North Dakota State University
NDSU Extension Service
Volume 16, No. 3, July 1998
One Company's Approach to Developing a Pesticide
Coordinator's Comments
Pesticide Program Phone System
FAQs, Reminders, and Other Tidbits
Strict Liability
Home Lawn Use of Pesticides
Summary of What a Section 18 Label is
EPA's Improvements in the Section 18 Process
Recycle Pesticide Containers
Mapping Pesticide Sensitive Aquifers in North Dakota
Project Safe Send
Coordinator's Note: Ever wonder how pesticides are developed? Ever wonder why many promising products never make it to market? Then consider more observations from Dr Alan Schreiber who describes one manufacturer's view of the pesticide development process. Alan is the former head of the Food and Environmental Quality Laboratory for Washington State University. His article is reprinted from the February 1997 issue of Agri-chemical and Environmental News, Washington State University.
Pesticide product development may be visualized as a development "funnel." The process begins when scientists synthesize or acquire compounds for initial screening evaluations. Of the thousands of compounds evaluated, only a few show sufficient potential to enter more extensive evaluations. These advance to the discovery stage, where they are evaluated against increasingly stringent performance, registration, and safety criteria. Compounds showing sufficient promise advance to the second, or predevelopment, stage. The objective at this stage is to synthesize, acquire and evaluate enough new compounds to advance two compounds to predevelopment each year. At the end of predevelopment, compounds with sufficiently high potential enter the development stage.
Only 50% of compounds that enter predevelopment are expected to pass stringent safety, manufacturing, and commercial standards of this stage and enter development. Once a compound completes development and is registered, it is ready for commercial launch. A compound requires about eight years from the time it enters the discovery stage until commercial launch. Direct costs will be $30 million, not counting costs associated with failed compounds. Total development costs, including costs associated with discovery research, are $85 million annually. The overall goal of this investment and effort is to launch one new compound each year.
The discovery stage is globally targeted and managed. This one to two year stage has two objectives. The first is the definition of desirable biological and performance properties in a research mode, primarily laboratory and small-plot global field trials. The second is to gain preliminary information on the compound's safety and commercial potential. Basically, the manufacturer desires enough information on the compound's performance, safety and market potential to justify investing an additional $15 million to $20 million required to take the compound through predevelopment.
Key discovery stage tasks include selection of a compound that demonstrates high potential against one or more key targets in laboratory or greenhouse evaluations. Once a compound is identified, potential use rates, use conditions, and competitive performance are defined. This is done both in laboratory or greenhouse tests and in small-plot global field trials.
While these tests continue, scientists evaluate formulations and manufac-turing potential and develop preliminary information on the compound's safety profile and registration potential.
Presuming favorable results, the compound can be protected by patents. Projected sales and profits will warrant additional investment, and senior management will consider the compound for advancement to predevelopment. Advancement to predevelopment represents major organizational commitment.
Predevelopment requires three years. Its one fundamental objective is to take compounds from discovery and complete all work needed to support a decision to commercially develop and launch the compound in the marketplace as a product, or alternatively, to drop it. At the end of predevelopment, there should be no major roadblocks to successful registration and commercialization; the investment required beyond predevelopment is substantial. As a result, the various activities associated with predevelopment are tightly focused on identifying problems that might preclude successful registration and commercialization.
Key tasks associated with this objective include full evaluation of label use rates, use conditions, and competitive performance against key commercial standards. Extensive global field research trials provide this information. Predevelopment is also the stage at which the manufacturer finalizes the formulations it wishes to commercialize and sell; identifies a process route; and, based on the process route, determines sales, manufacturing and supply strategies.
Some of the more critical tasks pursued during predevelopment are in the registration area, because compounds in this stage must prove themselves throughout toxicology, fish, wildlife, and environmental studies required by regulatory authorities around the world. By the end of predevelopment, the experimental phases of all critical studies will have been completed. This in turn will enable a thorough assessment of the compound's safety profile as well as ability to register the compound. These data, combined with validated commercial forecasts, will lead to a comprehensive project assessment and review by senior management.
Development requires three years. The basic objective of this stage is to prepare the compound for introduction into key global markets for specific applications. During this stage, outside research organizations and customers help confirm the compound's potential under the widest variety of global environmental, use, and growing conditions. This is the stage during which formulation, packaging and small market development manufacturing facilities are constructed. This is also the stage during which international registration specialists use data collected during discovery and predevelopment to guide the compound through approval for specific applications.
Once a compound is registered, it moves to full commercial status. Scientists conduct extensive and ongoing training of internal personnel and customers on proper handling and use of the product. Technical staff provides extensive ongoing support of the product in the field, assisting customers with proper label use and investigation of problems. During this stage also, full manufacturing and formulation production begins, and facilities are optimized to market demand and sales schedules.
Ongoing review continues to evaluate and seek new and expanded uses and registrations for the product.
Summertime is the off season for pesticide education and certification, but this doesn't mean we are just kicking back and enjoying the warmer weather. We are working on several fronts to improve both the quality and quantity of our program offerings. Our mission is to make your training and certification experience a valuable tool to help you conduct your job, rather than a mere bureaucratic hoop to jump through.
One of the more notable activities we are working is to upgrade our recertification program, so that when you attend a training you will obtain updated and topical information which builds upon what you already know. Instead of a handful of specialists presenting subjects for the entire state, we are enlisting the support of more than two dozen. This will greatly expand our subject matter availability, and we will be able to regionalize our topics so they will be relevant for Valley agriculture or the drylands of western North Dakota.
We are working in the area of serving you more efficiently. This month, Mary Beth Odegaard, our new Pesticide Program secretary, will describe our automated phone system. She is also working on web-based information delivery systems, and we hope to have this available in the next couple of months.
