Dr. Cushmac stated that when the Department of Transportation 
discussed the inclusion of animals in their regulatory proposals, 
it met with representatives of the Department of Agriculture, who 
had no objections to such an action. He noted that international 
shipments of hazardous materials already include animals, which are 
regulated as etiologic agents. If such materials are shipped by 
air, regardless of whether they cross national borders, the carrier 
company has the option to apply international regulations to their 
cargo. As a business matter, private airline companies prefer to 
apply regulations from the International Air Transport Association, 
thus forcing shippers to comply with them. United Nations 
recommendations for the regulation of etiologic agents for shipping 
purposes are "wide open." 
Mr. Brewer focused the discussion on two issues. First, the 
Subcommittee could defer proposing a change in the definition of 
"etiologic agents" for shipping purposes. The Subcommittee could 
wait until the CDC and other agencies further cooperate and thus 
better formulate their policies. Second, should the Subcommittee 
propose changes in the NIH Guidelines to make them current, the 
Subcommittee's proposals could become obsolete very quickly, if the 
expected changes in Postal Service regulations occur. 
Dr. Langston was concerned that the NIH Guidelines and current 
regulations would prohibit the shipment of transgenic animals and 
plants. Mr. Brewer added that this was due to the requirement for 
double packaging of etiologic agents. Dr. Stevenson argued that, 
due to the currently paucity of shipment requests for transgenic 
animals and plants, this was not the most important issue. He 
stated that current regulations require the shipment as "etiologic 
agents" of approximately 10,000 recombinant DNA products per year 
that lack etiologic properties. This is prohibitively costly for 
shippers and must change soon. 
Mr. Brewer believed that the RAC, NIH offices, and the biosafety 
apparatus should work to harmonize regulations and guidelines for 
both international and domestic shipments. He asked the 
Subcommittee to consider what changes in the NIH Guidelines could 
protect public health and safety as well as label organisms by 
their "right names." Perhaps the Subcommittee could recommend the 
label of "biologic products" for those recombinant DNA products 
that are not etiologic agents. 
Dr. McVicar stated that the current Federal Regulations for 
Interstate Shipment of Etiologic Agents had a distinct universe. 
First, 42 CFR, Section 72.2, refers to diagnostic specimens and 
biological products. Second, 42 CFR, Section 72.3, refers to 
etiologic agents or materials likely to contain etiologic agents. 
He noted that public perceptions were a problem with these 
regulations and attempts to increase their flexibility and 
applicability caused further problems. In order to protect health 
care workers with a more rational approach, the CDC attempted to 
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