CHAPTER 9

BIOLOGICAL SAFETY

5.0 TRANSPORTATION AND TRANSFER OF BIOLOGICAL AGENTS

 

5.1  Introduction

5.2  Transportation

5.3  Regulations

5.4  General Packaging Requirements for Transport of Biological Agents and Clinical Specimens

5.5  Shipment

5.6  Transportation and Transfer of Biological Material on Campus

5.7  SOP for Shipments of Select Agents


5.1       Introduction

Biological agents include infectious agents of humans, plants, and animals, as well as toxins that may be produced by microbes or 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. 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.

 

5.2       Transportation

Regulations on the transportation of biological agents are aimed at ensuring 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) rigorous packaging that will withstand rough handling and contain all liquid material within the package without leakage, (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, and (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.

Transportation of select agents is strictly regulated. No individual laboratory is allowed to receive or ship select agent material directly into the laboratory. 

 

5.3       Regulations

·         US Public Health Service (USPHS) 42 CFR Part 72. Interstate Transportation of Etiologic Agents. This regulation is in revision to harmonize it with the other U.S. and international regulations. A copy of the current regulation may be obtained from the Internet at:

http://www.cdc.gov/od/ohs or http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1. 

·         Department of Transportation. 49 CFR Parts 171-178. Hazardous Materials Regulations.  This regulation applies to the shipment of both biological agents and clinical specimens.  Information may be obtained from the Internet at:

http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1.

·         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 from the Internet at:

http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1.

·         Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens.  This standard provides minimal packaging and labeling requirements for transport of blood and body fluids within the laboratory and outside of it. Information may be obtained from your local OSHA office or from the Internet:

 http://www.osha.gov or http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

·         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. These are the regulations followed by the airlines. These regulations are derived from the Committee of Experts on the Transport of Dangerous Goods, United Nations Secretariat, and the Technical Instructions for the Transport of Dangerous Goods by air, which is provided by the International Civil Aviation Organization (ICAO). A copy of the DGR may be obtained by calling 1-800-716-6326 or through the Internet at:

http://www.iata.org , or http://www.who.org

 

5.4       General Packaging Requirements for Transport of Biological Agents and Clinical Specimens

Annex 3 shows the generalized "triple" (primary receptacle, water tight secondary packaging, durable outer packaging) packaging 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 shown in Figure 2 on the outside of the package.  This packaging must be certified to meet rigorous performance tests as outlined in the USDOT, USPS, USPHS, and IATA regulations.  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. USDOT, USPHS, and IATA require a "clinical specimen" label on the outside of the package.

 

5.5       Shipment

Regulations on the shipment 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 shipment and subsequent approval of the transfer process by a federal authority. The following regulations fit in this category:  

 

Importation of Etiologic Agents of Human Disease 

42 CFR Part 71 Foreign Quarantine. Part 71.54 Etiologic Agents, Hosts and Vectors. This regulation requires an import permit from the Centers for Disease Control and Prevention 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 on the Internet at:

 http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1.

 

Importation of Etiologic Agents of Livestock, Poultry and Other Animal Diseases  

9 CFR Parts 92, 94, 95 96, 122 and 130. These regulations require an import permit from the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (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 from the Internet at:

http://aphisweb.aphis.usda.gov or http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1    

 

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 through the Internet at:

http://www.aphis.usda.gov./ppq/.or http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1  

 

Transfer of Select Biological Agents of Human Disease  

42 CFR Part 73.16 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 on the Internet

at: http://www.cdc.gov/od/ohs/ or http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1    

 

Export of Etiologic Agents of Humans, Animals, Plants and Related Materials 

Department of Commerce. 15 CFR Parts 730 to 799. This regulation requires that exporters of a wide variety of etiologic agents of human, plant and animal diseases, including genetic material, and products which might be used for culture of large amounts of agents, will require an export license.  Information may be obtained by calling the DoC Bureau of Export Administration at 202-482-4811 or through the Internet at: http://bxa.fedworld.gov  or http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1

  

Shipment 

For further information on any provision of this regulation contact:

Centers for Disease Control and Prevention

Attn: External Activities Program

Mail Stop F-05

1600 Clifton Road N.E.

Atlanta, GA 30333

Telephone: (404) 639-4418

FAX: (404) 639-2294

 

IATA Guidance Document Infectious Substances

Note: 1. The following Guidance Document was developed by the ICAO DGP. The original ICAO document reflects references to the ICAO Technical Instructions these have been amended to reflect the references applicable to the 49th Edition (2008) of the IATA Dangerous Goods Regulations (DGR).

