PACKAGING AND LABELING SPECIMENS FOR SHIPMENT TO THE NVSL

Regulations

Regulations governing packaging and labeling of interstate shipments of etiologic agents are in Part 72, Title 42 of the Code of Federal Regulations (CFR). This contains the definitions of biological products, diagnostic specimens, and etiologic agents, and provides requirements for packaging and labeling these materials for transportation in interstate commerce. In addition to the requirements of 42 CFR Part 72, there are requirements in 49 CFR Part 173.386, 173.387, and 173.388 for the shipment of etiologic agents. Also, 49 CFR Part 173.615 has additional requirements for etiologic agents and on shipments containing solid carbon dioxide (dry ice).Anyone sending material to the NVSL that is a biological product, diagnostic specimen, or etiologic agent, as defined in the CFR, must package, label, and ship the material as specified. All specimens should be shipped in an insulated container with ice packs unless otherwise specified in this manual. If more information is needed, contact your carrier.

Definitions

Biological materials include all specimens or reagents sent to the Foreign Animal Disease Diagnostic Laboratory (FADDL) at Greenport, New York, or the Diagnostic Bacteriology Laboratory (DBL), Diagnostic Virology Laboratory (DVL), and Pathobiology Laboratory (PL) at Ames, Iowa.Specimens include, but are not restricted to: excreta, secreta, blood, serum, tissues, organs, animals or animal parts, tissue cultures, and viruses or other microorganisms (either infectious or inactivated).Biomedical materials that are known to contain, or could contain, etiologic agents are divided into two groups: 1) diagnostic specimens or biological products and 2) materials containing certain known identified infectious etiologic agents. The former are packaged according to 42 CFR Part 72.2 and the latter according to 42 CFR Part 72.3.A diagnostic specimen means excreta, secreta, blood and its components, tissue, tissue fluids, etc., which the shipper reasonably believes may contain an etiologic agent and that is being shipped for purposes of diagnosis.An etiologic agent means a known identified viable microorganism or its own toxin that causes, or may cause, human disease.A biological product means a product prepared in accordance with regulations that govern the manufacture of vaccines, reagents, etc.

Diagnostic versus Known Identified Etiological Samples

a. For serological testing, submit one tube containing 2 ml of clear serum per animal for each test requested.b. Pack fresh and formalin-fixed specimens separately. Ship in separate containers when possible.c. Prelabel specimen containers to insure all recommended specimens will be collected.d. Fresh specimens:

1) Double bag all tissues; refrigerate with ice packs if sample will reach laboratory within 24 hours.2) Tubes should be sent in shipping boxes with each tube labeled and arranged in numerical order starting with 1,2,3...N. Do not use animal identification numbers only on tubes.3) If tissues or swabs are to be in transit more then 48 hours, use dry ice unless agents should not be frozen. When using dry ice, all containers must be tightly sealed; CO2 gas can inactivate some viruses and prohibit isolation. Do not freeze or use dry ice in boxes that contain formalin-fixed tissues. Use of dry ice does require meeting the requirements for shipping known identified etiological agents since dry ice is considered a dangerous good. Therefore, it is recommended that ice packs be used with transit being accomplished within 48 hours.

e. Formalin-fixed specimens may be placed in a plastic bag with formalin-soaked cotton after they have remained in the 10:1 volume of formalin for at least 3 hours, or they may be shipped in 10:1 (liquid to tissue) formalin.

f. For diagnostic samples and biologics and diagnostic reagents: An approved exterior shipping container, such as that recommended by the USDA, APHIS or the National Centers for Disease Control must be used by all shippers. Examples would be TC-34s and Polyfoam Coolers. Prepare sample(s) according to above directions and place in one of the approved boxes with ice packs; if needed, use newspapers or peanuts to insure the sample(s) is secure. Tape the box and put a "Biological Sample" label on the top of the box.

g. For known identified infectious etiological agents: Such samples must be packaged to withstand leakage of contents, shocks, pressure changes, and other conditions in ordinary transportation handling. Dangerous Goods training is needed for anyone sending such infectious etiological samples. You cannot sign "The Declaration of Dangerous Goods" form unless you have been to training. (Federal Express currently provides the training required to be in compliance for shipping known identified infectious etiological agents.)h. You will need a primary container and secondary container. These containers must be rated class 6.2. Primary containers must be watertight tubes, vials, or ampules or tissues that are double bagged. Each primary container must be separately wrapped with packing material. The primary container is then placed in a durable watertight container referred to as a secondary container. There must be enough absorbent material (such as cotton or sponge) to absorb the entire contents of the primary container in case of breakage or leakage. However, materials such as sawdust, vermiculite, etc. should not be used. The secondary container (approved plastic or cans) usually comes with the class 6.2 outer fiberboard box.

i. If you have over 50 ml or 50 gms, you cannot send by passenger aircrafts; you will need to send by cargo aircraft only. If dry ice is used, it must be placed between the secondary container and the outer shipping container. Do not put dry ice in the secondary container and seal shut. Tape box and label: (a) Infectious label (6.2), (b) label with class and UN number next to Infectious label, (c) address label with consignee's phone number in upper right hand corner, (4) biological label, (5) Dry Ice label (if needed), (6) For Medical Use Only label (this goes with the dry ice label), (7) Cargo Aircraft Only (if over 50 ml), and (8) Declaration of Dangerous Goods Form.