EH&S: Biosafety Manual - Transportation and Transfer of Biological Agents

1. Biological agents include infectious agents of humans, plants, and animals, as well as the toxins that may be produced by microbes and by genetic material potentially hazardous by itself or when introduced into a suitable vector. Etiologic agents and infectious substances are closely related terms that are found in the transfer and transportation regulations. Biological agents may exist as purified and concentrated cultures but may also be present in a variety of materials such as body fluids, tissues, soil samples, etc. Biological agents and the materials that are known or suspected to contain them are recognized by federal and state governments as hazardous materials and their transportation and transfer is subject to regulatory control.

2. Transportation refers to the packaging and shipping of these materials by air, land or sea, generally by a commercial conveyance. Transfer refers to the process of exchanging these materials between facilities.

1. Regulations on the transportation of biological agents are designed to ensure that the public and the workers in the transportation chain are protected from exposure to any agent that might be in the package. Protection is achieved through:

a. The requirements for rigorous packaging that will withstand rough handling and contain all liquid material within the package without leakage to the outside.

b. Appropriate labeling of the package with the biohazard symbol and other labels to alert the workers in the transportation chain to the hazardous contents of the package.

c. Documentation of the hazardous contents of the package should such information be necessary in an emergency situation.

d. Training of workers in the transportation chain to familiarize them with the hazardous contents so as to be able to respond to emergency situations.

a. Public Health Service (PHS). 42 CFR Part 72. Interstate Transportation of Etiologic Agents. A copy of the current regulation may be obtained online at <http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ac.htm>.

b. U.S. Department of Transportation (DOT). 49 CFR Parts 171-178. Hazardous Materials Regulations. This regulation applies to the shipment of both biological agents and clinical specimens.

c. United States Postal Service (USPS). 39 CFR Part 111. Mailability of Etiologic Agents. Codified in the Domestic Mail Manual 124.38: Etiologic Agent Preparations. A copy of the Domestic Mail Manual may be obtained from the Government Printing Office by calling 1-202-512-1800 or online at <http://www.access.gpo.gov>.

d. Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens. Provides minimal packaging and labeling requirements for transfer of blood and body fluids within the laboratory and outside of it.

e. Dangerous Goods Regulations (DGR). International Air Transport Association (IATA). These regulations provide packaging and labeling requirements for infectious substances and materials, as well as clinical specimens that have a low probability of containing an infectious substance. A copy of the DGR may be obtained by calling 1-800-716-6326.

f. General Packaging Requirements for Transport of Biological Agents and Clinical Specimens:

(1) The generalized “triple” packaging (primary receptacle, water-tight secondary packaging and durable outer tertiary packaging) is required for a biological agent of human disease or materials that are known or suspected of containing them. This packaging requires the “Infectious Substance” label on the outside of the package. This packaging must be certified to meet rigorous performance tests as outlined in the DOT, USPS, PHS and IATA regulations.

(2) Clinical specimens with a low probability of containing an infectious agent are also required to be “triple” packaged but performance tests require only that the package shall not leak after a four-foot drop test. DOT, PHS and IATA require a “clinical specimen” label on the outside of the package.

Regulations on the transfer of biological agents are aimed at ensuring that the change in possession of biological materials is within the best interests of the public and the nation. These regulations require documentation of the personnel, facilities and justification of need for the biological agent in the transfer process and subsequent approval of the transfer process by a federal authority.