Introduction

Provisions applicable to the classification of Infectious Substances were extensively revised and then published in the 13th and 14th revised editions of the UN Recommendation on the Transport of Dangerous Goods (Model Regulations). The revised provisions were developed in coordination with experts from the World Health Organization (WHO) and other technical experts in the field of transport, packaging and health.

The purpose of this document is to provide guidance for complying with provisions applicable to the transport by air of infectious substances as set out in the DGR. Specifically the document provides guidance on:  

• Definitions

• Classification

• Exceptions

• Packaging Provisions for Infectious Substances, affecting humans or animals, UN 2814 or UN 2900

• Packaging Provisions for Biological Substances, Category B, UN 3373

• Packaging for Exempt Patient Specimens

• Prohibitions

• Passenger Provisions

• Training and Emergency Response 

Definitions

Infectious substances are substances which are known to contain, or are 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.

Cultures are the result of a process by which pathogens are intentionally propagated. This definition does not include human or animal patient specimens.

Patient specimens are those 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 purposes such as research, diagnosis, investigational activities, disease treatment and prevention.

Medical or clinical wastes are wastes derived from the medical treatment of animals or humans or from bio-research.

Classification

For transport purposes the classification of infectious substances according to risk groups was removed from the DGR in the 46th edition (2005).

Infectious substances are now classified either as Category A or Category B.

There is no direct relationship between Risk Groups and categories A and B.

Category A Infectious Substances are infectious substances in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. They are assigned the following UN numbers and proper shipping names:  

. • UN 2814 – Infectious Substance, affecting humans; or  

. • UN 2900 – Infectious Substance, affecting animals only.  

Assignment to UN 2814 or UN 2900 is to be based on the known medical history and symptoms of the source human or animal, endemic local conditions, or professional judgment concerning individual circumstances of the source human or animal. If there is any doubt as to whether or not a pathogen falls within this category it must be transported as a Category A Infectious Substance.

Clinical wastes containing Category A infectious substances must be assigned to UN 2814 or UN 2900, as appropriate.

To assist in the assignment of an infectious substance into Category A see the Indicative List provided in Table 3.6.D in the DGR. That list, however is not exhaustive. Infectious substances, including new or emerging pathogens, which do not appear in the table but which meet the same criteria must be assigned to Category A.

Category B Infectious Substances are Infectious Substances that do not meet the criteria for inclusion in Category A. They are assigned the following UN number and proper shipping name:

• UN 3373 – Biological Substance, Category B

Clinical wastes containing Category B infectious substances must be assigned to UN 3291.

Further assistance on the classification of infectious substances can be obtained from the national health or veterinary authority. (See Annex 1, for Classification Scenarios and Annex 2, for a Classification Flowchart.)

Exceptions  

. • Substances, which do not contain infectious substances, or substances, which are unlikely to cause disease in humans or animals, are not subject to the IATA DGR unless they meet the criteria for inclusion in another class.  

. • Substances containing micro-organisms, which are non-pathogenic to humans or animals are not subject to the DGR unless they meet the criteria for inclusion in another class.  

. • Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to the DGR unless they meet the criteria for inclusion in another class.  

. • Environmental samples (including food and water samples), which are not considered to pose a significant risk of infection, are not subject to the DGR unless they meet the criteria for inclusion in another class.  

. • Dried blood spots, collected by applying a drop of blood onto absorbent material; faecal occult blood screening tests; or blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation are not subject to the DGR.  

