\ 18 CFR 385.2007(a)(2) (2020).

    Dated: March 10, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-05381 Filed 3-15-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Pages 69451-69452]
[FR Doc No: 2012-28095]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0494; FRL-9752-9]

Proposed Information Collection Request; Comment Request; Tips
and Complaints Regarding Environmental Violations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Tips and Complaints Regarding
Environmental Violations'' (EPA ICR No. 2219.04, OMB Control No. 2020-
0032) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.).

Before doing so, EPA is soliciting public comments on specific aspects
of the proposed information collection as described below. This is a
proposed extension of the ICR, which is currently approved through
March 31, 2013. 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 submitted on or before January 18, 2013.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OECA-
20009-0494, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public 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.

FOR FURTHER INFORMATION CONTACT: Michael Le Desma; Legal Counsel &
Resource Management Division; Office of Criminal Enforcement, Forensics
and Training; Environmental Protection Agency, Building 25, Box 25227,
Denver Federal Center, Denver, CO 80025; telephone number: (303) 462-
9453; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act,
EPA is soliciting comments and information to enable it to: (i)
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; (ii) evaluate the
accuracy of the Agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (iii) enhance the quality, utility, and clarity
of the information to be collected; and (iv) 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. 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. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: The EPA tips and complaints web form is intended to
provide an easy and convenient means by which members of the public can
supply information to EPA regarding suspected violations of
environmental law. The decision to provide a tip or complaint is
entirely voluntary and use of the webform when supplying a tip or
complaint is also entirely voluntary. Tippers need not supply contact
information or other personal identifiers. Those who do supply such
information, however, should know that this information may be shared
by EPA with appropriate administrative, law enforcement, and judicial
entities engaged in investigating or adjudicating the tip or complaint.
    Form Numbers: None.
    Respondents/affected entities: Respondents are expected to be
members of the general public as well as employees of any company
subject to federal environmental regulation. There is no specific
industry or group of industries about which EPA expects tips or
complaints.
    Respondent's obligation to respond: voluntary.
    Estimated number of respondents: 630 per month (total).
    Frequency of response: generally, a one-time response.
    Total estimated burden: 3,780 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $75,146 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: There is expected to be an increase in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase would reflect an increase in the number
of tips and complaints being filed, not an increase in the time or
burden associated with filing each tip or complaint. Growing awareness
of the ease with which tips and complaints can be filed using the tips
and complaints webform is expected to result in, perhaps, a 20%
increase in usage.

    Dated: November 6, 2012.
Cynthia J. Giles,
Assistant Administrator, Office of Enforcement and Compliance
Assurance.
[FR Doc. 2012-28095 Filed 11-16-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Rules and Regulations]
[Pages 64369-64371]
[FR Doc No: 2021-25142]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0813]
RIN 1625-AA00

Safety Zone; Steak Restaurant Fireworks, San Francisco Bay, San
Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the San Francisco Bay near Rincon Point in San
Francisco in support of a fireworks display on December 18, 2021. The
safety zone is necessary to protect personnel, vessels, and the marine
environment from potential hazards created by pyrotechnics.
Unauthorized persons or vessels are prohibited from entering into,
transiting through, or remaining in the safety zone without the
permission of the Captain of the Port San Francisco or a designated
representative.

DATES: This rule is effective from 9 a.m. on December 18, 2021, until
12:45 a.m. on December 19, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0813 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Anthony I. Solares, U.S. Coast Guard District
11, Sector San Francisco, at<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule

without prior notice and opportunity to comment when the agency for
good cause finds that those procedures are ``impracticable,
unnecessary, or contrary to the public interest.'' Under 5 U.S.C.
553(b)(B), the Coast Guard finds that good cause exists for not
publishing a notice of proposed rulemaking (NPRM) with respect to this
rule because it is impracticable. The Coast Guard did not receive final
details for this event until October 20, 2021. It is impracticable to
go through the full notice and comment rule making process because the
Coast Guard must establish this safety zone by December 18, 2021 and
lacks sufficient time to provide a reasonable comment period and to
consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because action is
necessary to protect personnel, vessels, and the marine environment
from the potential safety hazards associated with the fireworks display
near Rincon Point in the San Francisco Bay on December 18, 2021.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port San
Francisco has determined that potential hazards associated with the
Steak Restaurant Fireworks on December 18, 2021, will be a safety
concern for anyone within a 100-foot radius of the fireworks vessel
during loading and staging, and anyone within a 700-foot radius of the
fireworks vessel starting 30 minutes before the fireworks display is
scheduled to commence and ending 30 minutes after the conclusion of the
fireworks display. For this reason, this temporary safety zone is
needed to protect personnel, vessels, and the marine environment in the
navigable waters around the fireworks vessel and during the fireworks
display.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 9 a.m. on
December 18, 2021, until 12:45 a.m. on December 19, 2021, during the
loading, staging, and transit of the fireworks vessel in San Francisco
Bay from Pier 50 to 1,000 feet off Rincon Point, San Francisco, CA, and
until 30 minutes after completion of the fireworks display. During the
loading, staging, and transit of the fireworks vessel scheduled to take
place between 9 a.m. and 11:15 p.m. on December 18, 2021, until 30
minutes prior to the start of the fireworks display, the safety zone
will encompass the navigable waters around and under the fireworks
vessel, from surface to bottom, within a circle formed by connection of
all points 100 feet out from the fireworks vessel. The fireworks
display is scheduled to start at 11:59 p.m. December 18, 2021, and end
at approximately 12:15 a.m. on December 19, 2021, 1,000 feet from
Rincon Point in San Francisco, CA.
    The fireworks vessel will remain at Pier 50 until the start of its
transit to the display location. Movement of the vessel from Pier 50 to
the display location is scheduled to take place from 10 p.m. to 11:15
p.m. on December 18, 2021, where it will remain until the conclusion of
the fireworks display.
    At 11:29 p.m. on December 18, 2021, 30 minutes prior to the
commencement of the 15-minute fireworks display, the safety zone will
increase in size and encompass the navigable waters around and under
the fireworks vessel, from surface to bottom, within a circle formed by
all connecting points 700 feet from the circle center at approximate
position 37 degrees 47'37.47'' N, 122 degrees 23' 14.45'' W (NAD 83),
or as announced via Broadcast Notice to Mariners. The safety zone will
terminate at 12:45 a.m. on December 19, 2021.
    This regulation is necessary to keep persons and vessels away from
the immediate vicinity of the fireworks loading, staging, transit, and
display site. Except for persons or vessels authorized by the COTP or
the COTP's designated representative, no person or vessel may enter or
remain in the restricted area. A ``designated representative'' means a
Coast Guard Patrol Commander, including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel, or a Federal,
State, or local officer designated by or assisting the Captain of the
Port San Francisco (COTP) in the enforcement of the safety zone. This
regulation is necessary to ensure the safety of participants,
spectators, and transiting vessels.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the limited
duration and narrowly tailored geographic area of the safety zone.
Although this rule restricts access to the waters encompassed by the
safety zone, the effect of this rule will not be significant because
the local waterways users will be notified to ensure the safety zone
will result in minimum impact. The vessels desiring to transit through
or around the temporary safety zone may do so upon express permission
from the COTP or the COTP's designated representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's

responsiveness to small business. If you wish to comment on actions by
employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The
Coast Guard will not retaliate against small entities that question or
complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
temporary safety zone in the navigable waters around the loading,
staging, transit, and display of fireworks near Pier 50 and 1,000 ft
off Rincon Bay in San Francisco Bay. It is categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1. 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T11-074 to read as follows:

Sec.  165.T11-074   Safety Zone; Steak Restaurant Fireworks, San
Francisco Bay, San Francisco, CA.

    (a) Location. The following area is a safety zone: All navigable
waters of San Francisco Bay, from surface to bottom, within a circle
formed by connecting all points 100 feet out from the fireworks vessel
during loading and staging at Pier 50 in San Francisco, as well as
transit and arrival 1,000 feet off of Rincon Point, San Francisco, CA.
Between 11:29 p.m. December 18, 2021, and 12:45 a.m. on December 19,
2021, the safety zone will expand to all navigable waters, from surface
to bottom, within a circle formed by connection all points 700 feet out
from the fireworks vessel in approximate position 37 degrees 47'37.47''
N, 122 degrees 23' 14.45'' W (NAD 83) or as announced via Broadcast
Notice to Mariners.
    (b) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel, or a Federal, State, or Local officer designated by or
assisting the Captain of the Port San Francisco (COTP) in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or the COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's designated representative to
obtain permission to do so. Vessel operators given permission to enter
or operate in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative. Persons and vessels may request permission to enter the
safety zone on VHF-23A or through the 24-hour Command Center at
telephone<PHONE_NUMBER>.
    (d) Enforcement period. This section will be enforced from 9 a.m.
on December 18, 2021, until 12:45 a.m. on December 19, 2021.
    (e) Information broadcasts. The COTP or the COTP's designated
representative will notify the maritime community of periods during
which this zone will be enforced, in accordance with 33 CFR 165.7.

