[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72852-72853]
[FR Doc No: 2016-25487]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0094; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
Model Year 1996 and 1997 Ferrari F50 Passenger Cars Are Eligible for
Importation

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

ACTION: Receipt of petition.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
model year (MY) 1996 and 1997 Ferrari F50 passenger cars (PC) that were
not originally manufactured to comply with all applicable Federal motor
vehicle safety standards (FMVSS) are eligible for importation into the
United States. A motor vehicle that was not originally manufactured to
conform to all applicable FMVSS, and has no substantially similar U.S.-
certified counterpart, shall be refused admission into the United
States unless NHTSA has decided that the motor vehicle has safety
features that comply with, or are capable of being altered to comply
with, all applicable FMVSS based on destructive test data or such other
evidence as NHTSA decides to be adequate.

DATES: The closing date for comments on the petition is November 21,
2016.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at https://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle has safety features that comply with or are capable
of being altered to comply all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    J.K. Technologies, LLC (J.K.), Inc. of Baltimore, Maryland
(Registered Importer R-90-006) has petitioned NHTSA to decide whether
nonconforming 1996 and 1997 Ferrari F50 PC's are eligible for
importation into the United States. J.K. believes these vehicles are
capable of being modified to meet all applicable FMVSS. The petitioner
seeks to use the U.S.-certified version of the 1995 Ferrari F50 PC for
comparative purposes in establishing the import eligibility of the non-
U.S. certified 1996 and 1997 models. The petitioner claims there is
precedence for this approach in action taken by the agency on a
petition involving Mercedes Benz S and SL class vehicles. The agency
notes that in a petition involving MY 2001 and 2002 Mercedes-Benz SL
class PC's, the petitioner, which was also J.K., asserted that even
though there were no substantially similar U.S.-certified vehicles of
the same model years, the petitioned vehicles had the same part numbers
as those found on the U.S.-certified MY 2003 Mercedes-Benz SL class
PC's, and that, as a consequence, the conformance modifications would
be the same and utilize the same procedures as those required for
conforming a non-U.S. certified version MY 2003 vehicle. See 67 FR
68908 (November 13, 2002). In like manner, J.K. asserts in this
instance that the 1995 Ferrari F50 PC uses all of the same safety
systems and part numbers to meet the FMVSS as the 1996 and 1997
versions.
    J.K. contends that non-U.S. certified 1996 and 1997 Ferrari F50
PC's, as originally manufactured, meet FMVSS in many areas in the same
manner as the U.S.-certified 1995 Ferrari F50 PC. The petitioner notes
that many of the concerned parts have the same parts numbers as those
on the U.S.-certified prior year model. Moreover, it claims that in all
areas that have to be modified the parts will be supplied by the OEM
manufacturer. J.K. asserts that the modifications that will be needed
do not concern the basic structure of the vehicle, but only removable
and available parts.
    Specifically, the petitioner claims that the non U.S.-certified MY
1996 and 1997 Ferrari F50 PC's, as originally manufactured, conform to:
Standard Nos. 102 Transmission Shift Lever Sequence, Starter Interlock,
and Transmission Braking Effect, 103 Windshield Defrosting and
Defogging Systems, 104 Windshield Wiping and Washing Systems, 105
Hydraulic Brake Systems, 106 Brake Hoses, 109 New

Pneumatic and certain Specialty Tires, 113 Hood Latch System, 116 Motor
Vehicle Brake Fluids, 124 Accelerator Control Systems, 201 Occupant
Protection in Interior Impact, 202 Head Restraints, 203 Impact
Protection for the driver from the Steering Control System, 204
Steering Control Rearward Displacement, 205 Glazing Materials, 206 Door
Locks and Door Retention Components, 207 Seating Systems, 210 Seat Belt
Assembly Anchorages, 212 Windshield Mounting, 216 Roof Crush
Resistance, 219 Windshield Zone Intrusion, and 302 Flammability of
Interior Materials.
    The petitioner also contends that the subject non-U.S certified
vehicles are capable of being readily altered to meet the following
standards, in the manner indicated:
    Standard No. 101 Controls and Displays: Replacement of the
instrument cluster with the U.S.-model component and reprogramming the
associated software as described in the petition.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: Installation of U.S.-conforming side marker lamps,
headlamps, tail lamps, stop lamps, parking lamps, backup lamps turn
signal lamps, and reflex reflectors with U.S.-model components if not
already so equipped.
    Standard No. 110 Tire Selection and Rims: Installation of the
required tire information placard.
    Standard No. 111 Rearview Mirrors: Inscription of the required
warning statement on the face of the passenger side rearview mirror or
replacement of the mirror with a U.S.-model mirror.
    Standard No. 114 Theft Protection: Reprogramming the body and
instrument ECU to activate the key warning and belt warning systems.
    Standard No. 118: Power Operated Window, Partition and Roof Panel
Systems: Reprogramming the window control module.
    Standard No. 208 Occupant Crash Protection: Replacement of passive
restraint system components, including the electrical wiring harness,
the passenger's side seat belt, seatbelt tracks and electronic control
unit (ECU), with U.S.-model components as described in the petition.
    Standard No. 209 Seat Belt Assemblies: Replacement of the seat
belts with U.S.-model components.
    Standard No. 214 Side Impact Protection: Installation of U.S.-model
side impact protection bars in the doors.
    Standard No. 301 Fuel System Integrity: Replacement of fuel system
components with U.S.-model components as necessary to meet all
applicable requirements of the standards.
    The petitioner additionally states that a vehicle identification
plate must be affixed to the vehicle near the left windshield pillar to
meet the requirements of 49 CFR part 565.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-25487 Filed 10-20-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22493-22495]
[FR Doc No: 2018-10329]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1837]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic User Fee Payment Request Forms

