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Shipping Infectious Substances by Air

Effective October 1, 2014, Category A, Infectious Substance and Dry Ice shipping labels are changing. Old labels will no longer be accepted as follows:

New Labels:
New Category A labels may be acquired from companies that provide Dangerous Goods supplies or contact EHS (434-982-4911) for more information.

Download and print the new Dry Ice Label or contact FedEx at 1-800-GO-FEDEX to request free dry ice labels. Current information on FedEx's dry ice shipping requirements can be found here.

Regulations

University departments ship a variety of "hazardous materials," also termed dangerous goods including infectious substances, dry ice, other biologicals, and sometimes may need to ship chemical or radioactive materials. These shipments are highly regulated depending upon the material, the mode of transportation, the commercial carrier, and the destination.

The U.S. Department of Transportation (DOT) is the federal authority overseeing enforcement, and their authority extends beyond U.S. boundaries. The governing law is known as the Hazardous Materials Regulations (or HMR), and anyone who offers packages for shipment from the university must be aware of the requirements and receive proper training. The International Air Transport Associations (IATA) Dangerous Goods Regulations are also followed, overlapping with the HMR, in terms of air shipments.

Fines and Penalties

University faculty, staff and students can be subject to inspection by federal enforcement officers (e.g., FAA or PHMSA/DOT) and if an error is made, departments may be subject to warning letters or tickets for less serious offenses. Most often, violating the HMR results in civil penalties of up to $50,000 per violation, or up to $500,000 and imprisonment for up to 5 years for criminal violations.

Therefore, if you are shipping hazardous research-related equipment, infectious substances, patient specimens, dry ice or other hazardous materials, EHS can provide guidance and support services for the proper shipping of these materials. Researchers must also be cognizant of relevant import, export, permit, licensing (FDA) or transfer requirements (i.e., MTA) that involve their research materials.

The American Biological Safety Association (ABSA) provides frequently asked questions (FAQ) for Infectious Substance Shipping.

Contact List for Guidance on Shipping Hazardous Materials (Dangerous Goods)

 

*All shipments of chemical or radiological materials MUST be shipped by EHS personnel*

Shipment of Hazardous Materials (Dangerous Goods) is highly regulated. Environmental Health & Safety (EHS) is available to assist faculty, staff, and students who make hazardous material shipments. EHS can provide training, guidance and support services that will help ensure hazardous material shipments arrive at their destination in the safest way possible.

Unregulated materials on dry ice will also be shipped by EHS upon request. The lab will provide a PTAO to EHS to pay for shipping costs, which will be recovered from the lab via cost transfer. A FedEx account number will be requested for radiological packages.

Hazardous Materials
(Dangerous Goods)
Examples EHS Contacts Can be shipped by?
Hazardous Chemicals Flammables, corrosives, biotoxins1, laboratory reagents comprised of hazardous chemicals Mike Cohen
or
Ericka Pearce
at
434-982-4911
EHS personnel only
Dry Ice only
 
printable label (pdf)2
Unregulated biological materials (e.g., proteins, antibodies, DNA) that must be shipped frozen on dry ice Ericka Pearce
or
Jennifer Branum
at
434-982-4911
EHS personnel upon request
or
EHS trained shipper
(Download Dry Ice Training)
Radiological materials Radioligands, radioactively labeled materials, tissues, medical devices, instruments and articles etc. Mike Cohen
or
Trevor Thomas
at
434-982-4911
EHS personnel only

Infectious Substances or Other Biological Materials
 
printable label (pdf)2

Infectious microorganisms, viral vectors, human cell lines and other human derived materials
or
Other: Exempt Patient or Animal Specimens, GMO/GMMO or unregulated biologicals
Ericka Pearce
or
Jennifer Branum
at
434-982-4911
Trained shipper in lab or department
 
Online training is available, here.
 
Information on Shipping Infectious Substances by Air can be found here.

1Biotoxins (biologically-derived) or those that are from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances meet Category 6.1 classification and are hazardous chemicals that MUST be shipped by designated EHS personnel. Contact EHS before shipping any biotoxin.

