[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78217-78219]
[FR Doc No: 2016-26788]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79209; File No. SR-NYSEArca-2016-138]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE
Arca Options Fee Schedule Effective November 1, 2016

November 1, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on October 25, 2016, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Options Fee Schedule
(``Fee Schedule''). The Exchange proposes to implement the fee change
effective November 1, 2016. The proposed rule change is available on
the Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to provide for fees for manually
executed Professional Customer orders, effective November 1, 2016.
    Currently, the Exchange does not differentiate between Customer and
Professional Customer orders for purposes of manual transaction fees,
and Customers and Professional Customers are not charged any fee for
orders executed in open outcry.\4\
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    \4\ Per the Fee Schedule, ``[u]nless Professional Customer
executions are specifically delineated, such executions will be
treated as Customer executions for fee purposes.'' See Fee Schedule,
available here, https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.

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    The Exchange proposes to assess a fee of $0.25 per contract for
Professional Customer orders that are executed manually, and to modify
the Fee Schedule to reflect this change. This proposed assessment would
mean Professional Customers are charged the same rate as Firms and
Broker Dealers for manual orders.
    The Exchange is not proposing any other modification to Transaction
Fees at this time.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\5\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\6\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposed change is reasonable,
equitable and not unfairly discriminatory because Professional
Customers submit more than 390 orders in listed options per day on
average and generally engage in trading activity similar to non-
Customers. Thus, the Exchange believes it is appropriate to charge
Professional Customers the same fee it assesses Firms and Broker
Dealers (i.e., non-Customers) for manual transactions. In addition, the
proposed change is competitive as other options exchanges likewise
treat Professional Customers as non-Customers for purposes of order
[sic] executed in open outcry.\7\
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    \7\ See, e.g., NYSE Amex Options fee schedule, available here,
https://www.nyse.com/publicdocs/nyse/markets/amexoptions/NYSE_Amex_Options_Fee_Schedule.pdf (charging the Professional
Customers the same rate as Broker Dealers and Firms); NASDAQ OMX
PHLX fee schedule, available here, http://www.nasdaqtrader.com/Micro.aspx?id=phlxpricing (same).
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    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\8\ the Exchange does
not believe that the proposed rule change will impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, the Exchange believes that the proposed
change would continue to encourage competition by treating Professional
Customers on the same basis as non-Customers. The Exchange's proposal
does not place on undue burden on inter-market competition because
other exchanges likewise charge Professional Customers the same rate as
non-Customer for manual transactions.\9\ The Exchange does not believe
that the proposed change will impair the ability of any market
participants or competing order execution venues to maintain their
competitive standing in the financial markets.
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    \8\ 15 U.S.C. 78f(b)(8).
    \9\ See supra note 6.
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    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues. In
such an environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the degree to which fee changes in this market
may impose any burden on competition is extremely limited. For the
reasons described above, the Exchange believes that the proposed rule
change reflects this competitive environment.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2016-138 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2016-138. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2016-138, and
should be submitted on or before November 28, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-26788 Filed 11-4-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Page 37762]
[FR Doc No: 2014-15571]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4173-DR; Docket ID FEMA-2014-0003]

Indiana; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Indiana (FEMA-4173-DR), dated April 22, 2014, and
related determinations.

DATES: Effective Date: June 23, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 22, 2014.

    Allen County for Public Assistance.
    Allen County for snow assistance under the Public Assistance
program for any continuous 48-hour period during or proximate to the
incident period.
    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; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-15571 Filed 7-1-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Rules and Regulations]
[Pages 24485-24487]
[FR Doc No: 2021-09278]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2006-25084; Project Identifier 2005-SW-38-AD; Amendment
39-21541; AD 2021-10-08]
RIN 2120-AA64

Airworthiness Directives; Bell Textron Canada Limited (Type
Certificate Previously Held by Bell Helicopter Textron Canada Limited)
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bell Textron Canada Limited (type certificate previously held
by Bell Helicopter Textron Canada Limited) Model 206L series
helicopters. This AD

was prompted by a manufacturing flaw that could cause low fuel level
detector switch units (switch units) to hang in the high position and
fail to indicate a low fuel condition. This AD requires removing
certain switch units from service and prohibits installing those switch
units. This AD also requires accomplishing an operational test of
certain other switch units, and depending on the results, removing the
switch unit from service. This AD also prohibits installing those
certain other switch units unless they pass an operational test. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective June 11, 2021.

ADDRESSES: For service information identified in this final rule,
contact Bell Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450)
433-0272; or at https://www.bellcustomer.com. You may view the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2006-25084; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
Transport Canada AD, any comments received, and other information. The
street address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a supplemental notice of proposed rulemaking (SNPRM)
to amend 14 CFR part 39 by adding an AD that would apply to Bell
Textron Canada Limited (type certificate previously held by Bell
Helicopter Textron Canada Limited) Model 206L, 206L-1, 206L-3, and
206L-4 helicopters, with certain switch units part number (P/N) 206-
063-613-003 installed. The SNPRM published in the Federal Register on
March 12, 2021 (86 FR 14020). The FAA preceded the SNPRM with a notice
of proposed rulemaking (NPRM) that published in the Federal Register on
June 22, 2006 (71 FR 35836).
    The NPRM was prompted by Canadian AD CF-2004-24, dated November 24,
2004, issued by Transport Canada, which is the aviation authority for
Canada, to correct an unsafe condition for Model 206L series
helicopters. Transport Canada advised that eight low fuel level
detectors of listed serial numbers (S/Ns) may have been installed on
Model 206L series helicopters. These detectors could hang in the high
position and fail to indicate the low fuel condition. Accordingly,
Transport Canada advised removing the affected switch units from
service.
    The SNPRM was prompted by a significant lapse of time since
publication of the NPRM. The SNPRM also revised the NPRM by updating
the type certificate holder's name, updating the estimated cost
information, clarifying and expanding the applicability, clarifying the
requirements, adding a compliance time, adding parts installation
prohibitions, and updating the AD format.
    The SNPRM proposed to require removing switch unit P/N 206-063-613-
003 with S/N 1413, 1414, 1415, 1424, 1428, 1430, 1432, and 1433 from
service and prohibit installing those switch units. The SNPRM proposed
to require accomplishing an operational test of switch unit P/N 206-
063-613-003 with a missing or illegible switch unit S/N or with an S/N
that cannot be determined, and if the operational test fails, removing
the switch unit from service. The SNPRM also proposed to prohibit
installing switch unit P/N 206-063-613-003 with a missing or illegible
switch unit S/N or with an S/N that cannot be determined unless it
passes an operational test.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the SNPRM or on the determination
of the costs.

Conclusion

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with Canada, Transport Canada, its
technical representative, has notified the FAA of the unsafe condition
described in its AD. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on these
helicopters.

Related Service Information

    The FAA reviewed Bell Helicopter Textron Alert Service Bulletin No.
206L-04-132, Revision A, dated October 4, 2004. This service
information specifies procedures for determining whether any of eight
specified serial-numbered detector switch units are installed because
they may fail to indicate a low fuel condition. If the S/N is missing
or unreadable, the service information specifies inspecting the switch
unit to determine if it is an affected switch unit. The service
information also specifies removing each affected switch unit.

Differences Between This AD and the Transport Canada

    This AD applies to switch units with a missing or illegible S/N or
with an S/N that cannot be determined, and requires certain actions for
those switch units, whereas the Transport Canada AD does not.

Costs of Compliance

    The FAA estimates that this AD affects up to 558 helicopters of
U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Replacing a switch unit takes about 4 work-hours and parts cost
about $921 for an estimated cost of $1,261 per switch unit and up to
$703,638 for the U.S. fleet. Accomplishing an operational test takes
about 4 work-hours for an estimated cost of $340 per switch unit and up
to $189,720 for the U.S. fleet.

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.
    The FAA is 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 helicopters identified in this rulemaking
action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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 Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 airworthiness
directive:

2021-10-08 Bell Textron Canada Limited (Type Certificate Previously
Held by Bell Helicopter Textron Canada Limited): Amendment 39-21541
Docket No. FAA-2006-25084; Project Identifier 2005-SW-38-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective June 11, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bell Textron Canada Limited (type certificate
previously held by Bell Helicopter Textron Canada Limited) Model
206L, 206L-1, 206L-3, and 206L-4 helicopters, certificated in any
category, with a low fuel level detector switch unit (switch unit)
part number (P/N) 206-063-613-003:
    (1) With a switch unit serial number (S/N) 1413, 1414, 1415,
1424, 1428, 1430, 1432, or 1433 installed, or
    (2) With a missing or illegible switch unit S/N or if the S/N
cannot be determined, installed.

