Site Visit Report

	Barney Davis Power Station

	4301 Waldron Road

	Corpus Christi, TX 78418

March 3, 2008

Background and Objectives

The Environmental Protection Agency (EPA) is in the process of
developing 316(b) cooling water intake structure requirements that
reflect the best technology available (BTA) for minimizing adverse
environmental impact for all existing power plants and manufacturing
facilities. As part of this process, EPA staff is visiting electric
generators and manufacturers to better understand the cooling water
intake structure (CWIS) technologies in use at facilities, including the
site-specific characteristics of each facility and how these affect the
selection and performance of CWIS technologies.  EPA is also visiting
facilities to better understand cooling water use and specific issues or
technologies that can affect 316(b) compliance.  Barney Davis Power
Station (Barney Davis) was selected for a site visit due to its use of
fine mesh traveling screens and its large intake flows.

Facility Description

Barney Davis is located on a 2000 acre site in Corpus Christi, Texas.
It withdraws water from the Laguna Madre estuary via a 1200 foot long
intake canal.  Heated effluent is discharged to a cooling pond west of
the facility, eventually flowing into Oso Bay.  The facility is owned by
Topaz Power Group and began operations of the first unit in 1974 and the
second unit in 1976.

The facility’s NPDES permit number is TX0008826, which expired on
December 5, 2006.  A permit renewal application has been submitted, but
the renewed permit is awaiting EPA approval and has not been issued by
the state.

Electricity Generation and Transmission

The facility has two natural gas-fired generating units, each capable of
generating 350MW.  The facility operates during times of high demand,
typically only in the summer; its capacity utilization is approximately
5%.  The facility has one scheduled outage per year, which typically
occurs during a time when demand is low.

Unit 2 is currently being upgraded to include a heat recovery steam
generator (HRSG) to increase its generating efficiency.  When completed
in 2010, the facility expects that its utilization will increase.  Unit
1 has no additional upgrades planned at this time.

American Electric Power (AEP) owns the switchyard and transmission
equipment.

Cooling Water Intake Structure

Water is withdrawn from Laguna Madre, a shallow estuary connecting to
the Gulf of Mexico with approximately 1 foot of tidal variation.  An
intake canal draws water to a shoreline intake structure adjacent to the
plant.  Boat traffic is blocked at the canal entrance.  Low currents and
predominant south to east winds cause broken or shed pieces of sea grass
(called wrack) accumulation along the western side of the Laguna Madre
that is drawn into the canal at the intake. A mechanical trash rack
(3.5” spacing between bars) screens debris, including extremely heavy
loadings from sea grasses.  Barney Davis was originally designed and
built with fine-mesh screens (single entry, double exit Passavant center
flow screens).  The screens are made of a semi-rigid polymer-based mesh
with 1mm by 2mm openings and typically must be replaced every 2-3 years.
 Impinged organisms are washed off the screens as the basket reaches the
top of its cycle into the trough and then into a holding well, where
they are pumped to a floating surface discharge in the cooling pond.
One FTE oversees operation of the CWIS equipment. The facility cleans
the condenser tubes with Amertap balls which has allowed the facility to
avoid the use of chlorine and biocides.

Once a year (during the planned facility outage), Barney Davis performs
maintenance on the system.  They remove the baskets, inspect the chain
and all moving parts, and replace parts as needed.  They hydroblast the
exterior system to remove oyster shells and mussels as needed. Both the
screens and baskets are made locally.

Barney Davis’ uses four circulating pumps, each rated at 82,000 gpm
(equal to a design intake flow (DIF) of 472 mgd) and the design intake
velocity has been calculated as 1.15 fps.  There will be no increase in
cooling water flows due to the addition of the HRSG.  The condenser is
single pass and consists of titanium tubes.

Impingement and Entrainment Information

The facility has recently conducted impingement and entrainment
monitoring and provided an interim report (see Attachment D).  A study
of organism survival was also conducted in 1977.  The facility did not
plan to make any operational or technological changes to comply under
the now-suspended Phase II rule; facility representatives believe that
the current configuration demonstrates compliance.  Representatives also
stated that a small number of fish species represent the bulk of the
impingement at the facility.

Cooling Tower Feasibility

Facility representatives noted that, due to the shallow depths in Laguna
Madre and summer weather conditions (heat and drought), the intake water
for Barney Davis can become hyper-saline (as high as 50 parts per
thousand).  Some stainless steel parts of the screen assembly have been
replaced with Teflon-coated parts to reduce the effects of corrosion.
Facility representatives stated that the high salinity levels could be
problematic for operation of a cooling tower, as frequent blowdown would
be required and corrosion of equipment may be accelerated.  They also
noted that the high summer temperatures would likely result in a
significant increase in evaporation rates of the cooling tower.
Facility representatives also stated that salt drift would be a concern,
as Barney Davis is located next to a military airfield used for training
pilots.  When questioned on the feasibility of dry towers, the facility
noted that the ambient summer temperature is typically 100 degrees F,
which, in their opinion, makes dry cooling problematic.

Additional Information

The facility is considering upgrades to its intake system to reduce sea
grass intake by deflecting the floating sea grass at the entrance to the
intake canal.  (See Attachment E.)

Attachments

Attachment A		List of Attendees

Attachment B		Aerial Photos

Attachment C		Proposal for Information Collection

Attachment D		Draft Interim Impingement and Entrainment Report

Attachment E		Wrack Control

Attachment F		Site Visit Photos

Attachment A--List of Attendees

Paul Shriner, EPA

Jan Matuszko, EPA

Kelly Meadows, Tetra Tech

Gary Eddins, Topaz Power Group

Nick Andrade, Topaz Power Group

Val Sepulveda, Topaz Power Group

Paul Jensen, PBS&J

Attachment B—Aerial Photos

Please see DCN 10-6500D accompanying this document.

Attachment C—Proposal for Information Collection

Please see DCN 10-6500A accompanying this document.

Attachment D—Draft Interim Impingement and Entrainment Report

Please see DCN 10-6500B accompanying this document.

Attachment E—Wrack Control

Please see DCN 10-6500C accompanying this document.

Attachment F—Site Visit Photos

Please see DCN 10-6500E-K accompanying this document.

