The following are guidelines for the intake of biological materials:.
The shipping and receiving of biological materials is regulated by several government agencies. According to federal regulations:
"It is the responsibility of the shipper to ensure correct identification, classification, packaging, labeling, marking and documentation for all shipments of infectious substances. In addition, the shipper must make advance arrangements with the recipient (consignee) and operator (carrier), including acquisition of any permits for the importation of infectious substances from foreign countries. Failure to comply with federal and international regulations can result in refusal of the shipment by the airline, penalties of fines, jail, or both. Hand carriage of infectious substances by air is strictly prohibited by law."
Applicable Transportation Regulations
Before requesting biological material to be shipped to you:
After receiving biological material:
Before shipping biological material:
The information provided in these guidelines is an overview and not meant to be comprehensive. It may be necessary to contact applicable government agencies for clarification and updates regarding permit requirements.
If you regularly ship Category A or B Infectious Substances on dry ice or toxins as described in Section IV, you must receive initial and update training to fulfill the requirements of the U.S. Department of Transportation and the shipping companies. Shipping training must be updated every two years or more frequently if regulations change.
These guidelines are meant to supplement the above training and are not a substitute for the hazardous material shipping class. Shipping biological materials listed as excluded from dangerous goods regulations in Section IV does not require training.
Federal permits are required to import/export disease-causing agents for humans and animals, vectors for those agents, animal products, plants, plant products and plant pests. Permits may also be required for domestic transport of some agents. The recipient of the material must obtain any required permits. If you are the shipper, request a copy of any applicable permits from the recipient.
The U.S. receiver (importer) is responsible for the package being sent to them from a foreign country. The receiver must assure that the foreign shipper has packed and labeled the material according to U.S. Public Health Service and the International Air Transport Association (IATA) regulations. The importer must send the proper shipping labels and a copy of their import permit to the shipper. Complying with foreign import regulations should prevent packages from being held at customs or denied entry. See Section VI for additional information.
Inquire to the proper government agency listed below for permit requirements and applications well before the material is needed, as it may take several weeks to process a permit application.
A. USDA/APHIS Transport Permits
The USDA/APHIS (Animal and Plant Health Inspection Service) regulates transport of materials that could potentially harm U.S. agricultural products including livestock, poultry and crops. APHIS permits may be required for import, export and interstate transport of animal or plant pathogens, pathogen vectors, animals, animal products, plants, plant products, and the introduction of genetically modified organisms into the environment.
1. Transportation of Infectious Substances
Visit U.S. Department of Transportation Overview on Transporting Infectious Substances for more information.
2. USDA Import Guidelines For Products That Do Not Require An Import Permit
USDA/ APHIS permits are required for imports/ exports and inter-state transport of:
*USDA/APHIS regulation 9 CFR Animals and Animal Products Parts 94, 95, and 122 covers transport of organisms or vectors that can cause infectious diseases of animals. The regulation defines material requiring a permit as, "(d) Organisms. All cultures or collections of organisms or their derivatives, which may introduce or disseminate any contagious or infectious disease of animals (including poultry). (e) Vectors. All animals (including poultry) such as mice, pigeons, guinea pigs, rats, ferrets, rabbits, chickens, dogs, and the like, which have been treated or inoculated with organisms, or which are diseased or infected with any contagious, infectious, or communicable disease of animals or poultry or which have been exposed to any such disease.
APHIS Imports and Export Guidelines
An Import/Transport permit:
To determine if the material you wish to transport requires a permit, visit the APHIS: National Center for Import and Export (NCIE) Website at APHIS Imports and Export Guidelines
NOTE: According to the USDA, "Generally, a USDA veterinary permit (VS-16-6) 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, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi. Exceptions to this requirement are human and non-human primate tissues, serum and blood."
USDA/APHIS regulation 7 CFR Part 330 Federal Plant Pest Regulations covers the transport of plant pests. For information on plant, pest transport, and plant product transport permits see APHIS Permits.
The intended receiver of plants and plant pests must obtain a permit for transport before shipment is made. Allow 6 to 8 weeks for processing.
Examples of some permit applications are:
Contact APHIS for clarification of which permit is required, instructions on how to obtain permit applications, and to determine if any changes have been made to the initial regulation. APHIS National Center for Import/Export Products (301 734-3277) http://www.aphis.usda.gov/lpa/about/welcome.html
5. Genetically Modified Organisms (GMOs)
To determine if a permit is needed to import or transport a GMO, contact the APHIS Biotechnology permit branch via a letter of notification.
B. Centers for Disease Control (CDC)
The Department of Health and Human Services, through the CDC, regulates the transport of biological materials that could cause illness in humans, including pathogens and biological toxins.
