1 Folpet Focus Meeting Summary

May 29, 2013

2:00

– 3 : 0 0 pm

A ttendees

Registrants: Adi Azmon (Makteshim Chemical Works or MCW ), Rob Everich (Makteshim

Agan of North America or MANA), Ephi Gur (LSR Associates), Tom Keenan (Ashland Inc.)

Environmental Prote ction 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 F ate and Effects Division (EFED) , Health Effects Division (HED)

, Antimicrobials Division (AD) , and Registration Di vision (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 a mendments for use on avocados and hops.

Discussion

Conventional Agricu ltural 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. M ANA and MCW mentioned the importance of folpet on hops and other crops grown in Europe, Ce ntral, and South America.
Last, M ANA mentioned that they can provide estimates of agricultural use of folpet in the

United States.

Label Amendments Makhteshim agreed to amend the label f o r Folpet 80W D G ( 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 s ummary of two folpet products: Fungitrol 11, for manufacturing use only, and Fungitrol 11

- 50S, used in2

nonaqueous paints, coatings, and caulking compounds. EPA /AD staff had several questions about the antimicrobial use patterns and will provide additiona l details regarding their questions.

Status of Folpet in the European Union (EU)

M CW 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. M CW also mentio ned 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 al so 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 80W D G label to EPA’s Registration Division for “fast track” review an d 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 a ntimicrobial use of folpet.
MANA will submit existing data and risk asse ssments to EPA ( ongoing ).