Changes in US Department of Transportation (DOT) Shipping Regulations for clinical specimens effective Oct.1, 2006* *Previous labeling allowed until January 1, Images from:

Background An infectious substance is regulated as a hazardous material under the U.S. Department of Transportation (DOT)’s Hazardous Materials Regulations (HMR; 49CFR Parts ). The HMR apply to any material DOT determines is capable of posing an unreasonable risk to health, safety, and property when transported in commerce. An infectious substance must conform to all applicable HMR requirements when offered for transportation by air, highway, rail, or water.

HMR Definition of Infectious Substances The HMR classifies hazardous materials. Division 6.2 (infectious substance) is for materials 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.

Previously, the labeling required for clinical specimens varied, depending on the carrier. Some shipping carriers followed the DOT regulations (ex: UPS) And some shipping carriers followed the United Nations Recommendations (ex: FEDEX)

Now --DOT requirements are harmonized with the United Nations Recommendations.

A two-tiered classification system has been set up for infectious substances: Category A and B. New Classification System for Infectious Substances, HMR Division 6.2

HMR Division 6.2 has 3 proper shipping names: Category A: Infectious substances, affecting humans UN2814 Infectious substances, affecting animals UN2900 Category B: Biological Substances, Category B UN23373

Step 1 in classification: is it a “Culture” or a “Patient Specimen”? Culture: An infectious substance containing a pathogen that is Intentionally propagated. Culture does not include a Human or animal patient specimen as defined below: Patient specimen. Human or animal materials 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.) Definitions from §

Step 2 in Classification: Is the substance on the DOT Category A List? Examples: Bacillus anthracis (cultures only) Crimean-congo hemorrhagic fever Ebola virus Highly pathogenic avian influenza virus (cultures only)

Category A, Infectious Substances affecting humans The complete list of category A infectious pathogens is in the regulation at: /edocket.access.gpo.gov/2006/ htmhttp://a257.g.akamaitech.net/7/257/2422/01jan /edocket.access.gpo.gov/2006/ htm Additional training requirements apply to preparation of shipments, and shipping documents, including a hazardous goods declaration form, for Category A shipments. Contact your Biosafety Office for details.

Biological Substance,Category B Category B: An infectious substance 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. Proper shipping name and identification number: Biological substance, Category B UN3373

Carefully evaluate shipments of “Biological Products.” Biological product: A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or asphernamine (or any other trivalent arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals. Biological products are assigned to: UN3373, UN2814, or UN2900, as appropriate. Definition from §

Classification Scenarios- Blood samples. Example 1: Blood sample taken from a patient known or suspected to have Hepatitis C and HIV. Proper shipping classification: Biological Substance, Category B, UN3373 Example 2: Blood sample from a patient known or suspected to have Ebola. Proper shipping classification: Infectious substance, Affecting Humans. UN2814

Packaging Requirements for Biological Substances, Category B Sturdy Primary Receptacle Absorbent Material Watertight secondary packaging List of contents Cushioning (prevent rattling) Rigid outer packaging Name and phone number of shipper on box or waybill.

Multiple tubes The regulation still states: “ If multiple fragile primary receptacles are placed in a single secondary packaging they must be either individually wrapped or separated to prevent contact”.

Additional packaging requirements for liquid shipments by aircraft… § For liquid shipments by aircraft, the primary receptacle or the secondary packaging must be capable of withstanding without leakage an internal pressure producing a pressure differential of not less than 95 kPa This means: 1) Use packaging certified for air transport. 2) If you prepare shipments using recycled materials, the primary containers must meet this requirement. [Vacutainers and Corning cryovials do; obtain documentation on other containers shipped].

Biological Substance, Category B Packaging Requirements Size: The smallest external dimension of the outer packaging must not be less than 100 mm (3.9 inches) Maximum quantity per package is 4 liters for Biological Substances, Category B.

The shipper’s name and phone number* must be on the waybill or box. *For category B, this does not have to be a 24- hour number. However, it should be a phone which is answered during normal business hours.

§ Required Marking for shipments which previously known as “diagnostic specimen” or “clinical specimen” UN3373 Biological substances, Category B

Examples of new labels for Shipments of Biological Substance, Category B Example below from 3_labels.htm. 3_labels.htm Example:catalog number , from

We have until Jan 1, 2007 to comply with the new labeling requirement-- Then “diagnostic specimen’ or “clinical specimen” must be replaced with “Biological Substance, Category B” You may start using the new label now.

For more information… DOT Guide to Changes effective October 1, Transporting Infectious Substances Safely. Available at: fectious_Substances_Safely.pdf fectious_Substances_Safely.pdf Federal Register n /edocket.access.gpo.gov/2006/ htm n /edocket.access.gpo.gov/2006/ htm Contact your shipping vendor. DFCI staff: Call Karen Byers

NOTE: Dry Ice labeling is NOT harmonized YET! UPS requires: Dry Ice for Medical Purposes stickers (Item #011127) online at UPS Supply Ordering or by calling 800-PICK-UPS.UPS Supply Ordering FEDEx requires :