 Of the 2000 acres, approximately 1100 acres are dedicated to the
facility’s cooling pond, with additional acreage loaned to the state
wildlife agencies and universities for hatchery rearing operations and
research.

 The generating units previously could burn either natural gas or oil,
but this flexibility was removed during recent upgrades.

 The trash rack uses traveling rakes to clear debris.  Seagrass loading
is the biggest concern, as facility representatives noted that as many
as 15 truckloads of seagrass may be removed per day and placed on land
at the site.  The facility designates a full-time operator for the
system at all times during its operation to constantly monitor debris
loading levels.

 The screen mesh (cloth with Teflon inserts) is fitted onto a
chain-driven metal frame.  Each piece of screen material is attached to
one of 52 baskets to form a trough.

 The screens are rotated continuously (typically at the maximum rotation
speed) when the generating unit is operating.  Originally, the fish
return was an open channel to Laguna Madre, but operational difficulties
and predation by seabirds prompted moving the fish return outfall to the
cooling pond.

 Amertap sponge rubber balls are passed through single-pass condenser
tubes as needed to maintain heat transfer efficiency.

 PAGE

 PAGE   5


[Federal Register Volume 79, Number 176 (Thursday, September 11, 2014)]
[Notices]
[Pages 54313-54315]
[FR Doc No: 2014-21648]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73009; File No. SR-CFE-2014-004]

Self-Regulatory Organizations; CBOE Futures Exchange, LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Position Limits for Individual Stock Based and Exchange-
Traded Fund Based Volatility Index Security Futures

September 5, 2014.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on August 26, 2014 CBOE
Futures Exchange, LLC (``CFE'' or ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change described in Items I, II, and III below, which Items have been
prepared by CFE. The Commission is publishing this notice to solicit
comments on the proposed rule change

from interested persons. CFE also has filed this proposed rule change
with the Commodity Futures Trading Commission (``CFTC''). CFE filed a
written certification with the CFTC under Section 5c(c) of the
Commodity Exchange Act (``CEA'') \2\ on August 26, 2014.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(7).
    \2\ 7 U.S.C. 7a-2(c).
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I. Self-Regulatory Organization's Description of the Proposed Rule
Change

    CFE proposes to amend the position limits for Individual Stock
Based and Exchange-Traded Fund Based Volatility Index Security Futures
(``Volatility Index security futures'') set forth in CFE Rule 1602(d).
    The scope of this filing is limited solely to the application of
the rule changes to security futures traded on CFE. The only security
futures currently traded on CFE are traded under Chapter 16 of CFE's
Rulebook which is applicable to Volatility Index security futures.
    The text of the proposed rule change is attached as Exhibit 4 to
the filing submitted by the Exchange but is not attached to the
published notice of the filing.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, CFE included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. CFE has prepared summaries, set forth in Sections A, B,
and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    CFE is amending the three tiered position limit levels for
Volatility Index security futures. CFE Rule 1602(d) currently provides
that a person may not own or control:
    (1) More than 50,000 contracts net long or net short in all
Volatility Index security futures contracts on the same Volatility
Index combined;
    (2) more than 30,000 contracts net long or net short in the
expiring security futures contract month for a Volatility Index
security future; and
    (3) more than 13,500 security contracts net long or net short in
the expiring contract for a Volatility Index security future held
during the last 5 trading days for the expiring Volatility Index
security futures contract month.\3\
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    \3\ For the purposes of CFE Rule 1602(d), the positions of all
accounts directly or indirectly owned or controlled by a person or
persons, and the positions of all accounts of a person or persons
acting pursuant to an expressed or implied agreement or
understanding shall be cumulated.
    The first and second tier position limit levels for Volatility
Index security futures are equivalent to the first and second tier
position limit levels for security options on these same Volatility
Indexes. See Chicago Board Options Exchange, Incorporated Rule
24.4C. (Position Limits for Individual Stock or ETF Based Volatility
Index Options). CFE adopted the third tier position limit level for
Volatility Index security futures because it was required by CFTC
Regulation Sec.  41.25(a)(3)(i). In relevant part, CFTC Regulation
Sec.  41.25(a)(3)(i) requires a designated contract market to
``adopt a net position limit no greater than 13,500 (100-share)
contracts applicable to positions held during the last five trading
days of an expiring contract month [ ]'' for security futures
contracts.
---------------------------------------------------------------------------

    CFE periodically reviews position limit levels and has determined
to make the following changes to the position limit levels for
Volatility Index security futures as follows:
    (1) Reduce the all months position limit from 50,000 contracts to
30,000 contracts;
    (2) reduce the spot month position limit from 30,000 contracts to
10,000 contracts; and
    (3) replace the 5 days-to-expiration spot position limit of 13,500
contracts with a 1 day-to-expiration spot position limit of 1,000
contracts.\4\
---------------------------------------------------------------------------

    \4\ The Exchange is replacing the 5-days-to-expiration limit
with a 1-day-to-expiration limit because any potential pressures on
liquidity are most acute on the day before expiration. In addition,
this change is consistent with CFTC Regulation Sec.  41.25(a)(3)(i)
described in footnote 3 because the newly reduced spot month
position limit of 10,000 contracts is applicable sooner than the
``last five trading days of an expiring contract month'' and is less
than the statutory maximum of 13,500 contracts during that five-day
period.
---------------------------------------------------------------------------

    The Exchange will continue to periodically review position limit
levels for Volatility Index security futures in order to determine
whether the existing position limit levels should remain or be
adjusted. Accordingly, the Exchange may determine to increase the
position limit levels that are the subject of this filing in the
future. Among other things, CFE will review trading volume data and
liquidity in the applicable Volatility Index security futures contract,
and may propose alternate position limit levels. Any such change would
be accomplished by way of a rule filing with the Commission.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\5\ in general, and furthers the
objectives of Section 6(b)(5) \6\ in particular in that it is designed
to prevent fraudulent and manipulative acts and practices, promote just
and equitable principles of trade, foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the Exchange believes that the position limit level
changes being made by this filing will diminish the opportunity to
manipulate Volatility Index security futures and will protect against
disruption in the underlying market.

