9 
experimental foundation. The British Genetic Manipulation Advisory Group has 
declared about this assumption that: 
we have reservations about the implied proposition (which is, of course, 
central both to the UK and NIH guidelines) that hazards are necessarily 
less with nucleic acids from evolutionarily more distantly related 
sources. It has, for example, been argued that for many genes, such as 
those for histones or actin, there has been conservation over a wide evo- 
lutionary span, so that if such a gene were cloned any hazard its growth 
might pose would be the same whatever species was the source of the nucle- 
ic acid. [First Report of the Genetic Manipulation Advisory Group, p. 11 
(May 1978).] 
There is simply no reason to warrant a relaxation of the guidelines at the 
present time. A systematic program of risk assessment experimentation must be 
conducted upon which to base any loosening of containment standards. This is 
the only rational approach to establishing safeguards, and it is nothing more 
than what is mandated in the Charter of the Recombinant DNA Advisory Committee. 
Specific recommendations 
1. Risk assessment . There should be a requirement in the regulations for 
adequate risk assessment prior to any determinations on exemptions from the 
regulations, exceptions to prohibitions (unless the exception is itself for 
risk assessment research), and certification of all host-vector systems. 
2. Higher containment . There should be provisions for higher contain- 
ment, new prohibitions, and the revocation of exemptions and exceptions to pro- 
hibitions. As currently written, the proposed revisions have no procedures for 
acting should previously unperceived hazards arise or become apparent, except 
for the second paragraph of Part III and Section II-D-2-a, which provides for 
the rescinding of host- vector certification. Not only should there be a provi- 
sion to cure this oversight, but it should provide for the prompt response to 
petitions. The following is a suggestion for such a provision: 
When information develops or circumstances indicate that permitted experi- 
ments have risks not previously recognized, such experiments may be pro- 
hibited or required to be performed at higher containment levels, notwith- 
standing any other provisions in these regulations. The Director may at 
[A-240] 
