UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON , D.C. 20460 

CERTIFIED MAIL 

Ms. Glenda Haage, Regulatory Agent 

AMY AC Chemical Corporation 

4695 MacArthur Court 

Suite 1200 

Newport Beach, CA 92660 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

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 AMY AC'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 AMY AC'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 AMY AC 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 , AMY AC 

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 AMY AC 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 of 
sugarcane. Specifically, the Agency was concerned about the potential exposure to workers 

involved in planting activities because of contact 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 of ethoprop 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 

of the weight of the sugarcane planting bins .. . 

Following placement of the sugarcane seed pieces in the furrow, ethoprop granules are 

mechanically applied over the top of the 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 of sugarcane 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 of the 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 of the product by soil is completed 

immediately .. . 

.. .In fact, there is no time either before or after application of the 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, AMY AC 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, AMV AC 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 of equipment making applications of ethoprop." 

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 

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would 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 AMV AC describe these "other direct field contact" types of activities 

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 of etboprop 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 

of fields that have had applications of ethoprop 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 of the 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 AMV AC, 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. If that is still AMVAC's intent, submit a revised 

label with this use site and directions for use for sugarcane. removed. 

• If AMV 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 of equipment making applications of ethoprop." 

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 of equipment making applications of 

ethoprop." 

For tracking purposes, please submit the label amendments to Monica Wait in the Pesticide Reevaluation Division within 30 days of receipt ofthis letter. Monica will transmit the revised 

labels to Venus Eagle, the Product Manager in the Registration Division, for review. If you have 

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any 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 

Jeff Dawson, OPP I HED 

Sincerely, 

Michael Good1s, 

Risk Management and Implementation Branch III 

Pesticide Re-evaluation Division 

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