B. Self-Regulatory Organization's Statement on Burden on Competition

    CFE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act. Specifically, the Exchange believes that the
proposed rule change will not burden competition because the new
position limit levels will apply to all persons and the revised rule
provisions do not discriminate between market participants.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The proposed rule change will become operative on September 11,
2014.
    At any time within 60 days of the date of effectiveness of the
proposed rule change, the Commission, after consultation with the CFTC,
may summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Act.\7\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule

change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CFE-2014-004 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-CFE-2014-004. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-CFE-2014-004,
and should be submitted on or before October 2, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21648 Filed 9-10-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Proposed Rules]
[Pages 4525-4527]
[FR Doc No: 2015-01603]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 174 and 180

[EPA-HQ-OPP-2014-0008; FRL-9921-55]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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SUMMARY: This document announces EPA's receipt of several initial
filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before February 27, 2015.

ADDRESSES: Submit your comments, identified by the Docket
Identification (ID) Number and the Pesticide Petition Number (PP) of
interest as shown in the body of this document, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), main telephone number:
(703) 305-7090, email address<EMAIL_ADDRESS>or Susan Lewis,
Registration Division (RD) (7505P), main telephone number: (703) 305-
7090, email address<EMAIL_ADDRESS>The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001. As part of the mailing address, include the contact person's

name, division, and mail code. The division to contact is listed at the
end of each pesticide petition summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT for the division listed at the end of the
pesticide petition summary of interest.

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 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 http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, EPA
seeks information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical or disproportionately high and adverse human health
impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is EPA taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. EPA is taking public
comment on the requests before responding to the petitioners. EPA is
not proposing any particular action at this time. EPA has determined
that the pesticide petitions described in this document contain the
data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C.
346a(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
pesticide petitions. After considering the public comments, EPA intends
to evaluate whether and what action may be warranted. Additional data
may be needed before EPA can make a final determination on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petitions so that the public has an
opportunity to comment on these requests for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petitions may be obtained
through the petition summaries referenced in this unit.

New Tolerances

    1. PP 4E8230. (EPA-HQ-OPP-2014-0600). BASF Corporation, 26 Davis
Dr., Research Triangle Park, NC 27709, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide
teflubenzuron, in or on apple at 0.5 parts per million (ppm); apple,
wet pomace at 0.8 ppm; broccoli at 0.2 ppm; cattle, muscle at 0.01 ppm;
cattle, meat byproducts at 0.01 ppm; cauliflower at 0.01 ppm; citrus
oil at 90 ppm; coffee, bean, green at 0.6 ppm; corn, field at 0.01 ppm;
corn, field, refined oil at 0.02 ppm; egg at 0.01 ppm; goat, muscle at
0.01 ppm; goat, meat byproducts at 0.01 ppm; horse, muscle at 0.01 ppm;
horse, meat byproducts at 0.01 ppm; lemon at 0.9 ppm; mango at 1.5 ppm;
melon at 0.3 ppm; milk at 0.01 ppm; orange at 0.6 ppm; papaya at 0.4
ppm; pineapple at 0.8 ppm; pork, muscle at 0.01 ppm; pork, meat
byproducts at 0.01 ppm; poultry, muscle at 0.01 ppm: Poultry, meat
byproducts at 0.01 ppm; sheep, muscle at 0.01 ppm; sheep, meat
byproducts at 0.01 ppm; soybean, seed at 0.05 ppm; soybean, hulls at
0.4 ppm; sugarcane, cane at 0.01 ppm; sunflower, seed at 0.3 ppm;
tomato at 1.5 ppm; and tomato, paste at 5 ppm. High performance liquid
chromatography with tandem mass spectrometry detection (HPLC-MS/MS) is
used to measure and evaluate the residues of teflubenzuron for the
proposed uses. Contact: RD.
    2. PP 4F8258. (EPA-HQ-OPP-2014-0357). E.I. du Pont de Nemours &
Company, 1007 Market St., Wilmington, DE 19898, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide
cyantraniliprole, in or on artichokes, globe (import tolerance) at 0.1
parts per million (ppm); berries, low growing, except strawberries
(crop subgroup 13-07H) (import tolerance) at 0.08 ppm; coffee, bean,
green (import tolerance) at 0.05 ppm; grapes (import tolerance) at 1.5
ppm; olives (import tolerance) at 1.5 ppm; peanuts at 0.01 ppm; peanut
hay at 3 ppm; pomegranates (import tolerance) at 0.01 ppm; rice, grain
(import tolerance) at 0.03 ppm; soybeans, seed at 0.4 ppm; strawberries
at 1.0 ppm; vegetables, foliage of legume (crop group 7) at 50 ppm;
vegetables, leaves of root and tuber (crop group 2) at 40 ppm;
vegetables, legume, dried shelled, except soybean (crop subgroup 6C) at
0.9 ppm; vegetables, legume, edible podded (crop subgroup 6A) at 2 ppm;
vegetables, legume, succulent shelled (crop subgroup 6B) at 0.2 ppm;
vegetables, root, except sugar beet (crop subgroup 1B) at 0.4 ppm; and
tea, dried (import tolerance) at 30 ppm. Adequate analytical
methodology, high-pressure liquid chromatography (HPLC) with
electrospray tandem mass spectrometry (ESI-MS/MS), is available for
enforcement purposes. Contact: RD.
    3. PP 4F8320. (EPA-HQ-OPP-2014-0890). Syngenta Crop Protection LLC,
P.O. Box 18300, Greensboro, NC 27419, requests to establish a tolerance
in 40 CFR part 180 for residues of the

insecticide cyantraniliprole, in or on corn, field and pop, forage at
0.04 parts per million (ppm); corn, field and pop, grain at 0.01 ppm;
corn, field and pop, stover at 0.015 ppm; corn, sweet, forage at 0.02
ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and
corn, sweet, stover at 0.08 ppm. Adequate analytical methodology, high-
pressure liquid chromatography (HPLC) with electrospray tandem mass
spectrometry (ESI-MS/MS) detection, is used to measure and evaluate the
chemical cyantraniliprole. Contact: RD.

