46286 
Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
FIGURE t 
PACKAGING AND 
LABELING OF 
ETIOLOGIC AGENTS 
FIGURE 2 
CROSS SECTION 
OF FROFER PACKING 
The Intern* t« Shipment of Etiologic Agents (42 CFR, Part 
72) was revised July 21. 1980 to provide for packaging and 
labeling requirements for etiologic agents and certain other 
materials shipped in interstate traffic. 
Figures 1 and 2 diagram the packaging and labeling of etio- 
logic agents in volumes of lets than 50 ml. in accordance with 
the provisions of subparagraph 72.3 (a) of the cited regula- 
tion. Figure illustrates the color and size of the label, de- 
cried In subparagraph 72.3 (d) (1 - 5) of the regulations, 
which shall be affixed to all shipments of etiologic agents. 
For further Information on any provision of this regulation 
contact: 
Centers for Disease Control 
Attn: Biohazards Control Office 
1600 Clifton Road 
Atlanta, Georgia 30333 
Telephone: 404-329-3883 
FTS— 236-3883 
FIGURE 3 
ETIOLOGIC AGENTS-. . 
BIOMEDICAL 
MATERIAL 
■V-Y TN CASE OF OAMA'GE 
fX:*? OR LEAKAGE- 
■ ^Notify r . oiRccTpR -cpc V:.;. 
; t ' .ATI Afi TA ■ C E bAp PA'.;.-’ 
; Api/63 a-s 3 f 3 V > ^ 7 . 
Appendix 1 — Biological Containment 
(See also Appendix E.) 
Appendix /-/. Levels of Biological 
Containment. In consideration of 
biological containment, the vector 
(plasmid, organelle, or virus) for the 
recombinant DNA and the host 
(bacterial, plant, or animal cell) in which 
the vector is propagated in the 
laboratory will be considered together. 
Any combination of vector and host 
which is to provide biological 
containment must be chosen or 
constructed so that the following types 
of “escape" are minimized: (i) survival 
of the vector in its host outside the 
laboratory, and (ii) transmission of the 
vector from the propagation host to 
other nonlaboratory hosts. 
The following levels of biological 
containment (HV, or Host- Sector, 
systems) for prokaryotes will be 
established: specific criteria will depend 
on the organisms to be used. 
Appendix 1-I-A. HVl. A host-vector 
system which provides a moderate level 
of containment. Specific system are: 
Appendix I-l—A-1. EKl. The host is 
always E. coli K-12 or a derivative 
thereof, and the vectors include 
nonconjugative plasmids (e.g., pSClOl, 
ColEl, or derivatives thereof(7-7)) and 
variants of bacteriophage, such as 
lambda(5-/5). The E. coli K-12 hosts 
shall not contain conjugation-proficient 
plasmids, whether autonomous or 
integrated, or generalized transducing 
phages. 
Appendix l-l-A-2. Other HVl. Hosts 
and vectors shall be, at a minimum, 
comparable in containment to E. coli K- 
12 with a non conjugative plasmid or 
bacteriophage vector. The data to be 
considered and a mechanism for 
approval of such HVl systems are 
described below (Appendix I— II). 
Appendix I-I-B. HV2. These are host- 
vector systems shown to provide a high 
level of biological containment as 
demonstrated by data from suitable 
tests performed in the laboratory. 
Excape of the recombinant DNA either 
via survival of the organisms or via 
transmission of recombinant INA to 
other organisms should be less than 
Vio G58 under specified conditions. 
Specific systems are: 
Appendix 1-I-B-l. For EK2 host- 
vector systems in which the vector is a 
plasmid, no more than one in 10* host 
cells should be able to perpetuate a 
cloned DNA fragment under the 
specified nonpermissive laboratory 
conditions designed to represent the 
natural environment, either by survival 
of the original host or as a consequences 
[ 283 ] 
