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Biological Material Transport & Transfer Documentation: Material Transfer Agreements Transport Permits (Import, Export, Domestic) www.ehso.emory.edu Click.

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Presentation on theme: "Biological Material Transport & Transfer Documentation: Material Transfer Agreements Transport Permits (Import, Export, Domestic) www.ehso.emory.edu Click."— Presentation transcript:

1 Biological Material Transport & Transfer Documentation: Material Transfer Agreements Transport Permits (Import, Export, Domestic) Click Here to Begin Click Here to Begin 1

2 Instructions Use the buttons at the bottom of the screen to navigate through this training tool 2 Next Slide Previous Slide More Information More Information Exit Program Click this button to see a page full of external links Click this button to see the last slide you viewed Click the house to go back to the first slide Click this button to see the next slide Click this button exit the training tool Click here to learn more Click here to learn more Click here to learn more Click here to learn more Click on boxes like this to answer questions and learn more about a topic Click on “Next Slide” to get started!

3 Course Objectives 3 Shipping Training Requirements Material Transfer Agreements Transport Permits Sending Material Receiving Material Domestic Transport International Transport Import Export This tool was developed to assist you in determining what documentation you need for sending or receiving biological material. Depending if you are sending or receiving material, this tool will guide you through the following topics: Next Slide Previous Slide More Information More Information Exit Program

4 Let’s go through a few questions to see what types of documentation / permits you need for your biological material… 4 Next Slide Previous Slide More Information More Information Exit Program

5 Before we get started, have you or someone in your lab completed Shipping of Infectious Agents & Biological Materials Training within the past 2 years? Previous Slide More Information More Information Exit Program Click on one answer… YES NO 5

6 Are you sending or receiving biological material? Previous Slide More Information More Information Exit Program I’m sending it! I’m sending it! I’m sending it! I’m sending it! I’m receiving it! I’m receiving it! I’m receiving it! I’m receiving it! Click on one answer… 6

7 Previous Slide More Information More Information Exit Program IMPORTANT If you are shipping infectious agents and/or biological material, you MUST be trained once every 2 years EHSO offers shipping training once a quarter Next Slide Click here for information about shipping training & upcoming training dates Click here for information about shipping training & upcoming training dates Click here for information about shipping training & upcoming training dates Click here for information about shipping training & upcoming training dates 7

8 Great! Let’s figure out what documentation and/or permits you need for your material! 8 Next Slide Previous Slide More Information More Information Exit Program

9 Are you sending or receiving biological material? Previous Slide More Information More Information Exit Program I’m sending it! I’m sending it! I’m sending it! I’m sending it! I’m receiving it! I’m receiving it! I’m receiving it! I’m receiving it! Click on one answer… 9

10 Great! You may need a Material Transfer Agreement. Previous Slide More Information More Information Exit Program Click here to learn more about MTAs and find out if you need one Click here to learn more about MTAs and find out if you need one Click here to learn more about MTAs and find out if you need one Click here to learn more about MTAs and find out if you need one 10

11 A contract between the owner of a material and the intended recipient governing the transfer and subsequent use of the material Used to transfer materials from one institution to another Examples: Material Transfer Agreements (MTA)  Bacteria  Plasmids  Cultures  Cell Lines  Nucleotides  Transgenic Animals  Proteins  Pharmaceuticals Next Slide Previous Slide More Information More Information Exit Program 11

12 MTA - Outgoing MTA does not need to go through the Office of Technology Transfer (OTT) if all of the following apply: 1. Material is provided to a non-profit institution 2. Material was not developed using research funding (having intellectual property provisions) from an industrial sponsor, foundation, or other similar source 3. Material has not been, nor is it expected to be, the subject of an invention disclosure or other potentially valuable intellectual property If all of the above conditions apply:  PI can use the Uniform Biological Transfer Agreement (UBMTA) Implementing Letter If any of the above conditions do not apply:  MTA must be handled through OTT Next Slide Previous Slide More Information More Information Exit Program 12

13 UBMTA Implementing Letter A simple letter agreement for the transfer of non-proprietary biological material Copies of the letter should be printed and signed by the provider of material and sent to the recipient The recipient should sign the letter and receive an institutional signature A list of all institutions that may sign a UBMTA letter are available on the Association of University Technology Managers (AUTM) website  If the receiving institution is not listed, notify OTT Next Slide Previous Slide More Information More Information Exit Program 13 Click here to link to the UBMTA Implementing Letter Template Click here to link to the UBMTA Implementing Letter Template Click here to link to the AUTM website Click here to link to the AUTM website

