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Table of Contents
- Import Permits
- Export Control Regulations and Export Licenses
- Select Agent and Toxin Shipments
- Impact of Non-Compliance
- Classifying Biological Material
- Packaging Instructions
- Transport on or around UI campus
- Precautions when receiving shipments
- UI Hospital and Clinics Resources
- Assistance and Resources
When packages containing dry ice or infectious substances are shipped off campus, they are classified as “Dangerous Goods” and must be shipped according to federal agency regulations. It is the responsibility of the shipper to be properly trained and follow all required regulations. Shipping training is offered in two courses:
EHS's Shipping Infectious Substances with or without Dry Ice course, available online, fulfills the training requirement, regardless if one ships infectious substances by air or ground. Training course covers Division 6.2-Infectious Substances and Class 9-Dry Ice.
EHS's Shipping with Dry Ice course, available online, fulfills the training requirement if one ships materials with dry ice and no other hazardous or infectious material. Training course only covers Class 9-Dry Ice.
The training record is not complete unless the individual prints and completes the Record of Employee Training and Certification, located within both ICON courses listed above. This form must be completed by the individual taking the course and their supervisor or designated work area trainer; the form should be updated each time the ICON course is renewed.
Training is required initially and then every two years, or with significant regulatory change. The training schedule is determined by IATA (International Air Transport Association) in order to ensure that a shipper’s knowledge remains current.
The Shipping Infectious Substances program is designed to assist researchers in meeting the required regulations when shipping biological material. The following agencies govern these shipments:
- Pipeline and Hazardous Materials Safety Administration, Department of Transportation (USDOT) – CFR 49 Part 171-180.
- Dangerous Goods Regulations, International air Transport Association (IATA).
Hazardous material means a substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce.
Infectious Substance: A substance known to contain or can reasonably be expected to contain pathogens.
Pathogen: Microorganisms (including bacteria, viruses, rickettsia, parasites, fungi) and other agents, such as prions, that can cause disease in humans or animals.
Infectious Substance, Category A: An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.
Infectious Substance, Category B: An infectious substance which does not meet the criteria for inclusion in Category A. Substances containing organisms in the World Health Organization (WHO) Risk Group 2, 3, and 4 are considered infectious substances.
The exchange of biological materials between institutions may require an MTA which addresses intellectual property, confidentiality and risk concerns. Incoming MTAs are sent to the University of Iowa by the institution providing the material; outgoing MTAs are sent to the institution requesting materials from the University of Iowa by the University of Iowa Research Foundation (UIRF). The Division of Sponsored Programs processes and negotiates MTAs and should be contacted with any questions; the main office help desk can be reached at 319-335-2123 or firstname.lastname@example.org.
The Principal Investigator must apply for and maintain all required import permits. Permits can take several weeks to obtain and therefore should be sought well before the desired shipment date. The importer bears the responsibility for assuring that the package is prepared and shipped according US regulations. Shipping companies may assist with additional paperwork that is required when shipping internationally. World Courier offers customs brokerage services; FedEx offers an International Resource Center for assistance.
Import permits will also be required for interstate transport of previously imported material.
Centers for Disease Control and Prevention, Etiologic Agent Import Permit Program (EAIPP) – regulates the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States.
United States Department of Agriculture, Animal and Plant Health Inspection Services (APHIS)- issues permits for the import, transit and release of regulated animals, animal products, veterinary biologics, plants, plant products, pests, organisms, soil, and genetically engineered organisms.
For more information on Import Permits, please visit our Permits - USDA and CDC website.
Federal export control regulations prohibit the export to foreign countries of certain goods, technology, and technical data without an export license issued by the government. The term “export” includes the actual export/shipment of goods to foreign countries but also “deemed exports” which includes the transfer/disclosure in any form (verbal, written, electronic, and visual) within the US of export-controlled items or information to a “foreign national,” anyone who is not a US citizen or permanent resident. The export control regulations most frequently encountered by the university research community include the Export Administration Regulations (EAR), administered by the U.S. Department of Commerce and the International Traffic in Arms Regulations (ITAR) administered by the US Department of State.
The EAR regulates “dual use” items, goods and related technology designed for commercial purposes but may have military applications (computers, aircraft, and pathogens). The Commerce Control List (CCL) is a list of EAR-controlled items; an EAR license will be required for export if the item is listed on the CCL and no exclusion or exemption applies. However, an item may not be listed on the CCL but still subject to the EAR; these items are generally low-technology consumer goods and do not usually require a license unless the export of this item is to an embargoed country, an end-user of concern or in support of a prohibited end-use.