In general, a permit is needed for any infectious agent known or suspected to cause disease in humans that you wish to import into the United States. In some cases subsequent distribution of an agent (i.e., SARS-CoV, select agents, viruses requiring BSL-4 containment) is prohibited within the United States and requires CDC authorization/permit prior to transfer to another location within the U.S. These permits may be obtained from the Centers of Disease Control and Prevention, Office of Health and Safety, Etiologic Agent Import Permit Program or telephone (404) 498-1600 for further information.
Foreign imports of the following materials require a Permit to Import or Transport Agents or Vectors of Human Disease:
Domestic transport may or may not require a permit.
To determine if your shipment requires a permit:
Some microorganisms and cell lines purchased from ATCC require permits to be shipped domestically. For ATCC permit info see ATCC Permits and Restrictions.
A phytosanitary certificate is a document often required by many states and foreign countries for the import of nonprocessed, plant products, APHIS Imports and Export Guidelines
D. Material Transfer Agreement
Steps to ship a Select Agent:
Steps to receive a Select Agent:
The Office of Research, Grants and Contracts handles all incoming Material Transfer Agreements. Contact Mary Ucci for details.
Biological materials that fall under the Dangerous Goods Regulations for shipping by air are classified in one of four different groups:
These classifications are used to select the proper shipping procedures, see Section V. Shipping Category A & B Infectious Agents, Toxins, and some GMOs require attending a training session, see Section II.
Note: If the material is also classified as a Select Agent, additional regulations apply, see Section E below.
The following materials are not classified as dangerous goods and are not subject to IATA regulations:
Note: Patient specimens are material collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purpose such as research, diagnosis, investigational activities, disease treatment and prevention.
Note: In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgement is required to determine if a substance is exempt. That judgement should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. If there is any reason to suspect that the specimen contains a pathogen, it cannot be shipped as exempt from Class 6.2 Hazardous Material.
Exempt substances do not require a Declaration of Dangerous Goods or hazardous material training. However, if the substance is shipped on dry ice the dangerous goods regulation for dry ice must be followed and training is still required.
USDA/APHIS permits may still be required even if IATA transportation regulations do not apply.
A. Category A Infectious Substances
Infectious substances are materials that are known or are reasonably expected to contain pathogens. Pathogens are defined as microorganisms (bacteria, viruses, rickettsiae, parasites, fungi) and other agents, such as prions, which can cause disease in humans or animals.
Category A Infectious Substances are agents which are transported in a form that, when exposure to it occurs, is capable of causing permanent disability or life threatening or fatal disease in otherwise healthy humans or animals. All material meeting these criteria must be shipped as Category A. Visit the un3373 website for more information.
NOTE: Some of the materials on this list only need to be shipped as Category A if it is cultured. Cultures do not include patient samples. Patient samples are collected directly from the patient and are not propagated for diagnosis. When in doubt, ship as Category A
B. Biological Substances Category B (Previously Called Diagnostic/Clinical Specimens):
Category B Infectious Substances are biological materials that:
Category B substances are shipped under the proper shipping name: Biological Substance, Category B.
Any material listed in Appendix 6 cannot be shipped as Category B. This is a list of examples only and is not meant to include all materials forbidden as Category B. When in doubt, ship as Category A.
C. Non-infectious Exempt Patient Specimens
IATA (air transport) regulations allow for some patient specimens to be shipped as exempt from Dangerous Goods requirements. These regulations are adhered to by FedEx and can also be used for DHL/Airborne shipments.
Exempt patient specimens are those for which there is minimal likelihood that pathogens are present, but that does not mean these are not regulated.
Note: Patient specimens are material collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purpose such as research, diagnosis, investigational activities, disease treatment and prevention.
Note: In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgement is required to determine if a substance is exempt. That judgement should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. If there is any reason to suspect that the specimen contains a pathogen, it cannot be shipped as exempt from Class 6.2 Hazardous Material.
Exempt substances do not require a Declaration of Dangerous Goods or hazardous material training. However, if the substance is shipped on dry ice the dangerous goods regulation for dry ice must be followed and training is still required.
Exempt patient specimens must be properly packaged.
Toxins are material obtained from a plant, animal, fungal, or bacterial source that are toxic to humans or animals. Shipping of toxins falls under Hazardous Material regulations. If the toxin is contained in an infectious substance or if the toxin contains an infectious substance, it must be classified as an Infectious Substance, not a toxin. Packing Group (PG I, II, or III) criteria for toxins is based on severity of risk according to its LD50. Shipping training is required. Toxins are Class 6.1.
