Dr. Donald S. Fredrickson 
- 2 - 
August 24, 1978 
health risks are attendant to any non-compliance, particularly that 
which results In a "spill" or otherwise exposes the population to 
potentially harmful recombinant organisms. Presently, the Guidelines 
simply require a report to the local Biosafety Committee and NIH. 
[Sec. IV-A-4-h] 
1 ) Recommendation 
Require that any research which Is found to be out of compliance 
with NIH be reported to the State Department of Health or Its 
local equivalent; and that any release of recombinant organisms, 
regardless of suspected pathogenicity, be reported to the proper 
health authorities. 
While I recognize the difficulty of a federal body mandating local 
activities, the fact that the research In question will be under 
federal aegis, means that the Federal Government must accept 
responsibility for any untoward health consequences. At a minimum, 
this requirement would reduce the Imperative felt by many states 
to establish their own conditions for regulating recombinant DNA 
research. 
2. Procedural Concerns 
A. As presently drafted, the Guidelines lack specificity In establishing 
the conditions for minimizing risks once an accident has occurred. 
1 ) Recommendation 
Include specifications for cleanup procedures to be followed should 
there be a spill or accidental release of organisms Into the environ- 
ment. Such procedural safeguards should Incorporate the suspected 
pathogenicity or hazard posed by the released organism. 
B. The Guidelines do not establish a central clearing house which would 
record and monitor the nature and kind of organisms being used In 
recombinant DNA work and collect data regarding the safety record of 
particular laboratories. 
1 ) Recormendation 
Identify an appropriate agency within NIH to maintain such data, 
Including accurate records of workers In recombinant DNA work, with 
particular regard to the Incidence and severity of possible work 
related Illness; or, require that special reporting requirements 
be met by research laboratories with their respective Biosafety 
Committees, who In turn will file reports with State or local 
agencies. 
[A-43] 