    Note 1 to paragraph (c): Helicopters with a 206L-1+ designation
are Model 206L-1 helicopters. Helicopters with a 206L-3+ designation
are Model 206L-3 helicopters.
    Note 2 to paragraph (c): The switch unit is located on the aft
fuel boost pump assembly. The P/N and S/N for the switch unit could
be on the outside face of the attachment flange, in the cross
hatched area of the switch unit.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 2842, Fuel
Quantity Sensor.

(e) Unsafe Condition

    This AD was prompted by a manufacturing flaw that could cause a
switch unit to hang in the high position and fail to indicate a low
fuel condition. The FAA is issuing this AD to prevent failure of the
switch unit to indicate a low fuel condition that could lead to fuel
exhaustion and which if not addressed, could result in a subsequent
forced landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) For a switch unit identified in paragraph (c)(1) of this AD,
on or before the next 100-hour time-in-service inspection after the
effective date of this AD, remove the switch unit from service.
    (2) For a switch unit identified in paragraph (c)(2) of this AD,
on or before the next 100-hour time-in-service inspection after the
effective date of this AD:
    (i) Determine the color of the switch unit mounting flange. If
the mounting flange color is any color other than red, determine the
purchase date. If the purchase date of the switch unit is between
April 19 and July 26, 2004, or cannot be determined, do an
operational test.
    (ii) If the switch unit fails the operational test, before
further flight, remove the switch unit from service.
    (3) As of the effective date of this AD, do not install a switch
unit identified in paragraph (c)(1) of this AD on any helicopter.
    (4) As of the effective date of this AD, do not install a switch
unit identified in paragraph (c)(2) of this AD on any helicopter
unless the actions in paragraphs (g)(2)(i) and (ii) of this AD have
been accomplished.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (i)(1) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, FAA, 950 L'Enfant
Plaza N SW, Washington, DC 20024; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) Bell Helicopter Textron Alert Service Bulletin No. 206L-04-
132, Revision A, dated October 4, 2004, which is not incorporated by
reference, contains additional information about the subject of this
AD. For service information identified in this AD, contact Bell
Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec
J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450) 433-
0272; or at https://www.bellcustomer.com. You may view this
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (3) The subject of this AD is addressed in Transport Canada AD
CF-2004-24, dated November 24, 2004. You may view the Transport
Canada AD on the internet at https://www.regulations.gov in Docket
No. FAA-2006-25084.

(j) Material Incorporated by Reference

    None.

    Issued on April 28, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-09278 Filed 5-6-21; 8:45 am]
BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES MEMORANDUM Date: November 2, 2005 Subject: Bitertanol. Summary of Analytical Chemistry and Residue Data for the Tolerance Reassessment Eligibility Decision ( TRED) Document.

DP Barcode: D302882 PC Code: 117801 40 CFR § : 180.457 Chemical Class: Azole From: Samuel Ary, Chemist Reregistration Branch II Health Effects Division ( 7509C)

Through: Sherrie L. Kinard, Chemist Reregistration Branch II Health Effects Division ( 7509C)

Chemistry Science Advisory Council Health Effects Division ( 7509C)

Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division ( 7509C)

To: Christina Jarvis, Risk Assessor Reregistration Branch II Health Effects Division ( 7509C)

Rosanna G. Louie, Chemical Review Manager Reregistration Branch III Special Review and Reregistration Division ( 7508C)

This summary of analytical chemistry and residue data document was originally prepared under contract by Versar, Inc. ( 6850 Versar Center, Springfield, VA 22151; submitted August 16, 2004). The summary document has been reviewed by the Health Effects Division ( HED) and revised to reflect current Office of Pesticide Program ( OPP) policies. Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 2 of 17 Executive Summary Bitertanol, $([ 1,1 ' biphenyl] 4 yloxy)"( 1,1 dimethylethyl) 1H 1,2,4 triazole 1 ethanol, is a fungicide used for the control of black sigatoka, a fungal disease that destroys the leaf tissue of the banana plant. Bitertanol is formulated as an emulsifiable concentrate ( EC) or suspension concentrate ( SC) and may be applied as a foliar spray by airplane, tractor driven equipment, or knapsack sprayer. Bitertanol end use products are marketed under the trade name Baycor ® . The active ingredient constitutes 30% for the EC formulation and 50% for the SC formulation. Applications are as needed and based on the speed of leaf emergence with a maximum of 8 applications during the development period of a fruit bunch. The rate per application is 0.13 lb ai/ A for a maximum seasonal application rate of 1.1 lb ai/ A. It is intended for use on bagged bananas only. There are no U. S. registrations for bitertanol.

A tolerance has been established under 40 CFR § 180.457 for the residues of bitertanol in/ on bananas at 0.20 ppm. This tolerance is an import tolerance since bitertanol is not registered for use in the U. S. The Codex Alimentarius Commission ( Codex) has established a maximum residue limit ( MRL) for bitertanol residues in/ on bananas at 0.5 mg/ kg. Additionally, the Codex MRL for bitertanol is expressed in terms of residues of bitertanol only, as is the U. S. tolerance expression. It is the Agency's policy to harmonize its tolerances with the levels established by Codex provided that the Agency has sufficient information to make a determination that the Codex MRLs will be protective of the health of the U. S. public and meet FFDCA standards. The established tolerance should be reassessed to 0.50 ppm to harmonize with Codex as the dietary exposure and risk are not of concern ( S. Ary, D302880, 11/ 2/ 2005).

The nature of residues in plants is adequately understood based on acceptable plant metabolism studies in apples and peanuts conducted with bitertanol labeled in the biphenyl ring system and additional studies submitted recently in apples, cotton, and tomatoes conducted with bitertanol labeled in the traizole ring system. The recently submitted studies are currently under review by the Agency, however it is noted that after initial review of the newly submitted studies, the data support the conclusions drawn from the two previous submissions. The residues identified in these studies consisted primarily of the parent compound with traces of the metabolites bitertanol ketone and 4 hydroxybiphenol. Although no metabolism studies for bananas are available, HED has concluded that the nature of residues in bananas is likely similar to that in apples, cotton, peanuts, and tomatoes. Therefore, HED has determined that the bitertanol residues of concern in/ on bananas for tolerance expression and for risk assessment are bitertanol.

Additionally, the Agency does have concern about the potential toxicity of 1,2,4 triazole and two conjugates, triazole alanine and triazole acetic acid, which are metabolites common to most of the triazole fungicides. To support the extension of existing and granting of new parent triazolederivative fungicide tolerances, the Agency will be conducting a human health assessment for aggregate exposure to 1,2,4 triazole.

An analytical method for analysis of residues of bitertanol has been submitted and found acceptable for data collection purposes. The submitted method is a modification of Mobay Chemical Corporation's Method 54166 for the analysis of bitertanol in apples. Analysis is by gas chromatography using a nitrogen phosphorus flame ionization detector. The limit of detection is Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 3 of 17 0.01 ppm. A method trial was successfully performed on banana pulp and peels at fortification levels of 0.1 ppm and 0.2 ppm. Recoveries ranged from 78 to 88% for pulp samples, and from 70 to 98% for peel samples. The method was approved by the Agency for the enforcement of tolerance in/ on bananas and the results were forwarded to FDA for inclusion in the Pesticide Analytical Manual ( PAM) Volume II.

The FDA PESTDATA database dated 11/ 2001 ( PAM Volume I, Appendix I) indicates that bitertanol was completely recovered using Multiresidue Method Section 302 ( Protocol D).

Storage stability data for bitertanol in/ on bananas have not been submitted by the registrant, therefore, storage stability data are required As indicated in the tolerance petition, bitertanol was originally marketed for use on bananas in Costa Rica and Honduras, but has expanded to include Ecuador, Guatemala, Honduras, Mexico, Nicaragua, Peru, Venezuela, Dominican Republic, and Panama. Residue data from trials conducted in Costa Rica and Honduras have been submitted and reviewed by the Agency. Bitertanol was applied to both bagged and unbagged bunches of green and ripe bananas at a rate of 0.26 lb ai/ A/ application ( 2x the current rate per application), the maximum rate per application indicated on the product label at that time. Samples of peel, pulp and whole fruit were collected 3 days after the last of 9 treatments and 0 days after the last of 12 treatments. Washed and unwashed samples were analyzed for bitertanol by Method 54166, with modifications. The number of trials, the location of the trials within Costa Rica and Honduras, and the formulation type were not specified. No data were provided on how long the samples were stored prior to analysis. Residues found in samples of whole fruit from unbagged and bagged bunches of ripe and green bananas were all below the recommended tolerance level of 0.5 ppm. The residue data are deemed adequate to support a tolerance of 0.5 ppm in/ on bananas.

