[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Rules and Regulations]
[Pages 49927-49932]
[FR Doc No: 2013-19867]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0384; FRL-9394-8]

Imazapic; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
imazapic in or on sugarcane, cane. BASF Corporation requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 16, 2013. Objections and

requests for hearings must be received on or before October 15, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0384, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0384 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 15, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0384, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8021) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.490 be amended by
establishing tolerances for residues of the herbicide imazapic 2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methyl-3-
pyridinecarboxylic acid in or on sugarcane at 0.01 parts per million
(ppm). That document referenced a summary of the petition prepared by
BASF Corporation, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance level and the commodity definition. EPA
is also revising the tolerance expression to clarify the chemical
moieties that are covered by the tolerances and specify how compliance
will be measured. The reasons for these changes are explained in Unit
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for imazapic including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with imazapic follows.

A. 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.
    Imazapic is categorized as having low acute toxicity by the oral,
inhalation, and dermal routes of exposure. It is minimally irritating
to the eye, non-irritating to the skin, and not a skin sensitizer.
    No evidence of subchronic toxicity was observed to rodents via the
oral or dermal routes. In the chronic oral toxicity study in dogs,
minimal degeneration and/or necrosis of the skeletal muscle of the
thigh and/or abdomen was seen at the lowest dose tested. At higher
doses, additional effects were seen in the liver (increased absolute
weights and changes in clinical chemical parameters), kidney (decreased
urinary pH in females), and erythropoietic system (changes in
hematological parameters, and microscopic changes in the bone marrow
and spleen). At the high dose, there was also inflammation in the
esophagus similar to that in skeletal muscle as well as discoloration
of the lung in both sexes.
    In the developmental toxicity study with rats, no maternal or
developmental toxicity was seen at the limit dose. In the developmental
toxicity study in rabbits, maternal effects of decreased body-weight
gain and food consumption were observed at the dose level that did not
result in developmental effects. In the 2-generation reproduction study
in rats, no parental or reproductive toxicity was seen at the limit
dose. In the battery of mutagenicity studies, no evidence of
mutagenicity was observed.
    Imazapic is classified as a ``Group E'' chemical (not likely to be
a human carcinogen) by any relevant route of administration based on
the absence of carcinogenicity seen in rodents.
    Since the last risk assessment in 2001, acute neurotoxicity,
subchronic neurotoxicity, and immunotoxicity studies were submitted in
response to the 40 CFR part 158 data requirements. There was no
evidence of immunotoxicity or neurotoxicity observed in the submitted
studies.
    In the 2001 risk assessment and in the Federal Register of December
26, 2001 (66 FR 66325) (FRL-6816-2), a 28-day inhalation toxicity study
was required due to the potential for repeated handler inhalation
exposure anticipated from use on pastures and rangeland. However, EPA
concluded in the April 17, 2012 document ``Imazapic: Summary of Hazard
and Science Policy Council (HASPOC) Meeting of March 15, 2012:
Recommendations on the Requirement of a 28-day Inhalation Study'' that
based on a weight-of-evidence approach, this study is not required at
this time.
    Specific information on the studies received and the nature of the
adverse effects caused by imazapic as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Imazapic. Human-Health Risk
Assessment. Petition for Tolerances for Use on Soybeans and Sugarcane
Without U.S. Registration,'' pp. 14-17 in docket ID number EPA-HQ-OPP-
2012-0384.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for imazapic used for
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Imazapic for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk         Study and
                                               factors                 assessment         toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      None...................  None...................  No acute dietary
 including infants and children; and                                                      endpoint selected
 Females 13-50 years of age).                                                             based on the absence
                                                                                of an appropriate
                                                                                endpoint attributed to
                                                                                a single dose.
Chronic dietary (All populations)....  LOAEL = 137 mg/kg/day..  Chronic RfD = 0.137 mg/  One-Year Dog Feeding
                                       UFA = 10X..............   kg/day.                  Study LOAEL = 137 mg/
                                       UFH = 10X..............  cPAD = 0.137 mg/kg/day.   kg/day based on
                                       FQPA SF/UFL = 10X......                            increased incidence of
                                                                                minimal degeneration
                                                                                and/or necrosis of
                                                                                skeletal muscle.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to imazapic, EPA considered exposure under the petitioned-for
tolerances as well as all existing imazapic tolerances in 40 CFR
180.490. EPA assessed dietary exposures from imazapic in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for imazapic; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated
tolerance-level residues and 100 percent crop treated (PCT) for all
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that imazapic does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for imazapic. Tolerance level residues and/or 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for imazapic in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of imazapic. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of imazapic for chronic
exposures for non-cancer assessments are estimated to be 1.46 ppb for
surface water and 13.73 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 13.73 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Imazapic is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    EPA has not found imazapic to share a common mechanism of toxicity
with any other substances, and imazapic does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that imazapic does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased pre- or postnatal susceptibility based on the results of the
rat and rabbit prenatal developmental toxicity studies and the 2-
generation reproductive toxicity study.
    3. Conclusion. EPA is retaining the default 10X FQPA safety factor
for all exposure scenarios due to the use of a LOAEL to extrapolate a
NOAEL for the POD for the chronic dietary endpoint. That decision is
based on the following findings:
    i. Although all required toxicity studies have been submitted for
imazapic, the chronic study used for chronic dietary risk assessment
did not demonstrate a NOAEL, and a LOAEL was used as an endpoint.
Therefore, EPA is retaining the 10X FQPA safety factor for use of a
LOAEL to extrapolate a NOAEL.
    ii. There is no indication that imazapic is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that imazapic results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessments were performed
based on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to imazapic in drinking water. These assessments
will not underestimate the exposure and risks posed by imazapic.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
imazapic is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
imazapic from

