Principles of Plant Genetics and Breeding

ISSUES IN THE APPLICATION OF BIOTECHNOLOGY IN PLANT BREEDING 267
2 The GE trait could negatively impact non-target organisms in the environment.
3 Organisms that the GE trait is intended to harm could develop resistance to the trait.
Currently, agency scientists and risk managers evaluate each submission on a case-by-case basis and determine the specific
data the applicant should submit depending on the product. However, as shown in Table 1, there are a number of concerns
Table 1 Risk assessment concerns and information used by the Food and Drug Administration (FDA),
Environmental Protection Agency (EPA), and US Department of Agriculture (USDA).
Agency
FDA, EPA, and/or
USDA-APHIS 3
EPA and
USDA-APHIS
USDA-APHIS
EPA
Risk assessment concerns
Characterization of inserted DNA
Characterization of expressed protein(s)
Stable inheritance of the transgene
Plant composition
Allergenicity of expressed protein
Effects on non-target organisms
Gene flow to wild and weedy relatives
Potential weediness of engineered plant
Threatened and endangered species impact
Plant pest risk
Agronomic management
Acute toxicity
Transgenic protein fate in environment
Cost benefit analysis
Insect Resistance Management
Typical data 1 and information 2 used in assessment
Data from Southern blots and/or sequencing
Data from western blots or ELISA assays often with
multiple plant tissues; data from phenotypic
analyses; data on peptide modification in vivo
Data from Southern blots and/or phenotypic
analysis over multiple generations
Data on measurements of amino acids, minerals,
fatty acids, carbohydrates, water, etc., including
amounts of any toxins and antinutrients that are
typically found in the plant
Data on in vitro digestibility, heat stability; data on
sequence similarity to known allergens
Data from toxicity assays on non-target insects, soil
organisms, birds, mammals, and fish; in some
instances, data from surveys of non-target
invertebrates in the field
Information on hybridization potential and
distributions of wild and weedy relatives; in some
instances, data on hybridization potential
Data describing plant characteristics relative to a
comparator plant line
Information on distributions of threatened and
endangered species that are related to the target
organism or could otherwise be affected
Data on incidence of plant pests in field trials
Agency assessments 4 ; information on alternative
agricultural management options
Mammalian toxicity assay
Half-life of protein under soil conditions
Agency assessments; information on alternative
agricultural management options with respect to
pesticide use
Agency assessments; data on effective dosage
compared with protein expression in the plant;
information on target insect biology and behavior
1 “Data” refers to original data, in the form of formal or informal observations, submitted by the applicant.
2 “Information” refers to information that is not typically generated by the applicant (i.e., not original data), typically public information
from the scientific or agronomic literature.
3 All three agencies evaluate molecular characterization data. FDA and USDA-APHIS examine plant composition. FDA and EPA evaluate
allergenicity potential of the expressed protein(s).
4 “Agency assessments” signify a particular reliance on agency risk assessment expertise and information that is not generated by the
applicant.
APHIS, Animal and Plant Health Inspection Service; ELISA, enzyme-linked immunosorbent assay.