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Fosetyl-Al - R.E.D. Facts 1/91

United States Environmental Protection Agency
Pesticides And Toxic Substances
21T-1001
January 1991
(H- 6O8W)

R.E.D. FACTS

Fosetyl-Al (Aliette)

Pesticide Reregistration:

     All pesticides sold or used in the United States must be registered by
EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.

     In evaluating pesticides for reregistration, EPA obtains from pesticide
producers and reviews a complete set of studies showing the human health and
environmental effects of each pesticide. The Agency imposes any regulatory
controls that are needed to effectively manage each pesticide's risks. EPA
then reregisters pesticides that can be used without posing undue hazards to
human health or the environment.

     When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Document, or RED. This fact sheet
summarizes the information in the RED for fosetyl-Al.

Fosetyl-Al:

     Fosetyl-Al, which is sold under the trade name Aliette, is a systemic
fungicide used to control damping-off and rot of plant roots, stems and fruit.
It is applied as a plant dip treatment and a drench for transplants, by
incorporating it into the soil prior to planting, and by applying it to
foliage. Fosetyl-Al is registered for use on the following food crops and
ornamentals, and all of these uses are eligible for reregistration:

            Almonds (non-bearing)             Ginseng
            Asparagus                         Ornamental plants, lawn and turf
            Avocados (non-bearing)            Caneberries
            Pome fruits (non-bearing)         Citrus (bearing and non-bearing)
            Pineapples                        Stone fruits (non-bearing)
            Only two pesticide products containing fosetyl-Al are registered,
            a technical grade product and an end use product.

Regulatory History:

Fosetyl-Al was first registered by EPA in 1983. EPA issued a Registration
Standard for fosetyl-Al in February 1988, after circulating a December 1986
draft for public comment.

Health Effects:

All of EPA's toxicology data requirements for fosetyl-Al have been satisfied.
These toxicity studies indicate the following effects.

     Acute and Subchronic Health Effects
          Fosetyl-Al is a severe eye irritant, but it does not irritate the
skin or pose a notable inhalation hazard.

     Chronic Health Effects
          Some laboratory animal feeding studies indicate that fosetyl-Al has
a slight degenerative effect on the testes of dogs and shows evidence of
cancer effects (urinary bladder tumors) in male rats, when these test animals
are fed high doses of the pesticide. Considering these and other available
oncogenicity studies, EPA has classified fosetyl-Al as a category C oncogen --
that is, a possible human carcinogen with limited evidence of carcinogenicity
in animals. Fosetyl-Al is not a mutagen and it does not pose developmental or
reproductive effects of concern.

Routes Of Exposure

Through the Diet
     People may be exposed to small amounts of fosetyl-Al through the food
supply. However, the amount of fosetyl-Al in the U.S. consumer's diet is far
below the level at which adverse health effects could occur. The dietary risk
from fosetyl-Al is very low.

     Tolerances, or legal residue limits, have been established for residues
of fosetyl-Al in or on food or feed crops, as follows. (Also see 40 CFR
180.415.) There are no international Codex tolerances established for fosetyl-
Al.

                    Asparagus                        0.1 ppm (California only)
                    Caneberries                      0.1 ppm
                    Citrus                           0.5 ppm
                    Ginseng root, fresh              0.1 ppm (Wisconsin only)
                    Pineapple                        0.1 ppm
                    Pineapple fodder                 0.1 ppm
                    Pineapple forage                 0.1 ppm

EPA has reassessed these existing tolerances and finds that they are set at
appropriate levels. They provide an adequate margin of safety to protect the
public health. No new tolerances are required to cover existing uses of the
pesticide.

      Studies available indicate that residues of fosetyl-Al decrease rapidly
in food. Most residues in crops are expected to decline to lower-than-
observable levels between the last field application of the pesticide and
harvest time.

