either genetic engineering or conventional breeding will have equal probability of resulting in unintended changes. It is the final product of a given modification, rather than the modification method or process itself, that is more likely to result in an unintended adverse health effect. In Figure 3-1 some of the methods used to generate GM plants are shown to illustrate the full range of possibilities that might lead to unintended changes (these methods are described in Chapter 2).

Analysis of the Continuum

As noted earlier in this chapter, unintentional changes are possible with all conventional and biotechnological breeding methods for genetic modification. It is possible to represent the likelihood of such changes as a continuum, albeit only a partially understood one. Placement along this continuum has no bearing on risk of adverse outcomes, but only on the probability of unintended changes, which need not be hazardous. The potential for hazard resides in specific products of the modification regardless of whether the modification was intentional or unintentional.

Again, unintended effects do not necessarily imply hazard. If a particular method were inherently hazardous, all products resulting from its use would be potentially harmful. However, it is known that each method can provide safe products, so the key for breeders and regulatory agencies, in their reviews of specific products, is to identify the relatively rare, potentially hazardous products resulting from any method.

In breeding, the developer can generate literally thousands of breeding lines; each might be progeny of the same parents, thus bringing together the same set of genetic information, and yet possess subtle differences. As noted previously in this chapter, conventional breeders may scrutinize 2,000 of these “sister lines” of a single cross of two parent plants. Meiotic recombination allows sister lines to show a continuum of phenotypic expression. Over several years, the breeder eliminates most, or sometimes all, of those breeding lines because they are unsuitable.

Plant breeding is often said to be a process not of selection, but of elimination. Any off-types, unstable lines, or lines showing characteristics such as significant differences in nutrient content, responses to environmental stresses, diseases, or the presence of other undesirable traits are discarded as soon as they are noticed. This winnowing takes place over several years, so the remaining lines identified for prospective commercial release are unlikely, but not guaranteed, to have any significant compositional changes other than those related to the desired trait. For this reason, regulatory scrutiny focuses most often on the new trait and its metabolic perturbations. Nevertheless, the appearance of subtle or obscure phenotypic changes can go unnoticed by breeders or regulators and may subsequently have to be recalled from the market, as in the case of the Lenape potato—



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