# FOLPET –

Focus Meeting

1 

# Makhteshim Chemical Works Ashland Inc 

# May 29 – EPA2



# Agenda

• Background and Introductions

• Reg Review team

• Folpet Registrants and stakeholders

• Adi Azmon
– MCW

• Dr. Rob Everich

– MANA

• Tom Keenan
– Ashland Inc

• Ephi Gur

- LSR

• Uses supported for reg review (MANA & Ashland)

• Ag uses, labels, usage information including history

• Description of non

- food, industrial uses. Label usage information including use history

• Global use of Folpet and the need for import tolerances

• Anticipated data needs identified in work plan

• Review of studies submitted since docket has opened

• Schedule for issuance of DCI

• Folpet label Amendments (avocadoes and hops)

• Next steps3



# Agricultural uses Identification of uses to be supported through Reg Review

• Use on Hops to control downy mildew



## • We agree to label changes reducing the maximum use rate

• from 3.0 lb /product/A/app ( 2.4 lb ai)



## • to 2.5 lb / product/A/app ( 2.0 lb ai)

• REI of 24 hrs to be retained

• Use on Avocado to control Scab ( Sphaceloma )45 2002 : Jim O’Brien elected Chairman

and CEO 2008 : Acquired Hercules Incorporated

2006 : Divested Ashland Paving and Construction, Inc. 2011 : Acquired International Specialty Products Inc. (ISP)

2011 : Divested Ashland Distribution 2005 : Sold stake in Marathon Oil joint venture 

# Our History6 Commercial Units Ashland Specialty Ingredients Ashland Water Technologies Ashland

Performance Materials Ashland

Consumer Markets Leading Products & Services #1 cellulose ethers, global leader in vinyl pyrrolidones #1 specialty papermaking chemicals #1 unsaturated polyester resins and vinyl ester resins #2

U.S. franchised quick - lube chain, #3 passenger - car motor oil
Sales 1 $2.9 billion $1.7 billion $1.5 billion $2.0 billion

1 For 12 Months ended Dec. 31 , 2012 

# Four Businesses7 

# Label Use Description

 Fungitrol 11 ( 95.9 % Folpet )

 Powder

 For manufacturing use only in the formulation of fungicides for agricultural and industrial use

 Formulators are responsible for obtaining their own EPA registration of their formulated product

 Fungitrol 11
- 50 S ( 48 % Folpet )

 For industrial use

• Non
- aqueous paints

• Coatings

• Caulking compounds

• Dosage levels of Fungitrol 11
- 50 S between 1.0

– 3.0 % by weight should be considered ( 0.48

– 1.44 % a.i .)8 

# Folpet Global Status

• Folpet is a broad spectrum contact fungicide used 

## world

- wide in agriculture and as a biocide in paints, coatings, adhesives, wood and plastics as an anti fungal agent.

• Folpet is a multi

- site active ingredient and has a major role in disease resistance management.

• Folpet is widely use in grapes, hops, fruit , vegetables 

## and cereals in Europe and Latin America.

• Posted comments from stake holders in Colombia and Mexico stress the need to maintain all current import 

## tolerances: apple , cranberry, cucumber, grape, raisin , lettuce, melon, onion (dry bulb), strawberry, and tomatoes)9



# EU Status

• Folpet re - included into Annex I in 2007 and was recently re

- registered in most of the EU member countries.



## • It is the primary choice as a partner to any new fungicide developed in Europe today.

• MCW has over 18 Folpet different mixtures

• Syngenta, Bayer, BASF, DuPont (and others) hold 19 additional mixtures

• During the re

- registration process, Folpet MRLs were increased in garlic and tomatoes and were doubled in wine grapes.10



# Rat 90 day inhalation Anticipated data gap



## • A guideline, GLP
- compliant 28 day inhalation toxicity study will be submitted shortly.

• Results are “as expected” with clear NOAELs



### • Systemic

– 25 μg/L

• Portal of entry
- 5 μg/L.

• 9 0 day study for Captan provides additional relevant 

### information.

• Based on the above a POD for RA can be set

• Use of additional animals for a 90
- day inhalation toxicity 

### study with Folpet is unethical given the available data.11



# Other anticipated studies EFED response posted May 21

• Efate studies will be evaluated (Soil photolysis, Aerobic soil metabolism, Aerobic and Anaerobic Aquatic metabolism, ECM/ILV for soil and water)



### • Note EFED’s comment re Mesocosm study, Vegetative vigor and will review them in greater detail

• We will look into the PI fate data and find out if additional 

### information exists.

• Bird repro studies

- we would like to confirm EEC’s.

• EFED uses default foliar 1⁄2
- life of 35 days where in the past used 2.55 days.

• Using old GAP a maximum EEC of 736 ppm on short grass food items (worst case) is calculated

.


### • Avian Inhalation

– non guideline study

.

# FOLPAN 80 WDG Label Changes
Hops: Downy Mildew

- Apply 3 2.5 pounds of Folpan 80 WDG per acre by ground.

- Do not apply more than 12 10 pounds of Folpan 80 WDG per acre per year.

- Do not enter or allow worker entry into treated areas during the restricted
- entry interval (REI) of 24 hours. (no change) Avocado: Scab ( Sphaceloma )

- Do not make applications within 1 7 days of harvest.

1213



# Next steps