Amended Tolerance

    1. PP 4F8290. (EPA-HQ-OPP-2014-0889). FMC Corporation, 1735 Market
St., Philadelphia, PA 19103, requests to amend the tolerances in 40 CFR
180.418 for residues of the insecticide, zeta-cypermethrin, in or on
raw agricultural commodities corn, field, forage from 0.2 parts per
million (ppm) to 9.0 ppm; corn, field, stover from 3.0 ppm to 30.0 ppm;
and corn, pop, stover from 3.0 ppm to 30.0 ppm. The Gas Chromatography
with Electron Capture Detection (GC/ECD) analytical method is used to
measure and evaluate the residues of zeta-cypermethrin for the
proposed, amended uses. Contact: RD.

New Tolerance Exemptions

    1. PP 2F8102. (EPA-HQ-OPP-2012-0963). BASF Corporation, 26 Davis
Dr., Research Triangle Park, NC 27709, requests to establish an
exemption from the requirement of a tolerance in 40 CFR part 180 for
residues of the fungicide Trichoderma asperelloides strain JM41R in or
on all food commodities. The petitioner believes no analytical method
is needed because, as proposed, the use of Trichoderma asperelloides
strain JM41R would not result in residues that are of toxicological
concern. Note: In the Federal Register of February 21, 2014 (79 FR
9870) (FRL-9904-98), EPA announced the filing of this petition to
establish an exemption from the requirement of a tolerance for residues
of Trichoderma fertile strain JM41R in or on all food commodities.
Since that time, the petitioner provided additional data on the
identity of the active ingredient to EPA. After reviewing these data,
EPA now considers the correct identity of the active ingredient to be
Trichoderma asperelloides strain JM41R and not Trichoderma fertile
strain JM41R. In order to give the public an opportunity to comment on
this new information, EPA is republishing its receipt of this tolerance
exemption petition filing with an updated and accurate description.
Contact: BPPD.
    2. PP 4F8252. (EPA-HQ-OPP-2014-0920). Certis USA LLC, 9145 Guilford
Rd., Suite 175, Columbia, MD 21046, requests to establish an exemption
from the requirement of a tolerance in 40 CFR part 180 for residues of
the fungicide Bacillus mycoides isolate J, in or on all agricultural
commodities. The petitioner believes no analytical method is needed
because an exemption from the requirement of a tolerance is being
sought for any residues and enforcement of residue levels would not be
needed. Contact: BPPD.
    3. PP 4F8271. (EPA-HQ-OPP-2014-0919). Marrone Bio Innovations,
Inc., 2121 Second St., Suite B-107, Davis, CA 95618, requests to
establish an exemption from the requirement of a tolerance in 40 CFR
part 180 for residues of the nematocide, fungicide, and insecticide,
sterile grain inoculated with Muscodor albus strain SA-13, in or on all
food commodities. The petitioner believes no analytical method is
needed because the active ingredient will not be in direct contact with
treated commodities, has limited survivability once the nutrient source
is exhausted, and will not result in residues of toxicological concern.
Contact: BPPD.
    4. PP 4F8276. (EPA-HQ-OPP-2014-0454). Monsanto Company, 800 North
Lindbergh Blvd., St. Louis, MO 63167, requests to establish an
exemption from the requirement of a tolerance in 40 CFR part 174 for
residues of the plant-incorporated protectant, Bacillus thuringiensis
Cry2Ab2 protein, in or on soybean. The petitioner believes no
analytical method is needed because an exemption from the requirement
of a tolerance is being sought. Contact: BPPD.
    5. PP 4F8289. (EPA-HQ-OPP-2014-0834). Southern Garden Citrus, 1820
Country Rd. 833, Clewiston, FL 33440, requests to establish an
exemption from the requirement of a tolerance in 40 CFR part 174 for
residues of defensin proteins derived from spinach (Spinacia oleracea
L.) and inserted into citrus plants in order to confer disease
resistance. The petitioner believes no analytical method is needed
because an exemption from the requirement of a tolerance is being
sought. Contact: BPPD.
    6. PP IN-10683. (EPA-HQ-OPP-2014-0176). Exponent, Inc., 1150
Connecticut Ave. NW., Suite 1100, Washington, DC 20036 (on behalf of
Huntsman Corporation, 8600 Gosling Rd., The Woodlands, TX 77381),
requests to establish an exemption from the requirement of a tolerance
in 40 CFR part 180 for residues of di-n-butyl carbonate (CAS No. 542-
52-9) when used as a pesticide inert ingredient in pesticide
formulations as a solvent without limits. The petitioner believes no
analytical method is needed because an exemption from the requirement
of a tolerance is being sought for this inert ingredient. Contact: RD.
    7. PP IN-10770. (EPA-HQ-OPP-2014-0874). BASF Corporation, 100 Park
Ave., Florham Park, NJ 07932, requests to establish an exemption from
the requirement of a tolerance in 40 CFR 180.960 for residues of 2-
propenoic acid, polymer with ethenyl acetate, ethenylbenzene, 2-
ethylhexyl 2-propenoate and ethyl 2-propenoate (CAS No. 85075-52-1)
with a minimum number average molecular weight (in amu) of 50,000
Daltons, when used as a pesticide inert ingredient in pesticide
formulations. The petitioner believes no analytical method is needed
because it is not relevant based upon the definition of a low risk
polymer under 40 CFR 723.250. Contact: RD.

    Authority:  21 U.S.C. 346a.

    Dated: January 20, 2015.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 2015-01603 Filed 1-27-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Rules and Regulations]
[Pages 52682-52684]
[FR Doc No: 2022-18512]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0647]
RIN 1625-AA00

Safety Zone; Pacific Airshow, Huntington Beach, California

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The U.S. Coast Guard is establishing a safety zone offshore of
Huntington Beach, CA, in support of the Pacific Airshow. This action is
necessary to provide for the safety of life on these navigable waters
in the area of the air and water demonstrations and to protect the high
concentration of people attending the event. This regulation prohibits
vessels from entering into, transiting through, or remaining within the
designated area unless specifically authorized by the Captain of the
Port, Sector Los Angeles--Long Beach (COTP), or a designated
representative.

