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flutolanil (Moncoat) NYS DEC Letter - Denial of Application for a Major Change in Label 10/00


New York State Department of Environmental Conservation 
Division of Solid and Hazardous Materials
Bureau of Pesticides Management, Room 498 
Pesticide Product Registration Section
50 Wolf Road, Albany, New York 12233-7257 
Phone: (518) 457-7446  FAX: (518) 485-8990 
Website: www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm 
E-Mail: ppr@gw.dec.state.ny.us


October 31,2000


CERTIFIED MAIL
RETURN RECEIPT REOUESTED


Mr. Richard M. Gorrell 
Manager, Registrations 
Aventis Environmental Science 
95 Chestnut Ridge Road 
Montvale, NJ 07648


Ms. Sherri McElroy
State Registration Specialist 
Scotts-Sierra Crop Protection Company 
14111 Scottslawn Road
Marysville, OH 43041


Dear Mr. Gorrell and Ms. McElroy:

Re:  Denial of Application for Registration of a Major Change in Label for the Active 
     Ingredient - Flutolanil - Contained in the Pesticide Product Contrast 70 WSP 
     Fungicide (EPA Reg. No. 45639-208-58185)


The Department of Environmental Conservation (the Department) has completed the review of 
Scotts-Sierra Crop Protection's application for registration of Contrast 70 WSP Fungicide 
(EPA Reg. No. 45639-208-58185). The application for registration of the product was 
submitted as a routine application for registration on September 9, 1999. Contrast 70 
WSP Fungicide contains the active ingredient, flutolanil, which was registered for use on
turf in New York State in the pesticide product Prostar 50 WP (EPA Reg. No. 45639-153) on 
September 18, 1995.


The Contrast 70 WSP Fungicide label adds the use of flutolanil for management of foliar, 
soilborne, cutting and bulb diseases caused by Basidiomycete fungi in greenhouses, saran 
and shade houses, outdoor container and field grown ornamentals. The Department determined 
that these additional uses would cause increased environmental and public exposure and, 
therefore, represented a major change in labeling for flutolanil. The application for Contrast 
70 WSP Fungicide was determined to be incomplete on December 9, 1999. AgrEvo USA Company 
(the basic registrant for Contrast 70 WSP Fungicide) submitted an application on December 
29, 1999 for Prostar 70 WP Fungicide (EPA Reg. No. 45639-208) which included the use in 
greenhouse, saran and shade houses, outdoor container and field grown ornamentals. The two 
applications were combined for purposes of review and a completeness decision date was set 
for February 25, 2000. The application was determined incomplete on February 25, 2000. On 
March 30, 2000, additional supporting data was received from Aventis Environmental Sciences 
USA LP and on June 7, 2000 the application was determined complete with a legislatively 
mandated registration decision due by November 4, 2000.


During the review of this application several changes in the ownership of the basic product 
occurred. The AgrEvo USA Company's product, Prostar 70 WP (EPA Reg. No. 45639-208), was 
transferred federally to Aventis CropScience USA LP, on February 22, 2000, and was assigned 
the EPA registration number of 264-665. The product was transferred again on June 16, 2000 
to Aventis Environmental Science USA LP. The product was assigned the new EPA registration 
number of 432-1223.


In our June 7, 2000 completeness letter, the Department requested that the registrant clarify 
which registration number they intended to market in New York State. Aventis Environmental
Science responded by submitting new labels on July 14, 2000 which were identified by EPA 
Reg. No. 432-1223. These labels contained only directions for use on turf. In an October 
26, 2000 telephone conversation with Mr. Richard (Mike) Gorrell of Aventis, he verified 
that Aventis will not be marketing the Prostar 70 WP label in New York State with the new 
greenhouse and ornamental uses. He stated that Scotts-Sierra Crop Protection has exclusive 
rights to market flutolanil on ornamentals in New York State. The Department will process 
the new label for Prostar 70 WP Fungicide (EPA Reg. No. 432-1223), which contains directions 
for turf only, as a routine application under separate cover.


Ms. Sherri McElroy of Scotts-Sierra stated, in an October 27, 2000 telephone conversation, 
that the only labels currently printed for Contrast 70 WSP Fungicide have the registration 
number which was assigned to AgrEvo USA Company (EPA Reg. No. 45639-208). Supplemental 
distributors are required to make changes to their label at the next printing or within 18 
months, whichever comes first. Scotts-Sierra has not printed new labels for Contrast WSP and 
the first transfer was only eight months ago. Therefore, they request registration of the 
Contrast WSP label bearing EPA registration number 45639-208-58185.


