[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Proposed Rules]
[Pages 29445-29448]
[FR Doc No: 2017-13498]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0648; Directorate Identifier 2017-CE-012-AD]
RIN 2120-AA64

Airworthiness Directives; Piaggio Aero Industries S.p.A.
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Piaggio Aero Industries S.p.A. Model P-180 airplanes. This proposed AD
results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as disbonding of the upper and lower metal skin
from the honeycomb core on the elevator assembly and other flight
control surfaces. We are issuing this proposed AD to require actions to
address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by August 14, 2017.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Piaggio Aero Industries S.p.A--Continued Airworthiness, Via Pionieri e
Aviatori d'Italia snc--16154 Genova, Italy; Telephone: +39<PHONE_NUMBER>;
Fax: None; email<EMAIL_ADDRESS>Internet:
www.piaggioaerospace.it/en/customer-support#care. You may review this
referenced service information at the FAA, Small Airplane Directorate,
901 Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0648; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2017-0648;
Directorate Identifier 2017-CE-012-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will

consider all comments received by the closing date and may amend this
proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD No.: 2017-0045, dated March 9, 2017 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    During a post flight inspection of a right hand (RH) elevator
assembly, disbonding was detected on the upper and lower metal skin
from the honeycomb core. Subsequent investigation identified that a
manufacturing deficiency caused the detected disbonding and that
other flight control surfaces could potentially be affected by the
same deficiency.
    This condition, if not detected and corrected, could reduce the
structural stiffness of the flight control surface and downgrade its
aerodynamic characteristics, possibly resulting in reduced control
of the aeroplane.
    To address this potential unsafe condition, Piaggio Aero
Industries (PAI) issued Service Bulletin (SB) 80-0455 to provide
inspection instructions.
    For the reasons described above, this [EASA] AD requires
repetitive inspections of the affected flight control assemblies
and, depending on findings, repair or replacement. This [EASA] AD
also requires reporting of the inspection result to PAI.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0648.

Related Service Information Under 1 CFR Part 51

    Piaggio Aero Industries S.p.A has issued Piaggio Aero Industries
S.p.A. Mandatory Service Bulletin N.: 80-0455, dated: January 13, 2017.
The service information describes procedures for repetitive inspections
to verify the structural integrity of the flight control assemblies.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section of this NPRM.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 103 products of U.S.
registry. We also estimate that it will take 9 work-hours per product
to comply with the basic requirements of the proposed AD. The average
labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $78,795, or $765 per product.
    The scope of damage found in the required inspections could vary
significantly from airplane to airplane. We have no way of determining
how much damage may be found on each airplane or the cost to repair
damaged parts on each airplane.
    In addition, we have no way of knowing how many products may need
replacement as a result of the required inspections. The following cost
estimates were obtained directly from the manufacturer and we estimate
that any necessary follow-on replacement actions would cost as follows:
    (i) Control surface repair: 10 work-hours for a cost of $850 per
product.
    (ii) Left Hand (LH) Forward Wing Flap Replacement: 4 work-hours and
require parts costing $30,079, for a total cost of $30,419.
    (iii) Right Hand (RH) Forward Wing Flap Replacement: 4 work-hours
and require parts costing $30,079, for a total cost of $30,419.
    (iv) LH Aileron Assembly: 7 work-hours and require parts costing
$40,715, for a total cost of $41,310.
    (v) RH Aileron Assembly: 7 work-hours and require parts costing
$86,050, for a total cost of $86,645.
    (vi) Main Wing LH Inboard Flap Assembly: 4 work-hours and require
parts costing $22,699, for a total cost of $23,039.
    (vii) Main Wing RH Inboard Flap Assembly: 4 work-hours and require
parts costing $22,699, for a total cost of $23,039.
    (viii) LH Elevator Assembly: 8 work-hours and require parts costing
$59,917, for a total cost of $60,597.
    (ix) RH Elevator Assembly: 8 work-hours and require parts costing
$59,917, for a total cost of $60,597.
    There is an additional 10 work-hours that may be required for post-
repair or post-installation replacment of flight control surface
adjustments and testing, for a total cost of $850.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Piaggio Aero Industries S.p.A.: Docket No. FAA-2017-0648;
Directorate Identifier 2017-CE-012-AD.

