[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Notices]
[Pages 67698-67699]
[FR Doc No: 2022-24434]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-E-0381]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TISSUEBLUE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for TISSUEBLUE and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by January 9, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 8, 2023. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 9, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2021-E-0381 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TISSUEBLUE.'' 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, 240-
402-7500.
     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 Sec.  10.20 (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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical

investigations of the drug product becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product TISSUEBLUE
(Brilliant blue G Ophthalmic Solution). TISSUEBLUE is a disclosing
agent indicated to selectively stain the internal limiting membrane.
Subsequent to this approval, the USPTO received a patent term
restoration application for TISSUEBLUE (U.S. Patent No. 7,731,941) from
Kyushu University, National University Corporation, and the USPTO
requested FDA's assistance in determining the patent's eligibility for
patent term restoration. In a letter dated June 8, 2021, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the approval of TISSUEBLUE represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TISSUEBLUE is 4,631 days. Of this time, 4,395 days occurred during the
testing phase of the regulatory review period, while 236 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
April 18, 2007. The applicant claims March 7, 2013, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was April 18, 2007,
which was 30 days after FDA receipt of an earlier IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: April 29,
2019. The applicant claims April 26, 2019, as the date the new drug
application (NDA) for TISSUEBLUE (NDA 209569) was initially submitted.
However, FDA records indicate that NDA 209569 was initially submitted
on April 29, 2019.
    3. The date the application was approved: December 20, 2019. FDA
has verified the applicant's claim that NDA 209569 was approved on
December 20, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,375 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24434 Filed 11-8-22; 8:45 am]
BILLING CODE 4164-01-P


1 of 5 MEMORANDUM SUBJECT: Product Chemistry Science Chapter for Dodecylbenzene Sulfonic Acid, C10 C16 Derivatives and Sodium Salt To: Heather Garvie, CRM for Dodecylbenzene Sulfonic Acid RED Regulatory Management Branch II Antimicrobials Division ( 7510C)

From: A. Najm Shamim, PhD, Chemist Regulatory Management Branch II Antimicorbials Division II Thru: Deborah Smegal, Risk Assessor for Dodecylbenzenesulfonic Acid RED Health Effects Division And Mark Harman, Chief Regulatory Management Branch II Antimicrobials Division ( 7510C)

DP Barcode: 323976 REG#: 4006 26242 2 of 5 A PRODUCT CHEMISTRY SCIENCE CHAPTER ON DODECYLBENZENE SULFONIC ACID FOR THE REREGISTRATION ELIGIBILITY DECISION Chemical Overview:

Dodecylbenzene Sulfonic Acid is used as a disinfectant Chemical Identification Chemical Name: Dodecylbenzene Sulfonic Acid, C10   C16 Derivatives Chemical Family: Surfactants CAS#: 68584 22 5 Molecular Formula: C16H26O3S Physical/ Chemical Properties Molecular Wt.: 298.44 Log KOW: 3.80 MP: 167.7 O C BP: 437 o C Solubility in water: 400 g/ L ( 25 O C) a Vapor Pressure: 5.1 x 10 10 mm Hg ( 25o C) Henry Law Constant: 2.8 x 10 11 atm m3/ mol Half Life in Air: 0.79 days = 9.48 hours ( measured against OH. Radical reaction)

a: source B. PRODUCT CHEMISTRY SCIENCE CHAPTER ON DODECYLBENZENE SULFONIC ACID, DODECYL: SODIUM SALT Chemical Overview Dodecylbenzenesulfonic Acid, Sodium Salt is used as a disinfectant Chemical Identification Chemical Name: Dodecyl Benzenesulfonic Acid, Sodium Salt. Chemical Family: Surfactants CAS#: 25155 30 0 Molecular Formula: C18H29O3S Na Physical/ Chemical Properties 3 of 5 Molecular Wt: 348.48 Log KOW: 1.96 MP: 287.6 o C BP: 660 o C Vapor Pressure: 6.02 x 10 15 mm Hg Water Solubility: Highly Water soluble Henry Law Constant: 6.02 x 10 17 atm. m3/ mol Half Life in Air: 0.660 days = 7.9 hours ( measured against OH radical reaction) Storage Stability: Stable Stability to Sunlight: 80% photodegradate at 223 nm within 10 hours. 4 of 5 C. PRODUCT CHEMISTRY SCIENCE CHPATER ON DODECYLBENZENESULFONIC ACID Chemical Overview DodecylBenzeneSulfonic Acid is used as a disinfectant Chemical Identification Chemical Name: Dodecylbenzenesulfonic Acid Chemical Family: Surfactants CAS#: 27176 87 0 Molecular Formula: C18H30O3S Physical/ Chemical Properties Molecular Wt.: 326.50 Log KOW: 4.78 MP: 178 o C BP: 460o C Vapor Pressure: 7.9 x 10 11 mm Hg Water Solubility: 0.7 mg/ L Henry Law Constant: 4.8 x 10 11 atm m3/ mol Half Life in Air: 0.654 days = 7.85 Hours ( Measured against OH radical reaction) 5 of 5 BIBLIOGRAPHY CITATIONS MRID#

4365640 01 and 02 1. Product Chemistry Data in support of Registration of Sodium Dodecylbenzenesulfonic Acid and Dodecylbenzenesulfonic Acid by John Todhunter, and Kelly White, 1995: SRS International Corp. Lab ID# DD13SA JV/ g63.13 433778 01 2. Physical/ Chemical Properties Data on DDBSA and its Salts by John Todhunter, 1995. SRS International Corp., Study ID#: DDBS/ 63 13/ Supplemental 3. US EPA: EPI Suite, A Modeling Program For Chemical and Fate Properties, Version 3.1, 2003 4. ChemIDplus: http:// chem. sis. nlm. nih. gov/ chemidplus/ jsp/ ChemFull


[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Page 36604]
[FR Doc No: 2018-16148]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0549]

Prescription Polyethylene Glycol 3350; Denial of a Hearing and
Order Withdrawing Approval of Abbreviated New Drug Applications;
Temporary Stay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice
that the effective date of an April 2, 2018, order denying requests for
a hearing and withdrawing approval of abbreviated new drug applications
(ANDAs) for certain prescription laxatives with the active ingredient
polyethylene glycol 3350 (PEG 3350) is stayed until November 2, 2018.

DATES: FDA is staying the effective date of the April 2, 2018, order
withdrawing approval of ANDAs for certain prescription laxatives with
the active ingredient PEG 3350 until November 2, 2018.