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on electronic user fee payment request forms.

DATES: Submit either electronic or written comments on the collection
of information by July 16, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 16, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note

that if you include your name, contact information, or other
information that identifies you in the body of your comments, that
information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-1837 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Electronic User Fee Payment
Request Forms.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Electronic User Fee Payment Request Forms--Form FDA 3913 and Form FDA
3914

OMB Control Number 0910-0805--Extension

    Form FDA 3913, User Fee Payment Refund Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment refund. The information collected includes the
organization, contact, and payment information. The information is used
to determine the reason for the refund, the refund amount, and who to
contact if there are any questions regarding the refund request. A
submission of the User Fee Payment Refund Request form does not
guarantee that a refund will be issued. FDA estimates an average of
0.40 hours per response, including the time to review instructions,
search existing data sources, gather and maintain the data needed, and
complete and review the collection of information. The estimated hours
are based on past FDA experience with user fee payment refund requests.
    In fiscal year 2017, approximately 1,657 user fee refunds were
processed for cover sheets and invoices including 12 for Animal Drug
User Fee Act, 2 for Animal Generic Drug User Fee Act, 13 for Biosimilar
Drug User Fee Act, 68 for Export Certificate Program, 14 for Freedom of
Information Act requests, 227 for Generic Drug User Fee Amendments,
1,021 for Medical Device User Fee Amendments, 227 for mammography
inspection fees, 67 for Prescription Drug User Fee Act, and 6 for
tobacco product fees.
    Form FDA 3914, User Fee Payment Transfer Request, is designed to
provide the minimum information necessary for FDA to review and process
a user fee payment transfer request. The information collected includes
payment and organization information. The information is used to
determine the reason for the transfer, how the transfer should be
performed, and who to contact if there are any questions regarding the
transfer request. A submission of the User Fee Payment Transfer Request
form does not guarantee that a transfer will be performed. FDA
estimates an average of 0.25 hours per response, including the time to
review instructions, search existing data sources, gather and maintain
the data needed, and complete and review the collection of information.
FDA estimated hours are

based on past FDA experience with user fee payment transfer requests.
    In fiscal year 2017, approximately 871 user fee payment transfers
were processed for cover sheets and invoices including 8 for Animal
Drug User Fee Act, 1 for Animal Generic Drug User Fee Act, 1 for
Biosimilar Drug User Fee Act, 163 for Generic Drug User Fee Amendments,
692 for Medical Device User Fee Amendments, and 6 for Prescription Drug
User Fee Act.
    Respondents for the electronic request forms include domestic and
foreign firms (including pharmaceutical, medical device, etc.).
Specifically, refund request forms target respondents who submitted a
duplicate payment or overpayment for a user fee cover sheet or invoice.
Respondents may also include firms that withdrew an application or
submission. Transfer request forms target respondents who submitted
payment for a user fee cover sheet or invoice and need that payment to
be reapplied to another cover sheet or invoice (transfer of funds).
    The electronic user fee payment request forms will streamline the
refund and transfer processes, facilitate processing, and improve the
tracking of requests. The burden for this collection of information is
the same for all customers (small and large organizations). The
information being requested or required has been held to the absolute
minimum required for the intended use of the data. Customers will be
able to request a user fee payment refund and transfer online at
https://www.fda.gov/forindustry/userfees/default.htm. This electronic
submission is intended to reduce the burden for customers to submit
user fee payment refund and transfer requests.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
User Fee Payment Refund                  1,657               1           1,657  0.40 (24                     663
 Request--Form FDA 3913.                                                         minutes).
User Fee Payment Transfer                  871               1             871  0.25 (15                     218
 Request--Form FDA 3914.                                                         minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             881
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. New information technology
applications have more accurately calculated the number of registrants
of drug facilities/food facilities/medical device facilities/medicated
feed facilities, and we have therefore revised the number of
respondents to the information collection.

    Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10329 Filed 5-14-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45361-45362]
[FR Doc No: 2017-20797]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2017-0073 (Notice No. 2017-04)]

Hazardous Materials: Information Collection Activities

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on an information collection pertaining to hazardous
materials transportation for which PHMSA intends to request renewal
from the Office of Management and Budget.

DATES: Interested persons are invited to submit comments on or before
November 27, 2017.

ADDRESSES: You may submit comments, identified by Docket No. PHMSA-
2017-0073 (Notice No. 2017-04), by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management System; U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: To the Docket Management System; Room W12-
140 on the ground floor of the West Building, 1200 New Jersey Avenue
SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    Instructions: All submissions must include the agency name and
Docket Number (PHMSA-2017-0073) for this notice at the beginning of the
comment. To avoid duplication, please use only one of these four
methods. All comments received will be posted without change to the
Federal Docket Management System (FDMS) and will include any personal
information provided.
    Requests for a copy of an information collection should be directed
to Steven Andrews or T. Glenn Foster, Standards and Rulemaking
Division,<PHONE_NUMBER>, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590-0001.
    Docket: For access to the dockets to read background documents or
comments received, go to http://www.regulations.gov or DOT's Docket
Operations Office (see ADDRESSES).
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Steven Andrews or T. Glenn Foster,
Standards and Rulemaking Division,<PHONE_NUMBER>, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: Section 1320.8 (d), title 5, Code of Federal
Regulations (CFR) requires PHMSA to provide interested members of the
public and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies an
information collection request that PHMSA will be submitting to the
Office of Management and Budget (OMB) for renewal and extension. This
information collection is contained in 49 CFR 171.6 of the Hazardous
Materials Regulations (HMR; 49 CFR parts 171-180). PHMSA has revised
burden estimates, where appropriate, to reflect current reporting
levels or adjustments based on changes in proposed or final rules
published since the information collection was last approved. The
following information is provided for this information collection: (1)
Title of the information collection, including former title if a change
is being made; (2) OMB control number; (3) summary of the information
collection activity; (4) description of affected public; (5) estimate
of total annual reporting and recordkeeping burden; and (6) frequency
of collection. PHMSA will request a 3-year term of approval for this
information collection activity and will publish a notice in the
Federal Register upon OMB's approval.
    PHMSA requests comments on the following information collection:
    Title: Hazardous Materials Shipping Papers & Emergency Response
Information.
    OMB Control Number: 2137-0034.
    Summary: This information collection is for the requirement to
provide a shipping paper and emergency response information with
shipments of hazardous materials. Shipping papers are a basic
communication tool in the transportation of hazardous materials and, by
definition (see 49 CFR 171.8), include a shipping order, bill of
lading, manifest, or other shipping document serving a similar purpose
and containing the information required by Sec. Sec.  172.202, 172.203,
and 172.204 of the HMR. A shipping paper with emergency response
information must accompany most hazardous materials shipments and be
readily available at all times during transportation.
    Shipping papers serve as the principal source of information
regarding the presence of hazardous materials, identification,
quantity, and emergency response procedures. They inform on compliance
with other requirements (i.e., the placement of rail cars containing
different hazardous materials in trains); prevent the loading of
poisons with foodstuffs; maintain the separation of incompatible
hazardous materials; and limit the amount of radioactive materials that
may be transported in a vehicle or aircraft. Shipping papers and
emergency response information also notify transport workers that
hazardous materials are present and serve as a principal means of
identifying hazardous materials during transportation emergencies.
Firefighters, police, and other emergency response personnel are
trained to obtain the DOT shipping papers and emergency response
information when responding to hazardous materials transportation
emergencies.
    The availability of accurate information concerning hazardous
materials being transported significantly improves response efforts in
these types of emergencies.
    Affected Public: Shippers and carriers of hazardous materials in
commerce.

    Annual Reporting and Recordkeeping Burden:
    Number of Respondents: 260,000.
    Total Annual Responses: 175,234,493.
    Total Annual Burden Hours: 4,598,685.
    Frequency of Collection: On occasion.

William S. Schoonover,
Associate Administrator of Hazard Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2017-20797 Filed 9-27-17; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Rules and Regulations]
[Pages 12401-12408]
[FR Doc No: 2014-04862]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0949; FRL-9906-47]

