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Fenpropathrin - Registration of Major Change in Labeling for Danitol 2.4 EC Spray (EPA Reg. No. 59639-35) and Tame 2.4 EC Spray (EPA Reg. No. 59639-77) 12/00

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

 December 15, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Harry Radke
State Registration Project Manager
Registration & Regulatory Affairs
Valent USA Corporation
PO Box 8025
Walnut Creek, CA 94596-8025

Dear Mr. Radke:

Re:  Registration of Danitol 2.4 EC Spray (EPA Reg. No. 59639-35) and Tame 2.4 EC Spray
     (EPA Reg. No. 59639-77), Which Represent a Major Change in Labeling for the Active
     Ingredient Fenpropathrin

The New York State Department of Environmental Conservation (the Department) has reviewed your
application, received August 10, 1999, and additional information, received November 3,
1999, February 7, 2000, February 15, 2000, May 5, 2000, September 27, 2000 and December
8, 2000. The products represent a major change in labeling for the active ingredient
fenpropathrin. The application was deemed complete for purposes of review on April 4, 2000
and a registration decision, originally due by September 1, 2000, has been waived and is
now due by December 15, 2000.

Danitol 2.4 EC and Tame 2.4 EC are identical insecticides. Both are emulsifiable concentrates
with 30.9% active ingredient fenpropathrin. Danitol is labeled for use on strawberries,
tomatoes, apples, melons, grapes, brassicas, pears, citrus fruit, cotton and peanuts.
Tame is labeled for commercial nonfood use on indoor and outdoor ornamental and nursery
plantings.

The Department has reviewed the information supplied to date in support of the pesticide
product registration application for Danitol 2.4 EC Spray (EPA Reg. No. 59639-35) and Tame
2.4 EC Spray (EPA Reg. No. 59639-77).

Our groundwater staff stated that based on the very high KocS, which ranged from 46,200 to
82,800 for both adsorption and desorption, and short field dissipation half-lives, the use
of this product as labeled should not cause an impact to ground or surface water in New York
State.

The Bureau of Habitat stated that fenpropathrin is a synthetic pyrethroid and it displays
characteristic toxicity of pyrethroids, that is, generally low toxicity to birds and mammals
and very high toxicity to aquatic organisms, particularly marine/estuarine crustaceans.
Fenpropathrin is stable to hydrolysis in water. Its rate of photodegradation in water is
dependent upon the presence of photosensitizers. In distilled water, the photolysis half-life
was >6 weeks; however it photodegraded with a half-life of 2.7 weeks in river water, 1.7 weeks
in sea water, and 0.5 days in water with 2% acetone. The primary route of degradation on soil
appears to be microbial degradation. The half-lives were quite variable, ranging from 152
days on a California soil to 11-17 days and 30-33 days in Japanese soils. Field dissipation
rates were also quite variable. In the August 31, 1993 EPA EFGWB review in which the field
dissipation study requirement was satisfied, six field dissipation rates were discussed with
the following half-lives reported: 144, 94.8, 29, 17, 16, and 8 days. The manufacturer was
never satisfactorily able to explain the high variability in field dissipation rates. They
suggested that although fenpropathrin was stable to photolysis on soil, adequate light could
photosensitize fenpropathrin for more rapid aerobic microbial degradation. The geometric mean
of the six studies listed above was 30 days, so the Bureau of Habitat used 30 as the average
field dissipation half-life for fenpropathrin. The half-life of fenpropathrin added to pond
water as spray drift was evaluated during an aquatic mesocosm study. This study showed the
average half-life of fenpropathrin in a pond to be about 1.1 days. The majority of the
fenpropathrin migrated to sediments where it degraded in hydrosoils with an average half-life
of 22-24 days.

When used as originally labeled, fenpropathrin does not appear to present any significant
risks to avian or mammalian populations. However, fenpropathrin does appear to present
significant risks to aquatic life.

The applicant conducted a mesocosm study in order to test the potential for adverse aquatic
impacts. The study exposed nine test ponds to different concentrations of fenpropathrin via
two simulated spray drift applications and five simulated runoff applications. The mesocosm
study showed significant treatment-related effects to a wide variety of taxa in the exposure
ponds, particularly the medium and high exposure ponds. Acute toxicity to fish occurred in
the high treatment ponds immediately after the first application of simulated spray drift.
The mesocosm study also showed that in most ponds, the overall taxa abundance and richness
was similar to that of the control ponds by

-  Addition of statements which prohibit single applications of more than 0.2 pounds
   fenpropathrin per acre. Application directions as currently labeled for grapes, melons and
   tomatoes are acceptable. Application directions as currently labeled for apples, pears,
   strawberries, brassicas, brussel sprouts and cauliflower must be revised to incorporate the
   0.2 lb. fenpropathrin/acre maximum application rate.

Tame 2.4 EC Spray

-  Addition of a statement which prevents use near coastal marshes; "In New York State, this
   product cannot be applied within 100 feet of a coastal marsh or any water that drains into a
   coastal marsh."

-  Addition of a statement which prohibits application within 100 feet of classified water
   bodies.

The Department received, on December 8, 2000, new USEPA stamped "ACCEPTED" labels dated
December 6, 2000 for both Danitol 2.4 EC Spray (EPA Reg. No. 59639-35) and Tame 2.4 EC
Spray (EPA Reg. No. 59639-77). The Department also received the corresponding updated
final labels. The final label for Danitol 2.4 EC Spray (EPA Reg. No. 59639-35) now
contains the following box:


ADDITIONAL RESTRICTIONS FOR USE IN NEW YORK

Do not apply this product within 100 feet of any freshwater lake, pond, river, stream
or wetland in the State of New York. Do not apply this product within 100 feet of a
coastal marsh or any water that drains into a coastal marsh in the State of New York.
Aerial application is prohibited in the State of New York. Applications greater than
0.2 lbs ai/acre are prohibited in the State of New York.


The final label for Tame 2.4 EC Spray (EPA Reg. No. 59639-77) now contains the following box:


ADDITIONAL RESTRICTIONS FOR USE IN NEW YORK

Do not apply this product within 100 feet of any freshwater lake, pond, river, stream or
wetland in the State of New York. Do not apply this product within 100 feet of a coastal
marsh or any water that drains into a coastal marsh in the State of New York.


The use of the products in accordance with the new updated labels, which contain the
mitigative label language specified by the Bureau of Habitat, should not present any
significant risks to avian or mammalian populations, or to aquatic life. The labeled
uses of Danitol 2.4 EC Spray and Tame 2.4 EC Spray do not appear to pose a significant
risk to workers or the general public.