DATES: This rule is effective from 7 a.m. on September 29, 2022,
through 5 p.m. on October 2, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0647 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 about this rule,
call or email LCDR Maria Wiener, U.S. Coast Guard Sector Los Angeles--
Long Beach; telephone<PHONE_NUMBER>, 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. The Coast Guard did not
receive final details for this event until August 9, 2022. There was
insufficient time to undergo the full rulemaking process, including
providing a reasonable comment period and considering those comments,
because the Coast Guard must establish this temporary safety zone by
September 29, 2022.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The COTP has determined that potential hazards associated with
this event. The sponsor will be conducting an air show in vicinity of
the Huntington Beach Pier, for a period of four days. This air show
will consist of numerous military and civilian aircraft performing
aerobatic maneuvers at high speed within the lateral limits of an
aerobatic box that would extend from the surface of the water to 15,000
feet above mean sea level (MSL). The event at Huntington Beach
generates over 800 spectator craft in attendance each year. The COTP
has determined that potential hazards associated with navigation safety
may arise due to multiple low flying aircraft flight paths and stunt
performances over the waters off Huntington Beach. This safety zone is
to ensure the safety of, and reduce the risk to, the public, and
mariners in the vicinity of the aerobatic performance.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7 a.m. on September 29,
2022, through 5 p.m. on October 2, 2022. Based on the safety risks
described above, the Coast Guard establishes a safety zone in the
vicinity of the Huntington Beach Pier during the Great Pacific Airshow
event. The safety zone will encompass all navigable waters from the
surface to the sea floor in an area bound by the following coordinates:
33[deg] 38.400' N; 117[deg] 58.834' W, 33[deg]37.992' N;
117[deg]59.204' W, 33[deg]39.625' N; 118[deg]1.806' W, 33[deg] 40.032'
N; 118[deg] 1.437' W. All coordinates displayed are referenced by North
American Datum of 1983, World Geodetic System, 1984.
    During the enforcement period, vessels are prohibited from entering
into, transiting through, or remaining within the designated area
unless authorized by the COTP or his designated representative. The
general boating public will be notified prior to the enforcement of the
temporary safety zone via Broadcast Notice to Mariners. No vessel or
person is permitted to operate in the safety zone without obtaining
permission from COTP or the COTP's designated representative. A
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 COTP in the enforcement of the security
zone. To seek permission to enter, hail Coast Guard Sector Los
Angeles--Long Beach on VHF-FM Channel 16 or<PHONE_NUMBER>. Upon being
hailed by a Coast Guard vessel or designated representative, by siren,
radio, flashing light or other means, the operator of the vessel shall
proceed as directed.

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, and duration of the safety zone. The size of the zone is the
minimum necessary to provide adequate protection for the waterways
users, adjoining areas, and the public. The zone will be in place
during the scheduled times of 7 a.m. to 5 p.m. Commercial vessel
traffic will not be affected by the establishment of the safety zone
due to its overall proximity to the shore.

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 encompassing an area in vicinity of Huntington Beach and
the Huntington Beach Pier. It is categorically excluded from further
review under paragraph L60(a), in Table 3-1 of U.S. Coast Guard
Environmental Planning Implementing Procedures. An environmental
analysis and checklist supporting this determination and Record of
Environmental Consideration (REC) are available in the docket where
indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T11-111 to read as follows:

Sec.  165.T11-111  Safety Zone; Pacific Airshow Huntington Beach,
California.

    (a) Location. The following area is a safety zone: All navigable
waters from the surface to the sea floor consisting of a line
connecting the following coordinates: 33[deg] 38.400' N; 117[deg]
58.834' W, 33[deg]37.992' N; 117[deg]59.204' W, 33[deg]39.625' N;
118[deg]1.806' W, 33[deg] 40.032' N; 118[deg] 1.437' W. All coordinates
displayed are referenced by North American Datum of 1983, World
Geodetic System, 1984.
    (b) Definitions. For the purposes of this section, designated
representative means a Coast Guard Patrol Commander, including a Coast
Guard coxswain, petty officer, or other officer operating a Coast Guard
vessel and a Federal, State, and local officer designated by or
assisting the Captain of the Port Sector Los Angeles--Long Beach (COTP)
in the enforcement of the security zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, hail Coast Guard Sector Los
Angeles--Long Beach on VHF-FM Channel 16 or call at<PHONE_NUMBER>.
Those in the security zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (3) Upon being hailed by the COTP's designated representative, by
siren, radio, flashing light or other means, the operator of the vessel
shall proceed as directed.
    (d) Enforcement period. The temporary safety zone will be enforced
from 7 a.m. to 5 p.m. each day from September 29, 2022, to October 2,
2022.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement date and times
for this safety zone via Local Notices to Mariners.

    Dated: August 23, 2022.
R.D. Manning,
Captain, U.S. Coast Guard, Captain of the Port, Sector Los Angeles--
Long Beach.
[FR Doc. 2022-18512 Filed 8-26-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54450-54453]
[FR Doc No: 2021-21382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3077]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Obtaining Information To Understand Challenges and
Opportunities Encountered by Compounding Outsourcing Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice requests comments on the information collection
associated with FDA research in obtaining information from pharmacists
and other management at outsourcing facilities and related human
prescription drug compounding businesses. The research supports a
comprehensive analysis of the outsourcing facility sector that informs
ongoing FDA work in this area.

DATES: Submit either electronic or written comments on the collection
of information by November 30, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 30, 2021. The https://www.regulations.gov electronic filing system will accept

comments until 11:59 p.m. Eastern Time at the end of November 30, 2021.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3077 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Obtaining Information to
Understand Challenges and Opportunities Encountered by Compounding
Outsourcing Facilities.'' 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Obtaining Information To Understand Challenges and Opportunities
Encountered by Compounding Outsourcing Facilities

OMB Control Number 0910-0883--Extension

    This information collection supports FDA research in obtaining a
range of information pertaining to human prescription drug compounding
by outsourcing facilities. Generally, drug compounding is the practice
of combining, mixing, or altering ingredients of a drug to create a
medication tailored an individual patient's needs. Although compounded
drugs can serve an important medical need for certain patients when an
approved drug is not medically appropriate, compounded drugs also
present a risk to patients. Compounded drugs are not FDA-approved;
therefore, they do not undergo FDA premarket review for safety,
effectiveness, and quality. Section 503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that
must be satisfied for compounded human prescription drug products to be
exempt from certain sections of the FD&C Act: (1) Section 501(a)(2)(B)
(21 U.S.C. 351(a)(2)(B))

