[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)]
[Proposed Rules]
[Pages 26501-26503]
[FR Doc No: 2016-10174]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-4629; Airspace Docket No. 16-AGL-8]

Proposed Amendment of Class E Airspace for the following Michigan
Towns; Alma, MI; Bellaire, MI; Cadillac, MI; Drummond Island, MI;
Gladwin, MI; Holland, MI; and Three Rivers, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 700 feet above the surface at Gratiot Community Airport,
Alma, MI; Antrim County Airport, Bellaire, MI; Wexford County Airport,
Cadillac, MI; Drummond Island Airport, Drummond Island, MI; Charles C.
Zettel Memorial Airport, Gladwin, MI; Park Township Airport and West
Michigan Regional Airport, Holland, MI; and Three Rivers Municipal Dr.
Haines Airport, Three Rivers, MI. Decommissioning of non-directional
radio beacons (NDB), cancellation of NDB approaches, or implementation
of area navigation (RNAV) procedures have made this action necessary
for the safety and management of Instrument Flight Rules (IFR)
operations at the above airports. This action would also update the
geographic coordinates of Three Rivers Municipal Dr. Haines Airport,
and the name change of West Michigan Regional Airport (formerly Tulip
City Airport) to coincide with the FAAs aeronautical database.

DATES: Comments must be received on or before June 17, 2016.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2016-
4629; Airspace Docket No. 16-AGL-8, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays. The Docket Office (telephone 1-800-
647-5527) is on the ground floor of the building at the above address.
    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.9Z at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, 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 would amend Class E airspace at Gratiot Community Airport, Alma,
MI; Antrim County Airport, Bellaire, MI; Wexford County Airport,
Cadillac, MI; Drummond Island Airport, Drummond Island, MI; Charles C.
Zettel Memorial Airport, Gladwin, MI; Park Township Airport and West
Michigan Regional Airport, Holland, MI; and Three Rivers Municipal Dr.
Haines Airport, Three Rivers, MI.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in

developing reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2016-4629/
Airspace Docket No. 16-AGL-8.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX, 76177.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document would amend FAA Order 7400.9Z, Airspace Designations
and Reporting Points, dated August 6, 2015, and effective September 15,
2015. FAA Order 7400.9Z is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B,
C, D, and E airspace areas, air traffic service routes, and reporting
points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class E airspace extending
upward from 700 feet above the surface at the following airports:
    Within a 6.5-mile radius of Gratiot Community Airport, Alma, MI;
    Within a 6.5-mile radius of Antrim County Airport, Bellaire, MI,
with a segment extending from the 6.5-mile radius to 6.9 miles south of
the airport;
    Within a 6.7-mile radius of Wexford County Airport, Cadillac, MI;
    Within a 6.5-mile radius of Drummond Island Airport, Drummond
Island, MI, with a segment extending from the 6.5-mile radius to 8.5
miles east of the airport;
    Within a 6.5-mile radius of Charles C. Zettel Memorial Airport,
Gladwin, MI;
    Within a 6.5-mile radius of West Michigan Regional Airport
(formerly Tulip City Airport), Holland, MI; Park Township Airport would
be removed as it no longer has instrument procedures and no longer
requires Class E airspace; and
    Within a 6.4 mile radius of Three Rivers Municipal Dr. Haines
Airport, Three Rivers, MI, and updating the geographic coordinates of
this airport to coincide with the FAAs aeronautical database. These
airspace reconfigurations are necessary due to the decommissioning of
NDBs, cancellation of NDB approaches, or implementation of RNAV
procedures at the above airports. Controlled airspace is necessary for
the safety and management of the standard instrument approach
procedures for IFR operations at the airports.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9Z, dated August 6, 2015, and effective September 15,
2015, 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.

Regulatory Notices and Analyses

    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, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (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, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 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(f), 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 FAA Order 7400.9Z,
Airspace Designations and Reporting Points, dated August 6, 2015, and
effective September 15, 2015, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL MI E5 Alma, MI [Amended]

Alma, Gratiot Community Airport, MI
    (Lat. 43[deg]19'20'' N., long. 84[deg]41'17'' W.)
Mount Pleasant VOR/DME
    (Lat. 43[deg]37'22'' N., long. 84[deg]44'14'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Gratiot Community Airport, and within
2.0 miles either side of a 270[deg] bearing from the airport
extending from the 6.5-mile radius to 10.1 miles west of the
airport, and within 1.5 miles either side of the Mount Pleasant VOR/
DME 178[deg] radial extending from the 6.5-mile radius to 10.3 miles
north of the airport.
* * * * *

AGL MI E5 Bellaire, MI [Amended]

Bellaire, Antrim County Airport, MI

    (Lat. 44[deg]59'19'' N., long. 85[deg]11'54'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Antrim County Airport, and within 1.9
miles each side of the 197[deg] bearing from the airport extending
from the 6.5-mile radius to 6.9 miles south of the airport.
* * * * *

AGL MI E5 Cadillac, MI [Amended]

Cadillac, Wexford County Airport, MI
    (Lat. 44[deg]16'31'' N., long. 85[deg]25'08'' W.)
    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of the Wexford County Airport.
* * * * *

AGL MI E5 Drummond Island, MI [Amended]

Drummond Island Airport, MI
    (Lat. 46[deg] 00'34'' N., long. 83[deg] 44'38'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Drummond Island Airport, and within 4
miles each side of the 072[deg] bearing from the airport extending
from the 6.5-mile radius to 8.5 miles east of the airport; that
airspace extending upward from 1,200 feet above the surface bounded
by long. 83[deg]57'00'' W., on the west; long. 83[deg]26'00'' W., on
the east; Lat. 46[deg]05'00'' N., on the north; and Lat.
45[deg]45'00'' N., on the south, excluding that airspace within
Canada.
* * * * *

AGL MI E5 Gladwin, MI [Amended]

Charles C. Zettel Memorial Airport, MI
    (Lat. 43[deg]58'14'' N., long. 84[deg]28'30'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the Charles C. Zettel Memorial Airport.
* * * * *

AGL MI E5 Holland, MI [Amended]

West Michigan Regional Airport, MI
    (Lat. 42[deg]44'34'' N., long. 86[deg]06'28'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the West Michigan Regional Airport.
* * * * *

AGL MI E5 Three Rivers, MI [Amended]

Three Rivers Municipal Dr Haines Airport, MI
    (Lat. 41[deg]57'35'' N., long. 85[deg]35'35'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Three Rivers Municipal Dr Haines
Airport, excluding that airspace within the Sturgis, Kirsch
Municipal Airport, MI, Class E airspace area.

    Issued in Fort Worth, Texas, on April 19, 2016.
Walter Tweedy,
Acting Manager, Operations Support Group, Central Service Center.
[FR Doc. 2016-10174 Filed 5-2-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 39 (Tuesday, February 28, 2023)]
[Notices]
[Pages 12716-12717]
[FR Doc No: 2023-04018]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2023-0002]

Draft Model Minimum Uniform Crash Criteria (MMUCC) Guideline,
Sixth Edition; Extension of Comment Period

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Extension of comment period.

