[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14269-14272]
[FR Doc No: 2012-5719]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No.30830; Amdt. No. 499]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This amendment adopts miscellaneous amendments to the required
IFR (instrument flight rules) altitudes and changeover points for
certain Federal airways, jet routes, or direct routes for which a
minimum or maximum en route authorized IFR altitude is prescribed. This
regulatory action is needed because of changes occurring in the
National Airspace System. These changes are designed to provide for the
safe and efficient use of the navigable airspace under instrument
conditions in the affected areas.

DATES: Effective Date: 0901 UTC, April 5, 2012.

FOR FURTHER INFORMATION CONTACT: Rick Dunham, Flight Procedure
Standards Branch (AMCAFS-420), Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes, ensure navigation aid
coverage that is adequate for safe flight operations and free of
frequency interference. The reasons and circumstances that create the
need for this amendment involve matters of flight safety and
operational efficiency in the National Airspace System, are related to
published aeronautical charts that are essential to the user, and
provide for the safe and efficient use of the navigable airspace. In
addition, those various reasons or circumstances require making this
amendment effective before the next scheduled charting and publication
date of the flight information to assure its timely availability to the
user. The effective date of this amendment reflects those
considerations. In view of the close and immediate relationship between
these regulatory changes and safety in air commerce, I find that notice
and public procedure before adopting this amendment are impracticable
and contrary to the public interest and that good cause exists for
making the amendment effective in less than 30 days.

Conclusion

    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.
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. For the
same reason, the FAA certifies that this amendment will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95

    Airspace, Navigation (air).

    Issued in Washington, DC, on March 2, 2012.
John McGraw,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, April 5, 2012.

0
1. The authority citation for part 95 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44719, 44721.

0
2. Part 95 is amended to read as follows:

                                Revisions to IFR Altitudes and Changeover Points
                                  [Amendment 499 effective date April 5, 2012]
----------------------------------------------------------------------------------------------------------------
                     From                                         To                        MEA          MAA
----------------------------------------------------------------------------------------------------------------
                                     Sec.   95.3000 Low Altitude RNAV Routes
                            Sec.   95.3223 RNAV Route T223 Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
NONDA, AK FIX.................................  BLUGA, AK FIX.........................        12400        17500
    *10000--MCA BLUGA, AK FIX, SW BND
----------------------------------------------------------------------------------------------------------------
                            Sec.   95.3288 RNAV Route T288 Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
GILLETTE, WY VOR/DME..........................  TRTTL, WY FIX.........................         7000        17500
TRTTL, WY FIX.................................  KARAS, WY FIX.........................         9000        17500
KARAS, WY FIX.................................  *PACTO, SD FIX........................        10000        17500
    *9700--MRA
PACTO, SD FIX.................................  RAPID CITY, SD VORTAC.................         7100        17500
----------------------------------------------------------------------------------------------------------------
                                    Sec.   95.4000 High Altitude RNAV Routes
                            Sec.   95.4044 RNAV Route Q44 Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
NOME, AK VOR/DME..............................  HLBLY, AK FIX.........................        18000        45000
    GNSS REQUIRED
HLBLY, AK FIX.................................  ANCHORAGE, AK VOR/DME.................        18000        45000
    GNSS REQUIRED
----------------------------------------------------------------------------------------------------------------
                            Sec.   95.4051 RNAV Route Q51 Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
KING SALMON, AK VORTAC........................  SLIIM, AK FIX.........................        18000        45000
    GNSS REQUIRED
SLIIM, AK FIX.................................  HLBLY, AK FIX.........................        18000        45000
    GNSS REQUIRED
HLBLY, AK FIX.................................  KOTZEBUE, AK VOR/DME..................        18000        45000
    GNSS REQUIRED
----------------------------------------------------------------------------------------------------------------
                            Sec.   95.4055 RNAV Route Q55 Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
KODIAK, AK VOR/DME............................  SLIIM, AK FIX.........................        18000        45000
    GNSS REQUIRED
SLIIM, AK FIX.................................  NOME, AK VOR/DME......................        18000        45000
    GNSS REQUIRED
----------------------------------------------------------------------------------------------------------------

