slide1
Download
Skip this Video
Download Presentation
Changes in US Department of Transportation (DOT) Shipping Regulations for clinical specimens effective Oct.1, 2006*

Loading in 2 Seconds...

play fullscreen
1 / 24

Changes in US Department of Transportation DOT Shipping ... - PowerPoint PPT Presentation


  • 544 Views
  • Uploaded on

Changes in US Department of Transportation (DOT) Shipping Regulations for clinical specimens effective Oct.1, 2006* *Previous labeling allowed until January 1, 2007. Images from: http://hazmat.dot.gov/training/Transporting_Infectious_Substances_Safely.pdf Background

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Changes in US Department of Transportation DOT Shipping ...' - Faraday


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

Changes in US Department of Transportation (DOT) Shipping Regulations for clinical specimens effective Oct.1, 2006*

*Previous labeling allowed until January 1, 2007.

Images from:

http://hazmat.dot.gov/training/Transporting_Infectious_Substances_Safely.pdf

background
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 1717-180). 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
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
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)
slide6

New Classification System for Infectious Substances, HMR Division 6.2

A two-tiered classification

system has been

set up for infectious

substances: Category

A and B.

hmr division 6 2 has 3 proper shipping names
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
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 § 171.134

step 2 in classification is the substance on the dot category a list
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
Category A, Infectious Substances affecting humans
  • The complete list of category A infectious pathogens is in the regulation at:
  • http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/06-4992.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
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
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 § 171.134
slide13

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
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
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
Additional packaging requirements for liquid shipments by aircraft…

§173.199For 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
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

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.

slide20
§ 173.99 - 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
Examples of new labels for Shipments of Biological Substance, Category B

Example below from www.casingcorp.com/un3373_labels.htm.

Example:catalog number 22-130-067, from www.fishersci.com

we have until jan 1 2007 to comply with the new labeling requirement
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
For more information…
  • DOT Guide to Changes effective October 1, 2006. Transporting Infectious Substances Safely. Available at: http://hazmat.dot.gov/training/Transporting_Infectious_Substances_Safely.pdf
  • Federal Register http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/06-4992.htm
  • Contact your shipping vendor.
  • DFCI staff: Call Karen Byers 617-632-3890
note dry ice labeling is not harmonized yet

Dry Ice for Medical Purposes

  • stickers (Item#011127) online at
  • UPS Supply Ordering or bycalling 800-PICK-UPS.
NOTE: Dry Ice labeling is NOT harmonized YET!

UPS requires:

FEDEx requires:

ad