Arla Rudy, our other secretary, is cheerfully working through the morass of financial responsibility issues. When she isn't answering your questions or updating records, she is beginning the process of reforming our testing program. You will see more on this later, but I will tell you that we are making considerable changes in this area. Testing is always an area of contention, but our hope is that in 1999 you will find our tests to be relevant, straightforward, practical, and challenging, but not overwhelming.
While we are making changes at the state level there are significant discussions going on at the federal level. EPA has convened an advisory committee to make recommendations to them regarding reforms in the structure and scope of pesticide training. The group, called CTAG or the Certification and Training Advisory Group, is made up of educators, regulators, and industry representatives. They are examining our present system and will likely be making suggestions to EPA regarding the elevation of standards for pesticide certification.
What does this mean to you? It means your trainings will inevitably become more rigorous and extensive than they are now, and measurements of competence (tests) will be much more thorough. CTAG is planning on submitting their report to EPA in August of 1999. Some of the recommendations will be enacted administratively via new regulations, and some changes will need to be made by Congress. I will have more on the activities of CTAG in future issues of the PQ. Stay tuned!
I wish you all a successful summer season and bountiful fall.
Andrew A. Thostenson
Pesticide Program Specialist
Mary Beth Odegaard, Pesticide Program Administrative Secretary
As of June 1 the Extension Pesticide Program implemented an auto phone attendant. "What is that?" you might ask. Well, it's one of those phone systems that everyone hates! When you dial the pesticide office (701-231-7180) you will hear a recording giving you a series of options to choose from.
Why did we do this? It was apparent that many people were calling and asking the same questions. Questions that would save us quality work time if we could just "put it on a recording," and give us time to address calls of a more pressing nature. Plus, with this system, you can get many of your answers 24 hours a day, seven days a week. While we regret the need to institute this system, the advantages definitely outweigh the disadvantages
The main options a caller is given are as follows:
The chart shows more in-depth information about our phone system.
As you can see by the chart, there is quite a lot of information on this phone system. We are reviewing other states' pesticide program phone systems to compare information given. We plan to incorporate meeting/testing sites and well as preregistration information into this system as well. We welcome any comments and helpful hints.
Arla Rudy, Pesticide Program Secretary
Laws Governing the Use and Impact of Agricultural Chemicals: An Overview, 1995, University of Florida Cooperative Extension Service Bulletin 311
In at least four states, Louisiana, Oklahoma, Oregon, and Washington, courts have labeled aerial application of pesticides an "ultra hazardous" or "abnormally dangerous" activity, and have imposed strict liability for damage done without requiring proof of fault.
In 1957, Louisiana was the first state to impose strict liability for damages caused by the aerial application of pesticides. In Gotreaux v. Gary, the defendant sprayed his rice crop with 2,4-D. This herbicide drifted onto the plaintiff's cotton and pea crops located over three miles away and destroyed them. The court recognized the necessity of applying pesticides, but held that the plaintiff could not be unreasonably inconvenienced or denied the right to enjoy his property. The court summed up the effect of the application of strict liability:
. . . negligence of fault, in these instances, is not a requisite to liability, irrespective of the fact that the activities resulting in damages are conducted with . . . reasonable care and in accordance with modern and accepted methods.
In 1961, the Oregon Supreme Court, in Loe v. Lenhardt, imposed strict liability in an unintentional trespass suit, finding that there was no need to prove fault or negligence where the defendants were engaged in an "extra hazardous" activity. In this case, the defendants were using a mixture of dinitro and diesel oil as an herbicide. The spray drifted, having, in the court's words, a "swift and drastic effect" on the plaintiff's crops.
The court, noting "the high degree of danger inherent in the spraying of agricultural chemicals from the aircraft" determined that strict liability should attach to the activity. The court stated the usual justification for the imposition of strict liability rather than a negligence standard:
". . . the element of fault, if it can be called that, lies in the deliberate choice by the defendant to inflict a high degree of risk upon his neighbor, even though utmost care is observed in doing so."
The Washington State Supreme Court in 1977 imposed strict liability on crop spraying operations in Langan v. Valicopters. In this case the plaintiffs were organic farmers. The defendant's helicopter sprayed a neighboring farm with the pesticides Thiodan and Guthion. The plaintiffs sought damages for pesticides which drifted onto their crop of organically grown vegetables, rendering them valueless as certified organic produce.
Plaintiffs proceeded to destroy their crop, and filed a claim for full damages. In upholding a verdict in the plaintiff's favor, the court applied the test for imposition of strict liability suggested by the Restatement (Second) of Torts, and concluded that crop spraying was an abnormally dangerous activity, justifying the imposition of strict liability.
In reaching this conclusion, the court stressed that there was no proof to suggest that it is possible to eliminate the risk of drift by the exercise of reasonable care. The court added that while aerial application was prevalent in the area, it was carried out by a relatively small number of people. In justifying its decision to impose strict liability, the court states that useful but dangerous activities must pay their own way."
[ NEXT ]
[ Home Lawn Use of
Pesticides ] [ Summary of What
a Section 18 Label is ]
[ EPA's Improvements in the Section
18 Process ] [ Recycle
Pesticide Containers ]
[ Mapping Pesticide Sensitive
Aquifers in North Dakota ] [ Project
Safe Send ]
Volume 16, No. 3, July 1998
NDSU Extension Service, North Dakota
State University of Agriculture and Applied Science, and U.S.
Department of Agriculture cooperating. Sharon D. Anderson,
Director, Fargo, North Dakota. Distributed in furtherance of the
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North Dakota State University
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