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flufenacet NYS DEC Letter - Withdrawal of Application for Registration 5/99

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

May 4, 1999


Ms. Karen S. Cain
Product Manager, State Regulatory Affairs 
Research and Development
Bayer Corporation Agriculture Division 
P.O. Box 4913
Kansas City, MO 64120-0013

Dear Ms. Cain:

Re:  Withdrawal of Application for Registration of One New Pesticide Product, AXIOM DF 
     Herbicide (EPA Reg. No. 3125-488), Which Contains the New Active 
     Ingredient Flufenacet

The Department received your letter, dated April 27, 1999, requesting the withdrawal of 
the application for registration of one new pesticide product, AXIOM DF Herbicide 
(EPA Reg. No. 3125-488), in New York State. The Department has reviewed the application, 
received August 25, 1998, and additional information, received November 20, 1998, for 
registration of the new product. The application was deemed complete on January 11, 1999 
and a registration decision is due by June 10, 1999.

AXIOM DF Herbicide contains the new active ingredient flufenacet, and the active ingredient 
metribuzin, which is a currently registered active ingredient in New York State. The product 
is labeled for control of certain grass and broadleaf weeds in corn and soybeans.

The Department acknowledges Bayer Corporation's decision to withdraw the application for 
New York State registration of AXIOM DF Herbicide (EPA Reg. No. 3125-488).

The Department has concerns regarding possible effects to human health, fish and 
wildlife, and groundwater and surface water.

Flufenacet caused a number of effects in laboratory animal studies at relatively 
low doses, including neurotoxicity, developmental toxicity and effects on thyroid 
hormone levels, as well as effects on numerous other tissues and organs. Flufenacet 
and its degradates appear to have the ability to leach through soil into groundwater 
and to run-off into surface water. Bayer Corporation is currently conducting prospective 
groundwater monitoring studies and a surface water monitoring program.

The product was also modeled for possible effects to fish and wildlife. Unacceptable algae 
and aquatic macrophyte effects were found from runoff at all modeled application rates. 
Marine invertebrate reproductive toxicity is likely at higher application rates. Mammalian 
chronic toxicity is possible at lowest application rate in areas adjacent to treated 
fields. Possible mammalian effects increase with application rate.

There are many concerns regarding the toxicity of the thiadone metabolite, a primary 
metabolite of flufenacet. The United States Environmental Protection Agency has required 
that a complete series of environmental fate and aquatic toxicity studies be conducted 
for the thiadone metabolite. A more accurate risk assessment will be possible when these 
studies are available.

Due to the above-mentioned concerns of the Department, Bayer Corporation has requested 
the withdrawal of the AXIOM DF Herbicide (EPA Reg. No. 3125-488) until such time as 
additional pertinent data is available.

Bayer Corporation understands that the $300 application fee is forfeited, and that 
any subsequent application for registration of this product will require a complete 
application and fee.

Please be aware that any unregistered product may not be sold, offered for sale, 
distributed, or used in New York State.

The Department does not have the space to store the data package of the withdrawn 
product. The data will be destroyed after thirty (30) calendar days from receipt of 
this letter unless Bayer Corporation makes arrangements to have the package returned 
at your expense.

Please contact Ms. Jeanine Broughel, of my staff, at (518) 457-7446, if you have any 

Maureen P. Serafini 
Pesticide Product Registration Section

cc:	N. Kim/D. Luttinger - NYS Dept. of Health 
J. Leach - NYS Dept. of Health
W. Smith - PMEP Cornell University