1. Importation of Etiologic Agents of Human Disease: 42 CFR Part 71 Foreign Quarantine and Part 71.54 Etiologic Agents, Hosts and Vectors. This regulation requires an import permit from the CDC for importing etiologic agents of human disease and any materials, including live animals or insects that may contain them. An application and information on importation permits may be obtained by calling 1-888-CDC-FAXX and enter document number 101000 or online at:

<Permit to Import or Transport Etiologic Agents Hosts or Vectors of Human Diseases

2. Importation of Etiologic Agents of Livestock, Poultry and Other Animal Diseases: 9 CFR Parts 92, 94, 95 96, 122 and 130. These regulations requires an import permit from the USDA, APHIS, Veterinary Services to import or domestically transfer etiologic agents of livestock, poultry, other animals and any materials that might contain these etiologic agents. Information may be obtained at (301) 734-3277 or online at:

<http://www.cdc.gov/od/ohs/biosfty/0753.pdf> [PDF]

3. Importation of Plant Pests: 7 CFR Part 330 Federal Plant Pest Regulations; General; Plant Pests; Soil; Stone and Quarry Products; Garbage. This regulation requires a permit to import or domestically transfer a plant pest, plant biological agent, or any material that might contain them. Information can be obtained by calling 301-734-3277 or online at <http://www.aphis.usda.gov/plant_health/permits/index.shtml>.

4. Transfer of Select Biological Agents of Human Disease: 42 CFR Part 72.6 Additional Requirements for Facilities Transferring or Receiving Select Agents. Facilities transferring or receiving select agents must be registered with the CDC and each transfer of a select agent must be documented. Information may be obtained online at <http://www.cdc.gov/od/ohs/lrsat.htm>.

5. Export of Etiologic Agents of Humans, Animals, Plants and Related Materials: Department of Commerce (DOC). 15 CFR Parts 730 to 799. This regulation requires that exporters of etiologic agents of human, plant and animal diseases, including genetic material, and products that might be used for culture of large amounts of agents, obtain an export license. Information may be obtained by calling the DOC Bureau of Export Administration at 202-482-4811 or online at <http://bxa.fedworld.gov>.

Note: documents in Portable Document Format (PDF) require Adobe Acrobat Reader 5.0 or higher to view; download Adobe Acrobat Reader.


