[Federal Register: October 27, 2009 (Volume 74, Number 206)]
[Rules and Regulations]
[Page 55136-55138]
[DOCID:fr27oc09-13]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 147

[Docket No. USCG-2008-1051]
RIN 1625-AA00

Safety Zone; Perdido Regional Host Outer Continental Shelf
Platform, Gulf of Mexico

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing a safety zone around the
Perdido Regional Host (PRH), a high-production, manned oil and natural
gas platform. The platform needs to be protected from vessels operating
outside the normal shipping channels and fairways. Placing a safety
zone around the platform will significantly reduce the threat of
allisions, oil spills, and releases of natural gas, and thereby protect
the safety of life, property, and the environment.

DATES: This rule is effective November 27, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket USCG-2008-1051 and are available online
by going to http://www.regulations.gov, inserting USCG-2008-1051 in the
``Keyword'' box, and then clicking ``Search.'' This material is also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey

Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Dr. Madeleine McNamara, U.S. Coast Guard, District Eight
Waterways Management Coordinator; telephone<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On February 13, 2009, we published an interim rule with a request
for comments entitled, ``Safety Zone; Perdido Regional Host Outer
Continental Shelf Platform in the Gulf of Mexico'' in the Federal
Register (74 FR 7181). We received no comments on the interim rule.

Background and Purpose

    The safety zone established by this regulation is in the deepwater
area of the Gulf of Mexico, located at 26[deg]07'44'' N,
094[deg]53'53'' W in Alaminos Canyon block 857. For the purposes of
this regulation, the deepwater area is considered to be waters of 304.8
meters (1,000 feet) or greater depth extending to the limits of the
Exclusive Economic Zone (EEZ), which is contiguous to the territorial
sea of the United States, and extends up to 200 nautical miles from the
baseline from which the breadth of the territorial sea is measured.
Navigation in the area of the safety zone consists of large commercial
shipping vessels, fishing vessels, cruise ships, tugs with tows and the
occasional recreational vessel. The deepwater area also includes an
extensive system of fairways.
    Shell Offshore, Inc. requested that the Coast Guard establish a
safety zone around the Perdido Regional Host. The request for the
safety zone was made due to the safety concerns for both the personnel
aboard the platforms and the environment. Shell Offshore, Inc.
indicated that the location, production level, and personnel levels on
board the platform makes it highly likely that any allision with the
platform would result in a catastrophic event. Perdido Regional Host is
a high production oil and gas drilling platform producing approximately
100,000 barrels of oil per day and 200 million standard cubic feet of
gas per day; it is manned with a crew of approximately 150 people.
    In evaluating this request, the Coast Guard explored relevant
safety factors and considered several criteria, including but not
limited to: (1) The level of shipping activity around the facility; (2)
safety concerns for personnel aboard the facility; (3) concerns for the
environment; (4) the likeliness that an allision would result in a
catastrophic event based on proximity to shipping fairways, offloading
operations, production levels, and size of the crew; (5) the volume of
traffic in the vicinity of the proposed area; (6) the types of vessels
navigating in the vicinity of the proposed area; and, (7) the
structural configuration of the facility.
    Results from a thorough and comprehensive examination of the
criteria, IMO guidelines, and existing regulations warrant the
establishment of a safety zone of 500 meters around Perdido Regional
Host at 26[deg]07'44'' N, 094[deg]53'53'' W.

Discussion of Comments and Changes

    We received no comments in response to the interim rule.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    This rule is not a significant regulatory action due to the
distance of the Perdido Regional Host from both land and safety
fairways. Vessels traversing waters near the safety zone will be able
to safely travel around the zone without incurring additional cost.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in Alaminos Canyon block 857. This safety zone will not have
a significant economic impact on a substantial number of small entities
for the following reasons: (1) This rule will enforce a safety zone
around a production platform that is in an area of the Gulf of Mexico
not typically frequented by vessel traffic; (2) this rule will enforce
a safety zone that is not in close proximity to a safety fairway; and,
(3) vessel traffic can pass safely around the safety zone without
incurring additional costs.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the interim rule we offered
to assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 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.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction, because the rule establishes a safety
zone. An environmental analysis checklist and a categorical exclusion
determination are will be available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 147

    Continental shelf, Marine safety, Navigation (water).

