[Federal Register Volume 88, Number 65 (Wednesday, April 5, 2023)]
[Rules and Regulations]
[Pages 20070-20073]
[FR Doc No: 2023-07034]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1063; Project Identifier AD-2021-01339-T;
Amendment 39-22375; AD 2023-05-06]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

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 The Boeing Company Model 737-8, 737-9, and 737-8200 airplanes.
This AD was prompted by a determination that new airworthiness
limitations are necessary to require periodic replacement; or testing,
and replacement if necessary; of the oxygen sensor of the nitrogen
generation system (NGS). This AD requires revising the existing
maintenance or inspection program, as applicable, to incorporate the
new airworthiness limitations. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective May 10, 2023.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 10, 2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1063; 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, any comments received, and other
information. The 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.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-1063.

FOR FURTHER INFORMATION CONTACT: Sam Dorsey, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain The Boeing
Company Model 737-8, 737-9, and 737-8200 airplanes. The NPRM published
in the Federal Register on November 28, 2022 (87 FR 72902). The NPRM
was prompted by a determination that a new airworthiness limitation is
necessary to require periodic replacement of the oxygen sensor of the
NGS. In the NPRM, the FAA proposed to require revising the existing
maintenance or inspection program, as applicable, to incorporate the
new airworthiness limitation. The FAA is issuing this AD to prevent
increasing the flammability exposure of the center fuel tank, which
together with an ignition source in the fuel tank, could lead to a fuel
tank explosion and consequent loss of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from the Air Line Pilots Association,
International (ALPA) and an individual who supported the NPRM without
change.
    The FAA received additional comments from four commenters,
including Boeing, American Airlines, SIA Engineering Company, and
United Airlines (United). The following presents the comments received
on the NPRM and the FAA's response to each comment.

Request To Refer to Latest Service Information

    Boeing and United requested that the proposed AD be revised to
specify compliance with Boeing 737-7/8/8200/9/10 Special Compliance
Items/Airworthiness Limitations, D626A011-9-04, dated May 2022, instead
of Boeing 737-7/8/8200/9/10 Special Compliance Items/Airworthiness
Limitations, D626A011-9-04, dated January 2019. Boeing noted that
Boeing 737-7/8/8200/9/10 Special Compliance Items/Airworthiness
Limitations, D626A011-9-04, dated May 2022 includes a revision to 47-
AWL-09 and the addition of new airworthiness limitation 47-AWL-10
(which is a Critical Design Configuration Control Limitation (CDCCL)
that specifies procedures for oxygen sensor repairs). Boeing added that
the revision to 47-AWL-09 provides additional options for operators
beyond replacing the oxygen sensor with a new oxygen sensor. Those
options include testing the installed NGS oxygen sensor using a
functional check described in the Airplane Maintenance Manual (AMM)
(and replacing if necessary), and replacing the oxygen sensor with an
NGS oxygen sensor repaired as specified in 47-AWL-10. United noted that
these changes provide operators with benefits necessary for the
efficient accomplishment of task 47-AWL-09.
    The FAA partially agrees with the commenters' requests. Boeing 737-
7/8/8200/9/10 Special Compliance Items/Airworthiness Limitations,
D626A011-9-04, dated May 2022, provides options that are relieving, but
also includes a new CDCCL requirement that was not included in the
proposed AD. The FAA has therefore revised this AD to require
incorporating the information specified in AWL No. 47-AWL-09,
``Nitrogen Generation System--Oxygen Sensor,'' of Boeing 737-7/8/8200/
9/10 Special Compliance Items/Airworthiness Limitations, D626A011-9-04,
dated

January 2019; or the information specified in 47-AWL-09 and 47-AWL-10
of Boeing 737-7/8/8200/9/10 Special Compliance Items/Airworthiness
Limitations, D626A011-9-04, dated May 2022.

Request To Refer to Latest Service Information

    American Airlines requested that the FAA add a provision to
accomplish the oxygen sensor replacement with a repaired or overhauled
sensor instead of a brand new sensor. The commenter noted that this
provision would ease the burden on operators by not requiring them to
scrap used sensors and buy new ones. American Airlines added that the
737NG fleet has a similar AWL requirement, with a provision that a
repaired sensor may be installed.
    The FAA agrees with the commenter's request. As noted previously,
this AD has been revised to allow incorporating the information in
Boeing 737-7/8/8200/9/10 Special Compliance Items/Airworthiness
Limitations, D626A011-9-04, dated May 2022, which includes provisions
for replacing the oxygen sensor with a repaired oxygen sensor or
testing the oxygen sensor, and replacing if necessary.

Request To Clarify Applicability

    SIA Engineering Company asked that the FAA confirm the commenter's
understanding of paragraph (c) of the proposed AD. SIA Engineering
Company requested confirmation that the proposed AD does not affect The
Boeing Company Model 737-8, 737-9, and 737-8200 airplanes having
original airworthiness certificate or original export certificate of
airworthiness issued on or before April 1, 2021, and with a line number
not identified in paragraph (c)(2) of the proposed AD.
    The FAA agrees to clarify. This AD applies to The Boeing Company
Model 737-8, 737-9, and 737-8200 airplanes having original
airworthiness certificate or original export certificate of
airworthiness issued on or before April 1, 2021, and it also applies to
The Boeing Company Model 737-8, 737-9, and 737-8200 airplanes with a
line number specified in paragraph (c)(2) of this AD. This AD does not
apply to any airplanes not specified in paragraph (c)(1) or (2) of this
AD.

Request To Revise a Sentence in the Background

    Boeing requested that the FAA revise a sentence in the Background
section. In the NPRM the sentence reads ``Degraded performance by the
sensor could result in the [air separation module] ASM failing to
produce nitrogen-enriched air, and the fuel tank becoming more
flammable due to excessive oxygen-enriched air.'' Boeing stated that
this sentence is inaccurate because it implies a causality between a
failing oxygen sensor and a degrading ASM, when there is none. Boeing
added that the sentence further implies that the oxygen enriched air
(OEA) is redirected to the fuel tanks if the ASMs start going bad.
Boeing stated that the sentence should state: ``Degraded oxygen sensor
performance could result in the system failing to detect when the ASM
performance degrades below the acceptable threshold for nitrogen-
enriched air, and the fuel tank becoming more flammable due to
receiving poor-quality nitrogen-enriched air.''
    The FAA agrees that there is no causality between the degraded
performance of the oxygen sensor and failure of ASM. Degradation of the
oxygen sensor performance does not directly result in the ASM failing
to produce nitrogen-enriched air, but rather it would result in a
failure to detect the condition of the ASM not performing at a required
level. However, the sentence in question from the Background section of
the NPRM will not be carried over to this final rule. Therefore, the
FAA has not changed this AD regarding this issue.

Request To Include Cost for Replacement Sensor

    United requested that the NPRM be revised to include the cost of a
replacement NGS oxygen sensor and its availability.
    The FAA disagrees with the commenter's request. This AD does not
require compliance with the maintenance actions specified in the AWL
items. Instead, this AD requires operators to revise their existing
maintenance or inspection program, as applicable, to incorporate the
new airworthiness limitations. Compliance with any airworthiness
limitation is required by 14 CFR 91.403(c). Therefore, compliance with
the AWLs is not a requirement of this AD, and including the cost of a
replacement part would be inappropriate. The FAA has not changed this
AD regarding this issue.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, 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 products. Except for minor editorial changes, and
any other changes described previously, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing 737-7/8/8200/9/10 Special Compliance Items/
Airworthiness Limitations, D626A011-9-04, dated January 2019. This
service information describes, among other airworthiness limitations
(AWLs), airworthiness limitation instruction (ALI) AWL No. 47-AWL-09,
``Nitrogen Generation System--Oxygen Sensor,'' for replacing oxygen
sensors.
    The FAA also reviewed Boeing 737-7/8/8200/9/10 Special Compliance
Items/Airworthiness Limitations, D626A011-9-04, dated May 2022. This
service information describes, among other AWLs, ALI AWL No. 47-AWL-09,
``Nitrogen Generation System (NGS)--Oxygen Sensor,'' for replacement;
or testing, and replacement if necessary; of the oxygen sensor of the
nitrogen generation system (NGS), and AWL No. 47-AWL-10, ``Nitrogen
Generation System (NGS)--Oxygen Sensor Repair,'' for repairing oxygen
sensors.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 62 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate. Therefore, the FAA estimates the average total cost per
operator to be $7,650 (90 work-hours x $85 per workhour).

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 products 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:

2023-05-06 The Boeing Company: Amendment 39-22375; Docket No. FAA-
2022-1063; Project Identifier AD-2021-01339-T.

(a) Effective Date

    This airworthiness directive (AD) is effective May 10, 2023.

