Features 
veterinary use, manufactured in accordance with the 
requirements of national public health authorities and 
moving under special approval or license from such 
authorities. Cultures of a known genus of microorgan- 
ism are either infectious biological substances — IBS — 
or noninfectious biological substances — NIBS. These 
acronyms cure used by the postal service. 
The Public Health Service (PHS) regulates the 
import of etiologic agents (infectious biological sub- 
stances) and subsequent transport. Although one lab- 
oratory originally imports a strain, all subsequent 
shipments from one laboratory to another within the 
country, must follow PHS regulations. Title 42, Sec- 
tion 72, of the Code of Federal Regulations (CFR) lists 
certain etiologic agents and minimum requirements 
for transporting them. A permit is required in some 
cases. In addition, some strains are considered suffi- 
ciently hazardous that special tracking during ship- 
ment is required. The 42 CFR 72 list addresses only 
transport of materials and is based on potential threat 
to public health if the package is damaged in transit. 
For International Postal Union shipments, nonin- 
fectious biological substances that are freeze-dried (not 
perishable, in a sense) have no special packaging and 
shipping requirements, except that a good quality box 
must be used. However, such shipments require U.S. 
Department of Commerce export licenses to most coun- 
tries. Shipments containing specimens that are not 
freeze-dried are considered perishable in the interna- 
tional posted mail. Hence, they must bear a special 
violet label (available from post offices) and must be 
sent by registered mail. Infectious biological sub- 
stances, in addition to requiring registration, must 
carry a black and white "Infectious Substance” label. 
Other regulations, administered through the U.S. 
Department of Agriculture (USD A), govern the import 
and shipment of animal (nonhuman) and plant patho- 
gens. Regulations for etiologic agents (or their vectors) 
affecting livestock and poultry are found in Title 9, 
CFR, Part 122. Any cell culture or virus propagated in 
a cell line grown in a medium containing serum of 
domestic livestock requires a permit from the USDA if 
imported. In practice, cell lines grown in media con- 
taining serum from countries having disease problems 
endemic to their domestic animals are barred from 
import by USDA authorities unless tested at a U.S. 
government facility. 
USDA requires a permit for interstate movement 
of pathogens that are enzootic or of extremely high 
virulence or for which there is a national disease 
eradication program, except tuberculosis and brucell- 
osis. Diagnostic specimens from domestic animals sus- 
pected of having a disease are subject to the same 
policy. However, when they are known or suspected 
carriers of agents indigenous to all the states, the need 
for permits is usually waived. 
Regulations governing the movement into the 
country and interstate shipment of plant pathogens 
are specified in the Federal Plant Pest Act of 1957 
(Title 1 71, Statute 31). Individual states may concur 
or deny permit applications prior to review by USDA. 
VOL. 54. NO. 5. 1988 
[402] 
Thus, individuals seeking to ship or import designated 
plant pathogens are required to file an application 
with state regulatory officials. After action at the state 
level, the application is forwarded to USDA. 
Other guidelines address recombinant DNA mate- 
rial. Although not necessarily infectious substances, 
recombinant DNA materials must be packaged as 
etiologic agents ("NTH Guidelines for Research Involv- 
ing Recombinant DNA Molecules,” Federal Register, 7 
May 1986, Part DI, Appendix H-l). 
Packaging Requirements 
Drying or freeze-drying is undoubtedly the safest 
and most practiced method of preparing specimens for 
shipment. In air transport, a package may be subjected 
to a wide range of temperatures from -40 to +55°C. In 
addition, packages sealed at atmospheric pressure 
(100 kilopascals) may become subject to reduced pres- 
sures of nearly two-thirds atmospheric (68 kilopa- 
scals). Samples sent as liquids, e.g., in test tubes, 
should be heat sealed in 5-mil polyethylene tubing 
before shipment. If improperly sealed, broth cultures 
will "disappear” during air shipment because of re- 
duced pressure. Every precaution should be taken to 
avoid having cultures leak away. 
Minimum packaging requirements for domestic 
shipments of etiologic agents are found in the Health 
and Human Services Act, Title 42, Section 72, which 
specifies: "Such material is packaged to withstand 
leakage of contents, shocks, pressure changes, and 
other conditions incident to ordinary handling in 
transportation.” Although, strictly speaking, the De- 
partment of Transportation regulations for testing of 
packages containing less than 50 milliliters (49 CFR 
173.38) do not apply, member airlines of the Interna- 
tional Air Transport Association (IATA) do not ob- 
serve this distinction. In addition, the International 
Recombinant DNA Research, Volume 13 
