The IR-4 Program

 Charles W. Meister
 Pesticide Research Laboratory
 IFAS, University of Florida
 Gainesville, FL 32611


 The IR-4 program is a nationwide cooperative effort which
aids in the development of data required for the registration of
animal drugs, biologic pest control agents and pesticides re-
quired for minor or specialty uses. Headquartered at Rutgers
University, New Jersey, it supports regional offices at four
locations across the country. The Southern Region Leader
Laboratory, located at the University of Florida, Gainesville,
coordinates the research and data collecting aspects of IR-4 in
thirteen states plus Puerto Rico and the Virgin Islands.


Registration needs identified by researchers, growers and other
users are brought to the attention of IR-4 and protocols are
written to outline research required for eventual registration.
IR-4 supports scientific research at Universities, State Experi-
ment Stations and USDA facilities and develops data into a
registration package. It usually requires two years from the
time a request is presented to IR-4 until ultimate registration.
Keywords: EPA, IR-4, pesticide registration.


 Any use of a pesticide in the United States and territories must
be registered with the Environmental Protection Agency (EPA).
By following a process described in Section 3 of the Federal Insec-
ticide Fungicide and Rodenticide Act, pesticides can obtain a full
national registration. Also, pesticides may be registered for one
year under an emergency or crisis exemption. Registrations are
permitted when scientific data comply with EPA standards and
regulatory restrictions are obeyed.
 Manufacturers budget time and funds for research and
development (R&D) to register major pesticide uses. It can re-
quire 10-15 years and over six million dollars to meet all data re-
quirements specified by EPA. The eventual pesticide use must be
large enough for sales to exceed costs or the manufacturer or
sponsor will not become involved in the registration process.
Potential small scale or minor pesticide uses would therefore re-
main unavailable to farmer, grower, nurseryman and others
needing small quantities of pesticide for pest control.
 The IR-4 program has been established to meet the needs of
the small farmer by aiding to secure pesticide registrations for
minor or specialty uses.
 The IR-4 program is a nationwide cooperative effort of the
USDA-SEA (ARS and CSRS), EPA, State Agricultural Experi-
ment Stations, individual researchers, manufacturers and
growers. With headquarters at Rutgers University, NJ, it is ad-
ministered through state agricultural experiment stations in each
of four regions (south, north east, north central and west) plus a
special agricultural research service unit. The southern regional
office is located at the University of Florida, Gainesville, and
coordinates work in 13 southern states plus Puerto Rico and the
Virgin Islands. Much of the pesticide residue analysis from
southern region projects is facilitated at the University of Florida.
 The regional offices coordinate IR-4 activities in their regions
by working with a liaison representative from each state or ter-
ritory. Each representative functions to identify pesticide needs,
select IR-4 projects of high interest and recruit scientists to carry
out research. The IR-4 liaison representatives for Puerto Rico and
the Virgin Islands are Mr. Rafael Montalvo-Zapata and Mr.
Walter Knausenberger, respectively.
 The IR-4 process is initiated when someone completes a
pesticide clearance request (PCR) and sends it to a liaison
representative. He, in turn, submits the PCR through the
regional office to national headquarters. The PCR, displayed in

VOL. XX-PROCEEDINGS of the CARIBBEAN FOOD CROPS SOCIETY


 Fig. 1 should be completed as thoroughly as possible. In par-
 ticular, IR-4 requires information on proposed labeling, item no.
 9. It is advisable to have some documentation that the pesticide
 formulation is efficaceous when applied according to recom-
 mended dosage and proposed directions for use.
 Each PCR is carefully screened first at the regional office and
 then at national headquarters to be sure that it meets certain
 criteria:
 1. There is a verifiable need for the new pesticide.
 2. The need is not satisfied by chemicals already labelled for
 control of the problem pest.
 3. The pesticide has a full registration (usually on a major
 commodity).
 4. The manufacturer desires registration, but does not wish to
 support research.
 5. There are no EPA data gaps on the pesticide such as:
 a) missing short- or long-term animal feeding study, or
 b) missing toxicology data.
 6. There are no other EPA constraints such as:
 a) acceptable daily intake (ADI) exceeded,
 b) under special review, or
 c) missing metabolite and/or impurity information.
 Many requests have been submitted to IR-4 for pesticide uses
on subtropical and tropical crops. Each was screened and
prioritized on a computerized listing. More than forty requests
originating from Puerto Rico and the Virgin Islands have been ac-
cepted as IR-4 projects and are in various stages of completion
(Table 1). During the past five years, field research has been car-
ried out in southern California, Guam, Florida, Hawaii, Puerto
Rico and the Virgin Islands on several hundred requests
originating in subtropical and tropical areas of the world.
Analytical laboratories in California, Florida and several other
locations in the U.S. have aided by developing residue analysis
data. Pesticide labels have been expanded to include uses on
many commodities grown on small acreages such as cassava,
guava, mango, pigeon pea, pepper, tanier and yam. It normally
requires about two years for IR-4 to expand the label of a
pesticide to a minor or specialty use.
 The IR-4 program is also expanding pesticide labels for uses in
ornamentals and obtaining new labels for biological agents and
animal drugs.


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