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SUMMARY: NHTSA received a petition to extend the comment period for a
Request for comments (RFC) notice on the Draft Model Minimum Uniform
Crash Criteria (MMUCC) Guideline, Sixth Edition. NHTSA published an RFC
notice announcing the draft of MMUCC on February 2, 2023. The comment
period for the RFC notice was scheduled to end on April 3, 2023. NHTSA
is extending the comment period for the February 2, 2023 RFC notice by
30 days.

DATES: The comment period for the RFC notice published on February 2,
2023 at 88 FR 7128, is extended to May 3, 2023.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System Docket ID, Docket DOT-NHTSA-2023-0002 using any of
the following methods:
     Federal Rulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Send comments to: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590.
     Fax: Written comments may be faxed to<PHONE_NUMBER>.
     Hand Delivery: If you plan to submit written comments by
hand or courier, please do so at 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590, between 9
a.m. and 5 p.m./Eastern Time, Monday through Friday, except Federal
holidays.
    Please submit all comments to the Docket by May 3, 2023.
    When you submit your comments, please remember to mention the
agency

and the docket number of this document within your correspondence.
Please note that all comments received will be posted without change to
https://www.regulations.gov, including any personal information
provided. Please see the ``Privacy Act'' heading below.
    Privacy Act: Anyone can search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comments (or signing the comments, if submitted on
behalf of an association, business, labor union, etc.). You may review
DOT's complete Privacy Act Statement in the Federal Register published
on January 17, 2008 (73 FR 3336) or at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices (select
``Department Wide System of Record Notices,'' then select DOTALL 14
Federal Docket Management System.)
    Confidential Information: If you wish to submit any information
under a claim of confidentiality, you should submit three copies of
your complete submission, including the information you claim to be
confidential business information, to the Chief Counsel, NHTSA, 1200
New Jersey Avenue SE, Washington, DC 20590. In addition, you should
submit two copies, from which you have deleted the claimed confidential
business information, to Docket Management at the address given above
under ADDRESSES. When you send a comment containing information claimed
to be confidential business information, you should include a cover
letter setting forth the information specified in our confidential
business information regulation (49 CFR part 512).
    Docket: For access to the docket to read the proposed changes to
MMUCC, background documents, or comments received, go to https://www.regulations.gov at any time and follow the online instructions for
accessing the dockets. Or go to West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m.
and 5 p.m., Eastern Time, Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: For information, please contact Beau
Burdett, National Center for Statistics and Analysis, NHTSA (telephone:
202-366-7338 or email: [email protected]).
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29A.

Chou Lin Chen,
Associate Administrator, National Center for Statistics and Analysis.
[FR Doc. 2023-04018 Filed 2-27-23; 8:45 am]
BILLING CODE 4910-59-P


  MacroButton macIb01 i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: RD

Docket Number: EPA-HQ-OPP-2016-0254

Interregional Research Project Number 4

Pesticide Petition #: 6E8484

	EPA has received a pesticide petition (6E8484) from The Interregional
Research Project Number 4 (IR-4), Rutgers, The State University of New
Jersey, 500 College Road East, Suite 201 W, Princeton, NJ  08540
requesting, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.475 by
establishing a tolerance for residues of difenoconazole
1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmeth
yl]-1H-1,2,4,-triazole, including its metabolites and degradates,
determined by measuring only difenoconazole in or on brassica, leafy
greens, subgroup 4-16B at 35 ppm; cranberry at 0.6 ppm; fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 4.0 ppm; guava
at 3.0 ppm; kohlrabi at 2.0 ppm; papaya at 0.6 ppm; and vegetable,
brassica, head and stem, group 5-16 at 2.0 ppm.

Upon approval of the aforementioned tolerances, it is proposed that 40
CFR 180.475 be amended to remove the established tolerances for the
residues of difenoconazole in or on the raw agricultural commodity:
Brassica, head and stem, subgroup 5A at 1.9 ppm, Brassica, leafy greens,
subgroup 5B at 35 ppm; Grape at 4.0 ppm; and Turnip, greens at 35 ppm.

EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of  FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The nature of the residues in plants is understood
for the purpose of the proposed tolerance.  The metabolism of
14C-difenoconazole has been studied using both phenyl and triazole
labels in wheat, tomatoes, potatoes, grapes, and spring rape.  The
metabolic pathway was the same in these four separate and distinct
crops.  Therefore, the metabolism of difenoconazole is considered to be
adequately understood for all crops, per EPA Test Guideline 860.1300.

	2. Analytical method. Syngenta Crop Protection, LLC has submitted a
practical analytical method (AG-575B), for detecting and measuring
levels of difenoconazole in or on food with a limit of quantitation
(LOQ) that allows monitoring of food with residues at or above the
levels set in the proposed tolerances.  Residues are quantified by gas
chromatography equipped with a nitrogen-phosphorous detector.  EPA has
validated this method and copies have been provided to FDA for insertion
into pesticide analytical manual (PAM) II. Method REM 147.08 is also
available for enforcement method, for the determination of residues of
difenoconazole in crops. Residues are qualified by liquid chromatography
(LC)/mass spectrometry (MS)/(MS) The method is available to anyone who
is interested, and may be obtained from the Field Operations Division,
Office of Pesticide Programs.  Syngenta Crop Protection, LLC has
submitted a practical analytical method (AG-544A) for detecting and
measuring levels of difenoconazole in or on cattle tissues and milk and
poultry tissues and eggs, with a LOQ that allows monitoring of food with
residues at or above the levels set in the proposed tolerances.  EPA has
validated this method and copies have been provided to FDA for insertion
into PAM II.  The method is available to anyone who is interested, and
may be obtained from the Field Operations Division, Office of Pesticide
Programs.  Tolerances in meat, milk, poultry or eggs were established
for enforcement purposes.

	3. Magnitude of residues. IR-4 conducted adequate magnitude of residue
trials under OPPTS 860.1500 to support the requested uses of
difenoconazole. These residue trials satisfy the requested tolerances on
guava, papaya, and cranberry.

B. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk.  EPA has also considered
available information concerning the variability of the sensitivities of
major identifiable subgroups of consumers, including infants and
children.  Specific information on the studies received and the nature
of the toxic effects caused by difenoconazole as well as the
no-observed-adverse-effect-level (NOAEL) from the toxicity studies can
be found at the following website:   HYPERLINK
"http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2014-0470-0010
"
http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2014-0470-0010
.

A summary of the toxicological endpoints for difenoconazole used for
human risk assessment is discussed in Unit III.A and B. of the final
rule published in the Federal Register of August 26, 2015 (80 FR pages
51732-51739) (FRL-9929-61). [2015-21078].