The SC formulation will be supported with additional field trials that are currently being conducted by the registrant. The studies are planned for completion in 2006.

Regulatory Recommendations and Residue Chemistry Deficiencies ° Revise tolerance to 0.50 ppm to harmonize with Codex.

° Storage stability data are required to determine the stability of residues in bananas during cold storage. No data were provided on how long the banana samples from submitted field trial studies were stored prior to analysis.

° Field trial data for the SC formulation are required.

° Additional data are required in order for the submitted field trials conducted in Costa Rica and Honduras to be acceptable. The number of trials, location of the trials within the countries, and the formulation type used. Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 4 of 17 O N N N OH Background The chemical structure and nomenclature of bitertanol are listed in Table 1 and the chemical names and structures of the metabolites of bitertanol are presented in Table 3. Table 2 presents the physicochemical properties of bitertanol.

Table 1. Test Compound Nomenclature.

Chemical structure Common name Bitertanol Trade name Baycor ®

Company experimental name KWG 0599 Molecular formula C20H23N3O2 IUPAC name 1( biphenyl 4 yloxy) 3,3 dimethyl 1( 1H 1,2,4 triazol 1 yl) butan 2 ol CAS name $( 1,1' biphenyl) 4 yloxy"( 1,1 dimethylethyl) 1H 1,2,4 triazole 1 ethanol CAS number 55179 31 2 PC Code 117801 Table 2. Physicochemical Properties of the Technical Grade Test Compound.

Parameter Value Reference Molecular weight 337.42 g/ mol MRID 46655901 Melting point/ range 145 155 ° C MRID 46655901 pH Not available Density 1.16 g/ mL at 20 ° C MRID 46655901 Water solubility 1.1 mg/ L at 20 ° C for isomer A MRID 46655901 2.7 mg/ L at 20 ° C for isomer B Solvent solubility ( temperature not specified) 1 5 g/ 100g of propan 2 ol, 1 5 g/ 100g of toluene, 5 10 g/ 100g of cyclohexane, 10 20 g/ 100g of methylene chloride Stable in aqueous acid and alkaline solutions. Merck Index 12th Edition Vapor pressure 10 5 mBar at 20 ° C Merck Index 12th Edition Dissociation constant ( pKa) None MRID 46655901 Octanol/ water partition coefficient Log( KOW) K OW log P = 4.04 at 20 ° C for isomer A MRID 46655901 K OW log P = 4.10 at 20 ° C for isomer B UV/ visible absorption spectrum Peak maximum at 255 nm MRID 46655901 Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 5 of 17 O N N N O O H Table 3. Chemical Names and Structures of Metabolites of Bitertanol.

Common Name Chemical Name Structure bitertanol ketone 1[( 1,1 biphenyl) 4 yloxy] 3,3 dimethyl 1( 1H 1,2,4 triazole 1 yl) 2 butanone p hydroxybiphenyl 4 hydroxybiphenyl Summary of Science Findings 860.1200 Directions for Use Product List There are no U. S. registrations for bitertanol. An import tolerance for residues of bitertanol in/ on bananas was established through a petition ( PP# 2E2756) submitted by Mobay Chemical Corporation. As indicated in the tolerance petition, bitertanol was originally marketed for use on bananas in Costa Rica and Honduras, but has expanded to include Ecuador, Guatemala, Honduras, Mexico, Nicaragua, Peru, Venezuela, Dominican Republic, and Panama. There are two Bayer CropScience end use products containing the active ingredient bitertanol as indicated in Table 4. The variation in product names reflect different product naming requirements depending on which country each product is registered in.

Table 4. Bitertanol End Use Products ( EPs) with Food/ Feed Uses.

EPA Reg. No. 1 Formulation2 Label Acceptance Date1 Registrant Product Name Commodity N/ A = not applicable 30% EC N/ A Bayer CropScience Baycor ® 300 EC, Baycor ® 30 EC, Baycor ® 300 DC, and Baycor ® 300 CE Banana N/ A 50% SC N/ A Bayer CropScience Baycor ® 500 EC and Baycor ® 50 SC Banana 1. There are no U. S. registrations for bitertanol. 2. EC = emulsifiable concentrate and SC = soluble concentrate.

Bitertanol is formulated as an emulsifiable concentrate ( EC) or suspension concentrate ( SC) and may be applied as a foliar spray by airplane, tractor driven equipment, or knapsack sprayer. The active ingredient constitutes 30% for the EC formulation and 50% for the SC formulation. Applications are as needed and based on the speed of leaf emergence with a maximum of 8 applications during the development period of a fruit bunch. The rate per application is 0.13 lb ai/ A for a maximum seasonal application rate of 1.06 lb ai/ A. It is intended for use on bagged bananas only, however, application to unbagged bananas may occur. The current labels do not Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 6 of 17 restrict application to bagged bananas and does not specify any pre harvest interval ( PHI) requirements.

There are no U. S. registrations for bitertanol. An import tolerance for residues of bitertanol in/ on bananas was established through a petition ( PP# 2E2756) submitted by Mobay Chemical Corporation. As indicated in the tolerance petition, bitertanol was originally marketed for use on bananas in Costa Rica and Honduras, but has expanded to include Ecuador, Guatemala, Honduras, Mexico, Nicaragua, Peru, Venezuela, Dominican Republic, and Panama.

Bitertanol is formulated as an EC that contains 30% active ingredient ( Baycor ® 300 EC, Baycor ®

30 EC, Baycor ® 300 DC, and Baycor ® 300CE) or SC that contains 50% active ingredient ( Baycor ® 500 EC and Baycor ® 50SC).

Use Patterns A summary of the direction for the use of bitertanol is presented in Table 5. Based on label information provided by the petitioner, bitertanol can be applied as needed based on the speed of leaf emergence with a maximum of 8 applications during the development period of a fruit bunch. The maximum rate per application is 0.133 lb ai/ A for a total seasonal application rate of 1.064 lb ai/ A. Bitertanol can be applied as a foliar spray by air in a minimum of 2 gallons of water per acre. It is intended for use on bagged bananas only, however, application to unbagged bananas may occur. The current labels do not restrict application to bagged bananas and does not specify any PHI requirements.

Table 5. Summary of Directions for Use of Bitertanol.

Applic. Timing, Type, and Equip. Formulation Applic. Rate ( lb ai/ A) Max. No. Applic. per Season Max. Seasonal Applic. Rate ( lb ai/ A) PHI ( days)

Banana Apply as needed based on speed of leaf emergence during fruit development. Minimum retreatment interval of 7 days. Apply specified dosage as a foliar spray by air, tractor driven equipment, or knapsack sprayer in a minimum of 2 gallons of water per acre. Baycor ®

30% EC 0.13 lb ai/ A 8 1.06 lb ai/ A None Apply as needed based on speed of leaf emergence during fruit development. Minimum retreatment interval of 7 days. Apply specified dosage as a foliar spray by air, tractor driven equipment, or knapsack sprayer in a minimum of 2 gallons of water per acre. Baycor ®

50% SC 0.13 lb ai/ A 8 1.06 lb ai/ A None A tabular summary of the chemistry science assessments is presented in Table 6. The conclusions listed in Table 6 regarding the reregistration eligibility of bitertanol food/ feed uses are based on the use patterns registered by the basic producer, Bayer CropScience. Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 7 of 17 Table 6. Residue Chemistry Science Assessment for Reregistration of Bitertanol.

GLN Data Requirements Current Tolerances ( ppm) [ 40 CFR] Additional Data Needed? MRID Nos.