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 147 as follows:

PART 147--SAFETY ZONES

0
1. The authority citation for part 147 continues to read as follows:

    Authority:  14 U.S.C. 85; 43 U.S.C. 1333; Department of Homeland
Security Delegation No. 1070.1.

0
2. Revise Sec.  147.845 to read as follows:

Sec.  147.845  Perdido Regional Host safety zone.

    (a) Description. The Perdido Regional Host is located at position
26[deg]07'44'' N, 094[deg]53'53'' W. The area within 500 meters (1640.4
feet) from each point on the structure's outer edge is a safety zone.
    (b) Regulation. No vessel may enter or remain in this safety zone
except the following:
    (1) An attending vessel;
    (2) A vessel under 100 feet in length overall not engaged in
towing; or
    (3) A vessel authorized by the Commander, Eighth Coast Guard
District or a designated representative.

    Dated: September 8, 2009.
Mary E. Landry,
Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. E9-25595 Filed 10-26-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 87, Number 137 (Tuesday, July 19, 2022)]
[Notices]
[Pages 43030-43035]
[FR Doc No: 2022-15384]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0132; FRL-9411-05-OCSPP]

Certain New Chemicals; Receipt and Status Information for June
2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA Section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 06/01/
2022 to 06/30/2022.

DATES: Comments identified by the specific case number provided in this
document must be received on or before August 18, 2022.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0132, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Jim Rahai, Project Management
and Operations Division (MC 7407M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 06/01/2022 to 06/30/2022. The Agency is providing notice of
receipt of PMNs, SNUNs, and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
    EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

B. What is the Agency's authority for taking this action?

    Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the

TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.
    Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
    TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: https://www.epa.gov/oppt/newchems.
    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.

C. Does this action apply to me?

    This action provides information that is directed to the public in
general.

D. Does this action have any incremental economic impacts or paperwork
burdens?

    No.

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

    1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
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 preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.

II. Status Reports

    In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (See the Federal
Register of May 12, 1995, (60 FR 25798) (FRL-4942-7). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

III. Receipt Reports

    For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.

                                            Table I--PMN/SNUN/MCANs Approved * From 06/01/2022 to 06/30/2022
--------------------------------------------------------------------------------------------------------------------------------------------------------
               Case No.                   Version     Received date         Manufacturer                   Use                   Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
J-22-0014.............................            1      05/05/2022  CBI......................  (G) Production of an       (G) Modified yeast,
                                                                                alcohol.                   chromosomally and stably
                                                                                modified to improve
                                                                                fermentation performance.

