North Dakota Section 18 Exemption Request For Tough® Herbicide (pyridate) in Chickpea



### Section 18 of amended FIFRA provides the Administrator may exempt a state or federal agency from pro visions ofFIFRA if a determination is made that emergency conditions exist that requires such an exemption. The North Dakota De partment of Agriculture is requesting a specific exemption for the us e ofTough SEC (pyridate) to control kochia, including glyphosate-resistant kochia in chickpea. Information required in 40 CFR 166.20(a):

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### Type of Exemption: Specific 2. Contact Person: Jerry Sauter Pesticide , Feed , and Fertilizer Team Leader ND Department ofAgriculture 600 E Boulevard, Department 602 Bismarck, ND 58505-0020 Phone: 701-328-2980 E-mail: jdsauter @ nd.gov Qualifi ed Expert: Brian M. Jenks , Ph.D. Weed Scientist North Dakota State University 5400 Highway 83 South Minot, ND 58701 Phone: 701-857-7677 E-mail: brian.jenks @ ndsu.edu Davy Van Berlamont (Registrant) Belchim Crop Potection , Inc. Technologielaan 7 1840 Londerzeel Belgium Phone: +3 2(0)473 865233 Email: Davy. VanBerlamont @ belchim

.com 

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### •••••3. Description ofthe Pesticide:
Common Name : Pyridate
Trade Name: Tough SEC , not currently registered in U.S.
Formulation: Emulsifiable concentrate formulated at 55.8% (5.0 lb. ai. per gal.) and 44.2% inert ingred ients

. Manufacturer : Belchim Crop Protection a Belgium based company (EPA Company No. 91746). The U.S. distributor is Engage Agro USA Corp. Material Safety Data Sheet (MSDS) and labels are attached.
4. Description of Proposed Use: a) Site to be Treated: Pyridate could be used statewide in North Dakota on chickpea where kochia or g lyphosate-resistant kochia are present at densities that would cause economic loss if not controll ed. b) Method of App lication:
Ground application 

### in 20 -30 gallons per acre broadcast with sprayers equipped with suitab le nozzles and screens no finer than 50 mesh. The herbicide will be app li ed by gro und-driv en spray equ ipment by licensed applicators according to the proposed Section 3 product label and Section 18 l abe l. Tough® SEC may not be applied by aerial methods or through any type of irrigation system and prohibitions on these types of applications are included on the Section 18 label. c) Rate of Application : 0.9375 pounds a.i per acre . This equates to 1.5 pt or 24 

### fl oz


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e) of product per acre. • • • • • • 

### •••• Maximum Number of Applications: 

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### • •••• • Two app lications ofT ough per growing season may be made if necess ru\ ,.)1' wi{ hl spray interval of 20 days (maximum of 3 pt or 48 

### fl oz per season). No • • • • 

### • • applications wi ll be made within 60 days of harvest. • • • Total Number of Acres to be Treated: 

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### •• • • • There were 9 ,600, 6 , 000 , and 7 , 000 acres of chickpea 

### in North Dakota in 

## 2 (9 i3, : 2014 , and 2015 , respectively. We expect up to 5 ,000 chickpea acres 

### in 2016 that may require treatment. f) Total Amount of Pesticide to be Used:
4 , 700 pounds active ingredient for one application. 9 , 400 pounds active 

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### • • •••••ingredient would be the maximum with two applications. g) Use Period: Aprill , 2016 through December 31, 2016 Chickpea is typically harvested in early to late September. A fall application after harvest may be necessary ifconditions promoting weed growth occur. No applications will be made within 60 days ofharvest.

h) Additional Restrictions:

(1) (2) (3) (4) (5) (6) (7) If this product is to be used in western Richland or eastern Ransom Counties, appropriate steps should be taken to minimize drift on and exposure to the threatened Western prairie fringed orchid 

### (Platanthera praeclara). Infonnation on measures to be taken to protect the Western prairie fringed orchid can be obtained by contacting the North Dakota Department of Agriculture at (701) 328

- 2231 or 1-(800) 242-7535
Federal and supplemental labels address reentry and worker protection , environmental hazards and restrictions (see attached label).
To avoid excess residues , do not apply within 60 days of harvest. 

### DO NOT make more than 2 applications 

### DO NOT apply by air. 

### DO NOT apply this product through any type of irrigation system. 

### DO NOT apply this product when wind conditions will allow drift to adjacent susceptible vegetation

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### DO NOT allow livestock to graze on treated fields. 

### DO NOT feed forage , hay or silage from treated fields to livestock. 

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# ..... To Protect endangered plant species, one of the following options must be us oo : : • (I) Appl y only when there is sustained wind away from wetland /transitiom tl zone 

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### • native plant communities , : • • • • • • •: • •: (2) Leave a 25

- foot buffer between treatment area and wetland/transitional**Z..<1If~** flil tive ••• ::



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# . . . . plant comrnurutles , or • • • • • • (3) U se low pressure nozzles according to manufacturer ' s specifications th..ns

.wv .duce only coarse or very coarse droplets. • 

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### • To protect endangered freshwater invertebrate species , do not apply Tough® 5EC within 100 yards of any freshwater spring. Any adverse e f fects resulting from the use of Tough ® 5EC under this emergency exemption must be immediately reported to the North Dakota State Department of Agriculture

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### Unused product: Any unused , unregistered product must e ither be returned to the manufacturer or distributor in unopened containers , or disposed of in accordance with the Resource Conservatism and Recovery Act (RCRA) regulations following the expiration ofthe emergency exemption. Chemigation: For use under this Supp lemental label , do not apply this product through any type of irrigation system. Users are required to comply with all directions , precautions, and directions the exemption use directions and approved lab eling for Tough SEC. 5. Alternat ive Methods of Control: a) Registered Alternative Pesticides

b) 

### Sulf entrazone , pendimethalin , ethalfluralin , trifluralin , metolachlor, and dimethenamid are soi l-app lied herbicides that provide poor to excellent kochia control. To be effective , these herbicides must be incorporated by mechanical tillage or rainfall into the top 1-2 inches of soil where weed seeds are germinating. However, all chickpeas in North Dakota are grown under no-till production systems to conserve moisture and reduce soi l erosion

. Thus , mechanical incorporation is not a viable option and growers must rely on timely rainfall for proper incorporation to activate the soil-applied herbicides. Without a timely rainfall, the herbicides will remain on the soil surface rather than be moved into the top 1-2 inches of so il and will not control weeds as they germ in ate

. It is not uncommon for weeds to escape the soil-applied herbicide because of lack ofrainfall for proper incorporation. Thus , a postemergence herbicide is needed to control escaped weeds. Pyridate is a postemergence herbicide that will control kochia that are not controlled by the soilappl ied herbicides. Imazethapyr is another soil-applied herbicide that controls kochia that is not ALS

resistant. However, it is known that most kochia in North Dakota is ALS resistant. Thus , imazethapyr is not a viable option since most kochia is resistant to

### it**::::** • Saflufenaci l is labeled for preplant use in chickpea, but does not provide resi dttal • control ofkochia. • •: •
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### Quizalofop , sethoxydim and clethodim are registered for foliar appl icationS O fl ' • • chickpea under several product names. However, these products control oqiy•. •, 

### grasses and have no activity on kochia. • • • Alternative Control Practices: • • •••••• 

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### •••• • • • Chickpea is a planted in the spring from late-April to mid-May. Kochia tend §t o • emerge with the crop , but may also germinate throughout the growing season. Therefor e, delayed seeding and/or tillage prior t o seeding do not effectively provide season- long kochia control. Chickpea is commonly seeded in narrow rows and thus in-crop cultivat ion is not a viable alternative for weed control. Hand rogueing is cost • t • • •• • 

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### •••••prohibitive and the labor force needed for hand weeding is not available in this regwn. 6. Efficacy ofthe Proposed Use Under Section 18 Tough selectively controlS many annual broadl eaf weeds including kochi a . Pyridate was safely used from 1999

- 2003 in North Dakota chickpea fie lds , but was vo luntarily withdrawn from the market by the manufacturer in 2004. Pyridate provided good to excell ent kochia control. Pyridat e is more effective applied under the fo ll owing conditions: 1 ) higher water volumes, 2) warm , sunny conditions , and 3) small weeds. Risks to rotational crops are m inima l due to the short half

- life and low soi l persistence leading to no residual impact to subsequent crops. Pyridate is the only known broadle af herbicide that can provide postemergence weed control without impacting chickpea yield.
The tab le below shows the results of a study where kochia was not controlled by soi l

applied herbicides such as Spartan and Sonalan . Dry conditions resulted in little herbicide incorporation and poor weed control. Tough app lied postemergence provided excellent kochia control. Treatments without Tough could not be harvested due to excessive weed growth.

Table. Kochia control in**chick~eas.** Jun 26 Treatmenta Rate Timingb**nju~** Kochc Colg c Y i eld Test wt. % c% control c lb/A lb/bu Son alan 2 pt PP I 0 20 30 0 Spartan I Poast 5

. 33 oz I 1 pt PRE/POST 0 7 13 0 Balance 1.25 oz PRE 0 1 7 23 0 Sonalan I Tough 2 pt/1.5 pt PPI I POST 0 98 99 1666 61.2 T ough+ Poast 1.5 pt + 1 pt 60% 0 87 91 1284 59.3 Tough+ Poastl 1

. 5 pt + 1 ptl 45%/ 0 88 91 1377 60

. 3 Tough+ Poast 0

. 75 pt + 1 pt 75% 

# ..... Tough I 1.5 pt + 2 ptl 60%1 

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### •••• 4 99 99 1641 60.8 Tough+ Poast 0.75 pt + 1 pt 75% 

### •• • • • Goa l + N I S 0

. 25 lb ai + 0

.25 % POS T 57 87 90 1119 " • • 60

. 6 

### • Untreated 0 0 0 

## o . • 8 AII Poast and Tough treatments applied with COG at 2 pt/A

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### • b Percentages refer to % cumulative weed emergence time. •• 

### • c Koch=Kochia; Colq=Common lambsquarters 

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### • 7. Expected Residue Level s in Food:
A permanent tolerance for pyridate of 0.1 ppm was set for chickpea. (Federal register Oct 7 , 1998. https ://www . gpo .gov/fdsys/pkg/FR

- 1998

- l 0

- 07 /html/98

- 26908

.htm)

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### • •••••Residue trials for chickpeas were conducted by the IR-4 Program in 1996. Applications made in accordance with the requested provisions a re not expected to result in residues of pyridate and its metabolites in excess of 0.1 ppm fo r garbanzo beans. These tolerances have been estab li s hed by the EPA and are recorded under CFR 180.462. Second ary res idues in m eat, poultry , and eggs are not expected to res ul t. 8. Di scussion of Risk Information:
On May 3 , 2000 the EPA establ ished tol erances of 0.1 ppm fo r residues of pyridate and its metabolites in/on chickpeas , seed

. Information regarding pyridate toxicology and aggregate exposure can be found in the fina l rule published in the Federal Register May 3, 2000 , vo lume 65 , number 86 , pages 25647-25652 (attach ed).

a . Human H ealth Tough® 5EC herbicide poses little potential risks to humans, domestic anima ls, wildlife, and the environment. The acute ora l LD50 for ma le rats is> 5 , 000 mglkg. T he active ingredient has a lo w dermal irritation pote nti al and a lo w in h al ation h azard. Acute dermal LD50 for rabbits i s > 2,000 mg/kg. Inh alation LC50 >4.3 7 mg ./L air. Primary dermal irri tat ion st udy indicated it is mildly irritating to rabb it skin (EPA Health Effec ts Division of the Office of Pe stic ide Programs, 2000).
The EPA conclud ed th at res idues of pyridate in drinkin g water do no t contribute s ig nificantly to the aggregate acute human health risk. The acute human health risks resulting from exposure to pyridate in foo d and water are below EPA ' s level of concern for all population subgroups. As for chronic risk , the EPA also co ncluded that no harm will result from aggregate chronic exposure. It was also determined that pyridate is not carcinogenic in either rat or mouse , and therefore is not expected to pose a cancer risk to humans. The product l abel addresses the risks to worker/app licator by outlining hand l er precautions and requ ire d personal protective eq ui p men t. b. Potential to be fo und in drinking water The potential for exposure to residues of pyridate in drinking water is negligibl t)**~~~ o**  its low water so lub ility ( 1. 5mg/L at 20 C), strong soi l adsorption (Kd 

### = .3-26) and sho rt

. half-life (7

- 21 days). Pyridate is essentiall y immobile in a ll so il types and any**ri ~&s-** **to** s urface or gro undwater contam ination will be negligib le . • 0 0 

### •••••• 0 The EPA Healt h Effects D ivision determined that pyridate does not poss ess the • • • 0 0 0 en v ironmental fate parameters associated with a compound that could l each to • • • groundwater

. However , the parameter s of its degradate indi cate that under unusual " 0 0 co ndi tions such as flooding , where anaerob ic conditions persist in topsoil for u }l**~** days , th e degradate could possibly leach to gro undwater or run off to surface**~te~** •. Pyridate is not listed in the E PA Pesticides in Ground Water Database , nor i s**th ~**  art EPA Max imum Containment Level or health advisory. •••••• 0 0 0 0 0 • 

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### •••••c. Residential Uses Pyridate is not registered for use in ornamentals or in residential areas. d. Common Mode of Action Pyridate is a Group 6 herbicide , HRAC Group C3 (Herbicide Resistance Action Committee , www.hracglobal.com). 

### It belongs to the phenyl-pyridazine family of herbicides. Its site of action is inhibition photosynthesis by blocking electron transport in photosystem II (reactions taking place in the chloroplast thylakoid membranes).

e. Endangered or Threatened Species See attached document
f. Beneficial Organisms Tough® SEC is not toxic to bees and other beneficial insects (i.e. lady beetles , predatory mites). See the attached EPA Environmental Fate and Effects Division (EFED) report

. g. Fish and Aquatic Organisms Pyridate is considered toxic to estuarine organisms. However, due to its strong soil adsorption and short half-life , if applied according to the label it should not pose a risk to estuarine organisms (see attached EPA EFED report). The label states that this material should not be applied within 100 yards of any freshwater spring , directly to water, to areas where surface water is present, or to intertidal areas below the mean high water mark

. 9. Notification of Other Agencies:
The North Dakota Game and Fish Department, the North Dakota Department of Health , and the local U.S. Fish and Wildlife Service have received copies of this request. Any comments will be forwarded.
10. Notification of Registrant/Manufacturer:

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### 12. Belchim Crop Protection has been notified and their letter of support is attached. o o o o o 

### •••• Enforcement Program: 

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0 The North Dakota Department of Agriculture will monitor applications ofpyridatet(l) •:• • determine that the conditions ofthe emergency exemption are correctly followed

. ••• Parameters monitored will include acres treated and any adverse effects that may 

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." Repeat uses: 

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### ••••• • •••• Pyridate was previously used from 

### 1999-2003. Pyridate was registered October 

### 7: •1 4 9 9 and later cancelled in 

### 2004.
13. Progress Toward Registration: • ••••• 0 • • • • •••••• • 

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### Registration and tolerance were established through IR-4 by EPA. The Final Rule was publ i shed in the Federal Register vo l. 63, No. 194 , October 7 , 1998 pages 53837

- 53844 (attached). Tolerance was estab lished for chickpea at 0.10 ppm (CFR 180.462). Product reg istration was voluntarily cancelled by the registrant (Syngenta) and the product was no longer marketed in the U.S. Recently, Belchim Crop Protection acquired the marketing rights for pyridate from Syngenta. It 

### is understood that Belchim is working with the EPA to re-register pyridate in the U.S. and is seeking full registration by 20 19.
Regist ration and tolerance were established through the IR-4 by the EPA in October 1998

. Tolerances were estab lished chickpeas at 0.10 ppm (CFR 180.462). Product reg istration was vo luntarily cancelled by the registrant (Syngenta) and the product was no longer marketed in the U.S. Recently , Belchim Crop Protection acquired the marketing rights for pyridate from Syngenta. It is understood that Belchirn is working with the E PA to re-register Tough ®

5 EC in the U

.S : List of s tudies th at would be r eq u ir ed by EPA to o btain a secti o n 3 r egistration Following the EPA pre-submission meeting of last year, the following major studies were scheduled in support ofupdating the pyridate dossier for the re-subrnission at EPA which is currently foreseen for September 2016: Field soil dissipation studies in 2 soils; Anaerobic water/sediment study; Aerobic soil metabolism study ; Seedling emergence and vegetative vigor study; Acute avian (passer ine species) toxicity study; Method validation aquatic stud i es . For the other parts ofthe dossier reference will be made to the original pyridate registration

. Additio n al in fo r espo nd ing to: c r o p s scheduled to b e register ed Formulation scheduled for registration : Tough® 5EC (5 lb

. per gallon) Re ference will be made to the existing tolerances as set by the original pyridate registration. Therefore , crops targeted to be registered for the 2016 submission: C urrent t o lerances as fo ll ows (ppm): Estab li s hed Chickpea, seed

. .... ......... .......... .. .. .... ... . ... . ........ . .. 0 .1 October 7 , 1998 Collards

. ..................................................... . ....... 0 .03 May 3 , 2000 Com, field, forage

.............................................. 0 .03 November 18 , 1992 Com, field , grain

................................................ 0 .03 November 18 , 1992 Com, fie ld , stover

......................... . ............ ........ 0

.03 November 18 , 1992 Com, pop , grain

.. ......... ...... .. .. . ... ............ .. .. ........ 0 .03 November 18 , 1992 Com, pop, stover..

........ ...... .. ........ . . .... ... . ............ 0 .03 November 18 , 1992 Peanut

.. . . ............................................................ 0 .03 November 18, 1992 Peppennint, tops

.... . ................. . ......................... 0 .20 May 3, 2000 Spearmint, tops

......................................... . ....... 0 .20 May 3, 2000 •••• 

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### •••••Information Required 

### in 40 CFR 166.20(b ):
1. Pest(s) to be controlled:
Kochia and ALS-resistant kochia 

### (Kochia scoparia)
2. Events Which Brought About the Emergency Condition: Glyphosate-resistant kochia: Glyphosate-resistant kochia has been identified in many areas of the state. Glyphosate is used in no-till production systems to control weeds just prior to or after planting. This glyphosate application is important to provide a clean , weed-free start to the s e ason and give chickpeas a competitive advantage over the weeds. If kochia is not controlled due to glyphosate resistance or cold weather, then kochia will grow uninhibited throughout the growing season as there is no postemergence herbicide label ed currently. Uncontrolled kochia will reduce chickp e a yield and will make harvest difficult. Kochia can grow to 5-6 ft tall similar to small Christmas trees. Mature kochia can plug and damage combines. Dry conditions cause poor weed control from soil-applied herbicides. Soil-applied herbicides such as sulfentrazone must be incorporated into the seed zone shortly after application to effectively control weeds as they germinate. If soil-applied herbicides are not incorporated by mechanical tillage or by rainfall, the herbicide will remain on the soil surface and will not be taken up by weed seedlings that are germinating in the top 1-2 inches of soil. Weeds that emerge before the herbicide is adequately incorporated by a rainfall event typically will not be controlled.
Sulfentrazone cannot be used on all soil types: Sulfentrazone cannot be applied to coarse soils with less than 1.5% organic matter. High soil pH can also limit whether the crop can be grown. Some fields in western North Dakota have high soil pH and low organic matter. Chickpea grows best in western North Dakota because the crop can withstand the drier conditions where ascochyta disease is less prevalent.
Thus , pyridate is needed to control kochia that has escaped control through glyphosate resistance or dry conditions that prevent proper incorporation of soil-applied herbicides

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. Figure 1. Kochia not controlled leads to reduced crop yield. (Minot, NO)

High kochia infestations like those seen above wou ld require a grower to harvest around dense populations, thus los ing 100% yield in those areas. Growers simply cannot risk harvesting dense infes tati ons because kochia will plug and severely damage the combine. New combines cost more than $300,000. Repairing combines cost tens of thousands of dollars , not to mention the time lost while repairs are made. Harvest timing is critical for growers to obtain optimum yield and quality. Pyridate is needed to help control kochia in chickpea.
Economic Analysis
Economic Impact of Kochia in Field Crops 

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### • • • The table below shows a research study where kochia was not controlled by**soil ~a** **~plied** herbicides. Sonalan , Spartan , and Balance provided only 7-20% kochia controL 

### Dcy conditions resulted in inadequate herbicide incorporation and poor weed contro t" " •• • However , pyridate applied postemergence provided excellen t kochia contro l.**lJ'e ~fu** **ents** without pyridate could not be harveste d due to excessive weed growth resulting 

# in ze · ro yield. This study shows a worst case scenario , but demonstrates the potential impact of kochia on yield and crop harvest. • 

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### • • •••••Table. Koch ia control in**chick~eas .**  Jun 26 Treatmenta Rate T imingb**lnju~** Kochc Colgc Yield Test wt. % c% control 

### c lb/A lb/bu Son alan 2 pt PPI 0 20 30 0 Spartan I Poast 5.33 oz /1 pt PRE/POST 0 7 13 0 Balance 1

. 25 oz PRE 0 17 23 0 Sona l an I Tough 2 pt/1.5 pt PPI/ POST 0 98 99 1666 61.2 Tough+ Poast 1

. 5 pt + 1 pt 60% 0 87 91 1284 59

. 3 T ough+ Poastl 1

. 5 pt + 1 ptl 45%/ 0 88 91 1377 60

. 3 Tough+ Poas t 0.75 pt + 1 pt 75% Tough I 1

. 5 pt I 60% I 4 99 99 1641 60.8 Tough+ Poast 0

. 75 pt + 1 pt 75% Goal+ N I S 0.25 lb ai + 0.25 % POST 57 87 90 1179 60.6 Untreated 0 0 0 0
8AI/ Poast and Tough treatments applied with COC at 2 pt!A. b Percentages refer to % cumulative weed emergence time. c Koch=Kochia; Colq=Common lambsquarters



### Tier I Significant Economic Loss (SEL) Analysis
For purposes of the Tier I analys is , the " Baseline " is theoretically a chickpea fie ld grown in a normal year with no kochia present. For purposes of estab li shing potential chickpea yield without chickpea, we must at look at trials in which clos e to 100% kochia contro l was achieved w ith herbicide treatments. From the trial described, clo se to 100% was ach ieved w ith the treatment of Sonalan followed by Tough. This treatment will be used as the " Baseline " , with a measured yield of 1 , 666 lb/A.
In comparison , the " Emergenc y" condition will be d efi ned as an average infestation of the emergency pest, using the best registered alternative (Sonalan or Spartan). The measured y ield following this treatment was 0 lb/A.
The diff erenc e in yield between the " emergency" and " baseline " treatments was I , 666 

# t-lifi\ : • Thi s equates to a yield loss of 100%. This meets the SEL threshold under Tier 1. • • • • 

### • •••• Base line Emergency Change %Chan ge 

### • Yield 1 , 666 0 1,666 -100 

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### • Supporting Documentation: 1. Tough SEC Package Label 2. Tough SEC Section 18 Supplemental Label 3. Tough SEC M S DS 4. Northern Pulse Growers Letter of Support 

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### 5. Belchim letter of support 6. North Dakota Threatened and Endangered Species Risk Assessment



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