The Department has reviewed the information supplied to date in support of the major change 
in labeling application for Contrast WSP Fungicide (EPA Reg. No. 45639-208-58185).


HEALTH EFFECTS:
On an acute basis, the product was not very toxic to laboratory animals by the oral, dermal 
or inhalation routes of exposure. The product also was not very irritating to rabbit skin or 
eyes and it did not cause dermal sensitization (tested in guinea pigs).


Flutolanil was not very acutely toxic in laboratory animal studies, did not cause oncogenic 
effects and was generally negative in genotoxicity studies. Some developmental effects 
(reduced fetal and pup body weights and body weight gains) were reported in one supplementary 
rat study but not in several other studies in rats and rabbits. The USEPA's Office of 
Pesticide Programs recently (Federal Register 63: August 7, 1998 pages 42,249 thru 42,2,5.7) 
established a reference dose (RfD) for	tolanil of 0.63 milligrams per kilogram body weight 
per day (mg/kg/day) based on a no-observed-effect level (NOEL) of 63 mg/kg/day in a 
multi-generation reproduction study in rats (reduced pup body weights and body weight gains 
during the lactation period and subsequent reduced adult body weights in both males and 
females) and an uncertainty factor of 100. This RfD has not yet been adopted by the USEPA's 
Integrated Risk Information System (IRIS) which, in 1989 adopted an RfD of 0.06 mg/kg/day 
based on the same study data but with an uncertainty factor of 1000. A current search of the 
toxicological literature did not find any significant new information on the toxicology of 
flutolanil.


The are no chemical-specific Federal or State drinking/groundwater standards for 
flutolanil. Based on its chemical structure, flutolanil falls under the 50 microgram per 
liter general New York State drinking water standard for an "unspecified organic 
contaminant" (10 NYCRR Part 5, Public Water Systems).


The available information on flutolanil and the formulated product Contrast 70 WSP Fungicide 
indicates that it is not very acutely toxic in laboratory animal studies. Flutolanil is also
not very toxic in chronic toxicity studies and it did not cause any oncogenic or 
teratogeinic effects. The Contrast product is labeled for indoor (as well as outdoor) fungus 
control and impacts to indoor air can be of concern for such products. However, in the case 
of Contrast, this appears very unlikely because the active ingredient flutolanil has a very 
low vapor pressure (4.87 x 10"8 millimeters mercury at 25 degrees Celsius) and the formulated 
product does not contain additional volatile components.


ECOLOGICAL EFFECTS:
The proposed new use would have minimal incremental impact on fish, wildlife or marine 
resources.


ENVIRONMENTAL FATE AND GROUNDWATER IMPACTS:
Based on the labeled use rates, the maximum application rate for greenhouses is a drench 
application of 85 pounds active ingredient per acre per year with a second application 
permitted to give a total of 1701b ai/A/year. The currently accepted rate for turf is for 
a maximum of 8.5 lbs ai/A/year.


Hydrolysis data indicated that flutolanil is stable at pHs of 5, 7 and 9. No acceptable soil 
photolysis data was provided. The aqueous photolysis study indicated flutolanil degradation 
of only 8% over a 30-day study. No half-life was indicated in this study. However, a 
half-life in sandy soil of 300 days was indicated by aerobic soil metabolism. The anaerobic 
aquatic, metabolism half-life of flutolanil was grey. than 13 years.


Adsorption/desorption studies indicated that flutolanil is highly mobile in sand and loam, 
with Kocs ranging from 288 to 375 and was moderately mobile in clay loam and loam sand with 
Kocs ranging from 317 to 527. Mobility was directly related to the percent of organic matter 
in the soil.


Staff used computer modeling to project the estimated total accumulation of flutolanil 
over a ten year period of use at the maximum labeled rate of use. The projection used 
Riverhead (Long Island) soil, an application rate of 170 lbs ai/A/year, applied as two 
applications, a Koc of 288, and an aerobic half-life of 300 days. The modeling projected 
accumulation reaching a maximum of 3,000 ppb or 3 ppm at about eight years. Running the 
same model using Howard (Upstate) soil and changing the Koc to 527; the model projected 
accumulation with a peak of 0.9 ppb.


Prostar 70 WP is currently registered in New York State for use on turf. When modeling was 
performed using the turf rate of 8.5 lbs ai/A/year, a Koc of 288 and an aerobic half-life 
of 300 days on bare Riverhead soils, the model projected accumulation that reached 150 ppb 
at about eight years.