	1. Acute toxicity.  [See above]

	2. Genotoxicty. [See above]

	3. Reproductive and developmental toxicity. [See above]

	4. Subchronic toxicity. [See above]

	5. Chronic toxicity. [See above]

	6. Animal metabolism. [See above]

	7. Metabolite toxicology. [See above]

	8. Endocrine disruption. [See above]

C. Aggregate Exposure

	1. Dietary exposure. Tier III acute, short-term, and chronic dietary
exposure evaluations were performed for difenoconazole using the Dietary
Exposure Evaluation Model (DEEM-FCID™ Version 4.02) from EPA and
consumption data from the USDA National Health and Nutrition Examination
Survey (NHANES) “What We Eat in America (WWEIA)” survey from
2005-2010.  These difenoconazole exposure assessments included all
current uses and recently proposed uses on rice and cotton as well as
proposed IR-4 uses on cranberry, guava, and papaya. These assessments
also included proposed crop group expansions and conversions to
Vegetable, brassica, head and stem, group 5-16, Brassica, leafy greens,
subgroup 4-16B, except Chinese broccoli, Broccoli, Chinese, Kohlrabi and
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F.
These assessments utilized residue data from field trials where
difenoconazole was applied at the maximum intended use rate and samples
were harvested at the minimum pre-harvest interval (PHI) to obtain
maximum residues.  Empirically derived processing factors were used in
these assessments when available; all other processing factors used the
DEEM-FCIDTM Version 7.87 defaults.  Secondary residues in beef liver and
kidney were estimated based on “maximum reasonably balanced diets”
and transfer information from feeding studies. Percent crop treated
(%CT) values were estimated based upon economic, pest, and competitive
pressures.  Drinking water estimates were selected using the higher of
the estimated drinking water concentrations (EDWCs) for surface and
ground water.

	i. Food. Acute exposure.  Acute (food only) risk assessments for
difenoconazole were performed for all population subgroups using an
acute reference dose (aRfD) of 0.25 mg/kg-bw/day, based upon a
neurotoxicity study in rats with a no observed adverse effect level
(NOAEL) of 25 mg/kg-bw/day and an uncertainty factor (UF) of 100X. The
100X safety factor includes intra- and inter-species variations; no
additional FQPA safety factor was applied.  For the purpose of the
aggregate risk assessment, the exposure value was expressed in terms of
margin of exposure (MOE), which was calculated by dividing the NOAEL by
the exposure for each population subgroup.  In addition, exposure was
expressed as a percent of the acute reference dose (%aRfD).  At the
99.9th percentile, acute (food only) exposure to the U.S. population
resulted in a MOE of 555 (18.0% of the aRfD of 0.25 mg/kg-bw/day).  The
most exposed sub-population was children (1-2 years old) with a MOE of
277 (36.0% of the aRfD of 0.25 mg/kg-bw/day).  Since the Benchmark MOE
for this assessment was 100 and since the EPA generally has no concern
for exposures above the Benchmark MOE or below 100% of the reference
dose, Syngenta believes that there is a reasonable certainty that no
harm will result from acute dietary (food) exposure to residues arising
from all current and proposed uses for difenoconazole.

Chronic exposure.  Chronic (food only) risk assessment for
difenoconazole were performed for all population subgroups using a
chronic reference dose (cRfD) of 0.01 mg/kg-bw/day, based on a combined
chronic toxicity/carcinogenicity study in rats with a no observed
adverse effect level (NOAEL) of 0.96 mg/kg-bw/day and an uncertainly
factor of 100X.  The 100X safety factor includes intra- and
inter-species variations; no additional FQPA safety factor was applied.
For the purpose of the aggregate risk assessment, the exposure values
were expressed in terms of margin of exposure (MOE), which was
calculated by dividing the NOAEL by the exposure for each population
subgroup.  In addition, exposure was expressed as a percent of the
chronic reference dose (%cRfD).  Chronic (food only) exposures to the
U.S. population resulted in a MOE of 641 (15.0% of the cRfD of 0.01
mg/kg-bw/day).  The most exposed sub-population was children (1-2 years
old) with a MOE of 159 (60.3% of the cRfD of 0.01 mg/kg-bw/day).  Since
the Benchmark MOE for this assessment was 100 and since the EPA
generally has no concern for exposures above the Benchmark MOE or below
100% of the reference dose, Syngenta believes that there is a reasonable
certainty that no harm will result from chronic dietary (food) exposure
to residues arising from all current, pending, and proposed uses for
difenoconazole.

Cancer.  A cancer dietary assessment was not conducted.  Difenoconazole
is classified as a Group C, “possible human carcinogen,” with a
non-linear (MOE) approach for human risk characterization (CPRC
Document, 7/27/94, Memo, P. V. Shah, March 3, 2007, Health Effects
Division (HED) of EPA: Doc. No. 0054532).

	ii. Drinking water. The Estimated Drinking Water Concentrations (EDWCs)
of difenoconazole determined as total toxic residues of difenoconazole
(CGA169374) and its degradate, CGA205375, were determined for ground
water using Tier 1 screening models SCI-GROW (version 2.3) and PRZM-GW
(version 1.07) and for surface water using Tier II Surface Water
Concentration Calculator (SWCC v1.106) for terrestrial uses and Modified
Tier 1 Rice Model and Provisional Cranberry Model for aquatic uses. The
modelling was conducted to identify the highest EDWCs of difenoconazole
determined as total toxic residues of difenoconazole (CGA169374) and its
degradate, CGA205375, from the proposed IR-4 uses such as guava, papaya,
and cranberry, and all existing and pending uses. For ground water,
PRZM-GW provided an EDWC of 2.0 ppb for acute and 0.66 ppb for chronic
concentration based on the currently registered use on turf. For surface
water, Provisional Cranberry Model provided a surface water acute EDWC
of 36.4 ppb and a surface water chronic EDWC of 32.1 ppb for the
proposed IR-4 cranberry use.  Since the surface water EDWCs exceed the
ground water EDWCs, the surface water values were used for risk
assessment purposes and will be considered protective for any ground
water exposure concerns.

Acute Exposure from Drinking Water.  The acute surface water EDWC of
36.4 ppb was input directly into the DEEM-FCID™ software as “water,
direct and indirect, all sources” to model the acute drinking water
exposures.  Exposure contributions at the 99.9th  percentile of
exposures were determined by taking the difference between the aggregate
(food + drinking water) exposures and the food (alone) exposures for
each population subgroup.  Acute drinking water exposure U.S. population
resulted in a MOE of 22,873 (0.4% of the aRfD of 0.25 mg/kg-bw/day).
The most exposed sub-population was all infants (<1 year old) with a MOE
of 12,801 (0.8% of the aRfD of 0.25 mg/kg/day).  Since the benchmark MOE
for this assessment was 100 and since EPA generally has no concern for
exposures below 100% of the aRfD, Syngenta believes that there is a
reasonable certainty that no harm will result from acute drinking water
exposure to residues arising from all registered and proposed uses for
difenoconazole.

Chronic Exposure from Drinking Water.  The chronic surface water EDWC of
32.1 ppb was input directly into the DEEM-FCID software as “water,
direct and indirect, all sources” to model the chronic drinking water
exposures.  Chronic drinking water exposure to the U.S. population
resulted in a MOE of 1,480 (6.5% of the cRfD of 0.01 mg/kg-bw/day).
Chronic drinking water exposure to the most exposed sub-population (all
infants, <1 year old) resulted in a MOE of 396 (24.2% of the cRfD of
0.01 mg/kg bw/day).  Since the Benchmark MOE for this assessment was 100
and since EPA generally has no concern for exposures below 100% of the
cRfD, Syngenta believes that there is a reasonable certainty that no
harm will result from chronic drinking water exposure to residues
arising from all registered and proposed uses for difenoconazole.

