Dr 
William Gartland 
2 
those for retroviruses on page I1I-7. Note that page III-7 does answer 
the question for retroviruses but not for DNA viruses. 
Also, what does free from infection mean? Free from all testable 
bacterial and viral infections? Or something more limited? Biohazards 
committees will need more guidance on thi3. 
Page II1-8, first full sentence. Some of these submissions may well 
be rather trivial. Perhaps then somewhat more flexibility shouLd be put 
into the procedures for guidance to avoid unnecessary work by both the 
Office, the Committee, and the Director. 
Page III-13, c.(l): The wording specifically omits purification by 
prior cloning, yet currently this is one of the best and most effective 
ways to purify. 
Page III-16, 3a: Sentence beginning "Also, a recombinant...." is 
unclear as to intent. 
Page IH-21, ( 2 ) ( b) ( i i) . . . of the three conditions in (ii) tne final 
one "previously cloned etc" omits certain ways of purifying the segment 
that are really just as satisfactory as cloning in a prokaryotic system 
or under P4 . One of these is chemical synthesis, such as the somatostatin 
situation (note that the wording here seems inconsistent with (b) on page 
III-18, line 17). Another method is cloning by nature in natural recom- 
binants between 3V40 or Adeno and host DNA. A fourth would be highly 
purified repetitive eukaryote DNA which can be purified by restriction 
digestion and electrophoretic separation. 
Section IV Roles and Responsibilities 
Page IV-6 and -7. The reasons for adding the requirement for an 
institutional biological safety officer are not made clear either in the 
Guidelines or in the Draft "Comparison" document. Without some compelling 
reasons, which do not occur to me, I believe that this added complexity is 
not warranted. While large institutions may wish to have such an individual 
to support the work of the Biohazards Committees, it will be quite a burden 
in smaller institutions. Further, it seems to me that each Institution, 
large and small, is in a better position than the NIH to develop operating 
procedures for itself. For example, different members of the Institutional 
Biohazards Committees might be appointed responsibility for the various 
individual tasks given the Safety Officer here. Inevitably, there will 
be added levels of review and paper work with the suggested system not to 
mention the unfortunate idea of a "policeman". I recommend omitting this 
requirement, or at the most, making it an optional suggestion. 
Page IV-9, E. (c): Memorandum of Understanding and Agreement is not 
defined. This is the first and only time the expression is used in the 
revised Guidelines. 
[Appendix A — 30] 
