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Guidance on Petitions for Extensions of Non-Regulated Status

The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has been given the responsibility, under the Federal Plant Pest Act (7 U.S.C. 150aa-150jj) and the Plant Quarantine Act (7 U.S.C. 151-167), to prevent the introduction and dissemination into the United States or interstate of plant pests. Under this authority, APHIS has published regulations found at 7 CFR part 340 pertaining to the introduction (importation, interstate movement, and release into the environment) of genetically engineered organisms and products derived from known plant pests (regulated articles). Before introducing a regulated article, a person is required under Section 340.0 of the regulations to either (1) notify APHIS in accordance with Section 340.3 or (2) obtain a permit in accordance with Section 340.4. An organism is not subject to the regulations when the organism is demonstrated not to present a plant pest risk. Section 340.6 of the regulations, entitled “Petition for determination of nonregulated status,” provides that a person may petition APHIS to evaluate submitted data to determine that a particular regulated article does not present a plant pest risk and should no longer be regulated. If APHIS determines that the regulated article does not present a risk of introduction or dissemination of a plant pest, the petition will be granted, thereby allowing unrestricted introduction of the article.

Section 340.6(e) of the regulations provides that APHIS may extend a determination of nonregulated status to additional regulated articles, upon finding that the additional regulated articles do not pose a potential for plant pest risk, and should therefore not be regulated. Such a finding would be made based on an evaluation of the similarity of the additional regulated articles to an antecedent organism, i.e., an organism that has already been the subject of a determination of nonregulated status by APHIS under Section 340.6, and that is used as a reference for comparison to the regulated article under consideration under the regulations.

The following guidance is intended to provide procedures, practices, and protocols which would be acceptable to APHIS in considering whether and how to prepare a request for an extension of a determination of nonregulated status. These may be illustrated by example. A person may follow this guideline or follow different procedures, practices, or protocols. When different procedures, practices, or protocols are followed, a person may, but is not required to, discuss the matter in advance with APHIS to help ensure that the procedures, practices, or protocols to be followed will be acceptable to APHIS. Whatever procedures, practices, or protocols are followed in preparing a request for an extension of a determination of nonregulated status, APHIS requests that those procedures, practices, or protocols be described to the Agency in order that the Agency may consider whether to add them to these guidelines if they are deemed acceptable.

Antecedent Organisms
APHIS' expectation is that many regulated articles will be developed that differ negligibly, from a safety standpoint, from others that have already been reviewed and subject to determinations of nonregulated status. The aim of making comparisons between regulated articles and their antecedent organisms is to ensure that the new regulated articles in question raise no serious new issues meriting separate review under the petition process.

The following examples illustrate molecular manipulations that individually yield regulated articles that APHIS believes are unlikely to pose new risk issues beyond those that would have been considered in the initial determination of nonregulated status.

 

  • Modifications in which the amino acid sequence of any encoded proteins is unchanged with respect to the corresponding sequence in the antecedent organism (i.e., synonymous codon changes).
  • Production of new transformants of the same cultivar as the antecedent organism, or new cultivars of the same plant species or variety that do not differ significantly from the antecedent cultivar in reproductive fitness, obtained via transformation using the same transforming nucleic acid as was used in producing the antecedent organism.
  • Production of new transformants of the same cultivar as the antecedent organism, using a transformation vector that differs from that used to produce the antecedent organism only: in noncoding regulatory sequences used to control expression of any of the introduced genes; or in other vector DNA sequences that were not incorporated into the recipient plant cells, unless the new regulatory sequences cause the expression of any introduced genes in plant tissues in which the introduced genes were not expressed in the antecedent organism.
  • Production of new transformants of the same cultivar as the antecedent organism, in which the genetic material transferred into the recipient plant to produce the antecedent organism is identical to that in the regulated article in question, but in which said material was introduced into the recipient plant using a different transformation vector or technique.
  • Modifications in which the antecedent organism and the regulated article in question contain different donor genes, but the donor gene used in producing the antecedent organism and the donor gene used in producing the regulated article in question encode enzymes catalyzing the same biochemical reaction (i.e., molecules that have the same substrates and products) or encode other proteins performing the same molecular function (i.e., molecules that bind to the same target molecule in vitro and either inhibit its function via the same mechanism, or cause the same biochemical change in the target molecule).
  • Modifications in which the antecedent organism and the regulated article in question differ only in 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.

Request for Extension of Nonregulated Status
For APHIS to grant an extension of a determination of nonregulated status to additional regulated articles, the agency must determine that the new regulated articles in question raise no serious new issues meriting separate review under the petition process. Accordingly, those who request such extensions to existing determinations of nonregulated status would need to substantiate this assertion in the specific instance of the regulated articles in question. This would entail precise description of the genetic modifications in the regulated articles under consideration and detailed comparison of the modifications in those regulated articles with those in the antecedent organism. This characterization may demonstrate that the modifications in the regulated articles are of any of the types illustrated in any of the examples above, or, for organisms not covered in the examples, may directly address why the particular organisms in question do not in and of themselves raise any issues, different from those considered in the determination for the antecedent organism, that merit separate consideration under a new petition.

To support the contention that the regulated articles in question do not pose new plant pest risk issues meriting separate consideration, requesters should also provide information on the phenotypic expression of the genetic modifications in the regulated articles and indicate any known differences in phenotype between the regulated articles and their antecedent organism. These known differences should be further categorized as to whether they are expected based on the intended effect of the new modifications. Data from at least one field trial should be included for any new regulated articles for which an extension of a determination of nonregulated status is requested. All data reports from completed field trials with a regulated article should be submitted with any request that the regulated article be included within a determination of nonregulated status.

APHIS believes that it is appropriate to minimize the need to submit redundant information by those who request extensions of existing determinations. Information referred to in the determination of nonregulated status may be incorporated by reference in any request by that petitioner for extension of the original determination, as may information contained in the petitioner's petition for determination of nonregulated status for the antecedent organism. Any information essential to the characterization of the genotype and phenotype of the regulated article under consideration, however, should not be incorporated by reference. APHIS recommends that requesters limit citation of data contained within petitions to only those petitions that they themselves have submitted, particularly for any data with respect to phenotypic comparison of regulated article and its antecedent organism. This will ensure that requesters have responsibility for any data contained within submitted requests.

   
 


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