[Federal Register Volume 75, Number 215 (Monday, November 8, 2010)]
[Rules and Regulations]
[Page 68416]
[FR Doc No: 2010-28103]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0690; Airspace Docket No. 10-ASW-2]

Establishment of Class E Airspace; Berryville, AR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace for Berryville, AR,
to accommodate Area Navigation (RNAV) Standard Instrument Approach
Procedures (SIAP) at Carroll County Airport, Berryville, AR. The FAA is
taking this action to enhance the safety and management of Instrument
Flight Rule (IFR) operations at the airport.

DATES: Effective Date: 0901 UTC, January 13, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On September 2, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to establish Class E airspace for
Berryville, AR, creating controlled airspace at Carroll County Airport
(75 FR 53876) Docket No. FAA-2010-0690. Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9U dated
August 18, 2010, and effective September 15, 2010, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by establishing Class E airspace extending upward from 700 feet
above the surface to accommodate SIAPs at Carroll County Airport,
Berryville, AR. This action is necessary for the safety and management
of IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, section 106, describes the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in subtitle VII, part A,
subpart I, section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it establishes
controlled airspace at Carroll County Airport, Berryville, AR.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

ASW AR E5 Berryville, AR [New]

Carroll County Airport, AR
    (Lat. 36[deg]22'53'' N., long. 93[deg]37'28'' W.)

    That airspace extending upward from 700 feet above the surface
within a 8.9-mile radius of Carroll County Airport and within 4
miles each side of the 253[deg] bearing from the airport extending
from the 8.9-mile radius to 11.3 miles west of the airport.

    Issued in Fort Worth, Texas, on October 26, 2010.
Anthony D. Roetzel,
Manager Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-28103 Filed 11-5-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Pages 29952-29957]
[FR Doc No: E9-14862]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2008-0503; FRL-8922-7]
RIN-2060-AO77

Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2009

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: With this action, EPA is allocating essential use allowances
for import and production of Class I ozone-depleting substances for
calendar year 2009. Essential use allowances enable a person to obtain
controlled Class I ozone depleting substances as part of an exemption
to the regulatory ban on the production and import of these chemicals,
which became effective January 1, 1996. EPA allocates essential use
allowances for production and import of a specific quantity of Class I
substances solely for the designated essential purpose. The allocation
in this action is 63.0 metric tons of chlorofluorocarbons for use in
metered dose inhalers for 2009.

DATES: This final rule is effective June 24, 2009.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2008-0503. All documents in the docket are listed on the
http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the Air
Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC 20460. This Docket Facility is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jennifer Bohman, by regular mail: U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205J), 1200 Pennsylvania Avenue, NW., Washington, DC, 20460; by
courier service or overnight express: 1301 L Street, NW., Room 1047A,
Washington DC, 20005; by telephone:<PHONE_NUMBER>; or by e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Basis for Allocating Essential Use Allowances
    A. What are essential use allowances?
    B. Under what authority does EPA allocate essential use
allowances?
    C. What is the process for allocating essential use allowances?
II. Essential Use Allowances for Medical Devices
III. Response to Comments
IV. Allocation of Essential Use Allowances for Calendar Year 2009
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act
VI. Effective Date of This Final Rule

I. Basis for Allocating Essential Use Allowances

A. What are essential use allowances?

    Essential use allowances are allowances to produce or import
certain ozone-depleting substances (ODSs) in the U.S. for purposes that
have been deemed ``essential'' by the U.S. Government and by the
Parties to the Montreal Protocol on Substances that

Deplete the Ozone Layer (Montreal Protocol).
    The Montreal Protocol is the international agreement aimed at
reducing and eliminating the production and consumption \1\ of ODSs.
Eliminating the production and consumption of Class I ODSs is
accomplished through adherence to phaseout schedules for specific Class
I ODSs \2\ which include chlorofluorocarbons (CFCs), halons, carbon
tetrachloride, and methyl chloroform. As of January 1, 1996, production
and import of most Class I ODSs were phased out in developed countries,
including the United States. However, the Montreal Protocol and the
Clean Air Act (the Act) provide exemptions that allow for the continued
import and/or production of Class I ODSs for specific uses. Under the
Montreal Protocol, exemptions may be granted for uses that are
determined by the Parties to be ``essential.'' Decision IV/25, taken by
the Parties to the Protocol in 1992, established criteria for
determining whether a specific use should be approved as essential, and
set forth the international process for making determinations of
essentiality. The criteria for an essential use, as set forth in
paragraph 1 of Decision IV/25, are the following:
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    \1\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported into the
United States, minus the amount exported to Parties to the Montreal
Protocol (see Section 601(6) of the Clean Air Act).
    \2\ Class I ozone-depleting substances are listed at 40 CFR part
82, subpart A, appendix A.
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     ``(a) That a use of a controlled substance should qualify
as `essential' only if:
     (i) It is necessary for the health, safety or is critical
for the functioning of society (encompassing cultural and intellectual
aspects); and
     (ii) There are no available technically and economically
feasible alternatives or substitutes that are acceptable from the
standpoint of environment and health;
     (b) That production and consumption, if any, of a
controlled substance for essential uses should be permitted only if:
     (i) All economically feasible steps have been taken to
minimize the essential use and any associated emission of the
controlled substance; and
     (ii) The controlled substance is not available in
sufficient quantity and quality from existing stocks of banked or
recycled controlled substances, also bearing in mind the developing
countries' need for controlled substances.''

