USDA Inspection report 01/24/2017 No non compliant items identified. Pass
USDA VS inspection 11/09/2017 Pass , inspection report 93-R-0434 PASS
IBC Approval 06/11/2018 1999-471 Approved
IACUC inspection 10/23/2018 UC Irvine Pass
| ISSUING AGENCY | DOCUMENT TYPE | REFERENCE | DATE APPROVED | EXPIRATION DATE |
| CDC 12/21/2017 | Import Permit Policy Statement: Date and Conditions of the Import Permit (Section 71.54(d) of these regulations provides that the CDC permit is valid only for: (1) the time period and/or term indicated on the permit, and (2) only for so long as the permit conditions continue to be met.) "The requested vectors are not capable of transferring an infectious biological agent to a human if it is uninfected; therefore, an import permit is not required. " | 10252017-10037 | 6/11/14 | N/A |
| UCI-IACUC | Expression of Exogenous Genes in Mosquitoes | Protocol No. 1998-1411-9 | 3/10/16 | 3/9/19 |
| Centers for Disease Control & Prevention (CDC) | Permit to Import Infectious Biological Agents, Infectious Substances, and Vectors | PHS PERMIT NO. 2016-06-052 | 6/13/16 | 6/13/17 |
| UCI- Institutional Biosafety Committee | Expression of Exogenous Genes in Mosquitoes | IBC Protocol Number: 1999-471 | 10/4/16 | 10/3/19 |
| USDA-APHIS | ROUTINE INSPECTION - No non-compliant items identified during the inspection. | 1/24/17 | ||
| UCI Radiation Safety Committee | RADIATION USE AUTHORIZATION | RUA#: R 8906 | 3/17/17 | 3/31/20 |
| PATH | Material Transfer Agreement - frozen aliquots proprietary | Protocol No. 1998-1411-9 | 5/2/17 | 9/30/20 |
| NIAID | Collaboration Agreement HNIH Carolina Barillas-Mury proprietary | Protocol No. 1998-1411-9 | 5/2/17 | |
| USDA-APHIS (DARPA) | US Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors | Permit No. 135681 | 8/12/17 | 8/12/18 |
| USDA-APHIS | Application 17299032 for University of California, Irvine for Aedes (mosquito eggs) - Aedes aegypti Higgs (Submitted 26 Oct 2017) | Ref. No. 17299032 | 8/12/17 | 12/8/18 |
| USDA | Interstate Movement of Anopheles gambiae | PERMIT NO. 17-233-101m | 9/7/17 | 9/7/18 |
| UCI and PENN STATE | Non-disclosure Agreement (Processes, designs, sequences, data and findings related to CRISPR/Cas9 and its uses for genome editing and gene regulation) | NDA | 9/25/17 | |
| California Department of Public Health | Authorizing UCI the continued usage and importation of the new Aedes aegypti strain for vector control | Signed: Vicki Kramer, Chief of Vector-Borne Disease Section | 10/13/17 | |
| USDA inspection IACUC | Pre inspection prior to permit | 18-004-106m | 11/7/17 | at will |
| UCSD MTA TIGS | Material Transfer agreement for Anopheles gambiae and stephensi | MTA00009219 | 1/30/18 | |
| USDA-APHIS 01/17/2018m interstate only, notified CDPH if movement within state (intrastate) | DARPA Akbari Aedes aegypti eggs Vector 986G-pBac-Aedes-Ubiq (AAEL006511)-dCas9-VPR-p10-UTR-Opie2-dsRed Vector 986H-pBac-Aedes-AAEL011410 (AaKLC2)-dCas9-VPR-p10-UTR-Opie2-eGFP Vector 1002-pBac-3xp3-eGFP-UTR-AAEL010097-RGR-dmeFlightN-UVW-iSce1CutSite-XYZ-optimized-tdTomato_Attb-Modified Vector 1003-pBac-3xp3-tdTomato-AEEL010097-Cas9-HR5Ie1-XYZ-Sce1-Sce1-UVW-eGFP-UTR_attB-Modified | 18-004-106m | 2/2/18 | 2/1/19 |
| USDA John Hopkins University | Anopheles stephensi 44c LINE | 18-012-101m | 2/22/18 | 2/22/19 |