               From                           To                 MEA
------------------------------------------------------------------------
                   Sec.   95.6001 Victor Routes--U.S.
     Sec.   95.6002 VOR Federal Airway V2 Is Amended to Read in Part
------------------------------------------------------------------------
REEPO, MT FIX....................  COLUS, MT FIX...........
                                   W BND...................         9700
                                   E BND...................         7000
COLUS, MT FIX....................  BILLINGS, MT VORTAC.....
                                   W BND...................         9700
                                   E BND...................         6400
------------------------------------------------------------------------
     Sec.   95.681 VOR Federal Airway V81 Is Amended to Read in Part
------------------------------------------------------------------------
SCOTTSBLUFF, NE VORTAC...........  TOADSTOOL, NE VOR/DME...         7000
------------------------------------------------------------------------
    Sec.   95.6086 VOR Federal Airway V86 Is Amended to Read in Part
------------------------------------------------------------------------
REEPO, MT FIX....................  COLUS, MT FIX...........
                                   W BND...................         9700

                                   E BND...................         7000
COLUS, MT FIX....................  BILLINGS, MT VORTAC.....
                                   W BND...................         9700
                                   E BND...................         6400
------------------------------------------------------------------------
     Sec.   95.689 VOR Federal Airway V89 Is Amended to Read in Part
------------------------------------------------------------------------
CHEYENNE, WY VORTAC..............  LITER, WY FIX...........         8300
LITER, WY FIX....................  TOADSTOOL, NE VOR/DME...         7800
------------------------------------------------------------------------
    Sec.   95.6101 VOR Federal Airway V101 Is Amended to Read in Part
------------------------------------------------------------------------
GILL, CO VOR/DME.................  *LIBEL, CO FIX..........      **10000
    *13500--MCA LIBEL, CO FIX, W
     BND
    **8900--MOCA
LIBEL, CO FIX....................  BROCC, CO FIX...........        16000
BROCC, CO FIX....................  ECHOA, CO FIX...........        13200
ECHOA, CO FIX....................  *HAYDEN, CO VOR/DME.....
                                   E BND...................        13200
                                   W BND...................        11500
    *11500--MCA HAYDEN, CO VOR/
     DME, E BND
------------------------------------------------------------------------
    Sec.   95.6169 VOR Federal Airway V169 Is Amended to Read in Part
------------------------------------------------------------------------
SCOTTSBLUFF, NE VORTAC...........  TOADSTOOL, NE VOR/DME...         7000
TOADSTOOL, NE VOR/DME............  WAXER, NE FIX...........         7000
------------------------------------------------------------------------
    Sec.   95.6170 VOR Federal Airway V170 Is Amended to Read in Part
------------------------------------------------------------------------
ABERDEEN, SD VOR/DME.............  SIOUX FALLS, SD VORTAC..        *5000
    *3400--MOCA
------------------------------------------------------------------------
    Sec.   95.6272 VOR Federal Airway V272 Is Amended to Read in Part
------------------------------------------------------------------------
SERTS, OK FIX....................  LIONS, OK FIX...........        *4500
    *3100--MOCA
    *3700--GNSS MEA
LIONS, OK FIX....................  WILL ROGERS, OK VORTAC..         3300
------------------------------------------------------------------------
    Sec.   95.6291 VOR Federal Airway V291 Is Amended to Read in Part
------------------------------------------------------------------------
WINSLOW, AZ VORTAC...............  FLAGSTAFF, AZ          10100
                                    VOR/DME.
    *11000--MCA FLAGSTAFF, AZ VOR/
     DME, NE BND
    MTA V327 N TO V291 E
     11000
------------------------------------------------------------------------
    Sec.   95.6421 VOR Federal Airway V421 Is Amended to Read in Part
------------------------------------------------------------------------
ROBERT, CO VOR/DME...............  HAHNS, CO FIX...........       *13000
    *12300--MOCA
------------------------------------------------------------------------
    Sec.   95.6437 VOR Federal Airway V437 Is Amended to Read in Part
------------------------------------------------------------------------
SAVANNAH, GA VORTAC..............  CHARLESTON, SC VORTAC...         2000
------------------------------------------------------------------------
    Sec.   95.6465 VOR Federal Airway V465 Is Amended to Read in Part
------------------------------------------------------------------------
DUNOIR, WY VOR/DME...............  REDLO, MT FIX...........       *17000
    *14500--MOCA
REDLO, MT FIX....................  LAREI, MT FIX...........
                                   N BND...................         7200
                                   S BND...................        17000
LAREI, MT FIX....................  *BILLINGS, MT VORTAC....
                                   S BND...................        17000
                                   N BND...................         6000
    *7000--MCA BILLINGS, MT
     VORTAC, S BND
------------------------------------------------------------------------
Sec.   95.6320 Alaska VOR Federal Airway V320 Is Amended to Read in Part
------------------------------------------------------------------------
WINOR, AK FIX....................  *FRIDA, AK FIX..........  10
                                                                     000