(a) Comments Due Date

    We must receive comments by August 14, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Piaggio Aero Industries S.p.A. P-180
airplanes, serial numbers 1002, 1004 through 1220, that are:
    (1) Equipped with flight control surfaces part numbers (P/Ns)
and serial numbers (S/Ns) not listed in table 1 of Piaggio Aero
Industries S.p.A. Mandatory Service Bulletin N.: 80-0455, dated:
January 13, 2017; and
    (2) certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as disbonding of
the upper and lower metal skin from the honeycomb core on the
elevator assembly and other flight control surfaces. We are issuing
this proposed AD to prevent structural stiffness of the flight
control surface and the downgrade of its aerodynamic
characteristics, resulting in reduced control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(8) of this AD. The parts affected by this AD are all left hand (LH)
forward flaps, right hand (RH) forward flaps, main wing LH inboard
flaps, main wing RH inboard flaps, LH ailerons, RH ailerons, LH
elevators, and RH elevators, hereafter referred to as ``affected
control surface'' in this AD.
    (1) Within the next 50 hours time-in-service (TIS) after the
effective date of this AD or within the next 200 hours TIS after the
last coin tapping inspection of the affected control surface
following PAI Non-Destructive Test Manual (NDTM) 180-MAN-0300-01107,
Chapter 51-00-01; whichever occurs later, do a coin tapping
inspection of each affected control surface. Repetitively thereafter
inspect at the intervals specified in paragraphs (f)(3)(i) and (ii).
Follow Part B of the Accomplishment Instructions in Piaggio Aero
Industries S.p.A. Mandatory Service Bulletin No.: 80-0455, dated
January 13, 2017 (PAI SB No. 80-0455).
    (i) Do two repetitive inspections at intervals not to exceed 200
hours TIS; and
    (ii) Repetitively thereafter inspect at intervals not to exceed
600 hours TIS.
    (2) If damage is found during any inspection required in
paragraph (f)(1) of this AD, before further flight, repair or
replace as necessary each damaged affected control surface following
Part B and/or C of the Accomplishment Instructions in Piaggio Aero
Industries S.p.A. Mandatory Service Bulletin (SB) No.: 80-0455,
dated January 13, 2017.
    (3) Within 50 hours TIS after the repair of an affected control
surface as required by paragraph (f)(2) of this AD, do a coin
tapping inspection of that repaired affected control surface.
Repetitively thereafter inspect at the intervals specified in
paragraphs (f)(3)(i) and (ii) of this AD. Follow the instructions in
Piaggio Aero Industries S.p.A. Mandatory Service Bulletin (SB) No.:
80-0455, dated January 13, 2017.
    (i) Do two repetitive inspections at intervals not to exceed 200
hours TIS; and
    (ii) Repetitively thereafter inspect at intervals not to exceed
600 hours TIS.
    (4) If damage is found during any inspection required in
paragraph (f)(3) of this AD, before further flight, repair or
replace as necessary each damaged affected control surface following
the instructions in Part B and/or C of the Accomplishment
Instructions in Piaggio Aero Industries S.p.A. Mandatory Service
Bulletin (SB) No.: 80-0455, dated January 13, 2017.
    (5) Repair of an affected control surface, as required by
paragraph (f)(2) or (4) of this AD, does not constitute terminating
action for repetitive inspections as required by this AD for that
affected control surface, unless the FAA-approved repair
instructions specify otherwise.
    (6) Replacement of the affected part on an airplane with a part
listed in Table 1 of Piaggio Aero Industries S.p.A. Mandatory
Service Bulletin (SB) No.: 80-0455, dated January 13, 2017,
constitutes terminating action for the repetitive inspections
required by this AD for that part.
    (7) You may incorporate the actions of Piaggio Aero Industries
S.p.A. Mandatory Service Bulletin (SB) No.: 80-0455, dated January
13, 2017, into your FAA-approved Airplane Inspection Program (AIP)
or maintenance program (instructions for continued airworthiness) to
ensure the continuing airworthiness of each operated airplane.
    (8) After the effective date of this AD, you may install on an
airplane an affected control surface not listed in table 1 of
Piaggio Aero Industries S.p.A. Mandatory Service Bulletin N.: 80-
0455, dated: January 13, 2017, provided that before further flight
after installation, the affected control surface has been inspected
as specified in this AD and found airworthy.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2017-0045, dated March 9, 2017; and Piaggio Aero Industries S.p.A.
Mandatory Service Bulletin (SB) No.: 80-0455, dated January 13,
2017; for related information. You may examine the MCAI on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0648. For service information related to this
AD, contact Piaggio Aero Industries S.p.A--Continued Airworthiness,
Via Pionieri e Aviatori d'Italia snc--16154 Genova, Italy;
Telephone: +39<PHONE_NUMBER>; Fax: None; email:
<EMAIL_ADDRESS>Internet:
www.piaggioaerospace.it/en/customer-support#care. You may review
this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on June 21, 2017.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-13498 Filed 6-28-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Rules and Regulations]
[Pages 75039-75045]
[FR Doc No: 2012-30447]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0772; FRL-9369-5]

