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 for the delay in my response, but I have been trying to organize the 

information that you requested. 

Information Being Submjtted wjth this Letter 

I am providing you with the following information: 

1. Revised "PRIMASTOP Biofungicide Powder" labeling that removes outdoor uses and 

specifies rates for foliar application. 

Five copies of the modified PRIMASTOP labeling are attached. A sixth copy has 

been highlighted to show the modifications from the previously submitted label. 

2. Justification for use of the 4-hour reentry interval (REI) 

•••• Gliocladium catenulatum meets the requirements for a REI of 4-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 ~t oGUQclad¥m-: 0 

catenulatum. We understand that PR Notice 95-3 indicates that the R'5L~hould nQ~ 

be 4-hours for a dermal sensitizer. We would like to point out that ~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. : 0::: 0 00 0 

000 

00 0 
The 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 pulmonary toxicity/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 

>4.2 x 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, EPA toxicity category III) 

• Acute dermal irritation in rats (minimal dermal irritant, EPA toxicity category IV) 

• Acute inhalation LC50 toxicity in rats (>5.57 mg/L, EPA toxicity category IV) 

• Primary eye irritation (minimal eye irritant, EPA toxicity category IV) 

• Skin sensitization (sensitizer) ; No hypersensitivity effects have been 

observed 

3. Submission of corrections relating to the following studies: 

• Gliocladium (J1446) Preparation Acute Dermal Irritation Test In Rats [MRID 

Number 44189312] 

• Gliocladium (J1446) Preparation Acute Eye Irritation Test In Rabbits [MRID 

Number 44189316] 

These documents are enclosed with this submission. 

Also in support of this submisSion, please find enclosed one (1) copy each of the 

following: 

• Application for Pesticide - Registration (Form 8570-1) 

• Transmittal Document for PRIMASTOP 

Data to Be Submitted Verv Soon 

Further, an amended report providing individual animal data for clinical signs and 

necropsy for the "Gliocladium catenulatum Cell Mass - Acute Intra-Peritoneal Toxicology 

and Pathogenicity to the Rat" [MRID Number 44189315] are being prepared by 

Huntingdon Life SCiences, Ltd. This report will be forwarded to you immediately upon 

receipt The laboratory has told us that at best we will receive the data by the first week 

in March. • ••• 

• • •••• 

I will submit ecological data next week. Per agreement between the Biopesticide lIrtd •• 

Pollution Prevention Division (BPPD) and Kemira, we are submitting these studiesior·· 

•••••• • informational purposes only in regard to our current application for regi~ratiot1 of. • 

PRIMASTOP for greenhouse only uses. This agreement was documen.lid.irl.my : ••••• 

November 30, 1995 "Minutes of Meeting" letter sent to 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 when we amend the PRIMASTOP latM"to include· 

• •• outdoor uses. • .: ••• 

•• • • •• •• • 
• 

Please give me a call if you have any questions or comments. 

Thank you for assistance. 

Sincerely, 

Regulatory 

~~utt~h~ Consultant 

Attachments 

cc: Mrs. Oili Mohammadi, Kemira Agro Oy (with attachments) 

Mrs. Kirsi Kuparinen, Kemira Agro Oy (without attachments) 

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.3 
TRANSMITTAL DOCUMENT 

for 

APPLICATION FOR REGISTRATION OF PRIMASTOP BIOFUNGICIDE 

CONTAINING THE NEW ACTIVE INGREDIENT 

Glioe/adiurn eatenu/aturn STRAIN J1446 

1. Name and Address of Submitter: 

Kemira Agro Oy 

c/o E.R. Butts International, Inc. 

26 Sherman Court 

P.O. Box 764 

Fairfield, CT 06430 

2. Regulatory Action in Support of Which 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 of Submitted Studies: 

MRID NUMBER 

'-!LfLf9aBol Document 1 Response to Questions Raised by EPA Regarding 

MRID Number 44189312 Entitled "Glioeiadiurn 

(J1446) Preparation: Acute Dermal Irritation Test in 

Rabbits." Unpublished letter prepared by Inveresk 

Research International. 3 p. 

Document 2 Response to Questions Raised by EPA Regarding 

MRID Number 44189316 Entitled "Glioeladiurn 

(J1446) Preparation: Acute Eye Irritation Test in 

Rabbits." Unpublished letter prepared by Inveresk 

Research International. 3 p. 

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