Federal Register / Vol. 45, No. 12 / Thursday, January 17, 1980 / Notices 
3555 
reduced risks the biology of extremely 
pathogenic and virulent viruses.” 
I-D. Amendment of Section 1-D of the 
Guidelines 
The following notice appeared in the 
Federal Register on November 1, 1979: 
"The NIAID Risk-Assessment Working 
Group has proposed a major change to 
the NIH Recombinant DNA Guidelines 
that will broaden the field of 
Investigations of risk assessment studies 
and will accelerate the process by which 
such studies will be carried out. At the 
present time, experiments allowable 
under the Guidelines are basically 
restricted to the use of DNA from non- 
pathogenic organisms which are 
propagated in host organisms that 
possess at least a moderate degree of 
biological containment. Experiments 
which involve genes for the biosynthesis 
of toxins potent for vertebrates, DNA 
from class 3, 4, and 5 pathogens, and 
DNA from plant pathogens. that may 
increase virulence or host range are 
specifically prohibited by the Guidelines 
as are experiments which may involve 
'wild type' host-vector systems: The 
design of risk assessment studies which 
now may be classified as allowable 
experiments may skew the studies 
toward negative results because of the 
absence of moieties which may confer 
hazardous qualities. Also, the results of 
such experiments may not allow 
extrapolation to assess risks of 
recombinant DNA experiments that may 
involve organisms which possess 
intrinsic hazardous qualities such as 
infectious microorganisms. On the other 
hand, it should be possible to measure 
more precisely the potential risk of 
recombinant DNA technology if 
experiments which fall within the 
prohibited categories were encouraged 
and carried out. While such experiments 
can be excepted from the prohibitions, 
the long process for granting exceptions 
discourages innovative research in the 
prohibited areas. The following major 
change is therefore recommended to 
encourage and stimulate relevant risk 
assessment studies that may lead to a 
more precise understanding of the 
potential hazards associated with 
recombinant DNA technology. The 
specific proposed change to the 
Guidelines is to add the following 
paragraph to the end of Section I-D: 
Experiments in Categories I-D-l, I-D-2, 
I-D-3. 1-D-5, and experiments involving 
'wild type' host-vector systems are 
excepted from the prohibitions provided 
that these experiments are designed for 
risk assessment purposes and are 
conducted within the NIH high 
containment facilities located in 
Building 41-T on the Bethesda campus 
and in Building 550 located at the 
Frederick Cancer Research Center. The 
selection of laboratory practices and 
containment equipment tor such 
experiments shall be approved by 
ORDA following consultation with the 
RAC Risk Assessment Subcommittee 
and the NIH Biosafety Committee.” 
No comments were received during 
the 30-day comment period. 
At the December 6-7, 1979, RAC 
meeting the importance of risk- 
assessment experiments was discussed. 
It was pointed out that acceptance of 
the proposed text to be added to the 
Guidelines could accelerate approval 
procedures for this class of risk- 
assessment experiments. 
It was suggested that the text 
proposed for addition to the Guidelines 
be modified to delete reference to 
category I-D-5, i.e., experiments 
involving “deliberate transfer of a drug 
resistance trait . . On the other hand, 
a number of RAC members spoke of the 
importance of retaining category I-D-5 
within the paragraph to be added, since 
valuable information might be learned 
about the mechanisms of antibiotic 
resistance. A motion to delete reference 
about category I-D-5 from the 
paragraph to be added to the Guidelines 
failed by a vote of 3 in favor, 13 
opposed, with 3 abstentions. 
In addition to the text to be added to 
the Guidelines as proposed in the 
Federal Register on November 1, 1979, 
additional text was suggested at the 
RAC meeting, dealing with notification 
of RAC members, and with destruction 
of clones. 
At the conclusion of the discussion, 
the RAC recommended by a vote of 17 
in favor, 1 opposed, with no abstentions 
that the following text be added at the 
end of Section I-D of the Guidelines: 
“Experiments in Categories I-D-l. I- 
D-2, I-D-3, I-D-5, and experiments 
involving 'wild type’ host-vector systems 
are excepted from the prohibitions, 
provided that these experiments are 
designed for risk-assessment purposes 
and are conducted within the NIH high 
containment facilities located in 
Building 41-T on the Bethesda campus 
and in Building 550 located at the 
Frederick Cancer Research Center. The 
selection of laboratory practices and 
containment equipment for such 
experiments shall be approved by 
ORDA following consultation with the 
RAC Risk-Assessment Subcommittee 
and the NIH Biosafety Committee. 
ORDA shall inform RAC members of the 
proposed risk-assessment projects at the 
same time it seeks consultation.from the 
RAC Risk-Assessment Subcommittee 
and the NIH Biosafety Committee. If a 
major biohazard is determined, the 
clones will be destroyed after the 
completion of the experiment rather 
than retaining them in the high 
containment facility. Other clones that 
are non-hazardous or not of major 
hazard will be retained in the high 
containment. 
I accept this recommendation and am 
today adding this text to the Guidelines. 
The importance of risk-assessment 
experiments has been discussed 
previously in detail. [See "NIH Program 
to Assess the Risks of Recombinant 
DNA Research; Final Plan" (Federal 
Register, September 13, 1979)). 
P4 physical containment consists of 
Laboratory Practices (Section II/B-4-a 
of the Guidelines), Containment 
Equipment (Section II-B-4-b of the 
Guidelines), and Special Laboratory 
Design (Section II-B-4-c of the 
Guidelines). The high containment 
facilities located in Building 41-T on the 
Bethesda campus and in Building 550 at 
the Frederick Cancer Research Center 
meet the P4 Special Laboratory Design 
requirements of Section II-B-4-c. (The 
great protection afforded by such P4 
laboratory design is discussed in the 
Environmental Impact Statement on the 
1976 Guidelines, and in the NIH 
Laboratory Safety Monograph.) For risk- 
assessment experiments to be 
conducted in these facilities, laboratory 
practices and containment procedures 
may be approved (by ORDA following a 
procedure specified above) which do not 
necessarily meet all the requirements of 
P4. ORDA will not approve selection of 
laboratory practices or containment 
equipment that presents a significant 
risk to health or the environment. The 
decision as to whether or not clones will 
be destroyed after completion of these 
experiments will be made by ORDA. 
II. Summary of Major Actions Under 
Guidelines 
II- A. Amendment of Sections II1-B-2, 
III- C-5, and 1II-C-6 of the Guidelines 
Sections III— B— 2, III-C-5, and III— C— 6 
of the Guidelines are amended to 
change the words “* * * may be 
inserted into a lambdoid phage vector or 
into a vector from a certified EK2 host- 
vector system and propagated * * *" to 
"* * * may be inserted into a vector and 
propagated.* * *” 
II — B. Transfer of Cloned Segments of 
Anabaena DNA Into Klebsiella 
Permission is granted to transfer 
certain cloned segments of Anabaena 
DNA into Klebsiella, at P2 physical 
containment. 
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