UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D

. C

. 20460

CERTIFIED MAIL


### Larry Hodges Bayer CropScience 2 T.W. Alexander Drive PO Box 12014 Research Triangle Park, NC 27709 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### February 2, 2011

Re: EPA's response to waiver requests submitted by Bayer CropScience with the ethoprop registration review data call-in 90-day res ponse (RR-0411 01-28718)
Dear Dr. Hodges, The Environmental Protection Agency (EPA or the Agency) received Bayer CropScience's (Bayer ' s) 90-day response, date d December 1, 

### 2010 , to the ethoprop registration review data call-in (DCI), RR-041 1 01-28718. The 90-day response included requests for waivers for several data requirements (Guidel i nes 850. 1500, 875.2400 , and 875.2500). The Agency has completed its review of the waiver requests and supporting documentation submitted by Bayer. Additional detai ls are below: Guideline 850.1500, Freshwater fish life cycle toxicity The Environmental Fate and Effects Division (EFED) reviewed Bayer' s request to waive the freshwater fish life cycle toxicity study. 

### In the 90-day DCI response , Bayer noted that the Endocrine Disruptor Screening Program (ED S P) DCI also required a fish reproduction assay , and they felt it inappropriate to conduct two studies. As is further explained in the enclosed review (DP Barcode D384811), EFED considers the des ign , scope, and objectives of the freshwater fish fu ll life cycle study (GDLN 850. 1 500) and the fish short-term reproduction assay (GLDN 890.1350, EDSP) to be substantially different, such that they are not interchangeable with re s pect to reproduction. Bayer's argument, as laid out in the DCI 90-day response, is not sufficient to support waiving GDLN 850.1500. However, because the Agency now has an acceptable estuarine I 

### marine fish full life cycle study, EPA agrees to waive GDLN 850.1500, freshwater fish life cycle toxicity study. TheOctober 30, 2008 Problem Formulation document (DP Barcode D353 378) , completed in support ofthe registration review of ethoprop, indicat e d the need for both a freshwater fish full life cycle and an estuarine I marine fish full life cycle st udy
. An estuarine I marine fish full life cycle study (MRID 46315401) had been submitted previously but was classified as invalid. After a careful re-analysis, requested by Bayer, the Agency upgraded the estuarine I marine study to a supplemental statu s on Apr il 30, 2009 (DP Barcodes D359201 and D306508 ). Since the estuarine 

### I marine fish full life cycle study was re-classified and can now be used for risk assess m ent purpo ses , EFED believes that a second fish full life cycle study conducted in freshwater is not warranted. The estuarine 

### I marine study allows EFED to sufficien tly quantify chronic risk to fish. 

### Guidelines 875.2400 and 875.2500, Post-application dermal and inhalation exposure studies The ethoprop registration review D C J required post-application dermal and inhalation exposure data due to potential ethoprop exposure to workers during the transplanting of sugarcane. Specifically , the Agency is concerned about the potential exposure to workers involved in planting activities because of contact with e ither treated cane seed pieces or activities in previously treated fields. In the DCI 90-day response, Bayer requested waivers for these two studies stating:

... Commercial sugarcane planting and the app lication of ethoprop are entirely mechanized proce sses with no post
-application exposure to workers
... The sugarcane seed pieces are mechanica lly dropped from large tractor-drawn bins into open 4-inch deep furrows. The tractors are generally large enclosed cab vehicles because ofthe weight ofth e sugarcane planting bins ... Follo wing placement ofthe sugarcane seed pieces in the furrow, et h

oprop granules are mechanically applied over the top ofthe sugarcane seed pieces and soil is thrown over the seed pieces to close the furrow
... Mix the soil with a disc hiller or other suitable equipment as the cane is covered
. . . The Health Effects Division (HED) has completed its review of Bayer's waiver request for GDLNs 875.2400 and 875.2500, and at thi s time, Bayer's waiver request is denied. The Agency continues to require the submission of post-application dermal and inhalation exposure data. RED's enclosed review (DP Barcode D 3 84788) found conflicting information regarding sugarcane planting practices from va rious reputable sources. Although agricultural websites from Louisiana and Texas indicate that sugarc a ne planting is highly mechanized , information from Florida indicates that sugarcane planting may be conducted manually. See the enclosed document for further details. Because there i s uncertainty regarding the method ofplanting sugarcane and whether post-application exposures to workers are likely , EPA continues to require the post-application dermal and inha lation exposure studies. If Ba y er wishes to provide further information regarding the mechanized planting of sugarcane or to propose label language that would specifically preclude the use of ethoprop during hand planting of sugarcane, please contact EPA within two weeks of receipt ofthis letter.

### If you have any additional questions regarding this letter, please contact Monica Wait at (703) 347-8019 or via emai l (wait.monica @epa.gov).



### Enclosures: Sincerely,

Michael Goodis, ef Ri sk Management and Implementation Branch III Pesticide Re-evaluation Division

EFED Response to Registrant Submitted Waiver Request for a Freshwater Fish Full Life Cycle Toxicity Study for Ethoprop. 

### January 1 1, 2011. J. Housenger. DP Barcode D384311. Ethoprop, PC Code 041101 , DP Barcode 384 788. Health Effects Division (RED) Review of Exposure Related Issues from 90-day Response to Ethoprop Generic Data Call-In. 

### January 7, 2011. J. Dawson
. DP Barco de 384788.
CC: Mr. Jon Wood AMYAC Chemical Corporation 4695 MacArthur Court, Suite 1250 Newport Beach, CA 92660