Submitted to: Society for Invertebrate Pathology Annual Meeting
Publication Type: Abstract Only
Publication Acceptance Date: April 4, 2003
Publication Date: July 1, 2003
Citation: Abstract. 2003 Annual Meeting of the Society for Invertebrate Pathology, Burlington VT USA July 26-30,2003. P. 36. Interpretive Summary: This presentation, part of a symposium comparing industrial-scale with cottage-scale production of microbial pesticides, reviews the characteristics, and challenges, of registration and commercialization of a microbial agent in the United States, based on the author's personal experiences with one mycoinsecticide product.
Technical Abstract: In the United States, biopesticide implementation is structured by the need to register any microbial with the Environmental Protection Agency and with individual states, some of whom can be more stringent than the federal agency. This process has significant time and money requirements ' approximately three years for generation of data and its review by regulators, and close to $1MM in internal and external costs, in addition to normal operating costs. Framed against this structure is an economic model in which private companies are almost the only route for commercialization in the U.S.; federal involvement through a state supported enterprise is statutorily minimal. The momentum of biopesticide development, therefore, has been largely with small companies. (Large, long established, agchemical companies have not been able to sustain a development effort where any has existed at all.) These small biopesticide enterprises subsist heavily on private venture capital, from investors whose ultimate goal is to make money in as little time as possible, and who may not understand the business. Meanwhile, American agriculture still operates in a largely chemical paradigm, one in which microbial agents may not easily fit. Thus, their successful development is often a challenge. Lastly, the biopesticide distribution system in the U.S. is expensive, which expense can add considerably to the cost of a microbial product. These aspects structure practical market sizes for a biopesticide, and, in turn, production capacity and efficiencies. Target crops have to be of sufficient size and nature so that low market penetration (in the face of chemical paradigms) still provides sufficient revenues to meet development (and survival) costs. Thus, some crops may have very low priority, and multiple targets for a given microbial agent (i.e., a wide host spectrum) may be highly desirable, even necessary. Biopesticide companies have to have a certain critical mass to be commercially successful; the locally oriented cottage industry model is rarely appropriate. Production scale has to be large enough, and cost efficiencies great enough (in the face of very expensive labor), for sales margins to pay for the effort. Production boils down to the fully loaded cost of a unit of fermentation per hectare of product. Steadily increasing 'red ink' and eventual failure has, all too often, been the outcome of an inability to meet these challenges. These concepts will be illustrated by the author's experience with one biopesticide company in the U.S.