B. Under what authority does EPA allocate essential use allowances?

    Title VI of the Act implements the Montreal Protocol for the United
States.\3\ Section 604(d) of the Act authorizes EPA to allow the
production of limited quantities of Class I ODSs after the phaseout
date for the following essential uses:
---------------------------------------------------------------------------

    \3\ See Section 614(b) of the Act. EPA's regulations
implementing the essential use provisions of the Act and the
Protocol are located in 40 CFR part 82.
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     (1) Methyl chloroform, ``solely for use in essential
applications (such as nondestructive testing for metal fatigue and
corrosion of existing airplane engines and airplane parts susceptible
to metal fatigue) for which no safe and effective substitute is
available.'' Under section 604(d)(1) of the Act, this exemption was
available only until January 1, 2005. Prior to that date, EPA issued
methyl chloroform allowances to the U.S. Space Shuttle and Titan Rocket
programs.
     (2) Medical devices (as defined in section 601(8) of the
Act), ``if such authorization is determined by the Commissioner [of the
Food and Drug Administration], in consultation with the Administrator
[of EPA] to be necessary for use in medical devices.'' EPA issues
allowances to manufacturers of metered dose inhalers (MDIs) that use
CFCs as propellant for the treatment of asthma and chronic obstructive
pulmonary disease.
     (3) Aviation safety, for which limited quantities of
halon-1211, halon-1301, and halon-2402 may be produced ``if the
Administrator of the Federal Aviation Administration, in consultation
with the Administrator [of EPA] determines that no safe and effective
substitute has been developed and that such authorization is necessary
for aviation safety purposes.'' Neither EPA nor the Parties have ever
granted a request for essential use allowances for halon, because
alternatives are available or because existing quantities of this
substance are large enough to provide for any needs for which
alternatives have not yet been developed.
    An additional essential use exemption under the Montreal Protocol,
as agreed in Decision X/19, is the general exemption for laboratory and
analytical uses. This exemption is reflected in EPA's regulations at 40
CFR part 82, subpart A. While the Act does not specifically provide for
this exemption, EPA has determined that an exemption for essential
laboratory and analytical uses is allowable under the Act as a de
minimis exemption. The de minimis exemption is addressed in EPA's final
rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol
subsequently agreed (Decision XI/15) that the general laboratory and
analytical use exemption does not apply to the following uses: testing
of oil and grease, and total petroleum hydrocarbons in water; testing
of tar in road-paving materials; and forensic finger-printing. EPA
incorporated this exemption at Appendix G to Subpart A of 40 CFR part
82 on February 11, 2002 (67 FR 6352). In a December 29, 2005, final
rule, EPA extended the general exemption for laboratory and analytical
uses through December 31, 2007 (70 FR 77048), in accordance with
Decision XV/8 of the Parties to the Protocol. At the 19th Meeting of
the Parties in September 2007, the Parties agreed to extend the global
laboratory and analytical use exemption through December 31, 2011, in
Decision XIX/18. In a December 27, 2007, final rulemaking EPA took
action to (1) extend the laboratory and analytical use exemption from
December 31, 2007, to December 31, 2011, for specific laboratory uses,
(2) apply the laboratory and analytical use exemption to the production
and import of methyl bromide, and (3) eliminate the testing of organic
matter in coal from the laboratory and analytical use exemption (72 FR
73264).

C. What is the process for allocating essential use allowances?

    The procedure set out by Decision IV/25 calls for individual
Parties to nominate essential uses and the total amount of ODSs needed
for those essential uses on an annual basis. The Protocol's Technology
and Economic Assessment Panel (TEAP) evaluates the nominated essential
uses and makes recommendations to the Parties. The Parties take the
final decisions on whether to approve a Party's essential use
nomination at their annual Meeting of the Parties. This nomination
process occurs approximately two years before the year in which the
allowances would be in effect. The allowances allocated for 2009 in
this final rule were first nominated by the United States in January
2007.
    For MDIs, EPA requests information from manufacturers about the
number and type of MDIs they plan to produce, as well as the amount of
CFCs necessary for production. EPA then forwards the information to the
Food and Drug Administration (FDA), which determines the amount of CFCs
necessary for MDIs in the coming calendar year. Based on FDA's
determination, EPA proposes allocations to each eligible entity. Under
the Act and the Montreal Protocol, EPA

may allocate essential use allowances in quantities that together are
less than or equal to the total amount approved by the Parties. EPA
will not allocate essential use allowances in amounts higher than the
total approved by the Parties. For 2009, the Parties authorized the
United States to allocate up to 282 metric tons (MT) of CFCs for
essential uses. In a notice of proposed rulemaking published in the
Federal Register on January 16, 2009 (74 FR 2954), EPA proposed to
allocate 63.0 MT of CFCs for the production of MDIs for the calendar
year 2009. In this final rule, EPA is allocating 63.0 MT of CFCs for
the production of MDIs for calendar year 2009.