J-22-0014A............................            2      06/16/2022  CBI......................  (G) Production of an       (G) Modified yeast,
                                                                                alcohol.                   chromosomally and stably
                                                                                modified to improve
                                                                                fermentation performance.
J-22-0015.............................            1      05/05/2022  CBI......................  (G) Production of an       (G) Modified yeast,
                                                                                alcohol.                   chromosomally and stably
                                                                                modified to improve
                                                                                fermentation performance.
J-22-0015A............................            2      06/16/2022  CBI......................  (G) Production of an       (G) Modified yeast,
                                                                                alcohol.                   chromosomally and stably
                                                                                modified to improve
                                                                                fermentation performance.
P-19-0154.............................            3      06/03/2022  CBI......................  (G) Intermediate in        (G) Alkane Ester of Maleic
                                                                                production of a wetting    Acid.
                                                                                additive.
P-19-0160A............................            5      06/14/2022  CBI......................  (S) Component of a UV      (G) Alkanesulfonic acid, 2-
                                                                                curable printing ink.      [(2-aminoethyl)heteroatom-
                                                                                substituted]-, sodium salt
                                                                                (1:1), polymer with alpha-
                                                                                [2,2-
                                                                                bis(hydroxymethyl)butyl]-
                                                                                omega-methoxypoly(oxy-1,2-
                                                                                ethanediyl) and 1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatocyclohexane],
                                                                                acrylic acid-
                                                                                dipenthaerythritol reaction
                                                                                products- and polypropylene
                                                                                glycol ether with
                                                                                pentaerythritol (4:1)
                                                                                triacrylate-blocked.
P-20-0118A............................            4      06/16/2022  CBI......................  (G) Additive in household  (S) Pyridine, 4-methyl-2-
                                                                                consumer products.         pentyl-.
P-21-0043A............................            4      06/06/2022  Advanced Polymer Coatings  (S) Component in           (G) Glycidyl ether of
                                                                                protective coatings that   (formaldehyde, polymer with
                                                                                provides chemical          mixed phenols).
                                                                                resistance.
P-22-0014A............................            4      06/06/2022  CBI......................  (G) Precursor............  (G) sodium
                                                                                bis(chloropropanediol)
                                                                                phosphate.
P-22-0050A............................            3      06/15/2022  CBI......................  (G) Lubricant............  (G) Alkene, alkoxy-, polymer
                                                                                with alkoxyalkene.
P-22-0068.............................            2      06/23/2022  Aditya Birla Chemicals     (S) An epoxy component     (S) 2-Propanamine, 1,1'-[(1-
                                                                      (USA), LLC.                used in a reaction with    methylethylidene)bis(oxy)]bi
                                                                                other components to        s-.
                                                                                produce an epoxy article.
P-22-0113.............................            3      06/16/2022  CBI......................  (G) Chemical               (S) D-Glucaric acid.
                                                                                intermediate, Additive.
P-22-0114.............................            3      06/22/2022  CBI......................  (G) Anode material,        (G) Edge oxidized carbon
                                                                                Corrosion protection       matrix.
                                                                                additive.
P-22-0115.............................            3      06/06/2022  Cyclopure, Inc...........  (S) Filter media           (G) Cyclodextrin, polymer
                                                                                integrated and             with halocarbonitrile and
                                                                                encapsulated in block      quaternary ammonium salt.
                                                                                filter articles and
                                                                                packed bed filters for
                                                                                consumer, industrial,
                                                                                and commercial
                                                                                applications.
P-22-0116.............................            2      06/07/2022  CBI......................  (G) Monomer..............  (G) Carbopolycycle octa-
                                                                                alkene, alkenylaryloxy-.
P-22-0116A............................            3      06/14/2022  CBI......................  (G) Monomer..............  (G) Carbopolycycle octa-
                                                                                alkene, alkenylaryloxy-.
P-22-0117.............................            2      06/15/2022  CBI......................  (G) Raw material in        (S) Iron oxide (Fe2O3), mixed
                                                                                ceramic tiles production.  with silica, calcined.
P-22-0118.............................            2      06/16/2022  Elantas PDG, Inc.........  (S) RV9054 is an           (S) Hexanedioic acid, polymer
                                                                                unsaturated polyester      with 1,2,3-propanetriol and
                                                                                resin used as a diluent    1,3,5-tris(2-hydroxyethyl)-
                                                                                in a finished product.     1,3,5-triazine-
                                                                                2,4,6(1H,3H,5H)-trione, 3-
                                                                                methyl-3-buten-1-yl ester.
P-22-0119.............................            2      06/16/2022  CBI......................  (G) Resin for packaging..  (G) Polyhydroxyalkanoate.
P-22-0120.............................            2      06/16/2022  CBI......................  (G) Resin for packaging    (G) Polyhydroxyalkanoate.
                                                                                materials.
P-22-0121.............................            1      06/03/2022  CBI......................  (G) Process Intermediate:  (G) polychloroalkene.
                                                                                New chemical substance
                                                                                will be used as a
                                                                                process intermediate.

