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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
In 1995 APHIS proposed a further simplification of the regulatory procedure to:
allow environmental release under the notification system of any plant not considered a noxious weed as long as the plant is not considered a weed in the intended area of release;
extend the notification procedures to include a number of genetic modifications resulting in virus resistance;
discontinue the requirements for each relevant state to concur with interstate movement;
simplify reporting requirements for field trials conducted under notification or permit; and
allow permissions for determination of nonregulated status to be extended to closely related articles (an “extension” process).
These proposed changes also proved to be controversial. A total of 50 comments were received from industry, universities, state departments of agriculture, science policy organizations, environmental groups, industry organizations, professional societies, consumer organizations, individuals, and a university cooperative extension office. The majority (over 60%) supported the proposed amendments. Those expressing opposition were concerned with the potential for increased risk posed by particular transgenic plants, especially those with wild or weedy relatives. Some opponents were concerned that regulatory oversight would be decreased in the shift from a permitting to a greater emphasis on the notification system and that notification was harder to enforce and therefore compliance might be compromised.
Part of the APHIS response to the expressed public concerns was publication of a revised user’s guide (APHIS 1997b), which provided examples of how applicants might meet the performance standards and other information to help applicants design their field trials for specific organisms. Although not a formal regulatory document, the user’s guide provides information to applicants on how to comply with the regulations. The guide gives specific examples and describes approaches to compliance on such matters as shipping and maintenance of regulated articles, how to avoid admixtures, devitalizing treatments, elimination of viable vectors, and minimizing dispersal and persistence in the environment. The guide emphasizes that these are examples only, that following the examples exactly does not necessarily ensure acceptability, and that alternative approaches might be equally acceptable. APHIS also argued that field inspections of trials conducted under the notification system (as well as those under permit) achieved a high degree of compliance.