food and water will utilize 4% of the cPAD for children 1-2 years old,
the population group receiving the greatest exposure. There are no
residential uses for imazapic.
    3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because there are no
currently registered residential uses, no short- or intermediate-term
aggregate risk assessments were conducted for imazapic.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, imazapic is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to imazapic residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method SOP-PA.0288, a liquid
chromatography with tandem mass spectroscopy (LC-MS/MS)) is available
to enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for imazapic on sugarcane.

C. Revisions to Petitioned-For Tolerances

    EPA revised the proposed commodity definition of ``sugarcane'' to
reflect the correct terminology of ``sugarcane, cane'' and revised the
proposed tolerance of 0.01 ppm to 0.03 ppm. All residues (parent plus
metabolites) were below the limit of quantification (LOQ). The revised
tolerance level is based upon the sum of the LOQs (0.01 + 0.01 + 0.01 =
0.03 ppm) for each of the three compounds in the tolerance expression.
In accordance with Agency guidance on tolerance expressions, the
tolerance expressions for imazapic are revised by clarifying that the
tolerances cover ``residues of imazapic, including its metabolites and
degradates''.

 V. Conclusion

    Therefore, tolerances are established for residues of imazapic, 2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
methyl-3-pyridinecarboxylic acid and its metabolites in or on
sugarcane, cane at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 7, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Amend Sec.  180.490 as follows:
0
a. Revise the section heading;
0
b. Revise the introductory text in paragraph (a)(1) and add
alphabetically the following commodity to the table;
0
c. Revise the introductory text in paragraph (a)(2); and
0
d. Revise the heading in paragraph (c).
    The amendments read as follows:

Sec.  180.490  Imazapic; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
herbicide imazapic, including its metabolites and degradates, in or on
the commodities listed in the following table. Compliance with the
tolerance levels specified is to be determined by measuring the sum of
imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-5-methyl-3-pyridinecarboxylic acid) and its metabolites ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-hydroxymethyl-3-pyridinecarboxylic acid and ()-2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
([beta]-D-glucopyranosyloxy)methyl-3-pyridinecarboxylic acid,
calculated as the stoichiometric equivalent of imazapic.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Sugarcane, cane.........................................            0.03
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide
imazapic, including its metabolites and degradates, in or on the
commodities listed in the following table. Compliance with the
tolerance levels specified is to be determined by measuring the sum of
imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-5-methyl-3-pyridinecarboxylic acid) and its metabolite ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-hydroxymethyl-3-pyridinecarboxylic acid, calculated as the
stoichiometric equivalent of imazapic.
* * * * *
    (c) Tolerances with regional registrations. [Reserved]
* * * * *
[FR Doc. 2013-19867 Filed 8-15-13; 8:45 am]
BILLING CODE 6560-50-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