	2. Non-dietary exposure. The use of difenoconazole on ornamentals and
flower gardens (Inspire®, Ready-to-Use spray) and golf courses (Quadris
Top™, Heritage Top™, Briskway™) may result in residential handler
or post application exposures to selected subgroups.  A short-term
toxicological dermal and inhalation endpoint of 1.25 mg/kg-bw/day was
selected based upon the no observed adverse effect level (NOAEL) from a
2-generation reproductive study in rats with an uncertainty factor of
100X, which includes intra- and inter-species variations; no additional
FQPA safety factor was applied.  Exposure values were expressed in terms
of margin of exposure (MOE), which was calculated by dividing the NOAEL
by the exposure for each subgroup.  Adult gardeners (19+ years old) were
most exposed via post-application exposures from treated gardens, with a
short-term MOE of 251.  Youth gardeners (6-11 years old) were most
exposed via post-application exposures from treated gardens, with a
short term MOE of 367.  Youth golfers (11-16 years old) were most
exposed via post application exposures from treated golf course turf,
with a short-term MOE of 2,659.  Residential exposure assessments were
performed for difenoconazole to evaluate exposures resulting from
off-site drift of agricultural products into residential areas.
Incidental exposure to consumers from spray drift from non-residential
uses were not included in the aggregate consumer risk; this approach
agrees with the EPA’s current policy and practice.  Since the
Benchmark MOE for this assessment was 100 and since the EPA generally
has no concern for exposures above the Benchmark MOE, Syngenta believes
that there is a reasonable certainty that no harm will result from
short-term residential exposure to residues arising from all current,
pending, and proposed uses for difenoconazole.

D. Cumulative Effects

	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity”.  An ongoing series of studies being
conducted by the U.S. Triazole Task Force (USTTF) are designed to
provide the Agency with more complete toxicological and residue
information for 1,2,4 triazole and two conjugates, triazolylalanine and
triazolyl acetic acid, metabolites common to most of the triazole
fungicides.  Upon completion of review of those data, EPA will prepare a
more sophisticated assessment based on the revised toxicological and
exposure databases.  For the purposes of this tolerance action, the EPA
has not assumed that difenoconazole has a common mechanism of toxicity
with other substances.

E. Safety Determination

	1. U.S. population. The acute dietary exposure analysis (food plus
water) showed that exposure from all current and proposed uses of
difenoconazole would result in a MOE of 542 (18.4% of the aRfD of 0.25
mg/kg-bw/day) for the U.S. population, which exceeds the Benchmark MOE
of 100.  For the short-term aggregate exposure analysis the
corresponding food, water and residential MOEs were aggregated using the
inverse MOE approach.  The short-term aggregate exposure analysis (food,
drinking water, and residential) showed that exposure from all current
and proposed uses of difenoconazole resulted in a MOE of 175 for the
U.S. population, which exceeds the Benchmark MOE of 100.  The chronic
dietary exposure analysis (food plus water) showed that exposure from
all current and proposed uses of difenoconazole resulted in a MOE of 447
(21.5% of the cRfD of 0.01 mg/kg-bw/day) for the U.S. population, which
exceeds the Benchmark MOE of 100.  Based on the completeness and
reliability of the toxicity data supporting these petitions, Syngenta
believes that there is a reasonable certainty that no harm will result
from aggregate exposure to residues arising from all current and
proposed uses of difenoconazole, including anticipated dietary exposure
from food, water, and all other types of non-occupational residential
exposures.

	2. Infants and children. The acute dietary exposure analysis (food plus
water) showed that exposure from all current, pending and proposed uses
of difenoconazole would result in a MOE of 273 (36.6% of the aRfD of
0.25 mg/kg-bw/day) for the most sensitive population subgroup, children
1-2 years old, which exceeds the Benchmark MOE of 100.  For the
short-term aggregate exposure analysis the corresponding food, water and
residential MOEs were aggregated using the inverse MOE approach.  The
short term aggregate (food, drinking water, and residential) MOE was 148
for all infants (<1 year), which exceeds the Benchmark MOE of 100.  The
chronic dietary exposure analysis (food plus water) showed that exposure
from all current, pending, and proposed uses of difenoconazole resulted
in a MOE of 114 (84.3% of the cRfD of 0.01 mg/kg-bw/day) for the most
sensitive population subgroup, all infants <1 year old, which exceeds
the Benchmark MOE of 100.  Based on the completeness and reliability of
the toxicity data supporting these petitions, Syngenta believes that
there is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to residues arising from all current
and proposed uses of difenoconazole, including anticipated dietary
exposure from food, water, and all other types of non-occupational
exposures.

F. International Tolerances

	Codex Alimentarius Commission established Maximum Residue Limits (MRLs)
for difenoconazole in various agricultural commodities including
asparagus, banana, beans, except broad bean and soya bean,  broccoli,
Brussels sprouts, cabbages, head, carrot, cauliflower,  celeriac,
celery, cherries, edible offal (mammalian), eggs, garlic,  ginseng,
grapes, leek, lettuce, head, lettuce, leaf, mango, meat, milks,
nectarine, olives, papaya, passion fruit, peach, peas (pods and
succulent/immature seeds), plums (including prunes), pome fruits,
potato, poultry meat, poultry, edible offal of, rape seed, soya bean
(dry), sugar beet, sunflower seed, tomato, tree nuts, wheat, and wheat
straw and fodder, dry.

 PAGE   1

 PAGE   7


[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37853-37855]
[FR Doc No: 2022-13519]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC22-19-000]

Commission Information Collection Activities (FERC-919 and FERC-
919A); Comment Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection FERC-919, (Refinements to Policies and
Procedures for Market-Based Rates for Wholesale Sales of Electric
Energy, Capacity and Ancillary Services by Public Utilities), and FERC-
919A, (Data Collection for Analytics and Surveillance and Market-Based
Rate Purposes).

DATES: Comments on the collection of information are due August 23,
2022.

ADDRESSES: You may submit your comments (identified by Docket No. IC22-
19-000) by one of the following methods:
    Electronic filing through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery:
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (including courier) delivery: Deliver to: Federal Energy
Regulatory Commission, Office of the Secretary, 12225 Wilkins Avenue,
Rockville, MD 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov. For user
assistance, contact FERC Online Support by email at
[email protected], or by phone at<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-919, (Refinements to Policies and Procedures for
Market-Based Rates for Wholesale Sales of Electric Energy, Capacity and
Ancillary Services by Public Utilities), and FERC-919A, (Data
Collection for Analytics and Surveillance and Market-Based Rate
Purposes).
    OMB Control No.: FERC-919 (1902-0234), FERC-919A (1902-0317).
    Type of Request: Three-year extension of these information
collection requirements for all collections described below with no
changes to the current reporting requirements.
    Please note: FERC-919A is a temporary collection number and will be
combined into FERC-919.
    Abstract: The FERC-919 collection is necessary to ensure that
market-based rates charged by public utilities are just and reasonable
as mandated by Federal Power Act (FPA) sections 205 and 206. Section
205 of the FPA requires just and reasonable rates and charges. Section
206 allows the Commission to revoke a seller's market-based rate
authorization if it determines that the seller may have gained market
power since it was originally granted market-based rate authorization
by the Commission. FERC-919, as stated in 18 Code of Federal
Regulations (CFR) Part 35, Subpart H,\1\ the Commission codifies
market-based rate standards for generating electric utilities for use
in the Commission's determination of whether a wholesale seller of
electric energy, capacity, or ancillary services qualify for market-
based rate authority. Subpart H mandates that sellers submit market
power analyses and related filings (descriptions below). Market power
analyses must address both horizontal and vertical market power.
---------------------------------------------------------------------------