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 sugarcane, cane. Syngenta Crop Protection, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective December 19, 2012. Objections and
requests for hearings must be received on or before February 19, 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-2011-0772, 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: Erin Malone, Registration Division
(7505P),

Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 347-0253; 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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0772 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 19, 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 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-2011-0772, 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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at 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 November 9, 2011 (Volume 76, FR 69690)
(FRL-9325-1), EPA issued a notice pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F7892) by Syngenta Crop Protection, LLC, P.O. Box 18300 Greensboro, NC
27419-8300. The petition requested that 40 CFR 180.434 be amended by
establishing tolerances for residues of the fungicide propiconazole,
1H-1,2,4-Triazole, 1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl{time} -, and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound in or on
sugarcane, cane at 1.0 parts per million (ppm). That notice referenced
a summary of the petition prepared by Syngenta Crop Protection, LLC,
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
proposed a different tolerance level for the reasons 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 toxicology database for propiconazole is adequate for
evaluating and characterizing toxicity and selecting endpoints for
purposes of this risk assessment. 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 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.
    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. Propiconazole was not carcinogenic to rats or to female
mice. The Agency has classified propiconazole as possible human
carcinogen used the reference dose (RfD) approach 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.
    Propiconazole has low to moderate toxicity in experimental animals
by the oral (Category III), dermal (Category III) and inhalation routes
(Category IV), is moderately irritating to the eyes (Category III),
minimally irritating to the skin (Category IV) and is a dermal
sensitizer.
    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 an Amended Section 3 Registration on Sugarcane'' on
pages 12-18 in docket ID number EPA-HQ-OPP-2011-0772.

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 propiconazole used for
human risk assessment is discussed in Unit B of the final rule
published in the Federal Register of Wednesday, May 11, 2011 (76 FR
27261) (FRL-8873-2).