P-22-0122.............................            1      06/08/2022  Shin-ETSU Microsi........  (G) Contained use for      (G) Heterotrisubstituted-bile
                                                                                microlithography for       acid, 1-
                                                                                electronic device          (difluorosulfomethyl)-2,2,2-
                                                                                manufacturing.             trifluoroethyl ester, ion(1-
                                                                                ), (5)-, 5-
                                                                                phenyldibenzothiophenium(1:1
                                                                                ).
P-22-0123.............................            2      06/20/2022  CBI......................  (G) Mineral processing     (G) Propaneamine, 3-
                                                                                aid.                       (alkyloxy)-, structural
                                                                                variants.
P-22-0123A............................            3      06/25/2022  CBI......................  (G) Mineral processing     (G) Propaneamine, 3-
                                                                                aid.                       (alkyloxy)-, structural
                                                                                variants.
P-22-0124.............................            3      06/16/2022  CBI......................  (S) Site Limited           (G) Propanenitrile, 3-
                                                                                Intermediate for final     (alkyloxy)-, structural
                                                                                product.                   variance.
P-22-0124A............................            4      06/25/2022  CBI......................  (S) Site Limited           (G) Propanenitrile, 3-
                                                                                Intermediate for final     (alkyloxy)-, structural
                                                                                product.                   variance.
P-22-0125.............................            2      06/20/2022  CBI......................  (G) Corrosion inhibitor..  (G) Isononanoylamidocaproic
                                                                                Acid.
P-22-0126.............................            1      06/10/2022  Takasago.................  (S) This polymer           (S) Cellulose, polymer with
                                                                                constitutes the wall of    1,1'-[2-ethyl-2-[(3-mercapto-
                                                                                microcapsules containing   1-oxopropoxy)methyl]-1,3-
                                                                                fragrance that can be      propanediyl] bis(3-
                                                                                used in different home-    mercaptopropanoate) and
                                                                                care and personal-care     1,2,3-propanetriol bis(2-
                                                                                applications.              methyl-2-propenoate),
                                                                                peroxydisulfuric acid
                                                                                ([(HO)S(O)2]2O2) ammonium
                                                                                salt (1:2)- and sodium
                                                                                (disulfite) (2:1)-initiated.
P-22-0126A............................            2      06/21/2022  Takasago.................  (S) This polymer           (S) Cellulose, polymer with
                                                                                constitutes the wall of    1,1'-[2-ethyl-2-[(3-mercapto-
                                                                                microcapsules containing   1-oxopropoxy)methyl]-1,3-
                                                                                fragrance that can be      propanediyl] bis(3-
                                                                                used in different home-    mercaptopropanoate) and
                                                                                care and personal-care     1,2,3-propanetriol bis(2-
                                                                                applications.              methyl-2-propenoate),
                                                                                peroxydisulfuric acid
                                                                                ([(HO)S(O)2]2O2) ammonium
                                                                                salt (1:2)- and sodium
                                                                                (disulfite) (2:1)-initiated.
P-22-0127.............................            1      06/14/2022  CBI......................  (S) The NCS is used as a   (S) Urea,N,N'-bis-[3-[[(4-
                                                                                developer in formulation   methylphenyl)sulfonyl]oxy]ph
                                                                                to produce thermal paper.  enyl]-.
P-22-0128.............................            2      06/21/2022  Resman USA 2.............  (S) Chemical tracer for    (G) Alkyl cycloalkane,
                                                                                production monitoring in   polyfluoro-.
                                                                                oil and gas wells, (S)
                                                                                Chemical tracer for use
                                                                                in interwell tracing
                                                                                between injector and
                                                                                production oil and gas
                                                                                wells.
P-22-0129.............................            1      06/15/2022  Shin-ETSU Microsi........  (G) Contained use for      (G) Substituted heterocyclic
                                                                                microlithography for       onium compound, salt with
                                                                                electronic device          heteropolysubstitutedalkyl
                                                                                manufacturing.             substitutedtricycloalkane
                                                                                carboxylate (1:1), polymer
                                                                                with 1-alkenyl-4-
                                                                                [(alkylcycloalkyl)oxy]carbom
                                                                                onocycle, 5-ethyloctahydro-
                                                                                4,7-methano-1H-inden-5-yl 2-
                                                                                methyl-2-propenoate,
                                                                                hexahydro-5-oxo-2,6-
                                                                                methanofuro[3,2-b]furan-3-yl
                                                                                2-methyl-2-propenoate and 4-
                                                                                hydroxyphenyl 2-methyl-2-
                                                                                propenoate.
P-22-0136.............................            2      06/29/2022  CBI......................  (G) Functional mineral in  (G) Mica-group minerals,
                                                                                automotive components,     reaction products with
                                                                                and plastics, lubricant    triethoxylsilyl substituted-
                                                                                in industrial machinery    alkane.
                                                                                parts.
P-22-0141.............................            1      06/27/2022  CBI......................  (S) Chemical intermediate  (G) Perhaloalkene oligomer.
P-22-0142.............................            1      06/28/2022  CBI......................  (S) Heat transfer fluid..  (G) Benzene, [(perfluoroalken-
                                                                                1-yl)oxy]-.
P-22-0143.............................            1      06/28/2022  Huntsman Corporation.....  (S) Exhaust dyeing of      (G) Acetamide, N-[3-
                                                                                cotton and cotton blends.  [alkyl(carbomonocyclic)
                                                                                substituted]carbomonocycle]-
                                                                                , coupled with diazotized 2-
                                                                                substituted-3-halo-5-
                                                                                nitrobenzonitrile.

