STATE OF CALIFORNIA— HEALTH AND WELFARE AGENCY 
EDMUND G. BROWN JR., Coverno 
714/744 P STREET 
SACRAMENTO, CA 95814 
DEPARTMENT OF HEALTH SERVICES 
(916) 445-1248 
September 18, 1978 
Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Sir: 
These comments are directed to the proposed guidelines for Recombinant DNA 
Research as printed in the Federal Register of July 28, 1978. 
The California Department of Health Services considers these guidelines 
unsatisfactory in five areas. 
1. The proposed guidelines as presently constituted fail to embody emer- 
gency or other intervention plans to involve state health agencies in 
minimizing any health risks which may attend to any noncompliance, par- 
ticularly 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. (Section IV-A-4-h) 
Recommendation 
Require that any research which is found to be out of compliance with 
NIH be reported to the California Department of Health Services or a 
local representative; and that any release of recombinant organisms, 
regardless of presumptive nonpathogenicity, be reported to the proper 
health authorities. 
2. As presently drafted, the Guidelines lack specificity in establishing 
the conditions for minimizing risks once an accident has occurred. 
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. 
[A-166] 
