UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: November 18,2014 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: 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 Applicable 

DP Barcode: 0423023 

Registration No.: Not Applicable 

Regulatory Action: Registration Review 

Reregistration Case No.: 0243 

TXR No.: Not Applicable CAS No.: Not Applicable 

FROM: Marquea D. King, Ph.D., Toxicologist/Risk Assess~ . 

Ivan ~ieves, ORE --:(-~ .....:....__ , . 

Bonnie Cropp-Kohlhgtan, Dtetary Exposure~ (\ ,..,.~{\ _ · 1 ~ Risk Assessment Branch IV ~~) ~ 

Health Effects Division (7509P) {jl/J j ~ ~ 

THROUGH: Elissa Reaves, Ph.D., Branch Chief~ j;,l::j{V} r 1/ 

Risk Assessment Branch IV 

Health 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 pertinent 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 of discussions/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 submitted studies showing no detectable residues in the 
Propargite: Human Health Risk Assessment Scoping Document in Support of Registration Review 

subsequent growing season fruit on peaches (MRID 44127201), apricots (MRID 44127202), or 

plums (MRID 44127204). Agency review (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 limit 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 44884 701) 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 of two post-harvest applications of either Omite®-

30WS (EPA Reg. No. 400-427) or Omite®-6E (EPA Reg. 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 of this use, i.e., the absence of fruit at time of application 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 essentially 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 Decision 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 guidelines 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. Therefore a 

tolerance must be established for this use if fruit is harvested within 1 year." The Agency did not 

allow expansion of post-harvest cherries to all stone fruits, but did allow 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 thus demonstrating no need for a tolerance with the 

post-harvest applications with propargite formulation, regardless of which stone fruit. 

The Registrant requests the Agency review these studies and to determine how this use can be 

maintained without associated tolerances at this time. 

HED Response: HED thanks the registrant for the information cited pertaining to the issue of 

post-harvest cherry labeling. The Agency will consider this information for the Registration 

Review risk assessment. 

Page 2 of3 
Propargite: Human Health Risk 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 pesticide handler exposure 

monitoring data that the Agency is using in place of PHED 

(http://www.epa.gov/pesticides/science/handler-exposure-table.pdf). As more reliable data 

become available, the Agency continues to replace existing data in the table. The Agency needs 

to utilize this information versus solely relying on PHED, as noted on page 8 in the HED scoping 

document (May 21, 2014. 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 updated exposure information and additional risk assessments may be 

conducted if there are any significant changes in policies and/or additional data which may 

become available that impacts registration review. 

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