Overview of IR-4 Biopesticide Research and Support Program

Robert E. Holm, Ph. D., IR-4 Executive Director

Thank you, Jerry. I'm Bob Holm, Executive Director of the IR-4 Program. And I add my thanks to our partners from EPA and Health Canada and the State of California for putting together this workshop, and we really look forward to quite an exciting meeting this week.

I want to give you a little history about the IR-4 program, how we got into the biopesticide area and the importance that we place, as Jerry mentioned, of biopesticides in our program.

We started out in 1963 as a joint effort between the USDA and the Land-Grant University system. And the premise that started our program is still with us now. Which is that there's not a sufficient economic incentive for a lot of the manufacturers to produce and market chemicals, and biopesticides to a lesser extent, for minor crops. The FQPA designated minor crops as those with acreages of 300,000 or less. And you probably recognize that covers most of the fruits and vegetables and good things that we eat in our diets every day.

In 1975, we expanded to what we call the Regional Laboratories. There are four regional laboratories around the country located at Michigan State University, East Lansing, Cornell University at Geneva, the University of Florida in Gainesville, and the University of California at Davis.

In 1996 we expanded into partnering with another component of the USDA and that's the Agriculture Research Service. The Cooperative States Research Extension Education Service or CSREES, and the Agriculture Research Service or ARS are our key funding USDA agencies.

We expanded into an ornamental program, a non-food crop program, in 1977. And then in 1982, our biopesticide program was initiated. Obviously, I'll talk about that in greater detail later in the presentation.

Jerry mentioned the GLP program and we've followed GLP practices since the late 1980's. Tammy White, our Manager of Quality Assurance, will be talking to you this afternoon about public use GLPs. In the '90s, we greatly expanded our quality assurance GLP effort. And one of things that IR-4 published in the mid '90s was our strategic plan which government rules require us to update every five years. In 1995, which was before FQPA, people on our Project Management Committee (PMC) including Dr. Neal Thompson, in attendance at this meeting and the Chair of our Administrative Advisors from the University of Florida, were looking ahead at emerging new trends in crop protection. The PMC felt that there were a lot of newer products in the pipeline that deserved our attention and interest. Time Reduced Risk/Safer Chemistries and biopesticides were high on our list at that time.

So when FQPA came out in August 1996, our Strategic Plan meshed with it and we focused our efforts on that area.

Our 2001 to 2005 Strategic Plan continued that focus. And contained a revised mission statement. And as Jerry said, our recent mission statement states that IR-4 will provide minor crop growers with pest-management solutions. It does not say chemicals. It does not say biologicals. It really means both. And we believe that both chemicals and biologicals play a very key role in the strategy that we have developed.

We initiated our biopesticide program, as I mentioned, in 1982. For the first 12 years, we provided, almost exclusively, regulatory support for companies. Many of the companies that are involved in biopesticides now, as in previous years only have one, two, and three employees. A few of the largest companies have 30, 50, to 100 employees at the most. A lot of these companies need regulatory support and help. We felt that this was a service that IR-4 could help provide and we've been doing it for a number of years.

However in 1995, IR-4 decided to provide some additional financial support so we started a competitive grant program at $300,000 a year. Over the last six years, we've put about $1.8 million dollars into that program. We've committed another $300,000 for 2002. If you add that amount to what we have supported as far as headquarters staffing and other support, I estimate that we're close to $3 million dollars in total biopesticide funding support over the last six years. So, obviously, that's a major effort for us.

We've classified the projects as Early Stage and Advanced Stage. The Early Stage ones are more in the feasibility and greenhouse testing stage at the university in the land-grant system and in the ARS. We feel that is important to support this type of research because many biopesticides companies don't have their own research efforts so they license the technology from the university system or ARS.

Recently, we've focused more on the Advanced Stage projects. And these are projects that are with the compounds that are further along in the regulatory pipeline. They may be close to registration by the Biopesticide and Pollution Prevention Division (BPPD) or registered and needing additional label expansion data.

You will hear a lot from the regulatory agencies, particularly, in California that efficacy data are required for registration purposes. The goal of the IR-4 Biopesticide Research Program/Advanced Stage Project is to work with university and USDA researchers to develop the data that would help support registrations and, also, work with key university researchers and extension agents who recommend to growers what biopesticides can be used.

That overview gives you a focus of where our program has come from and is heading in the future.

In 2001, we had 65 project proposals and funded 43 different projects. Twenty-seven of those projects were biofungicide, nine were bioinsecticide or pheromone, four bioherbicide, and three PGR's and biochemicals. The 2001 problem cut across the whole spectrum of products and crops (both food and non-food).

A year ago at our Food-Use Workshop, IR-4 sponsored along with BPPD and PMRA a biopesticide workshop that was well-attended by 65 people. Certainly, we're greatly pleased to have the number of folks here today.

In the 12-year period between 1982 and 1994 during which we were mainly supporting regulatory work for registrants, IR-4 was involved in helping register a number of important biopesisticides (Table). Probably the most important product was and still is Bacilus thuringensis or Bt.

Back in the 1970's before IR-4 had an official biopesticide program, we helped obtain most of the early registrations for the Bt's. And those of you that are involved in biopesticide on the world-wide basis, recognized that. Bt is still the worlds largest selling biopesticide with about 80 percent of the market share. So it's a very important product. Other products IR-4 helped register from 1982 to 1994 include gibberellic acid, some other Bacillus materials, some attractants, pheromones, viruses, and pseudomonas. So we have been involved in a number of various product projects over the years.

