US Environmental Protection Agency
Office of Pesticide Programs
pro^ Petition for Cyprodanil
February 1, 2008
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syngenta
FEDERAL EXPRESS
• s
February 1,2008 ** ** 7 * -*
» •
Document Processing Desk {Exclusive Use Extension Request)
Office of Pesticide Programs (7505P) • . ..
U S. Environmental Protection Agency *
One Potomac Yard - Room S-4900 » -¦ *
2777 South Crystal Drive
Arlington, VA 22202
» m
Attention: Ms. Cynthia Giles-Parker - Branch Chief, Fungicide Branch
Ms, Mary Waller, Team 21 Lead, Fungicide Branch
SUBJECT: EXCLUSIVEiUSE^EXTENSION REQUEST-CYPRODINIL (Cyprodmil Technical
epa no! ioo-'Isai 8 WG " 6PA R°9' Na 100-828'Swl,ch 62 5 WG
Dear Ms, Giles-Parker
fi^MeyFvC\r0PwPr0teCt!°n'r!oC ' submits this aPP'ication under the authority of FiFRA section
pin S?d rlqUSStS EPA srant S^Ser,ta Cr°P Protection, Inc., a 3-year elension of
exc us ve use for the cyprodmil data specified within the application The current cvDrodinil
exclusive use penod expires April 10, 2008. When EPA grants "Se new
exclusive use penod will extend through April 10, 2011. M SIOn'Ine new
^rCti0n?C)!1F)(,l) provides for up fc 3 3"Vear extension of the exclusive use penod for
for m n n9 certain Ratify,ng criteria are met and a sufficient number of registrations
for minor use crops are obtained within certain timeframes. 9 5
"*» N°- ,0°-828- Th"S' * fr Peri°d following the initial registration and must
rnnTo the minor use crop. Vanguai d WG Fungicide and another end -use product
hPPn m'r^7^? °W,tCh 62 5WG Fun9icide, have subsequently been registered for and
SS -Se°n many Tin0rcr0ps/uses' sVn9enta provides specific justificat.on within
reai^trat on gmp°*" ^ ^ appr°Ved ^ the 7^ear penod fol!o^S
SnSnnfTh ? reqU' Cf ena flhRA section WXHOi) stipulates that a 7-year
fnfal T ir exclusive use period will be granted for each 3 minor uses approved up to a
total of 3 additional years for all minor uses approved. Thus, cyprodinil fully meets the statutory
minimum number of required minor use reg stations and, therefore, qualifies fcr a 3-y«ar
exclusive use extension. y
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syngenta
Mb. Giles-Parker, Ms, Walter
February 1, 2008
Page 2 of 2
Additionally, the statute requires applicants to provide information that allows the Administrator
r Secre?fy « ****>*•<° that .he active ingredtenTfor wS
the extension is being pursued satisfies at least one of four "qualifying criteria " Synqenla
Se4r V3f 3 Q " me attachfd aP3liCali0n 10 c*»rodlnil the required
d»S for ?h-i ™"°r "$es and 10 3LPP°rt extending (he exclusive use period for cyprodinii
uses wLre se'-rid a?"™ r! " re9's'e'eC 00 over 70 minor crops and Ihe 9 supporting minor
o ^ , as &uPPortmg examples for consideration by EPA Please note hat
applSon oncrjnni3 "r °f ^ cHypro,liril data eliSibje for exclusive use extension within the
soedffcS iZnmZ* " 3r, ' We request !he A9enc* amend '< Publii: to
specifically identify the new exclusive use expiration date of April 10, 2011, for these data,
SEn r6?UeStS< !Hat the Agency Proceec with review and evaluation of our application
at ?336> 6?P Sq?' ne requeStfd eXtenS'Wn prior t0 APnl 1°. 2008. Please feel free contact me
request can be of assistance or answer any questions in association with this
Best regards,
Greg Watson, Ph.D.
NAFTA Fungicide and Insecticide Team Lead
Syngenta Regulatory Affairs
Syngenta Crop Protection, Inc.
cc: Ms. Lois Rossi, Director, Registration Division, EPA
Dr. Janis McFarland, Director, Regulatory Affairs, Syngenta Crop Protection
Enclosures
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Application For Extension of
Exclusive Use Period for Cyprodinil
Data Supporting the Registration of
Cyprodinil Technical, EPA
Registration Number 100-811,
Vangard® WG, EPA Registration
Number 100-828 and Switch®
62.5WG, EPA Registration Number
100-953
Supporting Minor Use Crops: Basil,
Blueberries, Broccoli, Cabbage,
Chives, Lychee, Mustard Greens,
Pistachio and Raspberry
Syngenta Crop Protection
Application for Exter sign of Exclusive Use Period
Piige 1 of 26
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Table of Contents
I. Introduction »
• ••*•«•»••« «JF
M
. SUMMARY AND CONCLUSIONS OF APPLICATION . _ 4
HI. Statutory Foundation . .1ZZZIZZIZIZ 4
IV. Cyprodinil Qualifies for Exclusive Use Extension .......IlTZIlZIll* 5
Cyprodinil and the Nine (9) Identified Minor Uses Were Registered After
August 3,1996 ......... I..................... 5
¦ ^ All Nine (9) Minor Uses Were Approved Within Seven Years of First
Cyprodinil Registration.......... *
J>
• Syngenta Markets Cyprodinil for Use on the Claimed Minor Uses..,....,,....,... 6
Each of the Nine (9) Identified Minor Uses Qualifies Under FJFRA section
2(11) as a Minor Use.... , §
Each of the Nine (9) Minor Uses Was Registered Within the 7-Year Window
and Applicable Residue Data Were Generated to Support the Minor 1st. 7
V. Procedure Used to Identify, Evaluate and Group Alternative Active
Ingredients - for purposes of comparisons under exclusive use qualifying
criterion 1 (biological efficacy) g
VI. Biological Profile for Cyprodinil..... Z!.."Z 12
Cyprodinil Resistance Management (Important for Exclusive Use
Extension Qualifying Criterion 3 — Plays a significant role in managing pest
resistance....................... # m 12
VII. Discussion of Minor Uses and Biological Efficacy of Cyprodinil
(Exclusive use extension qualifying criterion 1; insufficient efficacious
ALTERNATIVES) 13
Basil
Blueberry 14
Broccoli 1*
Cabbage 16
Chives 17
Mustard Greens - 18
Lychee «•••« 19
Pistachio ••••• 2©
Raspberry 22
Cyprodinil Resistance Management (Important for Exclusive Use Extension
Qualifying Criterion 3 - Plays a significant role in managing pest resistance 23
VIII. Request Three Year Extension of Cyprodinil Data Exclusive Use
Period.... 24
IX. Request for Meeting.....— 25
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 2 of 26
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Application For intension of Exclusive use Period for Cyprodinil data
THE RRWIRation of Cyprodinil Technical, EPA Registration Number
100-811,Vangard®WG, EPA Registration Number 100-828 and Switch® 62.5WG,
EPA Registration Number 100-983,
Supporting Minor Use Crops; Basil, Blueberries, Broccoli, Cabbage, Chives,
Lychee, Mustard Greens, Pistachio and Raspberry
I Introduction
Syngenta Crop Protection, Inc. submits this application under the authority of
FIFRA § 3(c)(1)(F)(ii) and requests EPA grant an extension of the exclusive: use period
for cyprodinil data for a period of 3 years. Under FIFRA § 3
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FIFRA stipulates that at least 3 minor use crops must be approved to qualify for a 1 year
exclusive use extension of the data up to a maximum of 3 additional years of exclusivity.
yngenta provides supporting documentation in this application for approved minor use
crops that support this extension. Thus, cyprodinil has met the statutory requirements
and ls a candidate for a 3-year extension of exclusive use of data This application
provides documentation that will allow the Administrator, in consultation with the
Secretary of Agriculture, to determine tnat the use of cyprodinil on each of the 9
identified minor use crops satisfies at least one of four stated qualifying criteria.
