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 request to CDC to import/move eggs

 Authorization from the state of California CDPH for exotic vector use

 

NDA Penn state and UC Irvine 

UCSD Shipping Permits

Biological Materials Permits

john Hopkins to UC, Irvine Interstate movement. A. Gambiae docking sites USDA interstate movement permit application preliminary review

 

 

Importation

Facility Inspection

Other

Comments

CDC

Need permit for importing from outside USA

Maybe / courtesy

 

https://www.cdc.gov/od/eaipp/importapplication/agents.htm

http://www.cdc.gov/od/eaipp/importApplication/

 

California Department of Public Health

Need to provide written request & receive written approval

None required

 

Law: California Health and Safety Code Section 116120

http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=116001-117000&file=116120 

Contact: Vicki Kramer, Vector-Borne Disease Section,

1616 Capitol Avenue MS 7307, P.O. Box 997413, Sacramento, CA 95899-7413

USDA/APHIS

Permit as a importation aid

Required for receiving transgenic mosquitoes from across state lines

 

https://www.aphis.usda.gov/aphis/ourfocus/biotechnology

https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/SA_Permits (look for transgenic insect tab)

Their primary focus is on animal / crop pathogens, but lack of a permit may stop shipments at customs.

USDA

For transgenic species

Yes

 

https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/SA_Permits (same site as above for export permit for some transgenic organisms.

 

USDA permits

MIT cheat sheet for permitting biological materials

 

Permits and Field work 

Duke Permits and Procedures for Field work

 

Guidelines for Shipping/Receiving Biological Materials

Unv Minn Guidelines

 

Permit to Import or Transport Etiologic Hosts or Vectors of Human Disease

Required for importation, interstate and intrastate transport of human pathogens. Expedites the package through customs.

 

Contact:

Centers for Disease Control and Prevention at 404-718-2093.

Materials such as blood, bodily fluid, animals, etc that come from areas of endemic infection should be permitted.

 

Takes 2 weeks to process, expires after movement of material occurs,

 

Examples of materials for permit: blood, serum or plasma from different countries unless verified to be virus free, dengue,

 

https://www.aphis.usda.gov/aphis/resources/permits

 

Apply for ePermit access and authenticate.   You may need to authenticate in person.

Fill out online questionnaire according to permit type and submit,.  You can check status https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_permits_notifications_and_petitions/sa_check_status

sample of status check

    

FDA and EPA would be for live mosquitoes.   The constructs should go through IBC and EHS locally, IATA...etc.

As of January 2017 the FDA defines GMO Mosquitoes as;

1. Examples of New Animal Drugs a. Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans. b. Products intended to prevent mosquito-borne disease in humans or animals.  (FDA)

     It recommends approvals from both agencies (FDA and EPA) to assure due diligence.


https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM533600.pdf

2. Example of Pesticide Products a. Products intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development)5 . (EPA)

https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/epas-regulation-biotechnology-use-pest-management#applying

 

 

UCI IRB does not have specific guidance for GMO mosquitoes, however it would expect documentation of community consent prior to any release.

 

 

 

 

 

 

 

You can email your approved documents to: UCI-Malaria-Initiative@uci.edu

 

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