dedicated to regulatory affairs who have extensive familiarity with the regulatory process and EPA staff; smaller entities do not. The incremental cost of complying with regulation of a single new product is thus considerably less for major agrichemical companies than for small entities.
EPA's published estimates of testing costs (EPA 1994d) were used to estimate the costs of meeting potential testing requirements imposed by USDA-APHIS regulation, safety reviews and data submissions under the FDA consultation process, as well as testing under pesticide regulation (table A.7). EPA's figures were converted to 1998 dollars by using the implicit GDP price deflator reported by the Council of Economic Advisers (1999). EPA estimates of Tier II and III testing costs for microbial pesticides were used to estimate potential costs of further testing new, unfamiliar products for human health effects and mammalian toxicity. EPA's estimated costs of providing material for testing for biological fate were then added.
Baseline data likely to be submitted to USDA-APHIS and FDA as well as EPA consists of product analysis (including crop residue), Tier I biological fate, acute oral toxicity, and digestibility for a total of about $20,000. Additional costs of regulating pesticidal substances in transgenic pest-protected plants as pesticides beyond that required for Bt and viral coat proteins would include the following:
Testing for effects on nontarget organisms. The cost of full batteries of tests ranged from about $76,000 for Tier I tests to over $410,000 for Tier I-III tests.
More extensive testing on biological fate. The cost of full batteries of tests ranged from about $46,000 for Tier II tests to over $735,000 for Tier II and III tests.
More extensive testing on human health and mammalian toxicity. The costs of testing ranged from about $10,000 for hypersensitivity and specific allergen screening to $1,667,000 for a full battery of testing, including Tier II and III toxicity testing.
Overall, then, according to EPA cost estimates the additional testing costs involved in regulating pesticidal substances in transgenic pest-protected plants as plant-pesticides (that is, the testing required by EPA beyond the data submitted to USDA-APHIS and FDA) could total as much as $2.8 million. As noted above, that total is modest compared with that for testing chemical pesticides. It might nevertheless be substantial relative to the cost of breeding new varieties and thus influence both the types of transgenic crops developed and entry by less well-capitalized entities. Moreover, EPA's estimates may understate the actual costs of conducting the required testing: Unpublished Monsanto estimates, for example, indi-