II. Essential Use Allowances for Medical Devices

    The following is a step-by-step list of actions EPA and FDA have
taken to implement the exemption for medical devices found at section
604(d)(2) of the Act for the 2009 calendar year.
    1. On January 16, 2008, EPA sent letters to MDI manufacturers
requesting the following information under section 114 of the Act
(``114 letters''):
    a. The MDI product where CFCs will be used.
    b. The number of units of each MDI product produced from 1/1/07 to
12/31/07.
    c. The number of units anticipated to be produced in 2008.
    d. The number of units anticipated to be produced in 2009.
    e. The gross target fill weight per unit (grams).
    f. Total amount of CFCs to be contained in the MDI product for
2009.
    g. The additional amount of CFCs necessary for production.
    h. The total CFC request per MDI product for 2009.
    The letters from EPA are available for review in the Air Docket ID
No. EPA-HQ-OAR-2008-0503. The companies requested that their responses
be treated as confidential business information; for this reason, EPA
has placed the responses in the confidential portion of the docket.
    2. At the end of January 2008, as required by 40 CFR 82.13(u), EPA
received annual reporting information from MDI manufacturers that
included such data as the type and quantity of CFCs held at the end of
the year (i.e. stocks of pre-1996 and post-1996 CFCs). The data
submitted from the MDI manufacturers is available for review in the Air
Docket ID No. EPA-HQ-OAR-2008-0503. The companies requested that their
individual responses be treated as confidential business information;
for this reason, EPA has placed the individual responses in the
confidential portion of the docket.
    3. On February 13, 2008, EPA sent FDA the information MDI
manufacturers provided in response to the 114 letters and information
required by 40 CFR 82.13(u) with a letter requesting that FDA make a
determination regarding the amount of CFCs necessary for MDIs for
calendar year 2009. This letter is available for review in Air Docket
ID No. EPA-HQ-OAR-2008-0503.
    4. On April 28, 2008, FDA sent a letter to EPA stating the amount
of CFCs determined by the Commissioner to be necessary for each MDI
company in 2009. FDA's letter informed EPA that it had determined that
88.0 MT of CFCs were necessary for use in medical devices in the year
2009. This letter is available for review in the Air Docket ID No. EPA-
HQ-OAR-2008-0503.
    5. On August 12, 2008, FDA sent a letter to EPA revising its April
28, 2008 essential use determination. FDA's revised letter informed EPA
that it had determined that 63.0 MT of CFCs were necessary for use in
medical devices for the year 2009. In its letter, FDA stated that ``The
amount of CFCs recommended in our April 28, 2008 letter was based on
information available then, that led to assumptions that are now
outdated.'' This letter is available for review in the Air Docket ID
No. EPA-HQ-OAR-2008-0503.
    With respect to the 2009 determination, FDA stated, ``FDA's
determination for the allocation of CFCs is lower than the total amount
requested by sponsors. In reaching this determination, we took into
account the sponsors' production of MDIs that used CFCs as a propellant
in 2007, their estimated production in 2008, their estimated production
in 2009, their anticipated essential-use allocations in 2008, their
current (as of December 31, 2007) stockpile levels, and any
intercompany transfers of CFCs. Finally, FDA based its determination
for 2009 on an estimate of the quantity of CFCs that would allow
manufacturers to have a 12-month stockpile at the end of 2009, in
accordance with paragraph 3 of Decision XVI/12 and paragraph 2 of
Decision XVII/5.''
    The letter stated that in making its determination, FDA made the
following assumptions:
     All manufacturers will receive the full essential-use
allocation proposed by EPA for calendar year 2008 (72 FR 32269, June
12, 2007);
     All manufacturers will procure the full quantity of CFCs
allocated to them for 2008; and
     No bulk CFCs currently held by, or allocated to, any
manufacturer will be exported from the United States.
    EPA has confirmed with FDA that this determination is consistent
with Decision XVII/5, including language on stocks that states that
Parties ``shall take into account pre- and post-1996 stocks of
controlled substances as described in paragraph 1(b) of Decision IV/25,
such that no more than a one-year operational supply is maintained by
that manufacturer.'' Allowing manufacturers to maintain up to a one-
year operational supply accounts for unexpected variability in the
demand for MDI products or other unexpected occurrences in the market
and therefore ensures that MDI manufacturers are able to produce their
essential use MDIs.
    For calendar year 2009, FDA's determination aggregates the amounts
of CFC-11, -12, or -114 being allocated to the MDI manufacturer. In its
letter FDA stated, ``As has generally been our practice, FDA is
aggregating the amounts for CFCs, and is providing recommendations on
the total amounts of CFCs necessary to protect the public health. FDA
expects manufacturers to maintain an appropriate balance of CFCs
necessary to produce their CFC MDIs.''
    6. In accordance with FDA's determination, EPA proposed to allocate
63.0 MT of CFCs for the production of MDIs for the calendar year 2009
in a proposed rulemaking published on January 16, 2009 (74 FR 2954).
    7. In this final rule, EPA is allocating 63.0 MT of CFCs for the
production of MDIs for calendar year 2009.

