212 • Impacts of Applied Genetics — Micro-Organisms, Plants, and Animals 
essarily considered to be more qualified to make 
decisions concerning social values than other 
well-informed persons; they may in fact be less 
qualified when the decision involves possible 
restrictions on scientific research because of the 
IconliniK'd from p. 211) 
'Alvin \V. VVninIxM'f', "Scitxirc and Irans-ScifMici!,'' MinorvH, 
10:2, April li)72. 
^Allan Mazur, Oisputes Between Kxpei ts,” Minerva 11:2, April 
1973. 
"Arthur Kanti-owitz, "The Science Court Experiment," Juri- 
metrics Journal, vol. 17, 1977, p. 332. 
“David E. Bazelon, "Risk and Responsibility," Science, vol. 205, 
July 20, 1979, pp. 277-280. 
high value they place on unrestricted research 
and because of possible conflicts of interest. 
Moreover, according to this view, if society is to 
bear a risk, it should judge the acceptability of 
that risk and give its informed consent to it.^* 
^Engelhard!, op.cil.; Eowi'ance, op.cit.: and Bazelon, op. cit. 
•In practice, it may olten be diUicult to keep the two kiiuls of 
decisions separate, since the values of indix idual scientists may in- 
fluence their interpi-etation of technical data, and since policy- 
makers may not have the technical competence to understand the 
I’isks sufficiently." 
"Weinberg, op. cit.: and Bazelon, op. cit. 
Current regulation: the NIH Guidelines 
The Guidelines have been developing in 
stages over a period of approximately 6 years as 
scientists and policymakers have grappled with 
the risks posed by rDNA techniques. (This his- 
tory, discussed in app. III-A, is crucial to under- 
standing current regulatory issues, and it serves 
as a basis for evaluating the Guidelines.) They 
represent the only Federal oversight mecha- 
nism that specifically addresses genetic engi- 
neering. 
Substantive requirements 
The Guidelines apply to all research involving 
rDNA molecules in the United States or its ter- 
ritories conducted at or sponsored by any in- 
stitution receiving any support for rDNA re- 
search from NIH. Six types of experiments are 
specifically prohibitedi) 1) the formation of 
rDNA derived from certain pathogenic orga- 
nisms; 2) the formation of rDNA containing 
genes that make vertebrate toxins; 3) the use of 
the rDNA techniques to create certain plant 
pathogens; 4) transference of drug resistance 
traits to micro-organisms that cause disease in 
humans, animals, or plants; 5) the deliberate 
release of any organism containing rDNA into 
the environment; and 6) experiments using 
more than 10 liters (1) of culture unless the 
rDNA is “rigorously characterized and the 
absence of harmful sequences established.’^ A 
procedure is specified for obtaining exceptions 
from these prohibitions. Five types of experi- 
ments are completely exempt. 
Those experiments that are neithffr prohib- 
ited nor exempt must he carried on in ac- 
cordance with physical and biological contain- 
ment levels that relate to the degree of potential 
hazard. (See table 33.) Physical containment re- 
quires methods and eciuipment that Ufssen the 
chances that a recombinant organism might es- 
cape. Four levels, designated FI for thi^ k’ast 
restrictive through F4 for the most, are defined. 
Biological containment recjuires working witli 
weakened organisms that are unlikedy to sur- 
vive any escape from the laboratory, three 
levels are specified. Glasses of pcMinitted e.x- 
periments are assigned l)oth |)hysical and bio- 
logical containment levels. Most experiments 
using Escherichia coli K-12, th(^ standard lal)ora- 
tory bacterium used in appro.ximately «() per- 
cent of all exjjeriments co\(!red by the (Guide- 
lines, may be perfornuHl at tlu* low(‘st contain- 
ment levels. 
AIIMINISTHA'I I(>\ 
The Guidelines pi'o\ ide an administrativ r 
framework foi' implementation that specifies 
the roles and I’esponsihilities of the scientists, 
their institutions, and the I'ederal Government. 
The parties who are crucial to the effective 
operation of the system are: 1) the Director ol 
NIH, 2) the NIH Hecomhinant D.VA Advisory 
Committee (RA(3, 3) the Mil Office ol Itecomhi 