			Issued by the Department of Transportation on  April 22, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST-2001-9137

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
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Applicant:  C.A.L. Cargo Air Lines Ltd.						Date Filed:  April 1, 2003

Relief requested:  Renew exemption from 49 U.S.C. 41301 to conduct
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If renewal, date and citation of last action:  Notice of Action Taken
dated April 3, 2002, in this docket

Applicant representative:  Evelyn Sahr<PHONE_NUMBER>			DOT analyst:
Shelita Smith<PHONE_NUMBER>

Responsive pleadings:  None

	DISPOSITION

Action:  Approved									Action date:  April 22, 2003

Effective dates of authority granted:  April 22, 2003 – April 22, 2004

Basis for approval (bilateral agreement/reciprocity):  U.S.-Israel Air
Transport Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

_X_ Standard exemption conditions (attached)        __ Foreign air
carrier permit conditions (Order   -  -  )

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
____________________________________________________________

We found that the applicant was qualified to perform its proposed
operations.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that  (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

												        Appendix A

FOREIGN AIR CARRIER CONDITIONS OF AUTHORITY

In the conduct of the operations authorized, the holder shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security;1

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are:

   (a)  based on its operations in international air transportation
that, according to the contract of carriage, include a point in the
United States as a point of origin, point of destination, or agreed
stopping place, or for which the contract of carriage was purchased in
the United States; or

   (b)  based on a claim under any international agreement or treaty
cognizable in any court or other tribunal of the United States.

In this condition, the term "international air transportation" means
"international transportation" as defined by the Warsaw Convention,
except that all States shall be considered to be High Contracting
Parties for the purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code (formerly the
Federal Aviation Act of 1958, as amended).__________________

1  To assure compliance with all applicable U.S. Government requirements
concerning security, the holder should, before commencing any new
service (including charter flights) from a foreign airport that would be
the holder’s last point of departure for the United States, inform its
Principal Security Inspector of its plans.

U.S. Department of Transportation

Office of the Secretary of Transportation									        (41301/40109)
10/2002


[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Notices]
[Page 21930]
[FR Doc No: 2013-08587]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-2428-004]

Aquenergy Systems, Inc.; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: P-2428-004.
    c. Date Filed: November 11, 2012.
    d. Submitted by: Aquenergy Systems, Inc., a fully owned
subsidiaries of Enel Green Power North America, Inc.
    e. Name of Project: Piedmont Hydroelectric Project.
    f. Location: On the Saluda River in Anderson and Greenville
counties near the town of Piedmont, South Carolina. No federal lands
are occupied by the project works or located within the project
boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Beth E. Harris, P.E., Southeast
Regional Manager, Aquenergy Systems, Inc., 11 Anderson St., Piedmont,
SC 29674<EMAIL_ADDRESS>    i. FERC Contact: Sean Murphy at<PHONE_NUMBER> or via email at
<EMAIL_ADDRESS>    j. Aquenergy Systems, Inc. filed its request to use the Traditional
Licensing Process/Alternative Licensing Procedures on November 11,
2012. Aquenergy Systems, Inc. provided public notice of its request on
February 13, 2013. In a letter dated April 5, 2013, the Director of the
Division of Hydropower Licensing approved Aquenergy Systems, Inc.'s
request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402; and (b) the South Carolina
State Historic Preservation Officer, as required by section 106,
National Historical Preservation Act, and the implementing regulations
of the Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Aquenergy Systems, Inc. as
the Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    m. Aquenergy Systems, Inc. filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 2428. Pursuant to 18 CFR
16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by December 31,
2015.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: April 5, 2013.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2013-08587 Filed 4-11-13; 8:45 am]
BILLING CODE 6717-01-P