Office of Research

Shipping of Infectious Substances

The Department of Transportation regulates shipment of infectious substances by commercial carrier through 49CFR173.134 as follows.

Title 49: Transportation 
PART 173—SHIPPERS—GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS 
 § 173.134   Class 6, Division 6.2—Definitions and exceptions.

(a) Definitions and classification criteria. For the purposes of this subchapter, the following definitions and classification criteria apply to Division 6.2 materials.

(1) Division 6.2 (Infectious substance) means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion) that can cause disease in humans or animals. An infectious substance must be assigned the identification number UN 2814, UN 2900, UN 3373, or UN 3291 as appropriate, and must be assigned to one of the following categories:

(i) Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. A Category A infectious substance must be assigned to identification number UN 2814 or UN 2900, as appropriate. Assignment to UN 2814 or UN 2900 must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal.

(ii) Category B: An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes. A Category B infectious substance must be described as “Biological substance, Category B” and assigned identification number UN 3373. This does not include regulated medical waste, which must be assigned identification number UN 3291.

(2) Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals. A biological product includes a material subject to regulation under 42 U.S.C. 262 or 21 U.S.C. 151-159. Unless otherwise excepted, a biological product known or reasonably expected to contain a pathogen that meets the definition of a Category A or B infectious substance must be assigned the identification number UN 2814, UN 2900, or UN 3373, as appropriate.

(3) Culture means an infectious substance containing a pathogen that is intentionally propagated. Culture does not include a human or animal patient specimen as defined in paragraph (a) (4) of this section.

(4) Patient specimen means human or animal material collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts and specimens in transport media (e.g. transwabs, culture media, and blood culture bottles).

(5) Regulated medical waste or clinical waste or (bio) medical waste means a waste or reusable material derived from the medical treatment of an animal or human, which includes diagnosis and immunization, or from biomedical research, which includes the production and testing of biological products. Regulated medical waste or clinical waste or (bio) medical waste containing a Category A infectious substance must be classed as an infectious substance, and assigned to UN2814 or UN2900, as appropriate.

(6) Sharps means any object contaminated with a pathogen or that may become contaminated with a pathogen through handling or during transportation and also capable of cutting or penetrating skin or a packaging material. Sharps includes needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires.

(7) Toxin means a Division 6.1 material from a plant, animal, or bacterial source. A toxin containing an infectious substance or a toxin contained in an infectious substance must be classed as Division 6.2, described as an infectious substance, and assigned to UN 2814 or UN 2900, as appropriate.

(8) Used health care product means a medical, diagnostic, or research device or piece of equipment, or a personal care product used by consumers, medical professionals, or pharmaceutical providers that does not meet the definition of a patient specimen, biological product, or regulated medical waste, is contaminated with potentially infectious body fluids or materials, and is not decontaminated or disinfected to remove or mitigate the infectious hazard prior to transportation.

Note the following EXCEPTIONS.

(b) Exceptions. The following are not subject to the requirements of this subchapter as Division 6.2 materials:

(1) A material that does not contain an infectious substance or that is unlikely to cause disease in humans or animals.

(2) Non-infectious biological materials from humans, animals, or plants. Examples include non-infectious cells, tissue cultures, blood or plasma from individuals not suspected of having an infectious disease, DNA, RNA or other non-infectious genetic elements.

(3) A material containing microorganisms that are non-pathogenic to humans or animals.

(4) A material containing pathogens that have been neutralized or inactivated such that they no longer pose a health risk.

(5) A material with a low probability of containing an infectious substance, or where the concentration of the infectious substance is at a level naturally occurring in the environment so it cannot cause disease when exposure to it occurs. Examples of these materials include: Foodstuffs; environmental samples, such as water or a sample of dust or mold; and substances that have been treated so that the pathogens have been neutralized or deactivated, such as a material treated by steam sterilization, chemical disinfection, or other appropriate method, so it no longer meets the definition of an infectious substance.