(current good manufacturing practice (CGMP) requirements), (2) section
502(f)(1) (21 U.S.C. 352(f)(1)) (labeling of drugs with adequate
directions for use), and (3) section 505 (21 U.S.C. 355) (approval of
drugs under new drug applications or abbreviated new drug
applications).
    The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created
outsourcing facilities--a new industry sector of drug compounders held
to higher quality standards to protect patient health. Section 503B of
the FD&C Act (21 U.S.C. 353b) describes the conditions that outsourcing
facilities must satisfy for drug products compounded in an outsourcing
facility by or under the direct supervision of a licensed pharmacist to
be exempt from the certain sections of the FD&C Act. Outsourcing
facilities are intended to offer a more reliable supply of compounded
drugs that hospitals, clinics, and other providers need.
    FDA continues to find concerning quality and safety problems during
inspections of outsourcing facilities. FDA has implemented and will
continue to implement programs to support compounding quality and
compliance. One initiative is FDA's Compounding Quality Center of
Excellence (Center of Excellence), https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence, which was
developed to focus on improving the quality of compounded human
prescription drugs to promote patient safety. One of our top priorities
is to help ensure that compounded drugs are safe by focusing on
quality. FDA, state regulators, pharmacy associations, and compounders,
including outsourcing facilities, share the responsibility of patient
safety.
    The Center of Excellence engages and collaborates with compounders,
including outsourcing facilities, and other stakeholders to improve the
overall quality of compounded drugs. Furthermore, the Center of
Excellence promotes collaboration to help compounders implement robust
quality management systems that are better for business and the safety
of patients.
    To help strengthen the outsourcing facility industry's ability to
provide quality compounded drugs to patients who need them, the Center
of Excellence offers training sessions and opportunities to develop
manufacturing quality and other policies for outsourcing facilities,
including CGMPs.
    The Center of Excellence offers several training sessions
(available at https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-training-programs). Self-guided
training sessions teach the following topics: (1) Environmental
monitoring, (2) sterile drug compounding, (3) cleanroom performance
tests, and (4) conducting investigations and formulating corrective and
preventive actions. Instructor-led sessions teach the regulatory
framework for these topics: (1) Human drug compounding, (2) airflow
practices, (3) insanitary conditions and sterility, (4) stability and
beyond use dates, (5) requirements for outsourcing facility guides, and
(6) conducting investigations and formulating corrective and preventive
actions. Management and staff from outsourcing facilities have attended
the training sessions. Feedback on the training sessions has been
positive, and interest in the sessions continues to grow.
    In addition, the Center of Excellence is conducting indepth
research to better understand outsourcing facilities' challenges and
opportunities in different areas to help guide decisions regarding
future training and other engagement. Outsourcing facilities encounter
the following challenges and opportunities: (1) Operational barriers
and opportunities related to the outsourcing facility market and
business viability, (2) knowledge and operational barriers and
opportunities related to compliance with Federal policies and good
quality drug production, and (3) barriers and opportunities related to
outsourcing facility interactions with FDA.
    FDA used previous research results under this information
collection to develop an understanding of the outsourcing facility
sector, the sector's challenges, and opportunities for advancement. The
information collected was an essential tool to help FDA identify
knowledge and information gaps, operational barriers, and views on
interactions with FDA. FDA has presented this information in public
settings such as stakeholder meetings. Continuing this collection will
enable FDA to deepen our understanding of the outsourcing facility
sector and increase our efficacy in developing a Center of Excellence
that is responsive to outsourcing facilities' needs. The research
results will inform FDA's future activities for the Center of
Excellence in the areas of communication, education, training, and
other engagement with outsourcing facilities to address challenges and
support advancement.
    Researchers engage with pharmacists, staff, and management from
outsourcing facilities and similar compounding businesses and may use
surveys, interviews, and focus groups to obtain information about
outsourcing facilities' challenges and opportunities. Within this
context, we may pose the following questions or similar, related
questions:
    1. What financial and operational considerations inform outsourcing
facility operational and business model decisions?
    2. What factors impact developing a sustainable outsourcing
facility business?
    3. What financial and operational considerations inform outsourcing
facility product decisions?
    4. Do outsourcing facilities understand the Federal laws and
policies that apply to them? What, if any, knowledge gaps do we need to
address?
    5. What are outsourcing facilities' challenges when implementing
Federal CGMP requirements?
    6. How do outsourcing facilities implement quality practices at
their facilities?
    7. How do outsourcing facilities develop CGMP and quality
expertise? How do they obtain this knowledge, and what training do they
need?
    8. What are the economic consequences of CGMP noncompliance and
product failures for outsourcing facilities?
    9. What are outsourcing facility management and staff views on
current interactions with FDA? How do they want the interactions to
change?
    10. What are outsourcing facilities' understanding of how to engage
with FDA during and following an inspection?
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveys, focus groups, and interviews..............................             300                2              600                1              600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our original request for the information collection was approved
January 21, 2020; however, the subsequent public health emergency
inhibited our ability to administer the requested survey. We have
therefore made no adjustments to our current burden estimate.

    Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21382 Filed 9-30-21; 8:45 am]
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[Federal Register Volume 85, Number 104 (Friday, May 29, 2020)]
[Proposed Rules]
[Pages 32324-32327]
[FR Doc No: 2020-11260]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2020-0213; FRL-10009-13-Region 9]

Air Plan Approval; California; Consumer Products Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the California Air Resources Board's Consumer
Products portion of the California State Implementation Plan (SIP).
These revisions concern volatile organic compound (VOC) emissions from
consumer products and a supporting test method. The EPA is also
proposing to approve revisions to California's Tables of Maximum
Incremental Reactivity (MIR) Values to support its Aerosol Coating
Products regulation. We are proposing to approve state rules to
regulate these emission sources under the Clean Air Act (CAA or the
Act). We are taking comments on this proposal and plan to follow with a
final action.

