In the future, the CDC hopes to clarify and strengthen 42 CFR, 
Section 72.2, of the regulations on diagnostic specimens and 
biologic products and yet keep the definition as generic as 
possible. Perhaps the label "clinical specimen" would be 
adequately broad and yet not as restrictive as "diagnostic 
specimens." The CDC is also developing new labels that will omit 
the designation of "etiologic agent." Currently, the regulations 
allude obliquely to "leak-proof packaging" without more precise 
specifications. Finally, the CDC is aware that other agencies are 
involved. Dr. McVicar suggested that the Postal Service wanted to 
draw attention to worker safety, rather than to block the shipment 
of all recombinant DNA products. Dr. Stevenson argued that the 
regulations will lack consistency when specifying the "clinical, 
chemical, and storage" classifications. 
Dr. McVicar hoped the Subcommittee would agree that the NIH 
Guidelines and other regulations should warn against all leakage 
during shipment of biomedical materials. He believed that all such 
materials in shipment should require special packaging and 
handling, whether they contained cultures or even the suspicion of 
etiologic properties. An inner container should be shock resistant 
so that even if the primary container is ruptured or crushed, the 
material will not leak to the outside. As such, even if problems 
with the definition should remain, the system would have a built-in 
safety net. The commercial marketplace will introduce new 
packaging products that will meet these safety requirements 
economically. Dr. McKinney asked if the exterior labelling should 
be changed. Dr. McVicar answered that part of it should be. 
Currently, the CDC was formulating proposals for the Regulations on 
Interstate Shipment of Etiologic Agents in 42 CFR, Section 72. 
Regarding labelling, the CDC may propose that shippers be required 
to affix a label that states that the "package is in compliance 
with 42 CFR, Part 72." 
Dr. McKinney asked what was the CDC's working definition of 
"etiologic agent." Dr. McVicar answered that the definition 
includes toxins and microbial agents that cause human disease. The 
legal basis of the regulations was to protect the public health. 
This excluded livestock. Animal agents covered by the regulations 
are those common to both humans and animals, which are zoonotic 
agents . 
Dr. Cushmac stated that international safety regulations applied to 
both humans and animals, such as the United Nations Recommendations 
for the Transport of Dangerous Goods, which the International Civil 
Aviation Organization (ICAO) oversees. ICAO publishes the 
Technical Instructions for the Safe Transport of Dangerous Goods by 
Air. An additional private group, the International Air Transport 
Association publishes the Dangerous Goods Transportation 
Regulations, which all commercial airlines use. Currently, the 
Department of Transportation regulates only human safety issues, 
though proposed regulations may treat animal aspects as well. Dr. 
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