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

MEMORANDUM
DATE: November 18,2014 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

S UBJECT: Propargite: Health Effects Divison Response to Comments from the Preliminary Work Plan in Support of Registration Review

PC Code: 097601 MRID No.: Not Applicable Petition No. : Not Applicable Assessment Type: Not App licable DP Barcode: 0423023 Registration No.: Not Applicable Regulatory Action: Registration Review Reregistration C ase No.: 0243
TXR No.: Not App licab le CAS No.: Not Applica ble


### FROM: Marquea D. King, Ph.D., Toxicologist/Risk

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### --:(-~ .....:....__ , . Bonnie Cropp -Kohlhgtan, Dtetary

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### Effects Division (7509P) 

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## j;,l::j{V} r 1 / Risk Assessment Branch IV Healt h Effects Division (7509P)
TO: Wilhelmena Livingston, Chemical Review Manager Risk Management and Implementation Branch IV Pesticide Re-Evaluation Division (7508P)
Public comments were received on August 20, 2014 in response to the propargite Preliminary Work Plan (EPA-HQ-OPP-2014-0131-0004) which are p ertinen t to the Health Effects Division (HED) concerns. These comments were submitted by MacDermid Agricultural Solutions, Inc. and were related to the post-harvest cherry labeling and the usage of the most up-to-date pesticide handler exposure monitoring data in the HED scoping document (DP0416480).

1st Comment from MacDermid Agricultural Solutions, Inc: (page 4-5 of 8) Post

-harvest cherry labeling Post-harvest cherry is noted for label cancellation since there is no established tolerance inion this crop (May 21,2014. Propargite Scoping Document) (page 3 in this link). The Registrant is aware ofdiscussions/meetings with the Agency taking place during the late 1990's concerning propargite applications to cherries/stonefruit after fruit harvest. The use has been labeled since 1974. The Registrant submitte d studies showing no detectable re s idues in thePropargite: Human Health Risk Assessment Scoping Do cument in Support of Regi s tration Review subsequent growing season fruit on peaches (MRID 44127201), apricots (MRID 44127202), or plums (MRID 44127204). Agency revi ew (D230866) notes that residues were less than the limit of quantitation ( <0.05 ppm) but did not represent adequate geographic representation as described in OPPTS 860.1500 since they were solely conducted in CA. Discussion notes that "Data which demonstrate that residues are less than the limi t of quantitation do not necessarily also demonstrate that no detectable residues occur. This would be best shown with a radiotracer study ... " (also see Appendix III, MRID 45815401).
The Registrant subsequently submitted study (MRID 44884701) that documented no residues (propargite or main metabolite TBPC above the I 0 ppb limit of detection) across 19 sites in 8 states on various stone fruit (peaches, plums and apricots). 

### In this study fruit was harvested 235 to 325 days after the latter oftwo post-harvest applications of either Omite®- 30WS (EPA Re g
. No. 400-427) or Omite ® -6E (EPA Re g. No. 400-89). We have no record that the Agency ever reviewed this study. 

### In the Registrant's April 16 , 1999 response to the Agency 's Ms

. Amy Caicedo ' s February 2, 1999 Registrant deficiency Jetter on certain propargite studies (as noted by HED ' s Chemistry Exposure Branch) , we wrote: "As reported to EPA in our 3/31/99 conference call, Uniroyal believes that given the low level zero detectable residues and the nature ofthis use , i.e. , the absence of fruit at time of app li cation of a non-systemic product , as well as 8-10 month period until harvest, there should be a finding of no reasonable expectation of finite residues , thus no need for a tolerance. This is es sentially the equivalent of a non- food use."
The Registrant then conducted the radiotracer study in 2002 where two post-harvest applications (each 3.2 lbs. a.i./acre equivalents of Omite-30WS) of I4C propargite were made to a peach tree (MRID 45815401). Only 0.0002% of that initially applied post-harvest was found the following year in new fruit 348 days after the 2nd application (MRID 45912301 ). Again , it is unclear if the Agency has conducted a formal review of this study, or the supporting method validation study (MRID 45912302).
We note that at the end of the previous Re-registration D ecis ion process for propargite that HED's January 21,2009 memorandum (0357829) agreed with an earlier one (0258349), and to a ChemSAC decision (8 /25 /99) that "The Agency's 860.1000 guideli nes states that for this use (' post-harvest application to non-bearing stone fruit trees ' ) to be considered a nonfood use, the label must contain a restriction against harvesting fruit within 1 year. T herefore a tolerance must be estab lished for this use if fruit is harvested within 1 year." The Agency did not allow expansion of post-harvest cherries to all s tone fruits , but did a ll ow continued labeling of cherries (without a 1-year restriction). However we see no discussion ofboth the extensive 'cold ' study (MRID 44884701) or the I4C study (MRIDs 45815401 /459 12301) which document no reasonable expectation of finite residues , and thu s demonstrating no need for a tolerance with the post-harvest applications with propargite formul ation, regardless of which stone fruit. The Registrant requests the Agency review the se st udie s and to determine how this use can be maintained without associated tolerances at thi s time.
HED Response: HED thanks the registrant for the information cited pertaining to the issue of post-harvest cherry labeling. The Agency will consider thi s information for the Registration Review risk assessment.

Page 2 of3Propargite: Human Health Ri s k Assessment Scoping Document in Support of Registration Review



### 2"d Comment from MacDermid Agricultural Solutions, Inc: (page 4 of 8) AHETF/ORETF Recently both the Outdoor Residential Exposure Task Force (ORETF) and the Agricultural Handler Exposure Task Force (AHETF) have produced pe sticide handler exposure monitoring data that the Agency is using in place of PHED (http: //www.epa.gov/pesticides/science/handler-exposure-table .pd f)

. As more reliable data become available , the Agency contin u es to replace existing data in the table. The Agency needs to uti lize this informati on versus solely relying o n PHED, as noted on page 8 in the HED scoping document (May 2 1 , 20 14

. Propargite Scoping Document).
HED Response: As more reliable data become available (i.e., AHETF/ORETF) HED will consider those data and render an opinion at that time as indicated in the scoping document. HED will utilize upd ated exposure information and additional risk assessments may be conducted ifthere are any significant changes in po li cies and/or additional data which may become available that impacts registration review.

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