860.1200: Directions for Use N/ A = Not Applicable No None 860.1300: Nature of the Residue  Plants  Bananas N/ A No 00025731, 00025734 860.1300: Nature of the Residue  Animals N/ A No None 860.1340: Residue Analytical Method  Plant Commodities N/ A No 00025716, 00071187  Animal Commodities N/ A No None 860.1360: Multiresidue Method N/ A No1 None 860.1380: Storage Stability Data  Plant Commodities N/ A Yes2 None  Animal Commodities N/ A No None 860.1400: Magnitude of the Residue  Water, Fish, and Irrigated Crops None established No None 860.1460: Magnitude of the Residue  Food Handling None established No None 860.1480: Magnitude of the Residue  Meat, Milk, Poultry, and Eggs None established No None 860.1500: Crop Field Trials  Bananas 0.2 [ 180.457] Yes3 00071186, 00071188, 00114273 860.1520: Processed Food/ Feed None established No None 860.1650: Submittal of Analytical Reference Standards N/ A Yes None 860.1850: Confined Accumulation in Rotational Crops N/ A No None 860.1900: Field Accumulation in Rotational Crops None established No None 1. There was no information in the review documents regarding submittal of data for FDA multiresidue methods by the petitioner. However, the FDA PESTDATA database dated 11/ 2001 ( PAM Volume I, Appendix I) indicates that bitertanol was completely recovered using Multiresidue Method Section 302 ( Protocol D). 2. Storage stability data for bitertanol in/ on bananas have not been submitted by the registrant, therefore, storage stability data are required ( HED SOP 98.6). No information on the stability of residues in/ on bananas during cold storage have been submitted. Additionally, no data were provided on how long the samples were stored from the submitted field trial studies conducted on bananas prior to analysis. 3. Additional data are required in order for the submitted field trials conducted in Costa Rica and Honduras to be acceptable. The number of trials, location of the trials within the countries, and the formulation type used. New field trial data are required for the SC formulation. 4. Analytical reference standards must be replenished as requested by the Repository.

860.1300 Nature of the Residue  Plants The nature of the residue in plants is adequately understood based on acceptable metabolism Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 8 of 17 studies on apples and peanuts. The residues consisted primarily of the parent compound with traces of the metabolites bitertanol ketone and 4 hydroxybiphenol. The Agency concluded that the residue of concern is the parent ( E. Zager, PP# 0G2311, 6/ 30/ 1980).

Apple ( MRID 00025731)

Golden Delicious variety apples were individually syringe treated to run off with a 50% wettable powder formulation at 0.015 g ai/ 100 mL ( 2 oz ai/ 100 gallons of water) of 14C bitertanol labeled uniformly in the biphenyl ring. Sampling ( 6 9 apples) was immediately after drying, at 3, 7, 14, 23, 35, 42, and 49 days. The apples were initially subjected to several methanol rinses. The rinses were collected and analyzed. The apples were then separated into peel and pulp, portions of which were separately homogenized in liquid nitrogen. Subsamples of each portion were analyzed for total activity. Analysis was by thin layer chromatography ( TLC) using radiochromatogram scanning and autoradiography techniques.

The peel contained 95% of the total recovered radioactivity even after 49 days, the rest being in the pulp, showing that little migration had occurred. Surface residues decreased from 92% at day 0 to 43% at 49 days while the radioactivity in the peel organic extract increased from 7% to 44% of the total. Peel solids increased to 12% in the same interval, indicating some binding had occurred.

The two diasterioisomers of bitertanol were the major residues, in roughly equal proportions throughout the 49 day study. The level of the two combined in peel and pulp ranged from 98% of the total radioactivity at day 0 to 83% at 49 days, with lower surface residues and greater peel uptake by the end of that time. The two had penetrated the pulp by day 7 from which time residues were relatively constant at about 3% over the remaining test period. Minor metabolites were bitertanol ketone and 4 hydroxybiphenyl, together never exceeding 3% of the total radioactivity. Both of the metabolites were found in the peel. The half life of bitertanol in this experiment was estimated at approximately 150 days.

Peanut ( MRID 00025734)

To investigate the fate of bitertanol in peanuts, bitertanol labeled in the biphenyl ring system was applied to peanut plant leaves; to 1 month old peanut plants; to 2 month old peanut plants which were grown to maturity; and to the nutrient solution of growing peanut plants.

Peanut plant leaflets were treated with 14C bitertanol and samples were taken at 3 and 14 days. At sampling the treated leaves were rinsed with methanol and subsequently extracted with dichloromethane and ACN. After 3 days, 1.7% of the applied 14C bitertanol was absorbed, nearly all of which was identified as bitertanol by TLC. After 14 days, 3% of the applied 14C bitertanol was found in the extract of the rinsed leaves, 82% of which was bitertanol and 14% unidentified polar material. The remainder of the applied 14C bitertanol was recovered in the methanol rinse and consisted of 96% bitertanol. Total recoveries at each interval were 100 101%. This evidence shows that foliar application result in poor leaf absorption ( 96% unchanged bitertanol on the leaf surface after 14 days), with no observable volatility losses. Only very little translocation was observed, as well as little translocation to opposite leaves. Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 9 of 17 In another study, 14C bitertanol uniformly labelled in the biphenyl ring was sprayed as a 50% WP formulation to both 1 month and 2 month old potted peanut plants at an approximate equivalent field rate of 2.7 lbs ai/ A. Young plants were sampled at 12 and 28 days after treatment and the older plants and nuts after 10 weeks. In the 1 month old plants, after 12 days 72% and after 28 days 61% of the total recovered radioactivity was surface residue, the remainder were extractable residues ( 28% at 12 days and 39% at 28 days). In the 2 month old plants the distribution was 46% surface and 50% extractable.

In the 1 month peanut plants, bitertanol comprised 93% and 86% of the total residue at 12 days and 28 days, respectively. Metabolite R 1, apparently a glucoside of bitertanol, constituted 2 4% of the total residue. Traces ( 0.6%) of the metabolite 4 hydroxybiphenyl were found in extracted shoot solids of the 28 day sample. Little movement of 14C was observed from shoots to roots of the peanut plants.

In the 2 month peanut plants, residues in the foliage were 16.8 ppm bitertanol equivalent, with 75% of the plant residue actually identified as bitertanol. Metabolite R 1 constituted 6% of the residue and several other polar metabolites were observed with none constituting more than 1% of the residue. Residues in nut meats were 0.06 ppm bitertanol equivalent, which is 0.008% of the total plant residue.

In the root uptake study, young peanut plants were grown for 7 days in a nutrient solution fortified with biphenyl labeled 14C bitertanol at 1 ppm followed by 7 days in an unfortified nutrient solution. A total of 94% of the administered radioactivity was recovered with 29% in the roots, 15% in the shoots, 40% in the fortified nutrient solution, and 11% in the non fortified solution. Bitertanol constituted a total ( roots and shoots) of 56% of the absorbed 14C while the metabolite R 1 ( glucoside of bitertanol) accounted for 16%. Unextracted shoot solids were reacted with HI which released 9% of absorbed 14C as 4 hydroxybiphenyl. Radioactivity was concentrated in the veins, but distributed throughout the plant. No translocation to new growth occurred after removal of the fortified solution. Radioactivity in the non fortified solution suggests desorption from within or from the surface.

Additional metabolism studies conducted with apples, cotton, and tomatoes have been submitted and are under review by the Agency. The apple ( Report No. 94373, 3/ 16/ 1987) and cotton ( Report No. 94382, 4/ 13/ 1987) metabolism studies were conducted with 14C bitertanol labeled in the triazole ring. The tomato ( Report No. M1731133 9, 1/ 15/ 2003) metabolism studies were conducted with 14C bitertanol labeled in the triazole ring and in the phenyl ring.

The apple metabolism study shows that bitertanol is slowly metabolized when 14C bitertanol labeled in the triazole ring is applied as the 50% WP at a field rate of 2 oz ai/ 100 gallons of water to apple fruit ( less than 5% degradation in 49 days). All samples were radioassayed for 14C content by liquid scintillation counting ( LSC). Quantitation of the parent and metabolites was achieved by LSC and identified by TLC and high performance liquid chromatography ( HPLC). There was very little penetration of bitertanol into the fruit pulp throughout the 49 day sampling interval. The majority of the radiocarbon ( 91 98%) was located in the methanol rinse of the bag and fruit at every time interval. From 2 to 9% of the total residues were found to be associated with the washed peel fraction, i. e. not removed by the methanol rinse. No more than 1.5% was Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 10 of 17 found associated with the pulp fraction at any sampling interval with no trend toward increased residues over time. The majority of organoextractable residues from peel and pulp were identified as bitertanol with only 0.4 2% of the total residues being identified in the organosoluble fractions. Therefore, 96 99% of the total recovered residues were identified as intact parent bitertanol. An additional 0.1 0.5% of the total residue was unidentified as water soluble components.