ADDRESSES: For access to the docket, 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, between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Julie Finegan, Office of Scientific
Integrity, Office of the Chief Scientist, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 2, 2018 (83
FR 13994), FDA denied requests for hearing and issued an order
withdrawing approval of ANDAs for certain prescription laxatives with
the active ingredient PEG 3350. The effective date of the order was May
2, 2018. Between April 6, 2018, and April 13, 2018, FDA received
petitions for stay under Sec.  10.35 (21 CFR 10.35) on behalf of four
ANDA holders: Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc.
(hereafter Breckenridge/Nexgen) who submitted a joint petition; Lannett
Company, Inc.; and Paddock Laboratories, Inc. (collectively the ANDA
holders). Breckenridge/Nexgen, Lannett, and Paddock petitioned FDA to
stay its order withdrawing the approval of their ANDAs for prescription
PEG 3350 and argued that all four criteria for a mandatory stay under
Sec.  10.35(e) were met. Bayer Healthcare, LLC, (Bayer) which holds an
approved New Drug Application for MiraLAX, an over-the-counter laxative
containing PEG 3350, responded. Bayer argued that the petitioners
failed to meet any of the factors in Sec.  10.35(e).\1\
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    \1\ On April 30, 2018, Bayer filed a submission titled ``Request
for Clarification of FDA Granting of a Petition for Stay of
Action.'' Bayer requested that FDA clarify that the stay allowed new
manufacturing only until May 2, 2018, with shipment of product
permitted until November 2, 2018. Breckenridge/Nexgen responded to
Bayer's request for clarification and argued that Bayer's submission
should have been a petition for reconsideration and that it failed
to meet the standards required for reconsideration. Regardless of
whether Bayer's submission should have been a petition for
reconsideration, FDA's letter granting the stay provides that the
order is stayed until November 2, 2018, without the limitations
Bayer now requests.
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    By a letter dated April 16, 2018, the Acting Chief Scientist,
pursuant to authority delegated by the Commissioner, concluded that the
ANDA holders had not met the criteria for a mandatory stay under Sec.
10.35(e). The Acting Chief Scientist granted a temporary, discretionary
stay of the effective date of the order until November 2, 2018. As
described in the April 16, 2018, letter, based upon information
submitted by the ANDA holders and not disputed by Bayer, it would
likely be difficult for manufacturers of OTC PEG 3350 products to
compensate for the removal of prescription PEG 3350 products within 30
days. The letter explained that public health interests would not be
served should the 30-day effective date negatively impact the
availability of PEG 3350, particularly given that the basis of the
withdrawal of the ANDA products is not an issue of safety or efficacy.
The April 16, 2018, letter additionally noted that FDA has provided
lengthier time frames to phase out manufacturing and distribution of
affected products in other cases. While the Acting Chief Scientist
rejected the petitioners' arguments that financial hardship and harm to
reputation resulting from the withdrawal order rise to the level of
irreparable injury necessary for a mandatory stay under Sec.  10.35(e),
she agreed that there may some validity to the petitioner's concerns of
harm to their business interests as a result of the 30-day effective
date. The Acting Chief Scientist concluded that it is in the public
interest and in the interest of justice to stay the effective date of
the April 2, 2018, order until November 2, 2018.
    The parties' submissions and the Agency's orders are available at
https://www.regulations.gov and with the Dockets Management Staff (see
ADDRESSES).
    FDA is providing notice of the decision to grant a temporary stay
in accordance with Sec.  10.35(f).

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16148 Filed 7-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Proposed Rules]
[Pages 17607-17610]
[FR Doc No: 2011-6884]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0014; FRL-8867-2]

40 CFR Parts 156 and 170

Receipt of Request To Require Pesticide Products To Be Labeled in
English and Spanish

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of receipt of petition and request for comment.

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SUMMARY: This notice is to advise the public that the Migrant
Clinicians Network and other farm worker interest groups have
petitioned EPA to require all pesticide labels be available in both
English and Spanish. The Agency is taking public comment on the request
before responding to the petitioners.

DATES: Comments must be received on or before June 28, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0014, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0014. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Katie Weyrauch, Pesticide Re-
evaluation Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including human health, farm
worker, agricultural and environmental advocacy groups; the chemical
industry; pesticide users; and members of the public interested in the
sale, distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain fully why you agree or disagree; suggest alternatives
and

substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used, as well as the sources of those data.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. Summary of Petition

    In December 2009, the Agency received a letter from the Migrant
Clinicians Network (MCN), Farmworker Justice, and other farm worker
advocacy organizations requesting that EPA require labeling in Spanish,
in addition to the current requirement for English, on pesticide
products. While this letter focused on farm workers, people in several
other types of occupations apply pesticides or are exposed to
pesticides routinely, such as lawn and landscape maintenance workers,
structural pest control technicians, and commercial and residential
cleaning staff. People in these occupations and Spanish-speaking
consumers who use pesticide products at home may also be affected by
the availability of pesticide labels in Spanish. The Agency is
therefore seeking comment on this request as it applies to all of these
stakeholders.
    Executive Order (EO) 13166 of August 11, 2000, orders federal
agencies to improve access to federally conducted and federally
assisted programs and activities for persons who, as a result of
national origin, are limited in their English proficiency (LEP). The EO
further states that, ``(in) carrying out this order, agencies shall
ensure that stakeholders such as LEP persons and their representative
organizations, recipients, and other appropriate individuals or
entities, have an adequate opportunity to provide input. This input
from stakeholders will assist the agencies in developing an approach to
ensuring meaningful access by LEP persons that is practical and
effective, fiscally responsible, responsible to the particular
circumstances of each agency, and can be readily implemented.'' EPA's
goals for this Federal Register notice are consistent with EO 13166 in
that EPA is seeking public comment on the request for EPA to require
that pesticide labels be available in English and Spanish. Input from
the public will inform EPA's decision whether a requirement for English
and Spanish on pesticide products ensures meaningful access by LEP
persons that meets the objectives of this EO.
    EPA is treating this letter as a petition and is taking public
comment on this request. The letter from the petitioners and EPA's
response letter are located in docket EPA-HQ-OPP-2011-0014 associated
with this Federal Register notice located at http://www.regulations.gov. The Agency would like the public to comment on the
request for requiring labeling in Spanish, including information such
as potential benefits, possible disadvantages, the potential scope of a
bilingual labeling requirement, and costs. Specific questions the
Agency would like the public to consider and respond to on this topic
are included below in Section II.G.