The ITAR regulates the export of defense articles, defense services and related technical data. The US Munitions List (USML) is a list of ITAR-controlled items, including chemical/biological agents, equipment and electronics). A license will be required for export if the item is listed on the USML and no exclusion or exemption applies.
The Department of Treasury’s Office of Foreign Assets Control (OFAC) administers and enforces economic and trade sanctions based on US foreign policy and national security goals. If the export is to an OFAC embargoed country, an OFAC license may be required.
For more information, contact Pat Cone-Fisher, Export Control Coordinator, 319-335-3585 or visit the Export Controls and University Research website.
Shipping companies may assist with additional paperwork that is required when shipping internationally. World Courier offers customs brokerage services; FedEx offers an International Resource Center for assistance.
Select Agents are agents identified by the Secretary of Health and Human Services which have the potential to pose a serious risk to public or animal health and safety; a listing of select agents and toxins can be found in 42 CFR Part 73. All select agents (with the exception of toxins under a permissible amount) are restricted from shipping unless the Principal Investigator/Institution is registered with appropriate federal agency and has received prior approval from the agency to ship/receive an agent.
Select agent toxins (under permissible amounts) can be shipped as dangerous goods, Class 6.1, UN 3172. The permissible amount varies per toxin; amounts can be found at http://www.selectagents.gov/PermissibleToxinAmounts.html. However, researchers must document the transfer of any quantity of the toxin(s) to provide due diligence that the receiver has a legitimate need to handle or use the toxin(s). The Exempt Select Agent Toxin Transfer Form has been developed by EHS staff for such documentation; this form should be kept by the transferor for a minimum of three years. The Select Agent Program reserves the right to review and copy this form.
A person who violates the requirements when shipping or transporting hazardous materials can face civil penalties up to $75,000; when the violation is a continuing one, each day of the violation constitutes a separate offense. Criminal penalties for willfully or recklessly violating the regulations can result in the individual being fined $500,000 or imprisoned for 5 years, or both. Penalties double when the violation results in serious injury or death.
Classifying Biological Material for Shipment
Several documents have been developed in order to assist shippers to properly classify biological material for shipment.
- A flow-chart assists in the classification of biological material for shipping requirements according to IATA’s DGR.
- A guideline lists frequently shipped biological material used in research labs and their proper classification. Examples of biological material exempt from the regulations are included in the guideline.
- IATA Dangerous Goods Identification Chart lists the shipment type/description and the associated UN number, proper shipping name, hazard class or division, hazard label, packing group, packing instructions, and maximum quantities for passenger and cargo aircraft.
- Category A, Infectious Substances affecting humans or animals must follow Packing Instructions 620.
- Biological Substances, Category B shipments must follow Packing Instructions 650.
- Exempt material should be shipped using triple packaging.
- Dry Ice shipments (without infectious substances) must follow Packing Instructions 954.
Safe biohazardous material transport is required to prevent spills and accidental exposure. Follow the procedures outlined below for safe transport:
- The biohazardous material must be placed in a plastic leak-proof primary specimen container secured with a tight-fitting cap, Parafilm, or tape. Each primary container should be labeled with its contents.
- The primary container (blood tubes, agar plates, flasks, test tubes, for example) is then placed in a plastic or metal leak-proof secondary container with absorbent towels to cushion the primary container and absorb liquids in the event of a leak or spill. If a small number of plates or tubes are involved, a ziplock bag containing absorbent material may be used.
- The secondary container should be labeled with your name and contact information and a biohazard symbol, if applicable.
Dangerous goods are not to be transported in a personal vehicle, use a University owned vehicle, if necessary.
Before arranging to receive infectious materials, verify that the shipment is being made in compliance with the regulations and know the hazards associated with the agent you will be receiving. When you receive the package:
- Make sure it isn’t damaged. Open it in a biological safety cabinet with protective gloves.
- First open the outer packaging and remove the secondary container. Because the primary container may have leaked, before opening the secondary container, wipe it down with an appropriate disinfectant.
- If the primary container has leaked, place all packaging material into an autoclave bag, autoclave and discard the autoclaved materials in a biohazard box.
- If your package is damaged, contents are missing, or the package does not arrive, you must contact the shipper and/or carrier. If the shipment involves a select agent, also notify the Biological Safety Officer who will notify CDC.
Shipping and Receiving facility at the University of Iowa Hospital and Clinics is responsible for receiving, delivering and shipping out hundreds of items on a daily basis. The facility may be used as a resource for hospital staff; all non-UIHC staff will be asked to provide a copy of their training certificate from EHS’s online ICON shipping course when using their services. Contact Shipping and Receiving staff at 319-356-2389 with any questions.