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% crop treated 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 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 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% crop treated for all existing and proposed uses.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data is not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. 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 and percent crop treated (PCT) 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://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) model, the estimated drinking water concentrations (EDWCs) of
propiconazole for acute exposures are estimated to be 55.78 parts per
billion (ppb) for surface water and 0.64 ppb for ground water. For
chronic exposures for non-cancer assessments EDWCs are 21.61 ppb for
surface water and 0.64 ppb for ground water. For chronic exposures for
cancer assessment EDWCs are 13.24 ppb for surface water and 0.64 ppb
for groundwater.
    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.
    EPA assessed residential exposure using the following assumptions:
Short-term risk to toddlers was assessed for incidental oral and dermal
exposure. The highest incidental oral and dermal exposure scenarios are
expected from residential use on turf. Short-term risk to adults was
assessed for dermal and inhalation residential handler exposure as well
as from post-application dermal exposure. Adult handlers have some
inhalation exposure; however, based on the low vapor pressure of
propiconazole, negligible post application inhalation exposure is
anticipated to occur. 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 dermal and incidental
oral post application exposure to children from wood treatment
(antimicrobial use).
    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://www.epa.gov/pesticides/cumulative.
    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, U.S. 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). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. 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
Identification (ID) Number EPA-HQ-OPP-2005-0497 and an update to assess
the addition of the commodities included in this action may be found in
docket ID number EPA-HQ-OPP-2011-0072, in the document titled ``Common
Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk
Assessment to Address the Amended Propiconazole Section 3 Registration
to Add Foliar Use on Sugarcane.''

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. 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. In the developmental toxicity study in
rabbits, neither quantitative nor qualitative evidence of increased
susceptibility of fetuses to in utero exposure to propiconazole was
observed in this study. In the 2-generation reproduction study in rats,
neither quantitative nor qualitative evidence of increased
susceptibility of neonates (as compared to adults) to prenatal and/or
postnatal exposure to propiconazole was observed. 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 mild neurobehavioral effects at 300 mg/kg/day, 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 except for
the lack of immunotoxicity and subchronic neurotoxicity studies. In the
absence of specific immunotoxicity studies, EPA has evaluated the
available propiconazole toxicity data to determine whether an
additional database uncertainty factor is needed to account for
potential immunotoxicity. There was no evidence of adverse effects on
the organs of the immune system in any propiconazole study. In
addition, propiconazole does not belong to a class of chemicals (e.g.,
the organotins, heavy metals, or halogenated aromatic hydrocarbons)
that would be expected to be immunotoxicity. Based on the
considerations in this Unit, EPA does not believe that conducting a
special Harmonized Guideline 870.7800 immunotoxicity study will result
in a POD less than the NOAEL of 10.0 mg/kg/day used in calculating the
cPAD for propiconazole, and therefore, an additional database
uncertainty factor is not needed to account for potential
immunotoxicity.
    ii. In the absence of the subchronic neurotoxicity study, EPA has
evaluated the available propiconazole toxicity data to determine
whether an additional database uncertainty factor is needed to account
for potential neurotoxicity after repeated exposures. With the
exception of the developmental studies in the rat, there were no
indications in any of the repeated dose studies that propiconazole is
neurotoxic. In the developmental studies in the rat, there were some
clinical signs of neurotoxicity at 300 mg/kg/day but not at lower
doses. Further, 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 mild neurobehavioral effects
at 300 mg/kg, but no evidence of neuropathology from propiconazole
administration. Based on the considerations in this Unit, EPA does not
believe that conducting a Harmonized Guideline 870.6200b subchronic
neurotoxicity study will result in a POD less than the NOAEL of 10 mg/
kg/day used in calculating the cPAD for propiconazole, and therefore,
an additional database uncertainty factor is not needed to account for
potential neurotoxicity from repeated exposures.
    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 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 propiconazole in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. 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 79% 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 21% 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 and
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
exposure result in aggregate MOEs of 200 for children and adults.
    4. Intermediate-term risk. The only residential use scenario that
will result in potential intermediate term exposure to propiconazole is
post application exposure to children from wood treatment
(antimicrobial use). The aggregate MOE is 120, which is greater than
the target MOE of 100. Therefore, this scenario is not of concern.
    5. Aggregate cancer risk for U.S. population. Propiconazole is
classified as a possible human carcinogen with risk quantitated using a
reference dose (RfD) approach, this determination is further explained
in section III.C.1.iii. As noted in Unit III.E.2., chronic exposure is
below the cPAD.
    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.
    The Codex has established MRLs for propiconazole per se in or on
sugarcane, cane at 0.02 ppm. These MRLs are different than the
tolerances established for propiconazole in the United States. Codex
MRLs apply only to applications by seed piece treatment for sugarcane.
The Agency considers seed piece treatment to be a non-food use and did
not set a tolerance for that use. In the U.S., application to sugarcane
is by foliar spray. This results in higher residues in sugarcane, and
thus EPA has established a higher tolerance level for propiconazole on
sugarcane than the Codex MRL.