B. Current EPA Provisions Relating to Pesticide Labeling in Spanish or
Other Languages

    Several current EPA regulations and guidance documents contain
provisions relevant to the issues raised by the petition. As stated in
40 CFR 156.10(a)(3), ``All required label or labeling text shall appear
in the English language. However, the Agency may require or the
applicant may propose additional text in other languages as is
considered necessary to protect the public. When additional text in
another language is necessary, all labeling requirements will be
applied equally to both the English and other-language versions of the
labeling.''
    Currently, the Agency allows a pesticide registrant to add labeling
in languages other than English. The Office of Pesticide Program's
first statement of policy regarding bilingual labeling occurred in
Pesticide Registration (PR) Notice 88-06. PR 88-06 was revised by PR
95-2 and PR 98-10. All PR Notices can be found at http://www.epa.gov/PR_Notices/. PR 98-10 states, ``A registrant may provide bilingual
labeling on any product without notification. The foreign text must be
a true and accurate translation of the English text. Note: Both
language versions of the labeling must appear on a container. Foreign
text may be used on all or part of the labeling.''
    For pesticide products subject to the agricultural Worker
Protection Standard (WPS) (40 CFR part 170), EPA requires that certain
portions of the pesticide label contain words or phrases in Spanish.
EPA regulations at 40 CFR 156.206(e) state:

    Spanish warning statements. If the product is classified as
toxicity category I or toxicity category II according to the
criteria in 156.62, the signal word shall appear in Spanish in
addition to English followed by the statement, ``Si usted no
entiende la etiqueta, busque a alguien para que se la explique a
usted en detalle. (If you do not understand the label, find someone
to explain it to you in detail.)'' The Spanish signal word
``PELIGRO'' shall be used for products in toxicity category I, and
the Spanish signal word ``AVISO'' shall be used for products in
toxicity category II. These statements shall appear on the label
close to the English signal word.

    Agricultural handlers are the agricultural employees responsible
for mixing, loading, and applying pesticides. EPA requires that before
the handler performs a handling activity, the handler employer ensures
that the handler has either read the product labeling or has been
informed, in a manner the handler can understand, of all labeling
requirements related to safe use of the pesticide. EPA regulations at
40 CFR 170.232(a)(1) state:

    The handler employer shall assure that before the handler
performs any handling activity, the handler either has read the
product labeling or has been informed in a manner the handler can
understand of all labeling requirements related to safe use of the
pesticide, such as signal words, human hazard precautions, personal
protective equipment requirements, first aid instructions,
environmental precautions, and any additional precautions pertaining
to the handling activity to be performed.

    These requirements were established to better protect agricultural
pesticide handlers covered by the WPS as they mix, load, and apply
pesticides.

C. Languages Spoken in the United States and by Agricultural Handlers

    The Agency recognizes that residents of the United States speak
many languages, with a significant proportion of the population being
Spanish-speakers. A recently published U.S. Census Bureau American
Community Survey report, Language Use in the United States: 2007, found
that of the 281 million people in the United States aged 5 and over,
55.4 million people (20% of this population) spoke a language other
than English at home. Of these 55.4 million people, 62% (34.5 million)
spoke Spanish. For comparison, the second most frequently spoken
language was Chinese, with 2.5 million speakers, or 4.5% of people who
speak a language other than English at home. Of the 34.5 million people
who speak Spanish at home, 52.6% reported that they speak English
``very well,''

18.3% reported that they speak English ``well,'' 18.4% reported that
they speak English ``not well,'' and 10.7% reported that they speak
English ``not at all'' (Shin, Hyon B. and Robert A. Kominski. 2010.
Language Use in the United States: 2007, American Community Survey
Reports, ACS-12. U.S. Census Bureau, Washington, DC).
    Data from the Department of Labor's National Agricultural Workers
Survey (NAWS) show that many agricultural handlers (agricultural
employees responsible for mixing, loading, and applying pesticides)
have limited ability to read English. Over a three-year period, NAWS
surveyors conducted nearly 6000 interviews across thirty-one states.
Sixteen percent of the respondents identified themselves as
``handlers,'' that is, crop workers who had mixed, loaded, or applied
pesticides in the previous twelve months. Fifty-three percent of
handlers report their dominant language as Spanish, and 46% of handlers
said that their dominant language is English. Of the handlers whose
dominant language was Spanish, 13% reported that they read English
``well,'' 11% reported that they read English ``somewhat,'' 33%
reported that they read English ``a little,'' and 43% reported that
they read English ``not at all.'' In contrast, 65% of handlers whose
dominant language was Spanish reported that they read Spanish ``well.''
(National Agricultural Workers Survey, public data for 1989-2009:
http://www.doleta.gov/agworker/naws.cfm). There may be bias in these
data, as it has been noted that self-reported estimates of reading
skills may be biased towards the high-end, as people often overstate
their abilities in interviews (Donaldson, Stewart I. Understanding
Self-Report Bias in Organizational Behavior Research, Journal of
Business and Psychology, Vol. 17, No. 2, Winter 2002).
    The National Agricultural Workers Survey reports that the average
highest grade of education for all handlers (both Spanish and English-
speaking) was tenth grade. A 1994 study, published in the Journal of
the American Optometric Association, found that an 11th grade cognitive
reading level is required to understand a pesticide label. This
suggests that although handlers may be relatively skilled Spanish
readers, they may not be able to fully comprehend the label material.

D. Current EPA Initiatives Focused on Environmental Justice as It
Pertains to Spanish Speakers in the United States

1. Consumer Protection
    People apply pesticides in and around their homes to control a
variety of pests. One type of product used is total release foggers,
also known as ``bug bombs.'' These pesticide products contain aerosol
propellants and release their contents as a concentrated spray to
fumigate an area. To ensure adequate protection of human health and the
environment with respect to fogger use, EPA is working with
stakeholders to make improvements to these product labels, including
the use of plain language, the addition of pictograms and door hang-
tags, and the provision that certain label statements appear in Spanish
as well as English.
2. Agricultural Worker Protection
    Agricultural workers can be exposed to pesticides through their
work activities. These include farm workers, who cultivate and harvest
crops treated with pesticides, and agricultural pesticide handlers, who
mix, load and apply pesticides to protect crops. The WPS provides
protections for both agricultural workers and handlers. For farm
workers, who are exposed to pesticides through contact with treated
crops but do not handle pesticides directly, the WPS establishes rules
that agricultural employers must follow to minimize risks from
pesticide exposure, such as those discussed in Section II B.