III. Response to Comments

    EPA received comments from two entities on the proposed rule.
    One commenter supported the proposed rule and opposed limiting the
use of ODSs in MDIs. The commenter noted that lower cost CFC MDIs are a
benefit for low-income individuals.
    EPA believes that only a limited amount of production or import of
CFCs for use in MDIs is necessary in 2009. Section 604 of the Clean Air
Act directs EPA to authorize the production of CFCs for essential MDIs
if FDA, in consultation with EPA, determines such production to be
necessary. FDA, in consultation with EPA, has determined that 63.0 MT
of CFCs are necessary to meet the demand for 2009 MDI manufacturing.
Therefore, this action allocates 63.0 MT of CFCs for use in MDIs in
2009.
    EPA and FDA understand that patients may incur additional costs to
purchase inhalers as the market transitions to CFC-free alternatives,
such

as HFA MDIs. For example, patients covered by medical insurance may
encounter higher co-payments to purchase HFA MDIs, which are brand name
products. However, patient assistance programs exist to assist patients
with the increased costs. For low-income patients, these programs
include free and/or discounted medicines. To assist patients facing
higher co-pays associated with the increased costs of the HFA MDIs,
programs such as coupons and discounted HFA MDIs are being made
available through physicians' offices, at pharmacies, and at individual
manufacturers' Web sites.
    In a related rulemaking, FDA responded to a similar comment
regarding the cost of CFC-free alternatives, stating, ``Considering the
availability of programs providing low-cost or free prescription drugs
that would allow low-income, elderly, and uninsured individuals to
purchase alternative MDIs, and the availability of physician samples,
we believe that patients will be adequately served by alternative
MDIs'' (73 FR 69532).
    A second commenter supported the proposed rule but believes that
the US Government should take actions to limit the amount of CFCs
needed for use in MDIs in the future. The commenter believes that the
U.S. Government should set up procedures or guidelines to encourage MDI
manufacturers to develop CFC-free MDIs. The commenter also asked
whether the global laboratory and analytical use exemption would extend
to the future use of MDIs.
    EPA notes that the transition to ozone-safe alternatives is well
underway and that, for example, the allocation of essential use
allowances for CFC-based MDIs significantly decreased from over 3,000
MT in 2000 to 63.0 MT in 2009. In this action, EPA is only allocating
essential use allowances to one manufacturer of CFC-MDIs.
    FDA has found the use of ODSs to be essential in a limited number
of medical products, including certain metered dose inhalers for the
treatment of asthma and chronic obstructive pulmonary disease (see 21
CFR 2.125(e)(1) and (e)(2)). When a specific medical product meets the
criteria for removal of the essential use designation, FDA initiates
rulemakings that remove the essential use designations for MDIs in a
manner that is protective of public health. Specifically, FDA published
a final rule in 2008 that removes the essential use designation for
epinephrine used in MDIs as of December 31, 2011 (73 FR 69532).
Further, FDA published a proposed rule in 2007 that proposes removing
the essential use designations for flunisolide, triamcinolone,
metaproterenol, pirbuterol, albuterol and ipratropium in combination,
cromolyn, and nedocromil used in MDIs as of December 31, 2009 (72 FR
32030).
    With respect to the comment that EPA should encourage MDI
manufacturers to develop CFC-free MDIs, EPA agrees that companies that
apply for essential use allocations should demonstrate ongoing research
and development of alternatives to CFC MDIs. Decision VIII/10, taken in
1997, provides for applicants to submit information on the status of
research and development into alternatives, and Decision XIX/13, taken
in September 2007, provides for applicants to submit related
information describing their progress in transitioning to CFC-free
formulations. Since 1997, EPA has requested that applicants provide
this information with their applications for CFC essential use
nominations. The MDI manufacturer that is receiving an essential use
allocation has submitted information to EPA pertaining to its research
and development efforts.
    Finally, the global laboratory and analytical exemption allows the
continued production and import of small amounts of class I ODSs for
use in essential laboratory and analytical methods. At the 19th Meeting
of the Parties in September 2007, the Parties agreed to extend the
global laboratory and analytical use exemption through December 31,
2011, in Decision XIX/18. The use of CFCs in MDIs is not a laboratory
or analytical use. Therefore, the use of CFCs in MDIs would not qualify
under the global laboratory and analytical use exemption.

IV. Allocation of Essential Use Allowances for Calendar Year 2009

    With this action, EPA is allocating essential use allowances for
calendar year 2009 to the entity listed in Table 1. These allowances
are for the production or import of the specified quantity of Class I
controlled substances solely for the specified essential use.

        TABLE I--Essential Use Allowances for Calendar Year 2009
------------------------------------------------------------------------
                                                           2009 quantity
            Company                      Chemical          (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong......................  CFC-11 or CFC-12 or CFC-           63.0
                                  114.
------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action'' because it raises
novel legal or policy issues. Accordingly, EPA submitted this action to
the Office of Management and Budget (OMB) for review under EO 12866 and
any changes made in response to OMB recommendations have been
documented in the docket for this action.
    EPA prepared an analysis of the potential costs and benefits
related to this action. This analysis is contained in the Agency's
Regulatory Impact Analysis (RIA) for the entire Title VI phaseout
program (U.S. Environmental Protection Agency, ``Regulatory Impact
Analysis: Compliance with Section 604 of the Clean Air Act for the
Phaseout of Ozone Depleting Chemicals,'' July 1992). A copy of the
analysis is available in the docket for this action and the analysis is
briefly summarized here. The RIA examined the projected economic costs
of a complete phaseout of consumption of ozone-depleting substances, as
well as the projected benefits of phased reductions in total emissions
of CFCs and other ozone-depleting substances, including essential use
CFCs used for MDIs.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
The recordkeeping and reporting requirements included in this action
are already included in an existing information collection burden and
this action does not make any changes that would affect the burden.
However, the Office of Management and Budget (OMB) has previously
approved the information collection requirements

