27940 
NOTICES 
Department of Health, Education, and Wel- 
fare; Public Health Service; Center for 
Disease Control; Atlanta, Georgia 30333; 
Telephone: (404) 633-3311, Ext. 3883 
TITLE 42 — PUBLIC HEALTH; CHAPTER I PUBLIC 
HEALTH SERVICE, DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE; . SUBCHAPTER F 
QUARANTINE, INSPECTION, LICENSING; PART 
72 INTERSTATE QUARANTINE; SUPPART C 
SHIPMENT OF CERTAIN THINGS 
Section 72.25 of Part 72, Title 42, Code ol 
Federal Regulations, is amended to read as 
follows: 
5 72.25 Etiologi/j agents.' 
(a) Definitions. As used in this section: 
(1) An "etiologic agent” means a viable 
microorganism or its toxin which causes, or 
may cause, human disease. 
(2) “diagnostic specimen” means any hu- 
man or animal material including, but not 
limited to, excreta, secreta, blood and its 
components, tissue, and tissue fluids being 
shipped for purposes of diagnosis. 
(3) A “biological product” means a bio- 
logical product prepared and manufactured 
in accordance with the provisions of 9 CFR 
Part 10, Licensed Veterinary Biological Prod- 
ucts, 42 CFR Part 73, Licensed Human Bio- 
logical Products, 21 CFR 130.3, New drugs 
for investigational use in humans, 9 CFR Part 
103, Biological Products for Experimental 
Treatment of Animals, or 21 CFR 130.3(a), 
New drugs for investigational use in animals , 
and which, in accordance with such provi- 
sions may be shipped in interstate traffic. 
(b) Transportation; etiologic agent mini- 
mum packaging requirements. No person 
may knowingly transport or cause to be 
transported in interstate traffic, directly or 
indirectly, any material, Including but not 
limited to, diagnostic specimens and biologi- 
cal products, containing, or reasonably be- 
lieved by such person to contain an etiologic 
agent unless such material is packaged to 
withstand leakage of contents, shocks, pres- 
sure changes, and other conditions incident 
to ordinary handling in transportation. 
(c) Transportation; etiologic agents sub- 
ject to additional requirements. No person 
may knowingly transport or cause to be 
transported in interstate traffic, directly or 
indirectly, any material, other than diag- 
nostic specimens and biological products, 
containing, or reasonably believed by such 
person to contain, one or more of the fol- 
lowing etiologic agents unless such material 
is packaged in accordance with the require- 
ments specified in paragraph (b) of this 
section, and unless, in addition, such ma- 
terial is packaged and shipped in accordance 
with the requirements specified in subpara- 
graphs (l)-(6) of this paragraph: 
1 The requirements of this section are in 
addition to and not in lieu of any other pack- 
aging or other requirements for the trans- 
portation of etiologic agents in Interstate 
traffic prescribed by the Department of 
Transportation and other agencies of the 
Federal Government. 
Bacterial Agents 
Actinobacillus — all species. 
Arizona hinshawii — all serotypes 
Bacillus anthracis. 
Bartonella — all species. 
Bordetella — all species. 
Borrelia recurrentis, B. vincentr 
Brucella — all species. 
Clostridium botulinum, Cl. chanvoei. Cl 
haemolyticum, Cl. histolyticum, Cl novyi. 
Cl. septicum, Cl. tetani. 
Corynebacterium diphtheriac C, equi, C. 
haemolyticum, C. pseudotuberculosis, C 
pyogenes, C. renale. 
Diplococcus (Streptococcus) pneumoniae 
Erysipelothrix insidiosa. 
Escherichia coll, all enteropatliogenlr sen- 
types. 
Francisella (Pasteurella) tularensis 
Haemophilus ducreyi, H. influenzae. 
Herellea vaginicola. 
Klebsiella — all species and all serotypes 
Leptospira interrogans— all serotypes. 
Listeria — all species. 
Mima polymorpha. 
Moraxella — all species. 
Mycobacterium — all species. . 
Mycoplasma — all species. 
Neisseria gonorrhoeae, N. meningitidis 
Pasteurella — all species. 
Pseudomonas pseudomallet. 
Salmonella — all species and all serotypes 
Shigella — all species and all serotypes. 