Triflumizole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
triflumizole 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 March 5, 2014. Objections and
requests for hearings must be received on or before May 5, 2014, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0949, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0949 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 May 5, 2014. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0949, 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 February 15, 2013 (78 FR 11126) (FRL-
9378-4), 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
2E8119) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ
08540. The petition requested that 40 CFR 180.476 be amended by
establishing tolerances for residues of the fungicide triflumizole, 1-
[1-((4-chloro-2-(trifluoromethyl) phenyl)imino)-2propoxyethyl]-1H-
imidazole, in or on berry, low growing, subgroup 13-07G at 2.0 parts
per million (ppm); fruit, pome, group 11-10 at 0.5 ppm; fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.5 ppm; and
tomato at 1.5 ppm. That document referenced a summary of the petition
prepared by Chemtura, the registrant, which is available in the docket,
http://www.regulations.gov. A comment was received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.
    In the Federal Register of October 25, 2013 (78 FR 63938) (FRL-
9901-96), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), which amended the notice of filing published on
February 15, 2013, for the pesticide petition (PP 2E8119) submitted by
IR-4, 500 College Road East, Suite 201W., Princeton, NJ 08540. The
modified petition requested that 40 CFR 180.476 be amended by
establishing tolerances for residues of the fungicide triflumizole, 1-
[1-((4-chloro-2-(trifluoromethyl) phenyl)imino)-2propoxyethyl]-1H-
imidazole, in or on berry, low growing, subgroup, 13-07G at 2.0 ppm;
fruit, pome, group 11-10 at 0.5 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 2.5 ppm; and tomato at 1.5
ppm. The petition also requested that EPA amend the existing tolerance
by modifying the vegetable, cucurbit, group 9 tolerance from 0.5 ppm to
0.8 ppm and, upon approval of the tolerances stated in this paragraph,
by removing established tolerances for apple at 0.5 ppm; grape at 2.5
ppm; pear at 0.5 ppm; and strawberry at 2.0 ppm.
    Based upon review of the data supporting the petition summarized in
the Notices of Filing, EPA has modified the tolerance level needed for
the cucurbit vegetable group 9. The reason for this change is 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 triflumizole including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with triflumizole 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 liver is the primary target organ of triflumizole. Liver
effects were seen in rat and mouse subchronic and chronic/
carcinogenicity studies. Subchronic effects included increased absolute
and relative liver weights, accumulation of fat droplets, and slight
hepatocyte centrilobular swelling. With increased length of exposure,
the types of microscopic lesions noted increased in number and
severity. Chronic effects included hepatocyte fatty vacuolization;
hepatocyte hypertrophy, focal inflammation, and necrosis; fatty
degeneration; eosinophilic foci of hepatocyte alteration; hepatic
nodules; bile duct hyperplasia; and hyaline degeneration/fibrosis of
the bile duct. The dog was less sensitive to the effects of
triflumizole. In the dog chronic study, effects included increased
liver weights, increased serum alkaline phosphatase levels, and a
macroscopic hepatic lobular pattern and granular texture. A very mild,
macrocytic anemia was also noted and was most likely secondary to liver
effects.
    Triflumizole is classified as not likely to be carcinogenic to
humans, based on a weight of evidence determination including the lack
of evidence of carcinogenicity in studies in rats and mice and the
absence of a mutagenicity concern.
    The oral rat developmental study showed an increased qualitative
susceptibility of the fetus to triflumizole in utero. Decreased numbers
of viable fetuses, increased dead or resorbed fetuses, increased
numbers of late resorptions, decreased fetal body weight and increased
incidences of cervical ribs was seen in the fetuses at the same doses
at which maternal toxic effects were noted. In addition, increased
incidences of 14th rudimentary ribs were observed at the next highest
dose.

