Dr. Donald S. Fredrickson 
September 23, 1978 
Page 11 
19. Section IV. Roles and Responsibilities (p.33084-33087). I believe this 
section has been thoroughly thought out and clearly written. I wholeheartedly 
support the concept that an institution receiving NIH funds should be responsible 
for adherence to the Guidelines even when recombinant DNA research at that in- 
stitution is not necessarily supported by NIH funds. I also believe that greater 
reliance needs to be placed on the Institutional Biosafety Committee and the pro- 
posals contained in Section IV will both better facilitate the research and result 
in better adherence to the Guidelines because of greater local responsibility. I 
also think that the insistence on a biological safety officer for institutions con 
ducting P3 and P4 level research is a wise decision which I fully support. 
20. Section V. Footnotes and References (p.33087-33089). Most comments I had per 
taining to this section have been given above. I should note in reference to foot 
note 1 and Appendix B to the Proposed Revised Guidelines (p.33089-33090) that the 
current listing of etiologic agents is incomplete and in some respects inaccurate. 
For example, under fungal agents that are Class 2 agents, one finds Actinomycetes 
which first of all are bacteria, not fungi. Furthermore, the term "Actinomycetes" 
is a group designation which includes among its eight families the genera 
Actinomyces , Nocardia , Streptomyces and Mycobacterium and all of these are then 
classified as Class 2 agents. Since most species of Streptomyces and many of 
Nocardia and Mycobacterium are harmless soil bacteria, I hope the revision of 
the list of etiologic agents will rectify these problems and errors. I might 
also note that Rickettsia and Chlamydia are obligate intracellular bacterial para- 
sites and not viral agents and should thus be classified under the bacteria. 
21. In view of my comments concerning biological containment of the E_. col i K-12 
host-vector systems and the large difference between the containment, and in some 
instances utility, provided by EK1 vs EK2 systems, it might be worthwhile for NIH 
to reconsider Dr. Waclaw Szybal ski's suggestion of several years ago to specify 
EK1.5 systems. In this regard, we have a reasonable number of well characterized 
strains already in our collection that should, in conjunction with nonconjugative 
plasmid vectors, satisfy anticipated requirements for such an EK1.5 level of bio- 
logical containment. 
Although my comments have been numerous and lengthy, I wish to reiterate my en- 
thusiastic support for adoption of the Proposed Revised Guidelines for Recombinant 
DNA Research following refinement and/or reconsideration based on comments I and 
others have made. If I can provide any additional information or advice, I would 
be pleased to do so. 
RCIII/pp 
Enclosures 
[A-318] 