(b) Affected ADs

    None

(c) Applicability

    This AD applies to The Boeing Company Model 737-8, 737-9, and
737-8200 airplanes, certificated in any category, identified in
paragraphs (c)(1) and (2) of this AD.
    (1) Airplanes with an original airworthiness certificate or
original export certificate of airworthiness issued on or before
April 1, 2021.
    (2) Airplanes with line numbers 7668, 7678, and 7915.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by significant changes made to
airworthiness limitations (AWLs) related to the nitrogen generation
system (NGS). The FAA is issuing this AD to prevent increasing the
flammability exposure of the center fuel tank, which together with
an ignition source in the fuel tank, could lead to a fuel tank
explosion and consequent loss of the airplane.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

    Within 60 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in AWL No. 47-AWL-09,
``Nitrogen Generation System--Oxygen Sensor,'' of Boeing 737-7/8/
8200/9/10 Special Compliance Items/Airworthiness Limitations,
D626A011-9-04, dated January 2019; or the information specified in
AWL No. 47-AWL-09, ``Nitrogen Generation System (NGS)--Oxygen
Sensor,'' and AWL No. 47-AWL-10, ``Nitrogen Generation System
(NGS)--Oxygen Sensor Repair,'' of Boeing 737-7/8/8200/9/10 Special
Compliance Items/Airworthiness Limitations, D626A011-9-04, dated May
2022. The initial compliance time for accomplishing task AWL No. 47-
AWL-09 is: Within 18,000 flight hours after the date of issuance of
the original airworthiness certificate or the original export
certificate of airworthiness, within 18,000 flight hours after the
most recent replacement or test was performed as specified in AWL
No. 47-AWL-09, or within 12 months after the effective date of this
AD, whichever is latest.

(h) No Alternative Actions, Intervals, or Critical Design Configuration
Control Limitations (CDCCLs)

    After the existing maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections), intervals, or CDCCLs may be used unless
the actions, intervals, and CDCCLs are approved as an alternative
method of compliance (AMOC) in accordance with the procedures
specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO 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 responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (j) of this AD. Information may be emailed
to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Additional Information

    For more information about this AD, contact Sam Dorsey,
Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch,
2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-
3415; email: [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing 737-7/8/8200/9/10 Special Compliance Items/
Airworthiness Limitations, D626A011-9-04, dated January 2019.
    (ii) Boeing 737-7/8/8200/9/10 Special Compliance Items/
Airworthiness Limitations, D626A011-9-04, dated May 2022.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 5, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-07034 Filed 4-4-23; 8:45 am]
BILLING CODE 4910-13-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

__________________________________________

Notice of						)

							)

	Alaska Juneau Aeronautics, Inc.		)	Docket OST-2006-

	d/b/a Wings of Alaska			)

							)

Under 49 U.S.C. 41734 and C.F.R. Part 323		)

of intent to terminate Essential Air Service		)

at Angoon and Tenakee, Alaska			)

__________________________________________)

90-DAY NOTICE OF

ALASKA JUNEAU AERONAUTICS, INC.

d/b/a WINGS OF ALASKA

OF INTENT TO TERMINATE ESSENTIAL AIR SERVICE

AT ANGOON AND TENAKEE, ALASKA

Communications with Respect to This Document Should Be Addressed to:

Robert Jacobsen, President						                Hank Myers

Wings of Alaska									   MTC

8421 Livingston Drive							P.O. Box 7341

Juneau, AK  99801							 Bellevue, WA  98008

(907) 789-9863<PHONE_NUMBER>

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
August 1, 2006

BEFORE THE

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

__________________________________________

Notice of						)

							)

	Alaska Juneau Aeronautics, Inc.		)	Docket OST-2006-

	d/b/a Wings of Alaska			)

							)

Under 49 U.S.C. 41734 and C.F.R. Part 323		)

of intent to terminate Essential Air Service		)

at Angoon and Tenakee, Alaska			)

__________________________________________)

90-DAY NOTICE OF

ALASKA JUNEAU AERONAUTICS, INC.

d/b/a WINGS OF ALASKA

OF INTENT TO TERMINATE ESSENTIAL AIR SERVICE

AT ANGOON AND TENAKEE, ALASKA

Pursuant to Section 401(j)(1) of the Federal Aviation Act of 1958, as
amended, Alaska Juneau Aeronautics, Inc. d/b/a Wings of Alaska hereby
serves its notice of intent to terminate all scheduled air service it is
providing at the points Angoon and Tenakee, Alaska.

In accordance with 14 CFR 323, Alaska Juneau Aeronautics provides the
following information:

Identification of Carrier

Alaska Juneau Aeronautics, Inc.

d/b/a Wings of Alaska

8421 Livingston Drive

Juneau, AK  99801

	Communications with respect to this document should be addressed to:

			Robert Jacobsen, President

			Wings of Alaska

8421 Livingston Drive

Juneau, AK  99801

(907) 789-9863

	and:		Hank Myers

			MTC

			P.O. Box 7341

			Bellevue, WA  98008-1341

<PHONE_NUMBER>

Wings of Alaska holds a certificate of public convenience and necessity.

Both Angoon and Tenakee receive scheduled passenger and cargo service
from Alaska Seaplane Service, LLC, which provides the full Essential Air
Service requirement.  Alaska Seaplane Service, LLC is a certificated air
carrier.

The service at Angoon and Tenakee to be terminated is:

Flight #		  71/72		  73/74		  75/76		  77/78

Aircraft		DHC-2		DHC-2		DHC-2		DHC-2

Depart JNU	0730		1000		1350		1630

Arrive AGN	0810		1040		1430		1710

Depart AGN	0820		 1050		1440		1720

Arrive TKE	0840		   -		1500		   -

Depart TKE	0850		   -		1510		   -

Arrive JNU	0920		1130		1540		1800

Frequency		X7		7 only		Daily		Daily

JNU = Juneau, AGN = Angoon, TKE = Tenakee

No point will be left without nonstop or single-plane service from a
certificated carrier by Wings’ termination.  The date of the intended
termination is on or before October 29, 2006.

The Department has determined the level of Essential Air Service for
Angoon (5 flights per week) and Tenakee (3 flights per week).
Termination of Wings’ service will not reduce air transportation to
both points below the Essential level as Alaska Seaplane Service already
provides this level of service.

Objections to termination of Wings scheduled air service at Angoon and
Tenakee shall be filed on or before August 21, 2006, and shall be served
upon all persons listed on the attached Certificate of Service.

Respectfully submitted,

Wings of Alaska

____________________________________

By Hank Myers, its authorized representative

August 1, 2006

CERTIFICATE OF SERVICE

I hereby attest that I have this day served a copy of the foregoing
Notice of Intent upon the following persons by first class mail:

Mayor (by registered mail)

Angoon, AK  99820

Mayor (by registered mail)

Tenakee, AK  99825

Honorable Frank Murkowski (by registered mail)

Governor

State of Alaska

P.O. Box 110001

Juneau, AK  99811-0001

Postmaster General

attn: Assistant General Counsel, Transportation

U.S. Postal Service

475 L’Enfant Plaza West, SW

Washington, D.C.  20260

Alaska Seaplane Service

8995 Yandukin Drive

Juneau, AK  99801


[Federal Register Volume 81, Number 179 (Thursday, September 15, 2016)]
[Notices]
[Pages 63490-63491]
[FR Doc No: 2016-22127]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2007-0008]

FEMA National Advisory Council (NAC)-Integrated Public Alert and
Warning System (IPAWS) Subcommittee

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee management; request for applicants for appointment to
the FEMA National Advisory Council-Integrated Public Alert and Warning
System Subcommittee.

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SUMMARY: The Federal Emergency Management Agency is requesting
qualified individuals interested in serving on the FEMA National
Advisory Council (NAC)-Integrated Public Alert and Warning System
(IPAWS) Subcommittee to apply for appointment. Pursuant to the
Integrated Public Alert and Warning System Modernization Act of 2015,
the IPAWS Subcommittee will consider common alerting and warning
protocols, standards, terminology, and operating procedures for an
integrated public alert and warning system.

DATES: Applications will be accepted until 11:59 p.m. EDT on October 6,
2016.

ADDRESSES: The preferred method of submission for application packages
is via email, but application packages may also be submitted by fax or
U.S. mail. Please submit by only ONE of the following methods:
     Email<EMAIL_ADDRESS>Please include ``IPAWS
Subcommittee Application'' on the subject line of the email. Please
save materials as one document using the naming convention, ``LAST
NAME_FIRST NAME'', and attach to the email.
     Fax:<PHONE_NUMBER>.
     U.S. Mail: Office of the National Advisory Council,
Federal Emergency Management Agency, 8th Floor, 500 C Street SW.,
Washington, DC 20472-3184.

FOR FURTHER INFORMATION CONTACT: Deana Platt, Designated Federal
Officer, Office of the National Advisory Council, Federal Emergency
Management Agency, 8th Floor, 500 C Street SW., Washington, DC 20472-
3184; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; and email<EMAIL_ADDRESS>For more information on the NAC, visit http://www.fema.gov/national-advisory-council.