| USDA to UC Davis | Permit to Import Infectious Biological Agents, Infectious Substances, and Vectors | 136098 | 2/28/18 | |
| UCSD MTA DARPA | Material Transfer agreement for Aedes aegypti | MTA 94443 | 4/6/18 | |
| John Hopkins University (Fidel Zavala MD) | Trap P berghei CSP P vivax CS repeat | MTA | 4/17/18 | 4/18/19 |
| Leids University (Shahid Kahn) | Pf CelTOS (NF54), Pv CelTOS, Pf CSP (NF54-full), PvCSP variant 210 full, Pv CSP variant 247 full, Pf TRAP NF54, Pv TRAP, Pf CSP/TRAP NF4, Pv CSP/TRAP, Pv CSP/TRAP/CelTOS | MTA | 5/2/18 | |
| SLA | Pfs14M etal | MTA/SLA | 5/2/18 | |
| USDA (UCIMI)interstate only, notified CDPH if movement within state (intrastate) | pCO-6-pSL_attB_AgvasCas9DsRed_3xP3CFP (VASA) and (Nanos) interstate transport for injection at UMD X1 gambiae | 18-100-103m | 5/7/18 | 5/4/19 |
| Leidos.com (Gabriel Gutierrez) | PFCelTos (Hybridoma sequence for 3C3 clone) | MTA | 5/14/18 | |
| UCI/UCSD USDA Interstate to UMD | 80.9 Helper line to UMD for injection from UCI (vasa cas9) | 18-141-101m | 6/13/18 | 6/13/19 |
| UCI Outgoing to UCSD TIGS Ethan Bier | Material Transfer agreement for Anopheles stephensi (research lines) 80.9 docking site submitted 06/12/2018 | MTA | 6/27/18 | 6/27/18 |
| USDA UCI Outgoing to UMD | Stephensi docking site 80.9 | 18-163-113-m | 6/29/18 | 7/1/19 |
| USDA Outgoing and incoming UMD UCI | Stephensi lines UMD PENDING helper line | 18-165-104m | 7/23/18 | 7/23/19 |
| UCSD DARPA Akbari Out and In UMD for injection | Aedes Aegypti 1002B and 1003B | 181-191-103m | 7/25/18 | 7/31/19 |
| Letter from STP | Acceptance of year 1 proposal to UC Davis, sample collection | N/REFa 1191p.n.6/GMS/18 | 9/14/18 | 9/13/19 |
| UMD to and from UCI USDA | X1 and Good direction + pC0-19 and pC0-28 gambiae | 18-260-101 | 9/28/18 | 9/28/19 |
| UMD to UCI Interstae USDA | Good Direction gambiae pC0-6 | 180-256-103 | 10/2/18 | pending |
| UC Irvine /TIGS India (Items deemed commercially availble and no MTA required) | Plasmid GS62894-2 pET-26b(+)-311_AA Plasmid GS62894-3 pET-26b(+)-317_AA Plasmid GD26894-1 pET-26b(+)-m2A10-_AA | MTA | N/A | N/A |
| Department of Health & Human Services (DHHS) | Approval to import infectious biological agents, infectious substances or vectors | |||
| UC Davis BUA #311 | IBC BUA approval Analysis of host pathogen interactions in Drosophila and Mosquito and CRISPR based drives | 311 | 11/26/18 | 2/12/21 |
| USDA UC Davis | Permit to Import Infectious Biological Agents, Infectious Substances, and Vectors | 136098/app #18053016 | 11/24/18 | |
| IBC | UCI BUA | 1999-471 | 6/11/18 | 3/19/19 |
| UCSD Beir UCI MTA | 80.9 Helper line and 80.9 docking site | MTA | 1/11/19 | N/A |
| IACUC UCI AUP-18-189 | 3 year renewal IACUC Exongenous genes of mosquitoes | 18-189 | 1/16/22 | 1/16/22 |
| LOI (letter of Intent) | Union of Comoros Ministry of Health Solidarity Social Protections and Gender Promotion (vector control Comoro Islands) | 1/28/19 | ||
| USDA permit outgoing JHU | AgCd1(lines) gambiae GATES | 19-061-101m | 4/8/19 | 4/8/20 |
| USDA import permit | Ag Vasa helper line Institut de Biologie Moléculaire et Cellulaire, France | 19-093-104m | 4/19/19 | 4/19/20 |
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
| 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
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.
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)
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