53264 
Federal Register / Vol. 53, No. 251 / Friday, December 30. 1986 / Notices 
inactivated by the parameters 
established to operate the equipment,’* 
After review for consistency with U.S. 
Department of Agriculture practices, the 
Agricultural Research Service has 
recommended the following additional 
changes. Agaim. paragraph numbers 
refer to the original Federal Register 
announcement 
39. Add: "The containment decision 
should be consistent with the APHIS 
Regulations identifying plant pests. 7 
CFTR Parts 330 and 340. “Plant Pests. 
Introduction of Cenetically Engineered 
Organisms or Products. Final Rule." 
70. Change to read Biosafety Level 4 
Plants (BLl-P to BL4-P]." 
100. Replace sentence reading 
"Decontamination of run-off water is not 
required." with "Run-off water which 
may contain organisms from the work 
tray must be appropriately 
decontaminated." 
106b. Insert after “pollen" — “normally 
10-20 um in size" 
133a. Insert sentence. “A HEPA filter 
may be used instead of the 80-65% 
filters and dampers." 
227. Insert after “director" — “and IBCs 
at the sending and receiving institution." 
233. Add additional sections: 
"Appendix Q-0-3-B-f. Floor drains 
must be permanently capped or 
screened.” 
“Appendix Q— 11-3— B— g All perimeter 
joints and openings must be sealed to 
form an insect-proof structure. 
"Appendix Q-U-3-B-h. All access 
control doorfs) to interior work zone(s) 
must be appropriately screened (52 
mesh).” 
“Appendix Q-D-3-B-i. If a forced air 
ventilation system is provided, vents 
must be appropriately screened (52 
mesh)." 
251. Add after “laundered." — 
"Personnel will shower before exiting 
the BL3-N area and donning of personal 
street clothing." 
255. Insert after "laboratory 
director” — “and IBC chairman." 
281. Replace "Molded surgical musics 
or respirators * * *” with "Appropriate 
respirator protection * * 
268. Add — "Liquid wastes from 
shower rooms and toilets may be 
decontaminated with chemical 
disinfectants by methods shown to be 
effective.” 
270. Add — "if arthropods are used in 
the experiment or the agent under study 
can be transmitted by an arthropod, the 
doors will be appropriately screened." 
271. Delete the last half of paragraph, 
beginning with "The exhaust air 
from ‘ 
275. Add new paragraphs — "Appendix 
Q-Il-C-3-n. Exhaust air from BL3-N 
containment zone must be appropriately 
treated by filtering through a single 
HEPA filter or incinerated before 
release to the atmosphere. Double HEPA 
filtration is required if a recombinant 
DNA-containing organism is excreted in 
animals and is capable of contaminating 
the room air at a level to exceed 1x10 * 
organisms per cubic foot of exhausted 
air. A single HEPA filter must be 
installed in the inlet air ventilation 
system. Double HEPA filters are 
required in the supply air system when a 
need is identified to equip the exhaust 
system with double HEPA filters. 
Heating Ventilation Air Conditioning 
(HVAC) supply and exhaust ducts and 
filter housing must have minimal air loss 
in 20 minutes at 4" of water gauge 
pressure, or pass a halogen test with a 
leak rate less than 0.00001 cc/sec at 4" 
water gauge pressure. 
“Appendix Q— ll-C-3— o. The integrity 
of the animal room must have an air 
leak rate (decay rate) not to exceed 7% 
per minute (logarithm of pressure 
against time) over a 20-minute period at 
2" of water gauge pressure (rate of 
decrease is 0.0S" wgp/min.)." 
308. Replace "Molded surgical masks 
or respirators" with "Appropriate 
respirator protection * * 
325. Delete sentence "Heating 
Ventilation * * 
III. Proposal To Clone the Gene Coding 
for Vancomycin Resistance into 
Streptococcus Sanguis 
Sandra Handwerger. MJ3.. Beth Israel 
Medical Center. New York, has 
requested permission to clone the gene 
coding for vancomycin resistance from 
leuconostoc species into streptococcus 
sanguis via a helper plasmid system. 
These experiments are covered under 
Section III-A-2 of the NIH Guidelines 
which reads: "Deliberate transfer of a 
drug resistance trait to microorganisms 
that are not known to acquire it 
naturally, if such acquisition could 
compromise the use of the drug to 
control disease agents in humans or 
veterinary medicine or agriculture." 
IV. Proposal To Amend Appendix H of 
the NIH Guidelines 
The Federal Register of June 24. 1988 
(53 FR 23775). contained a proposal by 
the Postal Service to ban the shipment 
of all etiologic agents, or materials 
believed to contain etiologic agents, as 
defined by the Department of 
Transportation and the Department of 
Health and Human Services regulations. 
Under Appendix H of the current NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules of May 7. 
1980 (52 FR 16976). this ban could apply 
to all shipments of recombinant 
molecules contained within an organism 
or virus, regardless of whether they are 
potentially hazardous to human health. 
Such a ban could inhibit the exchange of 
scientific information. It could also 
affect the terms and conditions under 
which commercial shippers would 
transport recombinant DNA products. 
The RAC recognized the potential 
significance of this issue and referred it 
to the Definitions Subcommittee of the 
RAC. which met on December 5. 1988. 
A. Proposed Replacement of Appendix 
H 
On December 5. 1988. the Definitions 
Subcommittee of the RAC unanimously 
recommended the following replacement 
of Appendix H of the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. 
“Preamble: 
“Recombinant DNA molecules 
contained in an organism or in a viral 
genome shall be shipped under the 
appropriate requirements of the U.S. 
Public Health Service (42 CFR. Part 72), 
U.S. Department of Agriculture (9 CFR. 
subchapters D&E; 7 CFR. Part 340) and/ 
or the U.S. Department of 
Transportation (49 CFR. Part 173). For 
purposes of these Guidelines the 
following recombinant DNA molecules 
contained in an organism or in a viral 
genome shall be shipped as etiologic 
agents: (1) Those listed as class 2. 3. or 4 
agents in Appendix B: and/or (2) those 
contained in reference G-UI-2 *: and/or 
(3) those regulated as animal or plant 
pathogens or pests und'r titles 7 and 9 
CFR; or (4) host organist*'* containing 
recombinant DNA derived from those 
organisms or viral genomes. 
“Appendix H-I: 
“An illustration of one method of 
packaging and labeling of recombinant 
DNA-containing microorganisms and 
viral genomes defined as etiologic 
agents in the Premable is shown in 
Figures 1. 2. and 3. Additional 
information on packaging and shipping 
is given in the "Laboratory Safety 
Monograph-A Supplement to the NIH 
Guidelines for Recombinant DNA 
Research." available from the Office of 
Recombinant DNA Activities and in the 
Biosafety in Microbiological and 
Biomedical Laboratories. 1 
"Appendix H-II — Footnote and 
References of Appendix H 1. Biosafety 
in Microbial and Biomedical 
Laboratories, 2nd Edition. (May 1988), 
U.S. Department of Health and Human 
Services. Centers for Disease Control, 
Atlanta. Georgia 30333. and National 
Institutes of Health. Bethesda. Maryland 
20892." 
Recombinant DNA Research, Volume 13 
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