Given the very high application rate, the very long half-life, fairly low Kocs and the 
amount of accumulation projected by our modeling; it appears that this compound will cause 
a significant negative impact to ground or surface water anywhere in the State when used 
as labeled. Therefore, our groundwater staff objects to the registration of this product 
as labeled in New York State.


A copy of the groundwater review was provided to Richard M. Gorrell, Aventis Environmental 
Science and Mr. Gorrell responded in a May 3, 2000 letter in which he provided a 6 point 
discussion of the actual use that can be expected for flutolanil in New York State. His 
letter outlined the following points:

1.	In NYS, there is approximately 400-500 acres of greenhouse grown ornamentals 90% cut 
    flowers. These flowers are grown in containers either on raised benches (3-4 ft above the 
    ground) or on the ground. About 60% of the 400-500 acres are found on Long Island. Very 
    few perennial ornamental plants are grown in greenhouses.

2.	Of the greenhouse acreages, only 60-70% of each acre is treated, and much less if 
    grown in containers (25-50%).

3.	Field grown ornamentals consist of 500-1000 acres in New York State. Most of these 
    acres are perennial plants grown in 8-10 "containers. Only 25-50% of an acre is treated.

4.	Some bedding plants (cut flowers) are grown in the field but only for a very short 
    period if at all. Due to work and harvesting space allocations bedding plants make up 
    only 25% of any given acre. Therefore only 25% of an acre is treated.

5.	If you apply the Prostar 70 WP label recommendation, container grown plants (outdoors) 
    even at 3 pints per ft2 2 would only amount to 42.5 lbs ai/A/year (four applications 
    on 25% of an acre) worst case.

6.	With a broadcast ground application on bedding plants (outdoors), the label 
    recommendation is for two pints per square foot amounting to 57.18 lbs ai/A worst 
    case (four applications on 50% of an acre). However, the acreage is extremely small 
    and only one application is normally applied.


In summary, New York has a very small acreage of ornamentals (approximately 1500 acres) and 
only 25-60% would be treated worst case. Most would not receive but 1-2 applications per 
year. But even with the worst case offour applications, the chance ofground water 
contamination is small especially since most of the acreage is container ornamentals. The 
fungicide is tied up in the soil within the container, and these containers are then sold 
throughout the country.


Staff reviewed Mr. Gorrell's May 3, 2000 letter. Staff responded that the use rate used in 
our assessment was the result of a straight calculation of the maximum application rate as 
stated on the product label. Additionally, Mr. Gorrell stated in his letter that the worst 
case rate would be 42.5 lbs ai/A/year. During the original flutolanil review for turf use, 
modeling was done at the rate of 8.51b ai/A/year, a KOC of 288, and a half-life of 300 days. 
The modeling predicted breakthrough in the second year, and increasing concentrations, 
reaching about 150 ppb in the seventh year. Using the 50 ppb groundwater standard for 
flutolanil, the modeling predicts that use of this product at the low rate of 8.5 lb ai/A/year 
will cause a significant impact to ground water on Long Island.


Given the high labeled rate, the mobility and the persistence of this product, staff does 
not believe that this product should be registered for use in greenhouses, saran and shade 
houses, outdoor containers and outdoor fields. The risk to groundwater in upstate New York 
is also very great if this product is used over sandy areas, many of which are drinking 
water sources.


Please note that there were no objections to registration of this product for use on turf 
because of the foliar application to the turf and the high level of breakdown due to 
photolysis.


DISCUSSION:
Staff spoke with Mr. Gorrell on several occasions regarding our concerns. Mr. Gorrell 
sent additional data to support the greenhouse use.


The registrant sent four studies with their September 12, 2000 letter. This information 
was submitted in response to discussions with the registrant regarding the interpretation 
of the label directions and the actual amount to be applied as a drench in greenhouses and 
whether this amount will negatively impact groundwater. Our groundwater staff reviewed the 
additional information. The following is a summary of the comments regarding the four 
additional studies:

l.  Leaching Characteristics of MONCUT in Three Soils.	The product label allows much 
    higher use rates that those used in the study, so the study is not representative of 
    actual usage.

2.  Dissipation of Flutolanil on Bare Soil Following Application of Flutolanil 50WP to 
    Turf, USA. This study applied 10.75 lbs ai/a to turf. We have already agreed that use 
    on turf is acceptable, so this does not provide any additional supportive information.

