UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES, AND

TOXIC SUBSTANCES

Memorandum

DATE: 	December 13, 2006

SUBJECT: 	Transmission of Background Materials and Charge to the Panel
for the January 9-12, 2007 Session of the FIFRA Scientific Advisory
Panel (SAP) Entitled “Review of Worker Exposure Assessment Methods”

FROM: 	Jeff Evans, Biologist

		Health Effects Division (7509P)

TO: 		Myrta Christian

Designated Federal Official

FIFRA Scientific Advisory Panel

Office of Science Coordination and Policy (7201M)

    Attached are 30 compact discs and 2 paper copies of all background
documents and the charge to the panel for the January 9-12, 2007 FIFRA
SAP session.  These materials do not contain any information protected
under statute as Confidential Business Information (CBI).  These
materials do not contain information protected from disclosure to
foreign and multi-national pesticide producers under FIFRA Section
10(g).  In addition, these materials include information protected by
copyright.  The attached documents and/or electronic files include the
following:

Document Title	Author(s)	Date	Indicate Whether FIFRA 10(g) or ©
Protected

Transmission of Background Materials and Charge to the Panel for the
January 9-12, 2007 Session of the FIFRA Scientific Advisory Panel (SAP)
Entitled “Review of Worker Exposure Assessment Methods”	Jeff Evans
12/13/06

	Review of Worker Exposure Assessment Methods	U.S. EPA et al.	12/13/06

	Excel Spreadsheet With Filename:

ExhibitA.PHEDCaseStudy.v102006	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitB.HandMethodsAnalysisPtA.102306	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitB.HandMethodsAnalysisPtB.110106	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_I_a_ML_DF_RawData.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_I_b_ML_DF_outer.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_I_c_ML_DF_inner.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_II_a_L_Gran_RawData.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_II_b_L_Gran_outer.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_II_c_L_Gran_inner.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_III_a_ML_Liq_RawData.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_III_b_ML_Liq_outer.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_III_c_ML_Liq_inner.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_IV_a_APP_Open-CabAirblast_RawData.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_IV_b_APP_Open-CabAirblast_outer.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_IV_c_APP_Open-CabAirblast_inner.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_V_a_APP_Closed-CabAirblast_RawData.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_V_b_APP_Closed-CabAirblast_outer.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_V_c_APP_Closed-CabAirblast_inner.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_VI_a_APP_Open-CabSolidSpreader_RawData.xls	U.S. EPA	12/13/06

	Excel Spreadsheet With Filename:

ExhibitC_VI_c_APP_Open-CabSolidSpreader_inner.xls	U.S. EPA	12/13/06

	Agricultural Handlers Exposure Task Force (AHETF) Technical Summary
Document For a Multi-Year Pesticide Handler Worker Exposure Monitoring
Program	AHETF	12/06/06

	The Conservative Nature of the Current Practice in Estimating Pesticide
Handler and Reentry Dermal Exposures and Doses	AHETF	12/07/06

	Passive Dosimetry Data Derived from the Outdoor Residential Exposure
Task Force & Pesticide Handler Exposure Databases - Comparisons to
Biomonitoring Data (Sponsor:  AHETF & ORETF)	AHETF	12/07/06

	Summary  Comparative Evaluation of Absorbed Dose Estimates Derived From
Passive Dosimetry Measurements With Those Derived From Biological
Monitoring : Validation of Exposure Monitoring Methodologies (Sponsor
AHETF)	AHETF	12/07/06

	Procedures for Determining the Required Number of Clusters and
Monitoring Units per Cluster to Achieve Benchmark Adequacy	AHETF
12/07/06

	Comparative Evaluation of Absorbed Dose Estimates Derived From Passive
Dosimetry Measurements With Those Derived From Biological Monitoring :
Validation of Exposure Monitoring Methodologies (Sponsor AHETF)	AHETF
12/08/06

	AEATF II Background and Scoping Summary	AEATF	11/28/06

	Data Review and Study Acceptance Criteria: For Inclusion of Existing
Antimicrobial Exposure Monitoring Studies in the Antimicrobial Exposure
Assessment Task Force II (AEATFII) Database	AEATF	11/28/06

	Glossary of Terms	AEATF	11/28/06

Charge to the Panel: January 9-12, 2007 FIFRA Scientific Advisory Panel

	EPA has prepared a document, dated December 12, 2006, that contains the
Agency’s technical review of worker exposure methods.  This memo
contains the questions and issues posed by EPA to the panel for
discussion.  In addition to this memo, several documents/files are
provided as supporting information.

I.  Overview of EPA’s Approach to Estimating Handler Exposure

	    The Agency defines individuals involved in pesticide applications
as handlers.   Handler tasks (e.g., aerial application of pesticides)
are routinely evaluated in exposure assessments using dermal and
inhalation variables referred to as unit exposures.   Unit exposures are
normalized values calculated from handler exposure studies described in
the 1986 Pesticide Assessment Guidelines, Subdivision U – Applicator
Exposure Monitoring (currently referred to as Series 875, Group A).   A
unit exposure (mg/lb active ingredient) is calculated by dividing the
pesticide residues (mg) measured using dosimetry, worn by a volunteer
performing a certain handler activity (scenario) by the number of pounds
of pesticide active ingredient (ai) used by that volunteer.  In exposure
assessments, scenario-specific unit exposures are multiplied by
estimates of the amount of ai handled for a given handler scenario
(e.g., number of pounds ai sprayed to wheat per day for an aerial
applicator).  These simple calculations are daily exposure estimates
(mg/day) which can then be adjusted by body weight (kg) and dermal
absorption if necessary.   The resulting metric (mg/kg/day) is then
compared to doses from toxicity studies (mg/kg/day) in Agency risk
assessments.

	A. The PHED database

The Agency relies on the Pesticide Handlers Exposure Database (PHED) as
a source of generic unit exposure estimates.  PHED was designed by a
task force of representatives from the U.S. EPA, Health Canada, the
California Department of Pesticide Regulation, and member companies of
the American Crop Protection Association.  PHED is a software system
consisting of two parts -- a database of measured exposure values for
workers involved in the handling of pesticides under actual field
conditions and a set of computer algorithms used to segment and
statistically summarize the selected data. Currently, the database
contains values for over 1,700 individual monitoring events (i.e.,
monitoring units).  Once the data for a given exposure scenario have
been selected, the data are typically normalized (i.e., divided) by the
amount of pesticide handled resulting in standard unit exposures.
Following normalization, the data are statistically summarized.  The
distribution of exposure values for each body part (e.g., chest, upper
arm) is categorized as normal, lognormal, or “other” (i.e., neither
normal nor lognormal).  A central tendency value is then selected from
the distribution of the exposure values for each body part.  These
values are the arithmetic mean for normal distributions, the geometric
mean for lognormal distributions, and the median for all “other”
distributions.  Once selected, the central tendency values for each body
part are summed to define the exposure for the entire body

The data in PHED are based on the use of passive dosimetry methods
(e.g., patches, gloves, wholebody dosimeters or washes) to estimate the
magnitude of, and patterns of exposure resulting from various handling
activities.  Knowledge of exposure patterns by body part is critical for
risk managers making exposure mitigation decisions.  For example, EPA
may require chemical resistant gloves if exposure is primarily to the
hands.

