Courtesy Permits for non-regulated organisms
Biotechnology Regulatory Services (BRS) issues courtesy permits for non-regulated organisms upon request in order to facilitate their movement, which might otherwise be impeded because of the similarity of the organism to other regulated organisms. A genetically engineered organism is considered a “regulated article” if the donor organism, recipient organism, vector or vector agent used in engineering the organism belongs to one of the taxonomic groups listed in 7 CFR part 340 and is also a plant pest, or if there is a reason to believe it is a plant pest. Since most transgenic Drosophila melanogaster developed for research purposes do not contain genetic sequences from plant pests and are themselves not considered plant pests, most transgenic Drosophila melanogaster do not require permits from BRS for their movement. However, shipments manifested as “fruit flies” have raised agricultural and environmental concerns because this common name also refers to plant pests like the Mediterranean and oriental fruit flies.
In the past, APHIS has accepted courtesy permit applications for importations of non-regulated Drosophila melanogaster that were based upon a template of a partially-completed APHIS Form 2000. As of January 1, 2008, applications based upon this template will no longer be accepted to issue a courtesy permit. BRS is requiring applicants requesting a courtesy permit for Drosophila melanogaster importations to apply through e-permits or to fully complete and submit an APHIS Form 2000 with all required information, including details of the inserted construct. This information is necessary for BRS to confirm that the transgenic Drosophila melanogaster are not regulated articles before issuing a courtesy permit. For additional information, please contact email@example.com.