Maternal toxic effects in the rat were decreased body weight gain and
decreased food consumption, increased placental weight, and increased
maternal spleen and liver weights.
    No increased susceptibility of the fetus was noted in utero in the
rabbit developmental study. Fetal effects included increased fetal and
litter incidences of lumbar ribs and decreased placental weights, which
was also included as a maternal toxic effect. Maternal toxic effects in
the rabbit included decreased body weight gain, decreased food
consumption, and decreased placental weights.
    In the 3-generation reproductive toxicity study in the rat,
offspring effects included decreased pup weights, survival indices, and
litter sizes in both F3 litters, reduced litter size in the
F1a litter, increased total-litter mortality in the
F3a litter, and developmental effects in the F1b
and F2b progeny. Reproductive toxicity, manifested as
increased gestation length, was increased in the F0 dams
which were pregnant with F1 offspring. Increased gestation
length can be due to either effect in the dams and/or the offspring,
and this alteration in normal reproductive function can result in
adverse consequences in both dams and offspring. Accordingly, there is
no increased quantitative susceptibility of the fetus. There is
increased qualitative susceptibility in pups; however, a clear no-
observed-adverse-effect-level (NOAEL) for this effect was established
for these effects, and risk assessment endpoints and points of
departures (PODs) were selected which are protective for these effects.
    In acute oral toxicity studies in the rat and mouse and an acute
inhalation study in the rat, animals developed neurotoxic signs within
30 to 60 minutes of administration, which resolved within 24 hours in
surviving animals. Signs included ataxia, hypotonia, ventral
positioning, urinary incontinence, decreased respiration and heart
rates, decreased locomotor movement, lacrimation, salivation, ptosis,
and/or rhinorrhea. No treatment-related histopathological effects were
found in surviving animals. In the chronic rat study, convulsions were
observed sporadically in all dosage groups, but the incidences were
significantly higher in the high-dose females. The majority of the
convulsions were noted within the first year. Cholinesterase activity
was also affected during the first year of the study, but not in a
consistent manner. High-dose males had decreased plasma and erythrocyte
cholinesterase activity while high-dose females had decreased plasma
cholinesterase activity only. There were no treatment-related effects
on cholinesterase activity in the brain in either sex at any dose and
no neuropathology was noted. No neurotoxic effects were observed in the
rat subchronic oral toxicity study or the mouse subchronic oral
toxicity and carcinogenicity studies.
    The evidence does not support the need for a developmental
neurotoxicity (DNT) study. This conclusion is supported by lack of
neurotoxic signs noted in the rat subchronic study at any dose, and in
the adult or offspring in the developmental and reproductive toxicity
studies in the rat. In an immunotoxicity dietary study in female Bagg
Albino (BALB/c) mice, a significant decrease in the anti-sheep red
blood cells immunoglobulin M (anti-SRBC IgM) response was observed at a
dose level of 285.7 milligrams/kilograms/day (mg/kg/day). The NOAEL was
28.6 mg/kg/day. The results of the immunotoxicity study do not impact
the PODs selected for dietary and non-dietary exposure risk
assessments.
    Specific information on the studies received and the nature of the
adverse effects caused by triflumizole as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in the document entitled
``Triflumizole: Human-Health Risk Assessment for the Proposed Uses on
Greenhouse-Grown Tomato and Cucumber; Pome Fruit Group 11-10, Small
Fruit Vine Climbing except Fuzzy Kiwifruit Subgroup 13-07F and Low
Growing Berry Subgroup 13-07G, Except Cranberry'' on pp. 33-36 in
docket ID number EPA-HQ-OPP-2012-0949.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological PODs and levels of concern (LOCs) 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 (UF) 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 triflumizole used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Triflumizole 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 = 10 mg/kg/day  Acute RfD = 0.1 mg/  Developmental Toxicity Study--Rat.
 years of age).                    UFA = 10x...........   kg/day.             Developmental LOAEL = 35 mg/kg/day
                                   UFH = 10x...........  aPAD = 0.1 mg/kg/     based on decreased numbers of
                                   FQPA SF = 1x........   day.                 viable fetuses, increased dead or
                                                                               resorbed fetuses, increased
                                                                               numbers of late resorptions,
                                                                               decreased fetal body weight, and
                                                                               increased incidences of cervical
                                                                               ribs.
----------------------------------

Acute dietary (General population  NOAEL = 25 mg/kg/day  Acute RfD = 0.25 mg/ Acute Neurotoxicity Study--Rat.
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 100 mg/kg/day based on FOB
                                   UFH = 10x...........  aPAD = 0.25 mg/kg/    findings (neuromuscular
                                   FQPA SF = 1x........   day.                 impairment) and decreased
                                                                               locomotor activity.
----------------------------------
Chronic dietary (All populations)  LOAEL = 3.5 mg/kg/    Chronic RfD = 0.012  Combined Chronic.
                                    day                   mg/kg/day.          Toxicity/Carcinogenicity Study--
                                   UFA = 10x...........  cPAD = 0.012 mg/kg/   Rat.
                                   UFH = 10x...........   day.                Based on liver toxicity
                                   FQPA SF = 3x UFL....                        (eosinophilic foci in male rats
                                                                               and fatty vacuolation and
                                                                               inflammation and necrosis in
                                                                               female rats).
----------------------------------
Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = 100..  Multi-generation Reproduction
                                    study NOAEL = 3.5                          Study--Rat.
                                    mg/kg/day (dermal                         LOAEL = 8.5 mg/kg/day based on
                                    absorption rate =                          decreased pup body weight,
                                    3.5%.                                      mortality, reduced litter size,
                                   UFA = 10x...........                        and increased incidence of
                                   UFH = 10x...........                        hydroureter and space between the
                                   FQPA SF = 1x........                        body wall and organs were
                                                                               observed at 8.5 mg/kg/day. In
                                                                               addition, gestation length was
                                                                               increased in the dams of F1a,
                                                                               F2a, and F3a intervals at the
                                                                               LOAEL of 8.5 mg/kg/day.
----------------------------------
Inhalation short-term (1 to 30     Oral study NOAEL =    LOC for MOE = 100..  Multi-generation Reproduction
 days).                             3.5 mg/kg/day.                             Study--Rat.
                                   UFA = 10x...........                       LOAEL = 8.5 mg/kg/day based on
                                   UFH = 10x...........                        decreased pup body weight,
                                   FQPA SF = 1x........                        mortality, reduced litter size,
                                                                               and increased incidence of
                                                                               hydroureter and space between the
                                                                               body wall and organs were
                                                                               observed at 8.5 mg/kg/day. In
                                                                               addition, gestation length was
                                                                               increased in the dams of F1a,
                                                                               F2a, and F3a intervals at the
                                                                               LOAEL of 8.5 mg/kg/day.
----------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based a weight of
                                    evidence determination including the lack of evidence of carcinogenicity in
                                    studies in rats and mice and the absence of a mutagenicity concern.
----------------------------------------------------------------------------------------------------------------
FOB = functional observational battery. 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).
  UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to triflumizole, EPA considered exposure under the petitioned-
for tolerances as well as all existing triflumizole tolerances in 40
CFR 180.476. EPA assessed dietary exposures from triflumizole 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 triflumizole and as noted in Table 1of this unit, separate acute
endpoints and PODs were selected for females of child-bearing age (13-
49) and the general population including infants and children. In
estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). A conservative acute dietary assessment was
conducted using tolerance-level residues, and 100 percent crop treated
(PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, a partially refined chronic
dietary assessment was conducted using average residues from supervised
field trials, and PCT estimates for currently registered commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that triflumizole does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. 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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.

