Environmental Effects of Transgenic Plants The Scope and Adequacy of Regulation (2002) / Chapter Skim
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3 APHIS Regulatory Policy for Transgenic Organisms
3 APHIS Regulatory Policy for Transgenic Organisms
Pages 101-120
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From page 101... ...
This chapter specifically examines the oversight of transgenic plants by APHIS under the Federal Plant Pest Act (FPPA) and the Federal Plant Quarantine Act (FPQA)
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In addition, APHIS has developed a process whereby an applicant can petition the agency to determine that a transgenic organism does not pose a plant pest risk and is therefore no longer a regulated article subject to APHIS regulatory oversight. The coordinated framework explicitly provides that federal agencies should focus on the characteristics of risks posed by a biotechnology product, not on the process by which it is created, but APHIS uses the process of genetic engineering to trigger oversight.
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From page 103... ...
APHIS REGULATORY POLICY FOR TRANSGENIC ORGANISMS 103 ring organisms, which might be plant pests. For example, APHIS regulates the movement and release of geographically separated populations of known plant pests because the source population can have characteristics that are absent in the recipient geographic population, which could
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From page 104... ...
That is consistent with the principle that transgenic organisms might have new characteristics that require oversight and that the genetic engineering process might trigger oversight, even if it is not considered in the evaluation of risks, as discussed in detail in Chapter 2. In 1993 APHIS proposed a simplification of the regulatory procedure in order to: · create a simplified notification procedure for transgenic plants that meet eligibility criteria and are tested using performance standards that .
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supported the proposed amendments. Those expressing opposition were concerned with the potential for increased risk posed by particular transgenic plants, especially those with wild or weedy relatives.
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Recommendation 3.1: For changes in regulatory policy, APHIS should convene an external scientific advisory group and hold at least one meeting to solicit public scientific input to review proposed changes. SCOPE AND REGULATORY PROCEDURES USED BY APHIS APHIS currently regulates transgenic plants under 7 CFR part 340, "Genetically Engineered Organisms and Products: Simplification of Reauirements and Procedures for Geneticallv Engineered Organisms," 1 J which was published in 1997.
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The exclusion also means that genetically engineered fish cannot be regulated as potential plant pests. There is some uncertainty about the status of algae as plants that could be affected by potential plant pests.
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The assessment of notifications is not subject to external scientific review or any other public input. A few transgenic plants are now grown to produce commercial products under notification.
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The description must include the identity of the transformed plant species, the method of gene transfer, and a full description of the inserted sequences, including the functions, encoded proteins, and source donor organisms for each segment. In addition, the notification application must include, for field releases, the geographic details, size, and duration of field trials and, if appropriate, information about
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The permitting process allows APHIS to evaluate the potential plant pest risk and prescribe prevention measures to reduce it (e.g., through confinement procedures, or limiting the spatial, temporal, and numerical scales of the release)
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APHIS has a procedure whereby an applicant can request that the agency determine that a particular transgenic plant is not a regulated article that is, that it does not fall under the definition of a plant pest (BOX 3.1~. This procedure is the sole route for commercialization of transgenic plants (e.g., sale of transgenic soybean seed)
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Because reviews are conducted on a case-by-case basis, the information needed may vary with plant species, the specific type of modificationts) , and end use of the transgenic plant.
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a detailed description of the genotypic differences between the regulated article and the nonmodified recipient organism; 4. a detailed description of the regulated article's phenotype, especially regarding known and potential differences from the nonmodified recipient organism that would indicate whether or not the regulated article poses a greater plant pest risk; and 5.
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For example, if in a chemically synthesized Bt gene amino acid 23 was changed from methionine to alanine, it should be stated without providing the complete sequence.
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Differences observed could include changes in leaf morphology, pollen viability, seed germination rates, changes in overwintering capabilities, insect susceptibilities, disease resistance, yield, agronomic performance, etc. Applicants must also note the types of characteristics that were compared between transgenic and nontransgenic plants and found to be unchanged.
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For direct transformation systems, applicants should determine which sequences are inserted in transgenic plants and whether they are expressed. PCR analysis may be used to prove that only the targeted DNA has been incorporated.
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Disease and pathogen susceptibility on wild type and transgenic plants should be determined preferably from natural infestations. However, if the applicant must use direct inoculations, i.e., with virus resistant transgenic plants, the source and taxonomic classification of the virus should be provided.
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From page 118... ...
Requests for Extension of Determination of Nonregulated Status to Additional Regulated Articles APHIS may extend a determination of nonregulated status to additional regulated articles if it finds that such articles do not pose a potential for plant pest risk. Extension requests are handled somewhat like petitions.
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." · "Modifications in which the antecedent organism and the regulated article in question differ only in [the] marker genes they contain, which were used in their identification or selection, provided that the new marker genes in the organism in question do not raise any new risk issues, i.e., do not encode substances toxic to plants; do not encode substances with pesticidal properties; do not confer resistance to any antibiotic of significant importance for veterinary or human use; and do not confer resistance to any different herbicide than was conferred by the marker genes in the antecedent organism." 119 To provide guidance for extension requests, the APHIS user's guide provides a sample request, which suggests that certain information be provided by the applicant.
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From page 120... ...
However, commercial products have also been created from regulated transgenic organisms that have been grown under notification and permit. It is not clear which of these regulatory pathways will become the option of choice for future field-based commercial plantations of transgenic plants.
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