Therefore, an extension of the exclusive use period for 3 years to April 10 2011 is
appropriate as provided by FIFRA.
il^yiliBI^P..COMCLOSiows of Application
Cyprodinil is registered for use on many groups of crops which permits use on a
substantial number (over 70) of minor crops. As evidenced by 40 CFR 180.532
(Appendix III), cyprodinil has been exteisively researched and has a substantial number
of tolerances established. Nine minor crops were selected as examples to support the
extension of the exclusive use period fcr cyprodinil. The nine crops include Basil,
Blueberries, Broccoli, Cabbage, Chives, Lychee, Mustard Greens, Pistachio and
Raspberry. A narrative discussion of how cyprodinil satisfies the required criteria is
presented in a separate discussion for each minor crop within this application. In
summary, the following FIFRA § 3(1)(F)(ii) qualifying criteria are satisfied for each minor
crop claimed within this application:
• E^ch minor crop meets the statutory definition of being a minor use,
• Each minor use was registered after August 3, 1936,
• Each minor use was first approved during the required 7-year window following
initial registration of a product containing cyprodinil,
• Syngenta has provided sufficient information to show that at ieast one of the four
qualifying extension criteria has oeen satisfied for each minor crop. For each
minor crop cyprodinil has superior biological efficacy, significant application rate
advantages reducing environmental loading, and resistance management
partnership benefits.
1L, STATUTORY FOUNDATION
FIFRA § 3!(1)(F)(ii) provides a one-year extension of the exclusive use period for each 3
minor uses approved after August 3, 1996 and within 7 years of the commencement
period of the exclusive use period up to a total of 3 additional years for all minor uses
registered by the Administrator,
The registrant or applicant must first demonstrate that each minor use it claims qualifies
under the statutory definition of minor use -at FIFRA section 2(H). The definition of minor
use at FIFRA section 2(H) means the use of a pesticide on an animal, on a commercial
agricultural crop or site, or the protection of public health where:
1. the total US acreage for the crop is less than 300,000 awes, as determined by the
Secretary of Agriculture; or
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 4 of 26
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2. the EPA Administrator, in consultation with the Secretary of Agriculture, determines
that, based on information provided by an applicant for registration or a registrant, the
use does not provide sufficient economic incentive to support the initial registration or
continuing registration of a pesticide for such use and
• there are insufficient efficacious alternative pesticides available for the use;
• the alternatives to the pesticide use pose greater risks to the environment or
human health;
• the minor use pesticide plays or will play a significant part in managing pest
resistance; or
• the minor use pesticide plays or will play a significant part in an integrated pest
management program.
The applicant must provide sufficient information that will allow the Administrator, in
consultation with the Secretary of Agriculture, to determine that, in addition to it
qualifying as a "minor use", at least one of the following four qualifying exclusive use
extension criteria is met:
¦ Qualifying Criterion 1 - there are insufficient efficacious alternative registered
pesticides available for the use (Biological Efficacy):
¦ Qualifying Criterion 2 - the alternatives to the minor use pesticide use pose
greater risks to the environment or human health (Risk);
¦ Qualifying Criterion 3 - the minor use pesticide plays or will play a significant role
in managing pest resistance (Pest Resistance), or
¦ Qualifying Criterion 4 - the minor use pesticide plays or will play a significant part
in an integrated pest management program (IPM Program).
IV, Cyprodinil Qualifies for Exclusive Use Extension
¦ Cyprodinil and the Nine (9) Identified Minor Use Crops Were Registered
After August 3,1996
Cyprodinil received Its first EPA registration on April 10, 1998 with the registrations of
two products containing cyprodinil and named Cyprodinil Technical (EPA Registration
Number 100-811) and Vangard WG (EPA Registration Number 100-828} (Appendix II -
Notice of Product Registration and stamped label for Cyprodinil Technical and Vangard
WG). On August 21, 2001 an additional product also containing cyprodinil named
Switch 62.5WG (EPA Registration Number 100-953) was registered. All minor use crops
claimed within this application were approved following the initial registration date for
cyprodinil and appear on product labeling for Switch 62.5WG.
¦ All Nine (9) Minor Us# Crops Were Approved Within Seven Years of first
Cyprodinil Registration
Syngenta markets cyprodinil for use on many crops to control a wide spectr jm of
diseases. Following the initial registration of Cyprodinil Technical and Vangard WG, all
minor use crops claimed in this applicat on were approved by EPA at various dates
during the 7-year period. The deadline date for cyprodinil for a minor use crop to be
Syngenia Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 5 of 26
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approved for it to be an eligible minor use crop is April 10, 2005 (7 year window date
following fire! registration on April 10,1998).
To demonstrate that approvals of all of the claimed minor use crops were? achieved
within the required period, the EPA stamped approved label for Switch 82.5WG that was
last approved before April 10, 2005 i s attached. This label was approved by EPA on
October 14, 2004 and includes direc'io is for use on ali of the claimed minor use crops
referenced in this application. (Appencix IV-A Notice of registration and EPA stamped
labe! for Switch 62.5WG and dated October 14, 2004).
• Syngenta Markets Cyprodlnil for Use on the Claimed Minor Us© Crops
Syngenta markets two branded products containing cyprodinil. These products include
Switch 62.5WG that is marketed in the vegetable, fruit and specialty crop segments and
Vangard WG that is marketed for us© on almonds, grapes, pome fruits and stone fruits.
Directions for use on all minor use crops claimed within this application are approved on
the current EPA accepted version of ihe Vangard WG and Switch 62.5WG label
Syngenta markets cyprodini! for use on the nine (9) minor use crops in this application
using the Switch 62.5WG product as srown below. A copy of the marketed container
label for Switch 62.5WG is shown in Appendix VS.
Product
Brand Name
Minor Uses on iPA Approved
Label
Switch 62.5WG, EPA Reg.
No. 100-953
Switch 62.5WG
Basil, Blueberries, Broccoli, Cabbage,
Chives, Lychee, Mustard Greens,
Pistachio and Raspberry
• Each of the Nine (9) identified Minor Use Crops Qualifies Under FIFRA
section 2(11) as a Minor Use Crop
Each minor use crop supporting this application is an agronomic crop that meets the
criteria for being a minor use on the basis that the total acreage for the crop in the United
States is less than 300,000 acres as recognized by the Department of Agriculture
To assure that a claimed crop is a minor use crop and therefore eligible to support an
application for exclusive use extension, Syngenta surveyed two recognized public data
resources that report crop production in the United States. Our survey of these data
sources confirmed that the total United States acreage for each crop would classify it as
a "Minor Use Crop' as described within the Food Quality Protection Act at Subtitle A-
Minor Use Crop Protection Section 210 (a) (II) (1). The two reference sources surveyed
are listed below With their website addresses:
1. National Agricultural Statistics Association 2002 Census of Agriculture report
http://www.nass.usda.gov/Census of Agriculture/index.asp
2. National Site for the USDA Regional IPM Centers Information System
http.//www ipmcenters.org/
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 6 of 26
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• Each of the Nine (9) Minor Use Crops Was Registered Within the 7-Year Window
and Applicable Residue Data Were Generated to Support the Minor Use Crop
The chart below lists the nine minor use crops supporting this application, the resoective crop
grouping, the MRiD number(s) assigned to the residue data supporting the minor use crops
tolerance and reference to a Syngenta product that is marketed for use on the minor crop.