     During Application
          People can be exposed to fosetyl-Al while applying the pesticide to
field crops, lawns and turf, or ornamentals. The pesticide poses a low degree
of oral, dermal and inhalation toxicity. However, fosetyl-Al is a severe eye
irritant. To protect applicators, therefore, labels of products containing
fosetyl-Al as the active ingredient must warn the user to wear goggles or a
face shield.

Environmental Hazards

All of EPA's environmental fate and ecological effects data requirements for
fosetyl-Al have been satisfied. The studies show the following.

     Environmental Fate
          The potential for ground water and/or surface water contamination by
fosetyl-Al is expected to be very low in most cases. Fosetyl-Al degrades
rapidly in soil to non-toxic components. However, the pesticide is quite
persistent on vegetation. When it is applied to plant foliage, it probably can
be washed off by heavy rainfall. Since it is soluble in water, susceptible to
leaching, and stable to decomposition by water, fosetyl-Al may possibly leach
to ground water in cases where unexpected heavy rainfall closely follows
foliar application of the pesticide.

     Ecological Effects
          The ecological effects data base for fosetyl-Al is complete. Studies
available to the Agency show that fosetyl-al does not pose a risk to birds or
fish. Two newly submitted studies also show that fosetyl-Al is practically
non-toxic to honey bees, and does not adversely effect aquatic plants.

      Risks to Non-Target Species
          Fosetyl-Al poses no risk to non-endangered species. However,
pesticides that are similar to fosetyl-Al and have similar use patterns have
been found to pose a hazard to endangered species. It is possible that use of
fosetyl-Al on apples and pears may pose undue risks to endangered freshwater
mussels as residues of the pesticide run off into adjacent ponds. EPA has
therefore initiated a consultation with the Office of Endangered Species of
the Fish and Wildlife Service (FWS) regarding the use of this pesticide on
pome fruits. No labeling changes are being required at this time, but they may
be required in the future as a result of the ongoing EPA/FWS consultation.

Additional Data Required

     EPA has sufficient data to support reregistration of the two currently
registered products containing fosetyl-Al; no further generic or product-
specific data are required.

Product Labeling Changes Required

     The end-use fosetyl-Al product label must include an additional water
contamination warning, and a reentry and protective clothing statement. End-
use products with citrus use on the label must also bear a grazing
restriction. Please see the Reregistration Eligibility Document for a detailed
list of labeling requirements.

Regulatory Conclusion

     -- EPA has some data indicating that fosetyl-Al is a possible human
cancer agent. However, the cancer evidence was observed only in certain
studies, and the amount to which people may be exposed.
     -- Fosetyl-Al's eye irritation risk to applicators can be managed by
product labeling that  requires protective clothing, especially goggles or a
face shield.
     -- An endangered species concern has been identified but no conclusion
has been reached. This concern may result in additional label requirements
later.

     In summary, EPA has sufficient data on fosetyl-Al to conduct a reasonable
risk assessment and to determine that the pesticide can be used without
causing unreasonable adverse effects in people or the environment. Therefore,
the two registered products containing fosetyl-Al are eligible for
reregistration. These products will be reregistered once revised labeling is
submitted to and accepted by EPA.

For More Information

     EPA will accept and consider public comments on the Reregistration
Eligibility Document for fosetyl-Al for several months. To obtain a copy, or
to submit written comments, please contact the Public Response and Program
Resources Branch, Field Operations Division (H-7506C), Office of Pesticide
Programs, U.S. EPA, Washington, D.C. 20460. Call 703-557 4436, or fax to 703-
557-1884.

     To obtain a copy of the Registration Standard for fosetyl-Al, please
contact the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA. 22161. Call 703-487-4650, and request document
#PB84206564.

     For more information about fosetyl-Al or EPA's pesticide reregistration
program, please contact the Special Review and Reregistration Division (H-
7508W), Office of Pesticide Programs, U.S. EPA, Washington, D.C. 20460. Call
703-308-8000, or fax your request to 703-308-8005.

     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-800-
858-7378, 24 hours a day, seven days a week, or fax your inquiry to 806-743-
3094.