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Tebuconazole - New Active Ingredient Registration 9/96

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 518-457-0629

September 5, 1996

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Karen Cain
State Regulatory Affairs Specialist
Registrations Department
Bayer Corporation
8400 Hawthorn Road

P.O. Box 4913
Kansas City, MO 64120-0013

Dear Ms. Cain:

Re: Registration of the New Active Ingredient - Tebuconazole Contained in the
Pesticide Product Elite 45 DF Foliar Fungicide (EPA. Reg. No. 3125-388)

The New York State Department of Environmental Conservation (NYSDEC) has
accepted your application for the registration of the new active ingredient,
tebuconazole, contained in the pesticide product Elite 45 DF Foliar Fungicide
(EPA Reg. No. 3125-388) for use, as labeled on peaches, cherries, and
nectarines in New York State.

The data package for this product was reviewed by the Division of Fish,
Wildlife & Marine Research (DFW&MR); the Technical Support & Laboratory
Services (TS&LS); and the New York State Department of Health (NYSDOH).

The DFW&MR Bureau of Environmental Protection (BEP) did not object to
registration. Tebuconazole is applied by ground to cherries, peaches, and
nectarines at a rate of 0.23 lbs ai/acre, with a maximum application rate of
1.35 lbs ai/acre/season.

According to aquatic and terrestrial models, tebuconazole is not toxic to
mammals, birds, aquatic invertebrates, or aquatic plants at the single
application rate of 0.23 lbs ai/acre. It is toxic to mammals, birds, and fish
on a chronic basis at the maximum application rate of 1.35 lbs/acre.

Tebuconazole has a half-life of 600 days in water and approximately 90
days on turf. As such, the use of Elite at labeled rates has the potential to
be chronically toxic to fish, mammals, and birds. When spraying pesticides in
fruit orchards, it is estimated that 60% of the chemical will be intercepted
by trees. When this is taken into account, revised rates are 0.09 lbs ai/acre
for single applications and 0.48 lbs ai/acre for the season. The BEP's models
indicate tebuconazole is not toxic to mammals, birds, or fish on a chronic
basis when applied to fruit orchards at labeled rates.

Elite 45 DF will not adversely impact the fish and wildlife resources of
New York State when used in orchards. It does have the potential to be toxic
to fish, mammals, and birds, if applied to ground crops and turf at the
current application rates. If tebuconazole is proposed for ground applications
in the future, Bayer Corporation should address these toxicity issues.

The NYSDOH stated in their review that tebuconazole was not highly toxic
to laboratory animals in acute studies but the formulated product can irritate
the eyes and skin and is a sensitizer. Technical tebuconazole caused a variety
of effects in laboratory animals in chronic studies at relatively low doses
and also produced some developmental effects in rodents and rabbits. The
United States Environmental Protection Agency (USEPA) Office of Pesticide
Programs calculated an oral reference dose of 0.03 milligrams per kilogram
body weight per day for tebuconazole, based on a no-observed-effect level from
two chronic dog studies combined and an uncertainty factor of 100. This value
has not yet been adopted on USEPA's Integrated Risk Information System.
Tebuconazole caused liver tumors in a chronic mouse study and is structurally
similar to other triazole pesticides that also cause liver tumors. The USEPA's
Carcinogenicity Peer Review Committee classified tebuconazole as a Group C
(possible human) carcinogen.

There are no chemical-specific federal or State drinking water/
groundwater standards for tebuconazole. Based on its chemical structure,
tebuconazole falls under the 50 milligram per liter general New York State
drinking water standard for an "unspecified organic contaminant" (NYCRR Part 5
- Public Water Systems). Based on the oral reference dose for tebuconazole
(0.03 milligrams per kilogram body weight per day) and the USEPA procedures
for determining maximum contaminant level goals for Group C carcinogens
(Federal Register, 55: 30374-30375, July 25, 1990) a potential chemical-
specific drinking water standard of 21 micrograms per liter (ppb) can be
calculated for tebuconazole.

Based on their review, NYSDOH does not expect significant dietary
exposure to the general public from the labeled uses of Elite 45 DF Fungicide.
Worker exposure should also be limited as the product label requires
applicators and other handlers to wear personal protective equipment.
Therefore, the NYSDOH does not object to the registration of Elite 45 DF
Foliar Fungicide for the labeled use on bananas, cherries, peaches and
nectarines.

The TS&LS Section stated in their review that they did not object to the
labeled use of Elite 45 DF Fungicide on orchards. However, should Bayer
Corporation apply for a major change in label to use tebuconazole at a higher
application rate or for field crops or turf, additional review will be needed.

Based on the environmental fate data and on computer modeling, it appears
that Elite 45 DF Foliar Fungicide is immobile and persistent; and when used
according to label directions on orchards is not expected to impact
groundwater. However, if Bayer applies for a major change in label to use
tebuconazole at a higher application rate or for field crops or turf, this
information should be reviewed.

After consideration of the reviews by NYSDOH, DFW&MR, and by TS&LS, the
Department accepts the federal label for registration of Elite 45 DF Foliar
Fungicide (EPA Reg. No. 3125-338) for use on bananas, peaches, cherries, and
nectarines in New York State.

Enclosed for your records are the stamped-accepted label and the
certificate of registration for the above product.

If you have any questions on this matter, please contact Maureen
Serafini, Supervisor of our Pesticide Product Registration Section, at (518)
457-7446.

Sincerely,

Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous Materials

Enclosures

cc: w/enc. - D. Rutz/W. Smith, Cornell University
N. Rudgers, NYS Dept. of Ag. & Mkts.
N. Kim/A. Grey, NYS Dept. of Health