SN-22-0004A...........................            2      06/07/2022  HPC Holdings, Inc........  (S) Carrier Fluid for      (S) Propane, 1,1,1,3,3,3-
                                                                                coating-type vapor         hexafluoro-2-methoxy-.
                                                                                degreaser and Process
                                                                                Solvent (Closed Systems).
SN-22-0006............................            2      06/14/2022  MacDermid Enthone Inc....  (G) Catalyst (contained    (S) Tungstate (W12(OH)2O386-
                                                                                use).                      ), sodium (1:6).
SN-22-0007............................            2      06/14/2022  Braven Environmental, LLC  (G) Product of Pyrolysis   (S) Waste plastics,
                                                                                manufacturing.             pyrolyzed, C5-12 fraction.
SN-22-0008............................            2      06/14/2022  Braven Environmental, LLC  (G) Product of Pyrolysis   (S) Waste plastics,
                                                                                Manufacturing.             pyrolyzed, C20-55 fraction.
SN-22-0009............................            2      06/14/2022  Braven Environmental, LLC  (G) Product of Pyrolysis   (S) Waste plastics,
                                                                                Manufacturing.             pyrolyzed, C9-20 fraction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided
  with the submission prior to the start of the 90 day review period, and in no way reflects the final status of a complete submission review.

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was received by
EPA, the date of commencement provided by the submitter in the NOC, a
notation of the type of amendment (e.g., amendment to generic name,
specific name, technical contact information, etc.) and chemical
substance identity.

                             Table II--NOCs Approved * From 06/01/2022 to 06/30/2022
----------------------------------------------------------------------------------------------------------------
                                                    Commencement    If amendment, type
            Case No.               Received date        date           of amendment        Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0005.......................      06/01/2022       05/18/2022  N..................  (G) Chromosomally-
                                                                                modified saccharomyces
                                                                                cerevisiae.
P-16-0408.......................      06/05/2022       06/01/2022  N..................  (G) Benzyloxy)-
                                                                                nitrophenyl diazen-1-
                                                                                yl]-hydroxy-dimethyl-2-
                                                                                oxo-dihydropyridine-
                                                                                carbonitrile.
P-16-0413.......................      06/13/2022       01/08/2021  N..................  (S) Siloxanes and
                                                                                silicones, di-me, 3-
                                                                                hydroxypropyl me, me
                                                                                3,3,4,4,5,5,6,6,6-
                                                                                nonafluorohexyl.
P-17-0195.......................      06/03/2022       06/25/2020  Amended generic      (G) 1,3-propanediol, 2-
                                                                    name.                methylene-, esters.
P-18-0281.......................      06/23/2022       06/05/2022  N..................  (G) Cyclic sulfate.
P-19-0166.......................      06/27/2022       06/27/2022  N..................  (G) Triarylsulfonium
                                                                                alkylestersulfonate.
P-21-0056.......................      06/03/2022       05/31/2022  N..................  (G) Isocyanic acid,
                                                                                polyalkylenepolyarylene
                                                                                ester, polymer with
                                                                                alkyl-hydroxyalkyl-
                                                                                alkanediol,
                                                                                alkoxyalcohol and
                                                                                alkoxylalkoxyalcohol-
                                                                                blocked.
P-21-0060.......................      06/03/2022       06/01/2022  N..................  (G) Bisphenol a
                                                                                epichlorohydrin polymer
                                                                                with alkylpolyalkene-
                                                                                polyarylene-
                                                                                hydroxypolyoxyalkyldiyl
                                                                                reaction products with
                                                                                alkylalkylidenealkylalk
                                                                                ylidene- aminoalkyl-
                                                                                alkanepolyamine and
                                                                                alkylaminoalkanol.
P-21-0061.......................      06/03/2022       06/02/2022  N..................  (G) Sulfur based acid,
                                                                                compds. with modified
                                                                                bisphenol a-
                                                                                epichlorohydrin-
                                                                                polyalkylene polyol
                                                                                ether with bisphenol a
                                                                                polymer-n-
                                                                                dialkylalkylidene-n-
                                                                                (dialkylalklyidene)amin
                                                                                oalkyl-alkanepolyamine-
                                                                                alkylaminoalkanol
                                                                                reaction products.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

    In Table III of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information that has been received during this time period: The
EPA case number assigned to the test information; the date the test
information was received by EPA, the type of test information
submitted, and chemical substance identity.