The cotton metabolism study was conducted with 14C bitertanol labeled in the triazole ring is applied as the 50% WP at a field rate of 250 g ai/ ha in a volume of 300 liters to cotton plants at early bloom stage. An identical second treatment was made 14 days following second treatment. Samples were collected following the second treatment and at 7, 21, 35, and 63 days following the second application. Whole plants were stored frozen pending processing and analysis for 0 through 35 day intervals. The 63 day interval plants ( mature sample) were separated into foliage, lint, calyx, seed, and hull and the comments also stored frozen pending processing and analysis. All samples were radioassayed for 14C content by liquid scintillation counting ( LSC). Quantitation of the parent and metabolites was achieved by LSC and identified by TLC and HPLC. In mature cotton plants 63 days after the second application of 14C bitertanol 91% of the total recovered radioactivity was associated with the foliage portion of the plant; 6% was associated with the calyx fraction; 1.3%, 1%, and 1% were associated with the lint, seed, and hull respectively. The majority of the recovered radiocarbon was was identified as intact bitertanol, amounting to a total of 79% of the mature harvest interval residue. The relative concentration of bitertanol isomers remained constant throughout the study period. There were trace amount of bitertanol acid and two metabolites tentatively identified as R 1 and R 2 present in the more mature time intervals, collectively accounting for 1.3% and 0.3% of the 35 day and 63 day interval samples respectively.

The metabolism of bitertanol was investigated in tomatoes following three spray applications at 600 g ai/ ha for a total of 1800 g ai/ ha. The active ingredient was 14C bitertanol labeled in the triazole and was formulated as a SC. The first application was performed when mainly small tomatoes were visible and a few flowers were still open. The treatment was performed when most of the fruits had reached ca. 50% of the final size. The third treatment was three days before harvest, when ca. 30% of the tomatoes showed the typical ripe color. All samples were radioassayed for 14C content by LSC. Quantitation of the parent and metabolites was achieved by HPLC and identified by LC/ MS, LC/ MS/ MS, and 1H NMR spectroscopy experiments. The total radioactive residue ( TRR) in tomatoes amounted for to 7.76 mg/ kg, expressed as parent compound equivalents. Most of the radioactivity ( 97%) was extracted by surface wash with methanol. After homogenisation of the tomatoes and extraction with acn/ water the residues were extracted quantitatively ( 99%). Unchanged parent compound accounted for 99% of the TRR. Two minor metabolites < 0.1% were also detected, but due to the low portion of the TRR, they were not further analyzed. Judged by HPLC, the ratio of the two diasterioisomers of bitertanol remained nearly unchanged during the course of the study.

The other tomato study was conducted in the same way as noted above, however, the active ingredient was 14C bitertanol labeled in the phenyl ring. The TRR amounted to 8.19 mg/ kg, expressed as parent compound equivalents. Most of the radioactivity ( 96%) was extracted by surface wash with methanol. After homogenisation of the tomatoes and extraction with acn/ water the residues were extracted quantitatively ( 99.6%). Unchanged parent compound accounted for 99.5% of the TRR and only a very small amount was detected as a metabolite (< 0.1%). Judged Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 11 of 17 by HPLC, the ratio of the two diasterioisomers of bitertanol remained nearly unchanged during the course of the study.

In the plant studies bitertanol penetration from surface applications was minimal and there was little volatility. Residues are taken up by roots, although translocation into the plant is relatively low. There are some measurable but not major differences in absorption, translocation, and plant metabolism rates of the two diasterioisomeric forms of bitertanol. Bitertanol is by far the main plant residue, with low levels of bitertanol ketone and 4 hydroxybiphenyl.

No metabolism studies for bananas were submitted. However, HED has concluded that the nature of residues in bananas is likely similar to that in apples, cotton, tomatoes, and peanuts. Therefore, HED has determined that the bitertanol residues of concern in/ on bananas for tolerance expression and for risk assessment are bitertanol.

Additionally, the Agency does have concern about the potential toxicity of 1,2,4 triazole and two conjugates, triazole alanine and triazole acetic acid, which are metabolites common to most of the triazole fungicides. To support the extension of existing and granting of new parent triazolederivative fungicide tolerances, the Agency will be conducting a human health assessment for aggregate exposure to 1,2,4 triazole.

860.1300 Nature of the Residue  Livestock Bitertanol is not intended for application to livestock exported to the U. S. In addition, there are no feedstuffs associated with bananas. Therefore, no residue chemistry data are required under this guideline topic.

860.1340 Residue Analytical Methods An analytical method for analysis of residues of bitertanol was submitted and reviewed in PP# 2E2756. The submitted method is a modification of Mobay Chemical Corporation's Method 54166 for the analysis of Baycor ® in apples. The modified method employs different gas chromatography ( GC) parameters and column packing than the original Method 54166. The modified method consists of extracting the residues by blending successively with acetone followed by dichloromethane. The samples are then shaken three times with water in a separatory funnel. The water is discarded and the organic phase is collected, evaporated, and cleaned up using a Florisil column. Analysis is by GC using a nitrogen/ phosphorus flame ionization detector ( NPD). The method was validated by the Biological and Economic Analysis Division's ( BEAD) Analytical Chemistry Branch ( ACB) and the limit of quantitation was determined at 0.1 ppm ( A. Burns, PP# 2E2756, 3/ 22/ 1983). The method trial was successfully performed on banana pulp and peels at fortification levels of 0.1 ppm and 0.2 ppm. Recoveries ranged from 78 to 88% for pulp samples, and from 70 to 98% for peel samples. The method was approved by the Agency for the enforcement of a tolerance in/ on bananas and the results were forwarded to FDA for inclusion in PAM Volume II as Method I for bitertanol ( M. Bradley, 9/ 15/ 92). The method has been received by FDA, however, it has not been compiled into PAM Volume II as of yet.

860.1360 Multiresidue Methods Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 12 of 17 There was no information in the review documents regarding submittal of data for FDA multiresidue methods by the petitioner. However, the FDA PESTDATA database dated 11/ 2001 ( PAM Volume I, Appendix I) indicates that bitertanol was completely recovered using Multiresidue Method Section 302 ( Protocol D).

860.1380 Storage Stability Storage stability data for bitertanol in/ on bananas have not been submitted by the registrant, therefore, storage stability data are required ( HED SOP 98.6). No information on the stability of residues in/ on bananas during cold storage have been submitted. Additionally, no data were provided on how long banana samples from the submitted field trials were stored prior to analysis.

860.1400 Water, Fish, and Irrigated Crops Bitertanol is not intended for direct use on water and aquatic food and feed crops; therefore, no residue chemistry data are required under this guideline topic.

860.1460 Food Handling Bitertanol is not intended for use in food handling establishments; therefore, no residue chemistry data are required under this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs Bitertanol is not intended for application to livestock exported to the U. S. In addition, there are no animal feedstuffs associated with bananas. Therefore, no residue chemistry data are required under this guideline topic.

860.1500 Crop Field Trials Residue data for bananas grown in Costa Rica and Honduras were provided by the petitioner. The petitioner indicated that these two countries are the only ones where bitertanol would be used. Bitertanol was applied to both bagged and unbagged bunches of green and ripe bananas at a rate of 4.2 oz ai/ A/ application, the maximum rate indicated in the product label. Samples of peel, pulp, and whole fruit were collected 3 days after the last of 9 treatments and 0 days after the last of 12 treatments. Washed and unwashed samples were analyzed for bitertanol by Method 54166, with modifications. No data were provided on how long the samples were stored prior to analysis. Control samples of washed or unwashed green peel, ripe peel, green pulp, and ripe pulp had no detectable (< 0.01 ppm) residues of bitertanol. Recoveries for control samples of peel and pulp from green and ripe bananas fortified at levels of 0.02  0.10 ppm were 56 to 120% ( A. Smith, PP# 2E2756, 1/ 28/ 83).