    *9500--MRA
    *7600--MCA FRIDA, AK FIX, W
     BND
    MEA IS ESTABLISHED
     WITH A GAP IN NAVIGATION
     SIGNAL COVERAGE
------------------------------------------------------------------------
Sec.   95.6440 Alaska VOR Federal Airway V440 Is Amended to Read in Part
------------------------------------------------------------------------
WINOR, AK FIX....................  *FRIDA, AK FIX..........  10
                                                                     000
    *9500--MRA
    *7600--MCA FRIDA, AK FIX, W
     BND
    MEA IS ESTABLISHED
     WITH A GAP IN NAVIGATION
     SIGNAL COVERAGE
------------------------------------------------------------------------

             From                     To            MEA          MAA
------------------------------------------------------------------------
                       Sec.   95.7001 Jet Routes
        Sec.   95.7537 Jet Route J537 Is Amended to Read in Part
------------------------------------------------------------------------
ROME, OR VOR/DME.............  MULLAN PASS, ID        22000        45000
                                VOR/DME.
------------------------------------------------------------------------

[FR Doc. 2012-5719 Filed 3-8-12; 8:45 am]
BILLING CODE 4910-13-P


22 Table 2b  Nationwide Industry Burden for Existing Major Sources ( Second Year)

Proposed NESHAP for Cyanide Chemicals Manufacturing Facilities A B C D E F G H Reporting and recordkeeping requirements Person hours Annual occurrences Annual person hours Total number Technical hours Management hours Clerical hours Total Annual per occurrence per respondent per respondent of respondents per year per year per year Cost ( A X B) ( C X D) @ $ 45.04 ( E x 0.05) @ $ 66.73 ( E x 0.10) @ $ 28.14 1. Reporting requirements a. Read rule and instructions 4 1 4 0 0 0 0 $ 0 b. Process/ Review information 4 4 16 0 0 0 0 $ 0 c. Write reports i. Initial notification 2 1 2 6 12 0.6 1.2 $ 614 ii. Performance test notification 2 1 2 6 12 0.6 1.2 $ 614 iii. Compliance status notification 2 1 2 6 12 0.6 1.2 $ 614 iv. Performance test reports 8 1 8 6 48 2.4 4.8 $ 2,457 v. Capture hood inspection report 2 4 8 6 48 2.4 4.8 $ 2,457 vi. Startup/ shutdown/ malfunction reports 2 4 8 6 48 2.4 4.8 $ 2,457 vii. Semi annual summary report 10 2 20 6 120 6 12 $ 6,143 2. Recordkeeping requirements a. Read rule and instructions 8 1 8 0 0 0 0 $ 0 b. Plan activities 40 1 40 6 240 12 24 $ 12,286 c. Implement activities i. Control devices 1. Design analysis 40 1 40 0 0 0 0 $ 0 2. Performance test 40 1 40 6 240 12 24 $ 12,286 3. Equipment inspection 1 52 52 6 312 15.6 31.2 $ 15,971 4. Monitoring activities 1 52 52 6 312 15.6 31.2 $ 15,971 5. Maintenance 2 52 104 6 624 31.2 62.4 $ 31,943 ii. LDAR program 1. Identify all affected streams 10 1 10 6 60 3 6 $ 3,071 2. Perform visual monitoring 0.1 1092 109.2 6 655.2 32.76 65.52 $ 33,540 d. Develop record system i. Develop startup/ shutdown/ malfunction plan 40 1 40 6 240 12 24 $ 12,286 ii. Control equipment/ maintenance plan 16 1 16 6 96 4.8 9.6 $ 4,914 iii. LDAR program 40 1 40 6 240 12 24 $ 12,286 e. Time to enter information i. Control equipment testing 1 1 1 6 6 0.3 0.6 $ 307 ii. Control equipment inspection 0.5 52 26 6 156 7.8 15.6 $ 7,986 iii. Control equipment monitoring 0.5 52 26 6 156 7.8 15.6 $ 7,986 iv. LDAR program 0.02 1092 21.84 6 131.04 6.552 13.104 $ 6,708 f. Time to train personnel i. Acquisition, installation, and use of technology & systems 40 1 40 6 240 12 24 $ 12,286 ii. Control equipment inspection and monitoring 40 1 40 6 240 12 24 $ 12,286 iii. LDAR program 2 1 2 6 12 0.6 1.2 $ 614 g. Store, file and maintain records 4 52 208 6 1248 62.4 124.8 $ 63,886 h. Retrive records/ Reports 4 52 208 6 1248 62.4 124.8 $ 63,886 Total 6756 338 676 $ 345,855 Total Burden Hours 7770


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Rules and Regulations]
[Pages 79711-79718]
[FR Doc No: 2015-32327]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0788; FRL-9939-83]

Propiconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
propiconazole in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 23, 2015. Objections and
requests for hearings must be received on or before February 22, 2016,
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-2014-0788, 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), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional

information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

B. 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-2014-0788 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
February 22, 2016. 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-2014-0788, 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.html.

