Applying for permits to import flies carrying transgenic constructs with sequences from plant pests
Updated October 25, 2013
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Overview

If you are importing transgenic Drosophila carrying sequences from a plant pest, you will need to provide detailed descriptions of the constructs and you will not be able to use the “Routine Drosophila Transgenic Constructs” attachment described in the instructions for importing routine constructs.

To import transgenic strains with plant pest sequences, you actually need two permits:  an Import Permit and an Interstate Movement Permit.  The e-permit applications for the two permits are almost identical, so once you’ve been through the Import Permit application, the Interstate Movement application will look very familiar.

Each Import or Interstate Movement permit for transporting transgenic strains carrying plant pest sequences may be used for a single shipment. You will receive only one import label per application. See What should I do with permits once I receive them?

Instructions for the Import Permit application

1. Go to Permits Log In page.

2. On eAuthentication page, type in 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 “No. I am applying for a standard 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 standard permit with no Confidential Business Information. 

15. On the “Application” page, choose “Traditional” from the “Purpose of Permit” pull-down menu. Type “Postal or Courier Service ” in the “Means of Movement” box. Click “No” to the question “Have you previously applied for variance(s) that you wish to apply to this permit?” Click “Continue”.

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

17. On the “Article” page, choose “Drosophila melanogaster” from the drop-down menu to fill in 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. Type “Artificial medium” in the box under “Any biological material (e.g., culture medium or host material) accompanying the regulated article during movement”. Though it’s an oversimplication, fill in the name of the country from which you’re getting the flies for “Country and locality where the donor organism, recipient organism, and vector or vector agent were collected, developed, and produced”. Click “Continue”.

18. On the “Article Supplier/Developer Summary” page, click “Add”. On the "Article Supplier/Developer - United States Verification" page, click "No. The person who developed and/or supplied the regulated article for this permit resides outside the United States". Click "Continue". On the "Article Supplier/Developer" page, fill in the required fields for the person sending you flies and click "Continue". On the "Article Supplier/Developer Summary” page, click “Done".

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

20. On the “Phenotypic Designation” page, type the name of the first transgenic construct you wish to import in the “Constructs” box. Type “Direct injection” into “Mode of transformation” box. Under “Phenotypic description” give a description of the phenotypic effects of the transgenic construct. This should be a description of the effects of the plant pest sequence, not a description of transformation markers such as miniwhite. If the plant pest sequence is expressed conditionally (as under heat shock or UAS control) and is not expressed in the flies you wish to import, indicate this explicitly. Provide published references if possible. Click “Continue”.

21. On the “Phenotypes” page, you may add as many phenotypes that apply to the construct as you wish. First select a “Phenotype category” from the left pull-down menu and a “Phenotype” from the pull-down menu that will appear when you click the “…” button. Different “Phenotype” pull-down menus appear for each “Phenotype category” chosen. If you wish to add multiple phenotypes, click “Add” after each phenotype chosen. When you are finished adding phenotypes, click “Continue”.

22. On the “Genotype” page, select a category that describes the plant pest sequence from the pull-down menu obtained from clicking the “…” button. In most cases, this will be “Gene of Interest”. Click “Continue”

23. On the “Construct Components” page, fill in each box as needed using the terms in the pull-down menus (the “…” buttons) whenever possible. After entering details for a construct component, you click “Add to Construct Components”. You will be given the opportunity to repeat the process for other construct components. When the construct has been described completely, click “Continue”.

If the construct carries unique sequences in an otherwise routine vector, you should describe unique sequences on this page and, rather than describing each component of the routine vector, you should copy the URL for the FlyBase description of the vector into the “Construct Component Detailed Description” box with an explanation. For example, you would cite http://flybase.net/reports/FBtp0000354.html for a P{UAST} construct. The point of the process is to document the components of the construct so that BRS can evaluate them. 

24. The “Phenotypic Designation Summary” page will appear. You have the choice to describe another construct by clicking “I want to enter a new genotype for this designation” or to choose “I am done entering all the phenotypic designation(s) for this permit application.” Click continue.

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

26. On the “Point of Origin” page, provide the required information for the institution from which you will receive the shipment and click “Continue”.

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

28. 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”.

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

30. Click "Continue" for the “Not Applicable” pages until you get to the “Destination or Release Description” page. Here, you must indicate that the transgenic flies will not be released into nature. Most investigators will include a statement similar to this:

“The transgenic Drosophila strain(s) will be received and bred under standard laboratory conditions at the applicant’s institution. They will not be released intentionally. Descendants of the imported sample may be provided to colleagues at other institutions.”

31. The “Confinement Protocols” page will include a statement similar to the following:

“The transgenic Drosophila strain(s) will be reared under standard laboratory conditions at the applicant’s institution using routine biosafety practices. The strains will be transported to the applicant’s institution in containers conforming to international postal regulations for the mailing of insect samples.”

32. On the “Final Disposition” page, choose “Destruction/Devitalization” for “Final Disposition Method”. The “Final Disposition Description” box will include a statement similar to the following:

“Progeny of the imported sample(s) of transgenic Drosophila will be destroyed according to standard laboratory practice, which includes freezing, desiccation and autoclaving.”

33. The “Supporting Documents” page allows you to attach any files you wish to use to support your application.

34. 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.

Instructions for the Interstate Movement Permit application

1. Go to Permits Log In page.

2. On eAuthentication page, type in 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”.

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

11. On the “Courtesy Permit Verification” page, choose “No. I am applying for a standard permit.” Click “Continue”.

12. On the “BRS Permit Introduction Type” page, choose “Interstate Movement”. 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 an Interstate Movement Standard Permit with no Confidential Business Information. 

15. Continue from Step 15 of Instructions for the Import Permit application above.