DATES: Comments must be received on or before June 29, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2020-0213 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jeffrey Buss, EPA Region IX, 75
Hawthorne Street, San Francisco, CA 94105,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revisions?
II. The EPA's Evaluation and Proposed Action
    A. How is the EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public comment and proposed action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were amended and submitted by the California Air Resources
Board (CARB). The rules rely on CARB Method 310, which was submitted by
CARB to the EPA on June 4, 2019.
---------------------------------------------------------------------------

    \1\ CARB adopted amendments to articles 1, 2 and 3 of subchapter
8.5 and article 1 of subchapter 8.6 on September 26, 2013. The
California Office of Administrative Law (OAL) approved the
amendments on September 17, 2014, effective January 1, 2015. CARB
submitted the September 26, 2013 amendments to the EPA as a SIP
revision on December 1, 2016. CARB adopted further amendments to
articles 1 and 2 of subchapter 8.5 on May 25, 2018. The 2018
amendments were approved by the California OAL on December 31, 2018,
effective January 1, 2019. CARB also adopted amendments to Test
Method 310 on May 25, 2018. CARB submitted articles 1 and 2 and Test
Method 310, as amended on May 25, 2018, to the EPA as a SIP revision
by letter dated June 4, 2019.
    \2\ Article 1 of subchapter 8.5 includes sections 94500, 94501,
94502, 94503, 94503.5, 94504, 94505, 94506 and 94506.5.
    \3\ Article 2 of subchapter 8.5 includes sections 94507 through
94517.
    \4\ Article 3 of subchapter 8.5 includes sections 94520 through
94528.
    \5\ Article 1 of subchapter 8.6 includes sections 94700 and
94701.

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                      California Code of
           Local agency                  Regulations               Title            Amended \1\      Submitted
----------------------------------------------------------------------------------------------------------------
CARB..............................  Title 17, Division 3,  Antiperspirants and         5/25/2018      06/04/2019
                                     Chapter 1,             Deodorants \2\.
                                     Subchapter 8.5,
                                     Article 1.
CARB..............................  Title 17, Division 3,  Consumer Products \3\       5/25/2018      06/04/2019
                                     Chapter 1,
                                     Subchapter 8.5,
                                     Article 2.
CARB..............................  Title 17, Division 3,  Aerosol Coating            09/17/2014      12/01/2016
                                     Chapter 1,             Products \4\.
                                     Subchapter 8.5,
                                     Article 3.
CARB..............................  Title 17, Division 3,  Tables of Maximum          09/17/2014      12/01/2016
                                     Chapter 1,             Incremental
                                     Subchapter 8.6,        Reactivity (MIR)
                                     Article 1.             Values \5\.
CARB..............................  Method 310--           5/25/2018............        6/4/2019
                                     Determination of
                                     Volatile Organic
                                     Compounds (VOC) in
                                     Consumer Products
                                     and Reactive Organic
                                     Compounds (ROC) in
                                     Aerosol Coating
                                     Products.
----------------------------------------------------------------------------------------------------------------

    CARB's December 1, 2016 SIP revision submittal became complete by
operation of law on June 1, 2017. CARB's June 4, 2019 SIP revision
submittal became complete by operation of law on December 4, 2019.

B. Are there other versions of these rules?

    We approved earlier versions of CARB's Consumer Products rules into
the SIP as follows: Subchapter 8.5, Article 1 (``Antiperspirants and
Deodorants'') at 74 FR 57074 (November 4, 2009); Article 2 (``Consumer
Products'') at 79 FR 62346 (October 17, 2014); Article 3 (``Aerosol
Coating Products'') at 74 FR 57074 (November 4, 2009), and Subchapter
8.6, Article 1 (``Tables of Maximum Incremental Reactivity (MIR)
Values'') at 70 FR 53930 (September 13, 2005). The EPA has not
previously approved CARB Method 310 as part of the California SIP.

C. What is the purpose of the submitted rule revisions?

    Emissions of VOCs help produce ground-level ozone, smog and
particulate matter, which harm human health and the environment.
Section 110(a) of the CAA requires states to submit regulations that
control VOC emissions. VOC emissions from consumer products contribute
to the formation of ozone. CARB's Staff Report: Initial Statement of
Reasons for Proposed Rulemaking for its consumer products amendments
states, ``For more than twenty years, the Board has taken actions
pertaining to the regulation of consumer products. Three regulations
[Antiperspirants and Deodorants, Consumer Products, and Aerosol
Coatings] have set VOC limits for 129 consumer product categories.
These three regulations, when fully effective, will reduce VOC
emissions by about 50 percent compared to 1990 levels.'' \6\ CARB
predicts that consumer products will, by 2020, become the largest
source category of VOC emissions in the South Coast Air Basin,\7\ which
is classified as an ``Extreme'' nonattainment area for the following
National Ambient Air Quality Standards (NAAQS): 1979 1-hour ozone, 1997
8-hour ozone, 2008 8-hour ozone, and the 2015 ozone NAAQS (see 40 CFR
part 81).
---------------------------------------------------------------------------

    \6\ ``Staff Report: Initial Statement of Reasons for Proposed
Rulemaking,'' California Air Resources Board, August 7, 2013
(``Staff Report'') at Executive Summary-2 available at https://ww3.arb.ca.gov/regact/2013/cp2013/cp13isor.pdf.
    \7\ Id. at Chapter II-9.
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    The current amendments to Article 1 (``Antiperspirants and
Deodorants'') of 17 CCR Division 3 (``Air Resources''), chapter 1
(``Air Resources Board''), subchapter 8.5 (``Consumer Products'')
update certain definitions and references. The current amendments to
Article 2 (``Consumer Products'') of subchapter 8.5 revise certain
definitions, lower certain VOC standards, and clarify and update
certain administrative and reporting requirements. Current amendments
to Article 3 (``Aerosol Coating Products'') of subchapter 8.5 clarify
applicability, revise certain definitions, delete mass-based VOC limits
and add new, lower reactivity-based limits for general and specialty
aerosol coatings. Lastly, the current amendments to Article 1 (``Tables
of Maximum Incremental

Reactivity (MIR) Values'') of 17 CCR Division 3, chapter 1, subchapter
8.6 (``Maximum Incremental Reactivity'') update MIR values for many
individual chemical compounds and hydrocarbon solvent groupings. CARB
estimates that the current amendments will result in equivalent VOC
emission reductions of approximately 4 tons per day (tpd) statewide, of
which approximately 1.8 tpd would occur in the area under the
jurisdiction of the South Coast Air Quality Management District.
    The EPA's technical support documents (TSDs) have more information
about these rules.

