untary consultation process. It should be noted, however, that FDA has the authority to require formal pre-market review in any case where it is deemed necessary by the agency. This review could take the form of a food additive petition or a GRAS clearance process, both of which are designed to demonstrate the safety of any added substances (see chapter 1 and chapter 4).

A.5.1 Regulatory Costs

Regulation of pesticidal substances in transgenic pest-protected plants as plant-pesticides by EPA will probably involve more extensive provision of data prior to commercialization and will therefore be more expensive than regulation by APHIS or oversight under FDA's consultation process. There are two reasons for the likely extra cost:

  • EPA will review pesticidal substances in transgenic plants for potential health and environmental effects not considered by USDA-APHIS or FDA, including acute and chronic toxicity to nontarget organisms (both vertebrate and invertebrate), potential for water pollution, and similar types of environmental effects.

  • EPA tends to rely more heavily on test data than USDA-APHIS and tends to require more extensive premarket submission of data than that submitted to FDA under the consultation process.

In 1993, EPA estimated that the costs of testing plant-pesticides would be around $64,000-1,070,000, depending on the origin of the pesticidal substance, the presence of wild relatives, and the extent of available information on the characteristics and function of the gene(s) involved (EPA 1994d). Those estimates are based on experience with such products as Bt and viral coat proteins and are therefore likely to understate the costs of testing new generations of products. Current transgenic pest-protected plants do not create exposures of a qualitatively new type: viral coat protein is present naturally in most plants, and Bt has been used in microbial form for a long time and is a familiar product. New generations of products, in contrast, will probably use less familiar proteins, so one would expect EPA to require more extensive testing of future transgenic pest-protected plant products.

EPA's estimates of testing costs also underestimate the costs of regulatory compliance because they ignore the cash costs and implicit costs of management time needed for overseeing the regulatory process and interacting with EPA staff. Those costs are likely to be higher for smaller entities, such as biotechnology startup companies, small to medium seed companies, and public-sector breeders. Major agrichemical firms have staff

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