6.4 Labeling and Packaging of Samples

Purpose of shipping regulations
Shipping regulations have been published by international and national regulators in order to provide procedures for the shipper by which articles and substances with hazardous properties can be safely transported by air or surface. “In the interest of global pubic health, of progress in scientific research, and of the development of new drugs and treatments to combat diseases, human and animal specimens need to be transported safely, timely, and efficiently from the place where they are collected to the place where they will be analyzed. Regardless of the presumed infection status of the patient, specimens of human and animal origin should be packaged and transported in such a way as to protect those engaged in transportation from the risk of infection. Risks of infections of personnel involved in transport may not be fully eliminated. However, they can undoubtedly be kept to a minimum.” (World Health Organization; Transport of Infectious Substances.)

What are “Dangerous Goods” and who regulates them?

Dangerous Goods are defined as “articles or substances which are capable of posing a significant risk to health, safety, property or the environment when transported by surface or air”. The recommendations for the transport of Dangerous Goods were first initiated to facilitate transport of those goods while ensuring the safety of people, property and the environment.

The United Nations publishes recommendations for packing and shipping Dangerous Goods. Although the International Civil Aviation Organization (ICAO) writes the technical instructions for the Safe Transport of Dangerous Goods by Air, the international community follows the IATA regulations.

The International Air Transport Association (IATA) is composed of the world’s major airlines. They write the “IATA Dangerous Goods Regulations” which are based on the ICAO Technical Instructions. The IATA Dangerous Goods Regulations designate the shipper as having the responsibility for making sure all packaging is done properly. The Department of Transportation (DOT) regulates the transport of “Hazardous Materials” in the United States. The Federal Regulations (49 CFR) also defer to the Technical Instructions from ICAO. DOT uses the term “Hazardous Materials” instead of “Dangerous Goods”. Hazardous Materials are defined as a substance or material the Secretary of Transportation has determined as capable of posing an unreasonable risk to health, safety, and property when transported by commerce.

Infectious Substances are materials which are known or are reasonably expected to contain an animal or human pathogen. Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions or recombinant microorganisms, which can cause disease in humans or animals. There are two divisions in Class 6. Class 6.1 is dedicated to toxins while 6.2 is for Infectious Substances. Toxins from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances should be considered for classification in Division 6.1.

Infectious Substances are divided into two categories, Category A and Category B.
These categories are based on a detailed, case-by-case, risk assessment of microorganisms known to be pathogens. The categorization is the result of the consideration of scientific data concerning the risks of transmission and infection posed during transport of each species of microorganism.

Category A - an infectious substance which is transported 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. An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals.

Category B – an infectious substance that does not meet the criteria for inclusion in Category A. These are referred to as Biological Substances.

Biological substances, category B, are substances that do not fall into infectious substances, category A.

Category A and Category B can be……

• Cultures - Cultures are the result of a process by which pathogens are intentionally propagated. This definition does not include patient specimens.
• Patient specimens (human or animal)
• Biological products
• Genetically modified organisms and microorganisms

Packaging

Federal regulations govern the packaging and labeling of diagnostic specimens. If spillage that damages mail or equipment occurs during the shipment, the shipper may face prosecution, even if the material involved was not hazardous.

Samples that may contain an agent infectious for humans or animals must be shipped by International Air Transportation Association, IATA, regulations if they are to be shipped by any common carrier (even if not by air).  These regulations include:

• Ship specimens in 2 appropriate leak-proof containers, i.e. red top and plastic bag.  If using bags, double-bag.
• Include packing material adequate to cushion the containers and absorb all fluids in the event of leakage or breakage
• Label each specimen with the owner’s name, the animal’s identification, and a tube number that correlates with the paperwork.
• Perishable specimens should be shipped on ice packs by same-day or overnight delivery. Label outside of box “perishable”. Do not put samples that should be chilled only in direct contact with the ice packs as it could damage the specimen.  Place absorbent material in between.
• Never ship on a Friday or the day before a holiday.
• Do not wrap forms around samples: if the sample leaks, the form will be damaged.
• Enclose the paperwork for all samples in a single zip-lock bag and place it on top of the samples.
• Do not send samples in syringes and remove all sharps from the boxes.   Packages with sharps will be rejected.
• Label the outside of the box clearly.  Remove old conflicting labels that could confuse delivery.
• Packages should be marked with a Diagnostic Specimen label on the outside of the box. 
• Your return address is important. This is one way to track packages received by the laboratory.
• Do not ship in unprotected Styrofoam containers: these break easily if squeezed or dropped.  Styrofoam within a cardboard box is recommended.
• IATA has recently tightened their guidelines for shipment of known pathogens and even diagnostic specimens for some diseases, including Rabies. If you are shipping a pathogen or a diagnostic specimen with potential zoonotic risks, http://www.iata.org/whatwedo/dangerous_goods contains online information about the regulations. Rabies specimens should be shipped by Courier and not by air.  The complete Federal Department of Transport (DOT) Regulation, HM226, can be found on their website at http://hazmat.dot.gov/67fr-53118.pdf . Related fines and penalties according to CFR Sec. 171.1(c) “ Any person who knowingly violates a requirement of the Federal hazardous materials transportation law….Is liable for a civil penalty of not more than…$27,500… and not less than $250. for each violation…and shall be fined under Title 18, United States code, or imprisoned for not more than 5 years, or both.”