contained in the existing regulations at 40 CFR 82.8(a) under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2060-0170. The OMB control numbers for
EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
    For purposes of assessing the impact of today's rule on small
entities, small entity is defined as: (1) A small business that is
primarily engaged in pharmaceutical preparations manufacturing as
defined by NAICS code 325412 with less than 750 employees; (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
    This action will provide an otherwise unavailable benefit to those
companies that are receiving essential use allowances by creating an
exemption to the regulatory phaseout of chlorofluorocarbons. We have
therefore concluded that today's rule will relieve regulatory burden
for all small entities. EPA solicited comments on the potential impact
of the proposed rule on small entities. EPA did not receive comments
related to the potential impact of the proposed rule on small entities.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. This action is deregulatory
and does not impose any new requirements on any entities. Therefore,
this action is not subject to the requirements of sections 202 and 205
of UMRA. This action is also not subject to the requirements of section
203 of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments because this rule
merely allocates essential use exemptions to entities as an exemption
to the ban on production and import of Class I ODSs.

E. Executive Order 13132: Federalism

    Executive Order 13132, titled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects 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.''
    This rule does not have federalism implications. It will not have
substantial direct effects 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, as
specified in Executive Order 13132. Thus, Executive Order 13132 does
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action does
not have tribal implications because it does not have substantial
direct effects 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. Thus, Executive Order 13175 does not
apply to this action. EPA solicited comment on the proposed rule from
tribal officials. EPA did not receive any comments from tribal
officials on the proposed rule.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets EO 13045 as applying to those regulatory actions
that concern health or safety risks, such that the analysis required
under section 5-501 of the Order has the potential to influence the
regulation. This rule is not subject to EO 13045 because it implements
Section 604(d)(2) of the Clean Air Act which states that the Agency
shall authorize essential use exemptions should the Food and Drug
Administration determine that such exemptions are necessary.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. This rule does not have any adverse
energy effects because it merely allocates essential use allowances to
entities manufacturing metered dose inhalers as an exemption to the ban
on production and import of Class I ODSs.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This rule does
not involve technical standards. Therefore, EPA did not consider the
use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has concluded that it is not practicable to determine whether
there would be disproportionately high and adverse human health or
environmental effects on minority and/or low income populations from
this rule. EPA believes, however, that this action affects the level of
environmental protection equally for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. Any ozone depletion that results from this rule will
impact all affected populations equally, because ozone depletion is a
global environmental problem with environmental and human effects that
are, in general, equally distributed across geographical regions.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Therefore, EPA will submit a report containing this rule
and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2). This rule will be
effective June 24, 2009.

VI. Effective Date of This Final Rule

    Section 553(d) of the Administrative Procedures Act (APA) generally
provides that rules may not take effect earlier than 30 days after they
are published in the Federal Register. This final rule is issued under
section 307(d) of the CAA, which does not include a 30-day effective-
date period requirement, and which precludes the application of section
553(d). CAA section 307(d)(1) (``The provisions of section 553 through
557 * * * of Title 5 shall not, except as expressly provided in this
subsection, apply to actions to which this subsection applies.'') EPA
is making this final rule effective June 24, 2009, and believes that
this is consistent with the policies underlying APA section 553(d).
Specifically, APA section 553(d) provides an exception for any action
that grants or recognizes an exemption or relieves a restriction.
Because this action grants an exemption to the phaseout of production
and consumption of CFCs, EPA is making this action effective
immediately to ensure continued availability of CFCs for medical
devices.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Imports, Methyl
Chloroform, Ozone, Reporting and recordkeeping requirements.

    Dated: June 18, 2009.
Lisa P. Jackson,
Administrator.

0
40 CFR part 82 is amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority:  42 U.S.C. 7414, 7601,7671-7671q.

Subpart A--Production and Consumption Controls

0
2. Section 82.8 is amended by revising table I in paragraph (a) to read
as follows:

Sec.  82.8  Grant of essential use allowances and critical use
allowances.

    (a) * * *

        Table I--Essential Use Allowances for Calendar Year 2009
------------------------------------------------------------------------
                                                           2009 quantity
            Company                      Chemical          (metric tons)
------------------------------------------------------------------------
(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
 and Chronic Obstructive Pulmonary Disease.
------------------------------------------------------------------------
Armstrong......................  CFC-11 or CFC-12 or CFC-           63.0
                                  114.
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-14862 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14452-14454]
[FR Doc No: 2012-5731]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66512; File No. SR-BX-2012-011]

 Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Chapter V, Section 26 of the BOX Rules

March 5, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 22, 2012, NASDAQ OMX BX, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I and II below, which Items have been
prepared by the self-regulatory organization. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Chapter V, Section 26 (Limitation of
Liability) of the Rules of the Boston Options Exchange Group, LLC
(``BOX''). The text of the proposed rule change is available from the
principal office of the Exchange, at the Commission's Public Reference
Room and also on the Exchange's Internet Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/.