SUPPLEMENTARY INFORMATION: The NAC is an advisory committee established
in accordance with the provisions of the Federal Advisory Committee Act
(FACA), 5 U.S.C. Appendix. As required by the Integrated Public Alert
and Warning System Modernization Act of 2015, the FEMA Administrator
established the IPAWS Subcommittee to develop recommendations for an
integrated public alert and warning system. The IPAWS Subcommittee will
review and make recommendations to the NAC on matters related to common
alerting and warning protocols, standards, terminology, and operating
procedures. The IPAWS Subcommittee will also make recommendations to
the NAC on having the capability to adapt the distribution and content
of communications based on locality, risks, or user preferences; to
alert and warn individuals with disabilities; incorporate multiple
communications technologies; provide alerts to the largest portion of
the affected population; promote local and regional community
preparedness and response; and provide redundant alert mechanisms.
    FEMA is requesting qualified individuals who are interested in
serving on the IPAWS Subcommittee to apply for appointment. Individuals
selected for appointment will serve as either a Special Government
Employee (SGE) or a Representative in one of the following disciplines:
State and local government officials; emergency management agencies;
emergency response providers; federally recognized Indian tribes and
national Indian organizations; communications service providers;
vendors, developers, and manufacturers of systems, facilities,
equipment, and/or capabilities for the provision of communications
services; third-party service bureaus; broadcasting industry (to
include public broadcasting); commercial mobile radio service industry;
cable industry; satellite industry; national organizations representing
individuals with disabilities; blind, deaf, and hearing loss
communities; individuals with access and functional needs; elderly;
consumer or privacy advocates; and organizations representing
individuals with Limited English Proficiency. The Administrator may
appoint up to four (4) additional candidates to serve as FEMA
Administrator Selections. The appointment will end upon the termination
of the IPAWS Subcommittee in April 2019.
    If you are interested and qualified based on leadership ability and
subject-matter expertise, please apply for consideration of appointment
by submitting an application package to the Office of the NAC as listed
in the ADDRESSES section of this notice. Each application package MUST
include the following information:

 Cover letter, addressed to the Office of the NAC, that
indicates why you are interested in serving on the IPAWS
Subcommittee, and includes the following information: The discipline
area(s) being applied for, current position title and organization,
home and work addresses, a current telephone number and email
address
 Resume or Curriculum Vitae

    Incomplete applications will not be considered. Each application
will be reviewed based on relevant expertise in the appropriate field,
and understanding of public alerts.
    Appointees may be designated as a SGE as defined in section 202(a)
of title 18, United States Code, or as a Representative member.
Candidates selected for appointment as SGEs are required to complete a
Confidential Financial Disclosure Form (Office of Government Ethics
Form 450) each year. This form can be obtained by visiting the Web site
of the Office of Government Ethics (http://www.oge.gov). However,
please do not submit this form with your application.
    The IPAWS Subcommittee will meet approximately four (4) times per
year, two in person and two via webinar. Members may be reimbursed for
travel expenses and per diem. All travel for IPAWS Subcommittee
business must be approved in advance by the Designated Federal Officer.
    The Department of Homeland Security (DHS) does not discriminate on
the basis of race, color, religion, sex, national origin, political
affiliation, sexual orientation, gender identity, marital status,
disability, genetic information, age, membership in an employee
organization, or other non-merit factor. DHS strives to achieve a
widely diverse candidate pool for all of its recruitment actions.
Current DHS and FEMA employees, FEMA Reservists, and DHS and FEMA
contractors and potential contractors will not be considered for
membership. Federally registered lobbyists may apply for positions
designated as Representative appointments but are not eligible for
positions that are designated as SGE appointments.

    Dated: September 9, 2016.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-22127 Filed 9-14-16; 8:45 am]
 BILLING CODE 9111-48-P


Nominating Party: 	The United States of America

FILE NAME: 	USA CUN 13 Soil EGGPLANT GROWN IN OPEN FIELDS

Brief descriptive Title of Nomination: Methyl Bromide Critical Use
Nomination for Pre-plant Soil Use for Eggplants Grown in Open Fields
(Submitted in 2011 for 2013 Use Season)

Crop name (open field or protected): Pre-plant Soil Use for Eggplant
Grown in Open Fields

Quantity of methyl bromide requested in each year of nomination:

Table 1: Quantity of Methyl Bromide Requested in Each Year of Nomination

Year	Nomination Amount

2013	1,381 kg

NOMINATING PARTY CONTACT DETAILS:

Contact Person:	John Thompson

Title:	Division Director

Address:	Office of Environmental Policy

	U.S. Department of State

	2201 C Street, N.W. Room 2658

	Washington, D.C. 20520

	U.S.A.

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

E-mail:	  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Following the requirements of Decision IX/6 paragraph (a)(1) The United
States of America has determined that the specific use detailed in this
Critical Use Nomination is critical because the lack of availability of
methyl bromide for this use would result in a significant market
disruption.                 ■  Yes	            ( No

Signature			       	Name				Date

Title:

(Details on this page are requested under Decision Ex. I/4(7), for
posting on the Ozone Secretariat website under Decision Ex. I/4(8).)

In assessing nominations submitted in this format, TEAP and MBTOC will
also refer to the original nomination on which the Party’s first-year
exemption was approved, as well as any supplementary information
provided by the Party in relation to that original nomination.  As this
earlier information is retained by MBTOC, a Party need not re-submit
that earlier information.

CONTACT OR EXPERT(S) FOR FURTHER TECHNICAL DETAILS:

Contact/Expert Person:	Jack Housenger

Title:	Director

Address:	Biological and Economic Analysis Division

	Office of Pesticide Programs

	U.S. Environmental Protection Agency

	1200 Pennsylvania Avenue, N.W. Mailcode 7503P

	Washington, D.C. 20460

	U.S.A.

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

E-mail:	  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

LIST OF DOCUMENTS SENT TO THE OZONE SECRETARIAT IN OFFICIAL NOMINATION
PACKAGE:

1.  PAPER DOCUMENTS:

Title of paper documents and appendices	No. of pages	Date sent to Ozone
Secretariat

USA CUN13 Soil Egg plant grown in open fields 	15

	2.  ELECTRONIC COPIES OF ALL PAPER DOCUMENTS:

*Title of each electronic file (for naming convention see notes above)
No. of kilobytes 	Date sent to Ozone Secretariat

USA CUN13 Soil Eggplant Open Field

* Identical to paper documents

METHYL BROMIDE CRITICAL USE RENOMINATION FOR Preplant Soil Use (OPEN
FIELD OR PROTECTED ENVIRONMENT)

EGGPLANT

1.  SUMMARY OF THE NEED FOR METHYL BROMIDE AS A CRITICAL USE

This nomination covers eggplant grown for fresh market in the States of
Florida and Georgia. The crop is generally grown in open fields and
followed by various other crops.  Harvest is mainly for fresh market.

The USG has reviewed all factors affecting transition rates in this
sector. Based on this assessment the transition rate has been greatly
increased for most portions of this sector.  For the area covered in
this nomination, the USG believes that the narrative discussion included
in this document is technically valid. The USG has nominated amounts of
methyl bromide based only on those sub-sectors that cannot transition
away from methyl bromide at the accelerated rate.

Georgia

Continued efforts are underway in Georgia to implement effective and
economical alternatives to methyl bromide.  A 3-WAY fumigation system,
developed by University of Georgia, and dimethyl disulfide (DMDS,
currently unregistered in the US) plus chloropicrin are two alternatives
that appear to be potential replacements for methyl bromide. During
2008, 40% of the fumigated plasticulture land for vegetable crops was
treated with the 3-WAY which includes a systems approach of
1,3-dichloropropene, chloropicrin, and metam sodium.  Dimethyl disulfide
plus chloropicrin has also proven to be effective in managing many
pests, including nutsedge, and has the potential to be adopted once the
product is registered assuming it is economically feasible.

Although both the Georgia 3-WAY and DMDS + chloropicrin appear
promising, neither fumigant system will stand alone in managing pests.
An effective herbicide program must also be developed to complement
these fumigant systems.  The 3-WAY does not provide adequate nutsedge
control with summer/fall fumigations and the DMDS system does not
adequately control grasses or Amaranthus species.  Until a program using
fumigants and herbicides is developed, having methyl bromide available
is essential.

The two aforementioned fumigant systems also pose significant challenges
when determining the time interval needed between fumigating and
planting.  Initial research results suggest the plant back interval for
the 3-WAY will be at least 3 times longer than that noted with methyl
bromide. Early indications suggest that the plant back interval for DMDS
plus chloropicrin applied under high barrier mulch will be similar to
the 3-WAY fumigation system.

The latest research information indicates that 3-way system continues to
perform well in the spring, but perform poorly on nutsedge control in
the fall.  Applications of mixture of DMDS and chloropicrin (79:21), at
45 to 50 gallons/acre in the spring and fall will effectively control
nutsedge. Present and future research is focusing on developing and
implementing a herbicide program to compliment both the 3-WAY and DMDS
fumigant systems as well as determining the amount of time that must
pass between fumigating with these alternatives and planting.

Florida

The nutsedge, root-knot nematodes, and fungal diseases like phytopthora
blight, and southern blights are continued to be major problems in
eggplant production in Florida.  In this State, eggplant is grown
year-round, and often double cropped with pepper or cucumber following
the eggplant harvest. The crop that follows eggplant in a double
cropping production system depends upon prevailing environmental and
economic factors. Growers in Florida often plant eggplant as an extra
crop and grow okra, squash, or cucumbers after eggplant has been
harvested.  A spring crop of eggplant may follow as a second crop after
a fall crop of pepper or tomato.  Eggplant does best on well-drained,
fertile, sandy-loam soils at a pH of 6.0-6.5.  Poorly drained soils may
result in slow plant growth, reduced root systems, and low yields.
Eggplant requires a long, warm, frost-free growing season, usually of
14-16 weeks. Cold temperatures below 5oC injure this crop. The best
temperatures are 27-32oC during the day and 21-32oC during the night.
Plant growth is curtailed at temperatures below 16oC.  Additionally,
soil temperature below 16oC restricts germination. However, most of the
eggplant is started in the field from transplants.  Methyl bromide is
always used in the full-bed mulch process.