2You may print and affix to your shipment using packing tape.

Shipping Infectious Substances

You will find the following on this page:

Training Requirements 

Only materials that are biological in nature can be shipped by university faculty, staff, and students. In order to satisfy the training requirement, EHS offers Shipping Infectious Substances Training (IATA/DOT) online. Trainees must:

  • Retain a training certificate for 2 years (provided by EHS).
  • Repeat training every 2 years if your job duties require you to ship.

Shipping Infectious Substances Training (IATA/DOT), click here to start online module.

In addition to the online training, EHS will provide in-person training for those groups (minimum of 10) who request in-person training.

Training for Dry Ice (no other infectious substances or dangerous goods included in the shipment) is available through EHS and can be found in a PDF download here.

Questions about training content: Ericka Pearce (eep3p) or Jennifer Branum (jmw4qs).

Computer or IT-related issues with online training modules: Jennifer Branum (jmw4qs).

What is Regulated? 

Biological Substance, Category A: Infectious substance known to contain or suspected of containing a pathogen (e.g., bacteria, viruses, rickettsiae, parasites, fungi, prions).

A specimen that is transported in a form that is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. For a complete list, refer to the EHS Shipping Infectious Substances training module (attachments can be downloaded and printed) or the IATA Dangerous Goods Regulations. Note that Category A microorganisms are almost exclusively in cultured form, with a few exceptions.

  • Examples: culture of Hepatitis B virus, culture of Coccidioides immitus, culture of E. coli (verotoxigenic strains), culture of Shigella dysenteriae type 1.

Special Requirements:

  • You must list Chemtrec 1-800-424-9300 as the emergency contact/24 hour number on the Shippers Declaration (this is in addition to the name and telephone number of the Responsible Person).
  • An SDS and a submission form (pdf or word) of the Category A material must be submitted to Mike Cohen or Ericka Pearce prior to shipping.
  • Pathogen SDS for Infectious Substances can be found here.
  • USPS, UPS, and many other domestic carriers do not ship Category A. FedEx in addition to other international carriers (DHL, World Courier) will accept Category A.
  • FedEx will only accept Shippers Declarations generated from pre-approved shipper proprietary software, a FedEx approved vendor software application, or FedEx Express Automated Shipping Solutions (FX-18) that have dangerous goods error checks.

Note: A list of approved dangerous goods shipping application vendors can be reviewed at www.fedex.com/us; dangerous goods (keyword); Saf-T-Pak also provides an online Shippers Declaration tool accepted by FedEx.

Biological Substance, Category B: Is an infectious substance which contains or is suspected to contain a pathogen and is in a form that is not found on the Category A List.

  • Examples:
    • Cultures of infectious microorganisms NOT on the Category A List (e.g., Salmonella typhimurium, Pseudomonas aeruginosa, Toxoplasma gondii)
    • Viral vectors (e.g., Adenovirus, HSV-1, Lentivirus)
    • Human or Non-human primate cell lines
    • Patient specimens (human or animal) with unknown or known pathogens present (e.g., human blood and its components, unfixed tissues)

Genetically-Modified Organisms/Microorganisms (GMO/GMMO): are non-pathogenic organisms or microorganisms whose genetic material has been intentionally altered in a manner (i.e., recombinant DNA techniques) that would not occur naturally. Pathogenic GMO/GMMO must be classified as either Category A or B. Replication defective vectors typically handled at BSL2 can be considered Category B.

  • Examples: Baculovirus, Bacteriophages, Murine retrovirus MoMuLV

GMO/GMMO are not regulated in the U.S. when transported by ground. IATA guidelines and UN 3245 apply for air shipments.

Exempt Patient and Animal Specimens: are patient specimens not likely to contain a pathogen. Although they fall under exemptions, it is not the same as "unregulated". Specific criteria have to be satisfied in order for the material to meet the exempt status. In determining the likelihood that a pathogen is present, professional judgment is based on known patient medical history, symptoms and individual circumstances of the source, and the human or animal endemic local conditions.