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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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
4E8321) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.434 be
amended by establishing tolerances for residues of the fungicide,
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]
methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,-
dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric
equivalent of propiconazole, in or on the following raw agricultural
commodities: Dill, dried at 80 parts per million (ppm); dill, fresh at
30 ppm; dill, seed at 15 ppm; fruit, stone, group 12-12, except plum at
4 ppm and nut, tree, group 14-12 at 0.1 ppm; leafy Brassica greens,
subgroup 5B at 20 ppm; quinoa, grain, at 3.0 ppm; radish, roots at 0.04
ppm; radish, tops at 0.2 ppm; ti palm, leaves at 10 ppm; ti palm, roots
at 0.3 ppm, and watercress at 6 ppm. IR-4 also requested that upon
establishment of the above tolerances, that the existing tolerances for
``fruit, stone, group 12, except plum'' and ``nut, tree, group 14'' be
removed. That document referenced a summary of the petition prepared by
Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. The October 21, 2015 notice supersedes a notice of
filing published in the Federal Register on February 11, 2015 (80 FR
7559) (FRL-9921-94). The October 21, 2015 notice includes the commodity
``quinoa, grain'' as well as the other commodities that were originally
requested in the February 11, 2015 notice. Two comments were received
in response to the October 21, 2015 notice of filing. EPA's response to
these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified some of the commodity vocabulary and rounded the significant
figures of some of the tolerances. The reason for these changes are
explained in Unit IV.D.

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 propiconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with propiconazole
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.
    The primary target organ for propiconazole toxicity in animals is
the liver. Increased liver weights were seen in mice after subchronic
or chronic oral exposures to propiconazole. Liver lesions such as
vacuolation of hepatocytes, ballooned liver cells, foci of enlarged
hepatocytes, hypertrophy, and necrosis are characteristic of
propiconazole toxicity in rats and mice. Decreased body weight gain was
also seen in subchronic, chronic, developmental and reproductive
studies in animal studies. Dogs appeared to be more sensitive to the
localized toxicity of propiconazole as manifested by stomach
irritations at 6 milligram/kilogram/day (mg/kg/day) and above.
    In rabbits, developmental toxicity occurred at a higher dose than
the maternally toxic dose, while in rats, developmental toxicity
occurred at lower doses than maternal toxic doses. Increased incidences
of rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft
palate malformations were noted in two studies in rats. In one
published study in rats, developmental effects (malformations of the
lung and kidneys, incomplete ossification of the skull, caudal
vertebrae and digits, extra rib (14th rib) and missing sternbrae) were
reported at doses that were not maternally toxic. In the two generation
reproduction study in rats, offspring toxicity occurred at a higher
dose than the parental toxic dose suggesting lower susceptibility of
the offspring to the toxic doses of propiconazole.
    The acute neurotoxicity study produced severe clinical signs of
toxicity (decreased activity, cold, pale, decreased motor activity,
etc.) in rats at the high dose of 300 milligram/kilogram (mg/kg).
Limited clinical signs (piloerection, diarrhea, tip toe gait) were
observed in the mid-dose animals (100 mg/kg), while no treatment
related signs were observed at 30 mg/kg. The current acute dietary
assessment for the general population is based on the NOAEL of 30 mg/kg
from the acute neurotoxicity study. A subchronic neurotoxicity study in
rats did not produce neurotoxic signs at the highest dose tested that
was associated with decreased body weight.
    Propiconazole was negative for mutagenicity in the in vitro BALB/
3T3 cell transformation assay, bacterial reverse mutation assay,
Chinese hamster bone marrow chromosomal aberration assay, unscheduled
DNA synthesis studies in human fibroblasts and primary rat hepatocytes,
mitotic gene conversion assay, and the dominant lethal assay in mice.
It caused proliferative changes in the rat liver with or without
pretreatment with an initiator, like phenobarbital, a known liver tumor
promoter. Liver enzyme induction studies with propiconazole in mice
demonstrated that propiconazole is a strong phenobarbital type inducer
of xenobiotic metabolizing enzymes. Hepatocellular proliferation
studies in mice suggest that propiconazole induces cell proliferation
followed by treatment-related hypertrophy in a manner similar to the
known hypertrophic agent phenobarbital.
    Propiconazole was carcinogenic to male mice but was not
carcinogenic to rats or to female mice. The Agency classified
propiconazole as a possible human carcinogen and recommended that, for
the purpose of risk characterization, the reference dose (RfD) approach
be used for quantification of human risk. Propiconazole is not
genotoxic and this fact, together with special mechanistic studies,
indicates that propiconazole is a threshold carcinogen. Propiconazole
produced liver tumors in male mice only at a high dose that was toxic
to the liver. At doses below the RfD, liver toxicity is not expected;
therefore, tumors are also not expected.
    Specific information on the studies received and the nature of the
adverse effects caused by propiconazole 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 titled, ``Propiconazole Human
Health Risk Assessment for the New Uses of Propiconazole on dill, leafy
brassicas crop subgroup 5B, ti palm, watercress, and quinoa, along with
expansion to fruit, stone, group 12-12; except plum, and nut, tree,
group 14-12'' on pp. 37 in docket ID number EPA-HQ-OPP-2014-0788.

