Montana Section 18 Exemption Reques t For Tough® Herbicide (pyridate) in Chickpea

Section 18 of amended FIFRA provides the Adm ini strat or may exempt a state or federal agency from provisions ofFIFRA if a determination is made that emergency conditions exist that requires such an exemption. The Montana Department ofAgriculture is requesting a specific exemption for the use ofTough SEC (pyridate) to control kochia, including glyphosate

-resistant kochia in chickpea. Information required in 40 CFR 166.20(a):

1. Type ofExemption: Specific 2. Contact Person: Linda Johns Pesticide Licensing , Registration , and Training Program Manager MT Department of Agri culture 302 N. Roberts St. Helena, MT 59601 Phone : 406-444-3676 E-mai l : l johns @ mt.gov Qualified Expert: Edward S. Davis Agriculture Specialist, C r opland Research Montana State University Land Resources and Environmental Science RmMarshLab Bozeman, MT 59717 Phone: 406

-994 -7 987 Emai l: edavis @ montana.edu Brian M. Jenks , Ph.D. Weed Scientist North Dakota State University 5400 Highway 83 South Minot, ND 58701 Phone: 701

- 857 -7 677 E

-mail: brian

. jenks @ ndsu.edu Davy Van Berlamont (Registrant) Belchim Crop Potection, Inc. Technologielaan 7 1840 Londerzeel Belgium Phone: + 32 (0) 473 86 52 33 Emai l: Davy

. VanBerlamont @ belchim.com

### 3. Description ofthe Pesticide: Common Name: Pyridat e Trade Name: Tough SEC, not currently registered 

### in U.S. Formulation: Emulsifiable concentrate formulated at 55.8% (5.0 lb. ai. per ga l. ) and 44.2% inert ingredients. Manufacturer: Belchim Crop Protection a Belgium based company (EPA Company No. 91746). The U .S. distributor is E ngage Agro USA Corp. Mater ial Safety Data Sheet (MS D S) and labels are attached. 4. Description ofProposed Use: a) Site to be Treated: Pyridate could be used statewide in Montana on chickpea where kochia or glyphosate-resistant kochia are present at densities that would cause economic loss if not controlled. b) Method of App lication: Ground application 

### in 20

- 30 gallons per acre broadcast with sprayers equipped with suitable nozzles and screens no fmer than 50 mesh. The herbicide will be applied by ground- driven spray equipment by licensed applicators according to the proposed Section 3 product label and Section 18 label. T ough® SE C may not be applied by aerial methods or through any typ e 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 of product per acre. d) Maximum Number of Applications: Two applications of Tough per grow ing season may be made if necessary with spray interval of 20 days (maximum of 3 pt or 48 fl oz per seaso n). No applications will be made within 60 days of harvest. e) Total Number of Acres to be Treated : Projected 61 ,200 (90% ofestimated 68,000 total acres planted) f) 

### Total Amount of Pesticide to be Used : 57 , 375 pounds active ingredient for one application, 114 ,750 pounds active in gred ient would be the maximum with two applications.

### g) Use Period: April 1 , 2016 through December 31 , 2016 Chickpea is typically harvested in early to late September. A fall application after harvest may be necessary if conditions promoting weed growth occur. No applications will be made within 60 days ofharvest.
h) Additional Restrictions: Additional measures should be taken to minimize drift and exposure on threatened and endangered plant species in Montana

. Federal and supplemental labels address reentry and worker protection, environmental hazards and restrictions (see attached label). (1) To avoid excess residues , do not apply within 60 days of harvest. (2) DO NOT make more than 2 applications (3) DO NOT apply by air. (4) DO NOT apply this product through any type of irrigation system. (5) DO NOT apply this product when wind conditions will allow drift to adjacent s u sceptibl e vegetation. (6) DO NOT allow livestock to graze on treated fields. (7) DO NOT feed forage, hay or silage from treated fields to livestock. To Protect endangered plant species , one of the following options must be used: (1) Apply only when there is sustained wind away from wetland/transitional zone native plant communities , (2) Leave a 25-foot buffer between treatment area and wetland/transitional zone native plant communities , or (3) Use low pressure nozzles according to manufacturer' s specifications that produce only coarse or very coarse droplets. To protect endangered freshwater invertebrate species, do not apply Tough ®

5EC within 100 yards of any freshwater spring. Any adverse effects resulting from the use of Tough ®

5EC under this emergency exemptio n must be immediately reported to Montana Department of Agriculture. Unused product: Any unused, unregistered product must either be returned to the manufacturer or distributor in unopened containers, or disposed of in accordance with the Resource Conservatism and Reco very Act (RCRA) regulations following the expiration of the emergency exemption.Chemigation: For use under this Supplemental 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 labeling for Tough 

### SEC. 5. Alternative Methods of Control : a) Registered Alternative Pesticides Sulfentrazone, pendimethalin, ethalfluralin, trifluralin , metolachlor, and dimethenamid are soi l-applied 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, nearly all chickpeas in Montana are grown under no-till production systems to conserve moisture and reduce soil erosion. T hus, 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 w ill not contro l weeds as they germinate. 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 soil-applied herbicides. Imazethapyr is another soil-appl i ed herbicide that controls kochia that is not ALSresistant. However, it is known that most kochia in North Dakota i s ALS resis tant. Thus , imazethapyr is not a viable option since most kochia is resistant to it. Saflufenacil is labeled for preplant use in chickpea, but does not provide residual control of kochia. Quizalofop , sethoxydim and clethodim are registered for foliar applications on chickpea under severa l p roduct names. However, these products control only grasses and have no activity on kochia. b) Alternative Control Practices: Chickpea is a planted in the spring from late-April to mid-May. Kochia tends to emerge with the crop , but may also germinate throughout the growing season. Therefore , delayed seeding and/or tillage prior to seeding do not effectively provide season-long kochia control. Chickpea is commonly seeded in narrow rows and thus in-crop cultivation is not a viab l e alternative for weed contro l. Hand rogueing is cost prohibitive and the labor force needed for hand weeding is not available in this region.

### 6. Efficacy ofthe Proposed Use Under Section 18 Tough selectively controls many annual broadleaf weeds including kochia. Pyridate is more effective applied under the following conditions: 1) higher water volumes, 2) warm, sunny conditions, and 3) small weeds. Risks to rotational crops are minimal due to the short half-life and lo w soil persistence leading to no residual impact to subsequent crops. Pyridate is the only known broadleaf herbicide that can provide postemergence weed control without impacting chickpea yield. The table below shows the results of a study where kochia was not controlled by soilapplied herbicides such as Spartan and Sonalan. Dry conditions resulted in little herbicide incorporation and poor weed control. Tough applied postemergence provided excellent kochia control. Treatments without Tough could not be harvested due to excessive weed growth.

Table. Kochia control in chickEeas. Jun 26 Treatrnent8 Rate**Tim in~** **b** lnju!2: Kochc Colgc Yield Test wt. % c% control c lb/A lb/bu Sonalan 2 pt PPI 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 17 23 0 Sona lan I Tough 2 pt I 1

. 5 pt PPI I POST 0 98 99 1666 61.2 Tough + Poast 1.5 pt + I pt 60% 0 87 91 1284 59.3 Tough + Poast I 1.5 pt + I pt I 45% / 0 88 91 1377 60.3 Tough + Poast 0

.75 pt + I pt 75 % Tough I 1.5 pt + 2 pt I 60% 1 4 99 99 1641 60.8 Tough + Poast 0.75 pt + I pt 75% Goal + NIS 0.25 lb ai + 0.25 % POST 57 87 90 1179 60.6 Untreated 0 0 0 0
0 A/I Poast and Tough trea tme nts appli ed wi th COC at 2 pt !A

. h Perc entages refer to % cumulative weed emer gence time.
" Koch =Kochia: Co lq = Common lambsq uart ers



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

- 1998-I 0-07 /html/98-26908

.htm)

. Residue trial s for chickpeas were conducted by the IR-4 Program in 1996. Applications made in accordance with the requested provisions are not expected to result in residues of pyridate and its metabolites in excess of 0.1 ppm for garbanzo beans

. These tolerances have been established by the EPA and are recorded under CFR 180.462. Secondary residues in meat, poultry , and eggs are not expected to result.

### 8. Discussion ofRisk Information : On May 3 , 2000 the EPA established tolerances of 0.1 ppm for residues of pyridate and its metabolites inion chickpeas, seed. Information regarding pyridate toxicology and aggregate exposure can be found in the final rule published in the Federal Register May 3, 2000, volume 65, number 86, pages 25647-25652 (attached).

a. Human Health Tough® 5EC herbicide poses little potential risks to humans , domestic animals , wildlife , and the environment. The acute oral LD50 for male rats is > 5 ,000 mg/kg. The active ingredient has a low dermal irritation potential and a low inhalation hazard. Acute dermal LD50 for rabbits is > 2,000 mg/kg

. Inhalation LC50 > 4.37 mg./Lair. Primary dermal irritation study indicated it is mildly irritating to rabbit skin (EPA Health Effects Division of the Office of Pesticide Programs , 2000). The EPA concluded that residues of pyridate in drinking water do not contribute significantly to the aggregate acute human health risk. The acute human health risks re su lting from exposure to pyridate in food and water are below EPA's level ofconcern for all population subgroups. As for chronic risk, the EPA also concluded 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 label addresses the risks to worker /applicator by outlining handler precautions and required personal protective equipment. b. Potential to be found in drinking water The potential for exposure to residues of pyridate in drinking water is negligible due to its low water solubility (1.5mg/L at 20 C), strong soil adsorption (Kd 

### = .3

-26) and short half-life (7-21 days). Pyridate is essentially immobile in all soi l types and any risks to surface or groundwater contamination will be negligible. The EPA Health Effects Division determined that pyridate does not possess the environmental fate parameters associated with a compound that could leach to groundwater. However, the parameters of its degradate indicate that under unusual conditions such as flooding, where anaerobic conditions persist in topsoil for up to 60 days , the degradate could possibly leach to groundwater or run off to surface water. Pyridate is not listed in the EPA Pesticides in Ground Water Database , nor is there an EPA Maximum Containment Level or health advisory

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 ofherbicides. Its site of action is inhibition photosynthesis by b locking e lectron transport in photosystem II (reactions taking place in the chloroplast thylakoid membranes).

e. Endangered or Threatened Species

Howellia aquatilis Water Howellia, threatened Spiranthes diluvialis Ute Ladies ' treesses , threatened

The use ofTough® SEC herbicide in accordance to the label in chickpea fields should not pose a risk to any threatened or endangered species. f

. Beneficial Organisms Tough® SE C 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 EFE D 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: Montana Department ofPublic Health and Human Services , Montana Department of Fish, Wild li fe , and Parks and tribal representatives will receive copies of request. Any comments will be forwarded. 10. Notification ofRegistrant/Manufacturer : Belchim Crop P rotection has been notified and their let1er of support is attached

. 11. Enforcement Progran1: The Montana Department ofAgriculture will monitor applications ofpyridate to determine that the conditions ofthe emergency exemption are correctly followed. Parameters monitored will include acres treated , weed control , chickpea tolerance , and any adverse effects that may occur. 12

. Repeat uses : Pyridate was previously used from 

### 1999-2003. Pyridate was registered October 7, 

### 1998 and later cancelled 

### in 2004.13. Progress Toward Registration: Registration and tolerance were established through IR-4 by EPA. The Final Rule was published in the Federal Register vol. 63 , No

. 194, October 7 , 1998 pages 53837-53844 (attached). Tolerance was established for chickpea at 0 .1 0 ppm (CFR 180.462). Product registration 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 2019. Registration and tolerance were established through the IR-4 by the EPA in October 1998. Tolerances were established chickpeas at 0.10 ppm (CFR 180.462). Product registration 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 Tough® 5EC in the U.S: List of studies that would be required by EPA to obtain a section 3 registration Following the EPA pre-submission meeting of last year, the following major studies were scheduled in support of updating the pyridate dossier for the re- submission atEPA which is currently foreseen for September 2016: Field soil dissipation studies in 2 soil s; Anaerobic water / sediment study ; Aerobic soil metabolism study; Seedling emergence and vegetative vigor study; Acute avian (passerine species) toxicity study ; Method validation aquatic stud ies. For the other parts ofthe dossier reference will be made to the original pyridate registration

. Additional info responding to : crops scheduled to be registered Formulation scheduled for registration: Tough® 5EC (5 lb. per gallon) Reference will be made to the existing tolerances as set by the original pyridate registration. Therefore , crops targeted to be registered for the 2016 submission: Current tolerances as follows (ppm): Established 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, field , 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 Peppermint, tops
................................................ 0 .20 May 3 , 2000 Spearmint, tops
. .... ..................... ............ ........... 0 .20 May 3 , 2000

### Informati on 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: G lyphosate

-resistant kochia has been identified in many areas ofthe 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 season and give chickpeas a competitive advantage over the weeds

. If kochia is not controlled due to g lyphosate res istance or cold weather, then kochia will grow uninhibited throughout the growing season as there is no postemergence herbicide labeled currently. Uncontro lled kochia will reduce chickpea yield and will make harvest diffic ul t. 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-appli ed herbic ides

. 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 rai nfall event typicall y will not be controlled

. Sulfentrazone cannot be used on all soil tvoes: Sulfentrazone cannot be appl ied to coarse soils w ith less than 1 .5% organic matter. High soi l 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 wi thstand the drier conditions where ascochyta disease is less preva lent. 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

.

### Figure 1 . Kochia not cont ro ll e d leads to reduced crop yi e ld. (Minot, NO)
High kochia infestations like those seen above would require a grower to harvest around dense populations , thus losing 100% yield in those areas. Growers simply cannot risk harvesting dense infestations 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. A near " zero tolerance " for glyphosate-resistant kochia is required due to its ability to roll and rapidly spread seed from field to field. Growers need liberty to spray kochia even if overall yield is not affected significantly to prevent widespread kochia distribution. 

### In field research with numerous crops such as sunflower, corn, wheat, and sugarbeet, kochia competition has been documented to reduce crop yield by 25% to 78%. Chickpea is less competitive with kochia than any of these crops , meaning that yield impacts from kochia can be higher. Growers will spray to control weeds , not only to limit yield loss of the current crop , but also to prevent weed seed production that will affect future crop losses. Growers may not spray ifkochia is present at one plant per 10, 000 sq ft, but will likely spray at one kochia plant per 1 , 000 sq ft. Again , the application may bejust as important for preventing weed seed production as it is for preventing yield loss in the current crop. Kochia can produce 15,000 or more seeds per plant.

### 3. Economic Analysis

Eco nom ic Impact of Koch ia in Field Crops

The table below shows a research study where kochia was not controlled by soil

- applied herbicides

. Sonalan , Spartan, and Balance provided only 7-20% kochia control. Dry cond itions resulted in inadequate herbicide incorporation and poor weed control. However, pyridate applied postemergence provided excellent kochia control. Treatments without pyridate could not be harvested due to excessive weed growth resulting in zero yield. This study shows a worst case scenario, but demonstrates the potential impact of kochia on yield and crop harvest.

Table. Kochia control in chickEe as. Jun 26 Treatment8 Rate Timingb lniu!l: Kochc Colg c Yield Test wt. % c% control C lb / A lb/bu Sonalan 2 pt PPT 0 20 30 0 Spartan I Poast 5.33 o z / I pt PRE / POST 0 7 13 0 Balance 1.25 oz PRE 0 17 23 0 Sonalan I Tough 2 pt I 1.5 pt PPI I POST 0 98 99 1666 61.2 Tough + Poas t 1.5 pt + I pt 60% 0 87 91 1284 59.3 Tough + Poast I 1.5 pt + I pt/ 45% / 0 88 91 1377 60.3 Tough + Poast 0.75 pt + 1 pt 75% Tough I 1.5 pt I 60 % 1 4 99 99 1641 60.8 Tough + Poast 0.75 pt + I pt 75 % Goal + NIS 0.25 lb ai + 0.25 % POST 57 87 90 1179 60.6 Untreated 0 0 0 0
0A /l Poast and T ou

g h treatme nts ap p li ed with C OC at 2 pt !A

. h Pe rcentages refe r to % c umulative weed eme rge nce tim e. < Koch = Kochia; Colq = Common /ambsquarte rs


### Tier l 

### Significant Economic Loss (SEL) Analysis For purposes ofthe Tier 1 analysis , the " Baseline " is theoretically a chickpea field grown in a normal year with no kochia present. For purposes of establishing potential chickpea yield without chickpea , we mus t at look at trials in which close to 1 00% kochia control was achieved with herbicide treatments. From the trial described , close to 100% was achieved with 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 " Emergency " condition will be defined as an average infestation of the emergency pest, using the b est registered alternative (Sonalan or Spartan). The measured yield following this treatment was 0 lb /A.

### The difference in yield between the "emergency" and "base line" treatments was 1,666 lb/A. This equates to a yield loss of 100%
. This meets the SEL thre shold under Tier 1. Baseline Emergency Change %Change Yield 1, 666 0 1,666 -100 (lb/A) Economic Benefits and Losses Expected

Year Y i eld/ A * Price/U nit Gross Revenue/ A Production Cost/ A Net Revenue/ A 2015 700 0.36 252 319 -67 2014 1100 0.24 264 323 -59 2013 1920 0.23 442 331 111 2012 1350 0.30 405 330 75 2011 1100 0.35 385 290 95 Average 1234 0.30 350 319 31

Year Yield/ A Price/ Unit Gross Revenue/ A Product i on Cost/ A Net Re venue/ A 2016 (1 ) 2016 (2 ) Difference 1600 1400 0 .25 0.25 400 350
( 1 )
- Current yea r w i th the use of proposed pest idde ( 2)
- Current yea r wi thout t h e use of proposed pestidde

* Yield an d pr i ce for large kabul i chi ckpeas 

### Sources: Yield : NASS Price: AGT Production Costs: NDSU Extension Ag Econ Department Supporting Documentation : 1

. Tough SEC Package Label 2. Tough SEC Section 18 Supplemental Label 3. Tough SEC MSDS 4. Northe rn Pulse Growers Letter of Support 315 315 85 35