    \1\ Market-Based Rates for Wholesale Sales of Electric Energy,
Capacity and Ancillary Services by Public Utilities, Order No. 697,
72 FR 39904 (Jul. 20, 2007), 119 FERC ] 61,295 (2007).
---------------------------------------------------------------------------

Horizontal Market Power Analysis

    This demonstrates a lack of horizontal market power, the Commission
requires two indicative market power screens: the uncommitted pivotal
supplier screen (which is based on the annual

peak demand of the relevant market) and the uncommitted market share
screen applied on a seasonal basis. The Commission presumes sellers
that fail either screen to have market power and such sellers may
submit a delivered price test analysis or alternative evidence to rebut
the presumption of horizontal market power. If a seller fails to rebut
the presumption of horizontal market power, the Commission sets the
just and reasonable rate at the default cost-based rate unless it
approves different mitigation based on case specific circumstances.
When submitting horizontal market power analyses, a seller must submit
the horizontal market power analysis into a relational database for it
to be retrievable in conformance with the instructions posted on the
Commission's website.\2\ A seller must also include all supporting
materials referenced in the indicative screens.
---------------------------------------------------------------------------

    \2\ See Data Collection for Analytics and Surveillance and Mkt.-
Based Rate Purposes, Order No. 860, 168 FERC ] 61,039 (2019), order
on reh'g, Order No. 860-A, 170 FERC ] 61,129 (2020).
---------------------------------------------------------------------------

Vertical Market Power Analysis

    To demonstrate a lack of vertical market power, if a public utility
with market-based rates, or any of its affiliates, owns, operates or
controls transmission facilities, that public utility must:

 Have on file a Commission-approved Open Access Transmission
Tariff \3\
---------------------------------------------------------------------------

    \3\ A part of the associated burden is reported separately in
information collections FERC-516 (OMB Control Number: 1902-0096).
---------------------------------------------------------------------------

 Submit a description of its ownership or control of, or
affiliation with an entity that owns or controls:
    [cir] Intrastate natural gas transportation, intrastate natural gas
storage or distribution facilities
    [cir] Physical coal supply sources and ownership or control over
who may access transportation of coal supplies
 Make an affirmative statement that it and its affiliates have
not erected and will not erect barriers to entry into the relevant
market

Asset Appendix

    In addition to the market power analyses, a seller must submit an
asset appendix in the relational database with its initial application
for market-based rate authorization or updated market power analysis,
and all relevant changes in status filings. The asset appendix must:
     List, among other things, all affiliates that have market-
based rate authority.
     List all generation assets owned (clearly identifying
which affiliate owns which asset) or controlled (clearly identifying
which affiliate controls which asset) by the corporate family by
balancing authority area, and by geographic region, and provide the in-
service date and nameplate and/or seasonal ratings by unit.
     Must reflect all electric transmissions and natural gas
interstate pipelines and/or gas storage facilities owned or controlled
by the corporate family and the location of such facilities.
     List all long-term power purchases and sales agreements
attributed to a seller and its affiliates by the corporate family by
balancing authority area, and by geographic region, and provide the
start date and end date.

Triennial Market Power Analysis

    Sellers that own or control 500 megawatts or more of generation
and/or that own, operate or control transmission facilities, are
affiliated with any entity that owns, operates or controls transmission
facilities in the same region as the seller's generation assets, or
with a franchised public utility in the same region as the seller's
generation assets are required to file updated market power analyses
every three years. The updated market power analyses must demonstrate
that a seller does not possess horizontal market power.

Change in Status Filings

    Concerning changes in status filings, the Commission requires that
sellers file notices of such changes no later than each quarter after
the change in status occurs. The Commission also requires that each
seller must include an appendix in the relational database identifying
specified assets with each pertinent change in status notification
filed.

Relational Database Updates

    A Seller must report on a monthly basis changes to its previously-
submitted relational database information, excluding updates to the
horizontal market power screens. These submissions must be made by the
15th day of the month following the change. These submissions include
the asset appendix information described above, as well as other
market-based information concerning seller category, operating reserves
authorization, identification of its ultimate upstream affiliate(s),
mitigation, and other limitations.

Exemptions From Submitting Updated Market Power Analyses

    Wholesale power marketers and wholesale power producers that are
not affiliated with franchised public utilities or transmission owners,
that do not own transmission, and that do not, together with all of
their affiliates, own or control 500 megawatts or more of generation in
a relevant region are not required to submit updated market power
analyses. The Commission determines which sellers are in this category
through information filed by the utility either when the seller files
its initial application for market-based rate authorization or through
a separate filing made to request such a determination.
---------------------------------------------------------------------------

    \4\ ``Burden'' is the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, refer to Title 5 CFR 1320.3.
    \5\ The estimated hourly cost (salary plus benefits) provided in
this section is based on the salary figures for May 2021 posted by
the Bureau of Labor Statistics for the Utilities sector (available
at http://www.bls.gov/oes/current/naics2_22.htm#13-0000) and scaled
to reflect benefits using the relative importance of employer costs
in employee compensation from May 2021 (available at https://www.bls.gov/oes/current/naics2_22.htm). The hourly estimates for
salary plus benefits are:
    Economist (Occupation Code: 19-3011), $75.75.
    Electrical Engineer (Occupation Code: 17-2071), $72.15.
    Legal (Occupation Code: 23-0000), $142.25.
    The average hourly cost (salary plus benefits), weighting all of
these skill sets evenly, is $96.72. The Commission rounds it to $97/
hour.
---------------------------------------------------------------------------

    Type of Respondents: Public utilities, wholesale electricity
sellers.
    Estimate of Annual Burden: \4\ The Commission estimates the total
annual burden and cost \5\ for this information collection as follows.

