containment levels are specifically mandated 
in the 1976 Guidelines but for which some 
discretion is permitted in the proposed revision. 
The logic and justification for such discretions should be matters 
for discussion by a wide range of individuals, and not confined to 
an Advisory Committee whose composition and scope are not represen- 
tative of the various positions and perspectives on this issue. 
One of the changes without ample justification appears in the 
intoduction and concerns the defintion of recombinant DNA. While it 
may be reasonable to exclude certain recombinants which are both 
"not novel" and deemed non-hazardous , the focus must always be on 
ensuring safety, not proving or protecting non-novelty. 
In addition, the last recommendation in the Introduction, where 
it is urged that all publicaitons dealing with recombinant DNA work 
include a description of the physical and biological containment 
procedures, should be made mandatory in order to convey the absolute 
importance of adheringto these guidelines. 
II. Physical Containment 
1. The principle of physical containment, especially as it is reflected 
in the upper ' P' levels in the guidelines, is a valid measure to take 
to minimize risk. However, all of the various matrices designed to 
create escape-proof situations may go for naught if a similarly detailed 
approach to shipping of recombinant DNA organisms is not developed. At 
present, the gradations for shipping requirements relate to the volume 
of the material sent, not to its level of potential hazard. This 
approach seems inconsistent with the philosophy of physical containment 
and does not adequately address the problems of ensuring safety when 
the state of the research will be characterized by extensive use and 
wide-scale productions of recombinant DNA organisms. The new requirement 
for use of registered mail for shipping, while an improvement, does 
not answer these concerns and is based on a perhaps unwarranted con- 
fidence in the reliability of the postal system. 
2. The emphasis on development of good working practices and training 
in aseptic techniques in section A is a welcome addition. To ensure 
that such procedures do, in fact, develop, I would recommend that the 
' shoulds ' be changed to ' shalls' (regarding establishing training, 
emergency plans and immunization of workers). In addition, a grievance 
procedure could be established to help those who feel that training 
and/or lab practices are inadequate to protect health and safety. 
[Appendix A — 188] 