14 Providing PI should:  Notify OTT  Provide OTT with necessary information and documentation to ensure that OTT can negotiate a timely and suitable MTA Outgoing MTAs through OTT Next Slide Previous Slide More Information More Information Exit Program 14 Click here to link to the OTT website Click here to link to the OTT website

15 Now, let’s see if you need a transport permit. Where are you sending the biological material? Previous Slide More Information More Information Exit Program Within the US Within the US Within the US Within the US Outside of the US Outside of the US Outside of the US Outside of the US Click on one location… 15

16 Great! You may need a Material Transfer Agreement. Previous Slide More Information More Information Exit Program Click here to learn more about MTAs and find out if you need one Click here to learn more about MTAs and find out if you need one Click here to learn more about MTAs and find out if you need one Click here to learn more about MTAs and find out if you need one 16

17 A contract between the owner of a material and the intended recipient governing the transfer and subsequent use of the material Used to transfer materials from one institution to another Examples: Material Transfer Agreements (MTA)  Bacteria  Plasmids  Cultures  Cell Lines  Nucleotides  Transgenic Animals  Proteins  Pharmaceuticals Next Slide Previous Slide More Information More Information Exit Program 17

18 All incoming MTAs must be forwarded to the Office of Technology Transfer (OTT) for approval along with a completed MTA questionnaire Incoming MTAs Next Slide Previous Slide More Information More Information Exit Program 18 Click here to link to the Incoming MTA Questionnaire Click here to link to the Incoming MTA Questionnaire Click here to link to the OTT website Click here to link to the OTT website

19 Now, let’s see if you need a transport permit. Where are you receiving the biological material from? Previous Slide More Information More Information Exit Program Within the US Within the US Within the US Within the US Outside of the US Outside of the US Outside of the US Outside of the US Click on one location… 19

20 Great! You may need an import permit. Previous Slide More Information More Information Exit Program Click here to learn more about import permits and find out if you need one Click here to learn more about import permits and find out if you need one Click here to learn more about import permits and find out if you need one Click here to learn more about import permits and find out if you need one 20

21 Who Regulates Importation? Center for Disease Control and Prevention (CDC):  Etiologic Agent Import Permit Program United States Department of Agriculture (USDA) / Animal Plant and Health Inspection Service (APHIS) / Veterinary Service (VS):  Plants Protection and Quarantine (PPQ) 526 Permit  Biotechnology permits  Live animal import permits  Animal product import permits United States Fish and Wildlife Service Next Slide Previous Slide More Information More Information Exit Program 21

22 USPHS 42 CFR - Part Items requiring a CDC import permit:  Etiologic Agents  Any infectious agent known or suspected to cause disease in humans  Biological Materials  Unsterilized specimens of human and animal tissues containing an infectious or etiologic agent  Hosts and Vectors  Any animal known or suspected of being infected with an organism capable of causing disease in humans  All live bats  Any living arthropod infected with an etiologic agent  Snail species capable of transmitting a human pathogen CDC Etiologic Agent Import Permit Program Next Slide Previous Slide More Information More Information Exit Program 22

23 What does not require a CDC import permit?  Non-infectious material (formalin fixed specimens, non-infectious human stem cells or organs for transplantation)  Human and animal diagnostic specimens (blood, urine, tissues) where there is no evidence of an etiologic agent  Laboratory rats, mice, and hamsters reared under specific pathogen-free conditions  Genetically modified animals provided that they are not infectious to humans  Full taxidermied or treated non-human primate trophies, skins, or skulls CDC Etiologic Agent Import Permit Program Next Slide Previous Slide More Information More Information Exit Program 23

24 If you need a CDC import permit complete the import application form  Link to CDC Import Application Form Link to CDC Import Application Form If you are importing material that does not require a CDC import permit, CDC advises to include a signed statement, on official letterhead, from the person responsible for the shipment of this material with the following information:  A description of the material  A statement that this material meets one of the previously listed criteria  Verification that the material has been packaged, labeled, and transported in accordance with all applicable regulations CDC Etiologic Agent Import Permit Program Next Slide Previous Slide More Information More Information Exit Program 24

25 Required for the importation of:  Plant pests  Plant feeding insects, mites, snails, slugs, and plant pathogenic bacteria, viruses, fungi, etc.  Biological control organisms of plant pests and weeds  Bees  Parasitic plants  Federally listed noxious weeds  Soil for the purpose of isolating or culturing microorganisms from the soil See the USDA website for more information and instructions on how to obtain a permit USDA/APHIS/VS: PPQ 526 Permit Next Slide Previous Slide More Information More Information Exit Program 25 Click here to link to the USDA/APHIS /VS Biotechnology Permit Program website Click here to link to the USDA/APHIS /VS Biotechnology Permit Program website

