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Recommendations : 
1. Requirements for data collection and record-keeping in a 
unified manner should be mandatory. This will obviously allow for 
easier accumulation and analysis. 
2. Encourage and support epidemiological studies of recom- 
binant DNA laboratories to develop the information needed to make 
decisions on the basis of experimental data. 
3. Carry out an assessment in a year or two to see if a cen- 
tralized collection of this data is required. 
Institutional Biohazard Committees 
The NIH has delegated considerable authority to the institu- 
tional biohazards committees (IBC) : 
1. to allow research to proceed prior to NIH approval on 
changes in P-1 through P-3 protocols. 
a. This policy will lead to confusion and discrepancies 
between institutions. Approximately 10-15% of all 
MUAs are disapproved by the NIH on non-trivial grounds. 
This creates ample opportunity for problems. Recent 
conversations with ORDA indicate that processing of 
MUAs is down to 24-48 hours. 
Recommendation: Require NIH approval on non-trivial changes on 
P-2 through P-4. If significant delays develop, hire more staff; 
fund less research. (one staff person worth) 
2. to approve for single step reductions in containment levels 
for experiments with purified DNA and characterized clones. 
a. authority for single step reductions in containment 
levels, as well as the previous provision, will lead 
to a patchwork of local regulation which was decried 
by the scientific community in regards to federal pre- 
emption of stricter standards, but is apparently wel- 
comed for lowering them. Furthermore, there is no 
requirement that these fully "characterized clones or 
purified DNA" be safer. 
Recommendation: Prior approval by the NIH should be required on 
P-2 through P-4 protocols and only granted on the basis of proven 
safety (ie. no significant risk). The function of the insert as 
well as its quantitative purity should be taken into account. 
3. to "review and oversee" all recombinant DNA projects 
because of the "impossibility of Federal surveillance to 
enforce these standards externally, and because it is an 
"effective and relatively inexpensive administrative 
mechanism . " 
a. It is the above sections which underlies the basis for 
our concern about the whole regulatory approach that 
the NIH has developed. The last year has shown that 
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