. • Patient specimens for which there is minimal likelihood that pathogens are present are not subject to the DGR if the specimen is transported in Packaging for Exempt Patient Specimens (see below for the Packaging requirements for Exempt Patient Specimens).

Note:

In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgment is required. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. Examples of specimens which may be transported as a patient specimen for which there is a minimal likelihood that pathogens are present include blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antigens PSA); tests required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or therapeutic drug monitoring; tests conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy tests; biopsies to detect cancer; and antibody detection in humans or animals.

Packaging for Exempt Patient Specimens

Patient specimens (human or animal) that have a minimal likelihood of containing pathogens must be packaged appropriately to further minimize the risk of exposure. While these specimens have a minimal likelihood of containing infectious pathogens in a form that would cause infection, appropriate packaging further minimizes the risk of exposure. Exempt human or animal specimens must be packaged and marked according to the following:

(i) a leak-proof primary receptacle(s);

(ii) a leak-proof secondary packaging; and

(iii) an outer packaging of adequate strength for its capacity, mass and intended use, and with at least one surface having minimum dimensions of 100 mm Χ 100 mm;

For liquids, absorbent material in sufficient quantity to absorb the entire contents must be placed between the primary receptacle(s) and the secondary packaging so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material. When multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. If such a packaging is used it must be marked "Exempt human specimen" or "Exempt animal specimen", as appropriate. (See Annex 5, for a graphic depiction of an Exempt Patient Specimen Packaging)

If other dangerous goods are present with patient specimens the relevant provisions of the DGR apply to those goods.

When dangerous goods intended for air transport are carried by surface transport to or from an airport, any other applicable national or modal transport requirements should be met in addition to those that are applicable for the goods when carried by air.  

 

Packaging Provisions for Infectious Substances, humans or animals, UN 2814 or UN

Packing Instruction 602 in the DGR specifies the type of packaging required for all Category A infectious substances. All other applicable provisions of the DGR apply (See Annex 3 for a graphic depiction of a package containing category A infectious substances).

Packaging Provisions for Biological Substances, Category B, Clinical Specimens, Diagnostic Specimens, UN 3373

Packing Instruction 650 in the DGR provides all the information necessary to prepare and transport Category B infectious substances (See Annex 4, for a graphic depiction of a package containing category B infectious substances).  

Prohibitions

A live animal that has been intentionally infected and is known or suspected to contain an infectious substance must not be transported by air unless the infectious substance contained cannot be consigned by any other means. Infected animals may only be transported under terms and conditions approved by the appropriate national authority.

Passenger Provisions

Category A or B Infectious Substances are not permitted for transport in carry-on or checked baggage and must not be carried on a person. Packages containing Exempt human or animal specimens may be carried in checked or carry-on baggage provided that they meet the applicable packaging requirements.

Training and Emergency Response

Effective employee training and appropriate emergency response procedures are required to significantly minimize the risk of exposure and subsequent transmission of infection or disease.  

Mitigation procedure:

DO NOT CLEAN-UP OR DISPOSE OF INFECTIOUS SUBSTANCES, EXCEPT UNDER SUPERVISION OF A SPECIALIST.

- Isolate spill or leak area immediately.

- Keep unauthorized personnel away.

- Obtain identity of substance involved if possible and report the spill to the appropriate authorities.

- Do not touch or walk through spilled material.

- Do not touch damaged containers or spilled material unless wearing appropriate protective clothing.

- Be particularly careful to avoid contact with broken glass or sharp objects that may cause cuts or abrasions that could significantly increase the risk of exposure.

- Damaged packages containing solid CO2 (dry ice) used as a refrigerant may produce water or frost from condensation of air. Do not touch this liquid as it could be contaminated by the contents of the parcel.

- Liquid nitrogen may be present and can cause severe burns.

- Absorb spilled materials with earth, sand or other non-combustible material while avoiding direct contact.

- Cover damaged package or spilled material with damp towel or rag and keep wet with liquid bleach or other disinfectant. Liquid bleach will generally effectively inactivate the released substance.  

First Aid:

- Move exposed person(s) to a safe isolated area.

