those that are only capable of attacking pest arthropods) are assumed by APHIS to be potential plant pests and therefore subject to regulation under FPPA.
FIFRA was intended for regulation of chemical pesticides and poses severe constraints to the efficient testing of microbial biological-control organisms. Once separated from exotic or endemic plant pests under quarantine or similar containment conditions, biological-control organisms should be subject to risk assessment protocols commensurate with their biological and ecological attributes.
Although there are cases in which the pesticide "template" functions effectively for large-scale commercial registration of biological-control products, they do not function efficiently for registration of biological-control organisms. Neither the intent of the biological-control organism application nor the process by which it operates parallels the chemical pesticide model.
A case in point is the convoluted process required for the registration of encapsulated Bt-endotoxins (a killed microbial pest control agent that was engineered to produce the Bt toxin). Killed microbial products produced through the fermentation of a live intermediate are further regulated by EPA under the Toxic Substances Control Act (TSCA) as pesticidal intermediates, despite the fact that such agents are contained within a fermentor until the final killed microbial pesticide is produced. Such evaluation includes a review of the potential health and environmental effects of the inadvertent release of the live intermediate. This situation results in a dual review process within EPA, with the manufacturing portion of the process reviewed separately from the field release of the killed microbial pesticide. This is apparently the result of the dual jurisdictions of FIFRA and TSCA for review of "chemical intermediates," a distinction that is irrelevant to microbial pesticides.
The existing fragmented oversight process employs different assessment criteria to biological-control organisms that pose similar human or environmental risks, resulting in unnecessary scrutiny of some low-risk organisms and almost complete lack of regulatory review of others. The most important inconsistency is the differential treatment of macroorganisms by USDA/APHIS under FPPA and of microorganisms by EPA under FIFRA. For example, neither EPA nor APHIS regulates nonpathogenic nematodes, whereas both agencies regulate microorganisms. In addition, microbes are exempt from oversight if vectored by a nonpathogenic, indigenous macroorganism (such as a nematode). There is no clearly defined process for risk assessment of biological-control macroorganisms that are not plant pests, resulting in indecisiveness in granting permits for field release. The current regulatory oversight of macroorganisms is thus reduced to case-by-case evaluations through environmental assessments or environmental impact statements under the National Environmental Protection Act (NEPA). To provide appropriate oversight of biological-control organisms and products, USDA, EPA, and other federal and state agencies with oversight authority should jointly develop criteria and protocols specifically for the testing, registration, and