E. Activities of Other Regulatory Entities

    The state of California reviews all marketed labels as they appear
on the container, whereas EPA reviews a text-only version of the label
that contains all approved information but not necessarily in the
format in which it will be presented in the marketplace. Some marketed
labels include full Spanish translations for home garden products or
antimicrobial products, and all agricultural pesticides under the
purview of the WPS include the required WPS Spanish statements (40 CFR
156.206(e)).
    In Puerto Rico, restricted use pesticides (RUPs) and pesticides
registered to meet Special Local Needs (SLNs) must include labeling in
Spanish (Puerto Rico Pesticide Act Part II, Section 4(D)(6)(a) and Part
II Section 4(G)(3)). The pesticide dealer is required to provide the
supplemental Spanish labeling to the buyer. The following portions of
the label are required to be translated into Spanish:
    1. The precautionary statement, ``Keep out of reach of children;''
    2. Precautionary statements to prevent injury to humans, vertebrate
animals, useful vegetation, and useful invertebrate animals, among
others, and those statements required by the WPS, Endangered Species
Act, and other statutes;
    3. Directions for use; and
    4. Pesticide use classification.
    In Canada, all pesticide products produced or sold domestically
require labels in both English and French.

F. Potential Scope of This Initiative

    In considering this petition for bilingual labeling, the Agency is
assessing the potential scope of such a requirement. EPA is considering
whether the proposed bilingual labeling would improve safety and what
potential effects it might have on industry and the enforcement
community. Labels in English and Spanish could be required for all, or
a subset of, pesticide products. Below are some potential options for
bilingual labeling.
    1. Certain types of pesticide products: Bilingual labeling could be
required for agricultural pesticide products, consumer pesticide
products, fumigant products, or some other classification of product.
    2. Certain use sites: If it is determined that labeling in Spanish
would be beneficial for a specific use site or commodity, products used
on that use site could be required to have bilingual labeling.
    3. Products containing particular active ingredients: Another
option could be to require the products with certain active ingredients
to have labeling in Spanish; therefore, all products containing
chemical X could require bilingual labels.
    4. Products of particular acute toxicity categories: Products with
more toxic acute toxicity categories (Categories I or II) could require
bilingual labeling.
    5. Either entire labels or portions of pesticide product labels
could be required in English and Spanish. For example, the Directions
for Use section of the product labeling could be required to be
bilingual, or labeling statements dealing with worker protection, such
as the personal protective equipment labeling, could be required to be
in both Spanish and English. Other portions of the label that could be
required to be in both languages include the general labeling
requirements, the ingredient statement, precautionary labeling,
environmental hazards, physical/chemical hazards, labeling claims, and
company name and address, among others.

    The Agency acknowledges that there could be disadvantages or
unintended consequences to a bilingual label recommendation or
requirement, and invites public comment on the petition. The State
FIFRA Issues Research and Evaluation Group (SFIREG) Pesticide
Operations and Management (POM) committee submitted a letter to EPA in
December 2010 outlining several concerns the committee has regarding
the inclusion of labeling in Spanish on pesticide products. The
December 2010 SFIREG POM letter is available in the docket. EPA is
dedicated to working with SFIREG and all stakeholders to obtain
information that will inform a decision on the petition for Spanish
labeling of pesticide products.

G. Questions for Public Comment

    EPA invites all members of the public to post comments on this
Notice and the petition it addresses. Specifically, EPA would like the
commenter to address the following questions. EPA also invites all
interested parties to comment on any other aspects of this petition's
proposal that are not directly addressed by a question below.
    For the General Public:
    1. Language characteristics vary by culture, region, and other
factors. How could EPA ensure that Spanish text on pesticide product
labels would be understood by all potential Spanish-speaking users?
    2. Labeling in Spanish could potentially be required for all
pesticide products, for a subset of pesticide products, or for a
portion of the product label as described in section II.F. If the
Agency concluded that translation of a portion or portions of the label
were appropriate, which portions of the pesticide label would it be
most beneficial to have in Spanish, and why? If the Agency were to
limit the requirement for translation to only certain products, which
products should be considered, and why? (Note: Please see the sample
label in the docket to consider the different sections of a pesticide
label.)
    3. Are there languages other than Spanish and English that EPA
should consider for inclusion on pesticide labels? Which languages?
Please explain your reasoning for including a language other than
Spanish or English on pesticide labels, and cite documents that would
further bolster your suggestion.
    For People Exposed to Pesticides:
    Farm workers, lawn and landscape maintenance workers, structural
pest control technicians, commercial and residential cleaning staff,
residential users of pesticides, children, pregnant or nursing women,
older adults, others and advocacy groups:
    4. Please describe how having labels available in English and
Spanish could increase or decrease pesticide user safety.
    5. How do you currently obtain information in Spanish regarding a
pesticide product?
    6. Please describe how farm workers, their families, and others
exposed to pesticides could benefit from this proposal.
    7. Would this proposal affect your day-to-day work? If so, how?
    8. Which parts of pesticide labeling, if any, would be most
valuable to have translated into Spanish, and why? (Note: Please see
the sample label in the docket to consider the different sections of a
pesticide label.)
    9. Would having a Spanish translation of labeling be more important
for some types of products than for others? Please describe why this
would be so. And if so, how should EPA select products that would bear
bilingual labeling?
    10. What effect would the availability of bilingual labeling have
on users' understanding of label text?
    11. Would pictograms or other non-language methods of communication
be beneficial for communication of labeling requirements?
    For Industry:
    12. Do you currently sell or distribute any pesticides with Spanish
labeling (other than as required by 40 CFR 156.206)? If so, why have
you decided to do so and what effects has the use of Spanish labeling
had on the marketing or safety of using these products? Can you
quantify or give examples of any added costs or benefits that have
resulted from providing your products' labels in English and Spanish?
    13. What additional economic costs and/or benefits would you
anticipate from having your products' labels available in Spanish as
well as English? Costs might include translation, printing, or
packaging. Benefits might include improved market penetration or
improved customer good will. Besides any increased monetary costs,
would there be other obstacles to printing bilingual labeling on your
pesticide products?
    14. How could electronic media be used to facilitate distribution
of bilingual or multilingual labeling?
    15. Apart from bilingual labeling, what past and current efforts
have you made to communicate with customers or potential pesticide
users who do not speak or read English fluently? What have you found to
be effective or ineffective?
    16. If you provide Spanish labeling, do you provide it on products
nation-wide or only in targeted regions? Why?
    17. How could EPA implement the petitioners' proposal or a version
of it efficiently and equitably?
    18. Please explain whether there are any portions of a product's
labeling that would not need to appear in both languages.
    For the State Pesticide Regulatory Community and the Enforcement
Community:
    19. Are there state or local laws that conflict with the proposed
bilingual labeling?
    20. What potential benefits or obstacles would a federal
recommendation or requirement for bilingual labeling pose to the state
regulation of pesticide products?
    21. What potential benefits would bilingual labeling provide and
what potential costs or obstacles would bilingual labeling pose to
enforcement activities?
    22. Do you know of any inspection or enforcement actions involving
bilingually labeled products where the existence of two languages on
the label has compromised bringing the action to closure?
    23. Do you know of any enforcement actions that have been taken
because of, or compromised by, inaccuracies in labeling translation?
    24. Do you know of misuse incidents, poisonings, or other mishaps
for which the lack of availability of bilingual labels may have been a
contributing factor?
    25. Would a requirement that pesticides bear bilingual labeling
increase or decrease the ability of people to use pesticides safely and
effectively? Why?
    26. If pesticide products are required to carry labeling in
Spanish, what effects, if any, would you anticipate on state pesticide
applicator certification programs?

