Chapter 11: Transportation of Biological Materials

Training is required prior to shipping of materials off campus. This does not count as training.

The packaging and transportation of biological materials are subject to strict local, state, federal, and international regulations. This is particularly so if the material is transported through the “public domain,” namely, those roadways, airways, and sea lanes accessible to the public.

Therefore, unless the material is being moved within a specific campus, legal requirements governing packaging, labeling, and handling must be followed.

The intent of the packaging and transportation regulations is to prevent accidental exposure of personnel who may handle the material during its shipment. Therefore, certain general criteria apply to all possible transportation scenarios.

Prior to transporting any biological materials, the following controls must be in place:

• Emergency procedures (e.g., contact names and information, spill cleanup, disinfection protocols, etc.) must be known to the person carrying the materials.
• Container must be appropriate for the material being transported.
• Material must be packed so that it will stay upright during transportation.
• The containers must be properly labeled.
• Proper PPE must be worn during the packaging of the material.
• Hands should be washed after handling materials.
• Open cuts or other wounds should be covered before handling the materials.
• Aerosol generation must be avoided when handling and packing the materials.
• The person packaging the material must ensure that the exterior surfaces of each package are free of any potential contamination by the packed material.

Transportation within a Campus

The following requirements must be observed during the transportation of biological materials within a campus (e.g., between two laboratories):

• At a minimum, all laboratory materials must be transported in a secondary container that is sealed, shatterproof, and leak-proof. Materials should never be carried in hands or pockets.
• The secondary container should be closeable and easy to decontaminate; an absorbent pad (or similar material) should be placed inside the secondary container to absorb any spills.
• A laboratory coat should be worn during transport.
• Label information must include the identity of the biological material or agent, the universal biohazard symbol (if the material or agent is in, or above, Risk Group 2).
• Each individual container must have enough label information to identify its contents. Other information should be on the outside of the package.
• The container should be carried directly to the intended laboratory and not taken to offices, cafeterias, or other public or inappropriate locations.
• Upon delivery, the receiving laboratory personnel should be informed and the material properly stored.
• The package should be carefully inspected for signs of leakage or other contamination and, if necessary, decontaminated before opening.

Transportation between Campuses (Ground)

Transportation of biological samples between campuses (e.g., BUMC and CRC) is subject to the general conditions described above. Biological materials should not be transported on the Boston University Shuttle (BUS). In addition, because the transportation takes place through the public domain, the following other conditions apply:

Packaging

• All biological samples must be packed according to Department of Transportation/International (DOT)/International Air Transport Association (IATA) regulations; this includes triple-packaging all samples, even if exempt materials.
• The specimen should be placed inside a primary container with a tight-fitting, leak-resistant top (e.g., full round-threaded screw cap with seal or stopper).
• The primary receptacle or secondary container should be labeled with the universal biohazard symbol if it contains bloodborne pathogen materials, as per required under the OSHA Bloodborne Pathogen standard 29 CFR 1910 1030.
• The primary receptacle is placed within a secondary (outermost) container that must meet the following specifications:
  • Enough extra space to hold absorbent and cushioning materials around the primary receptacle
• Label information must include the category of the infectious biological material or agent, (e.g. Category B, or exempt human or animal specimen), and the sending and receiving laboratory identification. Category A CANNOT be transported by hand between laboratories.
• Each individual container must have enough label information to identify its contents. In addition, a sheet containing a description of contents should be placed inside the container between the outer and secondary packaging.
• Any dry ice or other coolant can now be added between the secondary and outer packaging layers. This coolant material should be placed in a shipping box that contains a styrofoam liner or other appropriate material to ensure that the outer box is not damaged by moisture from cold packs or other coolants.
• All required DOT/IATA labeling and marking information should be on the outside of the package.
• The BU shuttle system, MBTA, taxi cabs, driving services, or other payment for transport methods must not be used for transportation of infectious agents or other biohazardous materials.
• If the package contains exempt human or animal specimens, or materials that fall under the “Category B Infectious Substances” category, the package may be moved over U.S. roadways by a member of the laboratory. This exclusion, called “Materials of Trade” (MOT) by the U.S. Department of Transportation allows some materials that are exempt or Category B Infectious materials to be transported by a research or clinical laboratory personnel Courier services fall under the “Exclusive Use” Exemption under DOT. This exclusion does not apply to Category A infectious substances or other categories of Dangerous Goods. This individual must have undergone shipping training in the last two years. This package must follow all requirements as described above. Contact the Office of Research Safety, EHS for further information and questions about these DOT exemptions.
• The container should be shipped directly to the intended laboratory and not taken to offices, cafeterias, or other public or inappropriate locations.
• Upon delivery, the receiving laboratory personnel should be informed and the material properly stored. The package should be carefully inspected for signs of leakage or other contamination and, if necessary, decontaminated before opening.