One of the fundamental limitations of PHED is the data come from
multiple study designs.  PHED contains studies that were conducted from
1977 to 1994.  Prior to the development of the Subdivision U guidelines,
investigators limited the collection of measurements to areas of the
body they believed to have the greatest potential for exposure.  After
the guidelines were established in 1986, measurements representing the
head, neck, chest, back, arms, legs and hands were more routinely
collected.  Consequently in PHED, a unit exposure for a given scenario
has the potential for a different number of observations and
distribution per body part when their central values are summed for a
total body estimate as described above.  For example a unit exposure for
a given scenario could include studies in which only the hands were
measured; plus studies in which only the hands and forearms were
measured, and so on.

The material and methods of collecting residues from volunteers
participating in handler studies have evolved over time, and these
competing study designs have a confounding effect on PHED outputs.  Like
the studies with differing body part measurements, the studies in the
database for a given scenario could also be based on studies having
differing dosimetry methods (e.g., patches or whole body dosimeters).
These methods are described in the background document.  One of the
primary concerns regarding competing monitoring methods is the putative
differences in the performance of cotton gloves and hand rinses used to
collect pesticide residues from hands.  A fundamental question is: do
estimates of exposure based on using cotton gloves as dosimeters
overestimate hand measurements?  Conversely; do estimates of exposure
based on hand rinses underestimate hand measurements?

The Agency has investigated the performance of various techniques for
measuring hand exposure and other biases of passive dosimetry for
underestimating exposure in a number of ways. First, a review of
available peer reviewed literature on the subject of hand rinses was
conducted.  Second, an analysis was performed comparing hand
measurements made with varying techniques based on data available in
PHED.  Third, comparisons were made of estimates of exposure made with
passive dosimetry and a more chemical-specific method - measuring
internal metabolites of pesticides in urine referred to as biological
monitoring.

B.  Exploring the Relationship of Handler Exposure to Amount of
Pesticide Handled

Since the establishment of the guidelines, the Agency has assumed that
the magnitude of exposure is proportional to the amount of active
ingredient handled (AaiH) and, that scenario and activity are
independent variables.  In a regulatory setting, the assumption of
proportionality is useful because it enables risk managers to mitigate
risk by reducing labeled application rates if mitigation involving
Personal Protective Equipment or engineering controls continue to
indicate risks of concern.

EPA analyzed and examined PHED data for six different handler scenarios
with respect to the relationship between AaiH and exposure.  Improving
our understanding of this phenomenon with the available data in PHED
will help the Agency 1) to determine the need for additional data and 2)
gain insight when evaluating data to populate a new database.  The AHETF
is proposing as part of its future studies to investigate
proportionality as a secondary objective of its study protocols.  They
intend to incorporate more advanced statistical concepts and designs in
their analysis to distinguish between complete proportionality and
complete independence of exposure and AaiH.  An important document to
consider is the AHETF document: Procedures for Determining the Required
Number of Clusters and Monitoring Units per Cluster to Achieve Benchmark
Adequacy.

.

C.  EPA Exposure Assessments (EA)

EPA currently conducts deterministic risk assessments by relying on
central tendency PHED unit exposures coupled with high-end label use
rates and work hours for each relevant handler scenario /activity.  As
the tools and techniques for performing probabilistic assessments
improve, the limitations of PHED become more apparent.  Chief among them
is the inability to construct individual full body exposure estimates
and develop ranges and distributions of AaiH.

II. Development of an Improved Approach

A.  PHED database limitations

PHED has been a valuable scientific and regulatory tool but has several
limitations.  These include scenarios consisting of values taken from
studies having multiple study designs,  compositing varying numbers of
body parts in a given unit exposure, and the inability to evaluate
inter- and intra- personal variability since varying numbers of
individuals were used in the sample collection process.  PHED has
limited (and in some cases is lacking) studies representing advances in
agricultural equipment, pesticide formulations and application
techniques.

B.  EPA desire to have more refined Exposure Assessments

The Agency envisions the next generation handler database to be one that
can be used to describe more fully the range of potential handler
exposures and that can produce inputs for use in probabilistic exposure
assessments.  We recognize that improvements in pesticide use
information (i.e., the amount of active ingredient handled) will also
need to be made.  However, until those advances are made, we believe it
is desirable to have scenario specific values that can be used to
develop distributions representing the advances made in pesticide
application equipment and techniques.

C.  Criticisms from stakeholders

Our exposure assessments generate a number of criticisms from important
stakeholders that the Agency would like to address.  Some of the
criticisms include the use of central tendency values, the potential for
certain passive dosimetry techniques to underestimate exposure, and that
the studies are based on activities involving outdated equipment.
Ideally a new database would consist of handler scenarios that would
have sufficient samples representative of as many monitoring activities
performed by as many different individuals and at as many different
locations as possible.  It is also important that the samples be
collected in as consistent a manner as possible such that confounding by
the use of multiple methods is minimized.

D.  Human Subject Review Board review

In June 2006, the AHETF submitted five protocols for field trials for an
ethics review by the Human Subjects Review Board (HSRB) pursuant to 40
CFR 26, subpart K.  The protocols described five field trials that were
part of their 2006 data collection efforts.  These trials are part of
multi-year effort to develop data to populate the Agricultural Handlers
Exposure Database (AHED).  In their review, the HSRB identified many
issues relating to dermal exposure collection methods selected by the
AHETF and noted that they did not adequately indicate how their sample
size was derived.  In addition, they asserted that the Agency had not
articulated the need for these data with respect to its current database
PHED. Consequently, the HSRB were unable to evaluate the ethical merits
of the AHETF protocols since key scientific issues were not addressed.
The report for this meeting of the HSRB can be found at     HYPERLINK
"http://www.epa.gov/osa/hsrb/files/june2006mtgreportfinal100606.pdf"
http://www.epa.gov/osa/hsrb/files/june2006mtgreportfinal100606.pdf .
Since the HSRB identified key scientific issues impacting many data
generating efforts such as the AHETF and Antimicrobial Exposure
Assessment Task Force (AEATF), the Agency believes the timing is
appropriate for a scientific review of the methods and data analysis
approaches that are to be used for the next generation of exposure data.

III. Charge questions

1) Data Needs

	EPA believes that many studies within our current database have
limitations.  In some cases, the Agency is lacking data to address
modern pesticide application equipment and techniques.  EPA believes
that additional data could significantly improve our ability to estimate
and better characterize the range of worker exposure with greater
certainty.

	Please comment on these limitations and EPA’s conclusion that
additional data could improve significantly the Agency’s ability to
assess worker exposure.  Also, please comment on the selection criteria
proposed by the AHETF and AEATF in their respective submissions for
evaluating the extent to which existing data would meet EPA’s exposure
assessment needs.

2) Passive Dosimetry Performance

The common approach for conducting dermal exposure monitoring studies
relies on the use of whole-body dosimetry, handwashing, and facial/neck
wipes.  In some cases, biological monitoring is also used as an
alternative method.  Exposure estimates in Agency risk assessments;
however, typically rely on “to the skin” measurements (i.e.,
potential dose) coupled with dermal absorption data or dermal toxicity
studies in order to calculate risks.  The Agency believes that these
methods are complementary and that they can provide appropriate
estimates for exposure assessment but that the results directly relate
to the reliability of the inputs used.  Please comment on the Agency’s
conclusion regarding passive dosimetry and biological monitoring,
including whether a systematic bias exists in either approach.