C. Response to Comments

    No comments received.

D. Revisions to Petitioned-for Tolerances

    The petitioned for tolerance level of 1.0 ppm has been revised to
0.40 ppm. The Organization for Economic Cooperation and Development
tolerance calculation procedures were utilized in determining the
appropriate tolerance level for the requested amended use. Changes in
recommended tolerance are based on the use of these calculation
procedures. Additionally, the registrant made a calculation error in
choosing the tolerance value.

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), in or on sugarcane, cane at 0.40 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 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: December 10, 2012.
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. Section 180.434 is amended by revising paragraph (a), introductory
text, and by adding to the table, alphabetically, an entry for
``sugarcane, cane'' to read as follows:

Sec.  180.434  Propiconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of
propiconazole, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only those
propiconazole residues convertible to 2,4-dichlorobenzoic acid (2,4-
DCBA), expressed as the stoichiometric equivalent of propiconazole, in
or on the commodity in the table below:

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

                                * * * * *
Sugarcane, cane........................................             0.4

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-30447 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 1, 2008 (Volume 73, Number 149)]
[Notices]
[Page 45029]
[DOCID:fr01au08-89]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1780-DR]

Texas; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Texas (FEMA-1780-DR), dated July 24, 2008,
and related determinations.

DATES: Effective Date: July 24, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, Washington, DC 20472,
(202) 646-2705.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 24, 2008, the President declared a major disaster under the
authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of Texas resulting from Hurricane Dolly beginning on July 22, 2008,
and continuing, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the
Stafford Act). Therefore, I declare that such a major disaster
exists in the State of Texas.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program in the designated
areas; Hazard Mitigation throughout the State; and any other forms
of assistance under the Stafford Act that you deem appropriate
subject to completion of Preliminary Damage Assessments (PDAs),
unless you determine that the incident is of such unusual severity
and magnitude that PDAs are not required to determine the need for
supplemental Federal assistance pursuant to 44 CFR 206.33(d).
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs, except for any particular
projects that are eligible for a higher Federal cost-sharing
percentage under the FEMA Public Assistance Pilot Program instituted
pursuant to 6 U.S.C. 777. If Other Needs Assistance is later
warranted, Federal funding under that program will also be limited
to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Sandy
Coachman, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared disaster.
    I do hereby determine the following areas of the State of Texas to
have been affected adversely by this declared major disaster:

    Aransas, Bexar, Brooks, Calhoun, Cameron, Hidalgo, Jim Wells,
Kenedy, Kleberg, Nueces, Refugio, San Patricio, Starr, Victoria, and
Willacy Counties for Public Assistance Category B (emergency
protective measures), including direct Federal assistance.
    All counties within the State of Texas are eligible to apply for
assistance under the Hazard Mitigation Grant Program.

    (The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032,
Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individual and Household Housing; 97.049,
Individual and Household Disaster Housing Operations; 97.050,
Individual and Household Program--Other Needs; 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-17686 Filed 7-31-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Page 83538]
[FR Doc No: 2023-26333]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0070; FRL-10841-08-OCSPP]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients (August 2023)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and
opportunity to comment on these applications.