Residue data were reported for both washed and unwashed samples of bagged and unbagged bananas. The results are summarized below in Table 7. All residues identified in the bagged samples were below the tolerance level of 0.2 ppm. In the bagged banana trials, after 9 applications of bitertanol, the highest residue in a washed sample was 0.5 ppm ( green and ripe Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 13 of 17 peel) and the highest residue in an unwashed sample was 0.01 ppm ( green pulp). After 12 applications of bitertanol, the highest residue in a washed sample was 0.15 ppm ( green peel) and the highest residue in an unwashed sample was 0.12 ppm ( ripe peel). Residues were detected above the tolerance level of 0.2 ppm in the unbagged samples. In the unbagged banana trials, the highest residues detected after 9 applications were 0.45 ppm ( ripe peel) in washed samples and 0.53 ppm ( green peel) in unwashed samples. After 12 applications, the highest residues detected were 0.73 ppm ( green peel) in washed samples and 0.76 ppm ( green peel) in unwashed samples. With few exceptions, residues were higher in washed samples than in unwashed samples for both bagged and unbagged bananas. No explanation was provided for the higher residues found in washed samples.

The petitioner originally had requested the establishment of a tolerance for residues of bitertanol at 0.5 ppm. However, based on the results of the field trials, HED concluded that a tolerance of 0.5 ppm was excessive and recommended that a tolerance of 0.2 ppm be proposed ( A. Smith, Memorandum, 1/ 28/ 83). The petitioner submitted a revised tolerance petition proposing a tolerance for residues of bitertanol of 0.2 ppm, which was later accepted by HED ( A. Smith, PP# 2E2756, 9/ 14/ 83). In order to harmonize with Codex, the established tolerance should be increased to 0.5 ppm.

It is noted that the number of trials, location of the trials within the countries were not specified, and the formulation type was not specified. The petitioner had originally proposed the use of a 50% WP and a 30% emulsifiable concentrate ( Baycor ® 300 EC). The use of the emulsifiable concentrate formulation was later withdrawn by the registrant ( G. E. Brussell, PP# 2E2756, 10/ 13/ 83).

At the time the import tolerance for bitertanol on bananas was established, HED provided caseby case advice on adapting data requirements for field trials to import situations. Since then, guidance on data requirements for import tolerance petitions has been issued. In the Federal Register of June 1, 2000 ( 65 FR 35069; FRL 6559 30), EPA provided detailed guidance on applying current U. S. data requirements for the establishment or continuance of tolerances for pesticide residues in or on imported foods. In addition, in 2003, Canada, Mexico and the United States jointly issued a guidance document on the data requirements needed to meet the North American Free Trade Agreement ( NAFTA) standards for the establishment of pesticide import tolerances or maximum residue levels in the NAFTA countries ( 68 FR 18638; FRL 7299 1). The NAFTA guidance document is consistent with the 2000 U. S. guidance. In general, the residue chemistry requirements for import tolerances listed in the NAFTA guidance document are similar to those for any other tolerance issued by the NAFTA countries. However, the NAFTA guidance document details a procedure for determining the minimum number and location of field trials, based on the maximum consumption of the commodity as a percentage of the U. S., Canadian, or Mexican diet, and the maximum relative amount imported into the U. S., Canada, or Mexico from outside of North America. The NAFTA guidance document also indicates that field trials generally will need to be conducted in all countries whose exports comprise at least 5% of the total amount of a specific commodity imported into any of the North American countries where a tolerance is being sought. It is noted that the field trials currently being conducted with the SC formulation should adhere to all guidance documents. Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 14 of 17 Table 7. Summary of Residues from the Crop Field Trials with Bitertanol.

Crop Matrix Applic. Rate ( lb ai/ A) Number of Applications PHI ( days) Residues ( ppm)

Bagged Unbagged Washed samples Unwashed samples. Washed samples Unwashed samples.

Green peel 4.2 oz ai/ A 9 3 0.05 < 0.01 0.41 0.53 Green pulp 0.01 0.01 0.09 0.11 Green fruit 0.03 < 0.01 0.22 0.24 Ripe peel 0.05 < 0.01 0.45 0.25 Ripe pulp 0.02 < 0.01 0.11 0.06 Ripe fruit 0.03 < 0.01 0.23 0.13 Green peel 4.2 oz ai/ A 12 0 0.05, 0.15 0.04 0.09 0.73 0.10 0.76 Green pulp 0.01, 0.02 0.01 0.03, 0.17 0.03, 0.08 Green fruit 0.03, 0.06 0.02 0.05, 0.36 0.06 0.33 Ripe peel 0.03 0.08 0.03 0.12 0.05, 0.51 0.03 0.32 Ripe pulp < 0.01, 0.02 0.01 0.02, 0.14 < 0.01, 0.08 Ripe fruit 0.01 0.04 0.02 0.05 0.03 0.28 0.01 0.17 860.1520 Processed Food and Feed There are no processed commodities associated with bananas. Therefore, no residue chemistry data are required under this guideline topic.

860.1650 Submittal of Analytical Reference Standards An analytical reference standard for bitertanol was submitted by Bayer in December of 2004 and expires October of 2010. The standard is available at the EPA National Pesticide Standards Repository.

860.1850 Confined Accumulation in Rotational Crops Rotational crop studies are not required for uses of pesticides on bananas ( HED SOP 96.6).

860.1900 Field Accumulation in Rotational Crops Rotational crop studies are not required for uses of pesticides on bananas ( HED SOP 96.6).

Tolerance Reassessment Summary The tolerance for residues of bitertanol in/ on plant commodities is expressed in terms of residues of bitertanol per se [$([ 1,1 ' biphenyl] 4 yloxy)"( 1,1 dimethylethyl) 1H 1,2,4 triazole 1 Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 15 of 17 ethanol].

A summary of the bitertanol tolerance reassessment for bananas is presented in Table 8.

Tolerances Listed Under 40 CFR § 180.457:

A tolerance has been established under 40 CFR § 180.457 for residues of bitertanol in/ on bananas imported into the U. S. Field trials conducted in Costa Rica and Honduras showed residues below the existing tolerance level of 0.2 ppm. In order to harmonize with Codex, the established tolerance should be increased to 0.5 ppm.

Since the tolerance for bitertanol is an import tolerance, it should be listed in a separate subsection of 40 CFR indicating that there are no U. S. registrations for bitertanol.

Table 8. Tolerance Summary for Bitertanol.

Commodity Established/ Proposed Tolerance ( ppm) Recommended Tolerance ( ppm) Comments [ correct commodity definition]

Banana ( whole) 0.20 ( established) 0.5 Tolerance should be listed in a separate subsection of 40 CFR indicating that there are no U. S. registrations associated with bitertanol. [ Banana]

Codex/ International Harmonization The Codex Alimentarius Commission has established a maximum residue limit ( MRL) for bitertanol residues in/ on bananas at 0.5 mg/ kg. The Codex MRL for bitertanol is expressed in terms of residues of bitertanol only, as is the U. S. tolerance expression. Various enforcement methods are listed for bitertanol under the Codex system including PAM Multiresidue Method Section 302 ( Protocol D).

It is EPA's policy to harmonize its tolerances with the levels established by Codex provided that the Agency has sufficient information to make a determination that the Codex MRLs will be protective of the health of the U. S. public and meet FFDCA standards. FQPA requires EPA to publish a notice for public comment whenever the Agency establishes a tolerance that differs from an established Codex MRL. The established tolerance should be reassessed to 0.50 ppm to harmonize with Codex as the dietary exposure and risk are not of concern ( S. Ary, D302880, 11/ 2/ 2005).

Bibliography NAFTA Guidance Document on Data Requirements for Tolerances on Imported Commodities. April 2003. ( http:// yosemite. epa. gov/ opp/ naftatwg. nsf/ 0/ ff1cbe90259cd6b985256d0900705b7e/$ FILE/ NAFT A% 20Import% 20Tolerances% 20Document. PDF) Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 16 of 17 65 FR 35069. Pesticides; Guidance on Pesticide Import Tolerances and Residue Data for Imported Food; Request for Comment. June 1, 2000 ( Volume 65, Number 106). ( http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ June/ Day 01/ p13708. htm)

68 FR 18638. Pesticides; North American Free Trade Agreement Guidance Document on Requirements for Tolerances on Imported Commodities; Notice of Availability. April 16, 2003 ( Volume 68, Number 73). ( http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2003/ April/ Day 16/ p9338. htm)

HED Standard Operating Procedure ( SOP) 98.6. Data requirements for Import Tolerances ( 12/ 3/ 1998).

Study Citations Table 9. Agency Memoranda Citations.

