10 
The full responsibility for the promulgation of the rules and regula- 
tions necessary to carry out all the sections of this act are the responsi- 
bility of the national Commission. 
The Committee believes that adequate monitoring is an important 
component of this regulatory process and believes that to be effective 
it must be carried out as a Federal responsibility. 
It is tba Committee's intention that within 150 days of enactment 
of this lvw. the existing XIH guidelines, for recombinant DXA activi- 
ties must be followed, as a minimum, by all researchers in the country, 
whether they be working for private or public institutions. Because 
it will take a longer period to set up and implement the licensing proce- 
dures. research may continue without a license until 265 days after the 
enactment of this law. After that point, no recombinant DXA activities 
may be conducted except in a licensed facility. 
The Committee believes the 265-day period permitted for DXA ac- 
tivities to continue without a license is sufficient time for the Commis- 
sion to review and act upon applications for licenses for existing 
activities. The Committee believes that the Commission should develop 
practices and procedures to enable it to review new applications 
promptly and fairly in the order they are received so that no unneces- 
sary delay will be imposed in the licensing of DXA activities. 
The Committee believes that the recombinant DXA research guide- 
lines of XIH. as of the date of enactment of this law. are a fine begin- 
ning point for the Xational Commission in its attempt to study and 
develop physical and biological containment requirements for recom- 
binant DXA activities. Thus, the first set of regulations to be promul- 
gated by the Xational Commission may be no less stringent than the 
requirements. 
III. Institutional Bio-Hazai'd Review Committees 
It is the Committee's intent that no licenses be issued to any recom- 
binant DXA research facility unless there is an Institutional Bio- 
Hazards Review Committee affiliated with the facility. This Institu- 
tional Bio-Hazards Review Committee represents another point where 
representatives of the general public can play an important role. It 
is the Committee's intent, through the mandated requirements for 
public participation on the Bio-Hazards Review Committees, to foster 
continuing discussion between scientists and representatives of the 
general public. Thus, the Committee believes that at least one-third of 
the total members of each Institutional Bio-Hazards Review Commit- 
tee must be individuals who are not and have never been professionally 
engaged in biologic research. The Committee believes at least another 
of the members should be employees of the owners and operators of 
the facility who are qualified to provide a diversity of viewpoints 
relevant to recombinant DXA activities and technology, biolosic safety 
and engineering, and bio-hazard monitoring. It is not intended to ex- 
clude anv category of employees from participation on Bio-Hazards 
Review Committees or in any way to limit participation to those en- 
gaged in recombinant DXA activities. The Committee leaves it to the 
local institution to determine the composition of the rest of the mem- 
ber? of the Bio-Hazards Review Committee. 
The Committee wishes to point out that several facilities may be 
served by the Bio-Hazards Review Committee if the facilities are part 
of a single institution. 
[ 750 ] 