                     FERC-919--Refinements to Policies and Procedures for Market Based Rates for Wholesale Sales of Electric Energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Annual number                                                                          Annual cost
            Requirement                Number of     of responses    Total number     Average burden & cost   Total annual burden  hours  per respondent
                                      respondents   per respondent   of responses         per response                & cost \6\                ($)
                                               (1)             (2)     (1) * (2) =  (4).....................  (3) * (4) = (5)...........       (5) / (1)
                                                                               (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Market Power Analysis in New                   144               1             144  135 hrs.; $13,095.......  19,440 hrs.; $1,885,680...         $13,095
 Applications for Market-based
 rates.
Triennial market power analysis...              65               1              65  133.23 hrs.; $12,923.31.  8,659.95 hrs.; $840,015.15       12,923.31
Asset appendix addition to change              149               1             149  49 hrs.; $4,753.........  7,301 hrs.; $708,197......           4,753
 in status reports.
FERC-919A Burden carried over from           1,000            .333             333  2.44 hrs.; \7\ $237.11..  814 hrs.; $78,958.........          237.11
 Order 860-A Category 1--(Ongoing).
FERC-919A Burden carried over from           1,500               1           1,500  4.10 hrs.; \8\ $397.96..  6,154 hrs.; $596,938......          397.96
 Order 860-A Category 2--(Ongoing).
FERC-919A Burden Carried over from             440               1             440  46 hrs.; $4,462.........  20,240 hrs.; $1,963,280...           4,462
 Order 860-A Upstream Affiliates.
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................           3,298  ..............           2,631  ........................  62,608.95 hrs.;
                                                                                $6,073,068.15.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Row 1 (Market Power Analysis in New Applications for Market-based
rates) will have 144 filings. Row 2 (Triennial market power analysis)
will have 65 filings. Row 3 (Asset appendix addition to change in
status reports) will have 149 filings. There are a total of 358 filings
in Rows 1 through 3.
    Currently, there are 2,729 sellers that would submit information
into the relational database. At the time of implementation of Order
No. 860, there were 2,647 sellers that would submit information into
the relational database in the first year of implementation. Six
institutional investors had FPA section 203(a)(2) blanket
authorizations, which collectively owned approximately 110 upstream
affiliates that themselves owned sellers. In the March Notice,\9\ the
Commission estimated an average of four sellers affected for every
upstream affiliate, equaling 440 total sellers.
    FERC-919A Burden carryover explanation:
     M16-17-000 Final Rule (Order No. 860) (Category 1, 2nd
Year and Ongoing), as modified by Order of August 2021--to 814 hrs.)
     RM16-17-000 Final Rule (Order No. 860) (Category 2, 2nd
Year and Ongoing) as modified by Order of August 2921--to 6,154 hrs.)
    Comments: Comments are invited on: (1) whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: June 17, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-13519 Filed 6-23-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Pages 19744-19745]
[FR Doc No: 2012-7942]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Advanced BioPhotonics, Inc., Advanced Viral Research Corp.,
Brantley Capital Corp., Brilliant Technologies Corporation, 4C
Controls, Inc., and 2-Track Global, Inc.; Order of Suspension of
Trading

March 29, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Advanced BioPhotonics, Inc. because it has not filed any periodic
reports since the period ended September 30, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Advanced Viral Research Corp. because it has not filed any periodic
reports since the period ended September 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Brantley Capital Corp. because it has not filed any periodic reports
since the period ended September 30, 2004.
    It appears to the Securities and Exchange Commission that there is
a

lack of current and accurate information concerning the securities of
Brilliant Technologies Corporation because it has not filed any
periodic reports since the period ended March 31, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
4C Controls, Inc. because it has not filed any periodic reports since
the period ended September 30, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
2-Track Global, Inc. because it has not filed any periodic reports
since the period ended September 30, 2009.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on March 29, 2012, and terminating at
11:59 p.m. EDT on April 12, 2012.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2012-7942 Filed 3-29-12; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Notices]
[Page 46251]
[DOCID:fr11au06-109]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Corpas Investments, Inc., Paving Stone Corp.,
and Wastech, Inc.; Order of Suspension of Trading

August 9, 2006.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Corpas Investments, Inc. (n/k/a Corpas Holdings, Inc.) because it has
not filed any periodic reports since the period ended September 30,
2001.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Paving Stone Corp. (f/k/a Royal Acquisition Inc.) because it has not
filed any periodic reports since the period ended September 30, 2003.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Wastech, Inc. because it has not filed any periodic reports since the
period ended March 31, 2003.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the above-listed
companies is suspended for the period from 9:30 a.m. EST on August 9,
2006, through 11:59 p.m. EST on August 22, 2006.

    By the Commission.
Nancy M. Morris,
Secretary.
[FR Doc. 06-6889 Filed 8-9-06; 11:49 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Rules and Regulations]
[Pages 77385-77387]
[FR Doc No: 2014-30144]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2009-F-0303]

Food Additives Permitted for Direct Addition to Food for Human
Consumption; Advantame

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections.

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SUMMARY: The Food and Drug Administration (FDA or we) is responding to
objections we received on the final rule that amended the food additive
regulations to provide for the safe use of advantame as a non-nutritive
sweetener and flavor enhancer in foods generally, except in meat and
poultry. After reviewing the objections to the final rule, we have
concluded that they do not provide a basis for modifying or revoking
the regulation. We are also confirming the effective date of May 21,
2014, for the final rule.

DATES: The effective date of the final rule published on May 21, 2014
(79 FR 29078), is confirmed: May 21, 2014.

FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 21, 2009 (74 FR 35871), we
announced that a food additive petition (FAP 9A4778), had been filed by
Ajinomoto Co., Inc., c/o Ajinomoto Corporate Services LLC, 1120
Connecticut Ave. NW., suite 1010, Washington, DC 20036. The petition

proposed to amend the food additive regulations in part 172, Food
Additives Permitted for Direct Addition to Food for Human Consumption
(21 CFR part 172), to provide for the safe use of advantame as a non-
nutritive sweetener in tabletop applications and powdered beverage
mixes. Subsequently, in a letter dated August 24, 2012, the petitioner
informed us that FAP 9A4778 had been transferred from Ajinomoto
Corporate Services LLC to Ajinomoto North America, Inc., One Parker
Plaza, 400 Kelby St., Fort Lee, NJ 07024.
    In an amended document published in the Federal Register of October
26, 2012 (77 FR 65340), we announced that Ajinomoto Co., Inc., c/o
Ajinomoto North America, Inc., One Parker Plaza, 400 Kelby St., Fort
Lee, NJ 07024, had amended its food additive petition to provide for
the safe use of advantame as a non-nutritive sweetener and flavor
enhancer in foods generally, except in meat and poultry.
    In response to FAP 9A4778, we issued a final rule in the Federal
Register on May 21, 2014 (79 FR 29078), permitting the safe use of
advantame as a non-nutritive sweetener and flavor in foods generally,
except in meat and poultry. This regulation is codified at Sec.
172.803. We based our decision on data contained in the petition and in
our files. In the preamble to the final rule (79 FR 29078 at 29079-
29084), we outlined the basis for our decision and stated that
objections to the final rule and requests for a hearing were due within
30 days of the publication date (i.e., by June 20, 2014).

II. Objections and Requests for a Hearing

    Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after
publication of an order relating to a food additive regulation, any
person adversely affected by such order may file objections,
``specifying with particularity the provisions of the order deemed
objectionable, stating reasonable grounds therefor, and requesting a
public hearing upon such objections.''
    Under 21 CFR 171.110, objections and requests for a hearing are
governed by part 12 (21 CFR part 12) of FDA's regulations. Under Sec.
12.22(a), each objection must meet the following conditions: (1) Must
be submitted on or before the 30th day after the date of publication of
the final rule; (2) must be separately numbered; (3) must specify with
particularity the provision of the regulation or proposed order
objected to; (4) must specifically state each objection on which a
hearing is requested; failure to request a hearing on an objection
constitutes a waiver of the right to a hearing on that objection; and
(5) must include a detailed description and analysis of the factual
information to be presented in support of the objection if a hearing is
requested; failure to include a description and analysis for an
objection constitutes a waiver of the right to a hearing on that
objection.
    Following publication of the final rule permitting the use of
advantame as a non-nutritive sweetener and flavor enhancer in foods
generally, except meat and poultry, we received 12 submissions with
objections to the rule within the 30-day objection period. The majority
of these submissions were letters expressing concern regarding one or
more of the following issues: (1) Labeling of products containing
advantame, and (2) advantame being mistaken for aspartame. A few of the
letters also expressed general opposition to the final rule, or
objected to the rule based on adverse effects believed to have been
caused by aspartame, and not advantame. None of these letters requested
a hearing, nor provided evidence in support of any of these objections
that could be considered factual information (Sec.  12.22(a)(5)).
Therefore, these objections do not justify the modification or
revocation of the regulation. We will not discuss these submissions
further.
    There was one submission that raised a specific objection. The
letter was from the Natural Resources Defense Council (NRDC) (letter to
Docket No. FDA-2009-F-0303, June 20, 2014). The letter from NRDC did
not request a hearing on their objection. Therefore, NRDC has waived
its right to a hearing on their objection (see Sec.  12.22(a)(4)). The
only remaining question under Sec.  12.24(a) is whether NRDC's
objection, and the information submitted in support of the objection,
establish that the regulation authorizing the use of advantame should
be modified or revoked. As discussed in detail in section III, we have
concluded that NRDC has not established a basis for modification or
revocation of the regulation authorizing the use of advantame.