DATES: Comments must be received on or before January 2, 2024.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0070, and the specific case number for the
chemical substance related to your comment, through the Federal
eRulemaking Portal at https://www.regulations.gov. Follow the online
instructions for submitting comments. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. To make
special arrangements for hand delivery or delivery of boxed
information, please follow the instructions at https://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or
visiting the docket, along with more information about dockets
generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, Biopesticides and
Pollution Prevention Division (BPPD) (7511M), main telephone number:
(202) 566-2425, email address: [email protected]. The mailing
address is Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. As part
of the mailing address, include the contact person's name, division,
and mail code.

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).

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4)
(7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications. For actions being evaluated under EPA's public
participation process for registration actions, there will be an
additional opportunity for public comment on the proposed decisions.
Please see EPA's public participation website for additional
information on this process (https://www.epa.gov/pesticide-registration/public-participation-process-registration-actions).
    The New Active Ingredient listed in this notice was incorrectly
identified as a New Use in the Federal Register on September 20, 2023
(88 FR 64909) (FRL-10578-08-OCSPP).

Notice of Receipt--New Active Ingredient

    File Symbol: 524-AAL. Docket ID number: EPA-HQ-OPP-2023-0379.
Applicant: Bayer CropScience LP, 700 Chesterfield Parkway West,
Chesterfield, MO 63017. Active ingredient: GA20ox_SUP miRNA. Product
type: Plant-incorporated Protectant. Proposed use: Plant Growth
Regulator. Contact: BPPD.
    Authority: 7 U.S.C. 136 et seq.

    Dated: November 16, 2023.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2023-26333 Filed 11-29-23; 8:45 am]
BILLING CODE 6560-50-P


Summary of Comments Received EPA received 4 letters submitting a total of sixty two suggestions and/ or comments to the Federal Register ( FR) notice published October 29, 2001 ( 66 FR 209). Comments were submitted from the American Water Works Service Company, Inc., Campaign for Safe and Affordable Drinking Water, American Water Works Association, and the Massachusetts Water Resources Authority.

The four commenters supported the Agency's efforts to evaluate the effectiveness of Consumer Right to Know efforts by assessing whether the Agency is reaching consumers through outreach initiatives ( e. g., the consumer confidence reports, source water assessments, etc.). A few commenters hoped this survey would help EPA evaluate the effectiveness of Consumer Confidence Reports ( CCR) and provide EPA with a basis to reevaluate CCR requirements. Two groups expressed concern, indicating CCRs are an expensive burden for small water systems. They hoped this survey would assist the agency in examining the need for future modifications to CCR requirements during its six year review. In addition, they both approved of EPA's efforts to improve public education measures, and applauded the Agency for taking the first steps to develop this survey as a tool to do so.

Several changes were made to the questionnaire based on the sixty two comments received. Of the 31 original questions, only four remain untouched. The agency evaluated each of the comments seriously and incorporated many of the suggestions received. Several edits were suggested to make the questions public friendly by using terminology the general public is familiar with ( e. g., not using words like " distill" rather using " treatment" instead). Other edits clarified the intent of the survey.

Phrases were edited based on several comments received from the American Water Works Association ( AWWA) to make the questions more public friendly. AWWA provided 33 comments, eleven of these being suggestions and comments the agency should consider. Overall the Association felt the survey would prove to be a very useful tool in evaluating the effectiveness of the consumer confidence report. Twenty two comments were specific to the questionnaire and provided edits for the agency to consider. EPA incorporated all the changes suggested unless based on consultation the question was dropped all together. AWWA felt the Agency needed to reflect on post September 11 health concerns. The agency did not make these changes, and rather proceeded to rephrase words such as threat, contaminate, etc. in order to reduce any potential to cause unnecessary alarm. While EPA appreciated AWWA's comments, the intent is to repeat this survey every 2 to 3 years. The agency did not want to cause unnecessary alarm and did not want to add questions that may not be appropriate in subsequent years. The Agency further looked at the general comments, and accepted changes to the survey ( e. g., clarifying the survey was being conducted on behalf of the US EPA not by water systems or utility providers). Other comments suggested EPA revitalize the Consumer Confidence Report Workgroup, provided suggestions for additions to the workgroup, develop an understanding for the drinking water and water utility practices of the respondents. EPA is considering the possibility of conducting focus groups after gathering initial baseline data through the Drinking Water Customer Satisfaction Survey. We will use AWWA's suggestions to benefit these focus groups.

