Transgenic Insect Permit Guidance

Information requirements for risk assessments may include:

Purpose and Description of the Transformation

1. Purpose & expression of inserted/altered genetic material?
   • Are there effects of the inserted material on other traits?
   • Does experience with similar constructs exist?
2. Description of genetic engineering methods & genes involved including transduction viruses, transposons, symbionts?
3. Phenotype, transgene, transposon stability over multiple generations?

Ecological Consequences of the Transformation

1. Horizontal movement of transgene, transposon, virus, symbiont to related species, parasites, predators?
2. Possible result if introduced trait fails?
3. Detection methods for presence or change in function of inserted/altered genes?
4. For mobile DNA elements or genetic driving factors, such as transposable elements, viruses, symbionts (Wolbachia), -- What is the known host range?
5. Likelihood of dissociation of the drive mechanism from gene of interest?
6. If natural selection is necessary to drive the trait in a population, what are selection criteria?

Biology of the Host Organism

1. What is the probability of establishment & movement of the GM arthropod? Are predictive models available?
2. Effects on biology & life cycle? Are there associated fitness costs?
3. Effects on invasive characteristics?
4. Possibility of effects on threatened or endangered species?
5. Effects on pesticide susceptibility?
6. Effects on disease transmission, pest or parasitic abilities, host range, host utilization?

Additional Useful Information May Include:

1. Net fitness supplied by the inserted transgene has been demonstrated in transgenic fish, and needs to be done with arthropods:
2. Juvenile viability (probability of survival to sexual maturity)?
3. Changes in adult viability (survival after sexual maturity)?
4. Mating advantage, female fecundity (number of offspring)?
5. Male fertility (male fertilization success)? Mating success?
6. Transgene effects on age at sexual maturity?

Still Other Information May be Required:

1. Development, validation, & deployment of monitoring measures and models to track releases & potential unintended or adverse effects?
2. Development of biological, chemical, & physical containments, limiting mechanisms, & other mitigation measures to reduce risks after environmental release?

Baseline Data Needed for Risk Assessment (Parental or Wild-type)

1. Taxonomy?
2. Geographic occurrence or range including habitats & climates?
3. Biology & life cycles in various habitats, climates and host range?
   • What is the ecology of the arthropod's occurrence?
   • Any dormant, hibernation, or estivation phases?
4. Means of movement?
5. Distribution of sexually compatible relatives?
6. Invasiveness, associated threatened or endangered species, & sexually compatible wild relatives?
7. Kinds of diseases vectored, pest, or parasite characteristics?
8. Associated parasites, predators, pathogens, symbionts, & commensals?

Baseline Data Needed for Risk Assessment (Gene Donor/Source or Source)

1. Taxonomy & distribution?
2. Biology?
3. Characteristics including whether a disease organism or toxin is produced?
4. Range of occurrence & function of genes of interest?
5. Description of genetic construct, associated regulatory sequences, & marker genes?
   • Are there undetermined sequences present in the genetic material of interest?
   • Are sequences present that are not necessary for the intended effect?

Risk Assessment of Genetically Modified Invertebrates/Arthropods that are Livestock (or, Farm-raised) Pests

1. Regulations & guidelines under development for livestock (not exclusively human) pests under AHPA
2. Regulations will include transgenic arthropods, vectors, parasites, & similar or allied organisms that are livestock pests (many, like mosquitoes, are also human pests & disease vectors)

Containment Guidelines for Transgenic Arthropods

Arthropod and other invertebrate containment guidelines may be found at the following locations:

• NIH Guidelines:http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
• Society of Tropical Medicine and Hygiene Arthropod Containment Guidelines: http://www.astmh.org/SIC/files/ACGv31.pdf

The APHIS, PPQ Containment Guidelines for Nonindigenous, Phytophagous Arthropods and their Parasitoids and Predators, Nonindigenous Snails, Plant Pathogenic Nematodes, and other organisms may be obtained by calling (301) 734-5304.