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

    In its filing with the Commission, the Exchange 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. The Exchange 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
    Chapter V, Section 26 of the BOX Trading Rules provides, in
general, that neither the Exchange, BOXR, BOX, nor any of their
respective affiliates with regard to BOX will be liable to BOX Options
Participants for any losses arising from the use of BOX or the BOX
Trading Host. The Exchange is proposing to codify provisions within the
BOX Trading Rules that permit BOX, for customer service reasons, to
compensate an Options Participant, within specified limits as proposed,
for certain identified losses. Additionally, the Exchange is proposing
to clarify certain provisions within Section 26 regarding to whom it is
applicable.
    Accordingly, the Exchange proposes to amend Chapter V, Section 26
of the BOX Trading Rules to (1) clarify certain provisions within
Section 26 regarding to whom the liability limitation applies; (2)
codify provisions within the BOX Rules to permit BOX to compensate
Participants for losses under certain circumstances; and (3) establish
the maximum amount of such compensation that BOX may provide during a
calendar month pursuant to Section 26.
    The Exchange proposes to clarify Section 26(a) by adding the
respective directors, officers, committee members, employees,
contractors, agents, and other persons acting on the behalf of the
Exchange, BOXR, BOX and any of their respective affiliates to the
paragraph that identifies the persons to which the limitation of
liability is applicable. The Exchange proposes that ``Exchange Related
Persons and/or Entities'' be defined to include the Exchange, BOXR,

BOX, and any of their respective affiliates, and their respective
directors, officers, committee members, employees, contractors, and
agents or other persons acting on their behalf.\3\ The Exchange
proposes corresponding changes in Sections 26(a)(ii), 26(a)(iii), and
in Sections 26(b), 26(c) and 26(d) to add references to the defined
term Exchange Related Persons and/or Entities. Additionally, the
Exchange proposes to add terrorism to the list of items beyond the
control of Exchange Related Persons and/or Entities for which liability
is limited.
---------------------------------------------------------------------------

    \3\ See proposed Section 26(a) of Chapter V of the BOX Rules.
---------------------------------------------------------------------------

    The Exchange proposes adding new Section 26(e) to establish,
subject to the express limits set forth in Section 26(e)(1) through
26(e)(3), that BOX may compensate Options Participants for losses
resulting directly from the malfunction of the physical equipment,
devices, or programming of Exchange Related Persons and/or Entities, or
from the negligent acts or omissions of employees of the Exchange, BOXR
or BOX.
    Under the proposal, BOX's payments for the aggregate of all claims
made by all Options Participants during a single calendar month would
not exceed the larger of $500,000, or the amount of any recovery
obtained by BOX under any applicable insurance maintained by BOX.
Additionally, in the event that all of the claims made during a single
calendar month cannot be fully satisfied because they exceed the
applicable maximum limitation, then the maximum permitted amount will
be proportionally allocated among all such claims. Finally, the
Exchange proposes that all claims for compensation under the new
proposed provisions must be submitted in writing no later than 12 p.m.
ET on the next business day following the day on which the use of BOX
gave rise to such claims. Once in receipt of a claim, BOX will verify
that: (i) a valid order was accepted into BOX; and (ii) any loss
claimed resulted directly from the malfunction of the physical
equipment, devices, or programming of Exchange Related Persons and/or
Entities, or from the negligent acts or omissions of employees of the
Exchange, BOXR or BOX during the execution or handling of that order.
BOX will only compensate Participants for valid claims, and will
compensate such Participants at the end of the month.
    BOX represents that the determination to compensate a BOX Options
Participant will be made on an equitable and non-discriminatory basis
without regard to whether the Participant is a Market Maker or Order
Flow Provider on BOX, and that such determinations will be made
pursuant to procedures of BOX Market Operations Center (``MOC'') with
regulatory oversight established by BOXR. Additionally, BOX represents
that BOX will maintain a record of Participant claims including
documentation detailing its findings and details for approving or
denying claims in accordance with its obligations under Section 17 of
the Act.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\4\ in general, and Section
6(b)(5) of the Act,\5\ in particular, in that it is designed to promote
just and equitable principles of trade, 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.
In particular, the proposal will amend Chapter V, Section 26 of the BOX
Trading Rules to codify provisions within the BOX Rules to permit BOX
to compensate Participants for losses resulting directly from the
malfunction of the physical equipment, devices, and/or programming of
Exchange Related Persons and/or Entities, or from the negligent acts or
omissions of employees of the Exchange, BOXR or BOX, and to establish
the maximum amount of such compensation that BOX may provide during a
calendar month.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Additionally, the Exchange believes that the codification of these
policies should add transparency to the BOX Rules and that its proposal
to amend Chapter V, Section 26 will promote fairness in the national
market system. The proposed change will allow BOX to address
Participant claims under various circumstances, and allow BOX to act in
a similar fashion as many of its competitors. Several exchanges have
substantially similar rules and the Exchange believes that the proposed
rule change would place BOX in a similar position to address
Participant claims.\6\
---------------------------------------------------------------------------

    \6\ See EDGA Exchange, Inc. (``EDGA'') Rule 11.12, NASDAQ Stock
Market LLC (``NASDAQ'') Rule 4626, Chicago Board Options Exchange,
Incorporated (``CBOE''), Rule 6.7, NYSE Arca, Inc. (``NYSE Arca'').
Options Rule 14.2, International Securities Exchange, LLC (``ISE''),
Rule 705, and BATS Exchange, Inc. (``BATS'') Rule 11.16.
---------------------------------------------------------------------------