     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Apple: 25%; cantaloupe: 10%; cherry: 25%; cucumber: 2.5%; filbert:
5%; grape: 5%; honeydew: 15%; pear: 45%; pumpkin: 5%; squash: 5%;
strawberry: 25%; and watermelon: 5%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which triflumizole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for triflumizole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of triflumizole. 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) models, the estimated drinking water concentrations (EDWCs) of
triflumizole for acute exposures are estimated to be 98 parts per
billion (ppb) for surface water and 3.1 ppb for ground water and for
chronic exposures are estimated to be 22 ppb for surface water and 3.1
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 98 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 22 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).
    Triflumizole is currently registered for the following uses that
could result in residential exposures: As a foliar spray by home owner
and commercial applicators to landscape grown trees, shrubs, and vines
and also for use on residential/non-commercially grown trees/vines
bearing apples, pears and grapes.
    EPA assessed residential exposure using the following assumptions:
For residential handlers, short-term dermal and inhalation exposures
are expected for triflumizole activities associated with use on
ornamental plants and bearing pome fruit trees. The dermal and
inhalation endpoints are based on the same toxicological effect for
triflumizole, and therefore the MOEs were combined to determine a total
risk estimates. For post-application, there is the potential for short-
term dermal exposure for adults and children (6-11 years old), exposed
as a result of being in an environment that has been previously treated
with triflumizole on landscape ornamentals. Post-application exposure
from triflumizole use on landscape ornamentals for children (1-2 years)
is expected to be negligible based on the following factors:
     Children young enough to exhibit hand-to-mouth behavior
would not typically play in ornamental beds or tree plots.
     If present, leaf to skin residue transfer would be
negligible because of the minimal frequency and duration of contact.
    The residential handler exposure for adults from the back pack
sprayer broadcast use of triflumizole to gardens and trees represents
the highest estimated risk, and was therefore combined with the chronic
dietary exposure for adults (general U.S. population), to estimate the
highest aggregate exposure and risk.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found triflumizole to share a common mechanism of
toxicity with any other substances, and triflumizole does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
triflumizole does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of

safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database on toxicity and exposure unless EPA determines based on
reliable data that a different margin of safety will be safe for
infants and children. This additional margin of safety is commonly
referred to as the 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. There is evidence of
increased qualitative susceptibility following in utero exposure to
rats in a developmental study. Developmental toxicity resulted in fetal
death as compared to maternal toxicity which included decreases in body
weight gain and food consumption and increases in placental, spleen,
and liver weights.
    No quantitative or qualitative evidence of increased susceptibility
was seen following in utero exposure to rabbits in a developmental
study. In the developmental rabbit study, a cesarean section was
performed with evaluation of 24-hour fetal survival. At this interval,
fetal survival was decreased. EPA does not consider this finding to
indicate an adverse effect because a cesarean section with 24-hour
fetal survival is more an indicator of fetal endurance after being
removed from the womb than a measurement of treatment-related effects
on fetal viability and, thus, is not appropriate to use to ascertain
fetal susceptibility. For similar reasons, such an endpoint survival is
not a standard measurement in the guideline developmental toxicity
protocols. In addition, the decreased 24-hour fetal survival occurred
in isolation and only at a high dose level (100 mg/kg/day) which is 10-
fold higher than the NOAEL of 10 mg/kg/day selected for the acute
dietary (females 13-49 years of age) exposure scenario for which this
endpoint might be pertinent. Further, the 24-hour fetal survival was
not replicated in a second developmental rabbit guideline study.
    Evidence of increased qualitative susceptibility in pups was
evident in the 3-generation reproductive toxicity study in the rat;
however, the use of the NOAEL of 3.5 mg/kg/day (offspring and
reproductive effects) for incidental oral scenarios and short-term
dermal and inhalation scenarios is protective of potential toxicity
(observed in the developmental and 2-generation reproductive toxicity
studies) following pre- and postnatal exposures.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF for the acute risk assessment, and short-term dermal and
inhalation exposure scenarios is removed (1X), and for chronic risk
assessment is reduced to 3X. A 3X FQPA SF is retained for the chronic
RfD because it is derived from the use of a LOAEL established in the
combined chronic toxicity/carcinogenicity study in rats. A 3X rather
than a 10X is adequate for the FQPA SF for the reasons provided below:
     For this chemical, the liver is the most sensitive target
organ and the histopathological lesions seen in the target organ is
used as the endpoint of concern.
     The Agency is confident that the extrapolated NOAEL of 1.2
mg/kg/day (LOAEL of 3.5 mg/kg/day / 3 UFL (use of a LOAEL to
extrapolate a NOAEL) = 1.2 mg/kg/day) would be protective of liver
effects in this species because the observed liver effects were minimal
in severity and did not progress into malignancy (i.e., no liver tumors
were seen) even after 2 years of treatment in either sex of rats.
     Retention of the 3X UFL results in an
extrapolated NOAEL of 1.2 mg/kg/day (LOAEL 3.5 mg/kg/day / 3
UFL= 1.2 mg/kg/day). This value, at a minimum, is
approximately 10-fold lower than all the NOAELs established in the
database with the other studies as shown in this unit.
    The FQPA SF provides adequate protection of infants and children
based on the following findings:
    i. The toxicity database for triflumizole is complete. Although no
subchronic inhalation data is available EPA has waived that data
requirement. In determining the need for a subchronic inhalation study,
EPA's weight of evidence decision process included both hazard and
exposure considerations as well as incorporation of a presumed 10X
Database Uncertainty Factor (UFdb) for the lack of this study.
Specifically, with regard to exposure considerations, the Agency's LOC
in the evaluating the need for the subchronic inhalation study is a MOE
of 1,000 for inhalation exposure, which includes the 10X inter-species
extrapolation factor, 10X intra-species variation factor, and the 10X
UFdb. For trifumizole, residential inhalation exposures resulted in
MOEs higher than the LOC of 1,000 when using an oral POD. This
indicates that the lack of an inhalation study does not reduce the
overall confidence in the risk assessment or result in an uncertainty
(i.e., the study will not provide a POD sufficiently low to result in a
risk of concern). Because EPA's decision to waive the subchronic
inhalation study essentially incorporates an additional 10X UFdb (i.e.,
the study was only waived because risks were at least 10X lower than
required by use of the inter- and intraspecies safety factors), a
second additional 10X FQPA SF is not being retained for the protection
of infants and children due to the absence of this study.
    ii. Signs of neurotoxicity were seen in the acute oral and
inhalation studies in the rat and mouse. Signs of neurotoxicity
(neuromuscular impairment and decreased locomotor activity) were noted
in the acute neurotoxicity study at mid and high doses. As a result,
the endpoint from this study was used to assess acute dietary risks
from one-day exposures to triflumizole in the diet of the general
population. There were no treatment-related neuropathological findings
observed in either sex in the acute neurotoxicity study. No evidence of
neurotoxicity was seen in the submitted subchronic neurotoxicity study.
Likewise, neuropathological evaluation of study animals in the
subchronic neurotoxicity study did not reveal any treatment-related
histological effects of the central and peripheral nervous systems. A
DNT study is not required based on the lack of neurotoxicity in the rat
subchronic neurotoxicity study, and in the adult or offspring in the
developmental and reproductive toxicity studies in the rat.
    iii. As noted in Unit III.D.2., there is evidence of increased
qualitative susceptibility following in utero exposure to rats in a
developmental study and pre- and or postnatal exposure in a 3-
generation reproductive toxicity study in the rat; however, there are
no residual uncertainties, and the use of associated RfDs will be
protective of the pre- and postnatal toxicity following an acute
dietary exposure, and short-term dermal and inhalation exposures.
    No quantitative or qualitative evidence of increased susceptibility
was seen following in utero exposure to rabbits in a developmental
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessment utilizes
tolerance-level residues, Dietary Exsposure Evaluation Model (DEEM
7.81) default processing factors (where available), and 100 PCT
information for all commodities. By using these screening-level
assessments, actual exposures/risks will not be underestimated. The
chronic dietary

food exposure assessment utilizes average field trial residues, and
percent crop treated information for established tolerances. Some
empirical processing factors were used in the chronic assessment along
with DEEM 7.81 default processing factors (where available). The
chronic assessment is partially refined; however, since it is based on
reliable, high-end data, it will not underestimate exposure/risk.
    EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to triflumizole in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children 6-11 years old and expects post
application exposure for children below 6 years to be negligible. These
assessments will not underestimate the exposure and risks posed by
triflumizole.