List of Subjects

    Environmental justice, environmental protection.

    Dated: March 17, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2011-6884 Filed 3-29-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Rules and Regulations]
[Page 32636]
[FR Doc No: 2016-12252]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 93

[Docket No. FAA-2008-0221]

Change of Newark Liberty International Airport (EWR) Designation;
Notification of Availability of Final CATEX Declaration and Supporting
Material

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notification of availability.

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

SUMMARY: This action announces the placement in the docket of the final
documented categorical exclusion (the signed CATEX declaration and
final Attachment A: Environmental Review of Proposed Change of
Operating Authorization Requirement at Newark Liberty International
Airport) for the redesignation of Newark Liberty International Airport
(EWR) as a Level 2 schedule-facilitated airport.

DATES: May 24, 2016.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Susan Pfingstler, System Operations Services, Air
Traffic Organization, Federal Aviation Administration, 600 Independence
Avenue SW., Washington, DC 20591; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 6, 2016, the FAA published the
``Change of Newark Liberty International Airport (EWR) Designation''
document in order to redesignate Newark Liberty International Airport
as a Level 2 schedule-facilitated airport under the International Air
Transport Association Worldwide Slot Guidelines effective for the
winter 2016 scheduling season, which begins on October 30, 2016.\1\
---------------------------------------------------------------------------

    \1\ 81 FR 19861.
---------------------------------------------------------------------------

    On April 5, 2016, the FAA posted a copy of a draft of Env Rev
Attach A in the docket associated with the April 6, 2016 document. The
FAA has corrected this action by posting the final CATEX documents (the
signed CATEX declaration and final Attachment A: Environmental Review
of Proposed Change of Operating Authorization Requirement at Newark
Liberty International Airport) to the docket.

    Issued in Washington, DC, on May 18, 2016.
Lorelei Peter,
Assistant Chief Counsel for Regulations.
[FR Doc. 2016-12252 Filed 5-23-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Notices]
[Page 16159]
[DOCID:fr31mr10-109]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2010-0121]

Prince William Sound Regional Citizens' Advisory Council
(PWSRCAC) Charter Renewal

AGENCY: Coast Guard, DHS.

ACTION: Notice of recertification.

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SUMMARY: The purpose of this notice is to inform the public that the
Coast Guard has recertified the Prince William Sound Regional Citizens'
Advisory Council (PWSRCAC) as an alternative voluntary advisory group
for Prince William Sound, Alaska. This certification allows the PWSRCAC
to monitor the activities of terminal facilities and crude oil tankers
under the Prince William Sound Program established by statute.

DATES: This recertification is effective for the period from March 1,
2010 through February 28, 2011.

FOR FURTHER INFORMATION CONTACT: LCDR Ken Phillips, Seventeenth Coast
Guard District (dpi), by telephone at<PHONE_NUMBER>, or by mail at
P.O. Box 25517, Juneau, Alaska 99802.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    As part of the Oil Pollution Act of 1990, Congress passed the Oil
Terminal and Oil Tanker Environmental Oversight and Monitoring Act of
1990 (the Act), 33 U.S.C. 2732, to foster a long-term partnership among
industry, government, and local communities in overseeing compliance
with environmental concerns in the operation of crude oil terminals and
oil tankers.
    On October 18, 1991, the President delegated his authority under 33
U.S.C 2732(o) to the Secretary of Transportation in Executive Order
12777, section 8(g) (see 56 FR 54757; October 22, 1991) for purposes of
certifying advisory councils, or groups, subject to the Act. On March
3, 1992, the Secretary redelegated that authority to the Commandant of
the Coast Guard (see 57 FR 8582; March 11, 1992). The Commandant
redelegated that authority to the Chief, Office of Marine Safety,
Security and Environmental Protection (G-M) on March 19, 1992 (letter
5402).
    On July 7, 1993, the USCG published a policy statement, 58 FR
36504, to clarify the factors that shall be considered in making the
determination as to whether advisory councils, or groups, should be
certified in accordance with the Act.
    The Assistant Commandant for Marine Safety and Environmental
Protection (G-M), redelegated recertification authority for advisory
councils, or groups, to the Commander, Seventeenth Coast Guard District
on February 26, 1999 (letter 16450).
    On September 16, 2002, the Coast Guard published a policy
statement, 67 FR 58440, which changed the recertification procedures
such that applicants are required to provide the USCG with
comprehensive information every three years (triennially). For each of
the two years between the triennial application procedures, applicants
submit a letter requesting recertification that includes a description
of any substantive changes to the information provided at the previous
triennial recertification. Further, public comment is not solicited
prior to recertification during streamlined years, only during the
triennial comprehensive review.
    The Alyeska Pipeline Service Company pays the PWSRCAC $2.9 million
annually in the form of a long-term contract. In return for this
funding, the PWSRCAC must annually show that it ``fosters the goals and
purposes'' of OPA 90 and is ``broadly representative of the communities
and interests in the vicinity of the terminal facilities and Prince
William Sound.'' The PWSRCAC is an independent, nonprofit organization
founded in 1989. Though it receives Federal oversight like many
independent, non-profit organizations, it is not a Federal agency. The
PWSRCAC is a local organization that predates the passage of OPA 90.
The existence of the PWSRCAC was specifically recognized in OPA 90
where it is defined as an ``alternate voluntary advisory group.''
    Alyeska funds the PWSRCAC, and the Coast Guard makes sure the
PWSRCRC operates in a fashion that is broadly consistent with OPA 90.

Recertification

    By letter dated February 24, 2010, the Commander, Seventeenth Coast
Guard District, certified that the PWSRCAC qualifies as an alternative
voluntary advisory group under 33 U.S.C. 2732(o). This recertification
terminates on February 28, 2011.

