increase the plant pest risk in the recipient population. In all cases a permit must be obtained from APHIS before importation and interstate movement of potential plant pests. For some transgenic organisms, APHIS has determined that release into the environment is tantamount to introduction of a new organism; therefore, it requires that a permit be obtained beforehand. In other words, APHIS considers that transgenic organisms are new organisms because they potentially have new ecological characteristics that could make them plant pests. That is consistent with the principle that transgenic organisms might have new characteristics that require oversight and that the genetic engineering process might trigger oversight, even if it is not considered in the evaluation of risks, as discussed in detail in Chapter 2.

In 1993 APHIS proposed a simplification of the regulatory procedure in order to:

  • create a simplified notification procedure for transgenic plants that meet eligibility criteria and are tested using performance standards that minimize risks;

  • allow under notification corn, cotton, potato, soybean, tobacco, tomato, or any additional plant that BBEP has determined may be safely introduced;

  • extend notification procedures to include a number of virus resistance modifications;

  • provide a petition process allowing for a determination that certain plants are no longer regulated articles; and

  • allow permissions for determination for nonregulated status to be extended to closely related articles (an “extension” process).

APHIS received 84 comments ranging from complete opposition to enthusiastic support for even greater reduction in regulation. According to the Federal Register notice (APHIS 1993), the majority of commenters expressed general or qualified support for the suggested changes. Prior to this proposed change, however, APHIS consulted with a scientific subcommittee of the USDA’s Agricultural Biotechnology Research Advisory Committee (ABRAC) in a public forum about the scientific basis for the proposed reduction in regulation. APHIS argued that the six specified crops had no weedy relatives, that only cotton had wild populations (in Florida), and that only cotton and potato had wild relatives in the United States. It also argued that the confinement criteria in the performance standards should protect against gene flow to these wild relatives and populations, and the subcommittee generally concurred. (ABRAC held its last meeting in January 1996.)



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