Air Transport of Materials

Occasions do arise when a PI must either ship or receive biological materials from another institution. Such activities are governed by strict federal and international guidelines. See Appendix A for detailed requirements pertaining to international (import/export) shipments.

Before exporting biological material, you should check:

1. whether the particular material requires an export permit by reviewing the Commerce Control List, Category 1;
2. check the recipient against the “Restricted Parties Lists;”
3. verify whether license is needed for the country of import;
4. and verify that the material will not be used to design weapons of mass destructions or another military development.

After determining U.S. export control requirements, you should verify the import requirements for the destination country and apply for import permits if required. Boston University’s Export Control Officer can provide assistance with this process.

All anticipated purchases/shipments of materials subject to the International Traffic in Arms Regulations (ITAR) must be reported to the Export Control Officer in advance of the purchase to ensure that laboratories are briefed on the licensing requirements for the use of such materials.

In addition to U.S. export regulations, you are required to review the dangerous goods shipping requirements outlined below.

The International Civil Aviation Organization (ICAO) is the United Nations entity that governs all international civil aviation matters. The ICAO’s Technical Instructions for the Safe Transport of Dangerous Goods by Air govern the shipping of dangerous goods. These technical instructions have been incorporated into U.S. law and are an acceptable method of transport in the United States (49 CFR 175).

Packaging and shipping biological materials involve certain risks with numerous potential liabilities. The International Air Transport Association’s (IATA) Dangerous Goods Regulations (DGR), latest edition, is the worldwide gold standard for shipping. The IATA regulations apply to all air transport, both domestic and international flights. Following IATA’s DGR ensures that a package will also meet U.S Department of Transportation requirements for ground transport.

All responsibilities for packaging and shipment of these agents have been assigned to the shipper. Only properly trained personnel may offer infectious materials for transport. The following is only a summary of the requirements for packaging and shipping infectious agents. All persons must complete the shipping training prior to the packaging and shipment of their materials.

Definitions and Applicability

Dangerous goods: articles or substances capable of posing significant risk to health, safety, property, or the environment when transported by surface or air. Most infectious or biological materials are considered dangerous goods and therefore are subject to shipping regulations.

Infectious substances: substances known or reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents, such as prions, which can cause disease in humans or animals. For the purposes of shipping classification, infectious substances are broken into two categories:

Category A: an infectious substance 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.

Category B: an infectious substance that does not meet the criteria for inclusion in Category A.

Biological products: those products derived from living organisms manufactured and distributed in accordance with the requirements of national governmental authorities (e.g., the FDA). They may have special licensing requirements and are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for developmental, experimental, or investigational purposes related thereto. Biological products manufactured and packaged in accordance with the requirements of appropriate national authorities that are transported for the purposes of final packaging or distribution and for personal health-care use by medical professionals are NOT subject to dangerous goods regulation. However, biological products not governed by national authorities and that are known or reasonably believed to contain infectious substances MUST be classified and shipped according to dangerous goods regulations.

Dry Ice: Commonly used a refrigerant.

Exempt Patient/Animal Specimens: patient or animal specimens for which there is a minimal likelihood that pathogens are present are exempt from most of the shipping regulations. However, they must be marked with the words “exempt human specimen” or “exempt animal specimen” and must be triple-packed as described below.

Genetically Modified Micro-Organism/Organisms (GMMO/GMO): materials in which genetic materials have been altered through genetic engineering which does not occur naturally.

