Packaging and Shipment
Practitioners should be aware that effective February 14, 2003, a new final rule by the U.S. Department of Transportation (DOT) went into effect, changing the way diagnostic specimens are defined, classified, packaged, and transported.
Diagnostic Specimens are now listed as Hazardous Materials: "Diagnostic Specimens" , previously exempt from regulation will now be listed in the Hazardous Material Tables of Title 49 CFR and will be subject to the new rules summarized here. According to 49 CFR Sec. 171.1 (c) "Any person who knowingly violates a requirement of the Federal hazardous material 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."
Definition of Diagnostic Specimens:
A Diagnostic Specimen is defined as "any human or animal material including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals" and is placed in the Hazard Class or Division 6.2.
Note: Plates or cultures of bacterial or viral organisms are NOT included in the definition of "Diagnostic Specimen" and may only be shipped under much more stringent requirements and regulations. Specimens from suspected cases of foreign animal diseases (FADs) and other very highly infectious and virulent diseases do not fall within the guidelines in this document. Contact your State Veterinarian or the Federal Veterinarian-in-Charge if an FAD is suspected.
Packaging Required For Shipment of Diagnostic Specimens:
Unless Diagnostic Specimens are transported by "ground based private or contract carriers using dedicated vehicles", these materials must conform to the standards listed below.
These regulations APPLY to FedEx, UPS, and other commercial shipping companies. The stringent parcel size limitation in the section "Shipment of Diagnostic Specimens by Air" is important for any air shipment. Ask your carrier for a copy of the document "Packing Instruction 650" which includes additional requirements.
Packing and Labeling Requirements for "Diagnostic Specimens"
Primary Receptacles:
Liquid:
Solid:
Sealant:
Absorbent Material:
Secondary Packaging:
Liquid:
Solid:
Outer Packaging:
Packing:
Diagnostic specimens must be packaged in a triple packaging, consisting of a primary receptacle, a secondary packaging, and an outer packaging.
- Primary receptacle: must be leak-proof with a not more than a 500 mL/500 gram volume/capacity (e.g., rubber-stopper tube or screw-cap container). Wrap stopper or screw-cap with Parafilm® to prevent leakage. The primary receptacle must be surrounded with absorbent material and placed in secondary packaging.
- Absorbent material must be placed between the primary and secondary packaging. If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them. The absorbent material must be sufficient to absorb the entire contents of all primary receptacles.
- Secondary packaging: must be leak-proof and for air transport withstand a pressure differential of NLT 14 psi (e.g., durable plastic bag that is tightly sealed). Secondary packaging must be secured in outer packaging with suitable cushioning material such that any leakage of the contents will not impair the protective properties of the cushioning material or the outer packaging. (For example, use a sealed plastic bag or screw-cap plastic container to surround both the absorbent material and primary receptacle.) Primary receptacles (surrounded with absorbent material) must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging.
- Outer packaging: may not exceed 1 gallon/8.8 pounds
capacity* (e.g., pack with enough wadded paper to ensure secondary packaging
fits snugly within the outer packaging). Secure [secondary packaging] with
suitable cushioning material such that any leakage of the contents will not
impair protective properties of the cushioning material or the outer packaging.
*These capacity limits apply to the diagnostic specimen only; packaging may be larger to accommodate frozen gel packs or dry ice used for preservation of specimens. - Completed package: must be capable of passing the drop test from a height of NLT 3.9 feet (e.g., corrugated box that is reinforced with tape). The outer packaging must be clearly and durably marked with the words: "Diagnostic Specimen" .
Liquid diagnostic specimens:
Liquid diagnostic specimens must be packaged in conformance with the following provisions:
- The primary receptacle must be leak-proof with a volumetric capacity of not more than 500mL (16.9 ounces).
- Absorbent material must be placed between the primary receptacle and secondary packaging. If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them. The absorbent material must be of sufficient quantity to absorb the entire contents of the primary receptacles.
- The secondary packaging must be leak-proof.
- For shipments made 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 (0.95 bar, 14 psi).
- The outer packaging may not exceed 4 L ( 1 gallon ) capacity.
Solid diagnostic specimens:
Solid diagnostic specimens must be packaged in a triple packaging, consisting of a primary receptacle, secondary packaging, and outer packaging, conforming to the following provisions:
- The primary receptacle must be sift-proof with a capacity of not more than 500 g (1.1 pounds).
- If several fragile primary receptacles are placed in a secondary packaging, they must be individually wrapped or separated so as to prevent contact between them.
- The secondary packaging must be leak-proof.
- The outer packaging may not exceed 4 kg ( 8.8 pounds ) capacity.
Labeling:
The outer packaging must be clearly and durably marked with the words "Diagnostic Specimen".
Shipment of "Diagnostic Specimens" by Air additionally requires that:
- The primary receptacle or the secondary container is capable of withstanding without leakage an internal pressure differential of 95 kPa (14 psi); i.e. pack in box manufactured to Class 6.2 specs.
- The outer packaging does not exceed 4 L (1 gallon) capacity; Passenger or Cargo Aircraft.
- Must be marked "Packed in Compliance with IATA Packing Instruction 650"
Sample Labels:
Packaging Instructions for 40-Count Test Tube Mailers Containing Animal Blood Samples for Diagnostic Testing
To meet US Postal requirements (39 CFR Part III, Section 8.10 "Packaging for Risk Group 1 Materials") the following steps must be followed: 1 st a quick Summary followed by a more detailed explanation.
- Stoppered test tubes are placed inside the 40 count blood box.
- An absorbent strip is placed inside the blood box with the tubes.
- A rubber band is placed around the 40 count box to secure the lid.
- A "BIOHAZARD" sticker and "ANIMAL DIAGNOSTIC SPECIMEN" label are attached to the outside of the 40 count blood box.**
- The labeled blood box is placed inside the cardboard mailer and taped shut.
- The bagged box is placed inside the cardboard mailer and taped shut.
**The labels can be placed on the plastic bag, but this would increase their replacement rate because the bags are one-time use items.
- The stoppered glass or plastic test tubes (called primary receptacles) are placed inside the 40-count test tube, cardboard partitioned, blood box (this box is called a secondary container).
- Along with the test tubes, a strip of Absorbent Material is placed inside the 40-count blood box. This absorbent material is required to be INSIDE the 40-count blood box and preferably placed beneath the cardboard partition.
- A heavy duty rubber band is placed around the 40-count blood box to hold the lid closed. The reason for the rubber band is that 'friction closed' rubber stoppers are not considered self secure and must be held into place by some physically restrictive method.
- LABELING: There are 2 labels, both are placed on the 40-count blood box that goes inside the mailer. Because our samples are Risk Group I, which means no real danger, placing them on the outside mailer would only cause needless worry for the mail handlers.
- A 1" X 1" fluorescent orange "BIOHAZARD" sticker
- A 4" X 2 ½" orange and white "ANIMAL DIAGNOSTIC SPECIMEN" label
- The labeled 40-count blood box is placed inside a zip lock plastic bag.
- The bagged box is placed inside the cardboard mailer which is then taped shut.