Based on the information presented, the Agency has particular concerns
over three specific aspects of how these studies are conducted including
(1) the possible need to correct for the efficiency of the handwashing
technique; (2) compensating for absorption of residues through the skin
during sample collection periods; and (3) the breakthrough of residues
under whole-body dosimeter garments. Please comment on the need to
systematically account for residue losses due to these potential method
biases.  If there is a need, please describe how these corrections
should be accomplished in a way that could reduce uncertainties in the
resulting exposure estimates.

3) Passive Dosimetry vs. Biomonitoring

EPA believes that a comparison of exposure estimates derived from data
collected through biomonitoring with data collected through passive
dosimetry is the most appropriate way to assess the predictive nature of
a passive dosimetry-based approach for estimating worker exposure.
Please comment on the strengths and limitations of this kind of
comparison for judging the potential utility of passive dosimetry data
in conducting exposure assessments.

EPA has conducted such a comparison using available data and believes
that the comparison shows sufficient concordance of estimates based on
biomonitoring data and passive dosimetry data to support the conclusion
that a passive dosimetry-based approach can generate data that can be
used to develop relatively predictive estimates of worker exposure for a
wide variety of scenarios and activities.  Please comment on the
adequacy of the analysis to support EPA’s conclusion.

4) Normalization of Exposure by Amount of Active Ingredient Handled
(AaiH)

The normalization of exposure by AaiH - the unit exposure - has, since
the mid-1980s, been the principle relationship underlying the use of
exposure data in the Agency's pesticide handler exposure assessments.
It is based on the assumption that the two variables are proportional.
That is, if one doubles the amount of pesticide they handled or applied,
the resultant exposure will be doubled as well.

The Agency is unsure whether the results of our exploratory work showing
that proportionality between exposure and AaiH is reasonable in some but
not all cases, is a function of limitations of the data within PHED or
whether this relationship is in fact not a reasonable assumption for all
scenarios.  It may be the case that an additional ancillary variable
(e.g., boom length, # of tank mixes, or # de-couplings in a closed
loading system), in addition to or in place of AaiH, may improve the
predictive capabilities of our exposure model.

Though it is recognized that neither the studies in our current database
nor the proposed studies by the AHETF were designed for the primary
purpose of examining proportionality between exposure and AaiH or to
determine the extent to which other parameters influence exposure,
compared with our current database, the Agency believes that the
proposed AHETF studies will generate data that will reinforce the
assumption of proportionality between exposure and AaiH or,
alternatively, inform the applicability of another variable as a more
appropriate predictor of exposure.

Based on the themes presented on this topic including its historical
precedent, its application in risk assessment and subsequent risk
management decisions, the Agency’s exploratory work using the six PHED
scenarios in the case study, and the study design and objectives of the
AHETF, please comment on the assumption of proportionality between
exposure and AaiH, as a default.   Also, please provide comments on
whether the proposed AHETF study design is adequate to evaluate
proportionality between exposure and AaiH?  What other parameters should
AHETF study designs measure in order to improve the prediction
capabilities of our exposure model?

5) Within-worker and Between-worker Variability

The proposed AHETF study design does not include true worker replicates
and is not intended to examine the issue of variability within workers.
The AHETF notes that to appropriately investigate this issue would
require significantly more sampling and resources.  They propose,
however, that their single-day exposure distribution results can be used
to evaluate longer term multiple day exposures by placing reasonable
limits on expected intra-class correlation coefficients (ICC):  they
indicate that, from their own research and review of the literature, the
ICC is likely to be between 0.3 and 0.5 over relatively short periods of
time (e.g., seasonal), and likely to be even lower over longer periods
of time.

Please comment on the AHETF’s approach to estimating the number of
samples (MU) needed to determine within worker variability and their
conclusion on the importance of measuring such variability in their
proposed studies.

6) Sample Size: Number of Sites and Subjects per Scenario/Activity

The Agency’s goal is to ensure that monitoring studies rely on sample
sizes that adequately represent the range of exposure of people who
engage in a particular handler scenario and activity.  It is also
recognized that occupational monitoring studies are costly and have many
logistical obstacles.  The Agency is also concerned about limiting the
numbers of participants in these types of studies in accordance with the
ethical requirements described in Subpart K (40CFR26) and the recent
criteria outlined by the Agency’s Human Studies Review Board.  The
Agency’s current guidelines recommend 15 monitoring units for each
scenario.  In addition, the AHETF has provided a rationale for the
number of samples in their study design.

	Please comment on the uncertainties associated with the Agency’s and
AHETF’s recommended number of monitoring units.  In your comments,
please include any recommendations you may have regarding specific
statistical analyses that may assist the Agency in developing better
understanding of these uncertainties and characterizing them in a
complete and transparent manner in Agency assessments based on these
data.

Page   PAGE  1  of   NUMPAGES  8


[Federal Register Volume 78, Number 237 (Tuesday, December 10, 2013)]
[Rules and Regulations]
[Pages 74008-74009]
[FR Doc No: 2013-29221]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0658; Airspace Docket No. 13-ASW-17]

Amendment of Class E Airspace; Del Rio, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace at Del Rio, TX. Controlled
airspace is necessary to accommodate new circling approach requirements
at Laughlin Air Force Base (AFB). The FAA is taking this action to
enhance the safety and management of Instrument Flight Rules (IFR)
operations at the airport. Geographic coordinates are also updated.

DATES: Effective date: 0901 UTC, February 6, 2014. 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 August 26, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace for the
Del Rio, TX, area, creating additional controlled airspace at Laughlin
AFB (78 FR 52716) Docket No. FAA-2013-0658. 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 6003 of FAA Order
7400.9X dated August 7, 2013, and effective September 15, 2013, 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 amending Class E airspace designated as an extension to a
Class C surface area at Laughlin AFB, Del Rio, TX. An additional
segment to the north is needed to contain approach category E military
aircraft conducting circling approaches to the airport, to retain the
safety and management of IFR aircraft in Class E airspace to/from the
en route environment. Geographic coordinates are also updated to
coincide with the FAA's aeronautical database.
    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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does 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 additional controlled airspace at Laughlin AFB, Del
Rio, TX.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air)

Adoption of the Amendment

    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 7400.9X, Airspace Designations and
Reporting Points, dated August 7, 2013, and effective September 15,
2013, is amended as follows:

Paragraph 6003 Class E airspace designated as an extension.

* * * * *

ASW TX E3 Del Rio, TX [Amended]

Del Rio, Laughlin AFB, TX
    (Lat. 29[deg]21'34'' N., long. 100[deg]46'40'' W.)
Laughlin VORTAC
    (Lat. 29[deg]21'39'' N., long. 100[deg]46'18'' W.)