    Dated: February 24, 2010.
C.C. Colvin,
Rear Admiral, U.S. Coast Guard Commander, Seventeenth Coast Guard
District.
[FR Doc. 2010-7157 Filed 3-30-10; 8:45 am]
BILLING CODE 9110-04-P


FILE NAME: company. wpt ( 7/ 1/ 2005) ( xml) Template Number P25 ATTENTION:

All commodity terms must comply with the Food and Feed Commodity Vocabulary database ( http:// www. epa. gov/ pesticides/ foodfeed/).

All text in blue font ( instructions for preparing the document), should be removed prior to sending the document to the Federal Register Staff. Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 1/ 1/ 2005)

EPA Registration Division contact: [ Janet Whitehurst, 703 305 6129]

INSTRUCTIONS: Please utilize this outline in preparing tolerance petition documents. In cases where the outline element does not apply please insert " NA Remove" and maintain the outline. The comment notes that appear on the left margin represent hidden typesetting codes designed to expedite the processing of the Federal Register document. Please do not remove or alter these comment notes or change the margins, font, or format in your document. Simply replace the instructions that appear in italics and brackets, i. e., "[ insert company name]," with the information specific to your action.

TEMPLATE:

Valent U. S. A. Company 5f7016 EPA has received a pesticide petition ( 5f7016]) from [ Valent U. S. A. Company], [ 1600 Riviera Ave., Walnut Creek, CA 94596 8025] proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.

Options ( pick one)

1. by establishing a tolerance for residues of [ fluopicolide] in or on the raw agricultural commodity [ Grape at 2 parts per million ( ppm), Raisin at 6 ppm, Vegetable, leafy, except brassica, group 4 at 20 ppm, Vegetable, fruiting, group 8 at 2 0.8 ppm, Vegetable, cucurbit, group 9 at 0.4 ppm, Potato at 0.02 ppm, Sweet potato, roots at 0.02 ppm, Wheat forage at 0.2 ppm, Wheat grain at 0.02 ppm, Wheat hay at 0.5 ppm, and Wheat straw at 0.5ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. [ The fate of fluopicolide in plants is clearly understood. Metabolism studies were conducted with grapes, potato, and lettuce. The metabolic profile of fluopicolide was similar in all three crops and demonstrated that fluopicolide is degraded by oxidation and hydrolysis. The primary residue found in all crops, and the only residue of concern, is the parent molecule fluopicolide. ]

2. Analytical method. [ A practical analytical method utilizing liquid chromatography and mass spectrometry detection is available and has been validated for detecting and measuring levels of fluopicolide in and on crops. The validated limit of quantitation is 0.01 ppm.]

3. Magnitude of residues. [ Residue data for the use of fluopicolide on the commodities listed within this notice has been submitted.]

B. Toxicological Profile 1. Acute toxicity. [ A battery of acute toxicity studies places technical fluopicolide in toxicity category IV. No evidence of sensitization was observed in guinea pigs. In an acute neurotoxicity study in rats, only statistically lower body temperature was observed 6 hours after dosing at the limit dose of 2000 mg/ kg. No other treatment related changes were noted in the study, and the NOAEL was considered to be 100 mg/ kg. ]

2. Genotoxicty. [ Fluopicolide has been evaluated for genotoxicity using a battery of tests, including bacterial reverse mutation tests, a mammalian cell gene mutation ( HPRT) assay, an in vivo mouse micronucleus assay, an in vitro chromosome aberration test, and an in vivo unscheduled 3 DNA synthesis test. The weight of evidence from all of these assays shows that fluopicolide is not genotoxic.]

3. Reproductive and developmental toxicity. [ i. In a developmental toxicity study in rats gavage dosed from gestation days 7 to 20 at levels of 0, 5, 60 or 700 mg/ kg/ day, evidence of maternal and fetal toxicity was observed at 700 mg/ kg/ day, the highest dose tested. The maternal and fetal NOAEL was 60 mg/ kg/ day based on statistically lower body weights in dams and fetuses, and skeletal findings in fetuses that included delayed ossification of some bones and slight increases in the incidence of various rib and thoracic vertebrae anomalies. ii. In a developmental toxicity study with rabbits, pregnant animals were given oral doses of 0, 5, 20 or 60 mg/ kg/ day on gestation days 6 to 28. At the high dose, 15 animals were sacrificed following spontaneous abortions and 3 animals were found dead. The few surviving animals in this group had live fetuses at cesarean sectioning but other than lower fetal weight and crown/ rump length, no treatment related findings were observed upon external, visceral and skeletal examinations of these fetuses. The NOAEL for maternal and fetal toxicity was 20 mg/ kg/ day. iii. In a 2 generation reproductive toxicity study, fluopicolide was administered to rats at dietary levels of 0, 100, 500, or 2000 ppm. The NOAEL was 500 ppm ( equivalent to 26 and 33 mg/ kg/ day for males and females, respectively) for developing offspring and for parental/ systemic toxicity. The LOAEL was 2000 ppm based on decreased body weight and organ weight changes in both F0 and F1 adults and F1 and F2 pups. The reproductive NOAEL was 2000 ppm. ]

4. Subchronic toxicity. [ Ninety day feeding studies were conducted in dogs, mice and rats. i. No evidence of toxicity was observed in dogs up to the limit dose of 1000 mg/ kg/ day. The NOAEL in dogs is 1000 mg/ kg/ day. ii. In 90 day feeding studies in both CD 1 and C57BL/ 6 mice, liver was the only target organ identified with hepatocellular hypertrophy seen at dietary levels of 320 ppm and higher. The NOAEL in C57BL/ 6 mice was 200 ppm ( equivalent to 37.8 and 52.8 mg/ kg/ day in males and females, respectively). iii. In a 90 day rat study with dietary levels of 100, 1400 and 20,000 ppm, the maximum tolerated dose ( MTD) was exceeded at 20,000 ppm based on body weight gain of 30 to 40% below control. The target organs identified in rats were the liver ( centrilobular hypertrophy) in both sexes and the kidneys in males ( accumulation of hyaline droplets, single cell death at the proximal tubule epithelium, slight foci of basophilic tubules and granular casts) at 1400 ppm and 20000 ppm. The NOAEL was 100 ppm, equivalent to 7.4 and 8.4 mg/ kg/ day, in males and females, respectively. iv. In a subchronic neurotoxicity study, rats were treated with 0, 200, 1400 or 10000 ppm in the diet for 13 weeks. The NOAEL for systemic toxicity is 1400 ppm ( 107 mg/ kg/ day in males and 125 mg/ kg/ day in females) based on findings in the liver and kidney. There were 4 no neurotoxicity findings. The NOAEL for neurotoxicity is 10,000 ppm ( 781 mg/ kg/ day in males and 866 mg/ kg/ day in females). iii. In a subchronic dermal toxicity study, male and female rats were treated with fluopicolide at dose levels of 0, 100, 250, 500 and 1000 mg/ kg/ day. There were no effects at any dose level. The NOAEL of the study is 1000 mg/ kg/ day.]