E. Genetically Modified Organisms (GMOs)
Genetically modified microorganisms (GMMOs) and genetically modified organisms (GMOs) are microorganisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally.
Classifying GMOs for shipping:
Individual countries have strict regulations regarding GMOs. Be sure to become informed of the receiving country's regulations.
The federal government regulates the use, handling, and transport of certain biological materials considered to be potential bioterrorism agents.
Select Agents are classified as either Infectious Substances or Toxins. Follow IATA packing and labeling instructions according to its classification. Transport of Select Agents is subject to the following additional regulations; The Department of Health and Human Services' Regulation 42 Part 73, Possession, Use, and Transfer of Select Agents and Toxins; Final Rule, selectagents.gov, the USDA's Agricultural Bioterrorism Protection Act, and university policy.
Notify the university's Institutional Biosafety Chairperson if you wish to ship, receive, or transfer any quantity of Select Agents. This includes on campus transfers. All infectious Select Agents and Select Agent toxins, in quantities above CDC exemption quantities, require DEHS and CDC or USDA approval prior to shipping. The Biosafety Chairperson is responsible for tracking all transfers of Select Agents both on and off campus, documenting and reporting transfers to CDC or the USDA, verifying that transfers are only made between registered facilities, maintaining an accurate Select Agent inventory, and notifying CDC or USDA of suspicious activity or requests regarding the transfer of Select Agents.
Federally Regulated Quantities of Select Agents
CDC or USDA must approve all shipments of Select Agents between entities. Both the receiving and the shipping entity must have a current Select Agent Certificate of Registration. The receiving entity is responsible for initiating the approval process. All documentation should be forwarded to Safety and Emergency Management.
Steps to ship a Select Agent:
Steps to receive a Select Agent:
Federally Exempt Quantities of Select Agent Toxins
Contact Safety and Emergency Management prior to shipping or receiving any quantity of Select Agent Toxins. Exempt quantities of Select Agent Toxins do not require submission of Report of Transfer Form EA101 to CDC/USDA but are still tracked by the Biosafety Chairperson in order to keep the university's biological material inventory up-to-date. Report to Safety and Emergency Management how much toxin is shipped, when it was shipped and to whom it was shipped.
On Campus Transfer of Select Agents
Follow all transfer of biological material guidelines in Section VIII. In addition:
Both transferring and receiving labs must immediately update their inventory including the date of transfer and a signature of the authorized individual making the transfer
The following information is an overview, not comprehensive instructions.
Hazard Class designations and packing groups are used to determine the packing instructions that must be followed for shipping.
FedEx's Web site gives instructions on filling out their U.S. Airbill required for all shipments.
Packages displaying UN markings referred to in the following packing instructions meet the United Nations (UN) packaging specifications and performance testing.
A. Category A Infectious Substances: Packing Instruction 620
Infectious substances require a Shipper's Declaration for Dangerous Goods. FedEx's Web site, provides helpful information on filling out the Shipper's Declaration for Dangerous Goods.
B. Category B Infectious Substances (Previously Called Diagnostic/Clinical Specimens): Packing Instruction 650
Shipments of Category B Infectious Substances do not require a Dangerous Goods Declaration.
Packaging must be of good quality, strong enough to withstand normal transport conditions including manual or mechanical handling, vibration, changes in temperature, humidity or pressure. Packaging must have:
The completed package must be capable of passing a drop test of at least 1.2 meters. An itemized list of contents must be enclosed between the secondary packaging and the outer packaging.
C. Non-infectious Exempt Patient Specimens
D. Toxins: Packing Instructions Vary
Biologically derived toxins that contain infectious substances or toxins that are contained in an infectious substance must be shipped as a Risk Class 6.2 Infectious Substances. All other biologically derived toxins fall under Risk Class 6.1. Risk Class designations and packing groups are used to determine the packing instructions that must be followed for shipping. Packing Group criteria for toxins is based on severity of risk according to LD50.
Very small amounts of toxins in Risk Class 6.1 may be shipped as "Dangerous Goods in Excepted Quantities." "Excepted Quantities" are accepted from the marking, labeling, and documentation requirements for shipping Dangerous Goods. No toxic label or Shipper's Declaration for Dangerous Goods are needed. On the FedEx waybill, check the box marked "Yes, does not require declaration of dangerous goods." If shipped by ground, the outer packaging must have the marking: "This package conforms to 49 CFR 173.4." If shipped by air, package must have a special handling label for "Excepted Quantities" indicating the hazard class and UN number.
Any quantity of inhalation toxins in Packing Group I may not follow "Excepted Quantities" procedures.