	Business and Financial Affairs > Environmental Health and Safety > Biosafety Program > Biosafety Manual > Contents >
	Environmental Health and Safety SDSU Biosafety Manual San Diego State University BIOHAZARD CONTROL PROGRAM Part XVIII: Transportation and Transfer of Biological Agents A. INTRODUCTION B. TRANSPORTATION C. TRANSFER A. INTRODUCTION 1. Biological agents include infectious agents of humans, plants, and animals, as well as the toxins that may be produced by microbes and by genetic material potentially hazardous by itself or when introduced into a suitable vector. Etiologic agents and infectious substances are closely related terms that are found in the transfer and transportation regulations. Biological agents may exist as purified and concentrated cultures but may also be present in a variety of materials such as body fluids, tissues, soil samples, etc. Biological agents and the materials that are known or suspected to contain them are recognized by federal and state governments as hazardous materials and their transportation and transfer is subject to regulatory control. 2. Transportation refers to the packaging and shipping of these materials by air, land or sea, generally by a commercial conveyance. Transfer refers to the process of exchanging these materials between facilities. B. TRANSPORTATION 1. Regulations on the transportation of biological agents are designed to ensure that the public and the workers in the transportation chain are protected from exposure to any agent that might be in the package. Protection is achieved through: a. The requirements for rigorous packaging that will withstand rough handling and contain all liquid material within the package without leakage to the outside. b. Appropriate labeling of the package with the biohazard symbol and other labels to alert the workers in the transportation chain to the hazardous contents of the package. c. Documentation of the hazardous contents of the package should such information be necessary in an emergency situation. d. Training of workers in the transportation chain to familiarize them with the hazardous contents so as to be able to respond to emergency situations. 2. Regulations: a. Public Health Service (PHS). 42 CFR Part 72. Interstate Transportation of Etiologic Agents. A copy of the current regulation may be obtained online at <http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ac.htm>. b. U.S. Department of Transportation (DOT). 49 CFR Parts 171-178. Hazardous Materials Regulations. This regulation applies to the shipment of both biological agents and clinical specimens. c. United States Postal Service (USPS). 39 CFR Part 111. Mailability of Etiologic Agents. Codified in the Domestic Mail Manual 124.38: Etiologic Agent Preparations. A copy of the Domestic Mail Manual may be obtained from the Government Printing Office by calling 1-202-512-1800 or online at <http://www.access.gpo.gov>. d. Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens. Provides minimal packaging and labeling requirements for transfer of blood and body fluids within the laboratory and outside of it. e. Dangerous Goods Regulations (DGR). International Air Transport Association (IATA). These regulations provide packaging and labeling requirements for infectious substances and materials, as well as clinical specimens that have a low probability of containing an infectious substance. A copy of the DGR may be obtained by calling 1-800-716-6326. f. General Packaging Requirements for Transport of Biological Agents and Clinical Specimens: (1) The generalized “triple” packaging (primary receptacle, water-tight secondary packaging and durable outer tertiary packaging) is required for a biological agent of human disease or materials that are known or suspected of containing them. This packaging requires the “Infectious Substance” label on the outside of the package. This packaging must be certified to meet rigorous performance tests as outlined in the DOT, USPS, PHS and IATA regulations. (2) Clinical specimens with a low probability of containing an infectious agent are also required to be “triple” packaged but performance tests require only that the package shall not leak after a four-foot drop test. DOT, PHS and IATA require a “clinical specimen” label on the outside of the package. C. TRANSFER Regulations on the transfer of biological agents are aimed at ensuring that the change in possession of biological materials is within the best interests of the public and the nation. These regulations require documentation of the personnel, facilities and justification of need for the biological agent in the transfer process and subsequent approval of the transfer process by a federal authority. The following regulations fit in this category: 1. Importation of Etiologic Agents of Human Disease: 42 CFR Part 71 Foreign Quarantine and Part 71.54 Etiologic Agents, Hosts and Vectors. This regulation requires an import permit from the CDC for importing etiologic agents of human disease and any materials, including live animals or insects that may contain them. An application and information on importation permits may be obtained by calling 1-888-CDC-FAXX and enter document number 101000 or online at: <Permit to Import or Transport Etiologic Agents Hosts or Vectors of Human Diseases 2. Importation of Etiologic Agents of Livestock, Poultry and Other Animal Diseases: 9 CFR Parts 92, 94, 95 96, 122 and 130. These regulations requires an import permit from the USDA, APHIS, Veterinary Services to import or domestically transfer etiologic agents of livestock, poultry, other animals and any materials that might contain these etiologic agents. Information may be obtained at (301) 734-3277 or online at: <http://www.cdc.gov/od/ohs/biosfty/0753.pdf> [PDF] 3. Importation of Plant Pests: 7 CFR Part 330 Federal Plant Pest Regulations; General; Plant Pests; Soil; Stone and Quarry Products; Garbage. This regulation requires a permit to import or domestically transfer a plant pest, plant biological agent, or any material that might contain them. Information can be obtained by calling 301-734-3277 or online at <http://www.aphis.usda.gov/plant_health/permits/index.shtml>. 4. Transfer of Select Biological Agents of Human Disease: 42 CFR Part 72.6 Additional Requirements for Facilities Transferring or Receiving Select Agents. Facilities transferring or receiving select agents must be registered with the CDC and each transfer of a select agent must be documented. Information may be obtained online at <http://www.cdc.gov/od/ohs/lrsat.htm>. 5. Export of Etiologic Agents of Humans, Animals, Plants and Related Materials: Department of Commerce (DOC). 15 CFR Parts 730 to 799. This regulation requires that exporters of etiologic agents of human, plant and animal diseases, including genetic material, and products that might be used for culture of large amounts of agents, obtain an export license. Information may be obtained by calling the DOC Bureau of Export Administration at 202-482-4811 or online at <http://bxa.fedworld.gov>. Note: documents in Portable Document Format (PDF) require Adobe Acrobat Reader 5.0 or higher to view; download Adobe Acrobat Reader.
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Environmental Health and Safety

SDSU Biosafety Manual

Part XVIII: Transportation and Transfer of Biological Agents

Part XVIII:
Transportation and Transfer of Biological Agents