5. Chronic toxicity. [ i. Lower body weight gain at the limit dose of 1000 mg/ kg/ day was the only treatmentrelated effect noted in a 52 week dog study performed at 70, 300, and 1000 mg/ kg/ day by gavage. Thus, the NOAEL in dogs was established at 300 mg/ kg/ day. ii. Chronic toxicity/ carcinogenicity was assessed in rats at dietary levels of 50, 200, 750 and 2500 ppm. The NOAEL was 200 ppm ( 8.4 mg/ kg/ day in males and 10.8 mg/ kg/ day in females) based on microscopic changes in the liver and kidneys similar to those observed in the 90 day rat study. No evidence of carcinogencity was observed in rats up to 2500 ppm. iii. The oncogenic potential of fluopicolide was investigated in C57BL/ 6 mice at dietary levels of 0, 50, 400, or 3200 ppm. Significantly lower body weight gain was seen at 3200 ppm in conjunction with a slight decrease in food consumption. Increased liver weight and centrilobular hepatocellular hypertrophy were observed at 400 and 3200 ppm in both sexes. In addition at 3200 ppm, an increased incidence of hepatocellular adenomas was noted in both sexes, but the incidence of hepatocellular carcinomas was not affected. The NOAEL was 50 ppm ( equivalent to 7.9 and 11.5 mg/ kg/ day in males and females, respectively). Subsequent mechanistic work demonstrated a marked transient hepatocellular proliferation, which returned to control levels after 28 days of treatment. This was accompanied by a clear induction of total cytochrome P 450 and related enzymes. These results parallel findings with Phenobarbital, which has a well understood thresholdbased mechanism of rodent tumor formation commonly known to be of no relevance to humans. ]

6. Animal metabolism. [ The animal metabolism of fluopicolide is well understood. Fluopicolide is rapidly absorbed and excreted when administered to rats and the resulting tissue residues are very low. The metabolic pathway for fluopicolide is similar in rodents, goats and hens. Metabolism in livestock proceeded primarily via hydroxylation and hydrolysis.]

7. Metabolite toxicology. [ Four metabolites ( AE C653711, AE C657188, AE C657378, and AE 1344122) were identified as low level plant and/ or soil metabolites of fluopicolide. Several of the metabolites were identified at low levels in the rat following fluopicolide or AE C653711 administration and were therefore covered by the tox studies conducted with the parent molecule. All compounds were tested for acute, subchronic ( 28 day) and genetic toxicity and AE C653711 and AE C657188 were additionally studied in in vivo ADME studies. All were found to be 5 equally or less toxic than the parent molecule itself. These metabolites are therefore considered not toxicologically relevant to the overall assessment of fluopicolide human health.. ]

8. Endocrine disruption. [ The toxicology database for fluopicolide is current and complete. No special studies to evaluate the potential endocrine effects of fluopicolide have been conducted. However, the studies in this database include evaluation of the potential effects on reproduction and development, and an evaluation of the pathology of the endocrine organs following shortor long term exposure. These studies revealed no endocrine related effects.]

C. Aggregate Exposure 1. Dietary exposure. [ An assessment was conducted to evaluate potential risks due to chronic and acute dietary exposure of the U. S. population subgroups to residues of fluopicolide. This analysis covers all pending crop uses. ]

i. Food. [ Acute: No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies conducted with fluopicolide. Since no acute toxicological endpoints could be established, the acute aggregate risk is considered to be negligible.

Chronic: Chronic assessments were conducted to evaluate potential risks due to chronic dietary exposure to the U. S. population and selected population subgroups to residues of fluopicolide. This analysis was conducted using the Cumulative and Aggregate Risk Evaluation System ( CARES) using actual field trial residue and estimated percent crop treated. ]

ii. Drinking water. [ Acute: Since no acute toxicological endpoints could be established, the acute aggregate risk is considered to be negligible.

Chronic: A tier II PRZM/ EXAMS assessment was conducted to determine the EECs in the standard EPA pond and the EDWCs in the Standard Index Reservoir associated with fluopicolide on crops. The EXPRESS, PRZM/ EXAMS shell was used to conduct the modeling. The worst case scenario was used in the drinking water exposure assessment and a refined chronic drinking water exposure risk analysis was conducted using the CARES Water Wizard. ] 6 2. Non dietary exposure. [ There is a potential residential exposure to adults applying , and adults and children entering residential turf areas treated with fluopicolide. Based on the application of fluopicolide to residential turf, conservative estimates of exposure were calculated for both children and adults. All estimates resulted in calculated margins of exposure in excess of 100.]

D. Cumulative Effects [ Section 408( b)( 2)( D)( v) 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". EPA does not have, at this time, available data to determine whether fluopicolide has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this tolerance action, EPA has not assumed that fluopicolide has a common mechanism of toxicity with other substances.]

E. Safety Determination 1. U. S. population. [ Acute: No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies conducted with fluopicolide. Since no acute toxicological endpoints could be established, the acute aggregate risk is considered to be negligible.

Chronic: The aggregate risk of the US population to fluopicolide was determine and the resultant exposure value was expressed in terms of margin of exposure ( MOE), which was calculated by dividing the no observable adverse effect level ( NOAEL) by the exposure for each population subgroup. In addition, exposure was also expressed as a percent of the chronic reference dose (% cRfD). The results of the chronic dietary and drinking water exposure and risk analyses presented here, demonstrate that there is a reasonable certainty that no harm will result to the U. S. population or sensitive sub populations, including infants and children, from chronic dietary exposure resulting from the proposed uses of fluopicolide.]

2. Infants and children. [ Acute: No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies conducted with fluopicolide. Since no acute toxicological endpoints could be established, the acute aggregate risk is considered to be negligible.

Chronic: The results of the chronic dietary and drinking water exposure and risk analysis demonstrate that there is a reasonable certainty that no harm will result to the U. S. subpopulations of infants and children from chronic dietary exposure resulting from the proposed uses of fluopicolide. The percentile of chronic dietary exposure ( food) was highest among children 1 to 2 years of age. The percentile of chronic drinking water exposure was highest 7 among infants " 0" years of age. The percentile aggregate chronic exposure from food and water was highest among infants " 0" years of age. The maximum chronic exposure from food and water for each population sub group was estimated to be less than 1 % of the c PAD.]