    Dated: November 10, 2021.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2021-25142 Filed 11-17-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Rules and Regulations]
[Pages 57894-57898]
[FR Doc No: 2023-18180]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0502; FRL-11272-01-OCSPP]

Trifluralin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
trifluralin in or on tea, dried and tea, instant. Gowan Company
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective August 24, 2023. Objections and
requests for hearings must be received on or before October 23, 2023,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0502, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and OPP Docket is<PHONE_NUMBER>. For the latest status
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0502 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 23, 2023. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0502, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 20, 2022 (87 FR 43231) (FRL-9410-
03-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8999) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition
requested that 40 CFR 180.207 be amended by establishing a tolerance
for residues of the herbicide trifluralin in or on tea at 0.05 parts
per million (ppm). That document referenced a summary of the petition
prepared by Gowan Company, which is available in the docket at https://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing tolerances for tea, dried and tea, instant. For
details, see Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for trifluralin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with trifluralin follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
    EPA has previously published tolerance rulemakings for trifluralin
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to trifluralin and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from these
rulemakings as described further in this rulemaking, as they remain
unchanged.
    Toxicological profile. For a discussion of the toxicological
profile of trifluralin, see Unit III.A. of the trifluralin tolerance
rulemaking published in the Federal Register of February 15, 2019 (84
FR 4345) (FRL-9983-89).
    Toxicological points of departure/levels of concern. A summary of
the toxicological endpoints for trifluralin used for human health risk
assessment is discussed in Unit III.B. of the trifluralin tolerance
rulemaking published in the Federal Register of July 31, 2013 (78 FR
46267) (FRL-9393-5). EPA notes that the unit of measurement for the no-
observed-adverse-effect level (NOAEL) in the inhalation short-term (1
to 30 days) exposure/scenario should be mg/m\3\, not mg/kg/day as
presented (i.e., the inhalation study NOAEL = 300 mg/m\3\). The unit of
measurement for the lowest-observed-adverse-effect level (LOAEL) is

correct as presented (i.e., LOAEL = 1000 mg/m\3\).
    Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the requested tolerance
for residues of trifluralin on tea and were conducted with the Dietary
Exposure Evaluation Model with the Food Commodity Intake Database
(DEEM-FCID, ver. 4.02), which incorporates food consumption data from
the United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA;
2005-2010). The unrefined acute dietary exposure and risk assessment
assumed 100 percent crop treated (PCT) for all commodities. The
partially refined chronic and cancer dietary exposure and risk
assessments incorporated average PCT estimates. As to residue levels in
food, the chronic and cancer exposure assessments incorporated
tolerance-level residues for the majority of commodities, average
screening level usage analysis (SLUA) PCT estimates, EPA's default
processing factors, and monitoring data from the USDA's Pesticide Data
Program (PDP) for a subset of risk driving commodities that
significantly reduced the cancer dietary exposure estimates. Dietary
exposure estimates for the established uses and requested tolerance are
below EPA's level of concern for the general population and all
population subgroups.
    Anticipated residue and PCT information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require, pursuant to FFDCA section
408(f)(1), that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    For the chronic dietary assessment, the following PCT assumptions
were made: asparagus 15%; barley 1%; beans, green 25%; broccoli 10%;
cabbage 35%; canola 2.5%; cantaloupes 25%; carrots 15%; cauliflower 5%;
celery 2.5%; corn 1%; cotton 25%; cucumbers 5%; dry beans/peas 10%;
honeydews 30%; onions 1%; peaches 1%; peanuts 2.5%; peas, green 10%;
pecans 1%; peppers 20%; potatoes 2.5%; pumpkins 2.5%; sorghum 1%;
soybeans 2.5%; squash 2.5%; sugar beets 1%; sunflowers 5%; tomatoes
50%; and watermelons 15%. EPA assumed 100 PCT for the other commodities
including tea. In the acute analysis, the Agency made the conservative
assumption of 100 PCT.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use 1%
or 2.5% as the average PCT value, respectively. The maximum PCT figure
is the highest observed maximum value reported within the recent 10
years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%, except where
the maximum PCT is less than 2.5%, in which case, the Agency uses 2.5%
as the maximum PCT.
    The Agency believes that the three conditions discussed in this
section have been met. With respect to Condition a, PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations are taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimates do not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
trifluralin may be applied in a particular area.
    Drinking water and non-occupational exposures. Because there are no
registrations for use of trifluralin on tea in the United States
associated with the requested tolerance, the estimated drinking water
concentrations and residential exposure assessment have not changed.
For a detailed summary of the drinking water analysis and residential
exposure assessment for trifluralin used for the human health risk
assessment, see Unit III.B. and C. of the February 15, 2019,
trifluralin tolerance rulemaking.
    Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.''
    Based on a review of the toxicological database for trifluralin and
the other dinitroanilines (benfluralin, butralin, ethalfluralin,
fluazinam, flumetralin, oryzalin, pendimethalin, and prodiamine), the
Agency has determined that although trifluralin shares some chemical
and/or toxicological characteristics (e.g., chemical structure or
apical endpoint) with these other dinitroanilines, the toxicological
database does not support a testable hypothesis for a common mechanism
of action. No further data are required to determine that no common
mechanism of toxicity exists for trifluralin and the other
dinitroanilines and no further