Minor Us®
Crop Nam©
on Label
Crop Group Number &
Name
Cyprodinii
Product/Registration
Number/Label
Approval Date
MRID Number
Supporting Minor
Use Crop Residue
Data
Basil
19-Herbs and Spices
Switch 62 4 WG /
EPA Reg. No. 100-
953 / October 14,
! 2004
45795301
457954 31
Blueberries
13B - Bushberry
Subgroup
! Switch 62.4 WG /
EPA Reg. No. 100-
953 t October 14,
2004
45522201
Broccoli
5-A Brassica Head and
Stem ©roup
Switch 62.4 WG /
EPA Reg. No. 100-
953 / October 14,
2004
45726001
Cabbage
5-A Brassica Head and
Stem Group
Switch 62.4 WG /
EPA Reg. No. 100-
953 / October 14,
2004
45839801
Chives
19A - Herb Subgroup
Switch 62.4 WG/'
EPA Reg. No. 100-
953 / October 14,
2004
45795302
45795402
Lychee
Tropical fruit
Switch 62.4 WG i
EPA Reg. No. 100-
953 1 October 14,
2004
45660001
Mustard
Greens
5 - Brassica (cole) Leafy
Vegetables
Switch 62.4 WG I
EPA Reg. No. 100-
953 1 October 14,
2004
45726002
Pistachio
14 - Tree Nuts Group
Switch 62.4 WG /
EPA Reg. No. 100-
953! October 14,
2004
45544601
Raspberry
13 - Berries group
Switch 82.4 WG i
EPA Reg. No. 100-
9531 October 14,
2004
45382801
Syngenta Crop Protection
Application for Extension of Exclusive Use Period
Page 7 of 26
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^Procedure Used to Identify, Evaluate and Group Alternative Active Inororiienfc -
undw exclusjveijse qualifying criterion 1
The active ingredients and products approved for use on the minor use crops claimed in
this application were identified by searching published tolerances from the 40 CFR S180
and the hPA Pesticide Product Label System (PPLS).
E^r>Can indePendent'y confirm the accuracy of these comparisons referencing the
eCFR and PPLS;
j]lig^m^ccfss,gpo,gov/nara/cff/waisidx 05/40cfr180 05.html
httpV/www epa.gov/pesticides/pestiabels/.
Utilizing these data and commercial experience, Syngenta then screened the
representative labels for registered products containing the active ingredients approved
for use on the minor use crops and selected those active ingredients considered to have
performance characteristics that we re competitive to cyprodinii
i here are many fungicides registered for control of plant diseases. In today's competitive
market, cyprodinii provides broad spectrum control of economically important pest
diseases, and is considered an effective competitor to a large number of active
ingredients that are labeled on the s ame crops. While there are many competitive
products registered for use on the crops listed in this application, many are relatively old
products for which performance is limited when compared with cyprodir il.
Cyprodinii was compared for each crop to the other active ingredients registered on that
crop. Specifically, the diseases claimed on each product label were compared to those
on the cyprodinii label. In most case5. there was a difference between cyp odinil and
other registered products. Within the total of actives registered for any one crop, three
distinct groups were identified. The se three groups are described as the;
(1) Biological Products,
(2) Partial Alternatives that are Commercially Used for control of specific
diseases, and
(3) Partial Alternatives Not Widely Used because they provide a tower level of
efficacy or other characteristic 'hat limits commercially acceptable use.
The products in the Groups 1 and 3 are excluded from the narrative crop discussions
because they fail to provide reasonable fungicidal performance and therefore do not
qualify as viable effective alternatives to cyprodinii.
These groups are described briefly below as to general use.
Biological*:
Several biological products are registered for control of one or more diseases on several
of the crops included in this petition. But, biological products are characterized with
multiple deficiencies compared to conventional fungicides. Of most concern is their high
susceptibility to environmental condi-iois that negatively affect expected efficacy.
Because of marginal efficacy, these products are only used when minor disease
Syngenta Crop Protection
Application for Extension of Exclusive Use Period
Page 8 of 26
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infestations are expected or when alternating with standard fungicides Biological
product5 are characterized as having only preventative action with no curative action,
nor "kick-back' action. Application rates are high, and they must generally be applied in
high water volumes per acre. The products have a relatively poor shelf l-fe and need
special cool storage conditions. High cost for what the products deliver fuiher limits
commercial acceptance. The products mentioned below are therefore not considered as
viable alternatives to provide commercial control, but they will be identifiec where
appropriate as being registered on th= specific crop (i.e., are registereo on a specific
crop and or they appear in use repotting).
Bacillus pumihis strain QST 2808: Sonato®ASO (69592-13)
Gliocladium catenulatum Strain J1446: Primastop Biofungicide Powder® (84137-8)
Partial Alternatives that are Commercially Used for Control of Specific Diseases;
A partial alternative is identified as a product that has some of the benefits of cyprodinil,
but not all, and therefore cannot completely replace the cyprodinil product. Within the
framework of these efficacy comparisons, this means that the alternative does not
provide the same biological benefits - such as control of the complete cyprodinil
spectrum, in some cases, other characteristics are considered, including application
rate and timing flexibility, number o1 aoplications to a crop, or comparisons of relative
activity compared to the commercial standards in the current marketplace. These partial
alternatives can be divided into two groups: highly effective - low rate products and the
older higher rate products with a lower level of fungicidal activity. This latter group is
considered of lesser importance and will not be considered as a realistic alternative in
the different crop sections, but they will be identified, where appropriate, as being
registered on the specific crop.
Azoxystrobin. (Abound® 100-1098).
Abound is a broad spectrum, preventative, low rate fungicide with s/stemic and
curative properties used for control of many important plant diseases. It can be applied
as 3 foiiar spray, in alternating spray programs, or in tank mixes with other products.
When compared to cyprodinil on ceitain crops, there are diseases it does not control.
Theie are also fungal resistance issues, as there are disease organisms that have
developed resistance to azoxystrobin. There is a disease management program that
includes alternation or tank mixes between it and other labeled fungicides that have a
different mode of action. I his is essential to prevent pathogen population from
developing resistance to azoxystrobin. But it should not be alternated or tank-mixed with
fungicides to which resistance has already developed. Continual use of azoxystrobin
may allow less sensitive strains of pathogens to increase in the population and reduce
the efficacy of azoxystrobin. Since it is a strobilurin fungicide, it should not oe alternated
with Oiher strobilunns. Cyprodinil has a different mode of action, and can b3 used in a
resistance management program that imits the number of consecutive azoxystrobin
applications. For these reasons, azoxystrobin is a considered an effective partial
alternative, with limitations in spectrum and number of consecutive applicat ons.
