This committee recommends that as much transgene sequence information as is reasonably feasible be reported as part of an application. Because the transgene region might be quite complicated, a protein product may or may not be produced, and the product may be inconsequential, any recommendation to require sequencing must remain flexible until much easier DNA sequencing and other technologies are available. For these reasons, the committee recommends that APHIS should require reporting of full DNA sequences of transgenes as they are integrated in the plant genome unless the applicant can provide scientific or technological justification not to do so.
Recommendation 5.5: APHIS should require reporting of full DNA sequences of transgenes as they are integrated in the plant genome unless the applicant can provide scientific or technological justification not to do so.
APHIS’s guidelines for applications for determination of nonregulatory status provide a suggested format for applicants to follow. Some of the features of this format are described in Chapter 3. While APHIS does not exactly give the applicant a checklist, it does come close to that in some places. In reading the guidelines this committee was often unsure of why some kinds of information were requested at all and was also unsure about what kind of evidence would be needed to respond to some of the questions asked. For example, the document states that:
Applicants must report any differences noted between transgenic and nontransgenic plants that are not directly attributed to the expected phenotype. Differences observed could include changes in leaf morphology, pollen viability, seed germination rates, changes in overwintering capabilities, insect susceptibilities, diseases resistance, yield, agronomic performance, etc. Applicants must also note the types of characteristics that were compared between transgenic and nontransgenic plants and found to be unchanged.
While this paragraph offers some general guidance, what is missing is information on the standards of evidence. Does an assessment of overwintering capability mean performing quantitative tests in a dozen distinct habitats for three years, or does it simply mean not noticing any major change in overwintering while conducting yield trials? While leaf morphology could be measured in the process of typical agronomic trials, measuring disease resistance could require special testing with a set of disease organisms under the environmental conditions best suited for a disease outbreak of each organism. The applicant could use common sense in determining what to do or could consult with APHIS personnel. The problem is that the answer to the question may depend on the APHIS