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

    The Exchange 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.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms, does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    The Exchange requested that the Commission waive the 30-day
operative delay so that the proposed rule change would become effective
and operative upon filing. The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest.\9\ The Commission notes that the waiver will allow
the Exchange to immediately implement the proposed rule change, which
should promote fairness in the market by allowing BOX to compensate
Options Participants for losses resulting directly from the
malfunctions of the physical equipment, devices, or programming of
Exchange Related Persons and/or Entities, or from the negligent acts or
omissions of employees of the Exchange, BOXR, or BOX. The Commission
also notes that the proposal is substantially similar to rules of other
registered national

securities exchanges and does not raise any new regulatory issues.\10\
For these reasons, the Commission designates the proposed rule change
as operative upon filing.
---------------------------------------------------------------------------

    \9\ For purposes only of waiving the 30-day operative delay, the
Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \10\ See supra note 6.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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-BX-2012-011 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2012-011. 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/vsro.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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office 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-BX-2012-011 and should be
submitted on or before March 30, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-5731 Filed 3-8-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 174 (Monday, September 9, 2013)]
[Notices]
[Pages 55089-55091]
[FR Doc No: 2013-21923]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2012-0797]

National Maritime Security Advisory Committee; Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee Meeting.

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

SUMMARY: The National Maritime Security Advisory Committee (NMSAC) will
meet on September 24-25, 2013 in Washington, DC to discuss various

issues relating to national maritime security. This meeting will be
open to the public.

DATES: The Committee will meet on Tuesday, September 24, 2013 from 9:00
a.m. to 4:00 p.m. and Wednesday, September 25, 2013 from 8:00 a.m. to
11:00 a.m. This meeting may close early if all business is finished.
All written material and requests to make oral presentations should
reach the Coast Guard on or before September 13, 2013.

ADDRESSES: This meeting will be held at the new Coast Guard
Headquarters, 2703 Martin Luther King Jr. Avenue SE., Washington, DC
20593, Room 6i10-01-b-17. Due to security at the new Headquarters,
members of the public wishing to attend shall register with Mr. Ryan
Owens, Alternate Designated Federal Officer (ADFO) of NMSAC, telephone
202-372-1108 or<EMAIL_ADDRESS>no later than September 18, 2013.
Additionally, all visitors to the Coast Guard Headquarters must provide
identification in the form of Government Issue picture identification
card for access to the facility. Please arrive at least 30 minutes
before the planned start of the meeting in order to pass through
security.
    This meeting will be broadcast via a web enabled interactive online
format and teleconference line. To participate via teleconference, dial
866-810-4853; the pass code to join is 9760138. Additionally,
if you would like to participate in this meeting via the online web
format, please log onto https://share.dhs.gov/nmsac/ and follow the
online instructions to register for this meeting.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in the FOR FURTHER INFORMATION CONTACT section as
soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the Committee as listed in the
``Agenda'' section below. Comments that the public wishes the members
to see prior to the meeting should be submitted no later than September
18, 2013. Identify your comments by docket number [USCG-2012-0797]
using one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001. We encourage use of
electronic submissions because security screening may delay delivery of
mail.
     Fax:<PHONE_NUMBER>.
     Hand Delivery: Same as mail address above, between 9:00
a.m. and 5:00 p.m., Monday through Friday, except Federal Holidays. The
telephone number is<PHONE_NUMBER>.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and docket number [USCG-2012-0797].
All submissions received will be posted without alteration at
www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008 issue of the Federal Register (73 FR 3316).
    Docket: Any background information or presentations available prior
to the meeting will be published in the docket. For access to the
docket to read background documents or submissions received by NMSAC,
go to http://www.regulations.gov insert ``USCG-2012-0797'' in the
``Search'' box, and follow instructions on the Web site.
    Public comments will be sought throughout the meeting by the
Designated Federal Officer (DFO) as specific issues are discussed by
the committee. Additionally, public oral comment period will be held
during the meetings on September 24, 2013, from 3:30 p.m. to 4:00 p.m.,
and September 25, 2013 from 10:30 a.m. to 11:00 a.m. Speakers are
requested to limit their comments to 5 minutes. Please note that the
public comment period will end following the last call for comments.
Contact the person listed in the FOR FURTHER INFORMATION CONTACT
section below to register as a speaker.

FOR FURTHER INFORMATION CONTACT: Mr. Ryan Owens, ADFO of NMSAC, 2703
Martin Luther King Jr. Avenue SE., Washington, DC 20593, Stop 7581,
Washington, DC 20593-7581; telephone<PHONE_NUMBER> or email
<EMAIL_ADDRESS>If you have any questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), Title 5, United States Code,
Appendix (Pub. L. 92-463). NMSAC operates under the authority of 46
U.S.C. 70112. NMSAC provides advice, consults with, and makes
recommendations to the Secretary of Homeland Security, via the
Commandant of the Coast Guard, on matters relating to national maritime
security.

Agenda of Meeting

Day 1

    The committee will meet to review, discuss and formulate
recommendations on the following issues:
    (1) Cyber Security Executive Order. On February 12, 2013, President
Barack Obama signed an Executive Order \1\ to strengthen the
cybersecurity of critical infrastructure by increasing information
sharing and by jointly developing and implementing a framework of
cybersecurity practices with our industry partners. This is a
continuation of a discussion held during the April 2013 public meeting.
NMSAC will meet to review the Executive Order and begin initial work in
developing a framework for the maritime community.
---------------------------------------------------------------------------

    \1\ The Executive Order (not numbered) is available for viewing
online at the White House's Web site: http://www.whitehouse.gov/the-press-office/2013/02/12/executive-order-improving-critical-infrastructure-cybersecurity.
---------------------------------------------------------------------------

    (2) Presidential Policy Directive-21.\2\ On February 12, 2013, the
White House Office of the Press Secretary published a Presidential
Policy Directive (PPD) on critical infrastructure security and
resilience. PPD-21 updates the national approach from Homeland Security
Presidential Directive-7 (issued in 2003) to adjust to the new risk
environment, understand key lessons learned, and drive toward enhanced
capabilities. This is a continuation of a discussion held during the
April 2013 public meeting. NMSAC will meet to discuss and make
recommendations on Coast Guard's implementation of PPD-21 that will
impact the maritime community.
---------------------------------------------------------------------------

    \2\ Presidential Policy Directive-21 is available for viewing
online at the White House's Web site: http://www.whitehouse.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil.
---------------------------------------------------------------------------

    (3) Chemical Facility Safety and Security Executive Order.
President Obama signed an Executive Order \3\ on August 1, 2013, with
the goal of improving information sharing among Federal departments and
agencies and furthering coordination efforts with State, Local, and
Tribal entities involved in chemical regulation and response. In
addition, the Executive Order directs Federal agencies to look for
opportunities to modernize policies, regulations and standards and to
seek out stakeholder input to identify best practices. NMSAC will meet
to discuss and make recommendations on the Executive Order impacts on
the maritime community.
---------------------------------------------------------------------------

    \3\ The Executive Order is available for viewing online at the
White House's Web site: http://www.whitehouse.gov/the-press-office/2013/08/01/executive-order-improving-chemical-facility-safety-and-security.

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

    (4) Transportation Security Worker Identification Credential (TWIC)
Notice of Proposed Rule Making. NMSAC will meet to receive an update,
discuss concerns and make recommendations concerning this Rule Making
project.
    (5) Radiation Portal Monitoring. NMSAC will meet to review and
discuss the Radiation Portal Monitoring Program and the challenges
involved in replacing/altering current monitor programs within ports.
    (6) Regulatory Agenda. NMSAC will meet to review, discuss and make
recommendations to the Coast Guard's future regulatory agenda.
    (7) Public Comment period.

Day 2

    The committee will meet to receive oral reports on the following
issues:
    (1) Lessons learned/best practices encountered during Maritime
Security (MARSEC) Level increase over the Boston Marathon bombing.
    (2) Lessons learned/best practices from Hurricane Sandy Recovery.
    (3) Facility Security Office (FSO) training initiatives. NMSAC will
discuss/make recommendations on current FSO training initiatives.
    (4) Future Security issues. NMSAC will be tasked to provide
guidance on emergent security issues. This will help the Coast Guard
develop a long term vision for its maritime security program.
    (4) Public comment period.

J.C. Burton,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2013-21923 Filed 9-6-13; 8:45 am]
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[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20353-20354]
[FR Doc No: 2019-09484]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2019-0206; FRL-9992-75]

Mefentrifluconazole; Receipt of Applications for Emergency
Exemptions, Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received specific exemption requests from the North
Dakota Department of Agriculture (NDA), the Michigan Department of
Agriculture and Rural Development (MDARD), and the Minnesota Department
of Agriculture (MDA) to use the fungicide mefentrifluconazole (CAS No.
1417782-03-6) to treat up to 376,000 acres of sugarbeets to control
Cercospora leaf spot disease. The applicants propose use of a new
chemical which has not been registered

by EPA as a pesticide. Therefore, EPA is soliciting public comment
before making the decision whether to grant the exemptions.

DATES: Comments must be received on or before May 24, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2019-0206, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    1. Submitting CBI. Do not submit this information to EPA through
www.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/commenting-epa-dockets.
    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, the
Agency 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 pesticide
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the EPA Administrator determines that emergency
conditions exist which require the exemption. The NDA, the MDARD, and
the MDA have requested the EPA Administrator to issue specific
exemptions for the use of mefentrifluconazole on sugarbeets to control
Cercospora leaf spot disease. Information in accordance with 40 CFR
part 166 was submitted as part of the requests.
    As part of the requests, the applicants assert that the development
of resistance to available fungicides in the fungal pathogen Cercospora
beticola, has resulted in an urgent and non-routine pest control
situation that is expected to cause significant economic losses without
the requested use. The applicants propose to make no more than two
applications at a rate of 0.13 lb. (maximum total of 0.26 lb.) of
active ingredient mefentrifluconazole per acre, on up to 376,000 acres
of sugarbeets grown in North Dakota, Michigan, and Minnesota from June
15 to September 7, 2019. A total of 97,760 lbs. of mefentrifluconazole
could be used (maximum acreage at highest rate), although the
applicants state that the affected acreage is more likely to receive
only one treatment.
    This notice does not constitute a decision by EPA on the
applications themselves. The regulations governing FIFRA section 18 at
40 CFR 166.24(a)(1), require publication of a notice of receipt of an
application for a specific exemption proposing use of a new chemical
which has not been registered by EPA as a pesticide. The notice
provides an opportunity for public comment on the application. The
Agency will review and consider all comments received during the
comment period in determining whether to issue the specific exemptions
requested by the NDA, the MDARD, and the MDA.

    Authority: 7 U.S.C. 136 et seq.

    Dated: May 1, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2019-09484 Filed 5-8-19; 8:45 am]
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