III. Analysis of Objection

    The objection raised by NRDC asserts that FDA did not comply with
section 409 of the FD&C Act in our evaluation of the advantame petition
because, they claim, we did not conduct a fair evaluation of the data
before the Agency as required by section 409(c)(3) of the FD&C Act and
did not consider the relevant safety factors as required by section
409(c)(5). Specifically, NRDC states that advantame and the sweetener
aspartame are structurally related and that FDA has stated that
``advantame actually contains a small amount of aspartame.'' NRDC
asserts that when we were considering potential effects of advantame,
we considered the health effects of aspartame but did not consider the
potential impacts of advantame on the hypothalamus despite having
evidence that aspartame significantly altered that part of the brain.
In support of their claim, NRDC cites five animal studies that they
state are in FDA's possession and indicate aspartame affects the
hypothalamus. NRDC requests that since the brain tissues from the key
advantame animal studies were preserved, FDA should withdraw its
approval of advantame until those tissues are examined for alteration
of the hypothalamus and the implications on a child's developing brain
are fully considered. In addition, NRDC claims that we did not comply
with Executive Order 13045 regarding protection of children from
environmental health risks and safety risks by not assessing the safety
of advantame on a child's brain development.
    The issue of whether aspartame poses a risk of hypothalamic adverse
effects, including endocrine dysfunction, was thoroughly addressed in
the Commissioner's final decision on aspartame published in the Federal
Register on July 24, 1981 (46 FR 38285). In that decision, the
Commissioner affirmed the safety of aspartame as a nutritive sweetener
and concluded that there is a reasonable certainty that human
consumption of aspartame at projected consumption levels will not pose
a risk to the brain, including endocrine function. We are not aware of
any new relevant evidence to the contrary. NRDC has not provided any
evidence that the effects on the hypothalamus in the aspartame studies
they cited are toxicologically significant at the expected levels of
intake of aspartame and, further, they have not provided evidence of
the relevancy of this information to the safety of advantame.
    We disagree with NRDC's characterization of the relationship
between advantame and aspartame. While advantame is structurally
related to aspartame, and aspartame is used as one of the starting
chemicals in the manufacture of advantame, which is what FDA was
referring to in the language quoted by NRDC, the two sweeteners are
chemically different and are metabolized differently in the human body.
When aspartame is consumed, it is metabolized into its two

constituent amino acids, phenylalanine and aspartic acid, and a small
amount of methanol. By contrast, the primary metabolite of advantame is
the de-esterified form of advantame, namely N-[N-[3-(3-hydroxy-4-
methoxyphenyl)propyl]-[alpha]-aspartyl]-L-phenylalanine. Because
chemically these two sweeteners are different compounds, FDA's safety
decision on advantame was based solely on studies conducted on
advantame. Therefore, we did not consider the health effects of
aspartame in our safety decision on advantame.
    Regarding concerns about possible effects of advantame on the
hypothalamus, the hypothalamus is involved with endocrine control via
the pituitary gland. Therefore, any long-lasting hypothalamic changes
would affect the pituitary gland. For this reason, we recommend in our
guidance ``Toxicological Principles for the Safety Assessment of Direct
Food Additives and Color Additives Used in Food'' that the pituitary
gland from subchronic and long-term animal studies be assessed for
treatment-related changes. Consistent with our guidance, the pituitary
gland was one of the organs evaluated in the animal studies on
advantame that were considered in the final rule, and there was no
evidence of toxicologically significant changes.
    As previously noted, NRDC has requested that we withdraw our
approval of advantame until we examine the brain tissues from the key
advantame animal studies that were preserved for alteration of the
hypothalamus and fully consider the implications on a child's
developing brain. NRDC has claimed that several studies on a different
substance showed effects on the hypothalamus, but has not provided any
information to support its view that additional histopathological
examination of brain tissue samples is necessary to establish the
safety of advantame. During our evaluation of the advantame petition,
we thoroughly reviewed all of the data provided by the petitioner on
the safety of advantame, including the results from a two-generation
study in rats, a chronic (52-week) dog study, a 104-week mouse
carcinogenicity study, and a combined 104-week rat carcinogenicity
feeding study with in utero and chronic (52-week) phases, which
included extensive histological evaluations of the brain, including the
hypothalamus. In evaluating these studies, we applied the appropriate
safety factors to extrapolate the findings from these animal studies to
humans as required by section 409(c)(5) of the FD&C Act. We also
considered the potential intake of advantame at both the mean and 90th
percentile of consumption for various age groups, including children.
Based on this exposure and toxicological information, the estimated
levels of daily intake for even high consumers of advantame were far
below (approximately 200 times) the acceptable daily intake level,
establishing that advantame is safe for the general population,
including children.
    NRDC's objection to the advantame final rule does not provide any
new evidence or identify any evidence that we overlooked in our
evaluation that would call into question FDA's determination of safety
for advantame. Moreover, NRDC has not provided a basis for concluding
that the information we evaluated is inadequate to support a finding
that the use of advantame as a non-nutritive sweetener in food is safe.
Therefore, this objection does not provide a basis for us to reconsider
our decision to issue the final rule on advantame.

IV. Summary and Conclusion

    Section 409 of the FD&C Act requires that a food additive be shown
to be safe before marketing. Under 21 CFR 170.3(i), a food additive is
``safe'' if ``there is a reasonable certainty in the minds of competent
scientists that the substance is not harmful under the intended
conditions of use.'' In our May 21, 2014, final rule approving the use
of advantame, we concluded that the data presented by the petitioner to
establish safety of the additive demonstrate that advantame is safe for
its intended use in food.
    The petitioner has the burden to demonstrate the safety of the
additive to gain FDA approval. However, once we make a finding of
safety, the burden shifts to an objector, who must come forward with
evidence that calls into question our conclusion (see section 409(f)(1)
of the FD&C Act). After evaluating the objection from NRDC, we have
concluded that the objection does not provide any basis for us to
reconsider our decision to issue the final rule permitting the use of
advantame as a non-nutritive sweetener and flavor enhancer in foods
generally, except meat and poultry. Accordingly, we are not making any
changes in response to the objection.
    Therefore, we have determined that the final rule should not be
modified or revoked based on the objections. Thus, we are confirming
May 21, 2014, as the effective date of the regulation.

    Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30144 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P


MEMORANDUM

DATE:  	December 5, 2006

FROM:  Keith Barnett, EPA/OAR/OAQPS/SPPD/MMG

TO: Portland Cement Docket EPA-HQ-OAR-2002-0051

SUBJECT:   Incorporation by reference of Docket A-92-53, Portland Cement NESHAP

Docket A-92-53 contains information that is relevant to the Portland Cement NESHAP rulemaking and docket A-92-53 is incorporated by reference into this docket EPA-HQ-OAR-2002-0051.


QUESTIONS TO SAP ON:

PROPOSED HAZARD IDENTIFICATION METHODOLOGY FOR ASSESSMENT OF DERMAL SENSITIZATION RISK Timothy F. McMahon, Ph. D Jonathan Chen, Ph. D.

Office of Pesticide Programs U. S. EPA, Washington D. C.

FIFRA Scientific Advisory Panel ( SAP)

Consultation On Dermal Sensitization Issues for Exposures to Pesticides May 4 6, 2003 May 4 6, 2004 2 Question For SAP ISSUE 1: Quantitative Risk Assessment for the Induction Phase of ACD May 4 6, 2004 3 Issue 1   Background Approaches for determination of quantitative assessment of sensitization induction thresholds have been proposed in the scientific literature using the results of murine LLNA data and/ or data from human patch testing ( Gerberick 2000, 2001; Griem et al., 2003). May 4 6, 2004 4 Issue 1 ( Cont.)

Gerberick ( 2000, 2001) proposed a methodology for determination of a ` sensitization reference dose' for sensitizers in consumer products. The lower boundary of the potency category for a sensitizing chemical is used as the starting point,

with application of uncertainty factors for interindividual variability, product matrix effects,

and use pattern. May 4 6, 2004 5 Issue 1 ( Cont.)

Griem et al ( 2003) proposed a quantitative approach in which identification of known human sensitizing chemicals used both an EC3 value ( defined as the concentration of a sensitizer required to generate a threefold stimulation of proliferation in draining lymph nodes) from an LLNA test and a NOAEL or LOAEL from human repeat insult patch tests ( HRIPT) or human maximization tests ( HMT). From this analysis it was concluded that the EC3 value could be used as a surrogate value for a NOAEL that can be used as a starting point in quantitative risk assessment ( Griem et al.,

2003). May 4 6, 2004 6 Issue 1 ( Cont.)

Uncertainty factors for:

interspecies variation

intraspecies variation

product matrix effects, and

conditions of exposure ( including repeated exposures) have been proposed for use in conduct of dermal risk assessments. May 4 6, 2004 7 Question For SAP   Question 1 What are the strengths and weaknesses of the proposed quantitative approach for determination of induction thresholds to dermal sensitizing chemicals?

What other approaches does the Panel recommend EPA consider? Which uncertainty factors does the Panel feel are the most appropriate for application to quantitative methods of induction threshold determination? What factors should be included in the determination of the magnitude of each uncertainty factor? May 4 6, 2004 8 Question For SAP ISSUE 2: Quantitative Risk Assessment for the Elicitation Phase of ACD May 4 6, 2004 9 Question For SAP Issue 2 ( Background)

The Minimum Elicitation Threshold ( MET) concept has been discussed in previous publications ( Nethercott et al.,

1994; Zewdie, 1998; NJDEP, 1998; Basketter et al., 2003)

specifically with respect to hexavalent chromium. The concept behind the MET is that there is an ` elicitation threshold' below which no sensitization reaction is expected ( Horowitz and Finley, 1994).

The setting of an MET is usually performed as a result of tests in previously sensitized individuals; thus, the MET is considered protective of elicitation reactions.

However, there has not been an extensive discussion of the criteria for employing this concept for purposes of risk assessment. May 4 6, 2004 10 Question For SAP   Question 2 What are the strengths and weaknesses of the proposed quantitative approaches for determination of elicitation thresholds to dermal sensitizing chemicals? What other approaches does the Panel recommend that EPA consider? Which uncertainty factors does the Panel feel are the most appropriate for application to quantitative methods of elicitation threshold determination? What factors should be included in the determination of the magnitude of each uncertainty factor? May 4 6, 2004 11 Question For SAP ISSUE 3: Children Sensitivity May 4 6, 2004 12 Background For SAP Issue 3 Paustenbach et al. ( 1992) and Felter et al. ( 2002) have discussed the issue of whether children are more or less at risk for development of ACD.

Paustenbach et al. addressed this issue specifically for hexavalent chromium, and this paper concluded that risk to children ages 3 to 8 is not likely to be greater than adults as there is no evidence that repeated exposures to hexavalent chromium places a person at greater risk of sensitization.

Felter et al. suggested that infants and children may actually be at lower risk for development of ACD based on data gathered from dinitrochlorobenzene and pentadecylcatechol ( poison ivy allergen). May 4 6, 2004 13 Background For SAP Issue 3 ( Continue)

However, it is also understood that young children may not have been exposed to different allergens as compared to adults. In addition, increased frequency of exposure in children may increase the chance of induction to different allergens. May 4 6, 2004 14 Question For SAP   Question 3 Does the Panel agree that the available scientific data suggest no significant difference in the relative sensitivity of children vs. adults to the induction and/ or elicitation of ACD? If so, please provide scientific justification for this position. If the Panel disagrees, please provide scientific justification, including supporting data and/ or uncertainties in the explanation. May 4 6, 2004 15 Question For SAP ISSUE 4: Case Study  Cr( VI) in treated wood May 4 6, 2004 16 Background For SAP Issue 4 Data from murine LLNA tests as well as from human patch testing studies using hexavalent chromium are available in the scientific literature.

Results of LLNA testing show EC3 values that indicate area doses that result in the induction of sensitization in the mouse, while the results of patch test studies in humans show area doses that result in elicitation of sensitization in already sensitized individuals. May 4 6, 2004 17 Background For SAP Issue 4 ( Continue)

In the Agency's initial assessment seeking to assess dermal sensitization risk from hexavalent chromium,

the lowest dose tested ( 0.018 ug/ cm2) from the human patch test study of Nethercott et al ( 1994)

was selected for determination of dermal risk from hexavalent chromium. A 10x uncertainty factor ( 3x for use of the lowest dose tested [ LOAEL] in this study, and 3x to account for the small size of the study population in the Nethercott study) was applied, resulting in a ` safe area' dose of 0.0018 ug/ cm2. May 4 6, 2004 18 Background For SAP Issue 4 ( Continue)

Use of the test data of Basketter et al. ( 2001) and Hansen et. al ( 2003) also result in derivation of similar ` safe' area doses of 0.001 and 0.003 µ g/ cm2 respectively. Use of the murine LLNA test data and application of an uncertainty factor of either 1000 or 3000 calculated ` safe' area doses of 0.01 or 0.003 µ g/ cm2 respectively. May 4 6, 2004 19 Question For SAP   Question 4 Please comment on the methods used for derivation of ` safe' area doses using the available LLNA data and the human patch test data, including the magnitude of the applied uncertainty factors, and include a scientific rationale in support of your position. Please comment on whether it is scientifically supportable to derive separate ` safe' area doses for protection against induction of dermal sensitization as well as elicitation in sensitized individuals by hexavalent chromium? May 4 6, 2004 20 END