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"Developer-Determination” Exemption Criteria for Proposed Rules for Plant-Incorporated Protectants (PIPs) Based on Plant Virus Coat Protein Genes (PVCP-PIPs)

Current as of April 18, 2007

To provide thorough and comprehensive oversight of plant-incorporated protectants (PIPs) that are based on plant viral coat protein genes (PVCP-PIPs), EPA is proposing a comprehensive structure to ensure these products are properly regulated based on the potential risk they may pose.

EPA is proposing to establish three categories of oversight. For products that meet the five risk-based criteria below, a developer would be able to self-qualify for an exemption from most pesticide registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). For products that do not meet these criteria, EPA would review the product to determine if it qualifies for exemption. If a PVCP-PIP did not qualify for exemption under either of these processes, EPA would then evaluate it under the existing registration requirements. Comments are due to EPA 90 days after publication in the Federal Register. How to comment.

The proposed "Developer-Determination" exemption criteria

  1. If the PVCP-PIP is in a plant that is used as human food or animal feed, then the protein portion of the PVCP-PIP (the "PVC-protein") must have a tolerance exemption under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    EPA has published a second proposed rule with proposed conditions under which the PVC-protein would automatically qualify for a tolerance exemption without Agency review: the PVC-protein must be virtually unmodified when compared to an entire unmodified coat protein from a virus that naturally infects plants that humans consume in their entirety or in part.


  2. The plant containing the PVCP-PIP must be one of the following:

  3. The variant of the virus, the "viral pathotype" used to create the PVCP-PIP must have at some time naturally infected plants in the United States and must naturally infect plants of the same species as those containing the PVCP-PIP,

    OR

    The coat protein gene must produce no protein either because the inserted nucleotides form an inverted repeat or because the gene has no initiation codon for protein synthesis.


  4. The coat protein gene must encode only a single virtually unmodified virus coat protein,

    OR

    The coat protein gene must produce no protein either because the inserted nucleotides form an inverted repeat or because the gene has no initiation codon for protein synthesis.


  5. Any selectable markers contained in the PVCP-PIP must be among the following:
Please go to the PVCP-PIP proposed rules page for how to comment on this proposal.

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