Regulatory problems associated with natural products and biopesticides

For registration, the United States Environmental Protection Agency (USEPA) separates pesticides into conventional chemical pesticides and biochemical and microbial pesticides. Natural products generally fall into the latter category. The USEPA has specified the test requirements for registration in the United States in the guidelines for registration of biorational pesticides (Subdivision M of 40 CFR Part 158). A discussion of the regulatory issues requires some reference to the accompanying scientific developments. The potential application of chemicals that affect insect behavior and development appeared an extremely promising approach to the reduction of adverse environmental and health impacts associated with many conventional pesticides. In addition to these benefits, the new biopesticides generally affected a very specific range of target species. However, although juvenile hormones and semiochemicals offer exciting new approaches to pest control, and are potentially valuable components of pest management strategies, acceptance of these techniques has been slow. Commercial development has been difficult for several reasons. Regulatory requirements may appear burdensome. Unconventional pest‐control technologies may call for special formulations or application equipment. It may not be easy to establish the efficacy of non‐lethal potential techniques. Investigators who derive funds from the public sector may have neither responsibility nor resources to carry the technology beyond the experimental stage. Because most activities in this field have been heavily research‐oriented, few workers have possessed the additional resources to obtain safety data or data to satisfy regulatory requirements. Difficulties in preparing and administering guidelines for registration of biopesticides lie in the novelty of the pest control agents and the diversity of the techniques involved in their effective use. Rapid advances in molecular biology and other disciplines continually strain the capabilities of regulators who are responsible for making safety assessments regarding pest‐control agents. Although regulatory authorities are familiar with conventional pesticides, safety assessment of biopesticides calls for totally different approaches.