DNA/6 
tion . Proposals for exemptions should be published in the Federal 
Register along with notice of where background documents can be ob- 
tained. There should be a minimum 30-day public comment period. 
Containment 
II-A. This section admits that individuals engaged in recombinant 
DNA activities should receive "adequate instruction" in good microbio- 
logical practices. Yet PRG-NIH does not require that individuals 
complete specified training courses or demonstrate a certain level 
of competence. DD-NIH (43 Fed . Reg . 33053) indicates that while the 
Director feels that certification of adequate instruction is a good 
idea, NIH does not now intend to develop formal certification require- 
ments. NIH concludes that because it currently has a contract with 
the American Society for Microbiology (ASM) to develop minimum standards 
for those engaged in recombinant DNA activities, formal certification 
requirenents at this time are premature. 
EDF disagrees with this conclusion. NIH should have targeted the 
ASM contract for completion in time for inclusion in PRG-NIH. Given 
its failure to do so, NIH should now take the steps necessary to issue 
formal certification requirements as socn as the ASM report is avail- 
able. NIH should indicate in PRG-NIH that formal certification requirements 
will be issued as soon as the ASM report is complete. ASM should 
complete- its contract at the earliest possible date. The responsibility 
for implementing the certification program should be given to the Insti- 
tutional Biosafety Committee (IBC) . 
NIH also acknowledges that all recombinant DNA experiments with 
known or potential biohazards should have an emergency plan in case 
accident. Yet PRG-NIH fails to require such a plan. NIH should 
[A— 341 ] 