Date Barcode ID Number From To MRID Nos. Subject 6/ 30/ 1980 PP# 0G2311 E. Zager H. M. Jacoby 00025731, 00025734, 00025716, 00071187 PP# 0G2311. Baycor ® on apples, pears and peanuts. Evaluation of Analytical Methods and Residue Data.

1/ 28/ 1983 PP# 2E2756 A. Smith H. M. Jacoby 00071186, 00071188, 00114273 PP# 2E2756: Baycor ® in Bananas. Evaluation of residue data and analytical method.

3/ 22/ 1983 PP# 2E2756 A. Burns A. Smith 00025716, 00071187 Report on Method trial.

4/ 27/ 1983 PP# 2E2756 A. Smith H. M. Jacoby/ Toxicology Branch 00025716, 00071187 PP# 2E2756: Baycor ® in Bananas. Report on Method trial.

8/ 10/ 1983 PP# 2E2756 G. E. Brussell Mobay Chemical Corporation H. M. Jacoby Baycor ® 50% Wettable Powder and Baycor ®

300 EC. Pesticide Petition No. 2E2756. Tolerance for Baycor ® in or on Bananas.

9/ 14/ 1983 PP# 2E2756 A. Smith H. M. Jacoby PP# 2E2756: Baycor ® in Bananas. Amendment of 5/ 26/ 83.

10/ 13/ 1983 PP# 2E2756 G. E. Brussell Mobay Chemical Corporation H. M. Jacoby Baycor ® on Bananas. Pesticide Petition No. 2E2756 9/ 15/ 1992 M. Bradley A. Marcotte FDA Letter to FDA. Submission of Method I for bitertanol for inclusion in PAM Volume II.

11/ 2/ 2005 D302880 S. Ary C. Jarvis and R. Louie Bitertanol. Acute and Chronic Dietary Exposure Assessments for the Tolerance Reassessment Eligibility Decision ( TRED) Document.

Master Record Identification Numbers 00025716 Obrist, J. J.; Nichols, S. S. ( 1979) An Interference Study for the Baycor( TM) Residue Method for Apples and Peanuts: Report No. 68311. ( Unpublished study received Dec 21, 1979 under 3125 EX 168; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 099186 F)

00071187 Obrist, J. J.; Nichols, S. S. ( 1980) An Interference Study for the Baycor( TM) Residue Method for Apples and Peanuts: Report No. 68311. Rev. ( Unpublished study received Feb 2, 1981 under 1E2468; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 099905 C) Bitertanol Summary Analytical Chemistry and Residue Data DP Barcode: 302882 17 of 17 00025731 Puhl, R. J.; Hurley, J. B. ( 1979) The Metabolism of Baycor( TM) biphenyl UL 14C in Apple Fruit: Report No. 68305. ( Unpublished study received Dec 21, 1979 under 3125 EX 168; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 099185 O)

00025734 Puhl, R. J.; Hurley, J. B. ( 1979) Metabolism of Baycor( TM) biphenyl UL 14C in Peanut Plants: Report No. 68310. ( Unpublished study received Dec 21, 1979 under 3125 EX 168; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 099185 R)

00071186 Mobay Chemical Corporation ( 1980) Synopsis of Baycor: Residue Chemistry on Bananas. Summary of studies 099905 C and 099905 D. ( Unpublished study received Feb 2, 1981 under 1E2468; CDL: 099905 A)

00071188 Mobay Chemical Corporation ( 1980) ( Residue of Baycor ( TM): Bananas): Report No. 68896. ( Compilation; unpublished study, including report nos. 68897, 68898, 68899 received Feb 2, 1981 under 1E2468; CDL: 099905 D)

00114273 Mobay Chemical Corp. ( 1982) Addition No. 1 to the Brochure Entitled: Baycor Residue Chemistry on Bananas: Document No. AS 82 2104. ( Compilation; unpublished study received Sep 15, 1982 under 2E2756; CDL: 071088 A)


[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25337-25338]
[FR Doc No: 2022-09016]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0182]

Qualification of Drivers; Exemption Applications; Narcolepsy

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of denial.

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

SUMMARY: FMCSA announces its decision to deny the application from one
individual who requested an exemption from the Federal Motor Carrier
Safety Regulations (FMCSRs) prohibiting operation of a commercial motor
vehicle (CMV) in interstate commerce by persons with either a clinical
diagnosis of epilepsy or any other condition that is likely to cause a
loss of consciousness or any loss of ability to control a CMV.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing materials in the docket, contact Dockets Operations, (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2021-0182, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. 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.

II. Background

    On December 16, 2021, FMCSA published a Federal Register notice (86
FR 71537) announcing receipt of an application from one individual with
a diagnosis of narcolepsy and requested comments from the public. The
individual requested an exemption from 49 CFR 391.41(b)(8) which
prohibits operation of a CMV in interstate commerce by persons with
either a clinical diagnosis of epilepsy or any other condition that is
likely to cause a loss of consciousness or any loss of ability to
control a CMV. The public comment period closed on January 18, 2022,
and one comment was received.
    FMCSA has evaluated the eligibility of the applicant and concluded
that granting an exemption would not provide a level of safety that
would be equivalent to, or greater than, the level of safety that would
be obtained by complying with Sec.  391.41(b)(8). A summary of the
applicant's medical history related to the narcolepsy exemption request
was discussed in the December 16, 2021, Federal Register notice and
will not be repeated here.
    The Agency considered information from the 2009 Evidence Report,
``Narcolepsy (with and without cataplexy) and Commercial Motor Vehicle
Driver Safety,'' and the January 2010 Medical Review Board (MRB)
recommendation that individuals with narcolepsy be ineligible for a
commercial driver's license, even with treatment. A copy of the
Evidence Report is included in the docket.
    Narcolepsy is a chronic neurological disorder caused by autoimmune
destruction of hypocretin-producing neurons inhibiting the brain's
ability to regulate sleep-wake cycles normally. Persons with narcolepsy
experience frequent excessive daytime sleepiness, comparable to how
individuals without narcolepsy feel after 24 to 48 hours of sleep
deprivation, as well as disturbed nocturnal sleep, which is often
confused with insomnia. See National Institutes of Health Narcolepsy
Fact Sheet at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Narcolepsy-Fact-Sheet.
    The 2009 Evidence Report, ``Narcolepsy (with and without cataplexy)
and Commercial Motor Vehicle Driver Safety,'' addressed whether or not
individuals with narcolepsy are at an increased risk for motor vehicle
crashes; whether or not currently recommended treatments for

narcolepsy reduce the risk for motor vehicle crashes; and the impact of
various medication therapies for narcolepsy on driver safety.
    The evidence report reviewed studies from the available literature
and evaluated outcomes on measures of Excessive Daytime Sleepiness
(EDS), cataplexy, event rate, measures of cognitive and psychomotor
function, and driving performance. The currently available direct and
indirect evidence supports the contention that drivers with narcolepsy
are at an increased risk for a motor vehicle crash when compared to
otherwise similar individuals who do not have the disorder. The direct
evidence from three crash studies conducted of non-CMV drivers showed
that individuals with narcolepsy are at an increased risk for a crash
compared to individuals who do not have narcolepsy. The indirect
evidence from studies of driving tests and driving simulation examined
factors associated with simulated driving outcomes such as driving
performance, tracking error, fewer correct responses, and more
instances of going out of bounds compared to healthy controls. While
there are limitations in the quality of the studies that examined
direct crash risk, both the direct and indirect studies showed a strong
effect size and statistical significance. The American Academy of Sleep
Medicine (AASM) and the European Federation of Neurological Societies
recommend modafinil as the first treatment option and methylphenidate
as the second treatment option. The AASM also recommends amphetamine,
methamphetamine, or dextroamphetamine as alternative treatments. During
literature searches, no studies that directly examined the impact of
treatment with modafinil, armodafinil, sodium oxybate (used with
narcolepsy with cataplexy), or anti-depressants on crash risk or
driving performance were identified. Therefore, conclusions regarding
treatment with these medications on crash risk and driving performance
could not be made.
    Currently available evidence suggests that amphetamines and/or
methylphenidate are effective in improving symptoms of EDS in
individuals with narcolepsy (quality of studies range from ``moderate
to low''). However, these improvements do not result in levels of
daytime sleepiness that can be considered to be normal in the vast
majority of individuals. Therefore, conclusions regarding to the impact
of treatment with amphetamines, methylphenidate, or other related
stimulant drugs on cognitive and psychomotor function among individuals
with narcolepsy could not be made.
    In January 2010, the FMCSA's MRB recommended that individuals with
narcolepsy be ineligible for a commercial driver's license, even with
treatment.