  • Specimens collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. These may include: excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g.,transwabs, culture media, and blood culture bottles) not likely to contain pathogens.
  • Live animals are not considered exempt; infected animals cannot be transported by air unless the infectious substance contained cannot be consigned by any other means. Contact the Center for Comparative Medicine (CCM) regarding the shipping of research animals.
  • Example: cheek swabs for DNA testing taken from healthy babies, blood or urine taken from healthy individuals for routine drug testing

All Exempt shipments must be prepared using triple packaging. An Exempt Specimen Guide is provided here (pdf or word).

Other Exemptions:

Biological Products: are those products derived from living organism that are manufactured and distributed in accordance with the requirements of appropriate national authorities, and are applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals. In the U.S., biological products must be approved by the Food and Drug Administration (FDA), Department of Health and Human Services (HHS) or United States Department of Agriculture (USDA).

  • Examples: Non-pathogenic viruses, therapeutic serum, anti-toxins, vaccines, etc.

Used Medical Devices: are those that have been in contact with a patient or clinical specimen (Category B or Exempt Human Specimen) and are being returned to the manufacturer for repair, sterilization, or evaluation. These devices must not have been in contact with a Category A Infectious substance. DOT uses the phrase "Used Healthcare Products" to designate these exempted materials.

  • Example: Implanted device removed from cancer patients with Hepatitis C and returned to manufacturer for evaluation.

What is not Regulated? 

Many research-related materials that are biologically-derived are not regulated. The following are not subject to the regulations, unless they meet the criteria for another type of dangerous good (e.g., contain a preservative, fixative).

  • Substances which do not contain infectious substances or unlikely to cause disease
  • Substances containing non-pathogenic microorganisms
  • Substances in which pathogens have been neutralized or inactivated
  • Environmental samples (e.g. food, water) which do not pose a significant risk of infection
  • Dried blood spots or faecal occult (blood detection)
  • Blood products to be used for transfusion or tissues and organs for transplantation
  • Examples: Purified proteins, monoclonal or polyclonal antibodies, certain plasmids and nucleic acids (RNA/DNA)*, fixed human tissues, non-infectious microorganisms such as E.coli K-12 or Saccharomyces cerevisiae, many animal and insect cell lines (not including human or NHP).

Other exempt biological or non-regulated materials may be subject to the regulations when shipped on dry ice or with preservatives from other classes of dangerous goods (e.g., ethanol, methanol, formalin, phenol). For shipments containing chemicals, contact Mike Cohen or Ericka Pearce.

International Shipments 

Shipping and receiving infectious or biohazardous agents, animal specimens, and genetically modified organisms may require the approval of federal agencies, both domestic and foreign. Regulations that govern the transfer of biological materials help to minimize or eliminate the possible threats to public health and agriculture.

  • An import/export permit may be required when shipping biological materials internationally.
  • Every international shipment needs a document called the Commercial Invoice, and most international carriers will assist with completing customs-related regulatory documents.
  • Template for a Commercial Invoice can be found here.

Note: While EHS shipping consultants make reasonable efforts to provide accurate and up-to-date information on permitting and customs compliance, these are separate from IATA shipping requirements and are the researcher’s responsibility to obtain. The FedEx International Reference Guide. provides assistance, or by calling 1-800-GO-FEDEX (choose Dangerous Goods, International options).

Importing Biological Materials 

In addition to the IATA Dangerous Goods Regulations, many import and/or customs regulations may apply to materials your lab is importing. Principal Investigators are required to apply for and maintain valid permits and may contact EHS Biosafety for information on obtaining the necessary permits.

These additional requirements take time, therefore it is advisable to allow at least 4-6 weeks to obtain either a USDA or CDC permit before making arrangement to receive shipments. Canada, Australia, and the EU have similar import regulations. Please verify with the receiving lab before you ship for country-specific importation rules.

