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Appendix A 
PACKAGING AND SHIPPING OF RECOMBINANT DNA 
MATERIALS 
A- Introduction. Federal regulations and 
carrier tariffs have been promulgated to en- 
sure the safe transport of hazardous biologi- 
cal materials. The NIH Guidelines specify 
that all recombinant DNA materials will be 
packaged and shipped In containers that 
meet the requirements of these regulations 
and carrier tariffs. 
B. Packaging of recombinant DNA mole- 
cules. Recombinant DNA molecules shall be 
packaged to withstand leakage of contents, 
shocks, pressure changes, and other condi- 
tions Incident to ordinary handling In trans- 
portation. 
C. Packaging of host and vector organisms 
containing recombinant DNA molecules. 1. 
Volume less than 50 ml. Material shall be 
placed In a securely closed, watertight con- 
tainer (primary container (test tube, vial, 
etc.) ) which shall be enclosed In a second, 
durable watertight container (secondary con- 
tainer). Several primary containers may be 
enclosed In a single secondary container, II 
the total volume of all the primary contain- 
ers so enclosed does not exceed 50 ml. The 
space at the top, bottom, and sides between 
the primary and secondary containers shall 
contain sufficient nonparticulate 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, cardboard, wood, or other mate- 
rial of equivalent strength. 
FEDERAL REGISTER, VOL 42, NO. 187— TUESDAY, SEPTEMBER 
If dry Ice Is used as a refrigerant. It must be 
placed outside the secondary cpntalner(s). 
Descrlptlcns of this packaging method are 
given In Table I (see page A-7) . 
2. Volumes of 50 ml. or greater. Material 
shall be placed In a securely closed, water- 
tight container (primary container) which 
shall be enclosed In a second, durable water- 
tight 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 container. The space 
at the top, bottom, and sides between the 
primary and secondary containers shall con- 
tain sufficient non-partlculate absorbent ma- 
terial 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 corru- 
gated flberboard. cardboard, wood, or other 
material of equivalent strength. A shock ab- 
sorbent material, in volume at least equal to 
that of the absorbent material between the 
primary and secondary containers, shall be 
placed at the top, bottom, and sides between 
the secondary container and the outer ship- 
ping container. Not more than eight second- 
ary shipping containers may be enclosed In 
a single outer shipping container. (The maxi- 
mum amount of materials which may be en- 
closed within a single outer shipping con- 
tained 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 
6hock absorbent material shall be placed so 
that the secondary container does not Be- 
come loose Inside the outer shipping con- 
tainer as the dry Ice sublimates. 
Descriptions of packages which comply 
with the regulations of the Department of 
Transportation (DOT) are given in Table II 
(see page A-8). 
D. Labeling of packages containing host 
and vector organisms which contain recom- 
binant DNA molecules. Material data forms, 
leters, and other information Identifying or 
describing the material should be placed 
around the outside of the secondary con- 
tainer. The label for Etlologlc Agents/Blo- 
medlcal Material must be affixed to the outer 
shipping container. This label Is described 
In paragraph (c) (4) of 42 CFR 72.25. In ad- 
dition, If the materials to be shipped con- 
tain any portion of a plant pest (plant patho- 
gens) which Is so defined by the Department 
of Agriculture (USDA), the outer shipping 
container shall have affixed to It the shipping 
label furnished by the USDA as part of the 
General, Courtesy, or Special Permits re- 
quired for research with and shipment of 
such agents. 
E. Additional shipping requirements and 
limitations for host and vector organisms 
which contain recombinant DNA molecules . — 
1. Domestic transportation. Civil Aeronautics 
Board Rule No. 82 (Air Transport Association 
Restricted Articles Tariff 6-D) requires that 
a Shipper’s Certificate, depicted below, be 
completed and affixed to all shipments which 
bear the Etlologlc Agent/Blomedlcal Mate- 
rials label required under the provisions of 
the Interstate Quarantine regulations (42 
CFR 72.25(c) ) . The Certificate must be com- 
pleted in duplicate and affixed to the outer 
shipping container. 
27, 1977 
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