or toxins into food-plant varieties, the possibility of introducing new allergens into pollen, or the possibility that previously unknown protein combinations now being produced in food plants will have unforeseen secondary or pleiotropic effects. The use of antibiotic-resistance marker genes has also given rise to concern4.

In the regulation of recently approved transgenic pest-protected plant products (that is plant products with Bt and viral coat proteins), the emphasis has not been on detailed assessments of safety for humans or domestic animals. Rather, it has been on explaining the scientific basis for why there is probably no appreciable risk and justifying the tests which are required. Although the assumption of no appreciable risk from the recently reviewed transgenic pest-protected plants (for example, plants containing Cry1A and Cry3A Bt proteins and viral coat proteins) appears reasonable, it is important that the tests that are performed be rigorous, logical and scientifically sound. In most cases, the tests have these qualities. However, specific suggestions for improving the testing protocols can be found in sections section 2.5.1, section 2.5.2, and section 3.1.3).

A number of traditional chemical pesticides are considered human carcinogens (Hodgson and Meyer 1997). Others have been linked to human health problems, such as Parkinson's disease (Fleming et al. 1994). Therefore,

Human health benefits could arise from reductions in the application of chemical pesticides due to the commercial production of certain transgenic pest-protected plants.

But it is not necessarily true that all traditional chemical pesticides pose a risk to human or domestic-animal health, so the benefits will depend on the particular pesticides that transgenic pest-protected plants replace and the effects of the transgenic pest-protected plant on pest control practices.

The proposed human health testing for EPA, and the testing for FDA consultation, fall into the categories outlined in box 2.2. Those categories are general, and considerable variation in methodology is possible. There is evidence that this variation has occurred under the current guidelines (see discussion below). Even though the EPA rule is not final, more specific testing protocols should be developed and adopted (see section 4.3.5 and section 4.3.7).

4  

Issues surrounding antibiotic resistance, although mentioned, were not analyzed in this report (section ES.1 and ES.2).



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