3.  Dissipation of Flutalonil in Soil Following Application of Flutolanil 50WP. The study 
    confirms a half-life of 254 days in a sandy loam with 2.2% organic matter, which 
    correlates with the information submitted previously for this product. However, the 
    study used only 2 lbs ai/a, which is much less than the labeled rate in question.

4.  Long Term Dissipation of Flutolanil under Conditions of Peanut Cultivation Initiated 
    1989, USA. This study did not use soils typical of Long Island, but of upstate NY. 
    Previous reviews indicated that this product was acceptable in Howard-type soils. Our 
    concern was for greenhouses on Long Island and in sandy areas of upstate NY.


The following is a synopsis of our groundwater staff's opinion of all information submitted 
to date:

1.  The original groundwater review dated August 11, 1995 by the Division of Water indicated 
    that this active ingredient could potentially cause a significant negative impact to 
    groundwater in sandy areas. The registration letter indicated that
    "...when applied to turf, significant adsorption onto organic particles and uptake 
    into root systems will occur."

2.  LEACHM was run during the original review, dated January 6, 2000, using the Koc of the 
    soil from the study that was closest in type to Long Island soil, and using the 
    already-approved turf rate of 8.5 lbs ai/a/yr. The model projected that the
    chemical will accumulate, and reached a high of 150 ppb during the 10 year modeling period.

3.  The label directions are confusing regarding the number of applications and the 
    maximum amount of product that can be applied. Staff's initial calculations indicated 
    up to 170 lbs ai/a per year can be used, and the company calculated that up to 57.18 
    lbs ai/a per year can be applied.

4.  Staff has done some research into the actual amount of acreage that flower pots would 
    take up. The Department understands the company's argument that less than an acre 
    will be treated. However, the application rates are so high that the argument over 
    the actual square footage to be treated is moot. Even using the company's numbers of 
    how much is actually applied, the application rate of 57.18 lbs ai/a per year is still 
    much more than the rate of 8.5 lbs ai/a, which we have already stated is not acceptable 
    for sandy soils.

5.  In their letter dated March 13, 2000, the registrant stated "Keep in mind that the 
    product is applied to individual containers and not New York Soils" yet the label 
    bears the statement "A Systemic Fungicide ... in Greenhouses, Saran and Shade houses, 
    Outdoor Container and Field-Grown Nursery Stock" on the front of the label. This is 
    interpreted to be an outdoor use with even more potential to leach the active ingredient 
    to the groundwater.

6.  It is true that the soil in pots and containers is not sandy and has a much higher 
    organic carbon content. However, most greenhouses have no floors which act as barriers 
    to downward migration. Therefore, product applied to the pots and containers can drain 
    off onto the floor. Another concern is about the actual application method. The 
    label has directions for chemigation through flood, sprinkler or drip systems. It is 
    possible and probable that spray will miss the pots and containers and be applied to 
    the tables and/or the floor and, therefore, not be taken up by the plant.


CONCLUSION:
Given the high labeled rate, the mobility, the persistence of this product, and the lack 
of a barrier-type floor in greenhouses, it is still the opinion of our groundwater staff 
that this product should not be registered in New York State for use in green, saran, and 
shade houses, outdoor containers and outdoor fields without specific New York State label 
language. New York State specific labeling would have to specify the number of applications 
to container, grown ornamentals in greenhouses,	Also, the application techniques would have 
to be capable of applying the product directly to the container and limiting deposition 
outside of the container. The use of this product as currently labeled presents an 
unacceptable risk to groundwater in sandy areas of New York State, both upstate and 
on Long Island.


Therefore, your application for registration of Contrast 70 WSP Fungicide (EPA Reg. No. 
45639-208-58185) in New York State is denied.


You may pursue the options available under Article 33-0711 of the New York State 
Environmental Conservation Law.


Please be reminded that the application fee is nonrefundable. If you wish to reapply, you 
must submit a new application for registration as a Major Change in Labeling, applicable 
application fee and all required documents.


If you have any questions, please contact Frank Hegener, Chief of our Pesticide Product 
Registration Section, at (518) 457-7446.


Sincerely,
 
Maureen P. Serafini 
Chief
Bureau of Pesticides Management


cc:	N. Kim/D. Luttinger - NYS Dept. of Health 
E. Biel/R. Mungari - NYS Dept. of Ag. & Markets 
G. Good/W. Smith - Cornell University, PMEP
J. Conti - Aventis Environmental Science