Until 1999, the chemical formulation primarily used was 98 percent
methyl bromide and two percent chloropicrin. Since then, growers have
shifted to formulations with lower concentrations of methyl bromide and
higher amounts of chloropicrin due to the phase-out schedule of methyl
bromide.  At present, the standard formulation contains 50% methyl
bromide in Florida.

The best alternative, 1,3-D (Telone), may not be applied in Florida in
the areas overlying karst geology, which is common throughout the
Southeastern States.  There is also a 21-day planting delay (vs. 14 days
for MB) due to regulatory restrictions for 1,3-D + chloropicrin.

Currently, the best alternative to use of methyl bromide in Florida
seems to be applying Telone C-35 (1,3-Dichloropropene +  35%
Chloropicrin), applied at prebed 35 gal./acre  rate 3 to 5 wks before
transplanting.  This fumigant application is supplemented by an
herbicide treatment (tank mixed treatment of 2 lbs of napropamide with
0.5 lbs of trifluralin per acre to achieve a proper weed control.
However, the use of Telone in 63% of Florida eggplant production land is
restricted due to the presence of Kast topography.

Iodomethane, a new methyl bromide alternative, was registered in the
U.S., in October, 2007.  Iodomethane, however, is not registered for use
on eggplant. EPA feels that it is appropriate not to include iodomethane
as a methyl bromide substitute for eggplant at this time. The U.S.
nomination is only for those areas in Georgia and Florida where the
alternatives are not feasible.

If methyl bromide were to be unavailable for U.S. eggplant, growers in
the regions cited in this nomination would have to discontinue growing
this crop or suffer substantial losses.  Growers would either leave
agriculture entirely or switch to other crops that do not rely on
pre-plant fumigation to control soil pests.  The extent of this impact
on the affected growers is debatable, but given the early state of
commercial deployment of methyl bromide alternatives, it is possible
that growers who currently use methyl bromide would face this outcome.

U.S. reliance on methyl bromide has dramatically and rapidly been
reduced over the last eight years.  Critical use exemption (CUE)
requests have decreased every year since the U.S. phase-out process
began.  The development, registration, and use of new pest control
products and production methods have been key to the progress and
reductions made to-date.  As alternatives have demonstrated their
suitability, as thorough reviews of research results and applicant
information have been conducted, and contacts have been made with
regional crop experts to assess the technical and economic feasibility
of alternatives, U.S. Government (USG) requests have reduced by 99%, for
the fruiting vegetables, over the last 9 years.  However, as the amount
of methyl bromide available for use decreases each year, substantial
challenges exist in the collection of needed data to substantiate
on-going critical needs through the CUE process.

There are now several alternatives for soil fumigation, including
1,3-dichloropropene plus chloropicrin, the “UGA 3 Way” combination
(1,3-dichloropropene plus chloropicrin followed by metam sodium),
iodomethane plus chloropicrin, and dimethyl disulfide (DMDS) which have
demonstrated some technical and economic feasibility for pest control in
a number of vegetable crops in the U.S. Southeast.  However, CUE
applicants in this nominated sector have indicated that they are not
always suitable for all situations.  While DMDS has a Federal
registration and has demonstrated effectiveness, it is not currently
registered in all the relevant states.  Given the timing of state
registrations, lack of experience using this alternative, and
application methods still under development to minimize odor in
communities surrounding treated fields there is uncertainty in
predicting when this alternative can be reasonably expected to
adequately replace methyl bromide in specific application scenarios.
While the DMDS registrant has been working with the product to reduce
the odor, and growers are gaining experience in its use, work is still
needed on application approaches for the alternative to be fully
available for use in U.S. southeast vegetable crops.  For example
individual operators and small farms, which account for up to eighty
percent of the growers in this nominated sector are especially
hard-pressed to make this transition, because one of the most promising
alternatives requires additional money to convert their fumigation
equipment and custom fumigation applicators are not available in all
areas.  In addition to the expense to convert to the alternatives, there
have been reports that the alternatives do not perform as well as the
MeBr:pic combination.

These concerns about the alternatives have only recently been brought to
the USG attention and insufficient supporting information was provided.
Because of the uncertainties and challenges associated with the use of
the available alternatives, the USG believes it most prudent and the
best public policy to collect additional information so that the
technical and economic impacts of these reported problems can be
evaluated.  The USG will request the applicants provide additional
information to us no later than June 1, 2011 so that the information can
be analyzed and provided to MBTOC by July 15, prior to the Open Ended
Work Group (OEWG) meeting in early August.  The quality of any
additional information received will first be evaluated in terms of
whether or not it supports a compelling case and confirms problems with
the feasibility of alternatives. Then, on that basis, the USG will
either support or withdraw this nominated sector at that meeting.

The nomination attached specifies the correct year (2013) and amount of
methyl bromide that is being requested for the individual crops within
this sector.  However, there has been no attempt to update the
information in this document regarding the new research, availability of
alternatives, etc.  Since the USG learned of the issues facing the
growers within this sector, after speaking directly with researchers
familiar with the specific problems only very recently, this information
was not available at the time the USG recommendation was developed.

SUMMARIZE WHY KEY ALTERNATIVES ARE NOT FEASIBLE

Although both the 3-WAY and DMDS (dimethyl disulfide) plus chloropicrin
appear promising, neither fumigant system will stand alone in managing
pests.  An effective herbicide program must be developed to complement
these fumigant systems.   It is also important to keep in mind that DMDS
remains unregistered for use in the US. Current review of available
research indicate that the 3-WAY does not provide adequate nutsedge
control with summer/fall fumigations and the DMDS system does not
adequately control grasses or Amaranthus species. The most recent
studies have reported that a 79:21 mixture of DMDS and chloropicrin is
the most effective combination of these two fumigants (Culpepper et al.,
2008).

In the Southern U.S., mainly in Florida and Georgia, where nutsedge is a
main methyl bromide target pest, 1,3-D or metam sodium, alone or in
combination, may not adequately control this weed.  In karst
topographical feature areas, which include 31 counties in Florida.
1,3-D (Telone II) is highly restricted and metam sodium or metam
potassium is the best alternatives available.  However, further testing
of these chemicals in large scale commercial fields is needed.  In
Florida and Georgia, farmers using 1,3-D and metam sodium in the fall
would require longer waiting periods for planting.  Metam sodium or
1,3-D requires waiting periods of  28 and 21 days, respectively, whereas
only 14 days are needed for methyl bromide.  Such delays could result in
missed market windows.  Metam sodium efficacy appears to decline where
it is applied repeatedly due to enhanced degradation of its active
ingredient, methyl isothiocyanate, by soil microorganisms (Ashley, et
al., 1963; Ou et al., 1995; Verhagen et al., 1996; Gamlied et al.,
2003).

Iodomethane, a new methyl bromide alternative, was registered for some
crops in the U.S., in October, 2007.  Iodomethane, however, is not
registered for use on eggplant. EPA feels that it is appropriate not to
include iodomethane as a methyl bromide substitute for eggplant at this
time.

IS THE USE COVERED BY A CERTIFICATION STANDARD?

Methyl bromide is not used to meet a certification standard for eggplant
production

IF PART OF THE CROP AREA IS TREATED WITH METHYL BROMIDE, INDICATE THE
REASON WHY METHYL BROMIDE IS NOT USED IN THE OTHER AREA, AND IDENTIFY
WHAT ALTERNATIVE STRATEGIES ARE USED TO CONTROL THE TARGET PATHOGENS AND
WEEDS WITHOUT METHYL BROMIDE.

A three-way fumigation system developed by University of Georgia, as
well as dimethyl disulfide (DMDS) plus chloropicrin are the two
alternatives that appear the most promising to replace methyl bromide.
During the spring of 2008, at least 40% of the land fumigated for
vegetable crops in the spring was treated with the 3-WAY which includes
a systems approach of 1,3-dichloropropene, chloropicrin, and metam
sodium.   It is likely that 30 to 40% of Georgia’s total crop will be
treated with this alternative during 2008.  Dimethyl disulfide (DMDS)
plus chloropicrin also proven to be effective in managing many pests and
has the potential to be adopted once the price structure is known.
Although both the 3-WAY and DMDS appear promising, neither fumigant
system will stand alone in managing pests.  An effective herbicide
program must be developed to compliment these fumigant systems.  The
3-WAY does not provide adequate nutsedge control with summer/fall
fumigations and the DMDS system does not adequately control grasses or
Amaranthus species.  The reader is reminded that DMDS remains
unregistered for use in the United States. Until a program using
fumigants and herbicides is developed, having methyl bromide available
is essential.

