# E.R. BUTTS INTERNATIONAL, INC. 26 Sherman Court P.O. Box 764 Fairfield, CT 06430 Telephone: 203-256-0460 Fax: 203-256-0464

Via Federal Express
- Standard February 18, 1998 Ms. Susanne Cerrelli (PM-90) Biopesticides and Pollution Prevention Division Office of Pesticide Programs Environmental Protection Agency Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202 44492.8-00

Subject: PRIMASTOpTM
- Gliocladium catenulatum
- EPA File Symbol 64137-1 Response to Questions Raised by EPA Dear Ms. Cerrelli: This letter and attachments are a follow-up to our recent telephone discussions. apologize forthe delay in my response, but I have been trying to organize the information thatyou requested. Information Being Submjtted wjth this Letter Iam providing you with the following information: 1. Revised "PRIMASTOP Biofungicide Powder" labeling that removes outdoor uses and specifies rates forfoliar application. Five copies ofthe modified PRIMASTOP labeling are attached. A sixth copy has been highlighted to showthe modifications from the previously submitted label. 2. Justification for use ofthe 4-hour reentry interval (REI) 

### •••• Gliocladium catenulatum meets the requirements for a REI of4-hours per PR l1Ioliw 95-3. The toxicology studies conducted using Gliocladium catenulatum indicate-that 000 the microorganism is not pathogenic. The data further indicate that Gliocladium 00 catenulatum is a Toxicity Category III product. It was a skin**sensitiz~n~o~uinea** pit/s, however no hypersensitivity effects have been observed in the use

### ~toGUQclad¥m-: 0 catenulatum. We understand that PR Notice 95-3 indicates thatthe**R'5L~hould nQ~**  be 4-hours for a dermal sensitizer. Wewould like to point outthat

### ~e:<i,,~umen~: 0 0 0 indicates that a 4-hour REI is acceptable for microbial active ingredil!!rrts1f no knovt reports of hypersensitivity exist
- and none do exist. :

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00 0 000

00 0The acute toxicology and/or pathogenicity data are summarized below:
• Acute oral toxicity and pathogenicity in rats (acute oral LD50 >4.04-5.86 x 108 cfu/kg, clearance: 5.3 days) • Acute pulmonarytoxicity/pathogenicity in rats (acute pulmonary LC50 >6.60- 7.98 x 108 cfulkg, clearance: 

## g days) • Acute intraperitoneal toxicity/pathogenicity in rats (acute intraperitoneal LD50 >4.2x 108 cfu/kg, clearance:

## g days) • Acute oral LDso toxicity in rats (>2000 mglkg, EPA toxicity category III) • Acute dermal LDso toxicity in rats (>2000 mglkg, EPAtoxicity category III) • Acute dermal irritation in rats (minimal dermal irritant, EPA toxicity category IV) • Acute inhalation LC50toxicity in rats (>5.57 mg/L, EPAtoxicity category IV) • Primary eye irritation (minimal eye irritant, EPA toxicity category IV) • Skin sensitization (sensitizer) ; No hypersensitivity effects have been observed 3. Submission ofcorrections relating to the following studies:
• Gliocladium (J1446) Preparation Acute Dermal Irritation Test In Rats [MRID Number44189312] • Gliocladium (J1446) Preparation Acute Eye Irritation Test In Rabbits [MRID Number44189316] These documents are enclosed with this submission. Also in support ofthis submisSion, please find enclosed one (1) copy each ofthe following: • Application for Pesticide
- Registration (Form 8570-1) • Transmittal Documentfor PRIMASTOP Data to Be Submitted Verv Soon Further, an amended report providing individual animal data for clinical signs and necropsyforthe "Gliocladium catenulatum Cell Mass
- Acute Intra-Peritoneal Toxicology and Pathogenicity to the Rat" [MRID Number44189315] are being prepared by Huntingdon Life SCiences, Ltd. This reportwill be forwarded to you immediately upon receipt The laboratory has told us thatatbestwe will receive the data by thefirstweek in March. •••• 

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•••• Iwill submit ecological data nextweek. Per agreement between the Biopesticide lIrtd •• Pollution Prevention Division (BPPD) and Kemira, we are submitting these studiesior·· 

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### • informational purposes only in regard to our current application for**regi~ratiot1** of. • PRIMASTOP for greenhouse only uses. This agreementwas documen.lid.irl.my :••••• November30, 1995 "Minutes of Meeting" lettersentto BPPD and a respohoing

### lette~··. from BPPD (date not legible). I have attached both leiters for your**refe~Qee.** We**II\'n~·** reference these ecological studies whenwe amend the PRIMASTOP latM"to include· 

### • •• outdoor uses. •.:••• 

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### • Please give me a call ifyou have any questions or comments. Thankyou for assistance. Sincerely,

# ~~utt~h~ Regulatory Consultant Attachments
cc: Mrs. Oili Mohammadi, Kemira Agro Oy (with attachments) Mrs. Kirsi Kuparinen, Kemira Agro Oy (without attachments)



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# . 3TRANSMITTAL DOCUMENT for APPLICATION FOR REGISTRATION OF PRIMASTOP BIOFUNGICIDE CONTAINING THE NEWACTIVE INGREDIENT Glioe/adiurn eatenu/aturn STRAIN J1446

1. Name and Address ofSubmitter: Kemira Agro Oy c/o E.R. Butts International, Inc. 26 Sherman Court P.O. Box764 Fairfield, CT 06430 2. Regulatory Action in SupportofWhich This Package is Submitted: PRIMASTOpTM
- Glioeladiurn eatenulaturn
- EPA File Symbol 64137-1 Response to Questions Raised by EPA
3. Transmittal Date: February 18, 1998 4. List ofSubmitted Studies: MRID NUMBER 

# '-!LfLf9aBol Document 1 Response to Questions Raised by EPA Regarding MRID Number44189312 Entitled "Glioeiadiurn (J1446) Preparation: Acute Dermal Irritation Test in Rabbits." Unpublished letter prepared by Inveresk Research International. 3 p. Document2 Response to Questions Raised by EPA Regarding MRID Number44189316 Entitled "Glioeladiurn (J1446) Preparation: Acute Eye Irritation Test in Rabbits." Unpublished letterprepared by Inveresk Research International. 3 p.



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