produced by the viral gene in an infected nontransgenic plant. Applicants should address whether the transgene RNA (or protein) is present in the same tissues as are infected during natural infections. From transgenic plants singly infected with each of the widely prevalent viruses in the U.S. that normally infect the recipient plant (contact APHIS for the list of these viruses) determine the amount of both coat proteins (i.e., from both the transgene and the naturally infecting virus). For comparison, provide the amount of both coat proteins produced in the nonengineered plant in mixed infections of the virus from which the coat protein gene was derived and the same widely prevalent viruses used in the single infection study. Provide description of symptoms of infected plants in all cases.
For all diseases and pathogens surveyed, names of the diseases and the scientific names of the pathogens should be provided. Data from field tests in foreign countries are acceptable. If the data on diseases and pests were obtained in the foreign country, the applicant should submit information about the distribution of those pests, disease or pathogens in the U.S. Disease and pathogen susceptibility on wild type and transgenic plants should be determined preferably from natural infestations. However, if the applicant must use direct inoculations, i.e., with virus resistant transgenic plants, the source and taxonomic classification of the virus should be provided.
Certain plants have minute quantities of known toxicants which may adversely impact nontarget organisms and beneficial insects; e.g., tomatine in tomatoes, cucurbitin in cucurbits (APHIS identified cucurbitin as a known toxicant while they probably meant curcurbitacin. Cucurbitin is an amino acid that to the subcommittee’s knowledge is not highly likely to affect nontarget species, whereas cucurbitacins are highly toxic “bitter principles” long known to have effects against both herbivores and predators (which may attack cucurbitacin-sequestering herbivores), gossypol in cotton, etc. If such plants are recipients of transgenes, the applicant should provide information as to whether the level of toxicants is altered. If the plant produces no known toxicant, the applicant should state so and provide the reference to support the claim. Plant toxins can be assessed by the tests and criteria that plant breeders traditionally use in the crop. In some instances, this may be done qualitatively, e.g., taste testing of cucurbits.
Assuming that the levels of known toxicants in the regulated article reported in Section V are in acceptable range; that there were no notable