Comment submitted by S. Ferreira

The proposal suggests the need for further or more intense regulation of PVCP-PIP products without demonstrating a need. Previous history of regulation for PVCP-PIPs by EPA can only be characterized as practical and without significant problems to the environment. Why, then, is additional regulation necessary at this time? What problem or deficiency with the current regulation is being addressed? The case or justification for additional regulation was not made. My other concern is that the proposed regulation appears to be based on the assumption that PVCP-PIPs are risky. Undoubtedly PVCP-PIPs will pose some risk. However, the important question ought to focus on relative risk. That is, are risks associated with PVCP-PIPs more, less or equally as risky as natural virus situations? My view is that we are simply unable to answer that question at this time. There is little or no data to suggest that the risk of PVCP-PIPs would be more risky than the natural situation. Opinions to support or refute this position exist, but objective scientific data is simply lacking. While literature on viral recombination and PVCP-PIPS exists, a thorough understanding of the viral recombination is lacking. Similarly, variability in natural virus populations and the factors that influence viral recombination is also not well understood at this time. The situation occurs probably because the tools for addressing these kinds of questions have only recently become available. Research in this area is needed and ought to be encouraged by appropriate granting agencies. Until more data comes available to give us a more complete understanding of viral recombination, and given the situation that that PVCP-PIPs are not likely to be more risky than the natural virus situation, the imposition of what is likely to be onerous, unnecessary regulation is not justified. In the absence of data, the safe decision to make might be to tightly regulate a situation until more is known. I would argue the opposite. Since the risks are likely to be less than the natural situation, we ought to stay with current regulation until we understand a situation is at least as risky or more risky than the natural situation. We should keep in mind that plant viruses are not known to pose health or environmental risks. Viruses are not analogous to known toxins or toxic agents. Thus, PVCP-PIPs are not likely to pose risks, certainly not higher than for naturally occurring viruses. Why then, is additional regulation necessary? Keep in mind also, that the PVCP-PIPs being deployed or developed generally address serious agricultural production problems, where alternative controls are lacking or ineffective. Delaying the availability of effective solutions in the absence of true knowledge of risks at least as great as posed by naturally occurring viruses is, in my view, not defensible.