    That airspace extending upward from the surface within 2 miles
each side of the 003[deg] radial of the Laughlin VORTAC extending
from the 5-mile radius of Laughlin AFB to 10 miles north of the
airport, and from the 060[deg] radial of the Laughlin VORTAC
clockwise to the 195[deg] radial, extending from the 5-mile radius
of Laughlin AFB to the 5.5-mile radius, and 2.6 miles each side of
the 145[deg] radial of the Laughlin VORTAC extending from the 5.5-
mile radius of Laughlin AFB to 6.6 miles southeast of the airport,
and 2.6 miles each side of the 305[deg] radial of the Laughlin
VORTAC extending from the 5-mile radius of Laughlin AFB to 6.6 miles
northwest of Laughlin AFB, and from the 333[deg] radial of the
Laughlin VORTAC clockwise to the 342[deg] radial, extending from the
5-mile radius of Laughlin AFB to the 5.5-mile radius. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

    Issued in Fort Worth, Texas, on November 25, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-29221 Filed 12-9-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11576-11577]
[FR Doc No: 2016-04704]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3287]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device User
Fee Small Business Qualification and Certification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April
4, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0508 and
title ``Medical Device User Fee Small Business Qualification and
Certification.'' Also include the FDA docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Device User Fee Small Business Qualification and Certification

OMB Control Number 0910-0508--Extension

    Section 101 of the Medical Device User Fee and Modernization Act
(MDUFMA) (Pub. L. 107-250) amends the Federal Food, Drug, and Cosmetic
Act, to provide for user fees for certain medical device applications.
FDA published a Federal Register notice on August 3, 2015 (80 FR
46033), announcing fees for fiscal year (FY) 2016. To avoid harming
small businesses, MDUFMA provides for reduced or waived fees for
applicants who qualify as a small business. This means there are two
levels of fees; a standard fee and a reduced or waived small business
fee. You can qualify for a small business fee discount under MDUFMA if
you reported gross receipts or sales of no more than $100 million on
your Federal income tax return for the most recent tax year. If you
have any affiliates, partners, or parent firms, you must add their
gross receipts or sales to yours, and the total must be no more than
$100 million. If your gross receipts or sales are no more than $30
million, including all of your affiliates, partners, and parent firms,
you will also qualify for a waiver of the fee for your first (ever)
premarket application (product development protocol, biologics
licensing application, or premarket report). An applicant must pay the
full standard fee unless it provides evidence demonstrating to FDA that
it meets the small business criteria (Form FDA 3602, ``FY 2016 MDUFMA
Small Business Qualification Certification--For a Business
Headquartered in the United

States''). The evidence required by MDUFMA is a copy of the most recent
Federal income tax return of the applicant, and any affiliate, partner,
or parent firm. FDA will review these materials and decide whether an
applicant is a small business within the meaning of MDUFMA.
    The 2007 Amendments provide an alternative way for a foreign
business to qualify as a small business eligible to pay a significantly
lower fee when a medical device user fee must be paid (Form FDA 3602A,
``FY 2016 MDUFMA Foreign Small Business Qualification Certification--
For a Business Headquartered Outside the United States''). Before
passage of the 2007 Amendments, the only way a business could qualify
as a small business was to submit a Federal (U.S.) income tax return
showing its gross receipts or sales that did not exceed a statutory
threshold, currently, $100 million. If a business could not provide a
Federal income tax return, it did not qualify as a small business and
had to pay the standard (full) fee. Because many foreign businesses
have not, and cannot, file a Federal (U.S.) income tax return, this
requirement has effectively prevented those businesses from qualifying
for the small business fee rates. Thus, foreign governments, including
the European Union, have objected. In lieu of a Federal income tax
return, the 2007 Amendments will allow a foreign business to qualify as
a small business by submitting a certification from its national taxing
authority, the foreign equivalent of our Internal Revenue Service. This
certification, referred to as a ``National Taxing Authority
Certification,'' must: (1) Be in English; (2) be from the national
taxing authority of the country in which the business is headquartered;
(3) provide the business' gross receipts or sales for the most recent
year, in both the local currency and in U.S. dollars, and the exchange
rate used in converting local currency to U.S. dollars; (4) provide the
dates during which the reported receipts or sales were collected; and
(5) bear the official seal of the national taxing authority.
    Both Forms FDA 3602 and FDA 3602A are available in the guidance
document, ``FY 2016 Medical Device User Fee Small Business
Qualification and Certification; Guidance for Industry, Food and Drug
Administration Staff, and Foreign Governments'' available on the
Internet at<EMAIL_ADDRESS>This guidance describes
the criteria FDA will use to decide whether an entity qualifies as a
MDUFMA small business and will help prospective applicants understand
what they need to do to meet the small business criteria for FY 2016.
    The estimated burden is based on the number of applications
received in the last 3 years and includes time required to collect the
required information. Based on our experience with Form FDA 3602, FDA
believes it will take each respondent 1 hour to complete the form.
Based on our experience with Form FDA 3602A, FDA also believes that it
will take each respondent 1 hour to complete.
    In the Federal Register of September 17, 2015 (80 FR 55854), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          FDA Form No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
FDA 3602--FY 2016 MDUFA Small              3,600               1           3,600               1           3,600
 Business Qualification and
 Certification For a Business
 Headquartered in the United
 States.........................
FDA 3602A--FY 2016 MDUFA Foreign           1,400               1           1,400               1           1,400
 Small Business Qualification
 and Certification For a
 Business Headquartered Outside
 the United States..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04704 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P


maintenance plan must include a requirement that the state will
implement all measures with respect to control of the pollutant(s) that
were contained in the SIP before redesignation of the area to
attainment. See section 175A(d) of the CAA.
    As required by section 175A of the CAA, Texas has adopted a
contingency plan for the BPA area to address possible future ozone air
quality problems.
    The contingency measure trigger for the BPA maintenance plan is
based upon monitoring. The triggering mechanism for activation of
contingency measures is a monitored violation of the 1997 ozone
standard. In this maintenance plan, if contingency measures are
triggered, TCEQ has committed to adopt and implement the measures as
expeditiously as practicable, but no longer than 18 months following
the trigger. In order to accomplish this, in the submittal Texas
commits to adopt within nine months (and implement within eighteen
months) one or more contingency measures to re-attain the standard in
the event of a violation of the 1997 8-hour ozone NAAQS in the BPA
area. The measures to be considered include, but are not limited to the
following control measures:
     Revision to 30 TAC Chapter 117 to control rich-burn, gas-
fired, reciprocating internal combustion engines to meet NOX
emission specifications and other requirements to reduce NOX
emissions and ozone air pollution.
     Inclusion of one or more counties in the BPA area in 30
TAC Chapter 115 VOC rules for the control of crude and condensate
storage tanks at upstream oil and gas exploration and productions sites
or midstream pipeline breakout stations with uncontrolled flash
emissions greater than 25 tpy.
     Inclusion of one or more counties in the BPA area in 30
TAC Chapter 115 VOC rules for more stringent controls for tank fittings
on floating roof tanks, such as slotted guidepoles and other openings
in internal and external floating roofs.
     Inclusion of one or more counties in the BPA area in 30
TAC Chapter 115 VOC rules limiting emissions from landings of floating
roofs in floating roof tanks.
     Inclusion of one or more counties in the BPA area in 30
TAC Chapter 115 VOC rules for control of emissions from degassing
operations for storage tanks with a nominal capacity of 75,000 gallons
or more storing materials with a true vapor pressure greater than 2.6
pounds per square inch absolute (psia), or with a nominal capacity of
250,000 gallons or more storing materials with a true vapor pressure of
0.5 psia or greater. Degassing vapors from storage vessels, transport
vessels, and marine vessels would be required to vent to a control
device until the VOC concentration of the vapors is reduced to less
than 34,000 parts per million by volume as methane.
     Inclusion of one or more counties in the BPA area in 30
TAC Chapter 114 rule for TxLED compliant marine diesel.
    In addition, the maintenance plan states that the BPA area may also
be expected to voluntarily implement some additional local control
measures.
    These contingency measures and schedules for implementation satisfy
EPA's longstanding guidance on the requirement of section 175(A) for
continued attainment. Continued attainment in the Beaumont Port Arthur
area will depend, in part, on the air quality measures discussed
previously (see VI.B. and V.B.4. above). The State will continue to
operate appropriate

