### UNITED STATES EN V IRONMENTAL PR OT E CTION AGENCY WASHINGTON D
. C. , 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### PC Code: 044309 DP Barcode: 427484 MEMORANDUM DATE: SUBJECT:
TO:

FROM:

T hrou gh : 

### February 16 , 20 16 EFED Response to Public Comments Submitted on the Federal Register No ti ce of Receipt for the Cloth i anidin Experimental Use Permit (59639-EUP-Rl ) Marianne Lewis
. Risk Manager Reviewer Venus Eag le, Product Manager Team I Inverteb rate
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The notice of receipt of an application for a clothia ni din experimenta l us e permit (59 639-EUPRI) was open for a 30-day publ ic comment period in the docket EP A-I-I Q-O PP-20 14-0667 at regulations.gov. T h e purpose o f thi s document is to address public co mments and r espond to t ec hnical/sc ienc e-related qu est i o ns sub mitted by the Poll in ator S te ward ship Council.

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## Comments submitted by the Pollinator Stewardship Council (PCS)- EPA-HQOPP-2014-0667-0015 PSC Comment: PSC commented that Cloth ian i din is documented as caus in g both acute and chronic hann to honey bees when used on corn. To support this point , they cite Tapparo 

### et al., 2012 indicating that exposure l evels from use on corn can be very high and can result in colony lo sses as we ll as Di Pri sco 

### et al., 2013 wh ich they state indicates that clothianidin adverse ly affects the in sect immune response and promotes r epl ic ation ofviral pathogens. 

### EPA Response: EPA has previou s l y reviewed the Tapparo 

### eta/., 20 1 2 paper (ECOTOX r eference number E 159259) and cons idered the study to be of qualitative use in risk assessment , providing inform ation on potential fugitive dust emitted during the sowing of treated seed and the potential effects of equ ipm ent modifications on those residue leve ls. This study u sed clothianidin-treated seed at 1.25 mg a.i ./seed and measured clothianidin residues at the a ir fan outlet ofthe drilling machine , at 5 -10 meters from the seeding machine and in free foragi n g bees flying through the sown field and caged bees at 1-9 meters from the sowing equipment. Reported clothianidin residues in the free foraging (78

- 1240 ng/bee) and caged bees (25- 1 394 ng/ bee) however were considerable. However , in this study all honey bee exposure would have been to residues in abraded dust from th e seed treatment. According to the proposed EUP label , the maximum rate of active in gred i ent per seed is 0.5 mg a.i./seed , which indicates that exposure to clothianidin residues from abraded dust is likely to be lower than that under the current labeled maximum rate of 1.25 mg a. i ./seed. The rema inder of the c l othian idin application would be an in-furrow so il app li cation that is unlikely to r esult in significant spra y drift as in- furrow treatments ar e conducted at low boom heights. EPA therefore cons i ders that acute exposures to honey bees foraging in o r near the field at the time of application are like ly to be s im i lar or lower than those from the curr ently registered use on corn. However , it is difficult to determine from the current l y available data whether chronic r esidues in corn pollen following system ic uptake may be higher under the proposed EUP label than under the cur rently registered seed treatment. Us in g the limited corn pollen r esidue dataset (MR ID 49372102 , Appendix 26 , data c urrent ly in review) that the registrant submitted to support the EUP , residues from in-furrow applications (e ither on clothian idin treated-seed at 0.25 mg a .i./seed o r untreated seed) were generally reported to be simi lar to the ava il ab le data for corn pollen follow in g seed treatment at 1.25 mg a. i./seed (MRID 4829880 I , mean residues of3.4 ng/g , with an upper 90% bound of 5
. 2 ng/ g) though two sa mples in the new (i n- furrow treatment on ly) data contained substant iall y higher (25

-28 ng/ g) residues , w hich was likely at l east partially due to contamination at that site (contro l plant s at that s ite conta in ed pollen w ith c lothianidin residues of 12.4 n g/g)
. The avai lable data indi cates that cloth ian i din residues in pollen from corn plants following systemic uptake may be s im ilar under the proposed EUP as they are under the currently registered seed treatment application , but more data would be needed to conclusively determin e th is . Withou t addit ional data measuring residues in corn pollen from the in- fu rrow use pattern , any eco l ogical risk assessment conducted to evaluate the risk posed by this use pattern to honey
Page2of4bees and oth er beneficial terrestr ial insects wi ll use conservative measures to evaluate the potential residues in corn pollen. The Di Pri sco 