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 the NOAEL and the LOAEL are identified.
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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for propiconazole used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 30 mg/kg/day  Acute RfD = 0.3 mg/  Developmental Study--Rat
 years of age).                    UFA = 10x...........   kg/day.             LOAEL = 90 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.3 mg/kg/     increased incidence of
                                   FQPA SF = 1x........   day.                 rudimentary ribs, un-ossified
                                                                               sternebrae, as well as increased
                                                                               incidence of shortened and absent
                                                                               renal papillae and increased
                                                                               cleft palate.

Acute dietary (General population  NOAEL = 30 mg/kg/day  Acute RfD = 0.3 mg/  Acute neurotoxicity study--Rat
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 100 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.3 mg/kg/     clinical signs of toxicity
                                   FQPA SF = 1x........   day.                 (piloerection in one male,
                                                                               diarrhea in one female, tip toe
                                                                               gait in 3 females).
Chronic dietary (Adult Males and   NOAEL= 10 mg/kg/day.  Chronic RfD = 0.1    24-Month carcinogenicity study on
 Females 50+ yrs).                 UFA = 10x...........   mg/kg/day.           CD-1 mice. MRID 00129918
                                   UFH = 10x...........  cPAD = 0.1 mg/kg/    LOAEL = 50 mg/kg/day based on non-
                                   FQPA SF = 1x........   day.                 neoplastic liver effects
                                                                               (increased liver weight in males
                                                                               and increase in liver lesions:
                                                                               Masses/raised areas/swellings/
                                                                               nodular areas mainly).
Incidental oral short-term (1 to   NOAEL= 30 mg/kg/day.  LOC for MOE = 100..  Acute Neurotoxicity Study--Rats
 30 days).                         UFA = 10x...........                       LOAEL = 100 mg/kg/day based on
                                   UFH = 10x...........                        clinical signs of toxicity
                                   FQPA SF = 1x........                        (piloerection in one male,
                                                                               diarrhea in one female, tip toe
                                                                               gait in 3 females).
Incidental oral intermediate-term  NOAEL= 10 mg/kg/day.  LOC for MOE = 100..  24-Month carcinogenicity Study--
 (1 to 6 months).                  UFA= 10x............                        Mice
                                   UFH= 10x............                       LOAEL = 50 mg/kg/day based on non-
                                   FQPA SF = 1x........                        neoplastic liver effects
                                                                               (increased liver weight in males
                                                                               and increase in liver lesions:
                                                                               Masses/raised areas/swellings/
                                                                               nodular areas mainly).
Dermal short-term (1 to 30 days).  Oral study NOAEL =    LOC for MOE = 100..  Acute Neurotoxicity Study--Rats
                                    30 mg/kg/day                              LOAEL = 100 mg/kg/day based on
                                    (dermal absorption                         clinical signs of toxicity
                                    rate = 40%).                               (piloerection in one male,
                                   UFA = 10x...........                        diarrhea in one female, tip toe
                                   UFH = 10x...........                        gait in 3 females).
                                   FQPA SF = 1x........
Dermal intermediate-term (1 to 6   Oral study NOAEL= 10  LOC for MOE = 100..  24-Month carcinogenicity Study--
 months).                           mg/kg/day (dermal                          Mice
                                    absorption rate =                         LOAEL = 50 mg/kg/day based on non-
                                    40%).                                      neoplastic liver effects
                                   UFA = 10x...........                        (increased liver weight in males
                                   UFH = 10x...........                        and increase in liver lesions:
                                   FQPA SF = 1x........                        Masses/raised areas/swellings/
                                                                               nodular areas mainly).
Inhalation short-term (1 to 30     Oral study NOAEL= 30  LOC for MOE = 100..  Acute Neurotoxicity Study--Rats
 days).                             mg/kg/day                                 LOAEL = 100 mg/kg/day based on
                                    (inhalation                                clinical signs of toxicity
                                    absorption rate =                          (piloerection in one male,
                                    100%).                                     diarrhea in one female, tip toe
                                   UFA = 10x...........                        gait in 3 females).
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Group C, possible human carcinogen, RfD approach for risk
                                    characterization.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propiconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing propiconazole
tolerances in 40 CFR 180.434. EPA assessed dietary exposures from
propiconazole 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.
    Such effects were identified for propiconazole. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. As to residue levels in
food, EPA conducted an acute dietary analysis for propiconazole
residues of concern using tolerance levels and 100 percent crop treated
(PCT) for all existing and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. This dietary survey was conducted from 2003 to 2008. As to
residue levels in food, EPA conducted a chronic dietary analysis for
propiconazole residues of concern using tolerance levels for some
commodities, average field trial residues for the remaining
commodities, and 100 PCT for all existing and proposed uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has

concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to propiconazole. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for propiconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of propiconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and
Pesticide Root Zone Model--Ground Water (PRZM-GW) models, the estimated
drinking water concentrations (EDWCs) of propiconazole for acute
exposures are estimated to be 35.2 parts per billion (ppb) for surface
water and 37.9 ppb for ground water, and for chronic exposures are
estimated to be 18.6 ppb for surface water and 35.1 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 37.9 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 35.1 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).
    Propiconazole is currently registered for the following uses that
could result in residential exposures: Turf, ornamentals, and in paint.
The highest incidental oral and dermal exposure scenarios are expected
from residential use on turf. EPA assessed short-term risk to toddlers
from incidental oral and dermal exposure and short-term risk to adults
from dermal and inhalation residential handler exposure as well as from
post-application dermal exposure. The highest post-application exposure
from residential use on turf was used to assess risk to short-term
aggregate exposures.
    The only residential use scenario that will result in potential
intermediate term exposure to propiconazole is wood treatment, which
the Agency assumes may result in dermal and incidental oral post-
application exposures to children. No chronic exposures are expected.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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.''
    Propiconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    Propiconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including propiconazole, EPA conducted
a human health risk assessment for exposure to 1,2,4-triazole,
triazolylalanine, and triazolylacetic acid resulting from the use of
all current and pending uses of any triazole-derived fungicide. The
risk assessment is a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high end estimates of both dietary and
non-dietary exposures). The Agency retained a 3X for the LOAEL to NOAEL
safety factor when the reproduction study was used. In addition, the
Agency retained a 10X for the lack of studies including a DNT. The
assessment includes evaluations of risks for various subgroups,
including those comprised of infants and children. The Agency's
complete risk assessment is found in the propiconazole reregistration
docket at http://www.regulations.gov, Docket ID Number EPA-HQ-OPP-2005-
0497.
    An updated dietary exposure and risk analysis for the common
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA),
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was
completed on April 9, 2015, in association with registration requests
for several triazole fungicides, propiconazole, difenoconazole, and
flutriafol. That analysis concluded that risk estimates were below the
Agency's level of concern for all population groups. This assessment
may be found on http://www.regulations.gov by searching for the
following title and docket number: ``Common Triazole Metabolites:
Updated Aggregate Human Health Risk Assessment to Address The New
Section 3 Registrations For Use of Propiconazole on Tea, Dill, Mustard

Greens, Radish, and Watercress; Use of Difenoconazole on Globe
Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the
Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop
Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.;
and Use of Flutriafol on Hops'' (located in docket ID number EPA-HQ-
OPP-2014-0788).

