organisms over a short time period, on a small spatial scale (Chapter 5). Once the transgenic crop is marketed there is an opportunity for largescale, multi-year testing to determine the adequacy of the precommercialization testing. Comparisons of the population dynamics of non-target organisms in large (about 100 acre) paired fields (transgenic versus near isolines) and surrounding natural habitats in a number of locations would be one approach to such validation testing. If such paired fields were repeatedly planted to the same crop variety for a number of years it would be possible to examine population trends in non-target organisms that would be impossible to examine at a smaller spatial and temporal scale. The committee recognizes that even the 100-acre scale would be insufficient for examining organisms that move long distances. For such organisms it would be necessary to utilize epidemiological approaches that examined relationships between the intensity of planting of a specific crop variety in a locality, and the population dynamics of these non-target organisms. At this level, a gray area develops between what might be considered a postcommercialization validation test and a monitoring program. While this committee treats validation testing and monitoring separately in this report because of the distinct and complex type of infrastructure needed for monitoring, it is important to recognize that these two approaches are used to accomplish broadly similar goals.
Recommendation 6.1: Postcommercialization validation testing should be used to assess the adequacy of precommercialization environmental testing. This validation testing must always involve testing specific hypotheses related to the accuracy and adequacy of precommercialization testing.
Recommendation 6.2: Postcommercialization validation testing should be conducted at spatial scales appropriate to evaluate environmental changes in both agricultural and more natural ecosystems.
A funding mechanism for postcommercialization testing will need to be established. It would be preferable to have such testing involve public sector scientists to help alleviate real or perceived conflicts of interest. Although validation testing is costly, the recent postcommercialization testing for impacts of Bt corn on monarch butterflies (Chapter 2) demonstrates that such testing is feasible.
The USDA Biotechnology Risk Assessment Research Grants Program is small ($1.9 million for fiscal year 2000) (USDA 2001a) and is directed primarily toward small-scale hazard identification. The objectives of this program expanded recently to include risk issues associated with commercialization. The USDA’s Initiative for Future Agriculture and Food