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Bifenthrin - Registration of a Major Change in Labeling for Talstar 4/96

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York  12233-7250
Phone:518-457-6934 Fax 518457-0629
April 26, 1996
Mr. George L. Meindl
Associate Registration Specialist
APG Specialty Products
FMC Corporation
P .O . Box 8
Princeton, New Jersey  08542-0008
Dear Mr. Meindl:
Re:  Registration of a Major Change in Labeling for Talstar WP
Insecticide/Miticide (EPA Reg. No. 279-3057) and Talstar Flowable
Insecticide/Miticide (EPA Reg. No. 279-3105)
This Department has completed the technical review of your application
received on October 7, 1994, together with all of the supporting
supplemental information supplied to date, regarding registration of the
referenced pesticide products in New York State.  The products contain
bifenthrin as the active ingredient and are labeled to control insect
pests on landscape ornamentals, greenhouses and home lawns.  Bifenthrin
was previously registered for use in New York State on greenhouse grown
ornamental trees, shrubs, plants and flowers, and non-bearing fruit and
nut trees.  The addition of outdoor ornamentals and home lawns
represented a major new use pattern for the active ingredient bifenthrin
in New York State.
The submitted data package was reviewed by the New York State Department
of Health for public health effects, this Department's Division of Water
for groundwater impacts, and Division of Fish and Wildlife for
ecological impacts.
Based upon these assessments, we concluded that the labeled uses of
Talstar are not likely to result in significant impacts to groundwater
resources or public health in New York State. Bifenthrin has a low
potential to leach through soil and contaminate groundwater/drinking
water.  Based on its chemical structure, bifenthrin falls under the 50
microgram per liter New York State drinking water standard for an
"unspecified organic contaminant" (10 NYCRR Part 5-Public Water System).
Based on the reference dose for bifenthrin (0.015 mg/kg/day) and the
United States Environmental Protection Agency (USEPA) procedures for
determining maximum contaminant level goals for Group C carcinogens
(Federal Register, 55:30374-30375, July 25, 1990), a potential drinking
water standard of 10 micrograms/liter can be calculated for bifenthrin.
In previous letters and telephone conversations between staff from FMC
Corporation and this Department's Pesticide Registration Section and
Division of Fish and Wildlife, we expressed concern regarding aquatic
toxicity from the use of Talstar WP and Flowable on turf in New York
State.
In response to our concerns, FMC Corporation submitted the following
additional data (received March 15, 1996) to support FMC's contention
that toxicity of bifenthrin to aquatic organisms is reduced by
interaction of the chemical with sediments:  results of a sediment-water
microcosm study, literature on computer modeling, pesticide runoff, and
vegetated buffer strips.  We reviewed the additional data; however, our
concerns regarding the potential for bifenthrin to harm fish and aquatic
invertebrate populations in waters adjacent to treated turf were not
alleviated.
Because the active ingredient bifenthrin is persistent and the Talstar
applications can be repeated, bifenthrin residue levels could be
maintained for prolonged periods of time at concentrations that will
significantly and adversely impact nontarget fish and invertebrates. In
light of this, we believe that specific restrictions regarding the use
of Talstar on turf are warranted to mitigate toxic impacts to aquatic
ecosystems in New York State.  (Note: FMC was informed of our intention
to impose such restrictions in a teleconference on April 12, 1996, and
agreed to comply.)
Therefore , Talstar WP Insecticide/Miticide and Tals tar Flowable
Insecticide/Miticide are acceptable for registration in New York State
contingent upon FMC's compliance with the special mitigative conditions
set forth by this Department.  To meet these conditions, FMC developed
Product Bulletin labeling for the Talstar products which adopts the
following language:
1.  The phrase "For Use by Certified Applicators Only" was added to the
Directions for Use section of each label. The products are classified as
"restricted use" pesticides.
2.  A statement was added which limits the maximum number of
applications per season to three and the period of time between
applications is 30 days. (There is currently no limit on total annual
usage on the federally approved label for Talstar.)
3.  A statement was added which indicates that a 100 foot buffer zone
must be maintained between the application site and waters of the state.
In addition to the above language, FMC Corporation will add the
statement "Not for Use in New York State without the Product Bulletin
for..." to the outermost container/packaging of each product.  This
statement is necessary to alert potential users that the products are to
be used only in conjunction with the referenced product bulletin
labeling.
We believe that these restrictions are adequate to protect fish and
wildlife resources in New York State.
We reviewed the facsimile received from FMC Corporation today (April 26,
1996) for the proposed final printed labeling and the accompanying
Product Bulletin labeling.  The submitted product label and the Product
Bulletin labeling incorporate the necessary language for use in New York
State.  This labeling is acceptable.
In a related matter, the Department also accepts for registration
Talstar Lawn & Tree Flowable Insecticide/Miticide (EPA Reg. No. 279-
3162), another pesticide product containing bifenthrin as the active
ingredient.  Talstar Lawn & Tree Flowable has similar use patterns to
Talstar Flowable and is, thus, subject to the conditions of registration
as previously described.
It is our understanding that FMC Corporation will notify the United
States Environmental Protection Agency (USEPA) of the intention to
modify the label as described before allowing the referenced products to
enter the channels of trade in New York State.  A copy of the written
notification to the USEPA must be submitted to this Department. Also,
this Department must be informed of any comments/revisions from the
USEPA regarding the referenced registrations.
A New York State Certificate of Registration and a stamped "ACCEPTED"
label for Talstar WP Insecticide/Miticide, Talstar Flowable Insecticide/
Miticide and Talstar Lawn & Tree Flowable Insecticide/Miticide are
enclosed for your records.
If you have any questions regarding these issues, please contact Ms.
Maureen Serafini, of my staff, at (518) 457-3016.
Sincerely,
Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous
Materials
cc:  B. Smith, Cornell University PMEP
     N. Rudgers, Dept. of Ag & Markets
     N. Kim/T. Grey, NYS Dept. of Health