Completely Exempt Substances: materials that are totally exempt for consideration under the shipping regulations:

• Substances containing micro-organisms that are non-pathogenic to humans or animals
• Substances in a form so that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk (the chemical itself may be regulated – Contact EHS prior to shipping)
• Environmental samples (including food and water samples) that are not considered to pose a significant risk of infection, and
• Dried blood spots, collected by applying a drop of blood onto absorbent material, fecal occult blood screening tests, blood or blood components intended or prep to be used for transfusion, and tissues or organs intended for transplantation.

Classification and Identification

The substance to be shipped must be classified as completely exempt from regulation, an exempt patient/animal specimen, or a Category A or B infectious substance. Once classified, proper shipping names and identification numbers can then be assigned to the material. Exempt patient specimens require shipping names. However, Category A and B materials are assigned the following names and numbers:

Category A

Assign one of two identifiers, depending on whether or the material infects humans:

• UN 2814 Infectious substance affecting humans
• UN 2900 Infectious substance affecting animals

Category B

UN 3373 biological substance category B

Dry Ice

Un 1845 Dry Ice

GMMO/GMO

UN 3245 Genetically Modified Micro-Organism/Organisms

Exempt Materials

Exempt Human or Animal Specimen

Packaging

All regulated infectious substances, including Category A, Category B, and exempt patient specimens, must be triple packed:

1. The innermost primary receptacle(s) is leak-proof.
2. A leak-proof secondary receptacle with absorbent material and cushioning material placed between the primary and secondary receptacles to prevent the release of liquid during transport and to shield multiple primary receptacles from coming in contact with one another.
3. Rigid, tertiary outer packaging that is at least 100 mm (4 in) in its smallest external dimension.

Additionally, shipments of Category A and Category B materials must be packaged according to IATA Packing Instructions 620 and 650, respectively. Those guidelines require the following:

• Shipments must be prepared in such a way that they arrive at their destination in good condition and present no hazard to persons, animals and/or environment during shipment.
• Outer packaging must meet structural strength requirements and carry defined specification markings.
• Packages must be at least 100 mm (4 in) in their smallest external dimension.
• An itemized list of contents must be enclosed between the secondary container(s) and the outer packaging.
• All packages containing infectious substances must be marked durably and legibly on the outside of the package with the name and telephone number of a person responsible for the shipment.
• The shipper must make advance arrangements with the recipient and the operator to ensure the shipment can be transported and delivered without unnecessary delay.
• Substances shipped at ambient temperatures or higher must be in primary receptacles made only of glass, metal or plastic, with a positive means of ensuring a leak-proof seal. Screw caps must be reinforced with adhesive tape.
• Substances shipped refrigerated or frozen must carry the refrigerant between the secondary container and outer packaging. Wet ice is not recommended for shipping as it may cause the package to leak during transport, thus delaying or causing rejection of the package by the transporter. If dry ice is used, the packaging must permit the release of CO2 gas.
• Primary and secondary containers must meet temperature and pressure requirements set out in the regulations.

Category A shipments require UN Spec packaging.

Labeling

Package labeling is in the form of standardized pictures that must be affixed to the outside. The color and design of each label is prescribed in the IATA regulations. All labels must be at least 4 inches on the smallest side.

For the purposes of infectious substances, five different labels must be considered:

Category A

Category B

Dry Ice

Cargo Aircraft Only

Must be affixed if shipping volumes greater than 50 ml of a Category A substances can be halved for use on a smaller category A box.

Orientation Arrows

If shipping liquids, two such labels must be affixed to the package, on opposing sides.

Marking

Markings are the words and numbers required to be on the outside of a package. The following markings must be present on any package containing a Category A or Category B material:

UN Number and Proper Shipping Name:

• UN 2814 Infectious substance affecting humans
• UN 2900 Infectious substance affecting animals
• Biological substance category B
  • Genetically Modified Micro-organisms/Organisms

Contact Information

• Name and telephone number of the responsible person
• 24-hour emergency telephone number in case of transportation emergency
• “To” and “from” information

If shipping a material under dry ice, the following additional marking is required:

• UN 1845 Dry Ice (the weight in kilograms of the dry ice present should also be noted)

If shipping an exempt patient or animal specimen, the only marking required is:

• Exempt Human Specimen or
• Exempt Animal Specimen

Training Requirements

Those involved in the packaging and shipping of infectious substances must undergo training every two years or when regulations change. It is the department’s responsibility to ensure training is completed. The Office of Research Safety, EHS can provide this training. The shipper is obligated to receive further qualification when shipping hazardous materials of a class or division (chemical, radiological, Li-Ion Battery, etc.) where current training is insufficient or contact EHS for more information..