New Courier Service for the Pennsylvania Animal Diagnostic Laboratory System (PADLS)

On February 28th, 2011, a new courier service took over PADLS shipping services that were previously provided by U.S. Cargo and Quick Courier.  The new company is American Expediting (AE).  This is a national company and its PA headquarters is in Pittsburgh.  Except for PADLS-paid pick up from veterinary practices and PADLS-paid pick up for rabies testing specimens from private residences, the service American Expediting provides will be identical to the service we previously had, plus there will be some added features that will be welcomed by most users.  In fact, in some areas, AE will subcontract and continue to use current U.S. Cargo personnel and vehicles.  So in some areas the people providing the courier service will not change. 

Please remember that, as with the previous couriers, packages picked up one day are stored in a warehouse before delivery the following day.  Samples that require refrigeration or freezing need to have appropriate cooling materials included in the package.  If shipping these “cold” packages on a Friday or before a holiday the sender must make the courier aware of the specific storage requirements for that package so that appropriate cold storage will be provided until delivery. 

There will be two ways to contact AE:  by telephone or through their website.  All customers can make requests by phone, but website access will only be available to users who have contacted AE and taken an online training webinar which they will provide.  Once trained, the user will be given the appropriate clearance and access information and can then place all pickup orders online.  American Expediting is quite willing to train any person/business who wishes to use their website for pickup requests.

Here is the phone number for placing all calls:  412-321-4546.  When calling, the account name is “PADLS”.   Their general email address is:  PIT@AMEXPEDITING.COM.  For any clinic/veterinary practice wanting to take the webinar for website training, please contact AE directly.

American Expediting is a 24/7 service with “before 3 PM same day pickup” offered for any requests placed before noon Monday through Friday.  For an additional fee, they also offer “after hours” pickup service to customers once a mutually agreeable site and access arrangements have been made.  Such arrangements would include agreed upon parcel locations and possibly key or swipe card availability for buildings locked after a certain hour.

For rabies testing, the PADLS courier service will no longer pick up specimens from private residences at PADLS expense.  When samples are to be tested for rabies and there has been human exposure, we encourage submitters to use the laboratory of the Pennsylvania Department of Health, at Lionville.  The Department of Health Laboratory has Saturday service.  Shipping, however, will be at the submitter’s expense, unless the specimens can be delivered to a PDA Regional Office for shipment.  Free delivery may also be possible from County Health Department offices and regional Pennsylvania Game Commission offices, but we strongly advise calling those offices beforehand to check if the service will be available.  Please label the outside of the package “Human Exposure –Rabies” so that the courier will be aware of the situation and direct the package to the Department of Health.

Charges for use of this courier system, if the package is shipped from a veterinary practice, will now be borne by the shipper, but at a contract rate.  When a “standard” pick-up and delivery is involved (call placed before noon and same day pick-up with next day delivery or call placed after noon and next day pick-up with following day delivery –except weekends) the charge will be $15.00 unless the package weighs more than 24.9 pounds.  Shipping fees for packages weighing in excess of 24.9 pounds increase on a sliding scale: for example 25.0 – 25.9 lb = $21.00, 41.0 – 44.9 lb = $26.00.  American Expediting will not bill your practice directly, instead they will bill PADLS.  In turn, PADLS will bill the practice and include the charge in your monthly statement.  Please be aware that shipments that involve non-standard courier services will exceed the $15.00 “contract” fee amount and will be reflected in the bill you receive from PADLS.  This billing procedure will begin on July 1, 2011. 

Packages delivered to a PDA Regional Office for shipment to PADLS (please be sure to call the regional office in advance to confirm that someone will be present to receive the package) will not be charged a shipping fee. 

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