In karst topographical feature areas, which include 31 counties in
Florida, Telone is highly restricted and metam sodium or metam potassium
is the best alternatives available.  However, further testing of these
chemicals in large scale commercial fields is needed.  In Florida and
Georgia, farmers using 1,3-D and metam sodium in the fall would require
longer waiting periods for planting.  Metam sodium or 1,3-D requires
waiting periods of  28 and 21 days, respectively, whereas only 14 days
are needed for methyl bromide.  Such delays could result in missed
market windows.  Metam sodium efficacy appears to decline where it is
applied repeatedly due to enhanced degradation of its active ingredient,
methyl isothiocyanate, by soil microorganisms (Ashley, et al., 1963; Ou
et al., 1995; Verhagen et al., 1996; Gamliel et al., 2003).

5.  Would it be feasible to expand the use of these methods to cover at
least part of the crop that has requested use of methyl bromide? What
changes would be necessary to enable this?

The USG has reviewed all factors affecting transition rates in this
sector. Based on this assessment the transition rate has been greatly
increased for most portions of this sector.  For the area covered in
this nomination, the USG believes that the narrative discussion included
in this document is technically valid. The USG has nominated amounts of
methyl bromide based only on those sub-sectors that cannot transition
away from methyl bromide at the accelerated rate.

6.  STATE RELATIVE EFFECTIVENESS OF RELEVANT ALTERNATIVES COMPARED TO
METHYL BROMIDE FOR THE SPECIFIC KEY TARGET PESTS AND WEEDS FOR WHICH IT
IS BEING REQUESTED

A: KEY PATHOGENS: Phytophthora capsici, Pythium spp. and nematodes
(Meloidogyne spp.)

Summary of studies relevant to key pathogens

New research information on use of soil fumigants, specifically in
eggplant production is not available in the public domain. Hausbeck and
Cortright (2004) conducted a small-plot field trial on several
vegetables, including eggplant.  Results, submitted with the 2007 CUE
request, indicate that 1,3 D + 35 % chloropicrin treatments
(shank-injected at 56.7 liters/ha) for control of Phytophthora and
Fusarium resulted in a 44% yield loss, compared to methyl bromide plots.
 Chloropicrin plots alone (shank-injected at 233.6 l/ha) showed a 15.5%
loss compared to methyl bromide plots. Metam-potassium + chloropicrin
plots showed yields similar to those treated with methyl bromide.
Metam-sodium was not tested, but can be assumed to be equivalent to
metam-potassium since the active ingredient is the same. Even large
differences in average yields across various treatments were often not
statistically significant.

In studies with other vegetable crops, fumigation with 1, 3 D +
chloropicrin has generally provided better control of fungi than
metam-sodium , though still not as good as control with methyl bromide.
For example, in a study using a bell pepper - squash rotation in small
plots, Webster et al. (2001) found significantly lower fungal
populations with 1,3 D + 35 % chloropicrin (drip applied, 146 kg/ha of
1,3 D), as compared to the untreated control.  However, methyl bromide
(440 kg/ha, shank-injected) reduced fungal populations even more.  P.
capsici was not present in test plots, though Fusarium spp. were.
However, as compared to the methyl bromide standard treatment plots,
squash fruit weight was 63 % lower in the 1,3 D plots.  The proportion
of marketable squash fruit in the 1,3 D plots was 30 % lower than that
in the methyl bromide plots. In another study, conducted on tomatoes,
Gilreath et al. (1994) found that metam-sodium treatments did not match
methyl bromide in terms of plant vigor at the end of the season.
Fusarium (but not P. capsici) was one of several pests present.

These studies indicate that, trials show promise for
metam-sodium/potassium + chloropicrin, there is inconsistency in
efficacy and protection from yield losses. However, the trials were
conducted in June, and it is unclear whether these results would hold if
fumigation were done under cooler spring temperatures.  Further, no
large scale field trials have yet been performed to demonstrate
consistent pest control similar to that provided by methyl bromide.

Culpepper and Langston (2004) compared the effectiveness of several soil
fumigants on nematodes affecting peppers in Tifton, Georgia.  Since
eggplants were not included in these tests, data from peppers are again
used to “bridge” a discussion.  Results show that 1,3-D followed by
chloropicrin was as effective as methyl bromide against nematodes.
Spring and fall crop yield in these plots were similar to yield in
methyl bromide plots.

Root knot nematodes Meloidogyne spp., also affect Georgia eggplants.
Their damage to the root may facilitate plant invasion by fungal
pathogens, which can lead to wilt, loss of plant vigor, and yield
losses.  Fumigant alternatives such as metam-sodium have proven
inconsistent (Noling, 2003; FFVA, 2002).

Diseases caused by soil-borne fungi, (e.g., Phytophthora spp., Pythium
spp. and Sclerotium rolfsii) are endemic in many vegetable production
areas in Georgia.  Fungicides such as chlorothalonil and
azoxystrobilurin are only used prophylactically and may not offer
sufficient plant protection.  Resistance of Phytophthora spp. to
metalaxyl and mefenoxam has been reported in tomato and pepper (Lamour
and Hausbeck, 2003)

The use of 1,3-D and metam sodium in the fall is impractical because of
the long waiting periods for planting following application under
plastic mulch. For 1,3-D there is a 28 day waiting period; for metam
sodium, there is a 21-day waiting period.  Such delays would cost
growers at least half of the harvest season, thereby missing the higher
market windows.  Thus, since the fall crop is dependent upon timely
planting, the required waiting period would cost growers at least half
of the harvest season, thereby missing the higher market windows
(Kelley, 2003).

B: KEY WEEDS: Nutsedges

Table 2: data on trials of Fumigant Alternatives to Methyl Bromide for
Polyethylene-Mulched Tomato (Locascio et al. 1997)

Chemicals	Rate (kg/ha)	Average Nutsedge Density

(#/m2)	Average Marketable Yield

(ton/ha)	% Yield Loss (compared to methyl bromide)

Untreated (control)	-	300 ab	20.1 a	59.1

methyl bromide + Pic (67-33), chisel-injected	390 kg	 90 c	49.1 b	---

1,3 D + Pic (83-17), chisel-injected	327 l	340 a	34.6 c	29.5

Metam Na, Flat Fumigation	300 l	320 a	22.6 a	54.0

Metam Na, drip irrigated	300 l	220 b	32.3 c	34.2

Narrative description of studies relevant to target weeds

For nutsedge, which is widespread in all requesting regions, growers do
not have technically feasible alternatives to methyl bromide use at
planting.  Metam-sodium and 1,3 D + chloropicrin have shown some
efficacy in small-plot trials in other vegetable crops (e.g, tomato).
However, metam sodium use may result in a 44% yield loss, while use of
1,3 D may result in a 29% loss.  These fumigants often provide less
control of nutsedges than methyl bromide.  Furthermore, there is
evidence that both 1,3 D and methyl isothiocynate levels decline more
rapidly due to enhanced degradation of these chemicals by soil
microorganisms, thus further compromising efficacy, in areas where these
are repeatedly applied (Smelt et al., 1989; Ou et al., 1995; Gamliel et
al., 2003; Dungan and Yates, 2003).

Results from small plot studies conducted in Tifton, Georgia, by
Culpepper and Langston (2004) show that 1,3-D followed by chloropicrin
was significantly less effective than methyl bromide against both purple
and yellow nutsedge, although this treatment performed as well as methyl
bromide relative to spring and fall crop yield.  1,3-D + chloropicrin,
followed by more chloropicrin was more effective than methyl bromide
against yellow nutsedge, but less effective against purple nutsedge.
This treatment performed as well as methyl bromide in terms of spring
yield, but poorly in terms of fall yield.  1,3-D + chloropicrin,
followed by metam sodium was 36% less effective than methyl bromide for
purple nutsedge control, but as effective as methyl bromide against
yellow nutsedge.  However, test plots were small, and it is unclear if
these results will hold in commercial fields, considering the variable
results reported elsewhere for these alternatives.  The nutsedge
populations in this study were dominated by yellow nutsedge (90% of the
total).  It is not clear if populations where purple nutsedge is
dominant would be controlled as effectively, since other studies have
shown that purple nutsedge is a hardier species. Current review of
available research indicate that the 3-WAY does not provide adequate
nutsedge control with summer/fall fumigations and the DMDS system does
not adequately control grasses or Amaranthus species. The most recent
studies have reported that a 79:21 mixture of DMDS and chloropicrin is
the most effective combination of these 2 chemicals (Culpepper et al.,
2008).  Present and future research are focusing on developing and
implementing a herbicide program to compliment both the 3-WAY and DMDS
fumigant systems as well as determining the amount of time that must
pass between fumigating with these alternatives and planting.

In Florida, the best currently available alternative for eggplant
production (which cannot be used in areas containing karst topographical
features) is an application of Telone C-35 (1,3-D + 35% chloropicrin),
at 35 gallons per acre, 3-5 weeks before transplanting, followed by an
application of a herbicide mix of napropamide and trifluralin to the top
of the raised bed at the time of tarp laying (Noling and Botts, 2007).

A soil treatment recently developed by the University of Georgia appears
to be promising as a methyl bromide replacement for Georgia’s eggplant
spring crop, although not for the summer or fall crops.  This treatment,
known as the “UGA 3-WAY”, consists of three successive soil
fumigations, beginning with 1,3-D, followed by a chloropicrin
application, followed by a metam-sodium or metam-potassium application
(Culpepper, 2007a). In 2006, Culpepper et al. (2007a) tested the
effectiveness of fall applications of methyl bromide alternatives,
including the UGA 3 WAY treatment, on nutsedges infesting the spring
bell pepper crop in Tyty, Georgia.   Results of this small-plot study
show that the UGA 3-WAY alternative (see above) performed as well as the
standard methyl bromide application.  Similarly, reducing the standard
rates of methyl bromide by 50%, from 392 kg/ha under standard LDPE film
to 196 kg/ha under metalized film, also provided excellent purple
nutsedge control.  Pepper yields were comparable in all treated plots.

In a related small plot trial, conducted by Culpepper (2007b) in Echols
County, Georgia, during the spring of 2006, excellent purple nutsedge
control was achieved with 484 kg of methyl bromide/ha under standard
film and 336 kg of methyl bromide/ha under metalized film.  However,
further reducing the methyl bromide rate by 50% to 224 kg/ha, under
metalized film, resulted in poor nutsedge control.  Soil fumigation took
place in February.  Culpepper concludes that, based on research
conducted over the past three years with methyl bromide applied under
metalized film, a 33% reduction of the standard 67:33 formulation is
possible in fields heavily infested with weeds, and a 40% reduction in
fields with light weed infestations, whereas reducing the methyl bromide
rate by 50% would be unsustainable for weed control.

Although these results are promising, results from small plot research
need to be verified at the commercial level, in on-farm trials.
Furthermore, most research in Georgia has so far focused on nutsedge.
Additional work is needed to determine the efficacy of alternatives on
other weed species, such as morning glory and pigweed.  Finally, the
economics of transitioning to alternatives has not been fully worked
out, including the cost and durability of films and the modification of
fumigation equipment

7.  ECONOMIC FEASIBILITY OF ALTERNATIVES

The following economic analysis is organized by methyl bromide critical
use application regions.

Readers please note that in this study net revenue is calculated as
gross revenue minus operating costs.  This is a good measure as to the
direct losses of income that may be suffered by the users.  It should be
noted that net revenue does not represent net income to the users. Net
income, which indicates profitability of an operation of an enterprise,
is gross revenue minus the sum of operating and fixed costs.  Net income
should be smaller than the net revenue measured in this study.  We did
not include fixed costs because it is often difficult to measure and
verify.

Summary of Economic Feasibility

The economic analysis of eggplant applications compared data on the
yields, crop prices, revenues and costs of using methyl bromide or
alternative pest control regimens. This was done in order to estimate
impacts on eggplant growers with the decreasing availability of methyl
bromide.  The Georgia 3-Way (1,3-dichloropropene with chloropicrin
followed by metam sodium) was identified as being a technically feasible
alternative (in cases of low pest infestation and in spring fumigations
only) to methyl bromide in Georgia and Florida eggplant production.
1,3-D + chloropicrin is also being recognized as an alternative to
methyl bromide; however, it is not considered technically feasible as
yield losses are expected.

The economic reviewers analyzed crop budgets for pre-plant sectors to
determine the likely economic impact if methyl bromide were unavailable.
 Various measures were used to quantify the impacts, including the
following:

(1) Loss per Hectare.  For crops, this measure is closely tied to
income.  It is relatively easy to measure, but may be difficult to
interpret in isolation.

(2) Loss per Kilogram of Methyl Bromide.  This measure indicates the
value of methyl bromide to crop production.

(3) Loss as a Percentage of Gross Revenue.  This measure has the
advantage that gross revenues are usually easy to measure, at least over
some unit, e.g., a hectare of land or a storage operation.  However,
high value commodities or crops may provide high revenues but may also
entail high costs.  Losses of even a small percentage of gross revenues
could have important impacts on the profitability of the activity.

(4) Loss as a Percentage of Net Operating Revenue.  We define net cash
revenues as gross revenues minus operating costs.  This is a very good
indicator as to the direct losses of income that may be suffered by the
owners or operators of an enterprise.  However, operating costs can
often be difficult to measure and verify.

(5) Operating Profit Margin.  We define operating profit margin to be
net operating revenue divided by gross revenue per hectare.  This
measure would provide the best indication of the total impact of the
loss of methyl bromide to an enterprise.  Again, operating costs may be
difficult to measure and fixed costs even more difficult, therefore
fixed costs were not included in the analysis.

These measures represent different ways to assess the economic
feasibility of methyl bromide alternatives for methyl bromide users, who
are eggplant producers in this case.  Because producers (suppliers)
represent an integral part of any definition of a market, we interpret
the threshold of significant market disruption to be met if there is a
significant impact on commodity suppliers using methyl bromide.  The
economic measures provide the basis for making that determination.

Georgia and Florida

In Georgia and Florida, using the Georgia 3-Way on spring plantings is
believed to be a technically and economically feasible alternative to
methyl bromide, although some limitations exist. Referring to Tables 3
and 4, the loss of net revenue using the Georgia 3-Way is negligible for
Florida in comparison to methyl bromide, while gains in net revenue are
expected in Georgia. Unlike spring plantings, however, yield losses are
expected in fall plantings, with studies in Georgia’s application
showing 50% yield losses. The Georgia 3-Way also cannot be used on
eggplants that are grown in karst soils since it contains 1,3-D.
Therefore, for fall plantings and areas with karst soils, the use of
methyl bromide is critical to Georgia’s and Florida’s eggplant
production. Note that data describing Georgia eggplant production is
based on double cropping production practices.

Florida Analytical Notes:

Florida’s application for methyl bromide critical use indicated that
more than one crop is typically grown per growing season but did not
provide specific production and sales data for this crop.  As a result
of this gap in data, economic assessment of Florida eggplant production
was based on a single crop production system.  This characterization of
growing conditions could result in the critical need for methyl bromide
appearing smaller than it actually is, because the value the second crop
derives from methyl bromide is not included in the analysis.

Table 3: Georgia - Economic Impacts of Methyl Bromide Alternatives

GEORGIA EGGPLANT	METHYL BROMIDE	GEORGIA 3-WAY: SPRING APPLICATION
GEORGIA 3-WAY: FALL APPLICATION

PRODUCTION LOSS (%)	0%	0%	50%

    PRODUCTION PER HECTARE	7,070	7,070	3,535

* PRICE PER UNIT (US$)	$8	$8	$8

= GROSS REVENUE PER HECTARE (US$)	$57,547	$57,547	$28,774

- OPERATING COST PER HECTARE (US$)	$45,271	$34,610	$34,610

= NET REVENUE PER HECTARE (US$)	$12,277	$22,938	-$5,836

LOSS MEASURES *

1. LOSS PER HECTARE (US$)	$0 	($10,661)	$18,113

2. LOSS PER KILOGRAM OF METHYL BROMIDE (US$)	$0 	($71)	$121

3. LOSS AS A PERCENTAGE OF GROSS REVENUE (%)	0%	-19%	31%

4. LOSS AS A PERCENTAGE OF NET OPERATING REVENUE (%)	0%	-87%	148%

5. OPERATING PROFIT MARGIN (%)	21%	40%	-20%

Note: Georgia eggplant revenue and cost measures were calculated using
data from a two crop per growing season production system.

Interpret the loss measures with caution. Negative numbers presented in
rows indicating a “loss” should be interpreted as a “gain”.
Positive numbers can be interpreted as losses.

Table 4: Florida - Economic Impacts of Methyl Bromide Alternatives

FLORIDA EGGPLANT	METHYL BROMIDE	GEORGIA 3-WAY: SPRING APPLICATION 	1,3-D
+ CHLOROPICRIN

PRODUCTION LOSS (%)	0%	0%	29%

    PRODUCTION PER HECTARE	1,764	1,764	1,252

* PRICE PER UNIT (US$)	$11	$11	$11

= GROSS REVENUE PER HECTARE (US$)	$19,983	$19,983	$14,188

- OPERATING COST PER HECTARE (US$)	$17,891	$17,976	$17,303

= NET REVENUE PER HECTARE (US$)	$2,092	$2,007	-$3,116

LOSS MEASURES *

1. LOSS PER HECTARE (US$)	$0 	$85 	$5,208

2. LOSS PER KILOGRAM OF METHYL BROMIDE (US$)	$0 	$1 	$70

3. LOSS AS A PERCENTAGE OF GROSS REVENUE (%)	0%	0%	26%

4. LOSS AS A PERCENTAGE OF NET OPERATING REVENUE (%)	0%	4%	249%

5. OPERATING PROFIT MARGIN (%)	10%	10%	-22%

* Interpret the loss measures with caution. Negative numbers presented
in rows indicating a “loss” should be interpreted as a “gain”.
Positive numbers can be interpreted as losses.

8.  RESULTANT CHANGES TO REQUESTED EXEMPTION QUANTITIES

The USG has applied an aggressive transition rate, which is reflected in
the nomination amount and detailed in Table 5.

Table 5. Nomination Amount:

Citations

Aerts, M. 2003. Asst. Director, Environmental and Pest Management
Division, Florida Fruit and Vegetable Association.  Personal
Communication with G. Tomimatsu, December 2, 	2003.

Banks, H. J.  2002.  2002 Report of the Methyl Bromide Technical Options
Committee, 2002 Assessment.  Pg 46.

Chellemi, D.O., R. C. Hochmuth, T. Winsberg, W. Guetler, K. D. Shuler,
L. E. Datnoff, D. T. Kaplan, R. McSorley, R. A. Dunn, and S. M. Olson.
1997. Application of soil solarization to fall production of cucurbits
and pepper. Proc. Fla. State Hort. Soc. 10:333-	336.

Cortright, B. 2003.  Field Research Associate University of Michigan.
Personal Communication with G. Tomimatsu, November 24, 2003.

Cortright, B.D. and M.K. Hausbeck. 2004. Evaluation of fumigants for
managing Phytophthora crown and fruit rot of solanaceous and cucurbit
crops, plot two, 2003.  Unpublished study (MI CUE # 03-0061).

Csinos, A.S., D.R. Sumner, R.M. McPherson, C. Dowler, C.W. Johnson, and
A.W. Johnson. 1999. Alternatives for methyl bromide fumigation of
tobacco seed beds, pepper, and tomato seedlings.  Proc. Georgia Veg.
Conf. Available on the Web at
http://www.tifton.uga.edu/veg/Publications/Gfvga99.pdf

Culpepper, A.S.  2007a.  Methyl bromide CUE data generated in Georgia
(Fall, 2006 – Spring, 	2007), Appendix 1.

Culpepper, A.S.  2007b.  Impact of mulch type on rate of methyl bromide
needed to control 	nutsedge.  Methyl bromide CUE data generated in
Georgia (Fall, 2006 – Spring, 2007), 	Appendix 4.

Culpepper, A.S., A.L. Davis, T.M. Webster, A.W. MacRae, and D.L.
Langston.  2007a.  Bell 	pepper and nutsedge response to fall applied
methyl bromide alternative fumigants in 	Georgia.  UGA Weed Science.
At:   HYPERLINK "http://www.gaweed.com"  www.gaweed.com

Culpepper, A.S., P. Sumner, D. Langston, K. Rucker, G. Beard, J.
Mayfied, T. Webster, and W. 	Upchurch.  2007b. Can Georgia growers
replace methyl bromide?  MBAO Conference, 	San Diego, California, 2007.

	  HYPERLINK "http://mbao.org/2007/PDF/Preplant/PP4/Culpepper(20).pdf"
http://mbao.org/2007/PDF/Preplant/PP4/Culpepper(20).pdf

Culpepper, A.S., P. Sumner, D. Langston, K. Rucker, G. Beard, J.
Mayfied, T. Webster, and W. Upchurch.  2008. DMDS or the 3-Way: Which is
more effective in Georgia.  Orlando, Florida, 2008.   HYPERLINK
"http://mbao.org/2008/007Culpepper.pdf"
http://mbao.org/2008/007Culpepper.pdf

Duncan, R. S. and S. R. Yates. 2003. Degradation of fumigant pesticides:
1,3-Dichloropropene, Methyl isothiocyanate, chloropicrin, and methyl
bromide.  Vadose Zone Journal 2:279-286.

Florida Fruit and Vegetable Association (FFVA).  2002. Application for
the Methyl Bromide Critical Use Exemption on Solanaceous Crops (other
than tomato).  September 9, 2002.

Frank, J.R., P. H. Schwartz and W.E. Potts. 1992. Modeling the effects
of weed interference periods and insects on bell peppers (Capsicum
annuum). Weed Sci. 40:308-312.

Gevens, A.J. and M.K. Hausbeck. 2003. A first report of Phytophthora
capsici in irrigating water near cucurbit fields in Michigan (Abstr).

Gilreath, J. P. B. M. Santos, T. N. Motis, J. W. Nolling, and J. M.
Mirusso.  2005.  Methyl Bromide alternatives for nematode and Cyperus
control in bell pepper (Capsicum annum). Crop Protection  24:903-908.

Kelley, W. T. 2003, Professor, University of Georgia. Personal
communication with G. Tomimatsu, November 24, 2003.

Lamour, K. H.  and M. Hausbeck.  2003.  Effect of Crop Rotation on the
survival of Phytophthora capsici in Michigan. Plant Dis. 87:841-845.

Lewis, C. 2003 (President, Hy-Yield Bromine).  Personal communication
through S.A. Toth (  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>) , Extension Entomologist & Pest Management
Information Specialist, North Carolina State University; message
forwarded electronically to G. Tomimatsu, December 29, 2003.

Melban, K. 2003. California Pepper Commission. Personal Communication
with G. Tomimatsu.   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>. 11/26/2003.

Noling, J. W. 2003. University of Florida-Lake Alfred. Personal
Communication with G. Tomimatsu.   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>. 11/25/2003.

Noling, J.W., E. Rosskopf, and D.L. Chellemi. 2000. Impacts of
alternative fumigants on soil pest control and tomato yield. Proc.
Annual Int. Res. Conf. on Methyl Bromide Alternatives and Emissions
Reductions. Available on the web at   HYPERLINK
"http://www.mbao.org/mbrpro98.html"  http://www.mbao.org/mbrpro00.html .

Noling, J.W. and D.A. Botts.  2007.  Alternatives to methyl bromide soil
fumigation for 	Florida 	vegetable production.  University of Florida
IFAS Publication.  At:

	  HYPERLINK "http://edis.ifas.ufl.edu/CV290"
http://edis.ifas.ufl.edu/CV290   and:

	  HYPERLINK "http://edis.ifas.ufl.edu/pdffiles/CV/CV29000.pdf"
http://edis.ifas.ufl.edu/pdffiles/CV/CV29000.pdf

Stall, W.M. and J. Morales-Payan. 2000. The critical period of nutsedge
interference in tomato. S.W. Florida Research & Education Center.
HYPERLINK "http://www.imok.ufl.edu/liv/groups/IPM/weed_con/nutsedge.htm"
 www.imok.ufl.edu/liv/groups/IPM/weed_con/nutsedge.htm

USDA.  2002.  Crop Profiles: Florida Eggplant.    HYPERLINK
"http://pestdata.ncsu.edu/cropprofiles/docs/FLeggplant_.html"
http://pestdata.ncsu.edu/cropprofiles/docs/FLeggplant_.html

U.S. EPA. 2002. Peppers-Field. Peppers Grown Outdoors on Plastic Mulch.
CUN2003/058

Webster, T. M., A.S. Csinos, A.W. Johnson, C. C. Dowler, D. R. Sumner,
R. L. Fery. 2001. Methyl bromide alternatives in a bell pepper-squash
rotation. Crop Protection 20:605-614.

 It should be noted that the USG does not request methyl bromide for use
in areas of low to moderate pest pressure.  Only cases where key pests
are present at moderate to high levels require methyl bromide for pest
pressure.

USA CUN13 Soil Eggplant Grown in Open Fields		Page   PAGE  1  of
NUMPAGES  16

COVER SHEETS

For Administrative Purposes only:

Date received by Ozone Secretariat:

YEAR:	CUN:


Reviewed by: Joycelyn E. Stewart, Ph. D. Registration Action Branch ( H7509C) Secondary Reviewer: William Sette, Ph. D. Science Analysis Branch I ( H7509C)

DATA EVALUATION REPORT STUDY TYPE: Subchronic oral/ human volunteers TOX. CHEM. No.: 328 MRID No.: 442488 01 GUIDELINE #: Non guideline TEST MATERIAL: 2,2 dichlorovinyl dimethyl phosphate SYNONYMS: dichlorvos, DDVP, dedevap, Vapona STUDY NUMBERS: XH6063 SPONSOR: Amvac Chemical Corporation TESTING FACILITY: Central Toxicology Laboratory Adderly Park, Macclesfield, Cheshire, U. K.

TITLE OF REPORT: Dichlorvos: A Single Blind, Placebo Controlled, Randomized Study to Investigate the Effects of Multiple Oral Dosing on Erythrocyte Cholin esterase Inhibition in Healthy Male Volunteers.

AUTHORS: Miss A. J. Gledhill REPORT ISSUED: March 24, 1997 EXECUTIVE SUMMARY: In a single blind oral study fasted male volunteers were administered DDVP in capsules daily at a dosage of 7 mg ( equivalent to approximately 0.1 mg/ kg/ day) in corn oil for 21 days. Control subjects received corn oil as a placebo. Any adverse events suffered by the participants were recorded on adverse events forms. Baseline values for RBC cholinesterase activity for each study participant were determined on days  14,  12,  10,  7,  5,  3, and immediately prior to dosing, and RBC cholinesterase activity was monitored on days 2, 4, 7, 9, 11, 14, 16, and 18.

No toxicity was reported which could be attributed to DDVP administration. While there were significant decrements in RBC cholinesterase activity in DDVP treated subjects at some reporting periods, the overall mean reduction from pretreatment values did not exceed 16 percent at any time. The cholinesterase activity values used to calculate the individual means varied by up to 21 percent. The LOEL for RBC cholinesterase inhibition is 0.1 mg/ kg/ day. The study is classified Acceptable Non Guideline.

MATERIALS:

Dichlorvos ( lot # 608002S074), 98% a. i., described as a clear colorless liquid, was the test chemical. Corn oil ( CTL reference # 00790/ 007/ 007, was the vehicle. Nine healthy Caucasion male volunteers, age 19 34 years, weighing 61 to 90 kg were the test subjects. In order to be included in the study, participants had to be between the ages of 18 and 45 years old, of a single ethnic group, be within normal range with respect to history and physical examinations, and EKG, routine clinical chemistry, hematology, urinalysis; have RBC cholinesterase values of 10,000 IU/ L, be negative for hepatitis B antigen and the human immunodeficiency virus, and negative screen for drugs of abuse.

