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Folpet Focus Meeting Summary

May 29, 2013

2:00 – 3:00 pm

Attendees

Registrants: Adi Azmon (Makteshim Chemical Works or MCW), Rob Everich (MakteshimAgan of North America or MANA), Ephi Gur (LSR Associates), Tom Keenan (Ashland Inc.)

Environmental Protection Agency (EPA or the Agency): Christina Scheltema (PRD), Tracy 

Perry (PRD), Bonnie Cropp-Kohlligian (HED), Ayaad Assaad (HED), Jessica Kidwell (HED), 

He Zhong (EFED), Michael Lowit (EFED), Sujatha Sankula (EFED), Donna Randall (AD), 

Siroos Mostaghimi (AD), Tony Kish (RD)

Objective

The purpose of the meeting was for members of the EPA’s Pesticide Re-evaluation Division 

(PRD), Environmental Fate and Effects Division (EFED), Health Effects Division (HED), 

Antimicrobials Division (AD), and Registration Division (RD), to meet with the folpet 

registrants to discuss the registration review schedule and the following aspects of the folpet 

registration review: 

Confirmation of registrant support for both conventional and industrial/antimicrobial uses 

of folpet for registration review

Discussion of the global use of folpet, potential trade issues, and the continued need for 

import tolerances; and 

Submission and processing of folpet label amendments for use on avocados and hops. 

Discussion

Conventional Agricultural Uses of Folpet

MANA provided a summary of information on the use of folpet to control scab on avocados 

grown in Florida and to control downy mildew on hops. MANA and MCW mentioned the 

importance of folpet on hops and other crops grown in Europe, Central, and South America. 

Last, MANA mentioned that they can provide estimates of agricultural use of folpet in the 

United States. 

Label Amendments 

Makhteshim agreed to amend the label for Folpet 80WDG (instructions for use) on hops and 

avocados, and to submit label amendments to RD by June 15, 2013. In the PWP, EPA identified 

the need for these label amendments to clarify the directions for use on hops and establish a 

longer Preharvest interval for avocadoes. RD expected to be able to process these as fast-track 

label amendments. 

Industrial/Antimicrobial Uses of Folpet

Ashland Inc provided a brief overview of their history, including acquisition of International 

Specialty Products, another folpet registrant, in 2011. They also provided a brief summary of 

two folpet products: Fungitrol 11, for manufacturing use only, and Fungitrol 11-50S, used in 
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nonaqueous paints, coatings, and caulking compounds. EPA/AD staff had several questions 

about the antimicrobial use patterns and will provide additional details regarding their questions.

Status of Folpet in the European Union (EU)

MCW provided a brief overview of recent regulatory activity in the EU and the importance of 

folpet as a conventional fungicide in EU member countries today. MCW also mentioned data 

and risk assessments developed to support the EU regulatory review. 

Anticipated Data Needs for the Folpet Registration Review

Makteshim mentioned their plans to submit a waiver for the expected inhalation study data 

requirement. Makhteshim also mentioned their plans to submit existing data to EPA prior to 

issuance of the registration review data call-in.

Follow-up Actions 

MANA will submit a label amendment for the Folpet 80WDG label to EPA’s 

Registration Division for “fast track” review and approval (completed). 

EPA/RD will review the amended Folpet 80WG label within the “fast track” time frame. 

MANA will provide an estimate of the agricultural use of folpet in the US. 

EPA/AD will provide a comprehensive list of questions regarding the antimicrobial use 

of folpet. 

MANA will submit existing data and risk assessments to EPA (ongoing).