CEI Comments on EPA Biopesticides Registration for Biotech Plum

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The Competitive Enterprise Institute (CEI) appreciates the opportunity to submit these comments regarding EPA’s Biopesticides Registration Action Document (BRAD) and Proposed Label for Coat Protein Gene of Plum Pox Virus. CEI is a non-profit research and advocacy organization, and for over 25 years CEI scholars have been extensively involved in research on issues of food and environmental safety, innovative food production technologies, and other issues of public health and consumer protection, including crop biotechnology.

CEI commends the Environmental Protection Agency for concluding that use of the Coat Protein Gene of Plum Pox Virus (CPG-PPV) in C5 Honey Sweet Plum would not result in unreasonable adverse effects to the environment or to human health. Indeed, the use of transgenic virus resistance in other crop plants—including papaya, squash, and potato—grown within the United States has already proven to deliver clear environmental benefits and no known risks to the environment or to human health. Commercial scale release of the C5 Honey Sweet Plum can be expected to provide the same safe and environmentally beneficial solution to the long-standing and intractable problem of PPV infection of plum trees. We therefore applaud the agency’s decision to exempt the C5 Honey Sweet Plum from the requirement of a tolerance for residues of the CPG-PPV.

However, there is no scientifically justifiable reason for EPA to consider the CPG-PPV in C5 Honey Sweet Plum to be a plant-incorporated protectant (PIP), a condition that makes it subject to burdensome pre-market and post-market regulatory requirements. The novel CPG-PPV transgene’s mode of action means that little or no virus coat proteins will be produced in the fruit. We recognize that the Federal Insecticide, Fungicide and Rodenticide Act defines a “pesticide” based on the manufacturer’s intent, not biochemical mode of action. Nevertheless, because no virus coat proteins are intended to be produced, the C5 plum does not in any meaningful sense contain a “substance” that should be classified as a PIP. EPA has had to classify both the virus coat protein and the novel DNA as a PIP. But it is not the coat protein that is intended to confer virus resistance, and EPA has never before considered DNA alone to be a pesticidal substance.

Even if the novel protein were to be expressed and PIP status could be defended, there is also no scientific justification for EPA to require C5 plum trees or fruit to carry a label indicating the presence of a pesticide product. EPA recognizes that plant viruses, including PPV, have a long history of safe consumption by humans, so the virus coat protein would not be injurious to human health or the environment in any way. Ultimately, trees and fruits of the C5 plum are functionally no different from non-transgenic plum infected with the PPV virus, but there is a substantial risk that consumer confusion would result from mandatory PIP labeling. We therefore urge EPA to remove the C5 Honey Sweet Plum’s classification as a PIP or, at the very least, to exempt trees, plantlets, cuttings, and fruit from the requirement to bear a pesticide product label.