Document ID: EPA-HQ-OPP-2012-0778-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-11-22T05:00Z

Notes from Imazalil All-Registrant Focus Meeting
              Wednesday, October 23[th] at 9-10am (Eastern Time)
                    Location: Potomac Yards South, Rm. 9100

Color code: 	Black = included in the meeting agenda
		Purple = things stated during the meeting itself
      Red = outstanding action items

Purpose of Meeting:
The upcoming focus meeting is intended as an opportunity for the EPA science divisions to ask registrants use/usage related-questions that will help refine the problem formulation and scoping document, also to be published publically in December.  The final content of those two science documents will feed into the final draft of the preliminary work plan.
EPA Attendees:
AD: Sharon Carlisle, Timothy Dole, Tim McMahon, Sandra O'Neill, Laura Parsons, Marshall Swindell
BEAD: Tara Chandgoyal, Cynthia Doucoure, Andrew Lee, Arnet (Skee) Jones
EFED: Brian Anderson, Christine Hartless, RDavid Jones, Paul Mastradone
HED: Jaime D'Agostino, Zaida Figueroa, Dennis McNeilly, Karlyn Middleton, Christina Swartz, Jess Rowland
PRD: Cathryn Britton, Kevin Costello, Meg Hathaway (Chemical Review Manager)
RD: Cynthia Giles-Parker, Tony Kish

Registrants (All Calling In):
Certis Europe
Marie Spirlet
Janssen PMF
Bill Goodwine
Makhteshim Chemical Works Ltd
Jonathan Janis

Agenda:
   I. Introductions
         
   II. Upcoming regulatory milestones
         a. December 2013 = Docket opening & Preliminary Work Plan (PWP) publication
         b. February 2014 = Close of public comment period on Imazalil PWP
         c. May 2014 = Final Work Plan (FWP) publishes 
            
   III. Brief review of type of data supplied thus far by registrants 
         a. Sales data [general discussion only - CBI]
         b. EFED/HED studies
         c. Dietary assessment by Janssen
                 i. Has been supplied by registrant but not yet reviewed by HED.
                  
   IV. Discussion of EPA science team concerns
         a. Egg hatchery use
                 i. Question relating to handler process and potential inhalation risks: What type of equipment is used in hatcheries for imazalil application, an automatic or a handheld fogger?
                     1. Janssen PMF says they will answer this question.
         b. Seed treatment use
                 i. Is imazalil still being used for seed treatment use (e.g. for barley or wheat)?  EPA data indicates low average usage from 2009-2011.
                     1. Certis Europe says seed treatment uses occur for imazalil in both Europe and the United States.  In the case of the US, Certis sell's the technical product to a formulator in the US.
         c. Postharvest use on citrus
                 i. Process questions
                     1. Describe how wash water is managed.
                           a. Janssen PMF and Makhteshim both say they will address this question.
                           b. Makhteshim notes that there is a difference between wash water and treating solution.  Notably, treating solution is recycled back into its storage tank, thereby minimizing environmental exposure. 
                     2. Is imazalil used as a postharvest treatment on fresh market citrus only, citrus fruits used for juicing only, or both fresh market & juicing citrus?
                           a. If both, what % of citrus treated is processed citrus?  Data for juicing in particular would be helpful.
                                   i. Janssen and Makhteshim confirm that only fresh market citrus is treated, not citrus used for juicing/processing.
                                       1. However, some fresh fruit is treated and then diverted back for juicing when it is culled for cosmetic defects.  Janssen says they will provide an estimate for what % of treated fruit is culled and used for jucing.
                                   ii. Janssen PMF notes that the citrus market share for processed citrus is far greater than the market for fresh citrus.
                     3. Labeling ambiguity: Current labels permit two treatments.
                           a. HED requests clarification on what treatments are included in a postharvest context.  For example, a before and after long-term storage treatment, a dip and then a wax before treatment, or something else?
                                   i. Janssen says there are 2 possibilities:  the first is a is a dip wash (treatment 1) followed by a rinsing spray (no treatment, just a rinse), then being coated in a fungicide-impregnated wax (treatment 2).  The other possible scenario is of a pre- and then post-storage treatment.  Janssen notes that the "dip then wax" scenario is the one in which the fruit's exposure to imazalil is highest, and should be considered the "worst-case scenario" for risk management purposes.
                                   ii. EPA-BEAD asks if there is any circumstance in which fruit would receive a third treatment, such as after long-term storage.
                                       1. Janssen PMF answers: no.  No third treatment is allowed.  If fruit is brought out from long-term storage, the processing plants will reopen boxes and throw out bad fruit, but not retreat the remaining good fruit. 
                                   iii. EPA asks whether the "no third treatment rule" applies to all types of citrus in addition to oranges.
                                   iv. Janssen PMF notes that facilities try to use different fungicidal chemicals for each of the two treatments.
                           b. Also, what is the required/allowed time interval between treatments?
                                   i. If it's not an immediate double-treatment scenario, such as a wash then wax, in the case of lemons there may be 3-6 months between pre- and post-storage treatments.
                 ii. Gaps in Sales Data provided
                     1. What volume of imazalil is used on citrus?
                           a. Janssen PMF will supply data.
                           b. The information provided so far by the registrants gives only the amount of AI sold in pounds.
                           c. Imazalil is not a typical field crop with a specific use in pounds per acre.  The active ingredient is put in spray solution and used. How much citrus is treated for a given solution (i.e. volume AI and dilution factor data)?
                                   i. Janssen PMF indicates that 2g ai is used to treat one ton of fruit.  They indicate that this amount of ai is for both treatments combined (e.g. a wash and a wax).  They will check with end-use registrants to clarify how this works in practice.  For example, Janssen will check whether the amount of ai used could double to 4 g ai/ton in the case of lemons receiving a pre- and post-storage treatment.
                           d. Janssen PMF notes that there is an overall market trend of declining imazalil use.  This is due to the recent registration of 4-5 other fungicides.  While imazalil has historically been the "workhorse" of agricultural fungicides, other fungicides are now replacing imazalil in various contexts.
                           e. EPA discusses the feasibility of bridging PDP data on oranges to lemons or other citrus.  It is noted that field trial residue studies find high q* values.
                     2. Of AI used on citrus, how much remains after treatment (residues)?
                           a. Janssen PMF will check their residue files.  They also refer EPA to the available PDP data.  EPA responds that due to the limitations of the PDP data, information on lemons would be especially helpful.
                           b. Janssen PMF notes that residues are desirable in the case of pre-storage treatments because they increase the shelf life of citrus.
                           c. EPA-RD asks whether all fresh market citrus is treated in some way (even if not treated with imazalil specifically.  Janssen PMF replies that unless the fruit is organic, the answer is yes.
         d. Other Concerns?
            
   V. Questions from the Registrants
         
   VI. Conclusion (Next Steps/Repetition of Action Items)
         a. Scheduling follow-up meeting with Janssen PMF to discuss cancer risk concerns.
                 i. EPA-PRD schedules a meeting for Nov. 6, 2013.
                 ii. EPA-AD notes that the sales volume of imazalil products used for antimicrobial purposes is low enough that cancer is not a major concern for AD's risk assessment.
         b. Other items as discussed in today's meeting