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Home > Biosafety > Biosafety Manual > Shipping, Transfer or Disposal of Biological Materials > Shipping > Guidelines for Shipping/Receiving Biological Materials

Guidelines for Shipping/Receiving Biological Materials

Table of Contents

  1. Introduction
  2. Training Requirements
  3. Permits to Receive Biological Material
    1. USDA/APHIS transport Permits ( United States Department of Agriculture/Animal & Plant Health Inspection Service)
    2. Centers For Disease Control (CDC)
    3. Phytosanitary Certificate
    4. Material Transfer Agreement
  4. Classification of Hazardous Material
    1. Category A Infectious Substances
    2. Category B Infectious Substance (Previously Called Diagnostic/Clinical Specimens)
    3. Non-infectious Exempt Patient Specimens
    4. Toxins
    5. Genetically Modified Organisms (GMOs)
    6. Select Agents
  5. Packing Instructions
    1. Category A Infectious Substance: Packing Instruction 620
    2. Category B Infectious Substance (Previously Called Diagnostic/Clinical Specimens): Packing Instruction 650
    3. Non-infectious Exempt Patient Specimens
    4. Toxins
    5. Genetically Modified Organisms: Packing Instructions 959
    6. Dry ice: Packing Instruction 954
    7. Liquid Nitrogen
    8. Transporting Infectious Substances Safely
    9. New Excepted Quantities Labels 2009
  6. International Shipment Regulations and Permits
    1. United States Department of Agriculture/Animal & Plant Health Inspection Service (USDA/APHIS)
    2. Department of Commerce
    3. U.S. Fish and Wildlife
    4. Food and Drug Administration (FDA)
    5. Canadian Import Regulations
  7. Receipt of Leaking or Damaged Package
    1. Leaking or Damaged Package
    2. Suspicious Package
  8. Transporting Infectious Substances by Ground
    1. Packaging and Training Requirements
    2. Means of Transport
  9. Appendices

    Appendix 1 - Materials Exempt From USDA/APHIS Import/Transport Permits
    Appendix 2 - Center For Veterinary Biologics Notice No. 02-15
    Appendix 3 - Application For Permit To Import/Transport Controlled Material Or Organisms Or Vectors
    Appendix 4 - Sample Importation Notification Letter
    Appendix 5 - Sample Interstate Movement Letter
    Appendix 6 - Application for Permit to Import of Transport Agents or Vectors of Human Disease
    Appendix 7 - Examples of Infectious Substances Included in Category A
    Appendix 8 - Record of Transfer of Select Agent
    Appendix 9 - Summary of IATA (International Air Transport Association) Shipping Information
    Appendix 10 - USDA/APHIS Courtesy Form Letter
    Appendix 11 - USDA/APHIS Application for Courtesy Permit
    Appendix 12 - How to Recognize and Handle a Suspicious Package or Envelope
    Appendix 13 - Infectious Substance Classification Flow Chart
    Appendix 14 - Shipper's Declaration of Dangerous Goods  (Note: must use proprietory software to fill these out call (612) 626-1604)
    Appendix 15 - Transporting Infectious Substances Safely
    Appendix 16 - Sample of a Customs Courtesy Letter
    Appendix 17 - New Excepted Quantities Labels 2009

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I. Introduction

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.

II. Training Requirements

If you seldom ship Category A or B Infectious Substances, or on dry ice, or toxins you may ask Environmental Health and Safety HazMat Shipping Program to ship the material for you.

If you regularly ship Category A or B Infectious Substances (see Appendix 13 Infectious Substance Classification Flow Chart) or 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. Environmental Health and Safety offers a quarterly hazardous material shipping class.

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.

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III. Permits to Receive Biological Materials

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.

Transportation of Infectious Substances Appendix C of the BMBL (Biosafety in Microbiological and Biomedical Laboratories), http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_appendixC.pdf and http://www.aphis.usda.gov/import_export/index.shtml

See ePermits for USDA/APHIS Import and transport permits. CDC regulations may apply to human and non-human primate samples excepted in Appendix 1, see Section B below.

USDA Import Guidelines For Products That Do Not Require An Import Permit

Animal Related

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." http://www.access.gpo.gov/nara/cfr/waisidx_03/9cfrv1_03.html.

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 http://www.aphis.usda.gov/import_export/index.shtml

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 ."