CAUTION: Exposed person(s) may be a source of contamination. Persons administering first aid should take precautions to avoid personal exposure or secondary contamination of others.

- Call emergency medical services.

- If clothing and/or shoes are significantly contaminated, remove and isolate them. However, do not allow this to delay other first aid interventions.

- In case of contact of the substance to skin, eyes, nose or mouth, immediately flush the exposed area with copious amounts of running water. Continue this until emergency medical services arrives. Follow their advice for further decontamination.

- Most effects of exposure (inhalation, ingestion or skin contact) to substance are likely to be delayed.

- Ensure that medical personnel are aware of the substances involved so they can take precautions to protect themselves.

For further assistance, contact the appropriate public health authority.

 

5.6       Transportation and Transfer of Biological Material on Campus

When moving material on campus the package will be put in secondary leak proof containment and clearly marked with the appropriate biohazard signs. All efforts will be made to prevent a spill or aerosol. The outer container needs to be properly surface decontaminated and the agent will never be left unattended while in transit between laboratories. The biohazard level of the agent needs to be respected; you may not take a biohazard agent in a laboratory that is of lower containment specification even if the secondary container is not opened in that laboratory (e.g. BSL3 agents may not be brought into a BSL2 laboratory).   

Transportation of select agent on campus is not regulated but needs to be documented and records kept in the laboratories. Transfer of select agent material needs to be approved by EHS, laboratories receiving select agent material need to be approved to do so and follow the proper regulation of select agent possession. Documentation of this transfer needs to be kept in the laboratory.

 

5.7       SOP for Shipments of Select Agents

Note:   Shipments must be packed by a DOT/IATA trained and certified person

            Select agents will be shipped on a Monday, Tuesday or Wednesday only.  

            Shipments are sent and received by EHS                       

Shipments will not occur during the winter holiday season when the University is closed. Black out dates will vary.  Contact EHS before arranging shipments in or out of campus.

 

ANNEX 1 - Classification Scenarios

 

1. A blood sample known or reasonably suspected to contain EBOLA VIRUS. Appropriate classification: Infectious substances, affecting humans UN 2814.  

2. A culture of FOOT AND MOUTH DISEASE. Appropriate classification: Infectious substances, affecting animals, UN 2900.  

3. A blood sample taken from a patient known or suspected to have a category B pathogen, such as HEPATITIS B or HIV. Appropriate classification: Biological substance, category B, UN 3373.  

4. Culture of BOVINE TUBERCULOSIS. Appropriate classification: Biological substance, category B, UN 3373.  

5. Laboratory stock culture of a pathogen in category B, e.g. INFLUENZA VIRUS. Appropriate classification: Biological substance, category B, UN 3373. Specimen containing a category A or B infectious substance, treated so as to inactivate or neutralise the pathogens such that they no longer pose a health risk. Appropriate classification: Not subject to the transport requirements for dangerous goods, unless meeting the criteria for another class or division.  

6. Patient specimens other than those known or reasonably suspected to contain a category A infectious substance e.g. those sent for testing for Cholesterol (blood), diabetes (urine), bowel cancer (faecal).Appropriate classification: this will depend on professional judgment, i.e.:  

i. If a professional judgment is made that there is only a minimal likelihood that pathogens are present, the specimen is not subject to the provisions of the DGR, provided they are packed in accordance with the provisions detailed under “Packaging for Exempt Patient Specimens” in this Guidance Document;  

ii. If no professional judgment is made, the specimen must be classified as UN3373.  

 

ANNEX 2 – Classification Flowchart

 

 

 

 

 

 

 

ANNEX 3

Example of Packing and Marking for Category A Infectious Substances

(See Packing Instruction 602 for additional requirements)

 

 

 

 

Notes:

 

   

ANNEX 4

Example of Packing and Marking for Category B Infectious Substances

 (See Packing Instruction 650 for additional requirements, e.g. drop test)

 

 

 

Notes:

 

ANNEX 5

Example of Packing and Marking for Exempt Specimens

 

Notes: