UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D
.C
. 20460



### CERTIFIED MAIL

Ms. Glenda Haage, Regulatory Agent AMYAC Chemical Corporation 4695 MacArthur Court Suite 1200 Newport Beach, CA 92660 OFF IC E O F CHE M ICAL SA F ETY AND POLLU TI ON PRE VENT ION

February 9, 2012

Re: Ethoprop: EPA ' s response to AMYAC ' s January 18, 2012 letter regarding waiver requests for ethoprop registration review data call-in Guidelines 875.2400 and 875.2500 Dear Ms. Haage, The Environmental Protection Agency (EPA or the Agency) received AMYAC ' s letter, dated January 18, 2012, providing additional information regarding your request to waive Guidelines (GLN) 875.2400, post-application dermal exposure and 875.2500, post-application inhalation exposure for ethoprop. Based on information provided in your January 18, 2012 letter and in previous communications, and provided that AMYAC ' s proposed label statement is incorporated on ethoprop labels for use on sugarcane, EPA is granting the requested waivers for GLNs 875.2400 and 875.2500. Additional history and details are included below. Bayer Crop Science (Bayer) , the technical registrant for ethoprop at the time the registration review data call-in (DCI) was issued, originally requested a waiver for the postapplication dermal and inhalation exposure studies in their**90~day** response to the DCI, dated December 1, 2010. EPA reviewed the information provided in that submission and responded to Bayer and AMYAC in a February 2, 2011 letter that additional information would be needed to support the waiver request. In a follow

-up submission dated October 21, 2011 , AMYAC provided some additional information in order to justify waiving GLNs 875.2400 and 875.2500. The information was again reviewed by EPA, but the Health Effects Division' s memorandum dated November 23 , 2011 (transmitted to AMYAC with a cover letter dated December 21, 2011) requested some additional clarification before agreeing to waive the two data requirements. The ethoprop registration review DCI required post-application dermal and inhalation exposure data due to potential ethoprop exposure to workers during the transplanting ofsugarcane. Specifically, the Agency was concerned about the potential exposure to workers involved in planting activities because ofcontact with ethoprop residues in treated cane seed pieces or during activities in previously treated fields
. In the DCI 90-day response, Bayer requested waivers for these two studies stating: " . . .Commercial sugarcane planting and the application ofethoprop are entirely mechanized processes with no post-application exposure to workers
... The sugarcane seed pieces are mechanically dropped from large tractor-drawn bins into open 4-inch deep furrows
. The tractors are generally large enclosed cab vehicles because ofthe weight ofthe sugarcane planting bins
.. . Following placement ofthe sugarcane seed pieces in the furrow, ethoprop 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 Agency denied Bayer' s waiver request for GLNs 8752400 and 875 .2500 because of conflicting information which indicated that although the bulk ofsugarcane planting is highly mechanized, some sugarcane planting may be conducted manually (Health Effects Division, DP Barcode D384788 ; January 7, 2011). Because uncertainty remained regarding the method of planting sugarcane and whether post-application exposures to workers were likely, EPA continued to require the post-application dermal and inhalation exposure studies. AMVAC ' s October 21 , 2011 re-submission included additional information regarding the waiver request and stated: " . ..Actual hand planting is conducted well ahead ofthe application I covering rig that applies the ethoprop. The ethoprop is covered with soil immediately following its application by the same equipment that mechanically applied the product. Covering ofthe product by soil is completed immediately
.. .

.. .In fact, there is no time either before or after application ofthe product in which dermal or inhalation
.exposure would be expected because the granular ethoprop product is packaged and applied using an approved closed delivery system (i.e. Lock 'N Load system). " In the re-submission, AMYAC stated that they would remove sugarcane from the list of registered use sites for the 15% granular ethoprop product (EPA Registration No . 5481-9040) that is not packaged in a closed delivery system. Lastly, AMVAC proposed to add the following label statement to the 20% Lock 'N Load ethoprop product registered for use on sugarcane only (EPA Registration No . 5481-9042):

" Workers doing hand planting or other direct field contact activities cannot be present within 100 feet ofequipment making applications ofethoprop
." EPA reviewed there-submission ofthe waiver requests for GLNs 875 .2400 and 875.2500 and documented its determination in a memorandum dated November 23 , 2011. EPA believed that under most circumstances the existing label language and the suggested label amendment 2would alleviate concerns over worker post-application exposure. However, the phrase 

### "other direct field contact activities" in the proposed label statement led to uncertainty regarding potential concern for workers involved in other activities in these fields. EPA's December 21, 2011 letter requested that AMVAC describe these "other direct field contact" types ofactivities in previously treated fields, and/or amend the proposed label statement to ensure post-application exposures to ethoprop residues do not occur. AMVAC's most recent January 18, 2012 letter verified that no manual labor activities are expected in recently treated ethoprop fields and stated the following: " ... Once the sugarcane is planted 6-12 inches deep and product applied via Lock 'N Load delivery system, no workers enter the field from that point because there is no manual labor beyond that point. The application ofetboprop to a planted field of sugarcane would be the very last step in the planting process (meaning all activities that require band labor wquld be completed prior to this step) [emphasis added]. In addition, signs are posted at the comers offields that have had applications ofethoprop and re-entry is prohibited for 48
- 72 hours .

. . .

the only activity that would be needed in a newly planted sugarcane field would be chemical weed control applications. These applications are only done after the 48 hour re-entry interval, with spray rigs having spray-safe cabs being used. These spray rigs with spray-safe cabs are typical ofthe sprayers used in the sugarcane industry. There is no chance for post-application exposure since there is no need for workers to enter the field again.. ." Based on these additional details indicating that post-application dermal and inhalation exposure to ethoprop residues from sugarcane hand planting activities is not expected given the methods used and the label statement proposed by AMVAC, EPA is granting the waiver requests for GLNs 875.2400 and 875.2500. Please amend ethoprop labels as follows: 

### EPA Registration No. 5481-9040, 

### MOCAP 15% 

### Granular Insecticide- Nematicide
• AMV AC has communicated to the Agency its intent to remove sugarcane from the list of registered use sites for this product. Ifthat is still AMVAC's intent, submit a revised label with this use site and directions for use for sugarcane.removed.
• IfAMV AC decides to keep the sugarcane use site for this product, add the label statement, "Workers doing hand planting or other direct field contact activities cannot be present within 100 feet ofequipment making applications ofethoprop." 

### EPA Registration No. 5481-9042, 

### MOCAP 20% 

### Granular Lock 'n Load Nematicide-, Insecticide (For Use on Sugarcane Only)
• Add the label statement, " Workers doing hand planting or other direct field contact activities cannot be present within 100 feet ofequipment making applications of ethoprop." For tracking purposes, please submit the label amendments to Monica Wait in the Pesticide Reevaluation Division within 30 days ofreceipt ofthis letter. Monica will transmit the revised labels to Venus Eagle, the Product Manager in the Registration Division, for review. Ifyou have 

### 3any additional questions regarding this letter, please contact Monica Wait at (703) 347
-8019 or via email (wait
.monica@epa.gov).

CC: Jon Wood, AMVAC Venus Eagle, OPP I RD JeffDawson, OPP I HED Sincerely,
Michael Good1s, Risk Management and Implementation Branch III Pesticide Re-evaluation Division

4