Trifloxvstrobin: Gem® 500SC (264-626)
Gem is similar to Azoxystrobin n both efficacy and mode of action There is
some variation in the spectrum of diseases on the product labe.'s for some c rops, but
Synge ita Crap Protection
Cyprodinil - Application for Extension of Exclusive Use Period
°age9 of 26
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both do not claim control of Botrytis. Within the crops in these comparisons, Gem is only
involved in pistachio. There are also resistance issues, as there are disease organisms
that have developed resistance. There is a disease management program that includes
alternation or tank mixes between t and other labeled fungicides that have a different
mode of action. I his is essential to prevent pathogen population from developing
resistance to trifloxysirobin; but it should not be alternated or tank mixed with fungicides
to which resistance has already developed. Continual use of trifloxysirobin may allow
[ess sensitive strains of pathogens to increase in the population and reduce the efficacy
of trifloxystrobin. Since it is a strobilurin fungicide, it should not be alternated with other
strobilurins. Cyprodinil has a different mode of action, and can be used in a resistance
management program that limits the number of consecutive trifloxystrobin applications.
For these reasons, trifloxystrobin is considered an effective partial alternat ve, with
limitations in spectrum and number of consecutive applications.
Pyraclostrobin: Cabrio® EG Fungicide (7969-187) and Pristine?© Fungicide (7969-199)
Cabrio and Pristine are similar to Azoxystrobin in both efficacy c-nd mode of
action. There is some variation in t ne spectrum of diseases on the product labels for
some crops, but both do not claim full control of Botrytis. Within the crops in these
comparisons, Cabrio is only involved n raspberry and blueberries. There are also
resistance issues, as there are disease organisms that have developed resistance
There is a disease management proy-am that includes alternation, or tank mixes
between it and other labeled fungicides that have a different mode of action. This is
essential to prevent pathogen population from developing resistance to pyraclostrobin;
but it should not be alternated or tank mixed with fungicides to which resistance has
already developed. Continual use of pyraclostrobin may allow less sens:tive strains of
pathogens to increase in the population and reduce the efficacy of pyraciostrobin. Since
it is a strobilurin fungicide, it should not be alternated with other strobilurins, Cyprodinil
has a different mode of action, and can be used in a resistance management program
that limits the number of consecutive pyraclostrobin applications. For these reasons
pyraclostrobin is considered an effective partial alternative, with limitations in spectrum
and number of consecutive applicat oris.
Pvrimethanil. Scala® SC Fungicide (234-788)
Scala is within the same group of chemistry as cyprodinil and has a similar
disease control spectrum. Within the crops claimed in this petition, it and cyprodinil are
registered only on pistachio. When considering that the resistance management
information on product labels restricts the number of consecutive applications by mode
°f action, there are relatively few alternatives for control of Botrytis and Alternaria
diseases. For this reason, it is not unreasonable to have more than one product from
the same chemical family,
Boscalid Endura® Fungicide (7969-137)
Endura belongs to the group of respiration inhibitors classified a;; csrboxamides
or Target Site of Action Group 7 fungicides. It has a protective effect because it inhibits
Spore germination and a curative-erad cative effect because it inhibits mycelial growth
and sporulation of the fungus on the leaf surface, it can be applied pre- or oost-
infection. Optimum disease control is achieved when used in a rotation program with
other fungicides, it contains a resistance management recommendation against
predominant and repeated use to prevent buildup of fungal isolates resistant to this
family of fungicides. In order to maintain the performance of boscalid, the Directions for
Syngeita Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 10 of 26
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use for each labeled crop lists the maximum number of sequential applications and the
total number of applications permitted per season. Thus, boscalid is considered to be a
product that cyprodinil would be rotated with in the norma! sequence to de ay ".he
expansion of resistant funga! isolates. But boscalid does not control Botryiis, on which
cyprodinil is efficacious, so it can b-3 considered only a partial alternative for cyprodinil.
Thiophanate methyl 85WPG: (721B7-18-66222)
Within the crops in this comparison, this carbamate fungicide is only registered
on pistachios. The label specifies that only one application should be applied and then
alternated with a different mode of action product. It has a high application rate for the
diseases it controls. Thiophanate methyl is not registered for Aiternaria, so it can only
be considered a partial alternative tor cyprodinil,
iPfOdione: Rovral® 4 (264-482)
Rovrai is a dicarboximide fungicide that is effective on many diseases. On
raspberries, it is only registered for control of Botrytis, with a maximum of four
applications per season, it can be used in rotation with cyprodinil for control of this
disease; but in addition to Botrytis, Cyprodinil is registered for control of Aiternaria,
Colletotrichum, and Monilinia. Because of this limited disease control spectrum,
iprodione can only be considered as a partial alternative for cyprodinil.
Fenhexamid: Elevate® 50WDG (66330-35)
Elevate is a hydroxyanilide protectant fungicide for control of Botrytis in
raspberries. The label specifies that there can be only two consecutive applications that
must be followed with two application of a product with a different mode of action. The
annual limit is 3.0 pounds active ingredient per acre per season. Its spectrum is limited,
not being registered for control of Aiternaria, Colletotrichum., or Monilinia diseases. Thus
it can only be considered as a partial alternative to cyprodinil, which controls all of these
diseases.
Chlorothaionil: Bravo WeatherStik€i(50534-l88-100)
Bravo is registered for use en blueberries for suppression of Monolinia and
Colletotrichum diseases It is a high rate product at 3 pounds Al/A that should be
followed with an alternative product of a different mode of action. The total rate that can
be applied is 9.0 pounds per acre per season. Thus, it can only be considered as a
partial alternative, at best, for use in resistance management programs as it does not
provide full control of the disease on which cyprodinil is effective.
Partial Alternatives Not Widely Used:
There are several products that hold registrations for control of one of more diseases
controlled by cyprodinil in the crops within this application. As a general group, they are
relatively ineffective, compared to the group above, or are not used to any extent
because of other biological or chemical limitations. For these reasons, while they are
mentioned within the narrative discussions for each crop as being registered, they are
not considered commercial alternatives that reach the commercial expectations growers
have to be considered as cyprodinil alternatives and are, therefore, exc uded from
consideration as viable effective alternatives to cyprodinil.
Captan 80WG (66222-58)
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 11 of 28
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Copper Basic Micro Flo Copper 41 (51036-28)
Copper Hydroxide Blue Shield 50WP (51036-270)
Copper Hydroxide Kocide®2000 (352-656)
Copper Sulfate basic Copper (51036-24)
Copper oxychloride Micro Flo Copper 50WP (51036-124)
Basic Copper Sulfate Cuprofix 40 Disperss® DF (4581-413)
Cupros Oxide Nordox® 75WG 48142-4
Cupris oxide Chem COP 50 Fungicide (26883-20)
Cinnamaldehyde Cinnacure® A3005 (58866-12)
Potassium bicarbonate Carbonic A;id Armicarb® 100 (5905-541)
Potassium salts of fatty acids M-Pede® (62719-515)
Sulfur 9QW (19713-238)
Calcium polysulfide lime Sulfur (51036-226)
Ziram® 4L (19713-93)
VI. Biological Profile for Cyprodinii
Cyprodinii is a broad spectrum pyrirnidinamine systemic fungicide that can be used on
many crops. Its mode of action is inhibition of amino acid synthesis which is essential
for fungal growth. There is also inh bition of secretion of hydrolytic enzymes (produced
by the fungi) which support the penetration of the fungi into leaves. Specifically it inhibits
the biosynthesis of methionine which is required for fungal growth. It acts at the
beginning of, or just after the initiation of plant penetration by the fungi. Cyprodinii
interferes with the funal life cycle by inhibiting penetration and disruption of inter- and
intra-celluiar mycelial growth. Because of its lipophilic properties, cyprodinii is easily
taken up into the cuticle and wax layers of plant leaves and fruits. From there it
continuously distributes and penetrates into the other plant parts.
Cyprodinii is highly active at low temperatures^ with preventive and curative activity, and
no cross-resistance to current market products Its unique mode of action makes it an
excellent fit with IPM spray programs. From the environmental side, it is immooile in the
soil, has fast degradation in soil by microorganisms, has fast photolytic degradation and
is non-toxic to birds and bees. Applied as a foliar fungicide, cyprodinii provides long
lasting protective activity and curative activity. It does not have strong eradicative
activity.
Cyprodinii Resistance Management (Important for Exclusive Us# Extension
Qualifying Criterion 3 - Plays a significant role in managing pest resistance!
As a member of the aniiinopyrimidms chemical class of fungicides, a Fungicide
Resistance Action Committee working group has been established to recommend best
practices to minimize the development of resistance. This class of chemistry has shown
no cross-resistance with other fungicide groups. After use of these procucts, there ts
field evidence that Botrytis populations have shown the occurrence of a low frequency of
less sensitive isolates without impacting efficacy in the field. In order to minimize the risk
of increasing the frequencies of resistance, anti-resistance strategies must be
Syngenta Crop Protection
Cyprodinii - Application tor Extension of Exclusive Use Period
Page 12 of 26
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implemented in order to assure the successful use of this family of chemistry over long
periods of time, y
VII. DISCUSSION OF MINOR Use Crcps ANn Bioi nrc.PA, pcc,n^v
OF CVPROOINIL
(Exclusive use extension qualifying criterion 1: insufficient efficacious
alternatives!
A discussion for each claimed miner use crop is presented below. This section identifies
potential alternative fungicide active ingredients that are registered on the specific minor
use crop and have been classified as a partial alternative. The biological efficacy
attributes of these partial alternatives are based on the diseases listed on their label as
being controlled and are compared with those of cyprodinil. A conclusion on whether
cyprodmil is superior is presented.
Sasil
There are insufficient efficacious alternatives to the use of cyprodinil on basii, and in
addition basil qualifies as a minor use crop for the purpose of an exclusive use
extension.
Cyprodinil is registered for use on basii and is labeled to control two diseases (Alternaria
leaf spot and Botrytis leaf blight),
A total of four other active ingredients are registered for use on basii including Bacillus
pulliam spp , potassium bicarbonate, Gliocladium catenulatum, and cinnamaldehyde.
While these products list the diseases on their label that cyprodinil controls, these
products have significant performance weaknesses when compared to cyprodinil and
therefore are insufficient efficacious alternatives to cyprodinil.
Basil Diseases Controlled By Cyprodinil Compared T® Registered Partial
Alternatives
Fungal Disease
Scientific
Name
0
1
Alternaria Leaf Spot
Alternaria
spp.
X
Botrytis Leaf Blight
Botrytis spp. } x
X - disease is listed on label for products containing the respective active ingredient.
The biological efficacy qualifies of cyprodinil are compared with the registered
alternatives in the following discussion
Exclusive Use Qualifying Criterion 1 - Biological Efficacy (Insufficient Efficacious
Alternatives)
Cyprodinil satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for use on basil.
Biological control agents such as Bacillus pulliam spp. and Gliocladium catenulatum are
sensitive to certain crop growing environments and climatic conditions and often fail to
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 13 of 26
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provide adequate efficacy when comoared to cyprodinil. This weakness teads to them
being classified as providing inconsistent and less than acceptable performance.
Alternatively, cyprodinil is highly eficacious against the diseases listed above and
provides consistent performance across a wide spectrum of growing conditions and:
under diverse climatic conditions.
Potassium bicarbonate and cinnamaldehyde are "early vintage" pesticide products which
fail to provide any measurable degree of control of the two diseases listed above for
which cyprodinil is highly effective. Many published articles that speak to the diseases
associated with basil production do not reference these products nor do they indicate
that they can be effectively used to control these two diseases controlled by cyprodinil.
For these reasons these products are not efficacious alternatives to cyprodinil.
Thus, since the other active ingredients registered for use on basfl have significant
performance and reliability issues and cyprodinil provides reliable biological efficacy
superior to them, cyprodinil is classified as a superior product for use on basil.
Since cyprodinil has a broader spectr jm of biological efficacy and is superior to other
products registered for use on basil, tiere are insufficient efficacious registered
alternatives to cyprodinil for use on basil,
Bjuebgrry
There are insufficient efficacious alternatives to the use of cyprodinil on blueberry, and in
addition blueberry qualifies as a minor use crop for the purpose of an exclusive use
extension.
Cyprodinil controls four major diseases including Alternaria, Colietotrichum, Botrytis and
Monilinia species. None of the potential alternatives provides control of this broad
spectrum. Azoxystrobin, Captan, Chlorothalonil, Pyraclostrobin, Fosetyl-al, and Ziram
are registered for use on blueberry out they are not alternatives to cyprodinil because
they neither control as broad a disease spectrum nor provioe the consistent
commercially acceptable control th&t cyprodinil claims on its label at a very low
application rate.
Blueberry qualifies as a minor use crop that supports an extension of the exclusive use
period for cyprodinil based upon cyprodinil satisfying the biological efficacy qualifying
criteria. A comparison of the biolog.cd efficacy of cyprodinil versus the potential
alternatives is presented below:
Syngenta Crop Protection
Cyprodinil - Applicatic n -or Extension of Exclusive Use Period
Page 14 of 26
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Blueberry Diseases Com
Registerec
trolled By Cyprodinil Compared To
Partial Alternatives
Fungal
Disease
Scientific Name
Cyprodinil
Vangaril
WG 100-
8 28
Azoxyst
robin
Abound
100-
1098
' Chlothal
onil
Bravo
Weathnf
Stilt
50534-
188
Pyraclostr
obin
Cabrio
7969-187
| Boscalid *
pyraclostr
obin
Pristine
Fungicide
7369-19S
Fosetyl-al
Aliette
WDG 264-
516
Aiternaria
Fruit Rot
Aiternaria
tenuissima
X
S
Aiternaria
Fruit Rot
Aiternaria spp.
X
X
X
Anthracnose
Colletotrichum sou.
X
X
X
Anthracnose
Fruit Rot
Colletotrichum
gfoeosporaides
X
X
Anthracnose
Ripe Rot
C. iloeosporoWes
s
Botrytis fruit
Rot
Botrytis cinerea
X
Mummy
Berry
Monilinia
vaccinitcorymbosi
X
s
Mummy
Berry
Monilinia spp.
X
Mummy
Berry | Vaccinium spp.
X
S - label claims suppression only
X - disease is listed on labei for products containing the respective active Ingredient.
Exclusive Use Qualifying Criterion 1 - Biological Efficacy (Insufficient Efficacious
Alternatives)
Cyprodini! satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for control of the Aiternaria, Colletotrichum. Botryt-s and
SVJonilinia diseases No other product controls this broad spectrum. Azoxystrobin does
not control Botrytis or Monilinia. Pyaclostrobin does not control Monilir ia and Botrytis.
Captan controls only the mummy berry species Vaccinium spp. Bacillus p is also
registered but it does not control Botrytis. Chlorothalonil only provides suppression of
Coiietotrichum and Monilinia species. The potassium bicarbonate carbonic acid is
relatively weak and has a limited spactrum. Ziram only controls a mummy berry species.
Fosetyi-al only claims control of anthracnose fruit rot and provides only suppression of
Aiternaria fruit rot and does not control other diseases controlled by cyprodinil.
The above table shows that cyprodinil is labeled for control of four diseases and while
one or more of these appears on labels of other active ingredients, none have the broad
spectrum of cyprodinil. Thus, there are insufficient efficacious alternatives to cyprodinil
for use on blueberries
Syngenta Crop Protection
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Page 15 of 26
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Broccoli
There are insufficient efficacious alternatives to the use of cyprodinit on broccoli, and in
addition broccoli qualifies as a minor use crop for the purpose of an exclusive use
extension.
Three active ingredients including, Bacillus p., Potassium bicarbonate, and Sulfur are
registered tor use on broccoli but are not efficacious alternatives to cyprodinil. They are
unacceptable alternatives because they do not provide the consistent commercially
acceptable control of powdery mildew lErysiphe polygoni) that cyprodinil claims on its
label at a very low application rate
Broccoli qualifies as a minor use crop that supports an extension of the exclusive use
period for cyprodinil based upon cyprodinil satisfying the biological efficacy qualifying
criteria. A comparison of the biological efficacy for cyprodinil against powdery mildew is
presented below:
Broccoli Disea
R
s«s Controlled By Cyprodinil Compared To
tegistered Partial Alternatives
Fungal Disease
Scientific Name
Cyprodinil Vangard WG
100-828
Powdery Mildew
Erysiphe polygoni
X - disease is listed on label for products containing the respective active ingredient
The biological efficacy qualities of cyprodinil are compared with the registered
alternatives in the following discussion.
Exclusive Use Qualifying Criterion 1 - Biological Efficacy (Insufficient Efficacious
Alternatives)
Cyprodinil satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for control of powdery mildew on broccoli.
The above table shows that cyprodinil is labeled for control of powdery mildew and while
this disease occurs on three other procuct labels, they are not considered efficacious
alternatives. Thus, there are insufficient efficacious alternatives to cyprodinil for use on
broccoli.
Cabbage
There are insufficient efficacious alternatives to the use of cyprodinil on cabbage, and in
addition cabbage qualifies as a minor ise crop for the purpose of an exclusive use
extension.
Three active ingredients including, Bacillus p., Potassium bicarbonate, and Sulfur are
registered for use on cabbage but are not efficacious alternatives to cyprodinil. They are
unacceptable alternatives because they do not provide the consistent commercially
acceptable control of powdery mildew {Erysiphe polygoni) that cyprodinil claims on its
Syngenta Crop Protection
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label at a very low application rate. Bacillus p. does not provide consistent control and
other alternatives are high rate products and provide a lower level of efficacy.
Cabbage qualifies as a minor use crop that supports an extension of the exclusive use
period for cyprodinil based upon cyproriinil satisfying the bioiogical efficacy qualifying
criteria. A comparison of the biological efficacy for cyprodinil against powdery m.ldew is
presented below:
Cabbage Disea
F
ses Controlled By Cyprodinil Compared To
Registered Partial Alternatives
Fungal Disease
Scientific Name
Cyprodinil Vangard WG
100-828
Powdery Mildew
Erysiphe polygoni
X
X - disease is listed on label for products containing the respective active ingredient
The biological efficacy qualities of cyprodinil are compared with the registered
alternatives in the following discussion.
Exclusive Use Qualifying Criterion 1 - Biological Efficacy (Insufficient Efficacious
Alternatives!
Cyprodinil satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for control of powdery mildew on cabbage.
The above table shows that cyprodinil is labeled for control of powdery milcew and while
this disease occurs on three other product labels, they are not considered efficacious
alternatives. Thus, there are insufficient efficacious alternatives to cyprodirii. for use on
cabbage.
Ch'ves
There are insufficient efficacious alternatives to the use of cyprodinil on chives and in
addition chives qualify as a minor use croo for the purpose of an exclusive use
extension.
Cyprodinil controls two important diseases of chives including Alternaria and Botrytis
species. None of the potential alternatives provides control of both these diseases.
Bacillus p., Gliocladium catenulatum ard Cinnamaldehyde are registered for use but
these products are not efficacious alternates to cyprodinil. They are not acceptable
alternatives because they do not control both diseases nor provide the consistent
commercially acceptable control that cyprodinil claims on its label at a very low
application rate.
Chives qualifies as a minor use crop that supports an extension of the exclusive use
period for cyprodinil based upon cyprocirt;! satisfying the bioiogical efficacy qualifying
criteria. A comparison of the biological efficacy of cyprodinil versus the potential
alternatives is presented below:
Syngertti Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page "> 7 of 26
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Chives Diseases Controlled By Cyprodinii Compared To
Registered Partial Alternatives
Fungal Disease
Alternaria Leaf Spot
Botrytis Leaf Blight
X - disease is listed on label
Scientific Name
Alternaria spp.
Botrytis spo.
Cyprodinii VangardWG
100-828
:or products containing the respective active ingredient.
The biological efficacy qualities of cyprodinii are compared with the registered
alternatives in the following discussion.
Exclusive Us© Qualifying Criterion 1 - Biological Efficacy (insufficient Efficacious
Alternatives)
Cyprodinii satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinii for control of tie Alternaria and Botrytis diseases. No other
product controls this spectrum. Bacillus p. and Gliocladium catenulatum are registered
for the control of diseases incited by Ahernaria and Botrytis, respectively, however, these
biological products are subject to environmental variables and do not consistently
provide the expected level of control. Oirnamaldehyde controls Botrytis, but requires a
high application rate and this does not consistently provide the desired leve I of control.
The above table shows that cyprodinii is labeled for control of two diseases and while
one or more of these appears on labels of other active ingredients, none have the broad
spectrum of Cyprodinii Thus, there are insufficient efficacious alternatives to cyprodinii
for use on chives.
Mustard Greens
There are insufficient efficacious alternatives to the use of cyprodinii on mustard greens,
and in addition mustard greens qualify as a minor use crop for the purpose of an
exclusive use extension.
Six active ingredients including, Bacillus p , Potassium bicarbonate, Sulfur, Boscalid,
Cinnamaldehyde, and potassium salts of fatty acids are registered for use on mustard
greens but are not efficacious alternatives to cyprodinii. They are not acceptable
alternatives because they do not provide the consistent commercially acceptable control
of powdery mildew (Erysiphe polygoni) that cyprodinii claims on its label at a very low
application rate. The Bacillus p. does not provide consistent control and others are high
rate products while providing a lower level of efficacy. Boscalid only claims suppression
on its label, making it clear that this active ingredient has a lower level of efficacy than
cyprodinii.
Mustard greens qualify as a minor use ciop that supports an extension of the exclusive
use period for cyprodinii based upon cyprodinii satisfying the biological efficacy
qualifying criteria. A comparison of the biological efficacy for cyprodinii against powdery
mildew is presented below:
Syngertii Crop Protection
Cyprodinii - Application for Extension of Exclusive Use Period
Page 18 of 26
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Mustard Greens Diseases Contrc
Registered Pan
>lled By Cyprodinil Compared To
tial Alternatives
Fungal Disease
Scientific Name
Cyprodinil Boscalid Endura
Vangard WG 10®- 7969-197
828
Powdery Mildew
Erysiphe polygoni
X | S
S - label claims suppression only
X - disease is listed on label for products containing the respective active ingredient.
The biological efficacy qualities of cyprodinil are compared with the registered
alternatives in the following discussion.
Exclusive Use Qualifying Criterion 1 - Biological Efficacy {Insufficient Efficacious
Alternatives)
Cyprodinil satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for control of powdery mildew on mustard greens.
The above table shows that cyprodinil i s labeled for control of powdery mildew and while
this disease occurs on six other product labels, they are not considered efficacious
alternatives. Thus, there are insufficient efficacious alternatives to cyprodinil for use on
mustard greens.
Lychee
There are insufficient efficacious alternatives to the use of cyprodinil on lychee, and in
addition lychee qualifies as a minor use crop for the purpose of an exclusive use
extension.
Four active ingredients including, azoxyst'obin, copper hydroxide, copper sulfate and
cupros oxide are registered for use on lychee but are not considered to be efficacious
alternatives to cyprodinil because they tai to claim control of two diseases that cyprodinil
claims on its label.
Lychee qualifies as a minor use crop that supports an extension of the exclusive use
period for cyprodinil based upon cyprocirv! satisfying the biological efficacy qualifying
criteria. The biological efficacy for cyprodinil against certain diseases is presented
below
Lychee Diseases Controlled By Cyprodinil Compared To
Fungal Disease
Scientific Name
Cyprodinil Vangard WG
100-828
Botrytis Fruit Rot
Botrytis spp.
X
Alternaria Fruit Rot
Alternaria spp.
X
X - disease is listed on abel for products containing the respective active ingredient.
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 19 of 26
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The biological efficacy qualities of cyprodinil are compared with the registered
alternatives in the following discussion.
Exclusive Use Qualifying Criterion 1 - Biological Efficacy (Insufficient Efficacious
Alternatives)
Cyprodini! satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for use on lycbee.
The above table shows that cyprodinil is labeled for control of two foliar diseases
including Botrytis Fruit Rot (Botrytis spp.), and Alternaria Fruit Rot (Alternaria spp } and
these diseases are not claimed on labeling for the other products registered for use on
lychee.
Since cyprodinil is labeled for control of diseases that are not on the alternate product's
label cyprodinil has a broader spectrum of biological efficacy than other alte rnatives and
is therefore superior to the other registered alternative products for use on lychee.
mmm
There are insufficient efficacious alternatives to the use of cyprodinil on pistachio, and in
addition pistachio qualifies as a minor use crop forth© purpose of an exclusive use
extension.
Cyprodinil controls two major diseases ncluding Alternaria and Botrytis species. Most of
the potential alternatives do not provide control of this disease spectrum, Azoxystrobin,
Bacillus p., Potassium bicarbonate Carbonic Acid, Copper hydroxide, Trifloxystrobin,
Boscalid, Cinnamaldehyde, and Thiophanate methyl are registered for use on pistachio
but are not considered to be efficacious alternatives to cyprodinil. These act ve
ingredients are not acceptable alternatives because they do not control as broad a
disease spectrum or provide the consistent commercially acceptable control that
cyprodinil claims on its label at a very low application rate. Pyrimethanil controls both
Alternaria and Botrytis and is considered a viable alternative to cyprodinil
Pistachio qualifies as a minor use crop that supports an extension of the exclusive use
period for cyprodinil based upon cyprodinil satisfying the biological efficacy qualifying
criteria A comparison of the biological efficacy of cyprodinil versus the potential
alternatives is presented below:
Syngen.a Crop Protection
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Page 20 of 26
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Pistachio Dise
ases Controlled By Cyprodinil Compared To
Registered Partial Alternatives
Fungal
Disease
Scientific
Name
Cyprodin
il
Vangard
WG 100-
828
i
Azoxystr j Pylmeth
obirs i an.I
Abound I Scala
100-1098 . 264-788
1
TrifioKys i
trobin
Gem I Boscalid
500SC ] Endura
264 826 I 7969-197
Boscalid ~
pyraclostrobi
n Pristine
Fungicioe
7369-19S
Thiophan
ate-Methyl
Thiophan
atemethyl
4.SAG
51036-432
Alternaria
Leaf Spot
Alternaria
alternata
X
Alternaria
Alternaria
alternata
X
Alternaria
Late Blight
Alternaria
alternata
X
X
X
X
Botrytis
Botrytis
spp.
X
Shoot
blight
Botrytis
X
Jacket rot.
green fruit
rot
Botrytis
cinerea
X
Blossom
and Shoot
Blight
Botrytis
cinerea
X
X - disease is listed on labe
for products containing the respective active ingredient.
The biological efficacy qualities of cyprodinil are compared with the registered
alternatives in the following discussion.
Exclusive Use Qualifying Criterion 1 - Biological Efficacy (Insufficient Efficacious
Alternatives)
Cyprodinil satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for control of tie Alternaria and Botrytis diseases Botrytis is
not controlled by azoxystrobin, trifloxyslrcbin, boscalid, and the biological product
Bacillus p. Alternaria is not controlled by potassium bicarbonate carbonic acid,
cinnamaldehyde. and thiophanate-methyl. While copper hydroxide is labeled for both
diseases, it is relatively weak on both and not considered a viable alternative.
Pyrimethanil is similar to cyprodinil and is considered a realistic alternative.
The above table shows that cyprodinil is labeled for control of two diseases Each has
deficiencies, except for pyrimethanil, which can be a realistic alternative. With only one
product of similar activity, there are insuff cient efficacious alternatives to cyprodin l for
use on pistachios.
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Face 21 of 26
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Raspberry
There are insufficient efficacious alternatives to the use of cyprodinil on raspberry, and in
addition raspberry qualifies as a minor use crop for the purpose of an exclusive use
extension.
Cyprodini! controls four major diseases including Alternaria, Colletotrichum, Botryiis and
Monilinia species. None of the potential alternatives provides control of this broad
spectrum. Copper products, Iprodione, Sulfur, Pyraclostrobin, Boscalid.
Cinnamaldehyde, Captan and fenhexatiid are registered for use on raspberries but are
not efficacious alternatives to cyprodinil because they neither control as broad a disease
spectrum, nor provide the consistent corrmercially acceptable control that cyprodinil
claims on its label at a very low application rate.
Raspberry qualifies as a minor use croo that supports an extension of the exclusive use
period for cyprodinil based upon cyprodiril satisfying the biological efficacy qualifying
criteria A comparison of the biological efficacy of cyprodinil versus the potential
alternatives is presented below:
Raspberry Diseases Controlled By Cyprodinil Compared To
Registered Partial Alternatives
Fungal
Disease
i
j Cyprodinil iprodione
j Vangard WG Kovral 4
Scientific Name 100-828 .234-482
Pyraclostrobin
Cabrio 7969-
187
Boscalid
Endura
7969-197
Fenhexamid
Elevate
50WDG
66330-35
Alternaria
Fruit Rot
Alternaria
tenutssima
X
Alternaria
Fruit Rot
Alternaria spp
X
Anthracnose
Colletotrichum
spp
X
X
Antbracnose
Elsinoe spp.
X
Botrytis Fruit
Rot
Botrytis cinema
X
X
Botrytis blight
Botrytis cinerea
Gray mold
Botrytis cinerea
s
X
X
Mummy B«fry
Monilinia
vaccinitcorymbosi
X
Manilla blight
Monilinia spp.
s
S - label claims suppression only
X - disease is listed on label for products containing the respective active ingredient
The biological efficacy qualities of cyprodinil are compared with the registered
alternatives in the following discussion.