Since IR-4 started its dedicated research program in 1995, we have been involved in a lot of additional products as listed in the Tables. Some of them, without going into a lot of detail are: methyl anthranilate, which is a bird repellant, codling moth granulosis virus and cinnamaledhyde which is a product that is listed several different times for insect and disease control in different registrations. Aspergillus flavus AF36 is a very interesting product because its minor crop competes against the natural strain of Aspergillus which produces aflatoxin that contaminates cotton. Cotton is not a minor crop.

However, this in particular case, the cotton acreages are restricted to Arizona where the problem is and involve less than 300,000 acres. Other products on the list include Trichoderma and flavobacterium, and Beauveria bassiana.

Kaolin is an interesting product that we've been working with the last few years. It's actually finely ground clay that's has some very interesting properties both as a biofungicide and bioinsecticide. Lysophosphatidylethanolamine is an interesting PGR that increases yields and has post-harvest activity. Formic acid is another interesting product. A lot of people don't realize that bees are very important in pollination which is critical for fruit and vegetable production. Bees have pest problems, too, including mites. Which in some cases can wipe out entire bee colonies. IR-4 has been working with different compounds like formic acid to help the beekeepers control these mite pests. Here again is a very specialized industry, but a very important one to minor crop agriculture.

In 2000, IR-4 supported research on Chitosan, Messenger, and Milsana. These are very interesting materials in that they are termed SAR materials for systemic-acquired resistance. When you put these materials on plants, they don't have fungicidal activity themselves. They induce plants to protect themselves by producing natural products, which are fungicidal to invading pathogens.

In 2001, IR-4 funded 43 projects as noted previously - 28 were for food use and 15 for ornamental use. The funding was to 37 different researchers in 21 universities. In addition, two USDA, forest service researchers and two private growers were funded. IR-4 is spreading its funding across a number of researchers and land-grant institutions. Our main goal is trying to promote the use of biopesticides in production agriculture, particularly for minor crops. One of the more interesting minor crops is one called Stevia. Its probably one that many have never heard about unless you read at the life section of U.S. Today this past summer and found out that this is a new crop that's being grown as a natural sweetener in California. And, apparently, the sweetener is hundreds of times as sweet as sucrose. This is a minor crop that growers are looking at in California to grow as an alternative crop.

These examples provide an idea of some of the biopesticides that are being used in minor crops and the pest control needs. Just because it's a minor crop doesn't mean that pests don't attack them like they do on major crops.

However, the regulatory processes that you have to go through to register a biopesticide or traditional chemical are the same for minor crops as they would be in major crops.

Dr. Michael Braverman, IR-4 Biopesticide Coordinator, is on the program later and will discuss our 2002 program. The process will end for early stage in proposals November 15, 2001 and December 15, 2001 for the advanced stage project proposals. We require that each proposal contain efficacy data, so we can see that the products are working. So that's why we're convinced they can work in production agricultural and do have a fit.

I'd like to spend a few minutes talking about the Biopesticide Industry Alliance (BPIA), in order to give the industry some praise for the efforts they are undertaking. BPIA started about a year and a half ago and IR-4 has been at practically every meeting. I am an ad hoc member. And Jerry Baron and Michael Braverman also attend these meetings. We feel very strongly that this industry group is doing some great things and Gary will discuss them in greater detail in a later presentation.

I'd like to tell you about the companies that we've worked with and their products over the last few years. As Gary will tell you, there are 32 companies in BPIA. Just last year, IR-4 funded projects for 17 of the companies, involving eight biofungicides. The 8 biofungicides covered 27 different projects. We're seeing a lot more activity and interest in the biofungicide area. In addition, the funding in 2001 supported eight bioinsecticides with nine projects; four bioherbicides, and one PGR. In summary, we worked with 21 products from the industry the last year with the 43 projects. A list of the companies we worked with is found in the Table.

The coding means: BF for the biofungicides, BI for bioinsecticides, and BH for bioherbicide, and so on. Other than Dow AgroSciences, which is one is one of the largest major agrichemical companies, that acquired the biopesticide business from Mycogen and Valent Biosciences, this is an industry comprised of very small companies. IR-4 tries to treat them in the same way we work with our traditional clients, but we understand that they have specialized special regulatory help requirements.

As mentioned previously, the biopesticide industry is comprised of companies ranging from a few to a hundred employees at most. The major exception to this generality is Valent Biosciences, who is part of Valent U.S.A. Corporation, which is part of Sumitomo Chemical. Sumitomo Chemical purchased the Abbott business which was the U.S. and worldwide leader in Bt sales.

I appreciate the opportunity to tell you a little bit more about IR-4 and our Biopesticide Program.

There are a number of company representatives at the Workshop and Gary will be telling you about them and the BPIA in a later presentation. IR-4 looks forward to being a partner with the biopesticide industry in helping them get their products on the market and encouraging their use.

From a regulatory perspective, we also appreciate the opportunity to work with EPA, Health Canada and California's Department of the Pesticide Regulation to get these products registered and get them into the hands of growers. This is important because I think they have a real fit in our post-FQPA environment where consumers are looking for safer products to use and our growers are looking forward to using safer products for the production of food in the United States.