* As described in the latest edition of the IATA Dangerous Goods Regulations

Note

• When shipping biomaterials on dry ice, remember that dry ice is itself considered a dangerous good and must also be listed on the shipping documents as UN1845, Packing Group III, Packing Instruction 954.
• BU has adopted additional shipping requirements for “high hazard materials” with strict requirements for approved carriers, including a dedicated vehicle, point-to-point delivery, and specified shipping routes. For more information, contact EHS.
• The transportation must also meet the NIH guidelines.

BU Materials Transportation Management Policy

Purpose and Applicability

The purpose of this policy is to define the procedures used to manage the shipping, receiving, and transportation of items determined to be high-risk by EHS in accordance with Boston University policies and procedures and all applicable laws and regulations.

This policy applies to all items determined to be high -risk and to all employees and staff, including those who are visiting users of Institutional facilities and those who are contracted services involved in the shipping, receiving, handling or other use of subject materials as described below.

This policy defines the protocols for the selection of contracted services to be used in the shipping, receiving, and transport of subject materials. It also includes standards for packaging, transporting, delivery routes and the quality controls to be utilized to ensure that all those involved in the management of subject materials transport adhere to these standards.

Definitions

Subject Materials: A substance or material in a quantity and form that may pose a high level of risk to health, safety or property when received, transported and/or stored. These materials include, but are not limited to, toxic/infectious substances (including select agents), radioactive materials, chemicals, compressed gases, and any other materials that EHS deems a material that should be managed throughout its transport.

Select Agents: Biological agents and toxins that have the potential to pose a threat to public health and safety if used for bioterrorism purposes. The list includes over 80 bacteria, viruses, toxins, rickettsia, and fungi. The program is regulated by the Department of Health and Human Services (DHHS) and Department of Agriculture (USDA) under the Federal Regulation for Select Agents [42 CFR 73.0; 7 CFR 331; 9 CFR 121].

Shipper: The shipper is the person who packages the subject material and signs the shipper’s declaration form. This person is responsible for the material to be classified, identified, packaged, marked and labeled, with all appropriate documentation included with the package. This individual is required to have shipping training and notify the receiver regarding the planned shipment of high-risk material.

Transporter: The transporter is the individual, operator or contracted service that obtains the package from the shipper, verifies it has been packaged correctly, and carries the package to the receiver.

Receiver: The receiver, for the purposes of this policy, is the individual who receives the package. This individual is required to have shipping training. The receiver notifies the shipper upon receipt of the planned delivery of high-risk material.

Shippers Declaration Form: The documentation that a high-risk material will be shipped. These documents will be maintained in accordance with all laws, regulations and BU policies including standards for the maintenance of original forms to be maintained by the shipper, the transporter and the receiver.

Qualified Vendor: A vendor who meets or exceeds the criteria in Section 6.

Roles and Responsibilities

EHS

The EHS is responsible for the management and oversight of the Materials Transportation Management Policy and for ensuring compliance with the procedures outlined within this policy by all employees and staff, visiting users of BU facilities and contracted services including associated transporters.

Office of Mail Services

The Office of Mail Services will provide support to EHS and Department of Public Safety with the screening/examination of delivered packages, with the staffing of designated locations, and with the management of contracted services.

Office of Purchasing Services

The Office of Purchasing Services will be responsible for facilitating the selection of contracted service providers who are capable of providing services in accordance with this policy and in compliance with all applicable laws and regulations. The Office of Purchasing Services will select, monitor, manage and discharge all contracted services that are involved in the management and transport of subject materials.

Research Compliance

The Export Control Officer will assist with export license applications, international shipping documentation and will submit classification requests to the respective governmental agency if export classification is unclear.