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, EPA performed separate acute risk assessments
for females 13 to 49 years old and for the general population,
including infants and children, based on different endpoints and aPADs.
For females aged 13-49, acute dietary exposure to triflumizole from
food and water will occupy 66% of the aPAD chosen for that population
subgroup. For the general population and population subgroups other
than females aged 13-49, acute dietary exposure to triflumizole is
greatest for children 1-2 years old. That subgroup will occupy 40% of
the applicable aPAD.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
triflumizole from food and water will utilize 39% 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
triflumizole 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).
    Triflumizole 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 triflumizole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined worst case scenario
(adult handlers) for short-term food, water, and residential exposures
result in an aggregate MOE of 180 and an aggregate MOE of 600 for
children 6-11 years old. Because EPA's LOC for triflumizole is a MOE of
100 or below, these MOEs are not of concern.
    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).
    An intermediate-term adverse effect was identified; however,
triflumizole is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
triflumizole.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, triflumizole is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to triflumizole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen
phosphorous detector (GC/NPD); Method I in PAM Vol. II) is available to
enforce the tolerance expression.

B. International Residue Limits

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

C. Response to Comments

    A comment was received that opposed the establishment of these
tolerances. Part of the comment opposed the manufacturing and selling
of this product due to potential effects on the environment. This is
considered irrelevant because the safety standard for approving
tolerances under FFDCA section 408 focuses on potential harms to human
health and does not permit consideration of effects on the environment.
Another part objected to the proposed tolerances because of the amounts
of pesticides/toxic chemicals already consumed and carried by the
American population. The Agency understands the commenter's concerns
and recognizes that some individuals believe that pesticides should be
banned completely. However, under the existing legal framework provided
by FFDCA section 408 EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute.

D. Revisions to Petitioned-For Tolerances

    Using the Organization for Economic Co-operation and Development
(OECD) tolerance calculation procedures, it was initially determined
that the existing cucurbit vegetable group 9 tolerance of 0.5 should be
increased to 0.8 ppm. However, if the crop group 9 tolerance

was to be increased to 0.8 ppm, the U.S. tolerance will be higher than
the Canadian MRL of 0.5 ppm. After re-examining the residue data, EPA
is confident that the 0.5 ppm level will be high enough to cover
residues from maximum use under the pesticide registration, and
therefore, in order to remain aligned with Canada, the existing
cucurbit vegetable group 9 tolerance will remain at 0.5 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of triflumizole,
1-[1-((4-chloro-2-(trifluoromethyl) phenyl)imino)-2propoxyethyl]-1H-
imidazole, in or on berry, low growing, subgroup 13-07G at 2.0 ppm;
fruit, pome, group 11-10 at 0.5 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 2.5 ppm; and. tomato at 1.5
ppm. In addition, due to the establishment of these tolerances, the
existing tolerances for apple, pear, grape, and strawberry are removed
as unnecessary.

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: February 25, 2014.
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. In Sec.  180.476:
0
a. Remove the commodities ``Apple,'' ``Grape,'' ``Pear,'' and
``Strawberry'' from the table in paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in
paragraph (a)(1).
    The amendments read as follows:

Sec.  180.476  Triflumizole; tolerances for residues.

    (a) * * *
    (1) * * *

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

                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry...            2.0

                                * * * * *
Fruit, pome, group 11-10................................            0.50
Fruit, small, vine climbing, except fuzzy kiwifruit,                2.5
 subgroup 13-07F........................................

                                * * * * *
Tomato..................................................            1.5

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

* * * * *
[FR Doc. 2014-04862 Filed 3-4-14; 8:45 am]
BILLING CODE 6560-50-P


P-18-0341-0344 Sanitized Support Documents Index:
 P-18-0341-0344 Sanitized Determination Document (linked)
 P-18-0341 Sanitized CHEM Report (attached)
 P-18-0342 Sanitized CHEM Report (attached)
 P-18-0343 Sanitized CHEM Report (attached)
 P-18-0344 Sanitized CHEM Report (attached)
 P-18-0341 Sanitized ECO Report (attached)
 P-18-0342 Sanitized ECO Report (attached)
 P-18-0343 Sanitized ECO Report (attached)
 P-18-0344 Sanitized ECO Report (attached)
 P-18-0341-0344 Sanitized ENG Report (attached)
 P-18-0341 Sanitized EXP Report (attached)
 P-18-0342 Sanitized EXP Report (attached)
 P-18-0343 Sanitized EXP Report (attached)
 P-18-0344 Sanitized EXP Report (attached)
 P-18-0341 Sanitized Fate Report (attached)
 P-18-0342 Sanitized Fate Report (attached)
 P-18-0343 Sanitized Fate Report (attached)
 P-18-0344 Sanitized Fate Report (attached)
 P-18-0341-0344 Sanitized HLTH Report_POST-FOCUS FINAL (attached)