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dimethomorph (Acrobat MZ) NYS DEC Letter - Application for Registration 9/99

New York State Department of Environmental Conservation 
Division of Solid & Hazardous Materials
Bureau of Pesticides Management 
Pesticide Product Registration Section 
50 Wolf Road, Albany, New York 12233-7257 
Phone 518-457-7446 FAX 518-485-8990

September 2, 1999


Ms. Michaeleen E. Linahan 
State Registration Manager 
American Cyanamid Company 
P.O. Box 400
Princeton, NJ 08543-0400

Dear Ms. Linahan:

Re:  Application for Registration of a New Active Ingredient - Dimethomorph contained in
     the Pesticide Products Acrobat MZ Fungicide (EPA Reg. No. 241-383 and Acrobat MZ WDG
     Fungicide (EPA Reg. No. 241-395)

The New York State Department of Environmental Conservation (NYSDEC) has reviewed 
your application and supporting data, received on July 20, 199, to register the above 
pesticide products for use to control metalaxyl-resistant late blight on potatoes in
New York State. Both products contain the new active ingredient, dimethomorph, as well 
as the active ingredient mancozeb, which is already registered for this use. This 
application is incomplete for purposes of review.

Specifically, many issues remain unresolved between the EPA and your company. These
issues range from disagreement on statistical interpretation of study results to which
studies are in fact required. Many of the points of contention need to be settled before 
a sound risk assessment can be conducted by this Department.

The US Environmental Protection Agency (USEPA) Notice of Pesticide Registration for 
Acrobat MZ Fungicide lists nine toxicity tests to be conducted with the typical end-use 
product (TEP), three studies to be conducted with the technical grade active ingredient, 
four environmental fate studies or study categories (where multiple replicate studies 
are required), two crop rotation studies, and a bio-accumulation in fish study as conditions
of continued registration. Thirteen of the studies are marked with asterisks indicating 
that they are intended to clarify whether or not toxic synergism occurs between dimethomorph
and mancozeb. Please reference the notice of registration for details.

In the October 5, 1998 USEPA Environmental Fate and Effects Division's science chapter 
of the dimethomorph review, it is recommended that American Cyanamid Company either (1)
submit the studies on the TEP, or (2) submit or reference acceptable mancozeb studies 
and provide a rational for why TEP testing should not be necessary (i.e. provide an 
analysis refuting the perceived synergism).

On March 16, 1999, your company submitted to the EPA the results of two studies, plus 
rebuttal arguments, and testing waiver requests, which your company feel will reduce the 
list of required studies to two areas, namely the Terrestrial Field Dissipation and the 
Fish Bio-accumulation studies (both scheduled for completion in September 2000). No EPA 
response to your study submissions, arguments, or waiver requests are included in this 
data package.

Therefore, the Department would like to know the status of the following:

Upgrade requests for:

		MRID #
72-1a	Acute Fish Toxicity-Bluegill (TGAI)	43917209
72-2a	Acute Toxicity-Aquatic Invertebrate(TGAI)	43917213
72-4a	Freshwater Fish Early Life Stage Study (TGAI)	44418104

Testing Waiver requests for:

162-3	Anaerobic Aquatic Metabolism
162-4	Aerobic Aquatic Metabolism
71-1 a/b	Acute Avian Oral Toxicity-Quail/Duck(TEP)
71-2a/b	Acute Avian Dietary Toxicity-Quail/Duck(TEP)
71-4a/b	Avian Reproduction Toxicity-Quail/Duck(TEP)
72-1 b	Acute Fish Toxicity- Bluegill(TEP)
72-3d	Acute Estuarine/Marine Toxicity-Fish(TEP)
72-3e	Acute Estuarine/Marine Toxicity-Mollusk(TEP)
72-3f	Acute Estuarine/Marine Toxicity-Shrimp(TEP)
72-4b	Estuarine Life Cycle-Aquatic Invertebrate(TEP)
72-5	Freshwater Fish Life Cycle(TEP)
72-la	Acute Fish Toxicity-Bluegill(TGAI)
72-2a	Acute Toxicity Aquatic Invertebrate(TGAI)
72-4a	Freshwater Fish Early Life Stage Study(TGAI)
72-4b	Estuarine Life Cycle-Aquatic Invertebrate(TGAI)

EPA DERs, if available, for the following studies submitted March 16, 1999:

162-2	Anaerobic Soil Metabolism Study
163-1	Mobility (Adsorbtion/Desorbtion)

The above information will be necessary to continue the review of the above-referenced 
data package. American Cyanamid Company must submit the required information within 
forty-five (45) calender days of receipt of this letter. Failure to submit the requested 
information will result in the termination of the review process.

Please note that if you wish to reapply for registration after the specified 45 day 
deadline, you must submit the requested information along with new application forms and 
another fee.

If you have any questions on this matter, please contact Betty Seeley, of my staff, at 
(518) 457-7446.


Maureen P. Serafini 
Pesticide Product Registration Section