Import Permits

CDC Permit to Import or Transport Agents or Vectors of Human Disease 

CDC permits are required, when importing into the United States, any known or suspected material capable of causing disease in humans or transferring an infectious biological agent to a human:

  • Microorganism or cultures
  • Any patient specimens (including blood and other blood components, other body fluids, unfixed tissues or body parts) known or suspected of containing pathogens and capable of causing disease in humans
  • Any animals (vertebrate or invertebrate) including arthropods
  • Any noninfectious self-replicating system (e.g., plasmids or other molecular vector)
  • Animal products (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws of an animal)
  • Field-collected specimens or environmental samples (e.g., soil, effluent, sediment)

CDC's Etiologic Agent Import Permit Program

OR

Use the E-tool to determine if you need a CDC Import Permit

USDA/APHIS Permits

Veterinary Permit (16-6) 

When importing or domestically transferring live animals or animal products, animal pathogens or materials containing pathogens that affect poultry, livestock, a plant pest, or plant biological agent a permit from the USDA Animal and Plant Health Inspection Service (APHIS) is needed. Please note that any material containing fetal calf serum or bovine serum may require an APHIS permit.

Note: an import permit may be required for interstate transfer (state to state, or to Hawaii) of USDA/APHIS regulated materials.

APHIS Import Permit Program

Plant Import Permits

Plant Protection and Quarantine (PPQ) regulates the importation of plants and plant products under the authority of the Plan Protection Act.

APHIS information on Plant Health Import Permits

Materials that do not require a USDA Import Permit 

These materials do not require a USDA import permit, but do require a guidance letter that will be reviewed by APHIS inspectors at the port of entry. The sending lab should provide a letter containing specific information (see below) about the material and should be easily accessible.

  • 1100 Human Pharmaceuticals and Human Vaccines Containing Animal Components
  •  
  • 1101 Human and Non-Human Primate Material (excluding cell cultures)
  •  
  • 1102 Feline and Canine Material
  •  
  • 1103 Live Laboratory Mammals and Their Material (for research purposes)
  •  
  • 1104 Amphibians, Fish, Reptiles, Shellfish and Aquatic Species(includes venom) Revised June 2011
  •  
  • 1105 Chemically Synthesized Materials
  •  
  • 1110 Microbially Produced Materials
  •  
  • 1114 Recombinant Microbes and Their Products
  •  
  • 1116 Non-pathogenic Microorganisms
  •  
  • 1119 PET CHEWS / TREATS made of ANTLERS or RAWHIDE
  •  
  • 1120 Cell Cultures/Lines, Recombinant Cell Cultures/Lines, and Their Products (for in vitro use)
  •  
  • 1121 Test Kits
  •  
  • 1122 Vitamins and Minerals

FDA Import Permit 

All food (except most meat and poultry), drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation require a permit or registration before importation into the United States.

U.S. Fish and Wildlife Permit 

U.S. Fish and Wildlife Permit Program

Select Agents (Shipping/Transfer) 

Importation of Select Agents (42 CFR part 73, 7 CFR Part 331 and 9 CFR Part 121) requires special approvals and transfer documentation. Contact EHS Biosafety before planning to import or transfer any Select Agent or SA Toxin. A CDC import permit is no longer required if it is a select agent that has been authorized for transfer by the Division of Select Agents and Toxins (DSAT) with a Form 2.

A list of agents and their respective agency can be found here.

AND

More information on transferring Select Agents or Toxins can be found here.

Export of Biological Materials 

Universities are subject to the same export controls as other U.S. companies, organizations and individuals. The Department of Commerce, State Department, or other federal agency licenses may be required when exporting specific biological agents, genetic elements of these agents, toxins, or certain chemicals and equipment. Contact The Office of Export Controls (export-controls@virginia.edu) prior to exporting materials from your lab for an evaluation and guidance on obtaining any necessary licenses.

Material Transfer Agreements

A Material Transfer Agreement (MTA) is a contract that governs the transfer of research materials between two organizations, or within an institution, and defines the rights of the provider and the recipient with respect to the materials and any derivatives.

Although not directly related to biosafety, EHS is providing contact information for obtaining an MTA since many biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials. Materials derived from human subjects and slated for transfer, may be subject to additional approvals.

View more information on MTAs here.