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Plant Related

USDA/APHIS regulation 7 CFR Part 330 Federal Plant Pest Regulations covers the transport of plant pests (http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid=d3893c775af403b08c654c1f15a669be&c=ecfr&tpl=/ecfrbrowse/Title07/7tab_02.tpl). For information on plant pest transport permits see http://www.aphis.usda.gov/permits/ppq_epermits.shtml. For information on plant and plant product transport permits see http://www.aphis.usda.gov/permits/ppq_epermits.shtml.

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

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. See Appendix 4 & Appendix 5 for examples of Interstate Movement and Importation notification letters for genetically engineered plants and microorganisms.

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.

Human infectious substances. 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 at http://www.cdc.gov/od/eaipp/ 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 http://www.atcc.org/Order/permits.cfm.

C. Phytosanitary Certificate

A phytosanitary certificate is a document often required by many states and foreign countries for the import of nonprocessed, plant products, http://www.aphis.usda.gov/import_export/plants/plant_exports/pcit.shtml

D. Material Transfer Agreement

Materials Transfer Agreements

OTC handles all outgoing Material Transfer Agreements. The process is as follows:

  1. The U of M provider scientist fills out the outgoing MTA Request Form (MTARF). The form can be found on our website: http://www.research.umn.edu/techcomm/request.html
  2. The completed form is sent to the OTC contracts group via email at: otcagree@umn.edu
  3. The contracts group takes the information provided on the MTARF and creates a draft Material Transfer Agreement that is sent to the recipient for review/execution.
  4. Once the OTC office receives the signed agreement from the recipient, they will send a copy of the fully executed agreement to the providing scientist and the recipient via email. This email notifies the U of M scientist that the materials can now be sent.

Sponsored Projects Administration (SPA) handles all incoming Material Transfer Agreements. Contact Duane Oyen at doyen@umn.edu or 612-625-8826 for details. See the SPA web page for more information. http://www.ospa.umn.edu/policiesandprocedures/MTAs/receivingmaterial.html

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IV. Classification of Hazardous Material

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.

See Appendix 13 Infectious Substance Classification Flow chart to help determine if a material falls under Category A or B Infectious Substances.

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:

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.

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A. Category A Infectious Substances

Infectious substances are materials which 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 this criteria must be shipped as Category A. See Appendix 7 for examples of Category A agents.

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 Substabces 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 7 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. See Shipping Exempt Patient Specimens fact sheet.

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 can not 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, see Shipping Exempt Patient Specimens fact sheet.

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D. Toxins

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 micro-organisms (GMMOs) and genetically modified organisms (GMOs) are micro-organisms 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:

See the Shipping GMO Fact Sheet to help determine which classification a GMO falls under.

Individual countries have strict regulations regarding GMOs. Be sure to become informed of the receiving country's regulations.

F. Select Agents

The federal government regulates the use, handling, and transport of certain biological materials considered to be potential bioterrorism agents. See the select agents list to determine if a material is considered a Select Agent.

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, http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf, the USDA's Agricultural Bioterrorism Protection Act, and university policy.

Notify the university's Biosafety Officer at 626-6002 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. DEHS 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.

Steps to ship a Select Agent:

Steps to receive a Select Agent:

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Federally Exempt Quantities of Select Agent Toxins

Contact DEHS 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 DEHS in order to keep the university's biological material inventory up-to-date. Report to DEHS how much toxin is shipped, when it was shipped, and to whom it was shipped. Also report the disposal of all Select Agent Toxin quantities.

On Campus Transfer of Select Agents

Follow all transfer of biological material guidelines in Section VIII. In addition:

V. Packing Instructions

The material presented in this section is meant as a supplement to the Hazardous Material Shipping class. It is not a substitute for the class. 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. See Appendix 9 for a summary of shipment types, proper shipping names, UN numbers, hazard class, and packing instruction numbers. For complete details on acceptable packaging, required labels, maximum quantity per package, and filling out the Shipper's Declaration for Dangerous Goods, attend a Hazardous Material Shipping class.

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

To ship category A substances you MUST have attended a Category A training session within the last two years. 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.
Note: In order to save your filled out Declaration of Dangerous Goods you need to use Adobe Acrobat Professional.

Packaging material required for Packing Instruction 620 can be purchased from several venders including Label Master.