The Safe and Affordable Drinking Water Campaign provided 6 comments. The Campaign maintained the survey will show " people remain very concerned about their tap water quality from the point of view of health concerns as well as taste and odor." Based on this comment, the Agency added questions to establish a baseline of data that will allow us to gauge the level of concern and trust the public places in the safety and quality of their drinking water. The Campaign requested that the agency try to learn where consumers are likely to go in order to obtain more information, and who provides the most useful information. We agreed this was beneficial, as it would assist the agency in spending dollars to target trusted populations in our outreach efforts. Therefore, additional questions were added to determine how consumers are receiving their information, and the measure of trust they place in this information. The campaign also suggested the agency explore how individuals use their drinking water information. This comment was similar to a suggestion made by AWWA. We accommodated this request by adding an additional question to the survey.

The American Water Works Service Company ( AWWSC) provided 13 comments, five general comments and eight comments suggesting several edits to clarify the questionnaire. Seven of the eight recommendations to the content of the questionnaire were accepted, and one was not as it was no longer applicable due to comments made by other reviewers. EPA had already deleted the question. Of the five general comments, AWWA supported EPA's efforts and purpose to the conduct the survey. Three of the five were addressed by changes based on AWWA's suggestion. The final comment expressed concern that asking questions regarding the dissemination of Source Water Assessment Plans ( SWAPs) may be ill timed. AWWA broached that many states are currently in the process of conducting their assessments. " Using the results at this time can build in a bias that the program has been ineffective." EPA received similar comments from 2 other groups. The agency deleted several of the SWAP questions with respect to the comments received.

The Massachusetts Water Resources Authority ( MWRA) submitted general comments after the deadline published in the Federal Register Notice; however, EPA accepted and considered the ten comments submitted. Overall, the MWRA was very supportive of the survey's efforts and mirrored comments submitted by AWWA. Therefore, the concerns had already been addressed. MRWA also mentioned the need to determine if advisories are effectively alerting customers of public health concerns. EPA did not have any questions requesting this type of information. We added a question response to learn if respondents remembered seeing any Public Health Notices and if so, if they found the information informative and were they able to act based on the notice.


[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18910-18911]
[FR Doc No: 2017-08176]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to the Agency
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on May 17, 2017, from 8:30 a.m. to 4:45
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be
Web Cast and will be available at the following link: https://collaboration.fda.gov/rsvvaccine0517. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: CAPT Serina Hunter-Thomas or Rosanna
Harvey, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver
Spring, MD 20993-0002, at<PHONE_NUMBER><EMAIL_ADDRESS>and<PHONE_NUMBER><EMAIL_ADDRESS>or FDA

Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On May 17, 2017, the VRBPAC will meet in an open session to
discuss considerations for evaluation of Respiratory Syncytial Virus
vaccine candidates in seronegative infants. FDA intends to make
background material available to the public no later than 2 business
days before the meeting. If FDA is unable to post the background
material on its Web site prior to the meeting, the background material
will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA's
Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
10, 2017. Oral presentations from the public will be scheduled between
approximately 1:15 p.m. and 2:15 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before May 2, 2017. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by May 3, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact CAPT Serina Hunter-Thomas at least 7 days in advance of the
meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08176 Filed 4-21-17; 8:45 am]
 BILLING CODE 4164-01-P