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Several commentators were concerned about the adequacy of the 
inspection, certification, and surveillance processes to insure compliance 
with the NIH Guidelines [20, 29]. One thought that NIH staff should perform 
site inspections of P3 as well as P4 facilities and recommended that NIH 
consider cooperative Federal -State inspection capabilities [20]. 
Many aspects of the "Roles and Responsibilities" Section (IV) of 
the NIH Guidelines address the issues relating to inspection, certification, 
and surveillance. These roles and responsibilities are shared among 
the principal investigator, the institution, and NIH. The investigator 
is responsible for supervising safety performance at the bench level, 
and for reporting to the institution and to NIH (a) new information bearing 
on Guidelines, hazards, or safety procedures, (b) evidence of serious 
and extended illness among staff or serious accidental exposure to staff 
or environment, and (c) any problems pertaining to operation and 
implementation of biological- and physical -containment requirements. 
The NIH Guidelines require the institution to see that the responsibilities 
of the principal investigator are carried out. They also require the 
institution to establish an Institutional Biohazards Committee which, 
among other responsibilities, shall certify that facilities, procedures, 
practices, training, and expertise of involved personnel are adequate 
for the safe conduct of NIH-sponsored research and that they comply 
with the NIH Guidelines. 
Because of the different administrative schemes used by institutions 
engaged in recombinant DNA research, it is impossible to make specific 
rules guaranteeing the best method to provide institutional certification 
and surveillance of this work. NIH, however, is developing general 
guidelines for Institutional Biohazards Committees which will recommend 
several approaches for providing certification and surveillance. In 
this regard, recognition will be given to the significant role that environ- 
mental health and safety professionals can perform in providing support 
to the researcher and informing management on issues relating to 
compliance. 
NIH does not plan to routinely inspect P3 facilities. The safety 
aspects of such facilities can be adequately certified by institutional 
authorities and verified by review of the research application and 
supporting documentation. NIH will, however, conduct site inspection 
of all P4 facilities in which NIH-supported recombinant DNA research 
is to be performed. Inspection protocols and recommendations con- 
cerning frequency of site inspections are being developed by NIH staff. 
NIH is not considering the delegation to State or local authorities of 
on-site inspection of P4 facilities in which NIH-supported recombinant 
DNA research is to be conducted. 