Department of Public Safety

The Department of Public Safety (DPS) will, through its Investigations Unit, initiate, conduct and/or participate in audits and conduct investigations as necessary. DPS, through its Systems and Operations Units, will be responsible for maintaining the security of locations determined to be appropriate for the receiving, shipping and storage of designated materials as well as the screening and examination of vehicles, packages and personnel. DPS will provide security at the point of receipt of the high hazard material and escort the package from the point of entry to the final destination in the BUMC. Transport of select agents from one location to another outside of a contained area may require security escort to verify that the transporter is BUMC select agent authorized.

Office of Emergency Planning and Response

The Office of Emergency Planning and Response (OEPR) will provide to EHS, Facilities Management and Planning, the Department of Public Safety and members of the Emergency Response Team recommendations related to emergency management planning, training and response coordination. In addition, the OEPR will participate in the development and implementation of emergency response plans, exercises, risk reduction initiatives and risk prevention measures; and serve as the liaison to the Boston Mayor’s Office of Emergency Preparedness, the Massachusetts and Federal Emergency Management Agencies.

The Shipper

The Shipper will be responsible for ensuring that the material being shipped is appropriately packaged including classifying, identifying, marking, labeling and providing appropriate documentation with the package. The shipper must be trained in accordance with all applicable laws, regulations and BU policies including those that address the type and frequency of training and necessity of additional training should laws, regulations or BU policies change at any time.

The Transporter

The Transporter will be required to do the following:

• accept, store, load, inspect and deliver packages to an approved location using approved access routes;
• report any and all violations of law, regulation or policy;
• retain all records;
• and have proper shipping training.

The inspection of packages includes requirements involving

• damage to packages,
• reporting guidelines and immediate communication to the shipper and receiver,
• public health and regulatory authorities.

In addition to these requirements, transport companies may have their own specific safety requirements for subject material transport.

Procedures

Location

EHS and DPS will determine the best location for the receipt, control, audit, transport, and shipping of all items under this policy. Such location(s) will be operated or provided with oversight by representatives of EHS and other related user departments. These areas will be routinely audited. Transport to and from this location will be by major routes of travel that immediately border BUMC and are limited to Albany Street, Massachusetts Avenue and the highway/connector system in the rear of BioSquare.

Training

EHSEnvironmental Health & Safety will train all users of the laws, regulations, polices and requirements involved in the shipping and receiving of subject materials and will manage the tightly controlled, pre-approved, scheduling of shipment and delivery times.

EHS will train all BU users in the approved procedures for the packaging of materials, the approved contracted services to be used in the transport of such materials and the penalties of failing to follow all aspects of this policy.

Background Clearance Check

EHS and DPS will ensure that BU staff involved in the high-risk materials shipping / receiving areas undergo a background clearance check, as appropriate, consistent with the select agent regulatory requirements prior to being approved to work in these locations.

Packaging Requirements

EHS and DPS will determine the packaging requirements to be used in the shipping and receiving of subject materials. These requirements will comply with all applicable regulatory standards. These mandated packaging requirements would only be altered after obtaining any required approval from all relevant regulatory authorities.

Transport of Select Agents

Transport of select agents will be done in accordance with all laws and regulations including the approval from the U.S. Department of Health and Human Services/Center for Disease Control and Prevention (HHS/CDC) or United States Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS), prior to shipment, and notification within 24 hours of receipt.

The transport will also include the utilization of appropriate forms and the reporting of registration numbers of all parties involved in shipping, transporting and receiving packages.

Contractors

EHS, DPS and the Office of Purchasing will select contractors for the transportation of subject materials based on criteria including, but not limited to, the following:

