exemptions for certain sexually-compatible transgenic pest-protectants will be warranted; however, it questions the categorical exemption of these products. The committee recommends that

Given that transfer and manipulation of genes between sexually compatible plants could potentially result in adverse effects in some cases (for example, modulation of a pathway that increases the concentration of a toxicant), and given the public controversy regarding transgenic products, EPA should reconsider its categorical exemption of transgenic, pest-protectants derived from sexually compatible plants.

The committee also examined EPA's proposed exemption for viral coat proteins12 expressed in transgenic pest-protected plants. Viral coat proteins in transgenic pest-protected plants are not expected to jeopardize human health, inasmuch as consumers already ingest these substances in nontransgenic food, so the committee agrees with the exemption of these proteins from EPA jurisdiction under FFDCA. However, the committee questions the EPA's categorical exemption of all viral coat proteins under FIFRA due to concerns about the potential for outcrossing with weedy relatives. The committee agrees that exemption of particular viral coat proteins in certain plant species will be warranted. However, the committee suggests that

EPA should not categorically exempt viral coat proteins from regulation under FIFRA.

ES.6.4 Scientific Data Used by the Agencies in the Regulatory Process

The committee reviewed examples of data submitted by applicants to the regulatory agencies for currently commercialized transgenic pest-protected plant products (that is, products with Bt and viral coat proteins). The federal agencies already address most of the categories of scientific concerns presented in this report (see table 4.3). However, the committee found some areas where the risk assessment process for transgenic pest-protected plants could be improved.

In reviewing toxicity testing relevant to human health, the committee found that,

When the active ingredient of a transgenic pest-protected plant is a protein and when health effects data are required, both short-term oral


Virus-derived proteins that form a capsule around viral DNA or RNA.

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