Applying for a permit to import flies with routine transgenic constructs lacking plant pest sequences
Updated October 25, 2013
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Overview

The e-permit application forms were designed for you to describe in detail every sequence component in every transgenic construct you wish to import. To simplify the application process, BRS is allowing Drosophila researchers to attach a standardized file to the application to document sequence components. We have worked with BRS to create an attachment that will cover the majority of shipments of transgenic Drosophila strains lacking plant pest sequences. If this attachment accurately describes the transgenic constructs in your shipment, you will not need to describe individual sequence components in the application. If additional sequence components are present in your constructs that are not described by this attachment, you must detail these components in the application.

If you wish to import Drosophila with transgenic constructs carrying plant pest sequences, you cannot use these directions or the attachment; instead, you should follow the directions at Applying for permits to import flies carrying transgenic constructs with sequences from plant pests.

Instructions for the e-permit system

1. Go to Permits Log In page.

2. On eAuthentication page, type in your User ID and Password. If you have not yet registered, see Registering to use the Biotechnology Regulatory Services e-permit system.

3. On “Welcome to ePermits” page, click “Create Application”.

4. On “Choose Program Offices”, choose “Biotechnology Regulatory Services” and click “Continue”.

5. On “Choose Application types for BRS” page, choose “BRS Permit” and click “Continue”.

6. Read “Welcome to BRS Permit” page and click “Continue”.

7. Read “Select Agent Confirmation” page. Select agents are specific biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health. Very few Drosophila transgenic constructs contain select agent DNA sequences and most researchers will choose “No. This is NOT an application to move or import select agents…..” and then click “Continue”.

8. On the "Submission Method" page, select "Web entry form" and click "Continue".

9. On the “Application Ownership” page, most investigators will choose “Yes. I will sign the application, and I am responsible for regulatory compliance related to this BRS Permit” and then click “Continue”.

10. On the “Select New, Amendment, or Renewal” page, select “New” and click “Continue”.

11. On the “Courtesy Permit Verification” page, choose “Yes. I am applying for a courtesy permit.” Click “Continue”.

12. On the “BRS Permit Introduction Type” page, choose “Importation”. Click “Continue”.

13. On the “Confidential Business Information (CBI) Verification” page, most academic investigators will choose “No” to the question “Does this application contain Confidential Business Information?” (If you are doing commercial research and your application qualifies for CBI treatment, you can figure out for yourself all the special stuff you need to do if you click “Yes” on this page…..)

14. On the “BRS Permit Type Verification” page, choose “Yes” to verify that you are applying for a Courtesy Permit with no Confidential Business Information. 

15. On the “Application” page, choose “Traditional” from the “Purpose of Permit” pull-down menu. In the "Means of movement" box, type "Postal or Courier Service". In the “Courtesy Justification” box, paste the following statement and click “Continue”.

"The genetically engineered Drosophila strains described in this application do not meet the definition of a regulated article under 7 CFR 340, because they are not plant pests, do not express DNA sequences from a plant pest and expression of the DNA sequences in the transgenic constructs will not make them plant pests. Nontransgenic strains may also be part of this shipment."

16. On the “Applicant” page, fill in the required fields and click “Continue”.

17. On the “Article” page, type “Drosophila melanogaster” (unless you’re importing other Drosophila species carrying transgenic constructs) into the “Scientific name” box. Type “Pomace fly” in the “Common name” box. (Don’t use “Fruit fly”.) Leave the “Cultivar and/or Breeding Line” box blank. Click “Continue”.

18. On the “Article Supplier/Developer Summary” page, click “Done”.

19. On the “”Phenotypic Designations” page, click “Add”.

20. On the “Phenotypic Designation” page, type “As described in attachment” in the “Constructs” box. Type “Direct injection” into “Mode of transformation” box. Click “Continue”.

21. On the “Phenotypes” page, select “OO” from the “Phenotype category” pull-down menu and “Transposon inserted” from the “Phenotype” menu. Click “Continue”.

22. On the “Genotype” page, type “As described in attachment” in the box. Click “Continue”.

23. On the “Construct Components” page, type “As described in attachment” in all four boxes. Click “Add to Construct Components”.

24. When the “Construct Components” page reappears, click “Continue” and proceed to Step 25 if all sequence components are adequately described in the attachment. If you need to describe additional sequence components, fill in the boxes on the “Construct Components” page for the first component and then click “Add to Construct Components”. Repeat until all additional components have been described and then click “Continue”.

25. On the “Phenotypic Designation Summary”, choose “I am done entering all the phenotypic designation(s) for this permit application” and click “Continue” unless you wish to elaborate on the additional components you may have added. If you wish to provide additional information, follow the directions on the form.

26. On the “Importation Locations Summary” page, choose “Enter Point of Origin”. 

27. On the “Point of Origin” page, type “Various institutions” in the “Location name” box. Type the country of origin in the “Country” box. Click “Continue”.

28. On the “Importation Locations Summary” page, choose “Enter Destination”. 

29. On the “Importation – Destination” page, fill in address information for your lab. Enter the current date under “Proposed Start Date”. In the “Proposed End Date” box, type the same date three years later. (Permits are good for three years.) Under “Quantity”, enter the approximate number of culture vials in shipments you expect to receive; overestimating and including a margin of safety is acceptable. Under “Units of measure”, type “Culture vials”. Under “Material Types”, type "Eggs, larvae, pupae and adults”. Click “Continue”.

30. On the” Importation Locations Summary” page, click “Done entering locations”.

31. Click "Continue" for the “Not Applicable” pages until you get to the “Supporting Documents ” page. Download the pdf file titled “Attachment for e-permit application to import Drosophila carrying transgenic constructs lacking plant pest sequences” and attach it using the “Browse” button. Under “File Description”, type “Routine Drosophila Transgenic Constructs”. Click "Attach". IMPORTANT! BY ATTACHING THIS DOCUMENT, YOU ARE CERTIFYING THAT THE DOCUMENT ACCURATELY DESCRIBES THE DNA SEQUENCE COMPONENTS IN YOUR SHIPMENT. If additional sequence components are present that are not described by this document, they MUST be entered separately under steps 23 and 24 above.

32. When the "Supporting Documents" page reappears, click "Done" unless you wish to attach additional documents describing the transgenic strains you wish to import.

33. On the "Certify and Submit" page, click the “Certify and Submit" button.

34. The "Application Submitted" page will appear with an application number for your records. You may view the application or click "Home" to submit another application.

35. See What should I do with permits once I receive them?