Sphaerophorus necrophorus. 
Staphylococcus aureus. 
Streptobacillus moniliformis 
Streptococcus pyogenes. 
Treponema careteum, T. pallidum and T. 
pertenue. 
Vibrio fetus, V. comma, including blotype 
El Tor, and V. parahemolyticus 
Yersenia (Pasteurella) pestis. 
Fungal Agents 
Actinomycetes (including Nocardia species, 
Actinomyces species and Arachnia propi- 
onica) . 
Blastomyces dermatitidis. 
Coccidioides immitis. 
Cryptococcus neo for mans. 
Histoplasma capsulatum. 
Paracoccidioides brasillensis . 
Viral, Rickettsial, and Chlamydial Agents 
Adenoviruses — human — all types. 
Arboviruses. 
Coxiella burnetii. 
Coxsackie A and B viruses — all types 
Cyto megaloviruses . 
Dengue virus. 
Echoviruses — all types. 
Encephalomyocarditis virus. 
Hemorrhagic fever agents, including Crimean 
hemorrhagic fever (Congo), Junin, and 
Machupo viruses, and others as yet un- 
defined. 
Hepatitis-associated antigen. 
Herpesvirus — all members. 
Infectious bronchitis-like virus. 
Influenza viruses — sill types. 
Lassa virus. 
Lymphocytic choriomeningitis virus. 
Marburg virus. 
Measles virus. 
Mumps virus. 
Parainfluenza viruses — all types 
Polioviruses ^— all types. 
Poxviruses — all members. 
Psittacosis-Om ithosis-Trachoma- Lympho- 
granuloma group of agents. 
Rabies virus — all strains. 
Reoviruses — all types. 
Respiratory syncytial virus 
Rhinoviruses — all types. 
Rickettsia — all species. 
Rubella virus. 
Simian viruses — all types. 
Tick-borne encephalitis virus complex, in- 
cluding Russian spring-summer encepha- 
litis, Kyasanur forest disease, Omsk hemor- 
rhagic fever, and Central European en- 
cephalitis viruses. 
Vaccinia virus. 
Varicella virus. 
Variola major and Variola minor viruses 
Vesicular stomatis virus. 
Yellow fever virus. 
(1) Volume less than 50 ml. Material 
shall be placed in a securely closed, water- 
tight container (primary container (test 
tube, vial, etc.) ) which shall be enclosed in 
a second, durable watertight container (sec- 
ondary container) . Several primary contain- 
ers may be enclosed in a single secondary 
container, if the total volume of all the pri- 
mary containers so enclosed does not exceed 
50 ml. The space at the top, bottom, and 
sides between the primary and secondary 
containers shall contain sufficient nonpar- 
ticulate absorbent material to absorb the 
entire contents of the primary contalner(s) 
in case of breakage or leakage., Each set of 
primary and secondary containers shall then 
be enclosed in an outer shipping container 
constructed or corrugated fiberboard, card- 
board, wood, or other material of equivalent 
strength. 
(2) Volume 50 ml. or greater. Packaging 
of material in volumes of 60 ml. or more 
shall Include, in addition, a shock absorbent 
material, in volume at least equal to that of 
the absorbent material between the primary 
and secondary containers at the top, bottom, 
and sides between the secondary container 
and the outer shipping container. Single 
primary containers shall not contain more 
than 600 ml. of material. However, two or 
more primary containers whose combined 
volumes' do not exceed 600 ml. may be placed 
in a single, secondary container. Not more 
than eight secondary shipping containers 
may be enclosed in a single outer shipping 
container. (The maximum amount of etio- 
logic agent which may be enclosed within a 
single outer shipping container shall not ex- 
ceed 4,000 ml.) 
(3) Dry ice. It dry ice is used as a refrig- 
erant, it must be placed outside the second- 
ary container(s). If dry ice is used between 
the secondary container and the outer ship- 
ping container, the shock absorbent material 
shall be so placed that the secondary con- 
tainer does not become loose inside the outer 
shipping container as the dry ice sublimates. 
(4) Labels. The label for Etiologic Agents/ 
Biomedical Material, except for size and color, 
must be shown: 
FEDERAL REGISTER, VOL. 41, NO. 1 31— WEDNESDAY, JULY 7, 1976 
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