NOTICES 
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Fijura I 
A SECONDARY RESERVOIR AND FILTRATION APPARATUS 
9 
X. PACKAGING AND SHIPPING 
A. Introduction 
Federal regulations and carrier tariffs have 
been promulgated to ensure the safe trans- 
port of hazardous biological materials. The 
NIH Guidelines specify that all DNA re- 
combinant materials will be packaged and 
shipped in containers that meet the require- 
ments of these regulations and carrier tariffs. 
In addition when any portion of the recom- 
binant DNA material is derived from an 
etiologic agent listed in paragraph (c) of 42 
CFR 72.25 (which is Included at the end of 
this section, page D-85) the labeling require- 
ments in these regulations and carrier tariffs 
shall apply. 
B. Packaging of Recombinant DNA Materials 
1. Volume less than 50 ml. 
Material shall be placed in a securely 
closed, watertight container [primary con- 
tainer (test tube, vial, etc.)] which shall be 
enclosed in a second, durable watertight con- 
tainer (secondary container) . Several primary 
containers may be enclosed in a single sec- 
ondary container, if the total volume of all 
the primary 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 non- 
particulate absorbent material to absorb the 
entire contents of the primary container (s) 
in case of breakage or leakage. Each set of 
primary and secondary containers shall then 
be enclosed in an outer shipping container 
constructed of corrugated flberboard, card- 
board, wood, or other material of equivalent 
strength. 
If dry ice is used as a refrigerant, it must 
be placed outside the secondary container(s) . 
Descriptions of this packaging method are 
given in Table III. 
2. Volumes of 50 ml. or Greater. 
Material shall be placed in a securely 
closed, watertight container (primary con- 
tainer) which shall be enclosed in a second, 
durable watertight container (secondary 
container) . Single primary containers shall 
not contain more than 500 ml. of material. 
However, two or more primary containers 
whose combined volumes do not exceed 500 
ml. may be placed in a single secondary con- 
tainer. The space at the top, bottom, and 
sides between the primary and secondary 
containers shall contain sufficient non-par- 
ticulate absorbent material to absorb the en- 
tire contents of the primary container (s) in 
case of breakage or leakage. Each set of prim- 
ary and secondary containers shall then be 
enclosed in an outer shipping container con- 
structed of corrugated flberboard, cardboard, 
wood, or other material of equivalent 
strength. A shock absorbent material. In 
volume at least equal to that of the absorbent 
material between the primary and secondary 
containers, shall be placed at the top, bot- 
tom, and sides between the secondary con- 
tainer and the outer shipping container. Not 
more than eight secondary shipping con- 
tainers may be enclosed in a single outer 
shipping container. (The maximum amount 
of materials which may be enclosed within 
a single outer shipping container should not 
exceed 4,000 ml.). 
If dry ice is used as a refrigerant, it must 
be placed outside the secondary contalner(s) . 
If dry ice is used between the secondary con- 
tainer and the outer shipping container, the 
shock absorbent material shall be placed so 
that the secondary container does not become 
loose inside the outer shipping container as 
the dry ice sublimates. 
Descriptions of packages which comply 
with the regulations of the Department of 
Transportation (DOT) are given in Table TV. 
C. Labeling of Packages Containing Recom- 
binant DNA Materials 
1. Materials which do not contain any 
portion of an etiologic agent listed in para- 
graph (c) Of 42 CFR 72.25. 
Material ' data forms, letters, and other in- 
formation identifying or describing the mate- 
rial should be placed around the outside of 
the secondary container. Place only the ad- 
dress label on the outer shipping container. 
DO NOT USE THE LABEL FOR ETIOLOGIC 
AGENTS/BIOMEDICAL MATERIAL. 
2. Materials which contain any portion of 
an etiologic agent listed in paragraph (c) of 
42 CFR 72.25. 
Material data forms, letters, and other in- 
formation identifying or describing the mate- 
rial should be placed around the outside of 
the secondary container. In addition to the 
address label, the label for Etiologic Agents/ 
Biomedical Material must be affixed to the 
outer shipping container. This label is de- 
scribed in paragraph (c) (4) of 42 CFR 72.25. 
3. Materials which contain any portion of 
a plant pest (plant pathogens) which are so 
defined by the Department of Agriculture 
(USDA) . 
Material data forms, letters, and other 
information identifying or describing the 
material should be placed around the out- 
side of the secondary container. In addition 
to the address label, the shipping labels fur- 
nished by the USDA as part of the General, 
Courtesy, or Special Permits required for 
research with and shipment of such agent3 
shall be affixed to the outer shipping con- 
tainer. 
D. Additional Shipping Requirements and 
Limitations for Recombinant DNA 
Materials 
1. Domestic Transportation. 
Civil Aeronautics Board Rule No. 82 (Air 
Transport Association Restricted Articles Tar- 
iff 6-D) requires that a Shipper’s Certificate, 
depicted below, be completed and affixed to 
all shipments which bear the ETIOLOGIO 
AGENT/BIOMEDICAL MATERIALS label re- 
quired under the provisions of the Interstate 
Quarantine regulations [42 CFR Section 
72.25(c) ]. The Certificate must be completed 
In duplicate and affixed to the outer ship- 
ping container. 
FEDERAL REGISTER, VOL 41, NO. 131— WEDNESDAY, JULY 7, 1976 
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