Discussion of Comments

    FMCSA received one comment in this proceeding from a private
citizen who did not support granting an exemption in the interest of
public safety and the applicant's well-being. The commenter cites that
the applicant's medical provider states that the applicant's current
treatment has proven effective and that treatment continues without
explicit determination by the medical provider that the current regimen
has sufficiently remedied the applicant's medical condition such that
it would not interfere with the ability to drive a CMV in the future.
FMCSA acknowledges the commenter's concern. When evaluating a medical
exemption application request, FMCSA considers the applicant's relevant
medical information, however the Agency does not make a decision to
grant or deny a medical exemption solely on the basis of an applicant's
medical documentation.

III. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption.
    The Agency's decision regarding this exemption application is based
on an individualized assessment of the applicant's medical information,
available medical and scientific data concerning narcolepsy, and any
relevant public comments received.

IV. Conclusion

    The Agency has determined that the available medical and scientific
literature and research provides insufficient data to enable the Agency
to conclude that granting this exemption would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, the following applicant has been
denied an exemption from the physical qualification standards in Sec.
391.41(b)(8):

Sheila Bennett (TN)

    The applicant has, prior to this notice, received a letter of final
disposition regarding their exemption request. The decision letter
fully outlined the basis for the denial and constitute final action by
the Agency. The name of the individual published in this notice
summarizes the Agency's recent denials as required under 49 U.S.C.
31315(b)(4).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-09016 Filed 4-27-22; 8:45 am]
BILLING CODE 4910-EX-P


ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [ EPA R03 OAR 2006 0607; FRL ]

Approval and Promulgation of Air Quality Implementation Plans; Maryland; State Implementation Plan Revision for American Cyanamid Company, Havre de Grace, Maryland AGENCY: Environmental Protection Agency ( EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve a State Implementation Plan ( SIP) revision submitted by the State of Maryland. This revision pertains to the removal of an August 2, 1984 Secretarial Order ( Order) from the Maryland SIP. The Order constituted a Plan for Compliance ( PFC) and an alternative method of assessing compliance at an American Cyanamid Company ( Company) facility located in Havre de Grace, Harford County, Maryland ( the Facility). The Order allowed for certain volatile organic compound ( VOC) emissions sources at the Facility to achieve compliance with emissions limits through averaging ( or " bubbling") of emissions over a 24 hour period. Removal of the Order from the SIP will remove the " bubbling" compliance option for these sources at the Facility. In lieu of " bubbling," the sources must comply with the approved and more stringent Maryland SIP provisions for the control of VOC emissions, which do not allow averaging or " bubbling." This action is being taken under the Clean Air Act ( CAA or the Act).

DATES: Written comments must be received on or before [ insert date 30 days from date of publication]. 2 ADDRESSES: Submit your comments, identified by Docket ID Number EPA R03 OAR

2006 0607 by one of the following methods:

A. www. regulations. gov. Follow the on line instructions for submitting comments.

B. E mail: morris. makeba@ epa. gov C. Mail: EPA R03 OAR 2006 0607, Makeba Morris, Chief, Air Quality Planning and Analysis Branch, Mailcode 3AP21, U. S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D. Hand Delivery: At the previously listed EPA Region III address. Such deliveries are only accepted during the Docket =

s normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No. EPA R03 OAR 2006 0607. EPA's policy is that all comments received will be included in the public docket without change, and may be made available online at www. regulations. gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www. regulations. gov or e mail. The www. regulations. gov website is an " anonymous access" system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e mail comment directly to EPA without going through www. regulations. gov, your e mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other 3 contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the electronic docket are listed in the www. regulations. gov index.

Although listed in the index, some information is not publicly available, i. e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form.

Publicly available docket materials are available either electronically in www. regulations. gov or in hard copy during normal business hours at the Air Protection Division, U. S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Maryland Department of the Environment, 1800 Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Neil Bigioni, ( 215) 814 2781, or by e mail at bigioni. neil@ epa. gov.

SUPPLEMENTARY INFORMATION: On May 17, 2006, the Maryland Department of the Environment submitted a revision to its SIP entitled " Removal of the 1984 American Cyanamid Company Secretarial Order from Maryland's State Implementation Plan." The request was for the removal of a Secretarial Order ( by Consent) currently incorporated into the Maryland SIP. 4 EPA is proposing to approve Maryland's requested SIP revision removing the Order from the SIP.

I. Background EPA published a final rule on May 16, 1990 ( 55 FR 20269), approving the Order issued to the Company's adhesive manufacturing facility in Havre de Grace, Maryland ( the Facility), as a revision to the Maryland SIP. The Order provided the Company with a PFC and an alternative method of assessing compliance for certain installations located at the Facility by allowing the averaging or " bubbling" of the emissions of VOC over a 24 hour period. By allowing " bubbling" of VOC emissions the Company could over control emissions at some units and under control at other units such that the overall emissions from the sources collectively would be the same as those that would be achieved utilizing traditional control strategies at each source.

The VOC sources where " bubbling" was allowed at the Facility were components of the Facility's paper and fabric adhesive coating operation, and included Towers 2, 3, and 5 and the FM 1000 coater/ dryer.

Since EPA's May 16, 1990 approval of the Order as a SIP revision the Facility has been acquired by Cytec Engineered Materials, Inc. ( Cytec).

II. Summary of SIP Revision EPA is proposing to approve this SIP revision submitted by the State of Maryland. The revision will remove the Order from the Maryland SIP. Removal of the Order from the SIP will subject the VOC emissions sources at the Facility that formerly subject to the " bubbling" provisions of the Order to the Maryland VOC regulations and limits codified at Code of Maryland Regulations 5 ( COMAR) <IP_ADDRESS>. Those COMAR regulations are part of the Maryland SIP. ( 65 FR 2334,

January 14, 2000). The materials submitted by Maryland in support of the SIP revision indicate that the Facility currently intends to comply with the SIP approved VOC limits by reducing VOC emissions through use of a regenerative thermal oxidizer, as allowed by COMAR <IP_ADDRESS>B( 2)( b)( ii) and the Maryland SIP ( 68 FR 9012, February 27, 2003). This proposed SIP revision will remove the current ability for Cytec to comply with VOC emissions limits for the sources subject to the Order through averaging or " bubbling" of VOC emissions. The SIPapproved limits codified at COMAR <IP_ADDRESS>C do not allow for compliance through averaging/" bubbling." The applicable COMAR <IP_ADDRESS>C limits of 2.9 pounds of VOC per gallon of coating as applied ( minus water), are also more stringent than the emissions limit of 3.2 pounds of VOC per gallon of coating as applied ( minus water) imposed by the Order.

III. Proposed Action EPA is proposing to approve Maryland's SIP revision submitted May 27, 2006 to remove the August 2, 1984 Secretarial Order issued to American Cyanamid Company from the SIP. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.

IV. Statutory and Executive Order Reviews Under Executive Order 12866 ( 58 FR 51735, October 4, 1993), this proposed action is not a " significant regulatory action" and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, " Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, 6 or Use" ( 66 Fed. Reg. 28355 ( May 22, 2001)). This action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act ( 5 U. S. C. 601 et seq.). Because this rule proposes to approve pre existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 ( Public Law 104 4). This proposed rule also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 ( 65 FR 67249, November 9, 2000), nor will it have substantial direct effects 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, as specified in Executive Order 13132 ( 64 FR 43255, August 10, 1999), because it merely proposes to approve a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.

This proposed rule also is not subject to Executive Order 13045 ( 62 FR 19885, April 23, 1997),

because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards ( VCS), EPA has no authority to disapprove a 7 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( 15 U. S. C. 272 note) do not apply.

As required by section 3 of Executive Order 12988 ( 61 FR 4729, February 7, 1996), in issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity,

minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 ( 53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the " Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings" issued under the executive order. This proposed rule to remove the Secretarial Order for American Cyanamid from the Maryland SIP does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 ( 44 U. S. C. 3501 et seq.).

List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds Authority: 42 U. S. C. 7401 et seq. / s/

___________________________ ____________________________ Dated: August 16, 2006 Donald S. Welsh, Regional Administrator, Region III.