                       Table III--Test Information Received From 06/01/2022 to 06/30/2022
----------------------------------------------------------------------------------------------------------------
              Case No.                 Received date    Type of test information         Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0543...........................      06/06/2022  Industrial Hygiene Exposure   (G) Halogenophosphoric acid
                                                       Report.                       metal salt.
P-16-0543...........................      06/08/2022  Industrial Hygiene Exposure   (G) Halogenophosphoric acid
                                                       Report.                       metal salt.
P-16-0543...........................      06/17/2022  Industrial Hygiene Exposure   (G) Halogenophosphoric acid
                                                       Report (Revised).             metal salt.
P-18-0016...........................      06/20/2022  Dissociation Constant         (G) Aromatic sulfonium
                                                       Determination Study.          tricyclo fluoroalkyl
                                                                                sulfonic acid salt.
P-20-0042...........................      06/20/2022  Dissociation Constant         (G) Sulfonium, trisaryl-,
                                                       Determination Study.          7,7-dialkyl-2-
                                                                                heteropolycyclic -1-
                                                                                alkanesulfonate (1:1).
P-21-0018...........................      06/20/2022  Dissociation Constant         (G) Sulfonium, triphenyl-,
                                                       Determination Study.          heterocyclic compound-
                                                                                carboxylate (1:1).
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: July 14, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-15384 Filed 7-18-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 74 (Tuesday, April 17, 2012)]
[Rules and Regulations]
[Pages 22667-22668]
[FR Doc No: 2012-9196]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs for Use in Animal Feeds; Tiamulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of those parts
of a new animal drug application (NADA) for a tiamulin Type A medicated
article that pertain to the production indications for use of increased
rate of weight gain and improved feed efficiency in swine.

DATES: This rule is effective April 17, 2012.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish

Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Novartis Animal Health U.S., Inc.
(Novartis), 3200 Northline Ave., suite 300, Greensboro, NC 27408, has
requested that FDA withdraw approval of those parts of NADA 139-472 for
DENAGARD (tiamulin) Type A medicated article pertaining to the
production indications for use of increased rate of weight gain and
improved feed efficiency in swine. Novartis requested voluntary
withdrawal of approval of these indications for use because the product
is no longer marketed for these uses. Revised product labeling
reflecting the withdrawal of these indications has been approved in a
supplement to NADA 139-472.
    Elsewhere in this issue of the Federal Register, FDA gave notice
that the approval of those parts of NADA 139-472 pertaining to the
production indications for use of increased rate of weight gain and
improved feed efficiency in swine is withdrawn, effective April 17,
2012. As provided for in the regulatory text of this document, the
animal drug regulations are amended to reflect this withdrawal of
approval.
    With the withdrawal of approval of the production indications for
tiamulin, the lowest concentration of the drug in feed now has a
preslaughter withdrawal period. In accordance with 21 CFR
558.3(b)(1)(ii), tiamulin is now a Category II drug, and the table in
21 CFR 558.4(d) is revised to reflect that change. However, the maximum
concentration of tiamulin in Type B feeds is not being increased from
the current 3.5 grams per pound (g/lb) because there is an approved 5-
g/lb Type A medicated article.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director of the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In paragraph (d) of Sec.  558.4, in the ``Category I'' table, remove
the entry for ``Tiamulin''; and in the ``Category II'' table,
alphabetically add a new entry for ``Tiamulin'' to read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                                                Assay limits
                  Drug                     Assay limits percent \1\     Type B maximum  (100x)      percent \1\
                                                    Type A                                         Type B/C \2\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Tiamulin................................  113.4 g/lb, 100-108.......  3.5 g/lb (0.8%)...........          90-115
                                          5 and 10 g/lb, 90-115.....                                      70-130

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make Type C medicated feed.

* * * * *

Sec.  558.600  [Amended]

0
3. In Sec.  558.600, in the table, remove and reserve paragraph
(e)(1)(i).

    Dated: March 21, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-9196 Filed 4-16-12; 8:45 am]
BILLING CODE 4160-01-P