STATE OF CALIFORNIA— HEALTH AND WELFARE AGENCY 
EDMUND G. BROWN JR., Govemt 
DEPARTMENT OF HEALTH SERVICES 
714/744 P STREET 
SACRAMENTO, CA 95814 
(916) 445-8706 
August 24, 1978 
Dr. Donald S. Fredrickson, Director 
National Institute of Health 
9000 Rockville Pike 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
Thank you for inviting comment from members of the public on the newly 
revised NIH Guidelines for Recombinant DNA Research, as they appeared 
in the July 28, 1978 Federal Register. 
I am writing in my capacity as a public health official, but my views 
do not necessarily reflect those of the California Department of Health 
Services which is preparing a formal response from the Department to be 
sent under separate cover. 
My response bridges three areas: Administrative, Procedural and Sub- 
stantive. In general, I find the document reflects a thoroughness in 
scientific review of research objectives which might be safely met 
which is not found in the treatment of the public health Implications 
of the same work. 
1 . Administrative Concerns 
A. I would like to have seen a greater Involvement of 0SHA and EPA in 
the review of the research protocols in relevant classes of research, 
i.e., those which pose potential occupational hazards or environ- 
mental problems on the basis of research design and strategy. For 
instance, the proposed Guidelines only specify that the requirements 
of the National Environmental Policy Act be "considered" as a pre- 
condition for a waiver for environmental release of recombinant 
organisms. 
1 ) Recommendation 
I would like to see much stronger language requiring compliance 
with NEPA, with the notation that any additional safeguards to 
be stipulated by EPA are to be honored. 
B. I find the present document seriously remiss in not acknowledging the 
priority of local health departments in determining whether or not 
[A-42] 