All "Dangerous Goods in Excepted Quantities" must be considered material that is permitted for shipping on passenger aircraft. "Dangerous Goods in Excepted Quantities" cannot be transported in either checked or carry-on baggage or shipped via mail.
If shipping a quantity above the dangerous goods "Excepted Quantities", a shipper's Declaration for Dangerous Goods is required, toxic labels need to be attached, and package must be marked as meeting with UN performance requirements.
E. Genetically Modified Organisms: Packing Instruction 959 (see UPS tips for shipping with dry ice)
IATA regulated GMOs fall under Hazard Class 9, UN3245 and must follow Packing Instruction 959.
F. Dry Ice: Packing Instruction 954 (see UPS tips for shipping with dry ice)
Properly handled liquid nitrogen "dry shippers" can be transported without any additional regulations. Be sure that all the liquid nitrogen has been removed from the shipper before transport. Failure to do so can result in substantial fines. For further information, see University of Washington EH&S "Tips for Dry Shipping" (see UPS tips for shipping with dry ice).
H. Transporting Infectious Substances Safely
FedEx - General guidelines for packaging, marking and labeling clinical samples and biological substance, Category B, How To Ship Clinical Samples
The following agencies may require a permit for international shipments. Expect to need more preparation time to send or receive foreign shipments in order to process the required paperwork.
The U.S. receiver (importer) is responsible for the package being sent to them from a foreign country. The receiver must assure that the foreign shipper has packed and labeled the material according to U.S. Public Health Service and IATA regulations. The importer must send the proper shipping labels and a copy of the import permit to the shipper.
Taking care to comply with foreign import regulations should prevent packages from being held at customs or denied entry. As an extra precaution, you may wish to find out what carrier the shipper will use and what day and at what port your package is expected to arrive. Contact the U.S. Customs Office at that port and inform them that a package will be arriving for you and what the contents will be. Ask them to contact you immediately if there are any questions
A. USDA/APHIS
Section III covered USDA and CDC permits required to ship/receive biological material both within the U.S. and from a foreign country.
Be aware that Genetically Modified (Engineered) Organisms that are not controlled or subject to regulations, may be held by customs because of the similarity of the organism to other organisms that are regulated. To prevent an international shipment from being stopped at the port of entry:
B. Department of Commerce
Exports of designated biological agents and toxins that have the potential to pose a threat to human, animal or plant life may require a license from the U.S. Department of Commerce, Bureau of Industry and Security (BIS). The scope of items subject to this licensing requirement is broader than “select agents,” and researchers must consult with the Director of Safety and Emergency Management to conduct a separate review to determine if a BIS export license is required.
BIS may require a license for the export of:
These regulations are chemical and biological weapon controls and generally require licenses for all locations other than Canada. (Canada requires the recipient to have an import permit, see E. below.)
Obtaining a license is a long process, and a license may be denied at the discretion of BIS. Researchers should contact the Export Controls Officer as early as possible, should build in three (3) months' lead-time to initiate foreign shipments of material requiring a license, and should not commit to delivery prior to issuance of a license.
C. U.S. Fish and Wildlife
A permit may be required by the U.S. Fish and Wildlife to export/import non-agricultural biological samples, including artificially propagated plants and endangered species. Call 1-800-770-0150 or go to the U.S. Fish & Wildlife Service Permits web site to determine if your shipment needs a permit.
D. Food and Drug Administration (FDA)
The FDA controls most food and other products that enter the U.S. Foods (except for certain meats and poultry products), drugs (human, animal and biological), cosmetics, medical devices and radiation emitting devices, etc., offered for entry into the United States require a permit or registration. Go to FDA Import Basics to determine if your request for shipment of one of these products from another country is regulated.
E. Canadian Import Regulations
Shipments of human, animal, or plant pathogens to Canada will require a Canadian import permit. You will need to allow sufficient lead-time for the Canadian recipient to obtain the proper permits.
Packaging of shipments will need to comply with the Canadian Transport of Dangerous Goods Regulations. See the Transport Canada Web site for details.
A. Leaking or Damaged Package
Departments/laboratories that regularly receive shipments of biological materials should have a written procedure for the receipt of leaking or damaged packages.
If you receive a biological material package that is leaking or has broken containers inside, call Safety and Emergency Management.
If any material is spilled on a person, remove contaminated clothing and shoes, flush the skin for 15 minutes, and seek medical assistance immediately.
While waiting for help to arrive:
B. Suspicious Package
See the CDC Web site for guidelines on handling suspicious packages or envelopes.