II. The EPA's Evaluation and Proposed Action

A. How is the EPA evaluating the rules?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193). California's consumer products
regulations cover VOC area sources. In 1998, the EPA promulgated a
national rule to regulate VOC emissions from consumer products, 63 FR
48831 (September 11, 1998), and in 2008, the EPA promulgated a national
rule to regulate the ozone forming potential of aerosol coating
products, 73 FR 15621 (March 24, 2008). The amendments from CARB that
we are proposing to approve herein contain more stringent limits for
consumer products than the corresponding limits in the national
consumer products VOC rule. With respect to CARB's Aerosol Coatings
Products rule, we find that the amendments we are proposing to approve
herein contain limits that achieve lower ozone-forming potential
relative to the reactivity-based limits for aerosol coating products in
the EPA's national aerosol coatings rule.
    Guidance and policy documents that we used to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:
    1. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January 11,
1990).
    2. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    3. ``National Volatile Organic Compound Emission Standards for
Consumer and Commercial Products,'' 40 CFR part 59; particularly,
subpart C (``National Volatile Organic Compound Emission Standards for
Consumer Products,'' and subpart E (``National Volatile Organic
Compound Emission Standards for Aerosol Coatings'').
    4. ``Model Rule for Consumer Products,'' Ozone Transport
Commission, September 19, 2006.\8\
---------------------------------------------------------------------------

    \8\ Available at https://otcair.org/document.asp?fview=modelrules.
---------------------------------------------------------------------------

B. Do the rules meet the evaluation criteria?

    When the EPA developed its national consumer products rules in 40
CFR part 59, we reviewed existing consumer products and aerosol coating
regulations from states including those from California.\9\ Since the
EPA promulgated its national rules, California has periodically amended
its consumer products and aerosol coating rules to add new product
categories, combine similar product categories, generally reduce the
VOC content limits for consumer products or product-weighted maximum
incremental reactivity limits for aerosol coatings, and made other
amendments to improve implementation and enforcement of its rules. CARB
also updated its Tables of Maximum Incremental Reactivity consistent
with newer science.
---------------------------------------------------------------------------

    \9\ National Volatile Organic Compound Emission Standards for
Consumer Products--proposed rule 61 FR 14531 (April 2, 1996), and
National Volatile Organic Compound Emission Standards for Aerosol
Coatings--proposed rule 72 FR 38951 (July 16, 2007).
---------------------------------------------------------------------------

    We compared CARB's amended rules against the EPA's rules and find
that, overall, CARB's rules are the same or more stringent than the
national rules. We noted in our TSD for aerosol coatings that there are
a few limited instances where CARB adopted new aerosol coating
categories or where it merged existing aerosol coating product
categories, to streamline its regulation, that could result in a small
emissions increase. More specifically, when CARB merged existing
subcategories in the Hobby/Model/Craft aerosol coating category into a
single category and merged the existing subcategories in the Shellac
Sealer aerosol coating category into a single category, CARB estimated
that these amendments could have resulted in approximately 0.1 tpd
increase for 3-4 months, prior to 2015, if all of the products in these
coatings were to reformulate.\10\ CARB points out, however, that the
likelihood of an increase in the ozone forming potential for these
product categories is small because all products are already in full
compliance with the limits that took effect January 1, 2015. This
hypothetical and temporary increase in emissions (approximately 0.1 tpd
increase for 3-4 months) would not occur after January 1, 2015 because
the 2015 limits, with only minor exceptions, are, on the whole, more
stringent than the prior (i.e., 2003) limits for the affected
categories whether merged or not merged.
---------------------------------------------------------------------------

    \10\ CARB Staff Report at Chapter IV-60 and Chapter VIII-153.
---------------------------------------------------------------------------

    The EPA notes that, although its national Consumer Products and
Aerosol Coatings rules and CARB's rules are similar, they are not
identical. Products will need to comply with the regulations in effect
from each agency, and compliance with CARB's rules does not necessarily
mean that the product complies with the EPA's national rules. This
proposed rulemaking action is limited to an evaluation of CARB's
amended rules for compliance with the requirements under the CAA and
the EPA's regulations for SIP revisions and does not opine on whether a
product that meets CARB's rules can also satisfy requirements in the
national consumer product rules.
    In sum, this action is consistent with EPA regulations, policy and
guidance. The EPA has promulgated a national consumer products
regulation and a national aerosol coatings regulation (40 CFR part 59,
subparts C and E). There are similarities and differences between the
California regulations and the national regulations. The national
consumer products and aerosol coatings regulations do not preclude
states from adopting more stringent regulations. In this instance,
CARB's Consumer Products regulations are both broader and, in many
cases, the same or more stringent than the federal regulations. As
noted above, CARB estimates that the current amendments will result in
equivalent VOC emission reductions of approximately 4 tons per day
(tpd) statewide, of which approximately 1.8 tpd would occur in the area
under the jurisdiction of the South Coast Air Quality Management
District.
    These rules are also consistent with CAA requirements and relevant
guidance regarding enforceability and SIP revisions. The TSDs have more
information on our evaluation.

C. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted rules because they fulfill all relevant
requirements. We will accept comments from the public on this proposal
until June 29, 2020. If we take final action to approve

the submitted rules, our final action will incorporate these rules into
the federally enforceable SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the CARB rules described in Table 1 of this preamble. The EPA
has made, and will continue to make, these materials available through
www.regulations.gov and at the EPA Region IX Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve state
regulations as meeting federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the proposed rule does not have tribal implications and
will not impose substantial direct costs on tribal governments or
preempt tribal law as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000).

List of Subjects

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: May 18, 2020.
John Busterud,
Regional Administrator, Region IX.
[FR Doc. 2020-11260 Filed 5-28-20; 8:45 am]
BILLING CODE 6560-50-P