cumulative evaluation is necessary for trifluralin. For additional
details, refer to the document titled ``Dinitroanilines: Screening
Analysis of Toxicological Profiles to Consider Whether a Candidate
Common Mechanism Group Can Be Established'' in docket ID number EPA-HQ-
OPP-2017-0420 at https://www.regulations.gov.
    Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.B. of the February 15, 2019, trifluralin tolerance rulemaking for a
discussion of the Agency's rationale for that determination.
    Aggregate risks and Determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population-adjusted dose (aPAD)
and chronic population-adjusted dose (cPAD). Short-, intermediate-, and
chronic-term aggregate risks are evaluated by comparing the estimated
total food, water, and residential exposure to the appropriate points
of departures to ensure that an adequate margin of exposure (MOE)
exists.
    Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the aPAD; they are <1% of the aPAD
for females 13 to 49 years old, the only population group of concern.
Chronic dietary (food and drinking water) risks are below the Agency's
level of concern of 100% of the cPAD; they are 5.6% of the cPAD for all
infants <1 year old, the population group receiving the greatest
exposure. EPA's short-term aggregate exposure to trifluralin is based
on residential and dietary routes of exposure. The short-term aggregate
MOEs are 24,000 for adults and 15,000 for children 1 to less than 2
years old and are not of concern (i.e., the MOEs are > the LOC of 100).
Trifluralin is not registered for any use patterns that would result in
intermediate-term residential exposure, so intermediate-term aggregate
risk is the same as the chronic dietary risk and is not of concern.
    A cancer aggregate assessment was conducted for trifluralin since
it is classified as a ``Group C, Possible Human Carcinogen'' with a
Q1* of 2.96 x 10-3 (mg/kg/day)-1 based
upon male rat thyroid follicular cell combined adenoma, papillary
adenoma, cystadenoma, and carcinoma tumor rate in human equivalents.
The cancer aggregate risk assessment combines food and drinking water
exposures with the residential dermal and inhalation exposure from
post-application exposure from treated gardens. The resulting aggregate
cancer risk estimate is 1.5 x 10-6.
    EPA generally considers cancer risks (expressed as the probability
of an increased cancer case) in the range of 1 in 1 million (or 1 x 10
-6) or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the logarithmic scale; for
example, risks falling between 3 x 10 -7 and 3 x 10
-6 are expressed as risks in the range of 10 -6.
Considering the precision with which cancer hazard can be estimated,
the conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark level of concern of the range of 10
-6 until the calculated risk exceeds approximately 3 x 10
-6. This is particularly the case where some conservatism is
maintained in the exposure assessment. EPA has concluded the cancer
risk for all existing trifluralin uses and the uses associated with the
tolerances established in this action fall within the range of 1 x 10
-6 and are thus not of concern.
    Therefore, based on the risk assessments and information described
above, EPA concludes that there is a reasonable certainty that no harm
will result to the general population, or to infants and children, from
aggregate exposure to trifluralin residues. More detailed information
on this action can be found in the document titled ``Trifluralin. Human
Health Risk Assessment for a Section 3 Tolerance without U.S.
Registration on Imported Tea'' in docket ID EPA-HQ-OPP-2022-0502.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods, Methods GRM 96.12 and GRM 96.13 for
plant commodities, are available for trifluralin and utilize gas
chromatography (GC) with electron capture detection (ECD). The reported
limit of quantitation (LOQ) is 0.01 ppm.
    Trifluralin was evaluated using the Food and Drug Administration
(FDA) multiresidue method, which is also suitable for enforcement in
determining residues of trifluralin in plant commodities.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex has not established MRLs for trifluralin
on tea commodities.

C. Revisions to Petitioned-For Tolerance

    The petition requested a tolerance for residues of trifluralin in
or on tea at 0.05 ppm. Because residue data was provided for a
processed tea commodity rather than the raw agricultural commodity
(i.e., tea, plucked leaves), EPA is establishing tolerances at 0.05 ppm
on all of the processed tea commodities (i.e., tea, dried and tea,
instant).

V. Conclusion

    Therefore, tolerances are established for residues of trifluralin,
2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)benzenamine, in or on tea,
dried and tea, instant at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.

    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 14, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.207, amend paragraph (a) by designating the table as
table 1 and adding in alphabetical order in newly designated table 1 to
paragraph (a) the entries ``Tea, dried \1\'' and ``Tea, instant \1\''
and footnote 1 following the table to read as follows:

Sec.  180.207  Trifluralin; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Tea, dried \1\..............................................        0.05
Tea, instant \1\............................................        0.05

                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of August 24, 2023.

* * * * *
[FR Doc. 2023-18180 Filed 8-23-23; 8:45 am]
BILLING CODE 6560-50-P