The Enforcement Provisions of the Guidelines 
Are Inadequa^ ~~ 
The mechanisms for enforcing the Guidelines are 
not adequate to insure the high level of compliance which is 
necessary to protect the public from the hazards of recombinant 
DNA. The Guidelines rely primarily on the grantees to police 
themselves, this reliance is unrealistic. 
Primary responsibility for enforcement rests with 
the principal investigator and the biohazards committees. The 
principal investigator is responsible for evaluating the 
biohazards of the experiments, training staff and insuring that 
safety procedures are followed. The biohazards committee of 
the institution must certify to the NIH staff that the experiment 
and facility comply with the Guidelines. The NIH staff 
determines the proper containment level for individual experiments 
and evaluates compliance with the Guidelines primarily on the 
basis of documents submitted by the grantee. The NIH staff 
is responsible for some on-site inspection of facilities and 
epidemiological monitoring of workers, but it is not clear how 
thoroughly it will be able to do either. The staff of NIH is 
also required to make a number of detailed factual determinations: 
assigning containment levels, approving applications for lower 
containment levels, approving host-vector systems for biological 
containment and approving large scale experiments. The only 
sanction for non-compliance is revocation or denial of a grant. 
25 
Appendix K — 151 