General Requirements

Shipping Training within the last two years

Inner Packaging Requirements

Outer Packaging Requirements

A shipping checklist for Category A Dangerous Goods (must be non-radioactive) is available.

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B. Category B Infectious Sustances (Previously Called Diagnostic/Clinical Specimens): Packing Instruction 650

Shipping Training within the last two years is required.

2013 Shipping checklist for preparing shipments
Note: please choose English Non-Radioactive Checklist 2012 in order to access checklist.

Shipments of Category B Infectious Substances do not require a a Dangerous Goods Declaration.

Packaging material required for Packing Instruction 650 can be purchased from several venders including Label Master.

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 a:

The completed package must be capable of passing a drop test of of at least 1.2 meters. An itemized list of contents must be enclosed between the secondary packaging and the outer packaging. For complete details on package requirements see Packing Instruction 650.

New for 2006:

C. Non-infectious Exempt Patient Specimens

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D. Toxins: Packing Instructions Vary

Shipping Training within the last two years is required.

Biologically-derived toxins which 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 excepted 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" can not 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

IATA regulated GMOs fall under Hazard Class 9, UN3245 and must follow Packing Instruction 959.

F. Dry Ice: Packing Instruction 954

Shipping Training within the last two years is required.

G. Liquid Nitrogen

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. Contact DEHS for additional training on shipping biological materials with a "dry shipper". For further information, see University of Washington EH&S "Tips for Dry Shipping".

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H. Transporting Infectious Substances Safely

FedEx - General guidelines for packaging, marking and labeling clinical samples and biological substance, Category B, http://www.fedex.com/us/services/packageshipment/index.html?CMP=PAC-GTS-VURL008 (see Pack like a Pro in menu bar)

I. New Excepted Quantities Labels 2009

See New Excepted Quantities Labels 2009 at Appendix 17

VI. International Shipment Regulations and Permits

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 University's Export Controls Officer to conduct a separate review to determine if a BIS export license is required. The Export Controls Officer is Patrick Briscoe (612-625-3860, bris0022@umn.edu)

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.

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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 http://www.fws.gov/permits/ 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 http://www.fda.gov/ora/import/ 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, http://www.tc.gc.ca/eng/tdg/clear-tofc-211.htm.

VII. Receipt of Leaking, Damaged, or Suspicious Packages

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 the university's Biosafey Officer at 626-6002 to:

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 Appendix 12 or CDC Web site http://www.bt.cdc.gov/DocumentsApp/HAN50.pdf for guidelines on handling suspicious packages or envelopes.

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VIII. Transporting Infectious Substances by Ground

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 which 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).

You will find the following on this page:

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 (excludes hand-carry, see Transport (hand-carry)...):

Category A: It's 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.

Training is required every two years. Contact DEHS (612-626-6002) before planning to ship any Category A Infectious Substance.

Category B: must follow the IATA/DOT Packaging Instruction, PI 650.
Training is required every two years.

Exempt Patient/Animal Specimens2:

Dry Ice: Package must be labeled “Dry Ice” on two sides. No Training requirements for Ground. (Training is required every two years if shipping by air).

B. Means of Transport

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 (e.g., UMN BUSES, SHUTTLES, Twin Cities buses, private taxis, LRT etc.) 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

  1. have a valid driver’s license,
  2. be authorized to use a University vehicle,
  3. use the proper containment and packaging materials en-route and
  4. be trained and authorized to handle and transport hazardous materials within University property.
  5. should use a University vehicle when available.

DEHS encourages the use of university-owned vehicles rather than personal vehicles when transporting materials off grounds to another UMN facility or collaborator*. Accidents during movement or transportation of any of these materials can result in serious harm to persons and property. Release and spills of these materials may involve police and HazMat responders including clean-up and cost of recovery. The University also operates a courier service for transport for a nominal fee.

*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 DEHS (612-626-6002) for consultation.

PIs must participate in Hazardous Shipper Training before selecting a carrier or transporting material. 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:

Transport of Animals between University labs or buildings through public areas

References

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:

3) Important Shipping Information Links

Federal Aviation Administration, Dangerous Goods Program
Federal Motor Carrier Safety Administration, US Department of Transportation
International Air Transport Association
Office of Research Serivices, 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 packagings, 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 Virginia Biosafety website and used with their permission. http://ehs.virginia.edu/biosafety/bio.transport.ground.html

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