Exclusive Use Qualifying Criterion 1 - Biological Efficacy (Insufficient Efficacious
Alternatives)
Cyprodini! satisfies this criterion because there are insufficient efficacious registered
alternatives to cyprodinil for control of the Alternaria, Colletotrichum, Botrytis and
Moniimia diseases. No other product controls this broad spectrum. Azoxystrobm does
not controi Alternaria, Colletotrichum, or Boyrytis, and Monilinia. Pyraclostrobin does not
Syngerita Crop Protection
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Page 22 of 26
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control Monilinia and only claims suppression of Botrytis. Captan controls only
Anthracnose and Botrytis. The copper products, iprodione, fenhexamid, and Boscaiid
control only one of the diseases controlled by Cyprodinil.
The above table shows that cyprodinil is labeled for control of four diseases and while
one or more of these appears on labels: of other active ingredients, none have the broad
spectrum of Cyprodinil. Thus, there are insufficient efficacious alternatives to cyprodinil
for use on raspberries
Cyprodinil Resistance Management (Important for Exclusive Use Extension
Qualifying Criterion 3 - Plays a significant role in managing pest resistance)
As a member of the anilinopyrimidine chemical class of fungicides, a Fungicide
Resistance Action Committee working group has been established to recommend best
practices to minimize the development of resistance. This class of chemistry has shown
no cross-resistance with other fungicide groups. The importance of this benefit is clear
from the inclusion of cyprodinil in the USDA Pest Management Strategic Plans,
• Pest Management Strategic Plans (PMS Plans)
In addition to the above specifics, cyprodinil is recognized as a valuable component of
PMS Plans,
The USDA Office of Pest Management Policy (OPMP) is facilitating the production of
Pest Management Strategic Plans (PMS Plans) which are developed by growers,
commodity associations, land-grant specialists, food processors, crop consultants, and
EPA. These plans address pest management needs and priorities for individual
commodities.
Each plan focuses on commodity production in a particular state or region. The plans
take a pest-by-pest approach to identifying the current management practices (chemical
and non-chemical) and those under development. Plans also state the commodity's
priorities for research, regulatory activity, and education/training programs needed for
transition to alternative pest management, practices.
Cyprodinil is referenced in many of the PMS Plans as a valuable control agent. The
following table provides a reference to PMS Plans where products containing cyprodinil
are listed
Croo
PMSP Plan Name
Internet' Ad -
Lychee
Tropical Fruit
Management
Strategic Plan
(PMSP), March 31,
2003. Homestead,
FL (35 pages)
http://www.tpmcenters.orq/pmsp/pdf/FLTropicalfr
uit.pdf
Blueberry
Three separate
PMS Plans are in
piace for Oregon
httD7/www.iDmcenters.ora/DmsD/Ddf/ORWABIueb
errv.Ddf
Syngenta Crop Protection
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and Washington,
Michigan, and New
England States
htto://www ipmcenters.orq/pmsp/pdf/Mlbluebefrv
e£
htto://www.ipmcenters.org/pmsp/pdf/NE Btueber
ry PMSP.pdf
Carrots
Three Plans for
California, Michigan
and New Jersey
htto://www.iDm centers,ora/DmsD/odf/CACarrot.Dd
f
h tto://www.ipmcenters.org/pmsp/pdf/micarrots. pd
f
htt o: //www,ipmcenters.org/pmsp/pdf/NJ CarrotP
MSP.pdf
Peach
Plans are in place
htto //www.iDrncenters.ora/Dmso/Dclf/CAPEACHP
| for California,
] Florida, Georgia,
I Michigan, New
. Jersey, North
MSP.pdf
htt3://www.iDmcenters.ora/DmsD/Ddf/easternDeac
h.pdf
h tt d . //www, iDmcenters. ora/DmsDfodf/EastPeach. d
Carolina,
Pennsylvania and
South Carolina
df
htt //www jpmcenters.org/pmsp/pdf/njpeach. pdf
Pear
A Pest
Management Plan
for Pear Production
in California
http://www.ipmcenters.org/pmsp/pdf/CAPear.pdf
Plum
A Pest
Management Plan
for Plum Production
in California
http://www.ipmcenters.org/pmsp/pdf/CAPLUMPM
SF pdf
Prune
A Pest
Management Plan
for California Prune
Production
http://www.ipmcenters.org/pmsp/pdf/caprune.pdf
Raspberry
PMSP for
Caneberry
Production in
Washington and
Oregon
httx//www. ipmcenters.org/pmsp/pdf/PNWCaneb
erryFMSP.pdf
j
VIII, REQUEST THREE YEAR EXTENSION OF CYPRODINIL DATA EXSUSMEUSE PgRlOB
The information within this application provides sufficient evidence for the Administrator
in consultation with the Secretary of Agriculture to determine that registration of
cyprodinil for use on the minor uses basil blueberries, broccoli, cabbage, chives, lychee,
mustard greens, pistachio and raspberry satisfy the required qualifying criteria under
FIFRA § 3(c)1)(F)(ii) to support an extension of the cyprodinil data exclusive use period-
Based upon the information provided in this application Syngerita requests the Agency
grant a 3-year extension of the cyprodinil exclusive use period for (1) ail data submitted
by Syngenta in support of the initial registration of cyprodinil on Apnl 10, 19S8. (2) data
submitted as a condition of registration^ and (3) data submitted to add a new use to the
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 24 of 26
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registration and pertains soley to the new us®. These data are identified within Appendix
V.
We respectfully request that the exclusive use period for the data identified within
Appendix V be extended for a total period of three years This extension will revise the
present expiration date of April 10, 2008 to April 10, 2011
iX. Request for Meeting
Syngenta will formally request a meeting with the Agency to discuss this application
under separate cover and address any questions the Agency may have associated with
its content in the near future.
Dr. Greg Watson, NAFTA Fungicide ard InsecticideTeam Lead
Syngenta Crop Protection, Inc.
Regulatory Affairs
410 Swing Road
Greensboro, NC 27419
Telephone (316) 632-2993
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 25 of 26
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Appendix S - Copy of EPA publication titled Reduced Risk/Organophosphate
Alternative Decisions for Conventional Pesticides last updated August 10, 2007
' Appendix II - Notice of first product registration and stamped labels for Cyprodinil
j Technical. Switch 62.5WG and Vangard WG Fungicide
; Appendix Hi -4QCFR References (40CFR 180.532)
! Appendix IV - A Notice of registration and EPA stamped label for Switch 62 5WG
approved October 14, 2004 & Vanguard WG approved November 7, 2006
Appendix V - Data Matrices
Appendix V! - Copy of final printed label for Switch 62.5WG & Vanguara as sold
currently
Trademarks
Switch®62 5WG, Vangard® WG Fungicide, Abound® Flowable, Bravo WeatherStik®,
Switch® and the Syngenta logo are trademarks of a Syngenta Group Company
Gem© 500SC, Scaia© SC Fungicide, Rovral® 4 are trademarks of Bayer Crop Science
M Pede® Insecticide-Fungicide is a trademark of Dow Agrosciences
Alfiette WDG®, Cabrio®, and Endura© are trademarks of BASF Corporation
Kocide® 2000 is a trademark of E.I, DjFont de Nemours & Co.
Cuprofix 40 Disperss® DF is a trademark of Cerexagri, inc
Nordox® 75WG is a trademark of NORDOX Industries, Inc
Elevate® 50WDG is a trademark of Arvesta Corp.
Cinnacure® A3005 is a trademark of Prcguard, inc
Armicarb® 100 is a trademark of Church and Dwight
©2007 Syngenta
Syngenta Crop Protection
Cyprodinil - Application for Extension of Exclusive Use Period
Page 26 of 26
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