• Past performance on similar contracts.
• Ability to provide services as a qualified vendor for transport of all subject materials.
• Ability to provide transport services in accordance with all applicable regulatory standards.
• Ability to provide transport services in accordance with all applicable BU standards.
• BU requires that the DOT-compliant triple packaging be placed in a non-crushable liquid tight solid container for an added layer of safety.
• BU requires that packages be secured in the vehicle away from potential impact on outer walls.
• Ability to provide staffing that has undergone, and continues to undergo on an annual basis, appropriate background checks.
• Ability to provide courier services that may require that a single individual pick up and deliver packages.
• Ability to provide GPS tracking of packages or vehicles as determined appropriate and approved by BU.
• Ability to provide vehicles that are inspected in accordance with all applicable inspection standards at least every six months.
• Ability to provide customized services that require adherence to BU determined routes of travel, audit procedures and strictly defined schedules for both pick-ups and deliveries.
• Ability to maintain and to provide an all-inclusive chain of custody document upon delivery of each package.
• Ability to provide resources to participate in BU audits of services.
• Any transportation vendor personnel having relative proximity to the package must report all occurrences of illness to the BPHC for a period of three weeks from the delivery departure date.

Tracking Shipments

EHS will schedule all deliveries and will track the delivery with the contracted service performing the transportation by means of contractor-provided tracking methods. BU will initiate its own tracking methods at its discretion and will determine the type of packaging that the shipper, receiver and transportation company uses, and that it is in compliance with all laws and regulations.

Prior to the transport of a shipment to the NEIDL of a select agent, the Director of Emergency Planning and Response will ensure that the appropriate Commonwealth and Boston emergency response departments having jurisdiction are notified.

Off Peak Delivery

EHS will schedule all deliveries to arrive at off peak traffic hours through the City of Boston to ensure transport and reduce the possibility of accident or delay due to traffic congestion.

Clear Loading Dock

DPS will ensure that the loading dock or other facility where the transporter is delivering the high hazard material is free and clear of all parked vehicles to enable safe, secure transfer and receipt. Areas used for deliveries will include secure loading or vehicle inspection areas in which the delivery vehicle can be isolated from movement.

Delayed Receipt

Failure to receive package within the specified time range of delivery will result in an immediate investigation involving the transport contractor, the shipper, BU and all applicable regulatory personnel.

Receipt of Packages

Packages delivered to BU will be inspected, verified, documented and transported to the appropriate location within BU by EHS.

Prior to receipt of the package, the RO will verify with the driver that the package’s integrity is intact. In the event that the package’s integrity is compromised, the transport compartment will be sealed and the transporter’s emergency protocols will be followed.

OEPR will notify all appropriate local response agencies and initiate the BU Emergency Response Plan, the BU Select Agent Incident Response Plan, and Incident Command System.

Problems or Incidents On-Route

The transporter will contact the relevant law enforcement agency having jurisdiction for any problem or incident that may occur during transit or transport of the subject material. The transporter will also notify BU immediately of any such event.

The transporter will ask that the public safety agency having jurisdiction notify the local emergency responders having jurisdiction where any incident occurs.

Upon notification of an incident en route to BU, OEPR will ensure that the local emergency response departments having jurisdiction are notified.

The transporter will have a reputable hazardous materials cleanup contractor available on a 24-hour by seven days a week basis for response for a biological incident mitigation. The contractor will coordinate those mitigation efforts with the local emergency responder incident commander.

Notice of Successful Transport

Upon the successful receipt of a shipment under this policy, OEPR will notify all the appropriate public safety agencies of the conclusion of the transport.

Key References and Resources

• U.S. Department of Health and Human Services, Biosafety in Microbiological and Biomedical Laboratories, 6th Edition, June 2020
• U.S. Department of Transportation, 49 CFR Part 171 Final Rule, 03/18/05
• Current Revised International Air Transport Authority, Dangerous Goods Regulations
• U.S. Public Health Service (HHS)/ CDC 42 CFR Part 73.0, “Possession, Use & Transfer of Select Agents and Toxins,” 03/18/05
• Morbidity and Mortality Weekly Report Vol. 1 No. RR-19, “Laboratory Security and Emergency Response Guidance for Laboratories Working with Select Agents” 12/06/02
• National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Website References

BU EHS
BUMC, Public Safety Department
BU, Purchasing
Centers for Disease Control and Prevention Import Permit Program
Federal Select Agent Program, Laboratory Registration
Federal Express, Dangerous Goods Program
International Air Transport Authority
MA Department of Public Health-State Lab Institute
United Parcel Service, Hazardous Materials Support Center
United States Postal Service
United States Public Health Service
U.S. Department of Transportation
U.S. Department of Commerce