Table of Contents
Bischoff, R.F. 1993. Pesticide chemicals: An industry perspective on minor
crop uses. p. 662-664. In: J. Janick and J.E. Simon (eds.), New crops.
Wiley, New York.
Pesticide Chemicals: An Industry Perspective on Minor Crop Uses
Robert F. Bischoff
- COMMERCIALIZATION PROCESS FOR NEW AGRICULTURAL PESTICIDES
- PESTICIDES ON MINOR CROPS/CONCERNS AND ISSUES
- PESTICIDES ON MINOR CROPS/FUTURE OPPORTUNITIES
Presently, there are almost no incentives for pesticide chemical manufacturers
to develop their products for minor crop use applications. As a result of the
regulatory process including the Federal Insecticide Fungicide and Rodenticide
Act (FIFRA) of 1988, many minor crop uses are not being supported on product
labeling because of excessive costs to develop supportive data packages and
other factors that impact a product's regulatory status. Accordingly, minor
crop growers will find fewer and fewer products available to control their
various pest problems.
The purpose of this paper is to describe the commercialization process for new
pesticide agrichemicals as followed by the basic manufacturers of these
products, concerns that this industry has with minor crop uses, and finally
some thoughts on how to provide incentives to the agrichemical producers to
develop new and maintain existing minor crop uses on their pesticide product
The development of new pesticide products is a very costly, time consuming and
risky process that involves an extensive research and development component.
From a research and development perspective, the process begins in the
Discovery Laboratories, where teams of biologists and synthesis chemists
prepare new chemicals and evaluate them for effectiveness in a greenhouse or
small plot environment. Having determined that a new compound merits further
testing, field research scientists evaluate the material under expected
environmental use conditions by using larger test plots out-of-doors. Shortly
before and concurrently to field testing, other testing is implemented by
toxicologists to determine the impact on various mammalian and other non-target
organisms and by residue, environmental, and metabolism chemists who study the
effects of the potential chemicals on the environment. Formulation chemists
and process engineers define the composition and process for preparing the end
use formulations, i.e. liquid, granulars, etc., that are applied to the target
crop(s). Technical Service and Development take field testing beyond the
internal field testing facilities that a company has and serve as a technical
interface between the company, the scientific community, and the customer.
Finally, the regulatory function relying on data inputs from all of the various
R&D laboratories secures approval for the first registration from the
various federal and state regulatory agencies.
The process described above is driven by the need to satisfy data requirements
as prescribed by federal and state regulatory agencies to support a new
registration. These data requirements are listed by the Environmental
Protection Agency (EPA) under Title 40 Code of Federal Regulations Part 158,
and include product chemistry, environmental chemistry, residue chemistry,
hazards to humans and domestic animals, reentry protection, hazards to wildlife
and aquatic organisms, hazards to nontarget insects, spray drift evaluation,
phytotoxicity to target and non-target plants, and more.
Because of the extensive testing required, the agrichemical industry has
estimated that $40 to $60 million in development costs are incurred before the
first registration of a new pesticide chemical is received, and that the
process takes over seven years from discovery to registration. A recent
analysis for five compounds in predevelopment at DowElanco shows an average
anticipated expenditure of $46 million before first registration and sales
occur. It is further estimated that only one in twenty thousand new chemicals
tested in the discovery screening process survive as a new registered compound.
The development process is clearly a high risk venture in that at any time
during the development phase, an adverse finding in the tests being conducted
(such as a toxicological or environmental one) can limit the number of
potential end uses or result in the termination of the project.
For all these reasons, it is imperative that a discovery program focus its
screening tests to identify various herbicides, insecticides, fungicides, etc.,
on the crops with the greatest market potential, namely corn, soybeans, wheat,
cotton, and rice. There is little or no incentive for agrichemical companies
to develop pesticides for lower valued markets including fruits, vegetables,
and other minor crops.
Other than the innate costs associated with the development and maintenance of
a data base to support pesticide registrations, there are a number of other
factors that impact considerations of support for minor crop uses by pesticide
chemical producers. In general, minor crops are higher in value (in terms of
dollar return per unit area) than a rowcrop such as maize or soybeans. This
represents a greater potential product liability to the seller of pesticide
products, should a yield loss be linked to those products.
Another consideration involves the limited manpower, laboratory space, and
funding that an agrichemical producer has available for research and
development purposes and the balance to maintain between spending monies for
new product development versus maintaining existing products. FIFRA '88 and
other regulatory mandates have had a tremendous effect on this balance as
reflected by the numerous voluntary cancellations regarding existing products
and various minor crop uses.
Finally, there are concerns associated with dietary and non-dietary risk
assessments. Sometimes, the impact on the reference dose (acceptable daily
intake) is excessive and can prevent the pesticide chemical producer from
registering on crops of higher market potential. In other cases, there may be
a worker exposure issue particularly with many of the fruit and vegetable crops
which may involve a high level of hand labor.
There is indeed a crisis situation concerning the availability of pesticide
products for application on minor crops. However, there are a number of
possible solutions or opportunities to consider as a means of mitigating or
resolving this issue. Firstly, pesticide chemical manufacturers need
incentives to seek minor crop uses for their products. This can be
accomplished through the EPA registration process by reducing data requirements
through the use of surrogate data, waiving tolerance and registration
maintenance fees, and expediting the EPA review of a major crop submission if a
minor crop use is included in the submission package.
Second, product liability concerns affecting the basic pesticide chemical
suppliers have to be addressed. The use of indemnification/liability waiver
agreements appear to be a step in the right direction.
Third, more aware and involved minor crop growers and grower groups are needed.
When appropriate, this sector can pool its resources to fund data development
in support of minor crop use registrations. Implied in this process is better
communication and cooperation between pesticide chemical suppliers and the
minor crop grower community.
Finally, additional funding is needed to support the IR-4 minor crop use
program. Over time, the IR-4 program has been the most effective and prolific
organization in terms of supporting new minor crop uses. With the advent of
FIFRA '88, a considerable strain on the IR-4 budget developed causing
additional funding needs.
Many factors affect the pesticide registration process, resulting in fewer and
fewer products available to the grower for the control of pests on minor crops.
Presently, there are no incentives for pesticide chemical producers to develop
or maintain minor crop uses on their product labeling. High costs and risks
associated with developing and maintaining supportive data packages necessitate
a focus on major crops such as corn, soybeans, cotton, rice, and wheat. Other
concerns associated with minor crops include product liability claims, limited
research and development resources, and possible unfavorable impacts on dietary
and non-dietary risk assessments. Possible solutions to this crisis situation
include incentives for pesticide chemical producers to pursue minor crop use
registrations, product liability relief, a more involved minor crop grower
community, and additional funding for the IR-4 program.
Last update May 16, 1997