13 
Current Federal Regulation of Research 
ORIGIN AND PROVISIONS OF THE NIII GUIDELINES 
Research with recombinant DNA molecules has been subject to vol- 
untary or involuntary restrictions almost from its inception approxi- 
mately 5 years ago. Participants ‘in the 1973 Gordon Conference on 
Nucleic Acids raised the possibility that some experiments could be 
hazardous and urged the National Academy of Sciences to create a 
study group to recommend guidelines or other appropriate action. 
The following year the NAS committee proposed that scientists vol- 
untarily “defer” certain experiments that might, indirectly, encourage 
the spread of antibiotic resistance, toxin formation, and cancer-causing 
or other animal viruses. Other recommendations of the committee led 
to the creation of the NIH Recombinant DNA Molecule Program Ad- 
visory Committee in 1974 and to an international meeting of scientists 
and others at Asilomar, Calif., in February 1975. 
The consensus at Asilomar was that most of the contemplated work 
with recombinant DNA should proceed but that precautionary meas- 
ures should be used to minimize the spread of artificial recombinant 
DNA’s in human populations or other nonlaboratory environments. 
From the publication of the Asilomar report in May 1975 until June 
1976, the conference recommendations guided NIH-supported investi- 
gators and, apparently, were observed by scientists throughout the 
world. In the meantime, the NIH Recombinant Advisory Committee 
proceeded to draft a more detailed set of guidelines to govern NIH 
research projects. The Director of NIH issued these standards on 
June 23, 1976, and they were published in the Federal Register of 
Julv 7. 
The National Science Foundation, Department of Agriculture, and 
other Federal agencies subsequently agreed to applv them to their own 
grantees or in-house research activities. Other nations followed suit. 
British guidelines were announced in August 1976 a^cl Canadian 
guidelines earlv the following year. More recently, guidelines have also 
been published in France, the Federal Renublic of Germany, and the 
Soviet Union and are in preparation in other countries. According to 
a report on a recent survey bv a Federal interagency committee, some 
175 research projects are being conducted in Europe. Canada, Aus- 
tralia, Japan, and the. Soviet Union under various safety proeedures. 
most of them modeled on the NIH or United Kingdom guidelines. 
The NIH guidelines take several complementary approaches to 
preventing the spread of possiblv harmful products of recombinant 
DNA research. First, certain experiments continue to be prohibited. 
Examples are the introduction of antibiotic resistance traits to patho- 
genic organisms and the formation of recombinant molecules contain- 
ing genes for the production of dangerous toxins. Second, deliberate 
release into the environment of any organisms containing recombinant 
DNA G forbidden. Third, experiments producing more than 10 liters 
of culture containing recombinant DNA known to make harmful 
products are also banned. Fourth, permitted experiments must be con- 
ducted with procedures and equipment intended to prevent the 
escape of recombinant DNA material into the immediate or general 
[Appendix B — 273] 