26 A Biotechnology Permit is required for the importation of genetically engineered organisms that pose a plant pest risk, including plants, insects, or microbes USDA/APHIS/VS: Biotechnology Permits Next Slide Previous Slide More Information More Information Exit Program 26 Click here to link to the USDA/APHIS/VS Biotechnology Permit website Click here to link to the USDA/APHIS/VS Biotechnology Permit website

27 USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials Materials which require a permit include:  Animal tissues, blood, cells or cell lines of livestock or poultry origin  RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species  Certain polyclonal antibodies and antisera  Bulk shipments of test kit reagents  Microorganisms including bacteria, viruses, protozoa, and fungi Exceptions to this requirement are human and non-human primate tissues, serum, and blood USDA/APHIS/VS: Animal Product Import Permits Next Slide Previous Slide More Information More Information Exit Program 27 Click here to link to the USDA/APHIS/VS Animal Product Permit Program website Click here to link to the USDA/APHIS/VS Animal Product Permit Program website

28 Due to the vast variety of animals, go directly to the USDA/APHIS website for animal specific regulations, guidelines, and protocols pertaining to importation USDA/APHIS/VS: Live Animal Import Permits Next Slide Previous Slide More Information More Information Exit Program 28 Click here to link to the USDA/APHIS/VS Live Animal Permit Program website Click here to link to the USDA/APHIS/VS Live Animal Permit Program website

29 50 CFR Part 14 The US Fish and Wildlife Service regulates the importation of animals and plants The following laws and treaties require permits for importation:  Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)  Endangered Species Act  Injurious Wildlife (Lacey Act)  Marine Mammal Protection Act  Migratory Bird Treaty Act  Wild Bird Conservation Act US Fish & Wildlife Service: Import Permits Next Slide Previous Slide More Information More Information Exit Program 29

30 To determine if a US Fish and Wildlife Service import permit is required and how to obtain a permit, see the US Fish and Wildlife Service website US Fish & Wildlife Service: Import Permits Next Slide Previous Slide More Information More Information Exit Program 30 Click here to link to the US Fish and Wildlife Service Permit Program website Click here to link to the US Fish and Wildlife Service Permit Program website

31 Now you should have a better idea about what documents/permits you need! Click here for links to more resources Click here for links to more resources Click here for links to more resources Click here for links to more resources Click here to exit Click here to exit Click here to exit Click here to exit Previous Slide More Information More Information Exit Program 31

32 Shipping outside the US? You may need an export controls license. Previous Slide More Information More Information Exit Program Click here to learn more about export controls Click here to learn more about export controls Click here to learn more about export controls Click here to learn more about export controls 32

33 Exports are regulated in the US by:  US Department of State - Directorate of Defense Trade Controls:  International Traffic in Arms Regulations (ITAR)  US Department of Commerce - Bureau of Industry and Security:  Export Administration Regulations (EAR)  US Department of Treasury - Office of Foreign Assets Controls  OFAC The export regulations are intended to control access to certain technology, agents, military equipment, etc. that could be used by terrorists, drug cartels, rogue regimes, and others who may want to harm the U.S. or violate its laws and treaties Export restrictions under ITAR, EAR, and OFAC may apply to research activities and may require an export license Export Controls Next Slide Previous Slide More Information More Information Exit Program 33

34 What falls under the fundamental research exclusion?  “Basic and applied research in science and engineering when the resulting information is ordinarily published and broadly shared within the scientific community”  EAR What does not fall under the fundamental research exclusion?  Research that is “proprietary”, i.e., restricts publication and other forms of sharing research results  Industrial development, design production, and product utilization  Such activities usually restrict dissemination of research results for proprietary or national security reasons. NOTE: The fundamental research exclusion only applies to technical data/information; it does not apply to equipment or commodities. Fundamental Research Exclusion Next Slide Previous Slide More Information More Information Exit Program 34

35 Will I need a license? In most cases, an export license will not be required. There are a number of license exceptions that may apply to the shipment of many biological and chemical agents outside of the US BUT, we have to be able to show that we have screened the specific agent being shipped outside the US for compliance with US export controls laws and regulations. And, we have to document our use of any of the available license exceptions 35 Next Slide Previous Slide More Information More Information Exit Program

36 If it is determined that a license will be required, substantial time should be built into the project plan to accommodate the license application process  This process can take several weeks, even months, depending upon the agency and the nature of the export If a license is granted, the conditions of the license for the export activity must be carefully observed If a license application is denied, that activity, export or deemed export, is prohibited If you need an Export License Next Slide Previous Slide More Information More Information Exit Program 36