When these materials are transported, Department of Transportation (DOT) Hazardous Materials Regulations (HMR) may apply and are extremely complex in nature. Laboratory personnel must properly package, transport, and handle any Infectious substances that are used in their research. Labeling using the universal biohazard symbol is also required for any infectious biological materials in order to prevent accidental exposure to unsuspecting personnel who may be exposed to the biological material (e.g., couriers, administrative staff, and janitors).
A. Packaging and Training Requirements
The following packaging requirements apply to all ground transport of infectious substances prepared for transport either on-grounds or off-grounds irrespective of the mode of transportation .
Category A: It is permissible to hand-carry between buildings. IATA/DOT Packing Instruction PI 620 must be followed. If the distance is too great for carrying by hand, materials must be shipped by air with a commercial carrier (e.g. FedEx, DHL). Cat.A material must NEVER be transported by ground in a motor vehicle.
Category B: must follow the IATA/DOT Packaging Instruction, PI 650.
Exempt Patient/Animal Specimens2:
Dry Ice: Package must be labeled “Dry Ice” on two sides. No Training requirements for Ground.
The following are means by which Infectious Substances may be legally transported within and around the University. The DOT Hazardous Material Regulations (49 CFR Parts 171-180) regulates the movement of Division 6.2 Infectious Substances and are regulated when carriage is considered to be "in commerce".
Transport in Personal or University Vehicle
Under NO circumstances may public transportation be used for transport of Hazardous Materials.
In general, movement or ground transport of regulated materials is covered by the DOT's Hazardous Materials Regulations (HMR) only when they are considered to be “in commerce.” If a Division 6.2 infectious substances is transported in a personal or university (i.e., government) vehicle for use in university activities (projects, research, etc.) it is generally not considered to be “in commerce.” However, these personnel must:
NOTE: If using a personal vehicle to transport the individual should consult with his/her personal insurance policy regarding liability and coverage in this instance.
Transport By Contracted Carrier
Commercial or Private carriers (i.e., commercial transport companies) are subject to the HMR. These include companies such as FedEx, DHL as well as medical couriers etc. Transport of infectious substances to other institutions or entities such as another university, a waste disposal facility or a return to the manufacturer, should only be done by DOT licensed hazardous materials carriers to another location via a public thoroughfare. When Principal Investigators leave an institution, the research may be transferred to the new institution, which then becomes the owner, however, the original institution is legally responsible for the shipment to the new institution. Contact the Biological Science Lab Manager for consultation.
Category A and Category B Infectious Substance should be consigned by air (exempt human specimens are exempt but regulated). Assurance from the carrier must be given that DOT regulations are being met.
As of October 1, 2006 the DOT regulations state that Materials of Trade (MOTS) see 49 CFR §173.6 exceptions only apply to patient specimens or those samples that would be otherwise considered Category B that are contained in a human (patient) or animal sample (no cultures). Therefore personal or dedicated vehicle transport in addition to carrier transport can only use a MOTS exception for Patient Specimens.
Transport (hand-carry) between University labs or buildings through public areas
Infectious substances must be transported or moved between laboratories in way as to prevent spills and accidental exposure or release. Include the following:
1) The handling and movement of hazardous materials within a building between rooms is governed by:
29 CFR 1910.1030, Bloodborne Pathogens Standard
29 CFR Part 1910.1200, Hazard Communication
29 CFR Part 1910.1450, Occupational Exposure to Hazardous Materials in Laboratories
40 CFR Part 262, Standard Applicable to Generators of Hazardous Waste.
The ground (vehicle) transport of hazardous materials between buildings or off-site to other entities is governed by:
49 CFR Parts 171-180, Hazardous Materials Regulations 171.1 (d)
2) Functions not subject to the requirements of the HMR
The following are examples of activities to which the HMR do not apply:
Federal Aviation Administration, Dangerous Goods Program
Federal Motor Carrier Safety Administration, US Department of Transportation
International Air Transport Association
Office of Research Services, National Institutes of Health - Shipping Hazardous Materials Safely
Research and Special Programs Administration, US Department of Transportation
1 The amount of Division 6.2 material in a combination packaging must conform to the following limitations: (A) one or more inner packaging, each of which may not contain more than 0.5 kg (1.1 lbs) or 0.5 L (17 ounces), and an outer packaging containing not more than 4 kg (8.8 lbs) or 4 L (1 gallon); or (B) A single inner packaging containing not more than 16 kg (35.2 lbs) or 16 L (4.2 gallons) in a single outer packaging.
2 DOT’s "Patient Specimen" definition and exemption differs from the IATA definition when materials are shipped by air. Contact EHS Biosafety for more information if shipping by air.
3 Pressure-tested (i.e., 95 kPa) secondary containers not required for ground transport
Adapted from the University of Minnesota website.
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