### eta/., (20 13) article cited b y PSC does not provide any information d irectly related to EPA ' s apical endpoints of survival , growth or reproduction. However, the study authors ' reported effects of adverse effects on terrestrial in sects (honey bees and flies) immunosuppression capabi lit ies and consequential promotion of deformed wing v iru s replication in honey bees may be considered in future risk assessments , a l ong w ith other reported subleth al effects in registrant subm itted and open I iterature data.
PSC Comment: P SC r eiterated that the re gistrant requested a n EUP not an emergency use which wou ld have been considered as per the April2, 2015 l etter. PSC supports the EPA's decision for not allow in g any new uses until the pol lin ator data has been received and assessed. They are particularly concerned that cloth ian id in is so lubl e in water and has the potential to contaminate surface waters wh ich honeybees rely upon fo r drinking. PS C cites a study " Widespread Use and Frequent Detection ofNeonicotinoid In secticides in Wetlands of Canada's Prairie Pothole Region (20 14) " which states that researchers found: "
... neonicotinoid use in increasing and becoming more widespread w ith concerns for environmental loading , wh il e frequent ly de tecte d neonicotinoid concentrat ions in Prairie wetlands suggest high persistence and transport into wetlands
. " In anothe r paper cited by PSC: "
... In fact , ou r data shows that honey bees and native pollinators are facing unprecedented cumulative exposure to these in sect i cides from combined residues in pollen , nectar and water. " PSC is opposed to the proposed so il drenching of cloth ianidin- they feel that this would increase the soi l profile compared to a seed treatment. "So il drench appl ic ation enables the crop root system to take up more of the systemic pesticide tr eatment appl i cation. T h is ensu re s that plant will retain a higher l evel of pest i c ide for a l onger period of t ime . Th is is because the roots remain in the larger treated so il profile longer as the plant grows. The high solub il ity property of c l

othian idin would make the treated so il profile even large r. " P SC states: "
... we support E PA 's dec is ion not to approve new outdoo r uses , and strongly encourage E PA to stand by their dec is ion by denying the current app li cat ion for an EU P. " EPA Response: Several papers have r ecent ly been publ ished in the open sc i e ntific literature (see below) , in which concentrat ions of clothi an id in h ave been measured in various types of water bodies, inc lu d in g streams w i th drainage areas of 521 to 836 ,0 00 km 2 ( H ladik et al , 20 14) , prairie potholes (Ma in et al. , 20 14) , and puddle s on cloth ia nidin-treated fie ld s (Samson -Robert et al., 20 14). Exposures in the stream s and prairie pothole s are in lin e with EPA modeling est im ates using th e standa rd farm pond , but those measured in the on -fi e ld puddles are hi gher. Col l ective l y , these stud i es document that c l othianidin use has the pote ntial to reach water that m ight be used by honeybees or other w ild l if e for a drinking water sou rce. EPA has not current ly determined what dose of clothian id in consumed via drinking water might be harmful to honeybees , but general ly believes that the most relevant route of exposure of cloth ian idin to bees P age 3 of 4will be dietary through co n sumption of contam in ated pollen and nectar o r dermal through contact w i th abraded seed dust conta in ing cloth ianid in residues , s pray drift or contact with res i dues on plant su r faces (US E PA , 20 12). H owever, EPA is curren tly working to develop a framework to assess r isk to pollinators from the consumption of residues in drinking water.


### References:
• Hl adik , M.L. , D.W. Kolpin , and K.M
. Kuivi la , 20 14
. W idespread occurrence of neonicotinoid insecticides in streams in a high corn and soybean producing region , USA
. Environme nta l Pollution , 193 (20 14) 189-1 96
. • Main A. R. , J.V. H ead ley, K.M. Peru, N.L. M i che l, and A .J
. Cess na. 2014. Widespread Use and Frequent Detection ofNeon i cot in o id Insecticides in Wetlands of Canada's Prairie Pothole Region. PLoS ONE 9(3), Mar ch 2014.

• Samson-Robert, 

### 0
. , G
. Labrie , M
. Chagnon, and V. Fourn i er , 20 14
. Neo nicot inoid

Contaminated Puddles of Water Represent a Risk o f Intoxication for Honey Bees. PLoS ONE , December 1 , 2014.
• Di Prisco, G., V. Caval i ere , D. Annoscia , P. Varricchio , E. Caprio , F
. Nazzi , G. Gargiu l o and F. Pennachio , 2013. Neonicotino i d c lothianidin adversely affects insect immunity and promotes replicat ion of a v iral pat hogen in honey bees, PNAS, 110(46), November, 2013.

• Tapparo , A. , D. Marton , C
. Giorio , A. Zane lla , L. So l da , M. Marzaro, L. Vivan , V. Giro1ami , 20 1 2
. As sess ment of th e environmenta l exposure of honeybees to particulate matter containing neonicotinoid insecticides coming from corn coated seeds. Env iron. Sci. Techno., 46(5): 2592

-2599. March , 6, 2012.

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