If you’re unsure whether your shipment is regulated (infectious) or exempted, contact the Biosafety Officer, rclark3@clemson.edu.

Federal regulations require that the employer train and certify employees before they ship infectious substances. See

http://www.phmsa.dot.gov/hazmat/training/requirements

The training that Clemson requires for certification to ship infectious substances is geared toward shipping by air, but covers shipping by ground as well. See

http://www.iata.org/whatwedo/cargo/dgr/Pages/infectious_substances.aspx

 

How do I complete the training required for shipping biological materials?

You must follow one of the methods prescribed in the Clemson University Hazardous Materials Shipping policy. The approved courses are below. Once a course is completed, the BSO must sign the certificate verifying satisfactory completion of the approved course. Then the employee is authorized to ship regulated biological materials.

 

Training for Certification to Ship Chemical Hazardous Materials by AIR

A- 3-day FEDEX Dangerous Goods Seminar; see website for schedule and cost ($685).

http://fedex.com/us/services/options/

B- 2-day UPS Dangerous Goods Seminar for IATA Requirements; see website for schedule and cost ($600).

http://www.ups.com/content/us/en/resources/ship/hazardous/seminar .html

C- Environmental Resource Center Seminar Transportation of Dangerous Goods offered annually by Research Safety (free)

Training for Certification to Ship Biological Hazardous Materials by AIR

A- IATA self-study course with online examination Shipping Guidelines for Infectious Substances; see website for purchase and cost ($310).

http://www.iata.org/training/courses/tcgp43.htm

B- One of the courses required for chemical hazmat by air plus SAF-T-PAK DVDROM. See website for purchase and cost ($465 to include reference manual; limited to 6 users and expires with calendar year).

http://www.saftpak.com/Training/dvdtraining.aspx

C- 1-day SAF-T-PAK Compliance Seminar; see website for schedule and cost ($290).

http://www.saftpak.com/Training/seminartraining.aspx

D- One of the courses required for chemical hazmat by air plus SAF-T-PAK Online Course. See CU Biosafety Manual for purchase and cost ($105 to include reference manual on loan from BSO).

http://www.saftpak.com/Training/InternetTraining.aspx

E- One of the courses required for chemical hazmat by air plus: Environmental Resource Center Seminar Guide to Shipping Infectious Substances offered annually by Research Safety.

Training for Certification to Ship Chemical HAZMAT by AIR

A- 3-day FEDEX Dangerous Goods Seminar; see website for schedule and cost ($685).

http://fedex.com/us/services/options/

B- 2-day UPS Dangerous Goods Seminar for IATA Requirements ; see website for schedule and cost ($600).

http://www.ups.com/content/us/en/resources/ship/hazardous/seminar.html

C- Environmental Resource Center Seminar Transportation of Dangerous Goods offered annually by Research Safety (free)

Training for Certification to Ship Biological HazMat by AIR

A- IATA self-study course with online examination Shipping Guidelines for Infectious Substances; see website for purchase and cost ($310).

http://www.iata.org/training/courses/tcgp43.htm

B- One of the courses required for chemical hazmat by air plus SAF-T-PAK DVD  See website for purchase and cost ($465 to include reference manual; limited to 6 users and expires with calendar year).

http://www.saftpak.com/Training/dvdtraining.aspx

C- 1-day SAF-T-PAK Compliance Seminar; see website for schedule and cost ($290).

http://www.saftpak.com/Training/seminartraining.aspx

D- One of the courses required for chemical hazmat by air plus SAF-T-PAK Online Course. See CU Biosafety Manual for purchase and cost ($105 to include reference manual on loan from BSO).

http://www.saftpak.com/Training/InternetTraining.aspx

E- One of the courses required for chemical hazmat by air plus: Environmental Resource Center Seminar Guide to Shipping Infectious Substances offered annually by Research Safety.