ambient ozone monitoring sites in the BPA area to verify continued
attainment of the 1997 ozone NAAQS. The air monitoring results will
reveal changes in the ambient air quality as well as assist the State
in determining which contingency measures will be most effective if
necessary.
    As required by section 175A(b) of the CAA, Texas commits to submit
to the EPA an updated ozone maintenance plan eight years after
redesignation of the BPA area to cover an additional ten-year period
beyond the initial ten-year maintenance period. As required by section
175A(d) of the CAA, Texas has also committed to retain VOC and
NOX control measures contained in the SIP prior to
redesignation.
    EPA finds that the plan adequately addresses the five basic
components of a maintenance plan: Attainment inventory, maintenance
demonstration, monitoring network, verification of continued
attainment, and contingency plan. The maintenance plan SIP revision
submitted by Texas for BPA meets the requirements of section 175A of
the Act. Therefore, EPA is proposing to approve the maintenance plan
for the BPA area for the 1997 8-hour ozone standard as part of the
Texas SIP.

IX. What is EPA's evaluation of the BPA area's motor vehicle emissions
budget?

A. What are the transportation requirements for approvable MVEBs?

    A maintenance plan must include a MVEB for transportation
conformity purposes. ``Conformity'' to the SIP means that
transportation activities will not cause new air quality violations,
worsen existing violations, or delay timely attainment of the NAAQS. It
is a process required by section 176(c) of the Act for ensuring that
the effects of emissions from all on-road sources are consistent with
attainment or maintenance of the standard. EPA's transportation
conformity rules at 40 CFR part 93 require that transportation plans,
and programs, result in emissions that do not exceed the MVEB
established in the SIP. The maintenance plan established an MVEB for
2021, which is the last year of the maintenance plan.
    The MVEB is the level of total allowable on-road emissions
established by the maintenance plan. Maintenance plans must include the
estimates of motor vehicle VOC and NOX emissions that are
consistent with maintenance of attainment, which then act as a budget
or ceiling for the purpose of determining whether transportation plans,
and programs conform to the maintenance plan. In this case, the MVEB
sets the maximum level of on-road transportation emissions that can be
produced, when considered with emissions from all other sources, which
demonstrates continued maintenance of attainment of the 1997 8-hour
ozone NAAQS.

B. What is the status of EPA's adequacy determination?

    When reviewing submitted ``control strategy'' SIPs or maintenance
plans containing a MVEB, EPA determines whether the MVEB contained
therein is ``adequate'' for use in determining transportation
conformity. Once EPA finds a budget adequate, the budget must be used
by local, state and federal agencies in determining whether proposed
transportation plans and programs ``conform'' to the SIP as required by
section 176(c) of the Act.
    EPA's substantive criteria for determining ``adequacy'' of a MVEB
are set out in 40 CFR 93.118(e)(4). The process for determining the
adequacy of an MVEB was initially outlined in EPA's May 14, 1999,
guidance, ``Conformity Guidance on Implementation of March 2, 1999,
Conformity Court Decision.'' This guidance was finalized in the
Transportation Conformity Rule Amendments for the ``New 8-Hour Ozone
and PM2.5 National Ambient Air Quality Standards and
Miscellaneous Revisions for Existing Areas; transportation conformity
rule amendments--Response to Court Decision and Additional Rule
Change,'' on July 1, 2004 (69 FR 40004). Additional information on the
adequacy process for MVEBs is available in the proposed rule entitled,
``Transportation Conformity Rule Amendments: Response to Court Decision
and Additional Rule Changes,'' 68 FR 38974, 38984 (June 30, 2003).
    As discussed earlier, Texas' maintenance plan submission includes
NOX and VOC budgets for the year 2021. EPA reviewed the
budgets through the adequacy process. The availability of the SIP
submission with this 2021 MVEB was announced for public comment on
EPA's adequacy Web page on April 15, 2009, at: http://www.epa.gov/otaq/
transp/conform/adequacy.htm. The EPA public comment period on the
adequacy of the 2021 MVEB for BPA closed on May 15, 2009. EPA did not
receive any adverse comments on the MVEB. On April 1, 2010, EPA made a
finding of adequacy for the 2021 MVEB included in this 8-hour ozone
maintenance plan (75 FR 16456).

C. Is the MVEB approvable?

    Table 9 shows the total projected transportation emissions for
2021, as submitted by Texas.

                        Table 9--Beaumont/Port Arthur Projected Transportation Emissions
                                        [Tons per avg. ozone season day]
----------------------------------------------------------------------------------------------------------------
            Pollutant                  2005            2011            2014            2017            2021
----------------------------------------------------------------------------------------------------------------
NOX.............................           45.60           17.91           12.38            8.66            6.24
VOC.............................           11.63            7.92            6.51            5.58            4.77
----------------------------------------------------------------------------------------------------------------

    These transportation emissions are also represented in Table 8 of
this notice as the ``mobile'' emissions portion of emission inventory
data for the BPA area. As shown in Tables 8 and 9, substantial
reductions in both NOX and VOC transportation emissions are
projected between 2005 and 2021. Further, as previously stated in this
action, EPA finds that the State has demonstrated the future combined
emissions levels of NOX and VOC in 2011, 2014, 2017, and
2021 are expected to be similar to or less than the emissions levels in
2005. The projected transportation emissions for 2021 were used by
Texas as the basis of the 2021 NOX and VOC MVEB for the BPA
area. These emissions are consistent with the maintenance plan
demonstrating continued compliance with the 1997 ozone NAAQS for the
10-year period following redesignation to attainment.
    Under 40 CFR 93.101, the term safety margin is the amount by which
the total projected emissions from all sources of a given pollutant are
less than the total emissions that would satisfy the applicable
requirement for reasonable further progress, attainment, or
maintenance. The attainment level of emissions is the level of
emissions

during one of the years in which the area met the NAAQS. The safety
margin can be allocated to the transportation sector; however, the
total emissions must remain below the attainment level. Emission
projections contained in the BPA maintenance plan show the 2021
inventory in the BPA area represents a 20.53 tpd decrease in
NOX emissions compared with 2005 (Table 4-2), while VOC
emissions increase by 12.80 tpd (Table 4-1). Conservatively assuming a
1:1 ratio of NOX/VOC emissions in the formation of
O3, the net total reduction in NOX emissions is
7.73 tpd (Table 4-3). Texas has allocated one tpd of the NOX
emission reduction as a safety margin, which increases the 2021 MVEB
for NOX emissions from 6.24 tpd to 7.24 tpd. This is
discussed in greater detail in Part II.D. of the TSD. EPA finds this to
be an acceptable allocation.
    The submitted NOX and VOC MVEB for the BPA area is
defined in Table 10 below.

             Table 10--Beaumont/Port Arthur NOX and VOC MVEB
                      [Summer season tons per day]
------------------------------------------------------------------------
                        Pollutant                              2021
------------------------------------------------------------------------
NOX.....................................................         \*\7.24
VOC.....................................................            4.77
------------------------------------------------------------------------
\*\Includes an allocation of 1 tpd from the available NOX safety margin.

    Through this rulemaking, EPA is proposing to approve Texas' 2021
MVEB for VOCs and NOX for the BPA area for transportation
conformity purposes, because EPA has determined that the area maintains
the 1997 8-hour ozone standard with the emissions at the levels of the
budget. The submittal has met the adequacy criteria in 40 CFR
93.118(e)(4), and EPA has completed a comprehensive review of the
maintenance plan, concluding that the overall plan demonstrates
maintenance, is approvable and the budgets are consistent with the
overall plan. Therefore, the budgets can be proposed for approval.

X. EPA's Evaluation of the Backfill Contingency Measures for the 1-Hour
Ozone Failure-To-Attain Contingency Measures and the State's Request To
Remove an Unimplemented VOC Rule From the Texas SIP

    EPA approved the 1-hour ozone failure-to-attain section 172(c)(9)
and 182(c)(9) contingency measures for the BPA area on February 10,
1998 at 63 FR 6659 as part of EPA's approval of the BPA area's 15% VOC
ROP Plan. These contingency measures included the Federal Tier I rules,
the Federal small engine VOC rule, and excess reductions from the 15%
VOC ROP Plan. When EPA reclassified the BPA area to serious for the 1-
hour ozone NAAQS, these are the contingency measures that EPA
triggered. EPA approved a marine vessel-loading rule as part of the
Texas SIP for the BPA area on January 26, 1999 (64 FR 3841). As
written, it appears it is triggered upon an EPA finding of failure to
attain, but it was not included in the SIP-approved contingency plan
for the BPA area. EPA never approved it specifically as a section
172(c)(9) contingency measure nor did EPA approve it as a replacement
for the 1998-approved contingency measures. In the Federal Register
action for reclassification of the BPA area for the 1997 8-hour ozone
standard to moderate, EPA refers specifically to the 1998-approved 1-
hour contingency measures as the ones EPA triggered to be implemented
for failure to attain (73 FR 14391, March 18, 2008). Also in the
reclassification Federal Register action, EPA required the State to
submit additional contingency measures to replace, i.e., backfill, the
triggered contingency measures for its new serious area attainment
deadline under section 182(c)(9). The State submitted two control
measures on October 15, 2005, as a SIP revision to replace or backfill
the triggered contingency measures as required by the reclassification
notice. The proposed 1-hour section 182(c)(9) contingency measures are
emissions reductions from:
    (1) NOX and VOC reductions from three companies in the
BPA area through Agreed Orders, and (2) NOX reductions from
the Texas Emissions Reductions Program (TERP) projects.
    EPA approved the Agreed Orders into the SIP on April 12, 2005 (70
FR 18995). The TERP program was approved as part of the Texas SIP on
August 19, 2005 at 70 FR 48647 including the methodology for
calculating SIP credits for the individual TERP control measures. TERP
provides funding to offset the incremental costs of projects associated
with reducing NOX emissions from high-emitting internal
combustion engines.
    Together, reductions from these two control measures meet the 3
percent requirement for the 1-hour backfill failure-to-attain
contingency measures. The NOX reductions from the Agreed
Orders and the TERP projects were not relied upon for ROP or attainment
demonstration purposes and have already been implemented. Please see
the TSD: Part II.E. for additional detail. EPA is proposing to approve
the substitute control measures for the backfill failure-to-attain
contingency measures. Although, as noted in the discussion above, the
1-hour anti-backsliding contingency measure obligation is suspended
upon a final determination that the area is attaining the 1-hour ozone
standard, and terminates upon a final redesignation of the area for the
8-hour ozone standard, EPA understands that TCEQ nonetheless wishes EPA
to take action upon the submitted backfill measures. EPA notes that,
after the area is redesignated to attainment for the 8-hour ozone
NAAQS, these 1-hour contingency measures are replaced by the section
175A Maintenance Plan contingency measures.
    Also, in this SIP revision, TCEQ submitted a request to remove from
the Texas SIP, the ``contingency'' measure marine vessel loading rule
(30 TAC Sec.  115.219). This Texas marine vessel rule was approved into
the Texas SIP but was never implemented by the State. As discussed
above, this measure was not relied upon as part of a 172(c)(9) or
182(c)(9) contingency plans and was not triggered by the EPA as part of
the reclassification notice.
    Texas, in its SIP revision, made clear that the marine vessel
loading rule should not be a part of the backfill failure to attain
contingency plan required by the reclassification and that the two
measures used to comprise this plan were an appropriate substitute for
the marine vessel loading rule. In fact, Texas' sensitivity tests in
photochemical modeling runs indicate that reductions of 1 tpd of
NOX are equivalent to reductions of 3.8 tpd of VOC in
reducing ozone in the BPA area (TCEQ Attainment Demonstration SIP,
received October 18, 2005, section 5.3.1, p. 5-4). The two backfill
contingency measures are mostly NOX reductions and would be
expected to be more effective than the Marine Vessel Loading Rule, a
VOC control in reducing ozone.
    The SIP marine-vessel loading rule was never relied upon for
demonstrating attainment, achieving reasonable further progress, or as
a reasonable available control measure. It was not relied upon in the
15% VOC ROP plan or the post-1996 ROP plan. It was not relied upon in
any of the submitted attainment demonstration SIPs. It also is not
required to meet VOC RACT. EPA notes that since adoption by TCEQ,
federal rules for marine vessel loading have been adopted and achieve
much of the reductions that would have been achieved if the State rule
had been triggered.
    EPA has evaluated Texas' request to remove the marine vessel-
loading rule from its SIP. For the reasons cited above, whereas the
Texas rule was never

implemented or triggered as a contingency measure and whereas the rule
is not needed to satisfy any other statutory requirements, EPA proposes
that the Texas marine vessel-loading rule be removed from the Texas
SIP.

XI. Proposed Actions

    EPA is proposing several related actions under the Act for the BPA
ozone nonattainment area, consisting of Hardin, Jefferson, and Orange
counties. Consistent with the Act, EPA is proposing to determine that
the BPA area has attained the 1997 8-hour ozone NAAQS and to approve a
request from the state of Texas to redesignate the BPA area to
attainment of the 1997 8-hour ozone standard. This determination is
based on complete, quality-assured, and certified ambient air quality
monitoring data for the 2005-2007 ozone seasons and 2006-2008 ozone
seasons, as well as data for 2009 in AQS but not yet certified, that
demonstrate that the 1997 8-hour ozone NAAQS has been attained in the
area. EPA is also proposing to make a determination that the BPA area
is meeting the 1-hour ozone standard. This determination is based on
complete, quality-assured, and certified ambient air quality monitoring
data for 2005-2007 ozone seasons and 2006-2008 ozone seasons, as well
as data for 2009 in AQS but not yet certified, that demonstrate that
the 1-hour ozone NAAQS has been attained in the area. Finalizing the 1-
hour ozone attainment determination proposal will suspend the 1-hour
anti-backsliding requirements for a 1-hour attainment demonstration and
RACM analysis and contingency measures. These requirements will cease
to apply if the area is redesignated to attainment for the 1997 8-hour
ozone standard.
    EPA is proposing to approve the 2002 base year emissions inventory.
We are proposing to approve the State's CFV program equivalency
demonstration. We are proposing to find that the BPA area, upon final
approval of this emissions inventory and the CFV program equivalency
determination, will meet all the applicable CAA requirements under
section 110 and Part D for purposes of redesignation for the 1997 8-
hour ozone NAAQS including all the applicable antibacksliding CAA
requirements for a serious 1-hour ozone nonattainment area. Further,
EPA is proposing to approve into the SIP, as meeting section 175A and
107(d)(3)(E)(iv) of the Act, Texas' maintenance plan for the BPA area
for the 1997 8-hour ozone NAAQS. The maintenance plan shows maintenance
of the standard through 2021. Additionally, EPA is proposing to approve
the 2021 MVEB for NOX and VOC submitted by Texas for the BPA
area in conjunction with its redesignation request and maintenance
plan.
    Consequently, EPA is proposing to approve the State's request to
redesignate the area from nonattainment to attainment for the 1997 8-
hour ozone NAAQS. After evaluating Texas' redesignation request, EPA
has determined that upon final approval of the above-identified SIP
elements and the maintenance plan, the area will meet the redesignation
criteria set forth in section 107(d)(3)(E) and section 175A of the Act.
The final approval of this redesignation request would change the
official designation in 40 CFR part 81 for the BPA area from
nonattainment to attainment for the 1997 8-hour ozone standard. EPA
also notes that if EPA's proposed determinations of attainment for the
1-hour and 8-hour ozone NAAQS are finalized, the requirements to submit
certain planning SIPs related to attainment, including attainment
demonstration requirements (the RACM requirement, the RFP and
attainment demonstration requirements, and the requirement for
contingency measures) are suspended as long as it continues to attain
the NAAQS, and would cease to apply upon final redesignation.
    EPA also is proposing to approve the Post-1996 ROP Plan's
contingency measures and backfill failure-to-attain contingency
measures, and the removal from the Texas SIP under section 110(l) of a
VOC marine vessel loading contingency measure.

XII. Statutory and Executive Order Reviews

    Under the Clean Air Act, redesignation of an area to attainment and
the accompanying approval of a maintenance plan under section
107(d)(3)(E) are actions that affect the status of a geographical area
and do not impose any additional regulatory requirements on sources
beyond those imposed by state law. A redesignation to attainment does
not in and of itself create any new requirements, but rather results in
the applicability of requirements contained in the Clean Air Act for
areas that have been redesignated to attainment. Moreover, 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,
EPA's role is to approve state choices, provided that they meet the
criteria of the Clean Air Act. Accordingly, these actions merely do not
impose additional requirements beyond those imposed by state law and
the Clean Air Act. For that reason, these actions:
     Are not ``significant regulatory actions'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are 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.);
     Do 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);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are 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);
     Are 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
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Nitrogen dioxides, Reporting and recordkeeping
requirements, Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control.

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

    Dated: May 5, 2010.
Lawrence E. Starfield,
Acting Regional Administrator, Region 6.
[FR Doc. 2010-11694 Filed 5-14-10; 8:45 am]
BILLING CODE 6560-50-P


To:	Jeff Telander						From:	Dave Reeves

Project File						Date:	March 17, 2008

Re:	Mineral Wool Production – Acute Exposure Factor

When the initial acute health risk screening was performed, EPA used
conservative assumptions for emission rates, meteorology, and exposure
location.  The following worst-case assumptions were used in the
screening approach:

•	Peak 1-hour emissions were assumed to equal 10 times the average
1-hour emission rates.

•	For facilities with multiple emission points, peak 1-hour emissions
were assumed to occur at all emission points at the same time.

•	For facilities with multiple emission points, 1-hour concentrations
at each receptor were assumed to be the sum of the maximum
concentrations due to each emission point, regardless of whether those
maximum concentrations occurred during the same hour.

Based on the initial risk results, we then refined the approach to come
up with an acute exposure factor to be used in the subsequent risk
screening.  There are equipment and process limitations on how the
melting furnaces (cupolas) are operated – which limits the emissions
for a given facility.  The cupolas are considered batch operations, but
are run on a continuous or semi-continuous basis to save time and energy
to heat up the furnace for each batch.  Fiber collection, including the
application of the binder, curing, and cooling are not performed
intermittently during the course of a manufacturing campaign without the
loss of materials or product; therefore, these formaldehyde-emitting
processes in bonded mineral wool fiber manufacturing are continuous
processes with minimal fluctuation and not subject to large short-term
spikes in emission rates.

Discussions with industry experts indicated that the continuous nature
of the process would not lead to large fluctuations in the hourly
emission rates, and that a more reasonable, yet still conservative,
ratio of peak-to-mean hourly emission rate is 2, rather than 10 (see
NAIMA comments dated June 29, 2007 on ANPRM – Docket ID No.
EPA-HQ-OAR-2006-0859).   Raw material feed rates in mineral wool
processes are essentially constant with minimal fluctuation
(approximately ± 10 percent).  Consequently, emissions also have
minimal fluctuation. In refining the acute risk assessment, a short-term
emissions multiplier of 2 was used to estimate the maximum hazard from
acute exposures, with 1.5 of the factor accounting for two daily shifts,
and 0.5 of the factor accounting for up to 33% emissions variability in
the processes.


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as a consumer of electronic cigarette products to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me as a consumer of the products that will be regulated under the Proposed Rule. Having read the Proposed Rule it asks about a hundred different questions I feel I would want to respond to. Being how the answers to these questions directly impact me, I want to provide my thoughts and comments on many of these issues. However, working full time and providing support in my household limits my time to devote to researching and providing thoughtful comments on these very important questions. I have already spent many hours researching and dissecting these issues, but they take time. I have concerns that such a short time period for forming quality responses to the many questions asked is not sufficient and that my true voice will be missed, or possibly dismissed in the process. It is my understanding that the FDA took many years to even develop the Proposed Rule. I do not think it is at all unreasonable to allow the public six months to comment on it. This will be my only opportunity as a consumer of the product being proposed for regulation to provide feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I firmly believe that they saved my life and have great potential. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
[Notices]
[Pages 15095-15096]
[FR Doc No: 2012-6132]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-474-000.
    Applicants: Caledonia Energy Partners, L.L.C.
    Description: Change to FERC Gas Tariff to be effective 3/5/2012.
    Filed Date: 3/5/12.
    Accession Number: 20120305-5114.
    Comments Due: 5 p.m. ET 3/19/12.

    Docket Numbers: RP12-475-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Linking/Swing Supplier to be effective 4/6/2012.
    Filed Date: 3/6/12.
    Accession Number: 20120306-5070.
    Comments Due: 5 p.m. ET 3/19/12.

    Docket Numbers: RP12-476-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Modifications to Gas Quality Phase-In Provisions to be
effective 4/7/2012.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5036.
    Comments Due: 5 p.m. ET 3/19/12.

    Docket Numbers: RP12-477-000.
    Applicants: High Island Offshore System, L.L.C.
    Description: Compliance on Reserved Issue to be effective 9/30/
2010.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5050.
    Comments Due: 5 p.m. ET 3/19/12.

    Docket Numbers: RP12-478-000.
    Applicants: Empire Pipeline, Inc.
    Description: Deferred State Income Tax Balance (2011) to be
effective N/A.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5077.
    Comments Due: 5 p.m. ET 3/19/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP11-2449-003.
    Applicants: Portland Natural Gas Transmission System.
    Description: Amendment to RP11-2449-002 to be effective 9/30/2010.
    Filed Date: 3/5/12.
    Accession Number: 20120305-5184.
    Comments Due: 5 p.m. ET 3/19/12.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: March 8, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2012-6132 Filed 3-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33390-33392]
[FR Doc No: 2011-14036]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64582; File No. SR-NYSE-2011-23]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Exchange Price List

June 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on May 26, 2011, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the

proposed rule change as described in Items I, II, and III 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 modify the fees it charges for the
issuance of trading licenses that are required in order to effect
transactions on the floor of the Exchange or through any facility of
the Exchange. The Exchange proposes to amend its 2011 Price List
(``Price List'') to (i) Create a two-tiered pricing structure for the
annual fee, under which the fee would continue to be $40,000 per
license for the first two licenses held by a member organization but
would be reduced to $25,000 per license for any additional trading
licenses held by that member organization, (ii) provide a formula for
proration of the annual fee during a calendar month in which a trading
license has been in place for less than the full month, (iii) eliminate
the current $1,000 fee for approval of a new member, and (iv) eliminate
the $1,000 trading license transfer fee. The Exchange also proposes to
amend Exchange Rule 300 (Trading Licenses) to be consistent with these
changes and also to provide that the monthly installments of the annual
fee be payable in arrears at the end of each month. These changes will
become operational on June 1, 2011. The text of the proposed rule
change is available at the Exchange, the Commission's Public Reference
Room, http://www.sec.gov, and http://www.nyse.com.

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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to modify the fees it charges for the
issuance of trading licenses that are required in order to effect
transactions on the floor of the Exchange or through any facility of
the Exchange. As currently provided in Exchange Rule 300 (Trading
Licenses), the price per trading license sold in each annual offering
of such licenses is established each year by the Exchange pursuant to a
rule filing submitted to the Commission, and that price is published in
the Exchange's Price List. The Exchange has previously established the
trading license fee for calendar year 2011 at $40,000 per license,
which is currently reflected in the Price List.
    The Exchange proposes to modify the structure of its annual fee for
trading licenses by moving from a single price for all such licenses to
a two-tiered pricing structure. Under the proposal, the annual fee
would continue to be $40,000 per license for the first two trading
licenses held by a member organization but would be reduced to $25,000
per license for any additional trading licenses held by that member
organization. The price of each of these two tiers would continue to be
established each year by the Exchange pursuant to a rule filing
submitted to the Commission, with the tier prices being published in
the Price List.
    Pursuant to Exchange Rule 300(e), a buyer of a trading license is
required to pay the Exchange the trading license fee in equal monthly
installments in advance over the period during which the trading
license is in effect. The Exchange proposes to change its billing
schedule so that the monthly installments are payable in arrears at the
end of each month.
    In addition, Exchange Rule 300(d) provides that, following the
annual offering and at any time thereafter during the following
calendar year, the Exchange shall sell additional trading licenses
expiring at the end of the calendar year at the price set forth in the
Price List, but prorated to reflect the amount of time remaining in the
year. For any such additional trading license that is in place for 15
calendar days or less in a calendar month, the Exchange proposes that
the proration for that month will be computed based on a flat rate of
$100 per day with no tier pricing involved. For any such additional
trading license that is in place for 16 calendar days or more in a
calendar month, the Exchange proposes that the proration for that month
will be computed based on the number of days as applied to the full
annual fee for the license for the applicable tier.
    Finally, the Exchange proposes to eliminate the current $1,000 fee
provided for on the Price List for approval of a new member because it
believes the annual fee adequately covers any costs related to such
approval. The Exchange further proposes to eliminate the $1,000 trading
license transfer fee provided for on the Price List. This fee has
become obsolete due to the fact that trading licenses are no longer
transferred; instead, they are purchased following expiration or
termination pursuant to Exchange Rule 300.
    In addition to the proposed changes to the Price List, the Exchange
also proposes to amend Exchange Rule 300 to be consistent with these
changes.
    These changes will become operational on June 1, 2011. Licenses
that are already in place will be billed monthly for the remainder of
the year at the new tier rates beginning on that date, but there will
be no retroactive adjustment for the period prior to June 1 for those
trading licenses that qualify for the new $25,000 tier price. For the
June 2011 billing, the Exchange will begin invoicing in arrears as
discussed above.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Securities Exchange Act of 1934
(the ``Act''),\3\ in general, and Section 6(b)(4) of the Act,\4\ in
particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and other persons using its facilities. The Exchange believes
that the proposal does not constitute an inequitable allocation of
fees, as all similarly situated member organizations will be subject to
the same fee structure and access to the Exchange's market is offered
on fair and non-discriminatory terms. Any member organization that
holds more than two trading licenses will be able to benefit from the
new $25,000 annual fee tier for the additional licenses. The ability to
pay monthly installments of the annual fee in arrears instead of in
advance, as presently required, should be beneficial to all member
organizations that hold trading licenses.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).

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

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 that is 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 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 foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \5\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \6\ thereunder, because it establishes a due, fee, or other charge
imposed by the NYSE.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2011-23 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-NYSE-2011-23. This file
number should be included on the subject line if e-mail 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
a.m. and 3 p.m. Copies of such 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 publicly available. All
submissions should refer to File Number SR-NYSE-2011-23 and should be
submitted on or before June 29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-14036 Filed 6-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Rules and Regulations]
[Pages 43575-43576]
[FR Doc No: 2011-18126]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0047; Airspace Docket No. 11-AGL-1]

Amendment of Class E Airspace; Grand Marais, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace for Grand Marais, MN, to
accommodate new Area Navigation (RNAV) Standard Instrument Approach
Procedures at Grand Marais/Cook County Airport. 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, October 20, 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 May 18, 2011, the FAA published in the Federal Register a notice
of proposed rulemaking to amend Class E airspace for Grand Marais, MN,
creating additional controlled airspace at Grand Marais/Cook County
Airport (76 FR 28687) Docket No. FAA-2011-0047. 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 part 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 creating additional Class E airspace extending upward from
700 feet above the surface for new standard instrument approach
procedures at Grand Marais/Cook County Airport, Grand Marais, MN. 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 amends controlled airspace for Grand Marais/Cook County Airport,
Grand Marais, MN.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    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 Part 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 of the earth.

* * * * *

AGL MN E5 Grand Marais, MN [Amended]

Grand Marais/Cook County Airport, MN
    (Lat. 47[deg]50'18'' N., long. 90[deg]22'59'' W.)
Cook County NDB
    (Lat. 47[deg]50'24'' N., long. 90[deg]23'08'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Grand Marais/Cook County Airport, and
within 2 miles each side of the 275[deg] bearing from the airport
extending from the 6.4-mile radius to 8.3 miles west of the airport,
and within 2.2 miles each side of the 104[deg] bearing from the Cook
County NDB extending from the 6.4-mile radius to 7 miles east of the
airport, excluding that airspace which overlies P-204.

    Issued in Fort Worth, Texas, on July 13, 2011.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2011-18126 Filed 7-20-11; 8:45 am]
BILLING CODE 4910-13-P