METHODS:

1. Dosing Preparation Dichlorvos was dissolved in corn oil at 14 mg/ mL, placed in capsules which were passed through a disposable sterile filter ( 0.2 Fm Sartorius V115 filtraton unit) into a sterile container, then dispensed into sterile red # 0 gelatin capsules. Capsules were stored individually in sterile screw top containers. Two staff members were always present during the preparation of the dose formulations and dosing capsules in order to ensure accuracy in compound and dose preparation. Capsules were prepared on a weekly basis. The dichlorvos content of the dosing formulations, the dosing capsules and the stability of dichlorvos in the dosing formulation and capsules were determined by gas chromatography. Dosing volume was 0.5 mL.

2. Study Design The study was a single blind, randomized, placebo controlled study. Nine healthy males were selected from the Medeval Volunteer Panel. Each study participant was given a complete medical history review and was given a thorough physical examination. Blood was drawn for standard hematology and biochemistry, determination of hepatitis B antigen, humanimmunodeficiency virus, and erythrocyte cholinesterase activity. Heart rate, blood pressure and EKG were measured, and urine was collected for standard urinalysis and a drugs of abuse screen.

On the day of dosing, participants were fasted from midnight then randomly assigned to treatment groups receiving either 1 mg/ kg of dichlorvos in corn oil or the corn oil vehicle administered in gelatin capsules for twenty one days. Dosing volume was 500 FL. Each capsule was administered with 150 ml of water. RBC cholinesterase activity was measured on study days  14,  12,  10,  7,  5,  3, and immediately pre compound administration to establish baseline cholinesterase activity. Following compound administration RBC cholinesterase activity was measured on days 1, 2, 4, 7, 9, 11, 14, 16, 18, 25, 28, and 29/ 30. Additional samples were taken from volunteers 2, 3, 5, and 6 on day 24 for determination of cholinesterase activity.

Blood was collected into heparinized tubes and centrifuged at 2000 rpm at ambient temperature for 15 minutes to separate plasma from red blood cells. Plasma was snap frozen using dry ice and acetone and stored at  20EC for possible additional study. RBC were analysed for cholinesterase using a modified Ellman method and a Kone Specific analyser ( specifications to follow)

3. Protection of Subjects The study was conducted in accordance with the Declaration of Helsiinki including all amendments up to and including the Hong Kong revision.

4. Exclusion fron the Study The following persons were excluded from participation in the study: persons with frequent or regular use of medication or therapy; participation in another study within three months before the start of the study; any acute illness within two weeks of the start of the study; persons with suspected or definite personal or family history of adverse drug reactions or hypersensitivity to chemicals with a structure similar to that of dichlorvos; persons with history of g. i., hepatic or renal disease; donation of more than 1500 mL of blood in the 12 month period up to the end of the study; excessive alcohol intake; treatment within the previous three months with any drug known to have a well defined potential of toxicity to a major organ; persons exposed to organophosphorus compounds within the last three months; smokers of over 10 cigarettes per day; persons with planned need for general anesthesia within two months of the last day of study participation; and volunteers who, in the opinion of their physician should not participate in the study;.

QUALITY ASSURANCE: Signed and dated quality assurance statements were included in the submission.

STATISTICAL ANALYSIS: Differences in group mean cholinesterase activity between control and dichlorvos treated individuals at each time point were analysed by repeated measures analysis of variance using the MIXED procedure in SAS. The Leased Squares Mean ( LSM) for each period and treatment group were calculated, and the differences between the dichlorvos treated group LSM and the placebo treated group LSM were compared using a two sided Student's t test based on the standard error in the analysis.

Differences between pre study and subsequent group means for each treatment at each time point were compared using a paired t test.

Differences between pre study and subsequent cholinesterase levels for each individual were compared using the Good permutation test.

RESULTS: Several study participants reported non specific symptoms but there were no sympatomatology which could be attributed to DDVP administration. Of the three control subjects, one ( volunteer 1) reported mild dizziness on day 1, and coughing days 10 to 16; one ( volunteer 5) reported forgetfulness and tiredness on days 3 7, and flatulence on days 16 18, and backache days 4 through the end of the study. This subject was administered analgesics by the study nurse on days 9 and 10. Of the six participants treated with DDVP, one ( volunteer 8) complained of mild headache, one ( volunteer 6) suffered a nosebleed, one ( volunteer 2) reported tiredness on days 0 4, and one ( volunteer 4) complained of nausea on day 1 and tiredness on days 1 22. The symptoms reported did not seem to be associated with the results of the RBC cholinesterase measurements.

The results of the RBC Cholinesterase activity, taken from the investigators' report, are shown in the following two tables Table 1. Mean RBC Cholinesterase Activity ( I. U.) in Male volunteers administered 7 mg DDVP ( 0.1 mg/ kg/ day) for 21 days placebo treated n = 3 DDVP treated n = 6 Time Mean "

S. D % Mean "

S. D. %

Pre dose 18484" 1347 100 17738" 1713 100 Day 1 17930" 1404 97 17628" 1914 99 Day 2 18180" 1565 98 16817*" 1547 95 Day 4 18740" 1771 101 16933**" 1598 95 Day 7 18530" 1888 100 16182" 1796 91 Day 9 18460" 1007 100 16708" 2505 94 Day 11 19210" 1036 104 16037" ** 1654 90 Day 14 18490" 1642 100 15333**" 1250 86 Day 16 17706" 2470 96 15912**" 1063 86 Day 18 18260" 2299 99 14855**" 1199 84 * significantly different from pre dose values group ( t test based on repeated measures analysis of variance) p < 0.05 ** significantly different from placebo treated group p< 0.05.

Table 2 Individual RBC Cholinesterase Activity ( IU) in volunteers Administered DDVP 0.1 mg/ kg/ day for 21 days Volunteers 11 2 3 4 51 6 7 8 91 Predose Mean 18727 17204 17141 17480 17031 17069 16380 21156 19692 Day 1 17630 ( 94) 16940 ( 98) 17320 ( 101) 19380 ( 111) 16700 ( 98) 16180 ( 95) 15490 ( 95) 20460 ( 97) 19670 ( 100)

Day 2 18320 ( 98) 17150 ( 100) 16770 ( 98) 15550 ( 89) 16550 ( 97) 16430 ( 96) 15360 ( 94) 19640 ( 93) 19670 ( 100)

Day 4 19090 ( 102) 17280 ( 100) 16090 ( 94) 16650 ( 97) 16820 ( 99) 16370 ( 96) 15300 ( 94) 19910 ( 94) 20310 ( 103)

Day 7 18400 ( 98) 15230 ( 89) 15700 ( 92) 14570 ( 83) 16710 ( 98) 16790 ( 98) 15350 ( 94) 19910 ( 94) 20310 ( 103)

Day 9 17950 ( 96) 15080 ( 88) 16130 ( 94) 15180 ( 87) 17810 ( 105) 17640 ( 103) 14850 ( 91) 21370 ( 101) 19620 ( 100)

Day 11 19630 ( 105) 15680 ( 91) 15610 ( 91) 15020 ( 86) 18030 ( 106) 16300 ( 95) 14450 ( 88) 19160 ( 91) 19970 ( 101)

Day 14 19300 ( 103) 14500 ( 84) 15380 ( 90) 14580 ( 83) 16600 ( 97) 15300 ( 90) 14490 ( 88) 17750 ( 84) 19570 ( 99)

Day 16 18670 ( 100) 14710 ( 86) 15460 ( 90) 14530 ( 83) 14900 ( 87) 14420 ( 84) 14800 ( 90) 17230 ( 81) 19550 ( 99)

Day 18 19340 ( 103) 15800 ( 92) 15490 ( 90) 14680 ( 84) 15620 ( 92) 13310 ( 78) 13610 ( 83) 16240 ( 77) 19820 ( 101)

postdose 17410 ( 93) 14130 ( 82) 13970 ( 82) 13840 ( 79) 16470 ( 97) 15190 ( 89) 13920 ( 85) 17310 ( 82) 19630 ( 100)

( ) indicates percent of individual predose mean, which was derived from 7 measurements done prior to dosing 1 indicates placebo treated subject DISCUSSION: As shown in Table 1, mean RBC cholinesterase activity was significantly reduced in DDVP treated male subjects when compared to control subjects on days 7, 11, 14, 16, and 18. However, when compared to the pre treatment means, the mean RBC cholinesterase activity was reduced 14 percent on days 14 and 16, and 16 percent post dose on day 18. It should be noted that the pretreatment mean for the DDVP treated subjects was lower that of the placebo treated subjects. It should also be noted that even in the controls, there were up to 21 percent differences in individual RBC cholinesterase activity. The reduction in RBC cholinesterase activity was considered by the HAZARD ID Committee to be biologically significant. With respect to the use of male subjects only in this study, the NTP used lower doses in males in the mouse oncogenicity study based on information that males are more sensitive to the effects of DDVP than are females. SignOff Date: 3/ 24/ 1998 DP Barcode: D235158 HED DOC Number: 012541 Toxicology Branch: RAB2