F. International Tolerances [ There are no CODEX tolerances for residues of fluopicolide]


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Rules and Regulations]
[Pages 54156-54158]
[FR Doc No: 2022-19074]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0650]
RIN 1625-AA00

Safety Zone; Swim for Alligator Lighthouse, Islamorada, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
certain navigable waters of the Atlantic Ocean near Islamorada, Florida
during the Swim for Alligator Lighthouse, open water swim event. A
safety zone for recurring marine events exists; however, for this
year's event the date has changed. The safety zone is necessary to
ensure the safety of event participants and spectators. Persons and
non-participant vessels are prohibited from entering, transiting
through, anchoring in, or remaining within the safety zone unless
authorized by the Captain of the Port (COTP) Key West or a designated
representative.

DATES: This rule is effective from 7:30 a.m. until 4:00 p.m., on
September 10, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0650 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 junior grade Hailye Reynolds, Chief, Waterways
Management Division, Sector Key West, FL U.S. Coast Guard; telephone
305-292-8768, email [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 and contrary to
the public interest. The Coast Guard did not receive necessary
information from the event sponsor for this year's event until shortly
before the event was supposed to be held. The Coast Guard has an
existing safety zone for this recurring marine event at 33 CFR 165.786,
Table to Sec.  165.786, Item No. 9.1; however, the existing regulation
only covers the event when it is scheduled on the third Saturday of
September. The primary justification for this action is that the Coast
Guard received final details of the event shortly before it was
supposed to occur. Therefore, the Coast Guard lacks sufficient time to
provide a reasonable comment period and then consider those comments
before issuing the rule. It would be impracticable and contrary to the
public interest to delay promulgating this rule, as it is necessary to
protect the safety of participants, spectators, the public, and vessels
transiting in the area.
    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 impracticable because the event is taking place on
September 10, 2022, and immediate action is needed to respond to the
potential safety hazards associated with this event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under the authority in 46
U.S.C. 70034. The Captain of the Port Key West (COTP) has determined
that potential hazards associated with this open water swim event will
be a safety concern for persons and vessels in the safety zone. This
rule is needed to ensure the safety

of the event participants, the general public, vessels and the marine
environment in the navigable waters within the safety zone during the
Swim for Alligator Lighthouse open water swim event.

IV. Discussion of the Rule

    This rule establishes a safety zone on September 10, 2022 for a
period of 8.5 hours, from 7:30 a.m. to 4:00 p.m. The safety zone will
cover all waters of the Atlantic Ocean, between Amara Cay, and
Alligator Lighthouse, beginning at a point Latitude 24[deg]54.82' N,
longitude 080[deg]38.03' W, thence to latitude 24[deg]54.36' N,
longitude 080[deg]37.72' W, thence to latitude 24[deg]51.07' N,
longitude 080[deg]37.14' W, thence to latitude 24[deg]54.36' N,
longitude 080[deg]37.72' W, thence to point of origin at latitude
24[deg]54.82' N, longitude 080[deg]38.03' W. The event course begins
and ends at Amara Cay Resort in Islamorada, Florida, and extends
through Hawks Channel, with a turnaround at Alligator Lighthouse.
Approximately 500 swimmers with kayak escorts and ten safety vessels
are anticipated to participate in the event. The size and duration of
the zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters during the open water swim.
Persons and non-participant vessels are prohibited from entering,
transiting through, anchoring in, or remaining within the safety zone
without obtaining permission from the COTP Key West or a designated
representative. If authorization to enter, transit through, anchor in,
or remain within the safety zone is granted by the COTP Key West or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the COTP Key West or
a designated representative. The Coast Guard will provide notice of the
safety zone by Local Notice to Mariners, Broadcast Notice to Mariners,
or by on-scene designated representatives.

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 size,
location, duration and available exceptions to the enforcement of the
safety zone. The regulated area will impact small designated areas of
the Atlantic Ocean between Islamorada, Florida, and the Alligator
Lighthouse for only 9 hours and thus is limited in time and scope.
Furthermore, the rule will allow vessels to seek permission to enter
the zone. Non-participant persons and vessels may enter, transit
through, anchor in, or remain within the regulated area during the
enforcement periods if authorized by the COTP or a designated
representative. Vessels not able to enter, transit through, anchor in,
or remain within the regulated area without authorization from the COTP
or a designated representative may operate in the surrounding areas
during the 9 hour enforcement period. The Coast Guard will issue a
Local Notice to Mariners and a Broadcast Notice to Mariners, allowing
mariners to make alternative plans or seek permission to transit the
zone.

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
safety zone lasting only 9 hours that will prohibit entry into the area
being used by swimmers and safety craft for the Alligator Lighthouse
swim. 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.T07-0650 to read as follows:

Sec.  165.T07-0650  Safety Zone; Swim for Alligator Lighthouse,
Islamorada, FL.

    (a) Location. The following regulated area is a safety zone: All
waters of the Atlantic Ocean beginning at a point Latitude
24[deg]54.82' N, longitude 080[deg]38.03' W, thence to latitude
24[deg]54.36' N, longitude 080[deg]37.72' W, thence to latitude
24[deg]51.07' N, longitude 080[deg]37.14' W, thence to latitude
24[deg]54.36' N, longitude 080[deg]37.72' W, thence to point of origin
at latitude 24[deg]54.82' N, longitude 080[deg]38.03' W. The event
course begins and ends at Amara Cay Resort in Islamorada, Florida,
extending through Hawks Channel with a turnaround point at Alligator
Lighthouse. All coordinates are North American Datum 1983.
    (b) Definition. As used in this section, the term ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel and a Federal, State, and local officer designated by or
assisting the Captain of the Port Key West (COTP) in the enforcement of
the safety zone.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the COTP Key West or a designated
representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the COTP Key West
by telephone at<PHONE_NUMBER>, or a designated representative via VHF-
FM radio on channel 16 to request authorization. If authorization is
granted, all persons and vessels receiving such authorization must
comply with the instructions of the COTP Key West or a designated
representative.
    (3) The Coast Guard will provide notice of the regulated area by
Local Notice to Mariners, Broadcast Notice to Mariners via VHF-FM
channel 16, or the COTP's designated representative.
    (d) Enforcement period. This rule will be enforced from 7:30 a.m.
until 4:00 p.m., on September 10, 2022.

    Dated: August 29, 2022.
J. Ingram,
Captain, U.S. Coast Guard, Captain of the Port Key West.
[FR Doc. 2022-19074 Filed 9-1-22; 8:45 am]
BILLING CODE 9110-04-P