37 The penalties for noncompliance are quite severe:  The civil penalty fines for violation of these regulations is $250,000 per occurrence  The criminal penalty amounts are $1,000,000 per occurrence and/or imprisonment Export - Penalties for Non-Compliance Next Slide Previous Slide More Information More Information Exit Program 37 Click here to link to the ORC website for more information on export permits Click here to link to the ORC website for more information on export permits

38 Who do I contact about export controls? 38 Click here to find the export controls coordinator for your school or unit Scroll down to the bottom of the web page Click here to find the export controls coordinator for your school or unit Scroll down to the bottom of the web page Next Slide Previous Slide More Information More Information Exit Program

39 Now you should have a better idea about what documents/permits you need! Click here for links to more resources Click here for links to more resources Click here for links to more resources Click here for links to more resources Click here to exit Click here to exit Click here to exit Click here to exit Previous Slide More Information More Information Exit Program 39

40 Great! You may need a domestic transport permit. Click here to learn more about domestic transport permits and find out if you need one Click here to learn more about domestic transport permits and find out if you need one Click here to learn more about domestic transport permits and find out if you need one Click here to learn more about domestic transport permits and find out if you need one Previous Slide More Information More Information Exit Program 40

41 United States Department of Agriculture (USDA) / Animal Plant and Health Inspection Service (APHIS) / Veterinary Service (VS):  Plants Protection and Quarantine (PPQ) 526 Permit  Biotechnology permits  Live animal import permits  Animal product import permits Who regulates domestic transport? Next Slide Previous Slide More Information More Information Exit Program 41

42 Required for the interstate movement of:  Plant pests  Plant feeding insects, mites, snails, slugs, and plant pathogenic bacteria, viruses, fungi, etc.  Biological control organisms of plant pests and weeds  Bees  Parasitic plants  Federally listed noxious weeds  Soil for the purpose of isolating or culturing microorganisms from the soil See the USDA website for more information and instructions on how to obtain a permit USDA/APHIS/VS: PPQ 526 Permit Next Slide Previous Slide More Information More Information Exit Program 42 Click here to link to the USDA/APHIS/VS PPQ 546 Permit Program website Click here to link to the USDA/APHIS/VS PPQ 546 Permit Program website

43 A Biotechnology Permit is required for the domestic transport of genetically engineered organisms that pose a plant pest risk, including plants, insects, or microbes USDA/APHIS/VS: Biotechnology Permits Next Slide Previous Slide More Information More Information Exit Program 43 Click here to link to the USDA/APHIS/VS Biotechnology Permit Program website Click here to link to the USDA/APHIS/VS Biotechnology Permit Program website

44 USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials Materials which require a permit include:  Animal tissues, blood, cells or cell lines of livestock or poultry origin  RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species  Certain polyclonal antibodies and antisera  Bulk shipments of test kit reagents  Microorganisms including bacteria, viruses, protozoa, and fungi Exceptions to this requirement are human and non-human primate tissues, serum, and blood USDA/APHIS/VS: Animal Product Permits Next Slide Previous Slide More Information More Information Exit Program 44 Click here to link to the USDA/APHIS/VS Animal Product Permit Program website Click here to link to the USDA/APHIS/VS Animal Product Permit Program website

45 Due to the vast variety of animals, go directly to the USDA/APHIS/VS website for animal specific regulations, guidelines, and protocols pertaining to domestic transport USDA/APHIS/VS: Live Animal Permits Next Slide Previous Slide More Information More Information Exit Program 45 Click here to link to the USDA/APHIS/VS Live Animal Permit Program website Click here to link to the USDA/APHIS/VS Live Animal Permit Program website

46 Now you should have a better idea about what documents/permits you need! Click here for links to more resources Click here for links to more resources Click here for links to more resources Click here for links to more resources Click here to exit Click here to exit Click here to exit Click here to exit Previous Slide More Information More Information Exit Program 46

47 More Information 47 Previous Slide More Information More Information Exit Program Office of Technology Transfer (MTAs) Office of Technology Transfer (MTAs) Office of Research Compliance (Export Permits) Office of Research Compliance (Export Permits) Environmental Health and Safety Office Environmental Health and Safety Office Emory Links: External Links: CDC: Etiologic Agent Import Permit Program CDC: Etiologic Agent Import Permit Program USDA/APHIS/VS: Live Animal Permit Program USDA/APHIS/VS: Live Animal Permit Program USDA/APHIS/VS: Biotechnology Permit Program USDA/APHIS/VS: Biotechnology Permit Program USDA/APHIS/VS: PPQ 546 Permit Program USDA/APHIS/VS: PPQ 546 Permit Program US Fish and Wildlife Service Permit Program US Fish and Wildlife Service Permit Program USDA/APHIS/VS: Animal Product Permit Program USDA/APHIS/VS: Animal Product Permit Program


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