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 Food Quality
Protection Act Safety Factor (FQPA 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. In the developmental
toxicity study in rats, fetal effects observed in this study at a dose
lower than that evoking maternal toxicity are considered to be
quantitative evidence of increased susceptibility of fetuses to in
utero exposure to propiconazole. Neither quantitative nor qualitative
evidence of increased susceptibility was observed in utero or
postnatally in either the rabbit developmental or 2-generation
reproduction rat study. There is no evidence of neuropathology or
abnormalities in the development of the fetal nervous system from the
available toxicity studies conducted with propiconazole. In the rat
acute neurotoxicity study, there was evidence of clinical toxicity at
the high dose of 300 mg/kg, but no evidence of neuropathology from
propiconazole administration.
    Although there was quantitative evidence of increased
susceptibility of the young following exposure to propiconazole in the
developmental rat study, the Agency determined there is a low degree of
concern for this finding and no residual uncertainties because the
increased susceptibility was based on minimal toxicity at high doses of
administration, clear NOAELs and LOAELs have been identified for all
effects of concern, and a clear dose-response has been well defined.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for propiconazole is complete.
    ii. Other than the mild effects seen at 300 mg/kg in the acute
neurotoxicity study, neurotoxicity and neurobehavioral effects were not
seen in the propiconazole toxicity database. The liver, not the nervous
system, is the primary target organ of propiconazole toxicity.
    iii. Although an apparent increased quantitative susceptibility was
observed in fetuses and offspring, for the reasons noted in this Unit
residual uncertainties or concerns for prenatal and/or postnatal
toxicity are minimal.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessments were performed
based on 100 PCT and tolerance-level residues, while the chronic used a
combination of tolerance-level residues and reliable data on average
field trial residues and 100 PCT. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to propiconazole in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. A turf
transferable residue study is unavailable but being requested from the
registrant for registration review of propiconazole. In all probability
this study will reduce exposure estimates for both the incidental oral
and post-application exposure to children. These assessments will not
underestimate the exposure and risks posed by propiconazole.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to propiconazole will occupy 84% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
propiconazole from food and water will utilize 25% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
propiconazole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Propiconazole
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to propiconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs from post-
application activities (the highest exposure scenario) of 200 for
adults and 96 for children 1-2 years old. Although the MOE for children
1-2 years old is slightly below the target MOE of 100, the Agency does
not believe that propiconazole poses short-term risks of concern
because the difference is small and more than offset by the use of
conservative endpoints and conservative exposure assumptions. This
assessment is considered conservative since the short-term endpoints
are based on a conservative LOAEL that is 3x higher than the NOAEL.
Therefore, the true NOAEL is likely higher and would result in MOEs
greater than 100. Further, the assessment combines conservative
assumptions by using tolerance-level residues and reliable data on
average field-trial residues and 100 PCT, conservative assumptions in
the ground and surface water modeling, and conservative assumptions to
assess post-application exposure of children as well as incidental oral
exposure of toddlers. Refining any one of these conservatisms would
result in MOEs for this age group that are not of concern. Although
dietary (food and water) is not the aggregate exposure driver,
incorporating PCT would likely increase the aggregate MOE further above
100. For example, using the Agency's highest average PCT

reported for propiconazole residues on crops (i.e., 55%), which is
approximately half the currently assumed dietary exposure, the MOE for
this age group would exceed the target MOE of 100 and not be of
concern. Therefore, the Agency has determined that there is no short-
term risk of concern from exposure to propiconazole.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Propiconazole is currently registered for use as a wood treatment
that could result in intermediate-term residential exposure, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with intermediate-term residential
exposures to propiconazole.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 110 for children 1-2 years old. Because EPA's level of
concern for propiconazole is a MOE of 100 or below, this MOE is not of
concern.
    5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA considers the chronic aggregate risk
assessment to be protective of any aggregate cancer risk. As there is
no chronic risk of concern, EPA does not expect any cancer risk to the
U.S. population from aggregate exposure to propiconazole.
    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 propiconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a high performance liquid
chromatography with ultraviolet detection method (HPLC/UV Method AG-
671A) 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.
    There are no Codex MRLs for dillweed (fresh or dried), dill seed,
the brassica leafy greens subgroup 5B, ti palm, watercress, quinoa or
radish.
    Codex does have MRLs in place for peach and plums (part of the U.S.
stone fruit group), and pecans (part of the U.S. tree nut group) that
are different than the U.S. tolerances. The U.S. tolerance expression
is not harmonized with the Codex expression, which is expressed in
terms of propiconazole per se, and therefore, the U.S. tolerance level
for stone fruit and tree nuts cannot be harmonized with the Codex MRLs
that are currently established.

C. Response to Comments

    Two comments were received in response to the October 21, 2015
notice of filing. The first comment asserted that no residues should be
allowed and that the pesticide should not be approved for sale or use.
The Agency understands the commenter's concerns and recognizes that
some individuals believe that pesticides should be banned on
agricultural crops. However, the existing legal framework provided by
section 408 of the FFDCA states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. The
comment appears to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.
    The second comment was from the Center for Biological Diversity and
concerned endangered species; specifically stating that EPA cannot
approve this new use prior to completion of consultations with the U.S.
Fish and Wildlife Service and the National Marine Fisheries Service
(``the Services''). This comment is not relevant to the Agency's
evaluation of safety of the propiconazole tolerances; section 408 of
the FFDCA focuses on potential harms to human health and does not
permit consideration of effects on the environment.

