HELIOS JOSEPH HERNANDEZ, II 
Si a / .-/aw 
888 N. MAIN STREET, SUITE 417 
SANTA ANA, CALIF. 92701 
TELEPHONE (714) 558-0365 
Sept. 25, 1978 
Joseph G. Perpich, M.D., J.D. 
Assoc. Director for Program Planning and Evaluation 
National Institutes of Health 
Building 1, Room 137 
Bethesda, Md. 20014 
Dear Joe: 
My overall impression of the NIH Guidelines for Recombinant 
DNA Research is very favorable. They are an appropriate response 
to a difficult situation. As Federal regulations go, the Guidelines 
are brief and readable. My comments follow, and although they 
may seem critical, I want to emphasize that the vast majority of 
Guidelines are well done. 
I . SCOPE ? 
Section I.C., third paragraph is not clear. I suggest that you 
insert here the paragraph from page 33045, middle column, second 
full paragraph. Part IV of the July 28, 1978 Federal Register. 
Section I.D. and I.E. are confusing. I.D. contains some 
exemptions which are identified as exceptions and I.E. contains 
exemptions. These two sections should be reorganized. Also, I 
think this is the place for a statement on risk assessment 
experiments. Further, there should be a statement here on experiments 
not explicitly covered by the Guidelines. In such cases the Director, 
after receiving appropriate advice, allow or disallow such experi- 
ments. If the experiment (s) is allowed, the Director should be 
empowered to set such conditions as are deemed appropriate. 
II. CONTAINMENT 
Section II. B. which states physical containment requirements 
is too wordy. For example, at P3 containment the requirements are 
all PI and P2 requirements plus additional P3 requirements. The 
P3 requirements must, of course, be specified. There is no need to 
repeate those for PI and P2 since they appear immediately before 
the subsection on P3 requirements. 
Section II. C. should specify record keeping requirements. 
[A-385] 
