Director 
Office of Recombinant DNA Activities 
November 15, 1977 
Page three 
minimum quality assurance standards are maintained. 
In that light, ASMT suggests that the adoption of 
previously established standards for laboratory 
personnel prescribed under Title VIII of the 
Social Security Act and the Clinical Laboratory 
Improvement Act of 1967 would serve to provide a 
consistent HEW regulatory approach. 
4. ASMT recommends the acceptance of requirements for 
containment at the P4 and P3 level of research as 
previously defined in the NIH guidelines issues in 
July 1976. We take this position because it is 
clear that serious questions have yet to be satis- 
factorily answered regarding the manipulation of 
DNA molecules into various host cells which could 
result in converting that host cell into a dangerous 
pathogen, or transfer that genetic material to other 
healthy bacteria and transform them into pathogens. 
5. ASMT suggests that the proposed change in defining 
recombinant DNA activities which would be limited to • 
"novel" organisms only, fails to recognize the 
potential risks which may arise through the use of 
other host cells. The real question is not whether 
the organism is novel, but whether it is safe. 
In summary, ASMT would hope that the NIH enact appropriate 
guidelines regulating recombinant DNA research, cognizant that 
premature lienency in restrictions over research can result in 
unnecessary potential risks to the public health safety. 
■ • 
Sincerely, 
L' Nora Cross Wells 
President 
LCW/kay 
[Appendix A — 72] 
