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Proposed Regulatory Status Evaluation Data Requirements

DISCLAIMER:  This information maintained on, referenced to, or linked to from this website is preliminary or provisional and is subject to revision. It is provided as a public service and is intended solely to enhance transparency and understanding of the proposed revisions to the regulations at 7 CFR part 340.  This information has not received final approval, nor is any language contained herein promulgated by the U.S. Department of Agriculture (USDA), and is provided on the condition that neither the USDA nor the U.S. Government shall be held liable for any damages resulting from its authorized or unauthorized use.  The Federal Register and the Code of Federal Regulations remain the official sources for regulatory information published by the USDA.

Regulatory Status Evaluation Requirements

Each regulatory status evaluation request must include all of the following information:

  1. A description of the recipient organism to include:

    1. Common name(s);

    2. Genus, species, and any relevant subspecies information (e.g. variety) that would distinguish the organism; and

    3. For microorganisms, identification of the strain.

  2. The genotype of the modified organism, including a detailed description of the differences in genotype between the organism subject to the inquiry and the recipient organism. 

    1. If genetic material is inserted into the genome, the method of transformation (e.g. agrobacterium, biolistics, etc.) must be described and the following provided for each gene:

      1. For gene sequences, the name of the sequence, donor organism(s) or source, function of sequence, nucleic acid sequence, and publicly available sequence identification.  If genes have been modified (e.g. codon used efficiency, gene shuffling, etc.), state the nature of the modification and its purpose.  Identify and highlight the modifications by submitting an alignment of the modified sequence with the unmodified sequence.  If the gene is synthetic, state whether the sequence is based on that of a specific organism, and identify the organism and gene it was based on. 

      2. For regulatory sequences, the function of each regulatory sequence as it relates to the gene sequence and the source of each regulatory sequence.  Promoters must be identified as constitutive, inducible, developmental, or tissue specific.  If inducible, the inducer must be described (e.g. chemical, temperature, light, stress, wounding, etc.).  If developmental, the stage(s) at which the promoter is active must be described.  If tissue specific, the tissues in which the promoter is active (N/A for microorganisms) must be described.  The strength of the promoter must also be described.  For microorganisms, descriptions of mobile genetic elements (e.g. plasmids, transposons, double-stranded RNA, viruses, insertion sequences and other classes or elements with these general properties) must be included.

    2. If the genome is edited, but no genetic material is inserted, the following must be provided:

      1. The nature of the edit(s) and the gene(s) and function(s) being modified, as well as what pathway(s) are expected to be affected.

      2. For substituted base pairs, the number of substitutions.

      3. For deletions a description of the genetic material deleted.

      4. The original unmodified sequence aligned to the modified sequence. 

      5. If the edits were created using genetic material which was integrated into the chromosome, but later eliminated through segregation, techniques used to confirm absence of the genetic material.

  3. A detailed description of the intended phenotype(s) of the modified organism, including:

    1. The purpose of the new phenotype(s) and the mechanism(s) of action by which the intended phenotype(s) is conferred;

    2. Any new enzymes, other gene products, or expected changes in metabolism;

    3. If applicable, the protein accession number, and enzyme commission number; and

    4. Known and potential differences from the unmodified recipient organism that would substantiate that the modified organism is unlikely to pose a greater noxious weed risk or plant pest risk than the unmodified organism from which it was derived.

    5. For plants, any information that exists on known or likely changes that may affect the following must be provided:

      1. Weediness of the plant;

      2. Competitive growth ability;

      3. Reproduction, spread, and persistence;

      4. Stress tolerance, including a consideration of abiotic stresses such as cold and drought tolerance and biotic stresses such as herbivory or diseases; and

      5. Any other weediness characteristic identified of the plant or other plants with which the plant can interbreed. 

    6. For plant pests, any information that exists on known or likely differences to herbivory or virulence must be provided such as: 

      1. Any observed or anticipated changes due to the genetic modification that might affect the ability of the organism to cause direct or indirect damage to plants;

      2. A description of any changes to known factors of pathogenesis (plant degrading enzymes, plant growth regulators, phytotoxins, etc.) and virulence factors such as polysaccharides and suppressors;

      3. A consideration of changes that might affect geographic distributions, host range, means of dissemination, horizontal gene transfer, reproductive cycle, and persistence; and

      4. A description of any characteristics introduced to mitigate harms to plants (sterility in insects, hypovirulence in pathogens, etc.).

  4. Any experimental data, publications, and other science-based assessments that are relevant to APHIS’s evaluation of the potential of the organism to affect plant health.

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