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Shipping: Biological Materials Permits

This page is intended to serve as guidance and overview regarding import permits for shipments of diagnostic specimens, biological materials, or recombinant or synthetic nucleic acids.

Definition: A shipment importing, domestic transfers, or exporting, of biological materials may require permits from Center for Disease Control (CDC), United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Department of Commerce (contact Export Control) and U.S. Fish and Wildlife Service (FWS). The State of California may require additional permits for the importation of biological materials, for example from the California Department of Food and Agriculture for plant pests, and from the California Department of Public Health or California Department of Fish and Wildlife for importation of wild animals.

Note: the California Department of Fish and Wildlife is a distinct entity from FWS, and is also responsible for issuing additional in-state permits, including those for plant sampling and scientific collection. If you are proposing field research and are unsure if you need a permit, please reach out to EHSBIO@UCSD.EDU or iacuc@ucsd.edu.

Importing or Domestic Transfer Responsibilities

With shipping biological materials comes the responsibility to:

  • Identify if your material will require a federal permit for
    • Importation
    • Domestic transfer between states
  • Work with EH&S and Shipping Department for permit application and permitting process
  • Advise your collaborator/shipper of any needed permits
  • Submit complete documentation to obtain a permit
  • Arrange for any required on-site inspections
  • Complete shipping training
  • Receive the permit and follow all permit conditions
  • Appropriately ship and package materials

To help navigate the various permitting requirements for applicable regulatory agencies, here are some available resources:

Even if you think your material may be exempt from permitting requirements, please contact EHS Biosafety for assistance. EHS Biosafety is here to help you make determinations about permitting, and otherwise assist and inform you about the permitting process.

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Biological Materials Which Require a Permit

CDC Import Permits may be required for:

  • Infectious biological agent
  • Infectious substance
  • Vector - Any animals (vertebrate or invertebrate) or any noninfectious self-replicating system (e.g., plasmids or other molecular vector) or animal products that are known to transfer or are capable of transferring an infectious biological agent to a human.
  • Animals (species known or capable of transferring infectious agents)
  • Animal products (including hide, hair, skull, teeth, bones, or claws) from species known or capable of transferring infectious agents
  • Arthropods known to be capable of causing or vectoring human disease
  • Snails – Any freshwater snails (phylum Mollusca, class Gastropoda) capable of transmitting schistosomiasis.
  • Non-human primate or bat material (including diagnostic specimens)

USDA/APHIS permits may be required for interstate transport and import of:

  • All cultures or collections of organisms which may introduce or disseminate any contagious or infectious disease of livestock and poultry and their derivatives (DNA/ RNA, recombinants, inactivated/ attenuated).
  • Pathogens that can initiate or disseminate disease in livestock and poultry
  • Vectors that can serve as the carrier of or have been exposed to an infectious disease of livestock or poultry
  • Animal specimens from animals infected with pathogens or exposed to pathogens or vectors
  • Cell cultures exposed to organisms that cause disease in livestock or poultry
  • Human viruses and human vaccines intended for research use in livestock or poultry.
  • Attenuated live viruses and vaccine strains
  • Veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, other products of biological origin, specifically those derived from USDA-covered species
  • Fish pathogens
  • Regulated plants and plant products for consumption or propagation
  • Plants for planting such as nursery stock, small lots of seed, and post-entry
  • Plant products such as fruits and vegetable, timber, cotton and cut flowers
  • Protected plants and plant products such as orchids, and threatened and endangered plant species
  • Prohibited plant materials for research
  • Additional regulated materials including soil
  • Material which could be potentially injurious to livestock or agriculture in case of environmental release

U.S. Fish and Wildlife Service (FWS) issues permits under a variety of wildlife laws and international treaties to which the United States adheres. These include (but are not limited to):

  • Convention on International Trade in Endangered Species (CITES)
    • Regulated animal species or animal parts derived from those species (including diagnostic specimens such as serum, tissue, and urine)
    • Regulated plant species or plant parts derived from those species
    • A comprehensive list of species covered under CITES can be found in the CITES appendices
  • Endangered Species Act
  • Lacey Act
  • Marine Mammal Protection Act
    • Species and materials derived from marine mammal populations and their ecosystems (including bones and carcasses)
  • Migratory Bird Treaty Act

FWS may issue permits for import, interstate transport, or acquisition of a variety of wild plant and animal species, or parts derived thereof. Permitting requirements apply even in the case of species and samples being used for scientific research.

Apply for Permits

EH&S Biosafety Program is here to help you in every step of the application and permitting process. Part of our services are to offer support in working with these federal agencies. Here is a flow chart overview of the permitting process. Import Permit Flowchart

All permit applications must be submitted under the name of the Principal Investigator.

Permit applications for either CDC or UDSA/ APHIS may also include a site inspection and interview from the agency prior to approving the permit. If a site visit is requested, contact EHS Biosafety to assist with the site visit process. After completion of a site visit, the permitting agency will decide to issue a permit pending any identified corrective actions or conditions of approval.

All permits obtained by UCSD researchers should be submitted to the IBC by sending to ehsbio@ucsd.edu. The permit will be attached to the applicable BUA.