D. Revisions to Petitioned-for Tolerances

    The Agency is revising the petitioned-for tolerance requests for
``dill, fresh'' and ``dill, dried'' to ``dillweed, fresh leaves'' and
``dillweed, dried leaves'', respectively, for consistency with the
Agency's commodity vocabulary for those commodities. For the same
reason, the Agency is revising the petitioned-for tolerance request for
``leafy Brassica greens, subgroup 5B'' to ``Brassica leafy greens,
subgroup 5B''. In addition, EPA is revising the tolerance values for
radish, tops; ti palm, roots; and watercress to be consistent with
EPA's policy on significant figures for tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]
methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,-
dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric
equivalent of propiconazole, in or on brassica leafy greens, subgroup
5B at 20 ppm; dill seed at 15 ppm; dillweed, dried leaves at 80 ppm;
dillweed, fresh leaves at 30 ppm; quinoa, grain at 3.0 ppm; radish,
roots at 0.04 ppm; radish, tops at 0.20 ppm; ti palm, leaves at 10 ppm;
ti palm, roots at 0.30 ppm; and watercress at 6.0 ppm. In addition, the
existing fruit, stone, group 12, except plum and nut, tree, group 14
tolerances are modified to read ``fruit, stone, group 12-12, except
plum'' and ``nut, tree, group 14-12,'' respectively.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: December 14, 2015.
Susan Lewis,
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. In Sec.  180.434:
0
a. Revise the entries for ``Fruit, stone, group 12, except plum'' and
``Nut, tree, group 14.''
0
b. Add alphabetically the following commodities to the table in
paragraph (a).
    The revisions and additions read as follows:

Sec.  180.434  Propiconazole; tolerances for residues.

    (a) * * *

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

                                * * * * *
Brassica leafy greens, subgroup 5B......................           20

                                * * * * *
Dill, seed..............................................           15
Dillweed, dried leaves..................................           80
Dillweed, fresh leaves..................................           30

                                * * * * *
Fruit, stone, group 12-12, except plum..................            4.0

                                * * * * *
Nut, tree, group 14-12..................................            0.10

                                * * * * *
Quinoa, grain...........................................            3.0
Radish, roots...........................................            0.04
Radish, tops............................................            0.20

                                * * * * *
Ti palm, leaves.........................................           10
Ti palm, roots..........................................            0.30

                                * * * * *
Watercress..............................................            6.0

                                * * * * *
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* * * * *
[FR Doc. 2015-32327 Filed 12-22-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Rules and Regulations]
[Pages 11408-11409]
[FR Doc No: 2018-05047]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-1064; Airspace Docket No. 17-ANM-32]

Establishment of Class E Airspace, Yuma, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace extending upward from
700 feet above the surface at Yuma Municipal Airport, Yuma, CO, to
accommodate new area navigation (RNAV) procedures at the airport. This
action is necessary for the safety and management of instrument flight
rules (IFR) operations within the National Airspace System.

DATES: Effective 0901 UTC, May 24, 2018. The Director of the Federal
Register approves this incorporation by reference action under Title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11B, 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: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, call
(202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Tom Clark, Federal Aviation
Administration, Operations Support Group, Western Service Center, 2200
S. 216th Street, Des Moines, WA 98198; 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 establishes Class E airspace extending upward
from 700 feet above the earth at Yuma Municipal Airport, Yuma, CO, to
support IFR operations at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (82 FR 58144; December 11, 2017) for Docket No. FAA-2017-1064
to establish Class E airspace extending upward from 700 feet above the
surface at Yuma Municipal Airport, Yuma, CO. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, Airspace Designations and
Reporting Points, dated August 3, 2017, and effective September 15,
2017. FAA Order 7400.11B is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11B lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending Title 14 Code of Federal Regulations (14 CFR)
part 71 by establishing Class E airspace extending upward from 700 feet
above the surface within a 6.4-mile radius of Yuma Municipal Airport,
Yuma, CO. This airspace is necessary to accommodate the development of
RNAV (IFR) operations in standard instrument approach and departure
procedures at the airport.

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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

0
1. The authority citation for 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 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

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

* * * * *

ANM CO E5 Yuma, CO [New]

Yuma Municipal Airport, CO
    (Lat. 40[deg]06'21'' N, long. 102[deg]42'52'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Yuma Municipal Airport.

    Issued in Seattle, Washington, on March 5, 2018.
Shawn M. Kozica,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2018-05047 Filed 3-14-18; 8:45 am]
 BILLING CODE 4910-13-P