 

CDC Import permit application process:

If your material requires a CDC permit for importation, visit the  CDC Import Permit Program website and complete the  Permit to Import Biological Agents or Vectors of Human Disease or the  Permit to Import or Transport Live Bats.

The permit must be requested under the name of the Principal Investigator. Additional contact information provided in the application should be for personnel in the laboratory who are responsible for the material, and can answer pertinent questions about the material being shipped, from the CDC Import Permit Program, Customs and Border Protection agents, or the shipping company.

 

USDA/ APHIS Import or Domestic Transfer permit application process :

If your material requires an USDA/ APHIS permit, visit the  USDA/ APHIS Permits and Certification website and start the application using ePermits. ePermits is a web-based system that allows users to submit import /interstate movement/ transit/ release permit applications, track applications, apply for renewals and amendments, and receive copies of their permits.

The permit must be requested under the name of the Principal Investigator. Additional contact information provided in the application should be for personnel in the laboratory who are responsible for the material, and can answer pertinent questions about the material being shipped by USDA/ APHIS, Customs and Border Protection agents, or the shipping company.

 

U.S. Fish & Wildlife Service (FWS) Import or Domestic Transfer permit application process :

If your material requires an FWS permit, visit the U.S. Fish & Wildlife Service website for further instructions for obtaining the appropriate permit. Some examples of types of permits which are issued by FWS are listed below in the chart.

The permit must be requested under the name of the Principal Investigator. Additional contact information provided in the application should be for personnel in the laboratory who are responsible for the material, and can answer pertinent questions about the material being shipped by FWS, Customs and Border Protection agents, or the shipping company.

 

Types of Permits

This chart lists some types of permits which may be required to conduct your research. Please note this list is not comprehensive and is geared towards the types of permits more commonly encountered by researchers.

Centers for Disease Control and Prevention (CDC) United States Department of Agriculture/ Animal and Plant Inspection Service (USDA/APHIS) United States Fish and Wildlife Service (FWS)
Permit to Import Infectious Biological Agents, Infectious Substances, and Vectors. Plant Protection and Quarantine (PPQ)
  • PPQ 525A: Application for Permit to Receive Soil
  • PPQ 526: Application and Permit to Move Live Plant Pests or Noxious Weeds
  • PPQ 587: Application for Permit to Import Plants or Plant Products
  • PPQ 588: Application for Permit to Import Plants or Plant Products for Experimental Purposes
Export/Re-Export/Master File of Wildlife Samples and/or Biomedical Samples under the Convention on International Trade in Endangered Species (CITES)
Export/Re-Export of Plants and Plant Products under the Convention on International Trade in Endangered Species (CITES)
Introduction from the Sea under the Convention on International Trade in Endangered Species (CITES)
Veterinary Services (VS)
  • VS 16-3: Import Controlled Material or Transport Organisms or Vectors
  • VS 16-7: Supplemental Application Form (Supplemental to the VS 16-3)
  • VS 17-129: Application for Import or in Transit Permit (for Live Animals, Semen or Embryos)
  • (VS) APHIS: Application for United States Veterinary Biological Product Permit
Certificate of Scientific Exchange (COSE) under the Convention on International Trade in Endangered Species (CITES)
Captive-Bred Wildlife Registration (CBW)(U.S. Endangered Species Act) [ESA]
Import/Acquisition/Transport of Injurious Wildlife under the Lacey Act
Take/Import/Export of Marine Mammals for Public Display, Scientific Research, Enhancement, or Rescue/ Rehabilitation/Release Activities or Renewal/Amendment of Existing Permit (Marine Mammal Protection Act and/or ESA)
Import of Birds for Scientific Research or Zoological Breeding and Display under the Wild Bird Conservation Act (WBCA)
Biotechnology Regulatory Services (BRS)
  • BRS 2000: Application for Permit or Courtesy Permit for Movement or Release of Genetically Engineered Organisms
  • BRS Notification: Notification of Movement or Release of a Genetically Engineered Plant
Native Endangered & Threatened Species - Scientific Purposes, Enhancement of Propagation or Survival Permits (i.e., Recovery Permits) and Interstate Commerce Permits

Shipping Materials with a Permit

Once you have received your permit, the permit must be sent with the shipping documents as well as a copy kept with the shipper/receiver. Follow all restrictions or permit conditions listed in the permit. Remember that all accompanying paperwork including permits must be attached to the outside of the package so that it may be reviewed by customs and transportation officials.

UCSD strictly conforms to government regulations when transporting hazardous materials. All outbound shipments of infectious substances, diagnostic specimens, and other hazardous or biological materials must be processed by the Shipping Department.

Warning: Failure to comply with international and federal transportation regulations when shipping hazardous materials can result in civil penalties of $78,376 per occurrence, and additional criminal penalties may include up to 10 years of imprisonment  (49CFR 107.329-107.333).

For information on packaging and shipping requirements, contact the UCSD Shipping Department at ASK (login required). International collaborators may need training on their end to properly package shipments for importing into the US. Contact the Shipping Department outboundshipping@ucsd.edu for more information.

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